Science.gov

Sample records for recommendations draft guidance

  1. 78 FR 52777 - Draft Guidance for Industry on Bioequivalence Recommendations for Risperidone Injection...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-26

    ... on Bioequivalence Recommendations for Risperidone Injection; Availability AGENCY: Food and Drug... availability of a revised draft guidance for industry entitled ``Draft Guidance on Risperidone.'' The guidance... drug applications (ANDAs) for risperidone injection. DATES: Although you can comment on any guidance...

  2. 78 FR 66743 - Draft Guidance for Industry on Bioequivalence Recommendations for Iron Sucrose; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-06

    ... Recommendations for Iron Sucrose; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY... entitled ``Bioequivalence Recommendations for Iron Sucrose.'' The recommendations provide specific guidance... iron sucrose injection. The draft guidance is a revised version of a previously issued draft guidance...

  3. 77 FR 40068 - Draft Guidance for Industry: Recommendations for Donor Questioning, Deferral, Reentry, and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-06

    ... Questioning, Deferral, Reentry, and Product Management To Reduce the Risk of Transfusion-Transmitted Malaria...-Transmitted Malaria'' dated June 2012. The draft guidance document provides blood establishments that collect... malaria. This guidance replaces the draft guidance entitled ``Guidance for Industry: Recommendations...

  4. 78 FR 55263 - Draft Guidance for Industry on Bioequivalence Recommendations for Fluticasone Propionate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-10

    ... Recommendations for Fluticasone Propionate; Salmeterol Xinafoate; Availability AGENCY: Food and Drug... availability of a draft guidance for industry entitled ``Bioequivalence Recommendations for Fluticasone... bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for fluticasone propionate...

  5. 78 FR 70953 - Draft Guidance for Industry on Bioequivalence Recommendations for Fluticasone Propionate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-27

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Bioequivalence... Industry on Bioequivalence Recommendations for Fluticasone Propionate; Salmeterol Xinafoate'', published in... for Industry on Bioequivalence Recommendations for Fluticasone Propionate; Salmeterol...

  6. 77 FR 58399 - Draft Guidance for Industry on Bioequivalence Recommendations for Pentosan Polysulfate Sodium...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-20

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Bioequivalence Recommendations for Pentosan Polysulfate Sodium Capsule; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft...

  7. 78 FR 55727 - Draft Guidance for Industry on Recommendations for Preparation and Submission of Animal Food...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-11

    ... Preparation and Submission of Animal Food Additive Petitions; Availability AGENCY: Food and Drug... Submission of Animal Food Additive Petitions.'' This draft guidance describes the types of information that FDA's Center for Veterinary Medicine (CVM) recommends for inclusion in food additive petitions (FAPs...

  8. 75 FR 47603 - Draft Guidance for Industry and Food and Drug Administration Staff; Recommendations for Premarket...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-06

    ... HUMAN SERVICES Food and Drug Administration 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. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA...

  9. 77 FR 66621 - Draft Guidance for Industry on Bioequivalence Recommendation for Lenalidomide Capsules; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-06

    ... draft guidance, when finalized, will represent the Agency's current thinking on the design of BE studies... design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs)...

  10. 75 FR 41871 - International Conference on Harmonisation; Draft Guidance on Q4B Evaluation and Recommendation of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-19

    ... Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on... availability of a draft guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use... evaluation of the Bacterial Endotoxins Test General Chapter harmonized text from each of the...

  11. 78 FR 46965 - Draft Guidance for Industry on Bioequivalence Recommendations for Mesalamine Rectal Suppositories...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-02

    ... applications (ANDAs) for mesalamine rectal suppositories. The draft guidance is a revised version of a..., USP) Rectal Suppositories, new drug application 021252, 500 milligram (mg) and 1,000 mg strengths were... pharmacokinetic endpoints and comparative in vitro studies (melting point, differential scanning...

  12. 76 FR 6685 - Draft Guidance for Industry and Food and Drug Administration Staff; Recommended Warning for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-07

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration...; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug... about the potential adverse health effects from the use of powder on medical gloves and is...

  13. 78 FR 19271 - Draft Guidance for Industry on Bioequivalence Recommendations for Metronidazole Vaginal Gel...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-29

    ... Recommendations for Metronidazole Vaginal Gel; Availability AGENCY: Food and Drug Administration, HHS. ACTION... guidance for industry entitled ``Bioequivalence Recommendations for Metronidazole Vaginal Gel.'' The... abbreviated new drug applications (ANDAs) for metronidazole vaginal gel. DATES: Although you can comment on...

  14. 77 FR 18827 - Draft Guidance for Industry on Bioequivalence Recommendations for Iron Sucrose Injection...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-28

    ... Recommendations for Iron Sucrose Injection; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... industry entitled ``Bioequivalence Recommendations for Iron Sucrose.'' The recommendations provide specific...) for iron sucrose injection. DATES: Although you can comment on any guidance at any time (see 21 CFR 10...

  15. 78 FR 13069 - Draft Guidance for Industry: Recommendations for Screening, Testing, and, Management of Blood...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-26

    ...: Recommendations for Screening, Testing, and, Management of Blood Donors and Blood and Blood Components Based on... entitled ``Guidance for Industry: Recommendations for Screening, Testing, and Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis,'' dated March 2013. The...

  16. 78 FR 73200 - Draft Guidance for Industry on Bioequivalence Recommendations for Paliperidone Palmitate Extended...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-05

    ... Recommendations for Paliperidone Palmitate Extended-Release Injectable Suspension; Availability AGENCY: Food and... extended-release injectable suspension. DATES: Although you can comment on any guidance at any time (see 21... paliperidone palmitate extended-release injectable suspension. New drug application 022264 for INVEGA...

  17. 75 FR 40843 - International Conference on Harmonisation; Draft Guidance on Q4B Evaluation and Recommendation of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-14

    ... Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft... strategy in each regulatory region. This draft guidance is the thirteenth annex to the core Q4B guidance... harmonization and is committed to seeking scientifically based harmonized technical procedures for...

  18. 77 FR 7585 - Draft Guidance for Industry on Bioequivalence Recommendations for Rifaximin Tablets; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-13

    ... industry entitled ``Bioequivalence Recommendations for Rifaximin,'' one for the 200- milligram (mg) strength (rifaximin-200) and one for the 550-mg strength (rifaximin-550). The recommendations provide..., one for rifaximin-200 and one for rifaximin-550. Xifaxan (rifaximin) 200-mg tablets, approved by...

  19. 78 FR 74154 - Draft Guidance for Industry on Recommendations for Preparation and Submission of Animal Food...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-10

    ... Preparation and Submission of Animal Food Additive Petitions; Reopening of the Comment Period AGENCY: Food and... (GFI 221) entitled ``Recommendations for Preparation and Submission of Animal Food Additive Petitions... Preparation and Submission of Animal Food Additive Petitions.'' Interested persons were originally given until...

  20. 76 FR 53909 - Draft Guidance for Industry on Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-30

    ... cutting a higher- strength tablet into smaller portions.) Specifically, this draft guidance recommends... breaking or cutting a higher-strength tablet into smaller portions.) Specifically, this draft...

  1. 78 FR 53792 - Draft Guidance for Reciprocity

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-30

    ... COMMISSION Draft Guidance for Reciprocity AGENCY: Nuclear Regulatory Commission. ACTION: Draft NUREG; request... for reciprocity. The NRC is requesting public comment on draft NUREG-1556, Volume 19, Revision 1... (Reciprocity).'' The document has been updated from the previous revision to include safety culture,...

  2. 75 FR 43172 - International Conference on Harmonisation; Draft Guidance on Q4B Evaluation and Recommendation of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-23

    ... Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on... Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 13: Bulk Density and Tapped Density of...

  3. 77 FR 12852 - Draft Guidance for Industry on Limiting the Use of Certain Phthalates as Excipients in Center for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-02

    ... Phthalates as Excipients in CDER-Regulated Products.'' This draft guidance provides the pharmaceutical... (DEHP). In particular, the draft guidance recommends that the pharmaceutical industry avoid the use of... Products.'' This draft guidance provides the pharmaceutical industry with CDER's current thinking on...

  4. 78 FR 57394 - Draft Guidance for Industry on Patient Counseling Information Section of Labeling for Human...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-18

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products--Content and Format.'' The recommendations in the draft guidance are intended to help ensure that the labeling is clear, useful, informative, and to the extent possible,......

  5. 75 FR 73106 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-29

    ... Clostridium difficile; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The... Clostridium difficile.'' This draft guidance document describes FDA's recommendations concerning 510(k... Clostridium difficile (C. difficile). This draft guidance is not final nor is it in effect at this time....

  6. 76 FR 58018 - Draft Guidance for Industry on Self-Selection Studies for Nonprescription Drug Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-19

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Self-Selection Studies for... entitled ``Self-Selection Studies for Nonprescription Drug Products.'' The draft guidance is intended to provide recommendations to industry on the design of self- selection studies for nonprescription drug...

  7. 75 FR 48973 - Draft Guidance for Industry: Prevention of Salmonella

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-12

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Prevention of Salmonella... availability of a draft guidance entitled ``Prevention of Salmonella Enteritidis in Shell Eggs During... ``Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation''...

  8. 75 FR 59268 - Draft Guidance for Industry: Acidified Foods; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-27

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Acidified Foods; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Guidance for Industry: Acidified Foods...

  9. 76 FR 35450 - Draft Guidance for Industry on Clinical Trial Endpoints for the Approval of Non-Small Cell Lung...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-17

    ... the Approval of Non-Small Cell Lung Cancer Drugs and Biologics; Availability AGENCY: Food and Drug... Cell Lung Cancer Drugs and Biologics.'' This draft guidance provides recommendations to applicants on... draft guidance for industry entitled ``Clinical Trial Endpoints for the Approval of Non-Small Cell...

  10. 76 FR 5386 - Draft Guidance for Industry: Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-31

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Pre-Storage Leukocyte Reduction... availability of a draft document entitled ``Guidance for Industry: Pre- Storage Leukocyte Reduction of Whole... provides blood establishments with recommendations for pre- storage leukocyte reduction of Whole Blood...

  11. 77 FR 7584 - Draft Guidance for Industry on Heparin for Drug and Medical Device Use; Monitoring Crude Heparin...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-13

    ... (especially ruminant material) contaminants. This draft guidance on crude heparin recommends strategies to... contamination of heparin with the bovine spongiform encephalopathy (BSE) agent derived from ruminant materials... contaminated with OSCS or any non- porcine origin material, especially ruminant material (unless...

  12. CHARACTERIZATION OF ORGANIC EMISSIONS FROM HAZARDOUS WASTE INCINERATION PROCESSES UNDER THE NEW EPA DRAFT RISK BURN GUIDANCE: MEASUREMENT ISSUES

    EPA Science Inventory

    The paper discusses measurement issues relating to the characterization of organic emissions from hazardous waste incineration processes under EPA's new risk burn guidance. The recently published draft quidance recommends that hazardous waste combustion facilities complete a mass...

  13. CHARACTERISTICS OF ORGANIC EMISSIONS FROM HAZARDOUS WASTE INCINERATION PROCESSES UNDER THE NEW EPA DRAFT RISK BURN GUIDANCE: MEASUREMENT ISSUES

    EPA Science Inventory

    EPA's recently published draft Risk Burn Guidance recommends that hazardous waste combustion facilities complete a mass balance of the total organics (TOs) that may be emitted from the combustor. TOs, consisting of three distinct fractions (volatile, semivolatile, and nonvolatile...

  14. CHARACTERIZATION OF ORGANIC EMISSIONS FROM HAZARDOUS WASTE INCINERATION PROCESSES UNDER THE NEW EPA DRAFT RISK BURN GUIDANCE: MEASUREMENT ISSUES

    EPA Science Inventory

    The paper discusses measurement issues relating to the characterization of organic emissions from hazardous waste incineration processes under EPA's new risk burn guidance. The recently published draft quidance recommends that hazardous waste combustion facilities complete a mass...

  15. CHARACTERISTICS OF ORGANIC EMISSIONS FROM HAZARDOUS WASTE INCINERATION PROCESSES UNDER THE NEW EPA DRAFT RISK BURN GUIDANCE: MEASUREMENT ISSUES

    EPA Science Inventory

    EPA's recently published draft Risk Burn Guidance recommends that hazardous waste combustion facilities complete a mass balance of the total organics (TOs) that may be emitted from the combustor. TOs, consisting of three distinct fractions (volatile, semivolatile, and nonvolatile...

  16. 77 FR 69619 - Draft Recommendations of Joint Outreach Team

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-20

    ... Area Power Administration Draft Recommendations of Joint Outreach Team AGENCY: Western Area Power Administration, DOE. ACTION: Notice of Availability of draft recommendations of Western/DOE Joint Outreach Team... Department of Energy (DOE), is publishing the draft recommendations of the Western/DOE Joint Outreach Team...

  17. 77 FR 69632 - Draft Guidance for Industry on Electronic Source Data in Clinical Investigations; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-20

    ... document provides guidance to sponsors, contract research organizations (CROs), data management centers... Investigations.'' This revised draft document provides guidance to sponsors, CROs, data management centers... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Electronic Source Data...

  18. 77 FR 69631 - Draft Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities for Reviewing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-20

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research... availability of a draft guidance entitled ``Guidance for IRBs, Clinical Investigators, and Sponsors: IRB...

  19. 75 FR 49913 - Draft Guidance, “Federal Greenhouse Gas Accounting and Reporting”

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-16

    ... QUALITY Draft Guidance, ``Federal Greenhouse Gas Accounting and Reporting'' AGENCY: Council on... and accounting procedures. On April 5, 2010, DOE-FEMP submitted the final recommendations on Federal GHG reporting and accounting procedures to the Chair, Council on Environmental Quality (CEQ). Section...

  20. 78 FR 48175 - Retrospective Review of Draft Guidance Documents Issued Before 2010; Withdrawal of Guidances

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-07

    ... are no longer up to date, and for which more current information is available, will be withdrawn... guidances that are no longer up to date. CDER is also actively reviewing the draft guidances to determine... this process as transparent as possible. DATES: General comments on Agency guidance documents...

  1. 75 FR 73107 - Draft Guidance for Industry on Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-29

    ... this draft guidance is to assist clinical trial sponsors and investigators in the development of... bacterial pneumonia (VABP). The science of clinical trial design and our understanding of these diseases... recommendations for clinical development. DATES: Although you can comment on any guidance at any time (see 21 CFR...

  2. 75 FR 36421 - Draft Guidance for Industry on Chemistry, Manufacturing, and Controls Postapproval Manufacturing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-25

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Chemistry, Manufacturing, and Controls Postapproval Manufacturing Changes Reportable in Annual Reports; Availability AGENCY: Food and... the availability of a draft guidance for industry entitled ``CMC Postapproval Manufacturing...

  3. 77 FR 59928 - Draft Guidance for Industry on Complicated Intra-Abdominal Infections: Developing Drugs for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-01

    ... previously conducted clinical trials with various effective antibiotics. The draft guidance also provides a... resistance to most antibacterial drugs on in vitro susceptibility testing. ] This draft guidance is being...

  4. 76 FR 60055 - Draft Guidance for Industry: Applications for Premarket Review of New Tobacco Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-28

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Applications for Premarket Review of New Tobacco Products; Availability; Agency Information Collection Activities; Proposed... ``Applications for Premarket Review of New Tobacco Products.'' The draft guidance is intended to assist...

  5. 78 FR 63219 - International Conference on Harmonisation; Draft Guidance on Elemental Impurities; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-23

    ... HUMAN SERVICES Food and Drug Administration International Conference on Harmonisation; Draft Guidance on Elemental Impurities; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled...

  6. 76 FR 55927 - Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-09

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry; Dietary Supplements: New...: Food and Drug Administration, HHS. ACTION: Notice; extension of comment period. SUMMARY: The Food and... notice entitled ``Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications...

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

    SciTech Connect

    Posas, Paula J.

    2011-04-15

    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.

  8. 78 FR 33848 - Draft Guidance for Industry on Human Immunodeficiency Virus-1 Infection: Developing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-05

    ... antiretroviral drugs for the treatment of HIV. This draft guidance revises the guidance for industry entitled ``Antiretroviral Drugs Using Plasma HIV RNA Measurements--Clinical Considerations [[Page 33849

  9. 78 FR 44572 - Draft Guidance for Industry on Pre-Launch Activities Importation Requests; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-24

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Pre-Launch Activities... entitled ``Pre-Launch Activities Importation Requests (PLAIR).'' This draft guidance describes FDA's policy... announcing the availability of a draft guidance for industry entitled ``Pre-Launch Activities...

  10. 76 FR 16425 - Draft Guidance for Industry: Testing for Salmonella

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-23

    ... in Human Foods and Direct-Human-Contact Animal Foods; Availability AGENCY: Food and Drug... Direct-Human-Contact Animal Foods.'' The draft guidance, when finalized, is intended for firms that manufacture, process, pack, or hold human foods or direct-human-contact animal foods intended for distribution...

  11. FDA draft guidance on computerised systems used in clinical trials.

    PubMed

    Donawa, Maria E

    2005-01-01

    When using computer systems to manage clinical studies, it is important to understand how these systems should be controlled and, for studies intended to support United States (US) regulatory submissions, when and how US regulations on electronic records and signatures apply. This article discusses these issues and a draft guidance document.

  12. 75 FR 7591 - Guidance on Recommended Interim Preliminary Remediation Goals for Dioxin in Soil at CERCLA and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-22

    ... From the Federal Register Online via the Government Publishing Office ENVIRONMENTAL PROTECTION AGENCY RIN 2050-ZA05 Guidance on Recommended Interim Preliminary Remediation Goals for Dioxin in Soil at... draft Guidance on Recommended Interim Preliminary Remediation Goals for Dioxin in Soil at...

  13. 76 FR 55390 - Guidance on Exculpatory Language in Informed Consent, Draft

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-07

    ... HUMAN SERVICES Guidance on Exculpatory Language in Informed Consent, Draft AGENCY: Office for Human... the availability of a draft guidance entitled, ``Guidance on Exculpatory Language in Informed Consent... will supersede OHRP's November 15, 1996 guidance document entitled ```Exculpatory Language' in Informed...

  14. 78 FR 49271 - Draft Guidance for Industry on Frequently Asked Questions About Medical Foods; Second Edition...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-13

    ... About Medical Foods; Second Edition; Availability AGENCY: Food and Drug Administration, HHS. ACTION... guidance for industry entitled ``Frequently Asked Questions About Medical Foods; Second Edition.'' The... Foods; Second Edition.'' This draft guidance is being issued consistent with our good guidance...

  15. 76 FR 72710 - Agency Information Collection Activities; Proposed Collection; Comment Request; Draft Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-25

    ... Collection; Comment Request; Draft Guidance for Tobacco Retailers on Tobacco Retailer Training Programs... collection provisions of the draft guidance entitled ``Tobacco Retailer Training Programs.'' DATES: Submit...-2010-D-0350) and http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm...

  16. 78 FR 16676 - Agency Information Collection Activities; Proposed Collection; Comment Request; Draft Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-18

    ... Collection; Comment Request; Draft Guidance for Industry and FDA Staff; Total Product Life Cycle: Infusion... solicits comments on ``Guidance for Industry and FDA Staff; Total Product Life Cycle: Infusion Pump... technology. Draft Guidance for Industry and FDA Staff; Total Product Life Cycle: Infusion...

  17. 78 FR 63218 - Draft Guidance for Industry on Chronic Hepatitis C Virus Infection: Developing Direct-Acting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-23

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Chronic Hepatitis C Virus... availability of a draft guidance for industry entitled ``Chronic Hepatitis C Virus Infection: Developing Direct... guidance revises and replaces a previous draft guidance for industry entitled ``Chronic Hepatitis C Virus...

  18. 78 FR 32667 - Draft Guidance for Industry on Rheumatoid Arthritis: Developing Drug Products for Treatment...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-31

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Rheumatoid Arthritis... guidance for industry entitled ``Rheumatoid Arthritis: Developing Drug Products for Treatment.'' This... of patients with rheumatoid arthritis (RA). It also addresses additional considerations for...

  19. 77 FR 76049 - Draft Guidance for Industry on Electronic Source Data in Clinical Investigations; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-26

    ... guidance entitled ``Electronic Source Data in Clinical Investigations.'' The document was published with an... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Electronic Source Data in Clinical Investigations; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice;...

  20. 75 FR 47604 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-06

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Document; Reopening of Comment Period; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. SUMMARY...

  1. Draft Evaluation, Measurement and Verification Guidance for Demand-Side Energy Efficiency

    EPA Pesticide Factsheets

    EPA is sharing draft Evaluation, Measurement and Verification Guidance for Demand-Side Energy Efficiency for public comment. This guidance is not a regulatory document, and is intended to supplement information provided in the Clean Power Plan.

  2. 77 FR 24722 - Draft Guidance for Industry: Safety of Nanomaterials in Cosmetic Products; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-25

    ... Cosmetic Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The... ``Guidance for Industry: Safety of Nanomaterials in Cosmetic Products.'' The draft guidance, when finalized, will represent FDA's current thinking on the safety assessment of nanomaterials in cosmetic...

  3. 78 FR 20925 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-08

    ... provide product-specific guidance on the design of BE studies to support abbreviated new drug applications... FDA's Web site. The BE recommendations identified in this notice were developed using the process... the public on FDA's Web site at...

  4. 77 FR 35688 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-14

    ... provide product-specific guidance on the design of BE studies to support abbreviated new drug applications... FDA's Web site. The BE recommendations identified in this notice were developed using the process... FDA's Web site at...

  5. 78 FR 40199 - Draft Spent Fuel Storage and Transportation Interim Staff Guidance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-03

    ... COMMISSION Draft Spent Fuel Storage and Transportation Interim Staff Guidance AGENCY: Nuclear Regulatory... Regulatory Commission (NRC) requests public comment on Draft Spent Fuel Storage and Transportation Interim... Integrity for Continued Storage of High Burnup Fuel Beyond 20 Years.'' The draft SFST-ISG provides...

  6. 77 FR 14401 - Draft Guidance on Drug Safety Information-FDA's Communication to the Public; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-09

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance on Drug Safety Information--FDA's Communication to the Public; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance...

  7. 78 FR 68852 - Draft Guidance for Industry on Acrylamide in Foods; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-15

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Acrylamide in Foods; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...: Acrylamide in Foods.'' The draft guidance is intended to provide information that may help growers...

  8. 78 FR 31943 - Draft Guidance for Industry on Contract Manufacturing Arrangements for Drugs: Quality Agreements...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-28

    ... each party (or all parties) involved in the contract manufacturing of drugs subject to Current Good... for the manufacturing of drugs. This draft guidance is being issued consistent with FDA's good... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Contract...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-28

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Review Staff on Pediatric... announcing the availability of a draft guidance for industry and review staff entitled ``Pediatric... is intended to assist applicants and FDA review staff in making decisions about the placement and...

  10. 76 FR 55923 - Draft Guidance for Industry: Submission of Warning Plans for Cigarettes and Smokeless Tobacco...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-09

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Submission of Warning Plans for... Collection; Comment Request AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled...

  11. 77 FR 67379 - Draft Guidance for Industry and Food and Drug Administration Staff; Highly Multiplexed...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-09

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... Devices; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Highly...

  12. 76 FR 10908 - Draft Guidance for Industry on Medication Guides-Distribution Requirements and Inclusion of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-28

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Medication Guides--Distribution Requirements and Inclusion of Medication Guides in Risk Evaluation and Mitigation Strategies... Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Medication...

  13. 77 FR 19672 - Draft Guidances Relating to the Development of Biosimilar Products; Public Hearing; Request for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-02

    ... HUMAN SERVICES Food and Drug Administration Draft Guidances Relating to the Development of Biosimilar... Biosimilar Products; Public Hearing; Request for Comments'' to obtain input on recently issued draft guidances relating to the development of biosimilar products. The document published with an incorrect...

  14. 76 FR 68767 - Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-07

    ... entitled ``Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification...] [FR Doc No: 2011-28766] 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...

  15. 77 FR 34958 - Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-12

    ...); or the Office of Communication, Outreach and Development (HFM-40), Center for Biologics Evaluation.... Electronic Access Persons with access to the Internet may obtain the draft guidance at either http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ProposedRegulationsandDraftGuidances/default...

  16. 78 FR 66744 - Draft Guidance for Industry on Pulmonary Tuberculosis: Developing Drugs for Treatment; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-06

    ... electronic or written comments on the draft guidance by February 4, 2014. ADDRESSES: Submit written requests.... Submit electronic comments on the draft guidance to http://www.regulations.gov . Submit written comments... immunodeficiency virus/acquired immunodeficiency syndrome; and (3) new drugs that are active in the treatment of...

  17. 75 FR 62693 - National Organic Program: Notice of Draft Guidance for Accredited Certifying Agents and Certified...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-13

    ... Agricultural Marketing Service 7 CFR Part 205 National Organic Program: Notice of Draft Guidance for Accredited... availability with request for comments. SUMMARY: The National Organic Program (NOP) is announcing the... operations. The five draft guidance documents are entitled as follows: Compost and Vermicompost in...

  18. 78 FR 72899 - Draft Guidance for Industry on Registration for Human Drug Compounding Outsourcing Facilities...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-04

    ... Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act..., and Cosmetic Act.'' The draft guidance addresses new provisions in the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Drug Quality and Security Act (DQSA). The draft guidance...

  19. 75 FR 3238 - Draft Guidance for Industry and Food and Drug Administration Staff; Heart Valves...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-20

    ... Staff; Heart Valves -- Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications... Administration (FDA) is announcing the availability of the draft guidance document entitled ``Heart Valves... for heart valves. This draft guidance document is not final, nor is it in effect at this time. DATES...

  20. 78 FR 58545 - Global Unique Device Identification Database; Draft Guidance for Industry; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-24

    ... HUMAN SERVICES Food and Drug Administration Global Unique Device Identification Database; Draft Guidance... ``Global Unique Device Identification Database (GUDID).'' FDA is issuing this draft guidance to communicate... information on the database elements that must be submitted to the GUDID and their definitions. We intend...

  1. 76 FR 81510 - Draft Guidance for Industry and Food and Drug Administration Staff; the 510(k) Program...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-28

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Draft Guidance for Industry and...

  2. 75 FR 22601 - Draft Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-29

    ... Staff; User Fees for 513(g); Requests for Information; Availability AGENCY: Food and Drug Administration... the draft guidance entitled ``Draft Guidance for Industry and FDA Staff; User Fees for 513(g) Requests for Information.'' This draft guidance describes the user fees associated with 513(g) requests for...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-07

    ... No. FDA-2012-D-1092] Minimizing Risk for Children's Toy Laser Products; Draft Guidance for Industry... guidance entitled ``Minimizing Risk for Children's Toy Laser Products.'' This draft guidance is to inform... and Radiological Health's (CDRH) proposed approach on the safety of toy laser products. This draft...

  4. 76 FR 82306 - Draft Guidance for Industry on Use of Histology in Biomarker Qualification Studies; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-30

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Use of Histology in Biomarker... ``Use of Histology in Biomarker Qualification Studies.'' This guidance is intended to assist sponsors that conduct biomarker qualification studies for which histology is a reference standard. This guidance...

  5. 77 FR 16842 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-22

    ... provide product-specific guidance on the design of BE studies to support abbreviated new drug applications... that would be used to make product-specific BE recommendations available to the public on FDA's Web... the public on FDA's Web site at...

  6. 78 FR 66745 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-06

    ... provide product-specific guidance on the design of BE studies to support abbreviated new drug applications... that would be used to make product-specific BE recommendations available to the public on FDA's Web... the public on FDA's Web site at...

  7. 77 FR 74196 - Draft Guidance for Industry on Safety Considerations for Product Design To Minimize Medication...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-13

    ... Product Design To Minimize Medication Errors; Availability AGENCY: Food and Drug Administration, HHS... guidance for industry entitled ``Safety Considerations for Product Design to Minimize Medication Errors... using a systems approach to minimize medication errors relating to product design. The draft...

  8. 76 FR 70151 - Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-10

    ... HUMAN SERVICES Food and Drug Administration 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 Investigations; Availability AGENCY: Food and Drug Administration, HHS...

  9. 76 FR 1170 - Draft Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-07

    ... Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic; Availability AGENCY... for Medical Products and Dietary Supplements During an Influenza Pandemic.'' The draft guidance..., biologics, medical devices, and dietary supplements during an influenza pandemic. The agency makes...

  10. 78 FR 19637 - National Organic Program: Notice of Draft Guidance on Classification of Materials and Materials...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-02

    ...; ] DEPARTMENT OF AGRICULTURE Agricultural Marketing Service National Organic Program: Notice of Draft Guidance on Classification of Materials and Materials for Organic Crop Production AGENCY: Agricultural... operations, material evaluation programs, and other organic industry stakeholders. The first set of...

  11. 77 FR 58999 - Draft Guidance for Industry on Abbreviated New Drug Applications: Stability Testing of Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-25

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Abbreviated New Drug Applications: Stability Testing of Drug Substances and Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing...

  12. 78 FR 52931 - Draft Guidance for Industry on Abbreviated New Drug Applications: Stability Testing of Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-27

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Abbreviated New Drug...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is... to generic drug manufacturers to follow International Conference on Hamonisation (ICH)...

  13. 77 FR 8885 - Draft Guidance for Industry on Biosimilars: Questions and Answers Regarding Implementation of the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-15

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  14. 77 FR 39710 - Draft Guidance for Industry on Organ-Specific Warnings: Internal Analgesic, Antipyretic, and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-05

    ... Contain Acetaminophen; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY... Over-the-Counter Human Use--Labeling for Products That Contain Acetaminophen.'' The draft guidance is... antirheumatic (IAAA) drug products that contain [[Page 39711

  15. 75 FR 8045 - National Environmental Policy Act (NEPA) Draft Guidance, Establishing, Applying, and Revising...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-23

    ... fundamental tool used to harmonize our economic, environmental, and social aspirations and is a cornerstone of... From the Federal Register Online via the Government Publishing Office COUNCIL ON ENVIRONMENTAL QUALITY National Environmental Policy Act (NEPA) Draft Guidance, Establishing, Applying, and...

  16. 77 FR 8262 - Draft Guidance on Investigational New Drug Applications for Positron Emission Tomography Drugs...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-14

    ... HUMAN SERVICES Food and Drug Administration 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 Administration (FDA) is announcing the availability of a draft...

  17. 78 FR 14791 - Notice of Issuance of Exposure Draft on Implementation Guidance on General Property, Plant, and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-07

    ..., Plant, and Equipment Cost Accumulation, Assignment, and Allocation. The Exposure Draft is available on... ADVISORY BOARD Notice of Issuance of Exposure Draft on Implementation Guidance on General Property, Plant, and Equipment Cost Accumulation, Assignment, and Allocation AGENCY: Federal Accounting Standards...

  18. 78 FR 55261 - Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-10

    ... development and/or testing of generic drug products regarding the requirements and commitments of GDUFA. DATES... launch of the GDUFA program, FDA has revised the draft guidance and is issuing it again in draft...

  19. 76 FR 70768 - Common-Cause Failure Analysis in Event and Condition Assessment: Guidance and Research, Draft...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-15

    ... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY COMMISSION Common-Cause Failure Analysis in Event and Condition Assessment: Guidance and Research, Draft Report for Comment; Correction AGENCY: Nuclear Regulatory Commission. ACTION: Draft NUREG; request...

  20. 76 FR 14024 - Draft Guidance for Industry on Non-Penicillin Beta-Lactam Risk Assessment: A CGMP Framework...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-15

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Non-Penicillin Beta-Lactam... guidance for industry entitled ``Non-Penicillin Beta-Lactam Risk Assessment: A CGMP Framework.'' This... non- penicillin beta-lactam antibiotics. The draft guidance is intended to assist manufacturers...

  1. 76 FR 64228 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-17

    ... Special Controls Guidance Document: External Pacemaker Pulse Generator; Availability AGENCY: Food and Drug... Pulse Generator.'' This draft guidance document describes a means by which external pacemaker pulse generators may comply with the requirement of special controls for class II devices. This draft guidance is...

  2. 75 FR 55797 - Draft Guidance for Industry on Chronic Hepatitis C Virus Infection: Developing Direct-Acting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-14

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Chronic Hepatitis C Virus... availability of a draft guidance for industry entitled ``Chronic Hepatitis C Virus Infection: Developing Direct... specific steps in the hepatitis C virus (HCV) replication cycle. The guidance outlines the types of...

  3. 76 FR 41506 - Draft Guidance for Industry and FDA Staff on In Vitro Companion Diagnostic Devices; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-14

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and FDA Staff on In Vitro.... SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance.... This guidance defines in vitro companion diagnostic devices; explains the need for FDA oversight...

  4. 76 FR 61103 - Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-03

    ... (Evaluation of Automatic Class III Designation).'' The purpose of this document is to provide guidance to FDA... process. This draft guidance is not final nor is it in effect at this time. DATES: Although you can... predicate device, may remain in class III even if the risks it presents are relatively low. This is the...

  5. 79 FR 19620 - Draft Guidance for Industry: Proper Labeling of Honey and Honey Products; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2014-04-09

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Proper Labeling of Honey and Honey Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The... industry entitled ``Guidance for Industry: Proper Labeling ] of Honey and Honey Products.'' FDA...

  6. 77 FR 8883 - Draft Guidance for Industry on Scientific Considerations in Demonstrating Biosimilarity to a...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-15

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Scientific Considerations in... guidance for industry entitled ``Scientific Considerations in Demonstrating Biosimilarity to a Reference... protein product is biosimilar to a reference product for the purpose of submitting a marketing...

  7. 75 FR 57963 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-23

    ...-13 (\\13\\C) urea breath and blood tests, and the urease test. This draft guidance has been updated... technologies outside the scope of the old guidance, such as H. pylori urea breath tests and H. pylori antigen... detection of H. pylori bacteria in human blood, serum, urine, stool, or breath specimens. FDA believes these...

  8. 75 FR 44267 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-28

    ... HUMAN SERVICES Food and Drug Administration 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 Administration, HHS. ACTION: Notice; reopening of comment period...

  9. 78 FR 56718 - Draft Guidance for Industry on Bioanalytical Method Validation; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-13

    ... therapeutic biologics regulated by the Center for Drug Evaluation and Research. This draft guidance may apply to some studies related to the veterinary drug approval process (Investigational New Animal Drugs...)) regulated by the Center for Veterinary Medicine. This guidance was originally issued in 2001. FDA is...

  10. 76 FR 16424 - Draft Guidance for Industry: Compliance With Regulations Restricting the Sale and Distribution of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-23

    ... Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents... Smokeless Tobacco to Protect Children and Adolescents.'' This revised draft guidance replaces the original... Tobacco to Protect Children and Adolescents.'' DATES: Although you can comment on any guidance at any time...

  11. 78 FR 9688 - Pesticides; Draft Guidance for Pesticide Registrants on Antimicrobial Pesticide Products With...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-11

    ... AGENCY Pesticides; Draft Guidance for Pesticide Registrants on Antimicrobial Pesticide Products With Mold... for Antimicrobial Pesticide Products with Mold-Related Label Claims. This document extends the comment... guidance for antimicrobial pesticide products with mold-related claims. In response to comments...

  12. 75 FR 52755 - Draft Guidance for Industry on Acute Bacterial Skin and Skin Structure Infections: Developing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-27

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Acute Bacterial Skin and Skin... guidance for industry entitled ``Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for... the development of antimicrobial drugs for the treatment of acute bacterial skin and skin structure...

  13. 76 FR 72422 - Draft Guidance for Industry on Evaluating the Effectiveness of Anticoccidial Drugs in Food...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-23

    ... draft guidance, when finalized, is intended to provide guidance to industry for designing and conducting clinical effectiveness studies, and describes criteria that the Center for Veterinary Medicine (CVM) thinks... represent the Agency's current thinking on evaluating the effectiveness of anticoccidial drugs in food...

  14. 78 FR 27116 - Draft Guidance for Industry on Charging for Investigational Drugs Under an Investigational New...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-09

    ... considers your comment on this draft guidance before it begins work on the final version of the guidance..., to set forth criteria for charging for an investigational drug for the three types of expanded access.... Consistent with the goal of clarifying the requirements for charging for an investigational drug and the...

  15. 77 FR 74003 - Pesticides; Draft Guidance for Pesticide Registrants on Antimicrobial Pesticide Products With...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-12

    ... AGENCY Pesticides; Draft Guidance for Pesticide Registrants on Antimicrobial Pesticide Products With Mold... Registration Notice (PR Notice) titled ``Guidance on Antimicrobial Pesticide Products with Mold-Related Label... (efficacy) data and labeling for ``mold-related'' pesticide products. EPA believes that the label...

  16. 75 FR 984 - Draft Recommended Interim Preliminary Remediation Goals for Dioxin in Soil at CERCLA and RCRA Sites

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-07

    ... AGENCY RIN 2050-ZA05 Draft Recommended Interim Preliminary Remediation Goals for Dioxin in Soil at CERCLA...) developed in the Draft Recommended Interim Preliminary Remediation Goals for Dioxin in Soil at Comprehensive... draft recommended interim PRGs for dioxin in soil. These draft recommended interim PRGs were calculated...

  17. Draft guidance for industry; exports and imports under the FDA Export Reform and Enhancement Act of 1996--FDA. Notice.

    PubMed

    1998-06-12

    The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document entitled, "FDA Draft Guidance for Industry on: Exports and Imports Under the FDA Export Reform and Enhancement Act of 1996." The draft guidance document addresses issues pertaining to the exportation of human drugs, animal drugs, biologics, food additives, and devices as well as the importation of components, parts, accessories, or other articles for incorporation or further processing into articles intended for export.

  18. SSTAC/ARTS review of the draft Integrated Technology Plan (ITP). Volume 6: Controls and guidance

    NASA Technical Reports Server (NTRS)

    1991-01-01

    Viewgraphs of briefings from the Space Systems and Technology Advisory Committee (SSTAC)/ARTS review of the draft Integrated Technology Plan (ITP) on controls and guidance are included. Topics covered include: strategic avionics technology planning and bridging programs; avionics technology plan; vehicle health management; spacecraft guidance research; autonomous rendezvous and docking; autonomous landing; computational control; fiberoptic rotation sensors; precision instrument and telescope pointing; microsensors and microinstruments; micro guidance and control initiative; and earth-orbiting platforms controls-structures interaction.

  19. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance.

    PubMed

    2006-10-11

    and validly measure the specific concepts at issue. The glossary defines many of the terms used in this guidance. In particular, the term instrument refers to the actual questions or items contained in a questionnaire or interview schedule along with all the additional information and documentation that supports the use of these items in producing a PRO measure (e.g., interviewer training and instructions, scoring and interpretation manual). The term conceptual framework refers to how items are grouped according to subconcepts or domains (e.g., the item walking without help may be grouped with another item, walking with difficulty, within the domain of ambulation, and ambulation may be further grouped into the concept of physical ability). FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidance documents describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance documents means that something is suggested or recommended but not required. First publication of the Draft Guidance by the Food and Drug Administration--February 2006.

  20. 77 FR 34390 - Draft Guidance for Industry: Amendment to “Guidance for Industry: Revised Preventive Measures To...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-11

    ... proposes amendments to the labeling recommendations for plasma-derived products, including albumin and products containing plasma-derived albumin, in the guidance document entitled ``Guidance for Industry... in the 2010 CJD/vCJD guidance for plasma-derived products, including albumin and products...

  1. 76 FR 27059 - Solicitation of Written Comments on the Draft Report and Draft Recommendations of the Vaccine...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-10

    ... HUMAN SERVICES Solicitation of Written Comments on the Draft Report and Draft Recommendations of the... are preferred and may be addressed to vaccinesafetyRFI@hhs.gov . 3. Written responses should be... their comments posted. Written comment submission should not exceed six pages. Any information you...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-20

    ..., and Prominence in Advertising and Promotional Labeling; Availability AGENCY: Food and Drug... Advertising and Promotional Labeling.'' When finalized, the draft guidance will replace the guidance of the... placement, size, prominence, and frequency in promotional labeling and advertising for prescription...

  3. 76 FR 20686 - Draft Guidance for Industry on Safety Labeling Changes; Implementation of the Federal Food, Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-13

    ... product is approved under the FD&C Act or the Public Health Service Act (the PHS Act). This draft guidance... changes, and enforcement of the requirements for safety labeling changes. This draft guidance is being... collection to OMB for approval. To comply with this requirement, FDA is publishing this notice of the...

  4. 78 FR 2676 - Draft Guidance for Industry on Abuse-Deterrent Opioids-Evaluation and Labeling; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-14

    ... their development. This draft guidance is intended to provide industry with a framework for evaluating... Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry...-deterrent properties of opioid analgesic products should be studied and evaluated, and what claims regarding...

  5. 78 FR 42085 - Draft Guidance for Industry on Pediatric Study Plans: Content of and Process for Submitting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-15

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans.'' This draft guidance is intended to provide information to industry on how to submit initial and amended pediatric study plans (PSPs) as required under the......

  6. 77 FR 57094 - Draft Guidance for Industry on Self-Identification of Generic Drug Facilities, Sites, and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-17

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Self-Identification of Generic Drug Facilities, Sites, and Organizations; Availability; Correction AGENCY: Food and Drug... announced a draft guidance for industry entitled ``Self-Identification of Generic Drug Facilities, Sites...

  7. 76 FR 6143 - Draft Guidance on Positron Emission Tomography Drug Applications-Content and Format for New Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-03

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``PET Drug Applications-- Content and Format for NDAs and ANDAs.'' The draft guidance is intended to assist manufacturers of certain positron emission tomography (PET) drugs in submitting new drug applications (NDAs) or abbreviated new drug applications (ANDAs) in accordance with the Federal......

  8. 78 FR 66366 - Draft Guidance for Industry: Use of Donor Screening Tests To Test Donors of Human Cells, Tissues...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-05

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Use of Donor Screening Tests to Test Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) for Infection with Treponema pallidum (Syphilis),'' dated October 2013. The draft guidance document provides establishments that make donor eligibility......

  9. 76 FR 33752 - Notice of Availability of the External Review Draft of the Guidance for Applying Quantitative...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-09

    ... AGENCY Notice of Availability of the External Review Draft of the Guidance for Applying Quantitative Data... Draft of ``Guidance for Applying Quantitative Data to Develop Data-Derived Extrapolation Factors for... Applying Quantitative Data to Develop Data-Derived Extrapolation Factors for Interspecies and Intraspecies...

  10. 76 FR 43999 - Notice of Availability of the External Review Draft of the Guidance for Applying Quantitative...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-22

    ... From the Federal Register Online via the Government Publishing Office ENVIRONMENTAL PROTECTION AGENCY Notice of Availability of the External Review Draft of the Guidance for Applying Quantitative Data... Review Draft of ``Guidance for Applying Quantitative Data to Develop Data-Derived Extrapolation Factors...

  11. 75 FR 32952 - Draft Guidance for Industry and Food and Drug Administration Staff; “‘Harmful and Potentially...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-10

    ... the Federal Food, Drug, and Cosmetic Act''; Availability AGENCY: Food and Drug Administration, HHS... Products as Used in Section 904(e) of the Federal Food, Drug, and Cosmetic Act.'' This draft guidance... Cosmetic Act.'' This draft guidance, when finalized, will discuss the meaning of the term ``harmful and...

  12. 75 FR 8046 - National Environmental Policy Act (NEPA) Draft Guidance, “Consideration of the Effects of Climate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-23

    ... Availability, Draft Guidance, ``Consideration of the Effects of Climate Change and Greenhouse Gas Emissions... the NEPA Draft Guidance ``Consideration of the Effects of Climate Change and Greenhouse Gas Emissions... actions on global climate change, as well as the expected environmental effects from climate change that...

  13. 77 FR 16123 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-19

    ... Guidance Document: Nucleic Acid-Based In Vitro Diagnostic Devices for the Detection of Mycobacterium...; Class II Special Controls Guidance Document: Nucleic Acid-Based In Vitro Diagnostic Devices for the... availability of a draft guidance entitled ``Class II Special Controls Guidance Document: Nucleic Acid-Based...

  14. 78 FR 50421 - Guidance for Industry: Recommendations for Donor Questioning, Deferral, Reentry, and Product...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-19

    ..., Deferral, Reentry, and Product Management To Reduce the Risk of Transfusion-Transmitted Malaria...-Transmitted Malaria'' dated August 2013. The guidance document provides blood establishments that collect... malaria. This guidance finalizes the draft guidance of the same title dated June 2012, and supersedes...

  15. MARSSIM recommended in states' guidance document for decommissioning.

    PubMed

    McBaugh, Debra; Stoffey, Phillip; Shuman, Howard; Young, Robert; Zannoni, Dennis

    2003-06-01

    States appreciate guidance for activities done infrequently or at only a few locations in the state. For many states, this is the case for decommissioning. Some states have reactors being decommissioned, some DOE sites undergoing cleanup, and some uranium mill or radium sites. Many, however, only occasionally do a small facility cleanup or, once in a great while, a large one. For this reason, most states participated in the readily available MARSSIM training and now recommend its use. For this same reason, the CRCPD Committee on Decontamination and Decommissioning (E24) developed a brief guidance document for state and licensee use.

  16. 76 FR 38187 - International Conference on Harmonisation; Draft Guidance on Q11 Development and Manufacture of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-29

    ... and evaluating this information across the three regions. This draft guidance is being issued... written comments regarding this document. It is only necessary to send one set of comments. It is no..., HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of...

  17. 76 FR 34999 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-15

    ... Methicillin-Resistant Staphylococcus Aureus for Culture-Based Devices; Availability AGENCY: Food and Drug... Diagnostic Devices for the Detection of Methicillin-Resistant Staphylococcus Aureus for Culture- Based... monitoring blood culture systems. This draft guidance is not final nor is it in effect at this time. DATES...

  18. 76 FR 60847 - Draft Guidance on Media Fills for Validation of Aseptic Preparations for Positron Emission...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-30

    ... for the Agency's current good manufacturing practice regulations for PET drugs. DATES: Although you... HUMAN SERVICES Food and Drug Administration Draft Guidance on Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography Drugs; Availability AGENCY: Food and Drug Administration,...

  19. 77 FR 11553 - Draft Guidance on Food and Drug Administration Oversight of Positron Emission Tomography Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-27

    ... good manufacturing practices (CGMP) for PET drugs. The procedures were finalized and an implementation... HUMAN SERVICES Food and Drug Administration Draft Guidance on Food and Drug Administration Oversight of Positron Emission Tomography Drug Products--Questions and Answers; Availability AGENCY: Food and...

  20. 75 FR 2145 - Draft Guidance for Industry on Tobacco Health Document Submission; Availability; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-14

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Tobacco Health Document... entitled ``Tobacco Health Document Submission.'' The notice published with an inadvertent error in the... CONTACT: May Nelson, Center for Tobacco Products, Food and Drug Administration, 9200 Corporate...

  1. 78 FR 3418 - Pesticides; Draft Guidance for Pesticide Registrants on Web-Distributed Labeling for Pesticide...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-16

    ... AGENCY Pesticides; Draft Guidance for Pesticide Registrants on Web- Distributed Labeling for Pesticide... (PR Notice) titled ``Web-Distributed Labeling for Pesticide Products.'' PR Notices are issued by the... Internet. Web-distributed labeling would allow users to retrieve a streamlined version of the pesticide...

  2. 77 FR 8884 - Draft Guidance for Industry on Quality Considerations in Demonstrating Biosimilarity to a...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-15

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of...

  3. 75 FR 63188 - Draft Guidance for Industry: Early Clinical Trials With Live Biotherapeutic Products: Chemistry...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-14

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ] SUMMARY: The Food and Drug Administration (FDA) is announcing the...

  4. 77 FR 74852 - Draft Guidance for Industry on Certification of Designated Medical Gases; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-18

    ... ``Certification Process for Designated Medical Gases.'' This draft guidance describes the new certification process created by the Food and Drug Administration Safety and Innovation Act (FDASIA) for certain medical gases and explains how FDA plans to implement that process. DATES: Although you can comment on...

  5. 77 FR 2741 - Draft Guidance Regarding Inspection and Certification of Vessels Under the Maritime Security Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-19

    ... SECURITY Coast Guard Draft Guidance Regarding Inspection and Certification of Vessels Under the Maritime... sets forth the Coast Guard's policies and procedures regarding the inspection and certification of... Inspection and Certification of Vessels Under the Maritime Security Program. All comments received will be...

  6. 78 FR 57859 - Draft Guidance for Industry on Endocrine Disruption Potential of Drugs: Nonclinical Evaluation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-20

    ... determine the potential for a drug to disrupt the endocrine system. This draft guidance also discusses... compounds that have the potential to 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...

  7. 77 FR 14402 - Draft Guidance on Classifying Significant Postmarket Drug Safety Issues; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-09

    ... to classifying a significant postmarket drug safety issue as a ``priority'' tracked safety issue (TSI) or a ``standard'' TSI, with the capability of elevating some priority TSIs to an ``emergency'' status... CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it...

  8. 76 FR 30175 - Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-24

    ... regulations governing financial disclosure by clinical investigators, part 54 (21 CFR part 54), and to provide... Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators; Availability AGENCY... FDA Staff: Financial Disclosure by Clinical Investigators.'' This draft guidance is intended to assist...

  9. 75 FR 32791 - Draft Guidance for Industry: Compliance With Regulations Restricting the Sale and Distribution of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-09

    ... Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents... Smokeless Tobacco To Protect Children and Adolescents.'' The draft guidance is intended to help small... smokeless tobacco in order to protect children and adolescents. DATES: Although you can comment on any...

  10. 76 FR 55927 - Draft Guidance for Industry and Food and Drug Administration Staff; Demonstrating the Substantial...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-09

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked... the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions.''...

  11. 77 FR 125 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Device Classification...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-03

    ... educate regulated industry and FDA Staff on how, when, and why to use classification product codes for... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Medical Device Classification Product Codes; Availability AGENCY: Food and Drug Administration...

  12. 81 FR 35767 - Pesticides; Draft Guidance for Pesticide Registrants on Herbicide Resistance Management Labeling...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2016-06-03

    ... draft PR Notice (2016-XX) communicates the Agency's approach to addressing herbicide-resistant weeds by...-resistant weeds by providing guidance on labeling, education, training, and stewardship for herbicides... approach to slow the development and spread of herbicide- resistant weeds, and prolong the useful...

  13. 78 FR 41069 - Medical Device Reporting for Manufacturers; Draft Guidance for Industry and Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-09

    ... describes and explains the current FDA regulation that addresses reporting and recordkeeping requirements applicable to manufacturers of medical devices for certain device-related adverse events. This draft guidance... adverse event reporting obligations for manufacturers and importers. FDA published ``Medical Device...

  14. 78 FR 11654 - Draft Guidance for Industry and Food and Drug Administration Staff; Providing Information About...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-19

    ... Food, Drug, and Cosmetic Act; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act.'' FDA is... information required under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This draft guidance is not...

  15. 75 FR 17143 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-05

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA... six of them from the premarket notification requirements of the Federal Food, Drug, and Cosmetic...

  16. 76 FR 50740 - Draft Guidance for Industry and Food and Drug Administration Staff; Procedures for Handling...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-16

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is... Federal Food, Drug, and Cosmetic Act (the FD&C Act), procedural information on how to fulfill section...

  17. 78 FR 72897 - Draft Guidance for Industry on Interim Product Reporting for Human Drug Compounding Outsourcing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-04

    ... Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic... of the Federal Food, Drug, and Cosmetic Act.'' The draft guidance addresses new provisions in the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Drug Quality and Security Act...

  18. 77 FR 10753 - Draft Guidance for Industry: Food and Drug Administration Records Access Authority Under the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-23

    ... Records Access Authority Under the Federal Food, Drug, and Cosmetic Act; Availability AGENCY: Food and... Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act.'' This draft guidance provides updated... Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act.'' The...

  19. 76 FR 80948 - Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-27

    ... developed to promote the initiation of clinical investigations to evaluate the medical devices under FDA's... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff; Food and Drug Administration Decisions...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-02

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Initial Completeness... Amendments of 2012 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug... or prior approval supplements to these applications, will be required to undergo an initial...

  1. 76 FR 39111 - Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-05

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry; Dietary Supplements: New... Dietary Supplements, Center for Food Safety and Applied Nutrition (HFS-850), Food and Drug Administration... NDI and any other dietary ingredients in the dietary supplement ``have been present in the food supply...

  2. 78 FR 73199 - Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-05

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

  3. 76 FR 36133 - Draft Guidances for Industry and Food and Drug Administration Staff: Classification of Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-21

    ... if: ``through either chemical reaction or intermolecular forces or both, the product mediates a... Issues; and Interpretation of the Term ``Chemical Action'' in the Definition of Device Under Section 201...'' and ``Draft Guidance for Industry and FDA Staff: Interpretation of the Term 'Chemical Action' in the...

  4. 76 FR 50484 - Draft Guidance for Industry, Clinical Investigators, and Food and Drug Administration Staff...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-15

    ... Food and Drug Administration Staff; Design Considerations for Pivotal Clinical Investigations for... Considerations for Pivotal Clinical Investigations for Medical Devices.'' This document is intended to provide... to fulfill premarket clinical data requirements. This draft guidance is not final nor is it in...

  5. 78 FR 24211 - Draft Guidance for Industry on Safety Considerations for Container Labels and Carton Labeling...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-24

    ... Container Labels and Carton Labeling Design To Minimize Medication Errors; Availability AGENCY: Food and... Labels and Carton Labeling Design to Minimize Medication Errors.'' The draft guidance focuses on safety aspects of the container label and carton labeling design for prescription drug and biological products...

  6. 78 FR 68460 - Draft Guidance for Industry on Frequently Asked Questions About Medical Foods; Second Edition...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-14

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Frequently Asked Questions... Administration, HHS. ACTION: Notice; reopening of the comment period. SUMMARY: The Food and Drug Administration... to requests for an extension to allow interested persons additional time to submit comments. DATES...

  7. 78 FR 310 - Draft Revision of Guidance for Industry on Providing Regulatory Submissions in Electronic Format...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-03

    ... Electronic Format--Certain Human Pharmaceutical Product Applications and Related Submissions Using the... Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications.'' The draft guidance... of applications for certain human pharmaceutical products and is being issued for public comment. In...

  8. Regulatory Advocacy Update: ASPS Comments in Response to the FDA Draft Guidance Documents on Human Cell and Tissue Products.

    PubMed

    Rubin, J Peter; D'Amico, Richard A; Rodriguez, Ricardo; Coleman, Sydney R; Cederna, Paul; Glasberg, Scot; Neumeister, Michael; Song, David H; Butler, Charles; Hume, Keith M

    2017-02-09

    The Food and Drug Administration (FDA) released draft guidance documents on Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P) Regulations. These proposed guidance documents can impact the practice of plastic surgery in the area of tissue grafting procedures. This article describes the relevant issues in these draft guidance documents, and presents the comments provided to the FDA by the American Society of Plastic Surgeons (ASPS).

  9. 75 FR 59726 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-28

    ... Staff; Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological... Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays.'' This draft guidance document describes a means by which the herpes simplex virus (HSV) serological assay device type...

  10. 76 FR 9529 - Migratory Birds; Draft Eagle Conservation Plan Guidance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-18

    ... construction, operation and maintenance of land-based, wind energy facilities in the United States. DATES: We... Guidance describes a process by which wind energy developers can collect and analyze information that could lead to a programmatic permit to authorize unintentional take of eagles at wind energy facilities. The...

  11. 76 FR 58311 - Draft License Renewal Interim Staff Guidance LR-ISG-2011-05; Ongoing Review of Operating Experience

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-20

    ... request from the Nuclear Energy Institute (NEI), the NRC is extending the public comment period until... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY... Experience AGENCY: Nuclear Regulatory Commission. ACTION: Draft interim staff guidance; extension of...

  12. 76 FR 9027 - Draft Guidance for Industry and Food and Drug Administration Staff on Best Practices for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-16

    ... Staff on Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using... industry and FDA staff entitled ``Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data Sets.'' The draft guidance is intended to describe best...

  13. 78 FR 19495 - Draft Guidance for Industry on Scale-Up and Post-Approval Changes: Manufacturing Equipment...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-01

    ... Changes: Manufacturing Equipment Addendum; Availability AGENCY: Food and Drug Administration, HHS. ACTION... post-approval changes (SUPAC) draft guidance for industry entitled ``SUPAC: Manufacturing Equipment... Modified Release Solid Oral Dosage Forms: Manufacturing Equipment Addendum,'' published on January 1, 1999...

  14. 78 FR 38994 - Implanted Blood Access Devices for Hemodialysis; Draft Guidance for Industry and Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-28

    ... HUMAN SERVICES Food and Drug Administration 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 and Drug Administration (FDA) is announcing...

  15. 78 FR 78822 - Draft Guidance for Assessing the Effects of Anthropogenic Sound on Marine Mammals-Acoustic...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-27

    ... (NOAA), Commerce. ACTION: Notice; request for comments. SUMMARY: The National Marine Fisheries Service... Oceanic and Atmospheric Administration (NOAA)), announces the availability of draft guidance for assessing the effects of anthropogenic sound on marine mammal species under NOAA's jurisdiction. The...

  16. 75 FR 8046 - National Environmental Policy Act (NEPA) Draft Guidance, “NEPA Mitigation and Monitoring.”

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-23

    ... to harmonize our economic, environmental, and social aspirations and is a cornerstone of our Nation's... From the Federal Register Online via the Government Publishing Office COUNCIL ON ENVIRONMENTAL QUALITY National Environmental Policy Act (NEPA) Draft Guidance, ``NEPA Mitigation and...

  17. 78 FR 74154 - Draft Guidance for Industry on Size, Shape, and Other Physical Attributes of Generic Tablets and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-10

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft...

  18. 78 FR 72901 - Draft Guidance; Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-04

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance; Pharmacy Compounding of Human Drug Products... Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act''. The draft... Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, suite 5100, Silver...

  19. 75 FR 54347 - Draft Guidance for Industry: Bar Code Label Requirements-Questions and Answers (Question 12...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-07

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Bar Code Label Requirements-- Questions and Answers (Question 12 Update); Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft...

  20. 78 FR 37230 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-20

    ... reference listed drugs and dosage forms) For a complete history of previously published Federal Register... access to the Internet may obtain the document at either http://www.fda.gov/Drugs/GuidanceCompliance...

  1. 77 FR 74669 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-17

    ... Risedronate sodium T Tacrolimus Thalidomide Tinidazole For a complete history of previously published Federal... Persons with access to the Internet may obtain the document at either http://www.fda.gov/Drugs/Guidance...

  2. Turning point or tipping point: new FDA draft guidances and the future of DTC advertising.

    PubMed

    Pitts, Peter J

    2004-01-01

    According to Food and Drug Administration (FDA) research, direct-to-consumer (DTC) drug ads are not as empowering as they were even three years ago. How will the FDA's new draft guidances reverse this trend and affect the future of DTC advertising? Will they be a turning point, resulting in pharmaceutical companies' embracing an educational public health imperative, or a tipping point with politicians and the public zeroing in on aggressively targeted DTC ads as the postimportation pharmaceutical bête noire? The FDA believes that its new guidances strengthen the strategic argument that a better-informed consumer lays the groundwork for a better potential customer.

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

    NASA Technical Reports Server (NTRS)

    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.

  4. 77 FR 56851 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-14

    ... the public on FDA's Web site at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation...'s Web site and announced periodically in the Federal Register. The public is encouraged to submit... being posted on FDA's Web site concurrently with publication of this notice. II. Drug Products for Which...

  5. 75 FR 75482 - Draft Guidance for Industry on Residual Solvents in Animal Drug Products; Questions and Answers...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-03

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Residual Solvents in Animal... guidance for industry 211 entitled ``Residual Solvents in Animal Drug Products; Questions and Answers... Chapter Residual Solvents that applies to both human and veterinary drugs and to compendial and...

  6. 76 FR 51038 - Draft Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-17

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells; Withdrawal of... Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally...

  7. 76 FR 55384 - External Peer Review Meeting for the Draft Guidance of Applying Quantitative Data To Develop Data...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-07

    ... AGENCY External Peer Review Meeting for the Draft Guidance of Applying Quantitative Data To Develop Data... Protection Agency (EPA). ACTION: Notice. SUMMARY: EPA is announcing that Eastern Research Group, Inc. (ERG..., ``Guidance for Applying Quantitative Data to Develop Data-Derived Extrapolation Factors for Interspecies...

  8. 78 FR 9396 - Draft Guidance for Industry on Alzheimer's Disease: Developing Drugs for the Treatment of Early...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-08

    ... a draft guidance for industry entitled ``Alzheimer's Disease: Developing Drugs for the Treatment of... entitled ``Alzheimer's Disease: Developing Drugs for the Treatment of Early Stage Disease.'' This guidance... developing drugs for the treatment of early Alzheimer's disease. It does not create or confer any rights...

  9. 76 FR 13629 - Revised Draft Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-14

    ... Development (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401... Food, Drug, and Cosmetic Act (the FD&C Act). This revised draft guidance describes the types of waivers...ComplianceRegulatoryInformation/Guidances/default.htm ,...

  10. 76 FR 77542 - Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian Use Device...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-13

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... guidance for industry and FDA staff entitled ``Humanitarian Use Device (HUD) Designations.'' Devices are... HUD designation may be eligible for marketing approval under the Humanitarian Device Exemption...

  11. 76 FR 72006 - Draft Interim Staff Guidance: Evaluations of Uranium Recovery Facility Surveys of Radon and Radon...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-21

    ... COMMISSION Draft Interim Staff Guidance: Evaluations of Uranium Recovery Facility Surveys of Radon and Radon... Recovery Facility Surveys of Radon and Radon Progeny in Air and Demonstrations of Compliance with 10 CFR 20... that existing guidance does not sufficiently detail how the NRC staff reviews surveys of radon and...

  12. 76 FR 67764 - Common-Cause Failure Analysis in Event and Condition Assessment: Guidance and Research, Draft...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-02

    ... COMMISSION Common-Cause Failure Analysis in Event and Condition Assessment: Guidance and Research, Draft...-xxxx, Revision 0, ``Common-Cause Failure Analysis in Event and Condition Assessment: Guidance and... at (301) 492-3446. FOR FURTHER INFORMATION CONTACT: Song-Hua Shen, Division of Risk Analysis,...

  13. 78 FR 54899 - Draft Guidance for Industry on Specification of the Unique Facility Identifier System for Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-06

    ... Facility Identifier System for Drug Establishment Registration; Availability AGENCY: Food and Drug...) System for Drug Establishment Registration.'' This draft guidance specifies the UFI system for... and Innovation Act (FDASIA). DATES: Although you can comment on any guidance at any time (see 21 CFR...

  14. 76 FR 78670 - Draft Guidance for Industry and Food and Drug Administration Staff; Evaluation of Sex Differences...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-19

    ... Staff; Evaluation of Sex Differences in Medical Device Clinical Studies; Availability AGENCY: Food and... the availability of the draft guidance entitled ``Evaluation of Sex Differences in Medical Device Clinical Studies.'' This document provides guidance on the study and evaluation of sex differences in...

  15. 75 FR 53316 - Draft Guidance for Food and Drug Administration Staff and Tobacco Retailers on Civil Money...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-31

    ... Tobacco Retailers on Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers; Availability...) is announcing the availability of a draft guidance entitled ``Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers.'' This guidance document is intended to describe FDA's current...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-07

    ... Controls Guidance Document: In Vitro Diagnostic Devices for Yersinia Species Detection; Availability AGENCY... Vitro Diagnostic Devices for Yersinia Species Detection.'' This draft guidance document describes a means by which in vitro diagnostic devices for Yersinia species (spp.) detection may comply with the...

  17. 76 FR 72725 - Draft License Renewal Interim Staff Guidance LR-ISG-2011-05: Ongoing Review of Operating Experience

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-25

    ... Experience AGENCY: Nuclear Regulatory Commission. ACTION: Revision of draft interim staff guidance; request... Guidance (LR-ISG), LR-ISG-2011-05, ``Ongoing Review of Operating Experience.'' This LR-ISG provides... experience as an attribute of aging management programs used at nuclear power plants. As noticed on September...

  18. 75 FR 21632 - Draft Guidance for Industry and Food and Drug Administration Staff; Total Product Life Cycle...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-26

    ... Staff; Total Product Life Cycle: Infusion Pump--Premarket Notification Submissions; Availability AGENCY... announcing the availability of the draft guidance document entitled ``Total Product Life Cycle: Infusion Pump... external infusion pumps. DATES: Although you can comment on any guidance at any time (see 21 CFR...

  19. 78 FR 14305 - Draft Guidance for Industry and Food and Drug Administration Staff; Types of Communication During...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-05

    ... the Committee on Energy and Commerce of the U.S. House of Representatives setting out the goals of... considers your comment on this draft guidance before it begins work on the final version of the guidance... comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of...

  20. 77 FR 10536 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-22

    ... history of previously published Federal Register notices relating to product-specific BE recommendations.... VI. Electronic Access Persons with access to the Internet may obtain the document at either http...

  1. 76 FR 60937 - Draft License Renewal Interim Staff Guidance LR-ISG-2011-02; Aging Management Program for Steam...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-30

    ... Generators AGENCY: Nuclear Regulatory Commission. ACTION: Request for public comment. SUMMARY: The U.S...), LR-ISG-2011-02, ``Aging Management Program for Steam Generators,'' for public comment. This Draft LR... steam generator aging. The Draft LR-ISG revises the NRC staff's aging management recommendations...

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

    PubMed

    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.

  3. 77 FR 36273 - Public Meeting on Draft Permitting Guidance for Oil and Gas Hydraulic Fracturing Activities Using...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-18

    ...The Environmental Protection Agency (EPA or agency) is announcing a public meeting to discuss draft permitting guidance the agency has developed on the use of diesel fuels in oil and gas hydraulic fracturing and to solicit input during the public comment period. The meeting is open to all interested parties. The agency requests input on the following technical aspects of the draft permitting guidance: Diesel fuels description; diesel fuels usage information; permit duration and well closure; area of review; information submitted with the permit application; and monitoring.

  4. The New US Preventive Services Task Force "C" Draft Recommendation for Prostate Cancer Screening.

    PubMed

    Cooperberg, Matthew R

    2017-09-01

    The US Preventive Services Task Force has issued a new draft guideline, with a "C" recommendation that men aged 55-69 yr should be informed about the benefits and harms of screening for prostate cancer, and offered prostate-specific antigen testing if they choose it. For men aged ≥70 yr, the recommendation remains "D", or "do not screen." This draft represents substantial progress in the right direction towards offering men a fair opportunity to discuss the risks and benefits of screening with their primary care providers. However, the evidence review underlying the draft remains fundamentally inadequate, leading to biased presentations of both benefits and harms of screening. The final guideline and future revisions should reflect formal engagement with subject matter experts to optimize the advise given to men and their physicians. Copyright © 2017 European Association of Urology. Published by Elsevier B.V. All rights reserved.

  5. 75 FR 42098 - International Conference on Harmonisation; Draft Recommendation for the Revision of the Permitted...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-20

    ... Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH... solvents are considered safe in pharmaceuticals. The guidance recommends use of less toxic solvents and...

  6. 77 FR 48990 - Draft Guidance for Industry: Necessity of the Use of Food Categories in Food Facility...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-15

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Necessity of the Use of Food Categories in Food Facility Registrations and Updates to Food Categories; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the...

  7. 78 FR 18273 - Draft Guidance for Industry on Purchasing Reef Fish Species Associated With the Hazard of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-26

    ... Reef Fish Species Associated With the Hazard of Ciguatera Fish Poisoning; Availability AGENCY: Food and...: Purchasing Reef Fish Species Associated With the Hazard of Ciguatera Fish Poisoning.'' The draft guidance, when finalized, will advise primary seafood processors who purchase reef fish how to minimize the...

  8. 75 FR 22599 - Draft Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-29

    ... classification decisions and do not constitute FDA clearance or approval for marketing. Classification decisions and clearance or approval for marketing require submissions under different sections of the act... techniques, when appropriate, and other forms of information technology. Title: Draft Guidance for Industry...

  9. 75 FR 78705 - Issuance of Exposure Drafts on Implementation Guidance on the Accounting for the Disposal of G-PP...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-16

    ... From the Federal Register Online via the Government Publishing Office FEDERAL ACCOUNTING STANDARDS ADVISORY BOARD Issuance of Exposure Drafts on Implementation Guidance on the Accounting for the Disposal of... Accounting Standards Advisory Board. ACTION: Notice. Board Action: Pursuant to 31 U.S.C. 3511(d), the Federal...

  10. 78 FR 38349 - Draft Guidance for Industry on Expedited Programs for Serious Conditions-Drugs and Biologics...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-26

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Expedited Programs for Serious Conditions--Drugs and Biologics; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a...

  11. 78 FR 9396 - Draft Guidance for Industry and Food and Drug Administration Staff; Civil Money Penalties for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-08

    ... Staff; Civil Money Penalties for Tobacco Retailers: Responses to Frequently Asked Questions... Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Civil Money... responses to questions FDA has received regarding the issuance of civil money penalties for violations of...

  12. 76 FR 81511 - Draft Guidance for Industry and Food and Drug Administration Staff; Center for Devices and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-28

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Center for Devices and Radiological Health Appeals Processes; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing...

  13. 75 FR 45640 - Draft Guidance for Industry on Residual Drug in Transdermal and Related Drug Delivery Systems...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-03

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Residual Drug in Transdermal and Related Drug Delivery Systems; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a...

  14. 77 FR 7166 - Draft Guidance for Industry on Determining the Extent of Safety Data Collection Needed in Late...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-10

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Determining the Extent of...; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug... certain aspects of a drug's safety profile will be sufficiently well-established that comprehensive...

  15. 78 FR 78366 - Draft Guidance for Industry on Naming of Drug Products Containing Salt Drug Substances; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-26

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Naming of Drug Products Containing Salt Drug Substances.'' The United States Pharmacopeial (U.S.P.) Convention has adopted a monograph naming policy that changed the nomenclature for compendial drug products that contain a salt. Under the new policy, drug names and strengths for......

  16. 76 FR 51993 - Draft Guidance for Industry and Food and Drug Administration Staff on In Vitro Companion...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-19

    ... HUMAN SERVICES Food and Drug Administration 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 of comment period. SUMMARY: The Food and Drug Administration (FDA...

  17. 78 FR 68459 - Medical Device Development Tools; Draft Guidance for Industry, Tool Developers, and Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-14

    ... HUMAN SERVICES Food and Drug Administration 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 and Drug Administration (FDA) is announcing the...

  18. 77 FR 14811 - Draft Guidance for Industry on Direct-to-Consumer Television Advertisements-the Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-13

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Direct-to-Consumer Television Advertisements--the Food and Drug Administration Amendments Act of 2007 Direct-to-Consumer Television Ad Pre... entitled ``Direct-to- Consumer Television Advertisements--FDAAA DTC Television Ad Pre- Dissemination Review...

  19. 76 FR 24494 - Draft Guidance for Industry and FDA Staff: Processing/Reprocessing Medical Devices in Health Care...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-02

    .../ Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling; Availability AGENCY... Staff: Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling... ``Draft Guidance for Industry and FDA Staff: Processing/Reprocessing Medical Devices in Health Care...

  20. 77 FR 9946 - Draft Guidance for Industry on Drug Interaction Studies-Study Design, Data Analysis, Implications...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-21

    ... HUMAN SERVICES Food and Drug Administration (Formerly Docket No. 2006D-0344) Draft Guidance for Industry on Drug Interaction Studies--Study Design, Data Analysis, Implications for Dosing, and Labeling... entitled ``Drug Interaction Studies--Study Design, Data Analysis, Implications for Dosing, and...

  1. 76 FR 50483 - Draft Guidance for Industry and Food and Drug Administration Staff; Factors to Consider When...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-15

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Review; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-18

    ... Bacillus Species Detection AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability.... Detection.'' This draft guidance document describes means by which in vitro diagnostic devices for Bacillus species (spp.) detection may comply with the requirement of special controls for class II devices...

  3. 77 FR 37059 - Draft Guidance for Industry on Active Controls in Studies To Demonstrate Effectiveness of a New...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-20

    ... a New Animal Drug for Use in Companion Animals; Availability AGENCY: Food and Drug Administration... of a New Animal Drug for Use in Companion Animals.'' This draft guidance advises industry on the use of active controls in studies intended to provide substantial evidence of effectiveness of new animal...

  4. 77 FR 63837 - Draft Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-17

    ... solely on the paper version. This draft guidance is not final nor is it in effect at this time. DATES... rather than relying solely on the paper version. The eCopy Program is not intended to impact (reduce or... approval. An eCopy is defined as an exact duplicate of the paper submission, created and submitted on a...

  5. 77 FR 41413 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices: The Pre...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-13

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... establishment in 1995, the pre-IDE program has been a successful resource for both medical device applicants and... clinical studies conducted outside of the United States to support future U.S. marketing applications (Ref...

  6. 78 FR 60292 - Draft Guidance for Industry on Abbreviated New Drug Application Submissions-Refuse-to-Receive...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-01

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Abbreviated New Drug Application Submissions--Refuse-to-Receive Standards; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a...

  7. 76 FR 22903 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing That a Tobacco...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-25

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... Request AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug... February 15, 2007'' to the Center for Tobacco Products, Food and Drug Administration, 9200 Corporate...

  8. 77 FR 37058 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-20

    ...] [FR Doc No: 2012-15025] 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...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA)...

  9. 77 FR 51814 - Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-27

    ... effective generic drugs to the public and reduce costs to industry. GDUFA enables FDA to assess user fees to... safe and effective generic drugs to the public and reduce costs to industry. GDUFA enables FDA to... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Generic Drug User...

  10. 76 FR 3144 - Draft Guidance for Industry on Size of Beads in Drug Products Labeled for Sprinkle; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-19

    ... licensing applications (BLAs) the Center for Drug Evaluation and Research's (CDER's) current thinking on... provides sponsors of NDAs, ANDAs, and BLAs CDER's current thinking on appropriate size ranges for beads in...). The draft guidance, when finalized, will represent the Agency's current thinking on size of beads in...

  11. 77 FR 45357 - Draft Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Review...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-31

    ... HUMAN SERVICES Food and Drug Administration 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. ] SUMMARY: The Food and Drug Administration (FDA) is...

  12. 78 FR 20116 - Draft Guidance for Industry and Food and Drug Administration Staff; Glass Syringes for Delivering...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-03

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Glass Syringes for Delivering Drug and Biological Products: Technical Information To Supplement International Organization for Standardization Standard 11040-4; Availability AGENCY: Food and Drug...

  13. 77 FR 40354 - Permitting Guidance for Oil and Gas Hydraulic Fracturing Activities Using Diesel Fuels-Draft

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-09

    ...EPA published on May 10, 2012, Permitting Guidance for Oil and Gas Hydraulic Fracturing Activities Using Diesel Fuels--Draft. The initial public comment period for this proposal was 60 days, ending on July 9, 2012. In response to requests from several stakeholders, this action extends the public comment period for an additional 45 days.

  14. 78 FR 42086 - Draft Guidance for Industry on Arsenic in Apple Juice: Action Level; Supporting Document for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-15

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Arsenic in Apple Juice: Action Level; Supporting Document for Action Level for Arsenic in Apple Juice; A Quantitative Assessment of Inorganic Arsenic in Apple Juice; Availability AGENCY: Food and Drug Administration, HHS. ACTION...

  15. 78 FR 56719 - Draft Guidance for Industry on Arsenic in Apple Juice: Action Level; Supporting Document for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-13

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Arsenic in Apple Juice: Action Level; Supporting Document for Action Level for Arsenic in Apple Juice; A Quantitative Assessment of Inorganic Arsenic in Apple Juice; Extension of Comment Period AGENCY: Food and Drug Administration...

  16. 77 FR 48159 - Draft Guidance for Industry and Food and Drug Administration Staff; Refuse To Accept Policy for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-13

    ... Staff; Refuse To Accept Policy for 510(k)s; Availability AGENCY: Food and Drug Administration, HHS... draft guidance entitled ``Refuse to Accept Policy for 510(k)s.'' The purpose of this document is to... (510(k)) submission is administratively complete, which determines whether it should be accepted...

  17. 76 FR 44935 - Draft Guidance for Industry and Food and Drug Administration Staff; 510(k) Device Modifications...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-27

    ...] [FR Doc No: 2011-18923] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0453] Draft Guidance for Industry and Food and Drug Administration Staff; 510(k... AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA...

  18. 76 FR 6143 - Draft Guidance for Industry on “Target Animal Safety and Effectiveness Protocol Development and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-03

    ... No: 2011-2315] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA... Development and Submission,'' Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry...

  19. 76 FR 69274 - Draft Guidance for Industry and Food and Drug Administration Staff; 510(k) Device Modifications...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-08

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration...; Availability; Reopening of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; reopening of comment period. SUMMARY: The Food and Drug Administration (FDA) is reopening until November 28...

  20. 78 FR 31944 - International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-28

    ... HUMAN SERVICES Food and Drug Administration International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on... for Drug Evaluation and Research, International Programs, Food and Drug Administration, 10903...

  1. Older Adults Need Guidance to Meet Nutritional Recommendations

    PubMed Central

    Foote, Janet A.; Giuliano, Anna R.; Harris, Robin B.

    2009-01-01

    Objective The purpose of this study was to compare the diet of healthy, free-living senior volunteers to the dietary reference intakes (DRIs) and Food Guide Pyramid recommendations. Methods This study was a cross-sectional assessment of dietary habits, as measured using a standardized food frequency questionnaire, among 1740 healthy Southwestern U.S. adults, aged 51 to 85 years. Assessment of independently-living volunteers to chemoprevention trials provides an efficient mechanism to profile typical dietary habits among the older adult population. Results Daily estimated macronutrient intakes exceeded recommended proportions of protein and fat. In contrast, more than 60% of this senior population reported dietary vitamin D, vitamin E, folate and calcium intakes below estimated average requirements (EAR). Based on the Food Guide Pyramid recommendations, fewer than 10% of the older adults consumed the recommended daily dairy and grain servings. More females than males consumed recommended vegetable (49% versus 40%) and fruit (53% versus 48%) servings (p <, 0.05). More males consumed recommended grain (11% versus 7%) and protein (78% versus 73%) servings (p <, 0.05) than females. Conclusions Mean micronutrient intakes compared well with DRIs, although fewer than one-half of these older adults consumed recommended levels for vitamin D, vitamin E, folate, and calcium or daily food servings of dairy, grains, vegetables or fruits. Since the beneficial aspects of foods are not limited to essential nutrients, nutrition recommendations to older adults may be improved by emphasizing daily servings of nutrient-dense choices within the Food Pyramid. PMID:11022877

  2. 75 FR 33311 - Guidance for Industry on Bioequivalence Recommendations for Specific Products; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-11

    ... describes a new process for making available recommendations on how to design product- specific... FDA Web site. FDA believes that making this information available on the Internet will streamline the... guidance describes a new process for making available recommendations on how to design product-specific...

  3. 78 FR 63221 - International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-23

    ... Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on... availability of a guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the... ICH Q4B evaluation of the Bacterial Endotoxins Test General Chapter harmonized text from each of...

  4. 77 FR 22327 - Draft Guidance for Industry on New Animal Drugs and New Animal Drug Combination Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-13

    ... Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing... Drinking Water of Food- Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning... in or on medicated feed or in drinking water of food-producing animals. The purpose of this draft...

  5. 78 FR 39736 - Draft Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-02

    ... of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; Availability AGENCY: Food and... Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products'' dated July 2013. The draft... (CT) and gene therapy (GT) products (referred to collectively as CGT products) with recommendations to...

  6. 75 FR 13765 - Draft Guidance for Industry on Irritable Bowel Syndrome-Clinical Evaluation of Products for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-23

    ... of primary endpoints for IBS clinical trials, interim recommendations for IBS clinical trial design... clinical trials. This guidance is intended to assist the pharmaceutical industry and other investigators... on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your...

  7. Draft Area Recommendation Report for the Crystalline Repository Project: Overview. [Second repository

    SciTech Connect

    1986-01-01

    The draft Area Recommendation Report (ARR) for the Crystalline Repository Project identifies portions of crystalline rock bodies as proposed potentially acceptable sites for the Nation's second repository for deep geologic burial of high-level radioactive waste and spent nuclear fuel. This Overview provides a brief summary of that report. The US Department of Energy (DOE) evaluated available geologic and environmental data for 235 crystalline rock bodies in the North Central, Northeastern, and Southeastern Regions to identify preliminary candidate areas. The 12 proposed potentially acceptable sites are located in the States of Georgia (1), Maine (2), Minnesota (3), New Hampshire (1), North Carolina (2), Virginia (2), and Wisconsin (1). The data, analyses and rationale pertaining to the identification of the 12 proposed potentially acceptable sites are presented in the draft ARR. The analyses presented in the draft ARR demonstrate that the evidence available for each proposed potentially acceptable site supports (1) a finding that the site is not disqualified under Appendix III of the DOE Siting Guidelines and (2) a decision to proceed with the continued investigation of the site on the basis of the favorable and potentially adverse conditions identified to date. These potentially acceptable sites will be investigated and evaluated in more detail during the area phase of the siting process and considered along with other candidate sites in a progressive narrowing process to finally choose the site of the second repository in 1998.

  8. 78 FR 21128 - Molecular Diagnostic Instruments With Combined Functions; Draft Guidance for Industry and Food...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-09

    ... instrument that measures or characterizes nucleic acid analytes and has combined functions. This draft... assays that measure or characterize nucleic acid analytes, human or microbial, and that combine...

  9. 77 FR 71194 - Draft Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-29

    ...). The product areas covered by this guidance are cellular therapy, gene therapy, therapeutic vaccination..., therapeutic vaccination, and xenotransplantation. The guidance is intended to clarify current...

  10. 78 FR 68030 - Draft Guidance on Intellectual Property Rights for the National Network for Manufacturing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-13

    ... National Network for Manufacturing Innovation and Draft Institute Performance Metrics for the National Network for Manufacturing Innovation AGENCY: National Institute of Standards and Technology, Department of Commerce. ACTION: Notice. SUMMARY: The Advanced Manufacturing National Program Office (AMNPO), hosted...

  11. 77 FR 11133 - Draft Guidance for Industry on Complicated Urinary Tract Infections: Developing Drugs for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-24

    ... Infections: Developing Drugs for Treatment; Availability AGENCY: Food and Drug Administration, HHS. ACTION... guidance for industry entitled ``Complicated Urinary Tract Infections: Developing Drugs for Treatment... treatment of complicated urinary tract infections (cUTIs). Specifically, this guidance addresses...

  12. 76 FR 64353 - Request for Public Comment on Draft Document: “Criteria for a Recommended Standard: Occupational...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-18

    ... Occupational Safety and Health, Centers for Disease Control and Prevention. BILLING CODE 4163-19-P ... HUMAN SERVICES Centers for Disease Control and Prevention Request for Public Comment on Draft Document: ``Criteria for a Recommended Standard: Occupational Exposure to Diacetyl and 2,3- pentanedione''; Extension...

  13. Central European Vaccination Advisory Group (CEVAG) guidance statement on recommendations for the introduction of HPV vaccines.

    PubMed

    Prymula, Roman; Anca, Ioana; André, Francis; Bakir, Mustafa; Czajka, Hanna; Lutsar, Irja; Mészner, Zsófia; Salman, Nuran; Simurka, Pavol; Usonis, Vytautas

    2009-09-01

    Vaccines against human papillomavirus (HPV), the primary causative agent in cervical cancer, are licensed. This paper contains the Central European Vaccination Advisory Group (CEVAG) guidance statement on the introduction of HPV vaccines in central Europe. Eight countries currently have medical representatives on CEVAG: the Czech Republic, Estonia, Hungary, Lithuania, Poland, Romania, Slovakia and Turkey. By raising awareness and disseminating information, CEVAG aims to promote the efficient and safe use of vaccines to prevent, control and if possible eliminate infectious diseases. In January 2008, the European Centre for Disease Prevention and Control published a report entitled Guidance for the Introduction of HPV Vaccines in EU Countries. Members of CEVAG have taken the information relevant to their countries from this report and, with consideration of local issues, produced these guidance recommendations for the introduction of HPV vaccines in the CEVAG region, which may be adapted for use in individual countries.

  14. Twelve recommendations for integrating existing systematic reviews into new reviews: EPC guidance.

    PubMed

    Robinson, Karen A; Chou, Roger; Berkman, Nancy D; Newberry, Sydne J; Fu, Rongwei; Hartling, Lisa; Dryden, Donna; Butler, Mary; Foisy, Michelle; Anderson, Johanna; Motu'apuaka, Makalapua; Relevo, Rose; Guise, Jeanne-Marie; Chang, Stephanie

    2016-02-01

    As time and cost constraints in the conduct of systematic reviews increase, the need to consider the use of existing systematic reviews also increases. We developed guidance on the integration of systematic reviews into new reviews. A workgroup of methodologists from Evidence-based Practice Centers developed consensus-based recommendations. Discussions were informed by a literature scan and by interviews with organizations that conduct systematic reviews. Twelve recommendations were developed addressing selecting reviews, assessing risk of bias, qualitative and quantitative synthesis, and summarizing and assessing body of evidence. We provide preliminary guidance for an efficient and unbiased approach to integrating existing systematic reviews with primary studies in a new review. Copyright © 2016 Elsevier Inc. All rights reserved.

  15. 78 FR 63476 - Draft Guidance for Industry: Use of Nucleic Acid Tests To Reduce the Risk of Transmission of West...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-24

    ... Reduce the Risk of Transmission of West Nile Virus From Donors of Human Cells, Tissues, and Cellular and... ``Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus From... donors of HCT/Ps, with recommendations for donor testing for West Nile Virus (WNV) using an FDA-licensed...

  16. 76 FR 27331 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-11

    .... trachomatis and/or N. gonorrhoeae screening and diagnostic testing using nucleic acid based assays. This draft.... trachomatis and/or N. gonorrhoeae screening and diagnostic testing using nucleic acid based assays. These... characteristics of devices that detect chlamydial and/or gonococcal nucleic acid. It does not address detection...

  17. 77 FR 70167 - Draft Guidance for Industry on Vaginal Microbicides: Development for the Prevention of Human...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-23

    ... of HIV Infection.'' The purpose of this guidance is to assist sponsors in all phases of development of vaginal microbicides for the prevention of human immunodeficiency virus (HIV) infection. The... guidance for industry entitled ``Vaginal Microbicides: Development for the Prevention of HIV...

  18. 76 FR 52958 - Draft Guidance for Industry on Neglected Tropical Diseases of the Developing World: Developing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-24

    ... of the Developing World: Developing Drugs for Treatment or Prevention; Availability AGENCY: Food and... Developing World: Developing Drugs for Treatment or Prevention.'' The purpose of this guidance is to assist... developing world. Specifically, this guidance addresses FDA's current thinking regarding the overall drug...

  19. Why Career Information, Guidance and Counselling Matter for Public Policy. Working Draft.

    ERIC Educational Resources Information Center

    Organisation for Economic Cooperation and Development, Paris (France).

    Well-organized career information, guidance, and counseling services are important both to education systems, the labor market, and their interface. Career education is important within compulsory education because it lays the foundations for lifelong career development. In postcompulsory education, well-organized career information, guidance, and…

  20. 75 FR 1790 - Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: IRB...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-13

    ... review responsibility by providing recommendations regarding the criteria, process, and frequency of... recommendations regarding the criteria, process, and frequency of continuing review to assure the protection of...

  1. 78 FR 32668 - Draft Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-31

    ..., including Source Plasma, with recommendations intended to assist with determining which reporting mechanism..., including Source Plasma, with recommendations intended to assist with determining which reporting...

  2. Draft Guidance on EPA’s Section 8(a) Information Gathering Rule on Nanomaterials in Commerce

    EPA Pesticide Factsheets

    This guidance provides answers to questions the Agency has received from manufacturers (includes importers) and processors of certain chemical substances when they are manufactured or processed at the nanoscale as described in the final rule.

  3. 78 FR 17943 - Draft Program-Specific Guidance About Fixed Gauge Licenses

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-25

    ... safety culture, security of radioactive materials, protection of sensitive information, and changes in... NUREG-1556, Volume 4, Revision 1, ``Consolidated Guidance About Materials Licenses: Program-Specific... Materials and Environmental Management Programs; U.S. Nuclear Regulatory Commission, Washington, DC...

  4. 78 FR 36196 - Draft Guidance for Industry: Biologics License Applications for Minimally Manipulated, Unrelated...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-17

    ... for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for...: Biologics License Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord.../umbilical cord blood, for hematopoietic and immunologic reconstitution. The guidance document is intended to...

  5. 75 FR 32493 - NUREG-0654/FEMA-REP-, Rev. 1, Supplement 3, Guidance for Protective Action Recommendations for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-08

    ... SECURITY Federal Emergency Management Agency NUREG-0654/FEMA-REP-, Rev. 1, Supplement 3, Guidance for... be held to discuss the proposed Supplement 3 to NUREG-0654/FEMA-REP-1, Rev.1, Guidance for Protective Action Recommendations for General Emergencies (NUREG Supp 3). NUREG Supp 3 addresses onsite and...

  6. 75 FR 10524 - NUREG-0654/FEMA-REP-1, Rev. 1, Supplement 3, Guidance for Protective Action Recommendations for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-08

    ... COMMISSION NUREG-0654/FEMA-REP-1, Rev. 1, Supplement 3, Guidance for Protective Action Recommendations for... document entitled: ``NUREG-0654/FEMA-REP-1, Rev. 1, Supplement 3, Guidance for Protective Action...-4737, or by e-mail to pdr.resource@nrc.gov . NUREG-0654/FEMA-REP-1, Rev. 1, Supplement 3,...

  7. 75 FR 27840 - NUREG-0654/FEMA-REP-1, Rev. 1, Supplement 3, Guidance for Protective Action Recommendations for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-18

    ...: 2010-11842] NUCLEAR REGULATORY COMMISSION [NRC-2010-0080] NUREG-0654/FEMA-REP-1, Rev. 1, Supplement 3...: ``NUREG-0654/FEMA-REP-1, Rev. 1, Supplement 3, Guidance for Protective Action Recommendations for General... the existing guidance contained in Supplement 3 to NUREG- 0654/FEMA-REP-1, Rev. 1, ``Criteria...

  8. 76 FR 1173 - Draft Guidance for Industry on Electronic Source Documentation in Clinical Investigations...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-07

    ... guidance to sponsors, contract research organizations (CROs), data management centers, and clinical investigators on capturing, using, and archiving electronic data in FDA-regulated clinical investigations. It... traceability of electronic source data and source records maintained at the site for FDA inspection....

  9. 76 FR 34715 - Draft Guidance for Industry; Considering Whether an FDA-Regulated Product Involves the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-14

    ...-Regulated Product Involves the Application of Nanotechnology; Availability AGENCY: Food and Drug... the Application of Nanotechnology''. This guidance is intended to provide industry with FDA's current... nanotechnology. The points to consider are intended to be broadly applicable to all FDA-regulated products, with...

  10. 78 FR 20926 - Draft Guidance for Industry on Providing Postmarket Periodic Safety Reports in the International...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-08

    ... Safety Reports in the International Conference on Harmonisation E2C(R2) Format (Periodic Benefit-Risk... ``Providing Postmarket Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report).'' This guidance is intended to inform applicants of the conditions under which FDA will...

  11. 75 FR 54889 - Draft Guidance for Industry on Suicidality: Prospective Assessment of Occurrence in Clinical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-09

    ... guidance addresses FDA's current thinking regarding the importance of suicidality assessment in psychiatric... current thinking regarding the importance of suicidality assessment in psychiatric and nonpsychiatric drug... patients about the occurrence of suicidal thinking and behavior, rather than relying on patients to report...

  12. 77 FR 48989 - Draft Guidance for Industry on Suicidal Ideation and Behavior: Prospective Assessment of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-15

    ... Behavior: Prospective Assessment of Occurrence in Clinical Trials; Availability AGENCY: Food and Drug... of Occurrence in Clinical Trials.'' The purpose of this guidance is to assist sponsors in prospectively assessing the occurrence of treatment-emergent suicidal ideation and behavior in clinical trials...

  13. 75 FR 63189 - Draft Guidance for Industry on Investigational New Drug Applications-Determining Whether Human...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-14

    ... Applications--Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug... ``Investigational New Drug Applications (INDs)--Determining Whether Human Research Studies Can Be Conducted Without... requirements. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure...

  14. 78 FR 7786 - International Conference on Harmonisation; Draft Guidance on S10 Photosafety Evaluation of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-04

    ... and marketing authorization for pharmaceuticals. DATES: Although you can comment on any guidance at... Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD... Drug Evaluation and Research (ONDIO), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22...

  15. 77 FR 7586 - Draft Guidance for Industry on Bioequivalence Recommendation for Nitroglycerin Metered Spray...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-13

    ... attack or prophylaxis of angina pectoris due to coronary artery disease. Nitromist (nitroglycerin lingual... attack or acute prophylaxis of angina pectoris due to coronary artery disease. Nitrolingual Pumpspray...

  16. 78 FR 69693 - Draft Guidance for Industry: Recommendations for Premarket Notification (510(k)) Submissions for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-20

    ... Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen Test Kits Used for Matching of... (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Matching...) submissions for nucleic acid-based HLA test kits used for matching of donors and recipients in transfusion...

  17. 78 FR 15370 - Draft Guidance for Industry and Food and Drug Administration Staff: Recommendations for Labeling...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-11

    ... Container Is Not Made With Natural Rubber Latex; Availability AGENCY: Food and Drug Administration, HHS... to include in the labeling of a medical product to convey that natural rubber latex was not used as a... for inclusion in medical product labeling such as ``latex-free,'' ``does not contain natural...

  18. 76 FR 78659 - Solicitation of Written Comments on the Draft Report and Draft Recommendations of the Healthcare...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-19

    ... Healthcare Personnel Influenza Vaccination Subgroup for Consideration by the National Vaccine Advisory Committee on Achieving the Healthy People 2020 Annual Coverage Goals for Influenza Vaccination in Healthcare... recommended strategies for annually achieving 90% influenza vaccination coverage among healthcare...

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

    SciTech Connect

    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.

  20. Draft Guidance: Response, Restoration, and Recovery Checklist for Biologically Contaminated Facilities

    SciTech Connect

    Mancieri, S; Raber, E; Carlsen, T; Fish, C; MacQueen, D; Hoppes, W; Bunt, T; Intrepido, A; Wilson, W; James, S; Richards, J; Dzenitis, J; Folks, K

    2006-08-15

    The Checklist for Facility Response, Restoration, and Recovery presented in this document is principally focused on the Consequence Management Phase of a biothreat agent (i.e., Bacillus anthracis) release at a large facility, such as an airport or subway. Information in this document conforms to the National Response Plan (NRP) (DHS 2004) and the National Incident Management System (NIMS 2004). Under these two guidance documents, the personnel responsible for managing biological response and recovery efforts--that is, the decision-makers--are members of an Incident Command (IC), which is likely to transition to a Unified Command (UC) in the event of a biological warfare agent attack. A UC is used when more than one agency has incident jurisdiction or when incidents cross political jurisdictions. The location for primary, tactical-level command and management is referred to as the Incident Command Post (ICP), as described in the NRP. Thus, regardless of whether an IC or an UC is used, the responsible entities are located at an ICP. Agencies work together through designated members of the UC to establish their designated Incident Commanders at a single ICP and to establish a common set of objectives and strategies and a single Incident Action Plan. Initially during the Crisis Management Phase, the Incident Commander is likely to be the Chief of the fire department that serves the affected facility. As life-safety issues are resolved and the Crisis Management Phase shifts to the Consequence Management Phase, the work of characterization, decontamination, and facility clearance begins. There will likely be a coincident transition in organizational structure as well, and new restoration-focused groups, units, and personnel will be added as restoration needs are anticipated. Depending on the specific facility and type of incident, the responsible individual (Incident Commander or Unified Commander) within the UC during the Consequence Management Phase could be the

  1. 77 FR 74195 - Draft Guidance for Industry and Food and Drug Administration Staff; Design Considerations for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-13

    ...), the use environment, and the device. This document identifies several factors that manufacturers should consider, especially during device design and development, and provides recommendations for... Communication, Outreach and Development (HFM-40), Center for ] Biologics Evaluation and Research (CBER), Food...

  2. How a patient advocacy group developed the first proposed draft guidance document for industry for submission to the U.S. Food and Drug Administration.

    PubMed

    Furlong, Pat; Bridges, John F P; Charnas, Lawrence; Fallon, Justin R; Fischer, Ryan; Flanigan, Kevin M; Franson, Timothy R; Gulati, Neera; McDonald, Craig; Peay, Holly; Sweeney, H Lee

    2015-06-24

    Among the challenges confronting patients with rare diseases is a dearth of treatment options. The development of safe and effective new therapies is hampered by challenges associated with conducting clinical trials in small populations. In this article, we describe how the Duchenne muscular dystrophy community-led by Parent Project Muscular Dystrophy-created a proposed draft guidance document for industry for submission to the U.S. Food and Drug Administration. This unprecedented undertaking involved a broad coalition of more than 80 stakeholders collaborating across nine time zones to produce a document in only 6 months. We hope that other rare disease communities and advocacy organizations can use our experience as a model for developing their own draft guidance documents.

  3. Request For Guidance in Drafting a SIP Deficiency Notice For Michigan's Nonattainment New Source Review Program

    EPA Pesticide Factsheets

    This document may be of assistance in applying the New Source Review (NSR) air permitting regulations including the Prevention of Significant Deterioration (PSD) requirements. This document is part of the NSR Policy and Guidance Database. Some documents in the database are a scanned or retyped version of a paper photocopy of the original. Although we have taken considerable effort to quality assure the documents, some may contain typographical errors. Contact the office that issued the document if you need a copy of the original.

  4. Draft PSD Guidance for Impacts of the North County Resource Recovery PSD Remand

    EPA Pesticide Factsheets

    This document may be of assistance in applying the New Source Review (NSR) air permitting regulations including the Prevention of Significant Deterioration (PSD) requirements. This document is part of the NSR Policy and Guidance Database. Some documents in the database are a scanned or retyped version of a paper photocopy of the original. Although we have taken considerable effort to quality assure the documents, some may contain typographical errors. Contact the office that issued the document if you need a copy of the original.

  5. The impact of the draft 2005 recommendations of ICRP on secondary derived regulatory values being considered by the US Department of Energy.

    PubMed

    O'Connell, P

    2006-01-01

    The US Department of Energy, Office of Environment, Safety and Health, Office of Health is responsible for maintaining the Department of Energy's occupational radiation protection rule, Title 10 Code of Federal Regulations, Part 835, Occupational Radiation Protection. The Department of Energy is evaluating amending its rule to include the dose assessment methodology recommended in International Commission on Radiological Protection (ICRP) Publications 60 and 68. On 21 June 2004 the ICRP posted their draft, Recommendations of the International Commission on Radiological Protection 2005, which included revisions to the recommended dose assessment methodology. The Department of Energy compared the draft recommendations to determine their effect on the changes the Department of Energy is currently considering.

  6. Central European Vaccination Advisory Group (CEVAG) guidance statement on recommendations for influenza vaccination in children

    PubMed Central

    2010-01-01

    Background Influenza vaccination in infants and children with existing health complications is current practice in many countries, but healthy children are also susceptible to influenza, sometimes with complications. The under-recognised burden of disease in young children is greater than in elderly populations and the number of paediatric influenza cases reported does not reflect the actual frequency of influenza. Discussion Vaccination of healthy children is not widespread in Europe despite clear demonstration of the benefits of vaccination in reducing the large health and economic burden of influenza. Universal vaccination of infants and children also provides indirect protection in other high-risk groups in the community. This paper contains the Central European Vaccination Advisory Group (CEVAG) guidance statement on recommendations for the vaccination of infants and children against influenza. The aim of CEVAG is to encourage the efficient and safe use of vaccines to prevent and control infectious diseases. Summary CEVAG recommends the introduction of universal influenza vaccination for all children from the age of 6 months. Special attention is needed for children up to 60 months of age as they are at greatest risk. Individual countries should decide on how best to implement this recommendation based on their circumstances. PMID:20546586

  7. 75 FR 24718 - Guidance for Industry on Documenting Statistical Analysis Programs and Data Files; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-05

    ... entitled ``Documenting Statistical Analysis Programs and Data Files.'' This guidance is provided to inform study statisticians of recommendations for documenting statistical analyses and data files submitted to... guidance entitled ``Draft Guidance for Industry on Documenting Statistical Analysis Programs and Data Files...

  8. 76 FR 569 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-05

    ... Staff; Establishing the Performance Characteristics of Nucleic Acid- Based In Vitro Diagnostic Devices... ``Establishing the Performance Characteristics of Nucleic Acid-Based In vitro Diagnostic Devices for the... recommendations for studies to establish the analytical and clinical performance of nucleic acid-based in...

  9. 76 FR 44013 - Draft Guidance for Industry: Implementation of Acceptable Full-Length and Abbreviated Donor...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-22

    ... Screening Donors of Source Plasma; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Questionnaires and Accompanying Materials for Use in Screening Donors of Source Plasma'' dated July 2011. The... consistent with FDA's requirements and recommendations for collecting Source Plasma donor history...

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

    NASA Astrophysics Data System (ADS)

    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. Design and analysis of field studies with bees: A critical review of the draft EFSA guidance.

    PubMed

    Bakker, Frank

    2016-07-01

    The specific protection goal, primary assessment endpoints, acceptable effect thresholds, and experimental design proposed in the European Food Safety Authority (EFSA) update of the bee guidance document are subjected to critical review. It is concluded that the negligible effect criteria were established without sufficient regulatory definition and without convincing scientific argumentation. For the assessment endpoints, effects on hive strength lack temporal definition and the reduction to numbers of bees is inappropriate to evaluate effects. Restricting mortality assessments to homing failure is not theoretically justified and specific criteria were incorrectly derived. The combination of acute effect estimates with models for chronic stressors is biased risk assessment and a temporal basis for the acceptability of effects is missing. Effects on overwintering success cannot be experimentally assessed using the proposed criteria. The experimental methodology proposed is inappropriate and the logistical consequences, in particular those related to replication and land use are such that field studies are no longer a feasible option for the risk assessment. It may be necessary to explore new lines of thought for the set-up of field studies and to clearly separate experimentation from monitoring. Integr Environ Assess Manag 2016;12:422-428. © 2015 SETAC. © 2015 SETAC.

  12. Background Report: Recommendations on Guidance for Diagnostic X-Ray Studies in Federal Health Care Facilities

    EPA Pesticide Factsheets

    This document shares the guidance developed by the Interagency Working Group which was formed to develop guidance to reduce unnecessary radiation exposures from the use of x-rays in the healing arts in Federal health care facilities.

  13. Draft Guidance: Response, Remediation, and Recovery Checklist for Chemically Contaminated Facilities

    SciTech Connect

    Raber, E; Mancieri, S; Carlsen, T; Fish, C; Hirabayashi-Dethier, J; Intrepido, A; MacQueen, D; Michalik, R; Richards, J

    2007-09-04

    A key part of preparedness in the event of a chemical warfare agent (CWA) or toxic industrial chemical (TIC) release at a large facility, such as an airport or subway, is to develop a concept of operations that allows for an effective incident response and recovery. This document is intended as a component of the concept of operations and will be used in the Emergency Operations Center (EOC) as a decision tool for the Unified Command (UC). The Checklist for Facility Response, Remediation, and Recovery presented in this document is principally focused on the Consequence Management Phase (see Figure 1; LLNL 2007a and 2007b) of a chemical release. Information in this document conforms to the National Response Plan (NRP) (DHS 2004) and the National Incident Management System (NIMS 2004). Under these two guidance documents, personnel responsible for managing chemical response and recovery efforts--that is, the decision-makers--are members of an Incident Command (IC), which is likely to transition to a UC in the event of a CWA or TIC attack. A UC is created when more than one agency has incident jurisdiction or when incidents cross political jurisdictions. The location for primary, tactical-level command and management is referred to as the Incident Command Post (ICP), as described in the NRP. Thus, regardless of whether an IC or a UC is used, the responsible entities are located at an ICP. Agencies work together through designated members of the UC to establish their designated Incident Commanders at a single ICP and to establish a common set of objectives and strategies and a single Incident Action Plan. Initially during the Crisis Management Phase (see Figure 1), the Incident Commander is likely to be the Chief of the fire department that serves the affected facility. As life-safety issues are resolved and the Crisis Management Phase shifts to the Consequence Management Phase, the work of characterization, decontamination, and facility clearance begins. There will

  14. 78 FR 25758 - Migratory Birds; Eagle Conservation Plan Guidance: Module 1-Land-Based Wind Energy, Version 2

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-02

    ...-- Land-Based Wind Energy, Version 2 AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice of... Guidance: Module 1--Land-based Wind Energy, Version 2 is available. The guidance provides recommendations... issued a draft of The Eagle Conservation Plan Guidance: Module 1-- Land-based Wind Energy for public...

  15. General Drafting. Technical Manual.

    ERIC Educational Resources Information Center

    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…

  16. Recommended electromagnetic operating envelopes for safety-related I and C systems in nuclear power plants: Draft report for comment

    SciTech Connect

    Ewing, P.D.; Wood, R.T.

    1997-12-01

    This document presents recommendations for electromagnetic operating envelopes to augment test criteria and test methods addressing electromagnetic interference (EMI), radio-frequency interference (RFI), and power surges that are applicable to safety-related instrumentation and control (I and C) systems in nuclear power plants. The Oak Ridge National Laboratory (ORNL) was engaged by the US Nuclear Regulatory Commission (NRC) Office of Nuclear Regulatory Research to assist in developing the technical basis for regulatory guidance on EMI/RFI immunity and power surge withstand capability (SWC). Previous research has provided recommendations on electromagnetic compatibility (EMC) design and installation practices, endorsement of EMI/RFI immunity and SWC test criteria and test methods, and determination of ambient electromagnetic conditions at nuclear power plants. The present research involves development of recommended electromagnetic envelopes that are applicable to nuclear power plant locations where safety-related I and C systems either are or may be installed. These recommended envelopes establish both emissions criteria and the levels of radiated and conducted interference that I and C systems should be able to withstand without upset or malfunction. The EMI/RFI operating envelopes are derived from conditions in comparable military environments and are confirmed by comparison with the nuclear power plant electromagnetic environment based on measured plant emissions profiles. Detailed information on specific power surge conditions in nuclear power plants is not available, so industrial guidance on representative surge characteristics for susceptibility testing is adopted. An engineering assessment of the power surge environment in nuclear power plants leads to the recommendation of operating envelopes based on location categories and exposure levels defined in IEEE Std C62.41-1991, IEEE Recommended Practice on Surge Voltages in Low-Voltage AC Power Circuits.

  17. Recommendations for probabilistic seismic hazard analysis: Guidance on uncertainty and use of experts

    SciTech Connect

    1997-04-01

    Probabilistic Seismic Hazard Analysis (PSHA) is a methodology that estimates the likelihood that various levels of earthquake-caused ground motion will be exceeded at a given location in a given future time period. Due to large uncertainties in all the geosciences data and in their modeling, multiple model interpretations are often possible. This leads to disagreement among experts, which in the past has led to disagreement on the selection of ground motion for design at a given site. In order to review the present state-of-the-art and improve on the overall stability of the PSHA process, the U.S. Nuclear Regulatory Commission (NRC), the U.S. Department of Energy (DOE), and the Electric Power Research Institute (EPRI) co-sponsored a project to provide methodological guidance on how to perform a PSHA. The project has been carried out by a seven-member Senior Seismic Hazard Analysis Committee (SSHAC) supported by a large number other experts. The SSHAC reviewed past studies, including the Lawrence Livermore National Laboratory and the EPRI landmark PSHA studies of the 1980`s and examined ways to improve on the present state-of-the-art. The Committee`s most important conclusion is that differences in PSHA results are due to procedural rather than technical differences. Thus, in addition to providing a detailed documentation on state-of-the-art elements of a PSHA, this report provides a series of procedural recommendations. The role of experts is analyzed in detail. Two entities are formally defined-the Technical Integrator (TI) and the Technical Facilitator Integrator (TFI)--to account for the various levels of complexity in the technical issues and different levels of efforts needed in a given study.

  18. Review of ''Draft - Area Recommendation Report for the Crystalline Repository Project'', January 1986. [Rolesville pluton and Elk River complex

    SciTech Connect

    Butler, J.R.

    1986-03-13

    The Draft-Area Recommendation Report identifies portions of crystalline rock bodies as proposed potentially acceptable sites for consideration as repositories of high-level radioactive waste. The review is in three parts. Part I is a general summary of the main comments, written in semi-technical language and without detailed documentation or references. It includes summaries of comments on the two preliminary candidate areas for a nuclear-waste repository in North Carolina (Rolesville pluton and Elk River complex) and on the rest of the report. The following two parts are written in the technical language of a geological report and include both documentation and references for each of the points discussed: Part II - Rolesville pluton, Site SE-4; Part III - Elk River complex, Site SE-5.

  19. 75 FR 54153 - International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-03

    ... the International Conference on Harmonisation of Technical Requirements for Registration of... strategy in each regulatory region. This guidance is in the form of an annex to the core guidance on the... technical procedures for pharmaceutical development. One of the goals of harmonization is to identify and...

  20. 75 FR 17148 - International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-05

    ... of the International Conference on Harmonisation of Technical Requirements for Registration of... strategy in each regulatory region. This guidance is in the form of an annex to the core guidance on the... seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the...

  1. 75 FR 53973 - International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-02

    ... auspices of the International Conference on Harmonisation of Technical Requirements for Registration of... strategy in each regulatory region. This guidance is in the form of an annex to the core guidance on the... technical procedures for pharmaceutical development. One of the goals of harmonization is to identify and...

  2. 75 FR 17147 - International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-05

    ... auspices of the International Conference on Harmonisation of Technical Requirements for Registration of... strategy in each regulatory region. This guidance is in the form of an annex to the core guidance on the... harmonization and is committed to seeking scientifically based harmonized technical procedures for...

  3. 77 FR 27451 - Permitting Guidance for Oil and Gas Hydraulic Fracturing Activities Using Diesel Fuels-Draft...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-10

    ...: Underground Injection Control Program Guidance 84 AGENCY: Environmental Protection Agency (EPA). ACTION... describes Underground Injection Control (UIC) Program guidance for permitting the underground injection of... Injection Control Program, Drinking Water Protection Division, Office of Ground Water and Drinking Water...

  4. Expanding the evidence base for global recommendations on health systems: strengths and challenges of the OptimizeMNH guidance process.

    PubMed

    Glenton, Claire; Lewin, Simon; Gülmezoglu, Ahmet Metin

    2016-07-18

    In 2012, the World Health Organization (WHO) published recommendations on the use of optimization or "task-shifting" strategies for key, effective maternal and newborn interventions (the OptimizeMNH guidance). When making recommendations about complex health system interventions such as task-shifting, information about the feasibility and acceptability of interventions can be as important as information about their effectiveness. However, these issues are usually not addressed with the same rigour. This paper describes our use of several innovative strategies to broaden the range of evidence used to develop the OptimizeMNH guidance. In this guidance, we systematically included evidence regarding the acceptability and feasibility of relevant task-shifting interventions, primarily using qualitative evidence syntheses and multi-country case study syntheses; we used an approach to assess confidence in findings from qualitative evidence syntheses (the Grading of Recommendations, Assessment, Development and Evaluation-Confidence in Evidence from Reviews of Qualitative Research (GRADE-CERQual) approach); we used a structured evidence-to-decision framework for health systems (the DECIDE framework) to help the guidance panel members move from the different types of evidence to recommendations. The systematic inclusion of a broader range of evidence, and the use of new guideline development tools, had a number of impacts. Firstly, this broader range of evidence provided relevant information about the feasibility and acceptability of interventions considered in the guidance as well as information about key implementation considerations. However, inclusion of this evidence required more time, resources and skills. Secondly, the GRADE-CERQual approach provided a method for indicating to panel members how much confidence they should place in the findings from the qualitative evidence syntheses and so helped panel members to use this qualitative evidence appropriately. Thirdly

  5. 77 FR 28600 - Draft publication: Coal Dust Explosibility Meter Evaluation and Recommendations for Application

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-15

    ... Meter Evaluation and Recommendations for Application Authority: 30 U.S.C. 95l. AGENCY: National... publication available for public comment entitled ``Coal Dust Explosibility Meter Evaluation and... (MSHA) investigating the ability of the Coal Dust Explosibility Meter (CDEM) to accurately predict...

  6. Guidance on Conducting and REporting DElphi Studies (CREDES) in palliative care: Recommendations based on a methodological systematic review.

    PubMed

    Jünger, Saskia; Payne, Sheila A; Brine, Jenny; Radbruch, Lukas; Brearley, Sarah G

    2017-09-01

    The Delphi technique is widely used for the development of guidance in palliative care, having impact on decisions with relevance for patient care. To systematically examine the application of the Delphi technique for the development of best practice guidelines in palliative care. A methodological systematic review was undertaken using the databases PubMed, CINAHL, Web of Science, Academic Search Complete and EMBASE. Original articles (English language) were included when reporting on empirical studies that had used the Delphi technique to develop guidance for good clinical practice in palliative care. Data extraction included a quality appraisal on the rigour in conduct of the studies and the quality of reporting. A total of 30 empirical studies (1997-2015) were considered for full-text analysis. Considerable differences were identified regarding the rigour of the design and the reporting of essential process and outcome parameters. Furthermore, discrepancies regarding the use of terms for describing the method were observed, for example, concerning the understanding of a 'round' or a 'modified Delphi study'. Substantial variation was found concerning the quality of the study conduct and the transparency of reporting of Delphi studies used for the development of best practice guidance in palliative care. Since credibility of the resulting recommendations depends on the rigorous use of the Delphi technique, there is a need for consistency and quality both in the conduct and reporting of studies. To allow a critical appraisal of the methodology and the resulting guidance, a reporting standard for Conducting and REporting of DElphi Studies (CREDES) is proposed.

  7. 77 FR 75174 - Draft Guidance for Industry on Providing Submissions in Electronic Format-Summary Level Clinical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-19

    ... of the individual study site (summary level clinical site dataset). The summary level clinical site... investigator sites for onsite inspection by FDA during the review of marketing applications. This draft... investigators, sponsors, contract research organizations, and institutional review boards. The study-related...

  8. 77 FR 21782 - International Conference on Harmonisation; Draft Guidance for Industry on E2C(R2) Periodic...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-11

    ... and combines two ICH guidances, ``E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs'' (E2C guidance) and ``Addendum to E2C Clinical Safety Data Management: Periodic... Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852....

  9. 76 FR 53683 - Draft Guidance for Industry on Oversight of Clinical Investigations: A Risk-Based Approach to...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-29

    ... developing risk-based monitoring strategies and plans for investigational studies of medical products....'' This guidance is intended to assist sponsors in developing risk-based monitoring strategies and plans... device exemption (IDE) studies. DATES: Although you can comment on any guidance at any time (see 21 CFR...

  10. Development of clinical recommendations for progressive return to activity after military mild traumatic brain injury: guidance for rehabilitation providers.

    PubMed

    McCulloch, Karen L; Goldman, Sarah; Lowe, Lynn; Radomski, Mary Vining; Reynolds, John; Shapiro, Rita; West, Therese A

    2015-01-01

    Previously published mild traumatic brain injury (mTBI) management guidelines provide very general recommendations to return individuals with mTBI to activity. This lack of specific guidance creates variation in military rehabilitation. The Office of the Army Surgeon General in collaboration with the Defense and Veterans Brain Injury Center, a component center of the Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury, convened an expert working group to review the existing literature and propose clinical recommendations that standardize rehabilitation activity progression following mTBI. A Progressive Activity Working Group consisted of 11 Department of Defense representatives across all service branches, 7 Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury representatives, and 8 academic/research/civilian experts with experience assessing and treating individuals with mTBI for return to activity. An expert working group meeting included the Progressive Activity Working Group and 15 additional subject matter experts. In February 2012, the Progressive Activity Working Group was established to determine the need and purpose of the rehabilitation recommendations. Following literature review, a table was created on the basis of the progression from the Zurich consensus statement on concussion in sport. Issues were identified for discussion with a meeting of the larger expert group during a July 2012 conference. Following development of rehabilitation guidance, the Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury coordinated a similar process for military primary care providers. End products for rehabilitation and primary care providers include specific recommendations for return to activity after concussion. A 6-stage progression specifies activities in physical, cognitive, and balance/vestibular domains and allows for resumption of activity for those with low-level or

  11. MORECare research methods guidance development: recommendations for ethical issues in palliative and end-of-life care research.

    PubMed

    Gysels, Marjolein; Evans, Catherine J; Lewis, Penney; Speck, Peter; Benalia, Hamid; Preston, Nancy J; Grande, Gunn E; Short, Vicky; Owen-Jones, Eleanor; Todd, Chris J; Higginson, Irene J

    2013-12-01

    There is little guidance on the particular ethical concerns that research raises with a palliative care population. To present the process and outcomes of a workshop and consensus exercise on agreed best practice to accommodate ethical issues in research on palliative care. Consultation workshop using the MORECare Transparent Expert Consultation approach. Prior to workshops, participants were sent overviews of ethical issues in palliative care. Following the workshop, nominal group techniques were used to produce candidate recommendations. These were rated online by participating experts. Descriptive statistics were used to analyse agreement and consensus. Narrative comments were collated. Experts in ethical issues and palliative care research were invited to the Cicely Saunders Institute in London. They included senior researchers, service providers, commissioners, researchers, members of ethics committees and policy makers. The workshop comprised 28 participants. A total of 16 recommendations were developed. There was high agreement on the issue of research participation and high to moderate agreement on applications to research ethics committees. The recommendations on obtaining and maintaining consent from patients and families were the most contentious. Nine recommendations were refined on the basis of the comments from the online consultation. The culture surrounding palliative care research needs to change by fostering collaborative approaches between all those involved in the research process. Changes to the legal framework governing the research process are required to enhance the ethical conduct of research in palliative care. The recommendations are relevant to all areas of research involving vulnerable adults.

  12. 77 FR 51811 - Draft Guidance for Industry on Self-Identification of Generic Drug Facilities, Sites, and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-27

    ... explains who is required to self- identify, what information must be requested, how the information should be submitted to FDA, and what the penalty is for failure to self-identify. DATES: Although you can... and compliance. This guidance is intended to assist human generic drug facilities, sites, and...

  13. 76 FR 82303 - Draft Guidance for Industry on Responding to Unsolicited Requests for Off-Label Information About...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-30

    ... ``Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools'' to provide an... internet and social media promotion, particularly when using tools that are associated with space... encounter through emerging electronic media. DATES: Although you can comment on any guidance at any...

  14. 75 FR 21000 - Draft Guidance for the Public, Food and Drug Administration Advisory Committee Members, and Food...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-22

    ... presented or discussed. (See ``Conflict of Interest in Medical Research, Education, and Practice, Committee on Conflict of Interest in Medical Research, Education, and Practice, Board on Health Sciences Policy.... ADDRESSES: Submit written requests for single copies of the guidance to Office of Special Medical...

  15. 78 FR 39737 - Draft Guidance for Industry on Antibacterial Therapies for Patients With Unmet Medical Need for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-02

    ... bacteria). DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure... against a single genus or species of bacteria). Efforts to develop new antibacterial drugs have diminished in the past few decades. Because bacteria continue to develop resistance to available antibacterial...

  16. Guidance on radiation dose limits for the lens of the eye: overview of the recommendations in NCRP Commentary No. 26.

    PubMed

    Dauer, Lawrence T; Ainsbury, Elizabeth A; Dynlacht, Joseph; Hoel, David; Klein, Barbara E K; Mayer, Donald; Prescott, Christina R; Thornton, Raymond H; Vano, Eliseo; Woloschak, Gayle E; Flannery, Cynthia M; Goldstein, Lee E; Hamada, Nobuyuki; Tran, Phung K; Grissom, Michael P; Blakely, Eleanor A

    2017-10-01

    This review summarizes the conclusions and recommendations of the new National Council on Radiation Protection and Measurements (NCRP) Commentary No. 26 guidance on radiation dose limits for the lens of the eye. The NCRP addressed radiation protection principles in respect to the lens of the eye, discussed the current understanding of eye biology and lens effects, reviewed and evaluated epidemiology, and assessed exposed populations with the potential for significant radiation exposures to the lens while suggesting monitoring and protection practices. Radiation-induced damage to the lens of the eye can include the loss of clarity resulting in opacification or clouding several years after exposure. The impact is highly dependent on the type of radiation, how the exposure of the lens was delivered, the genetic susceptibilities of the individual exposed, and the location of the opacity relative to the visual axis of the individual. The preponderance of epidemiological evidence suggests that lens damage could occur at lower doses than previously considered and the NCRP has determined that it is prudent to reduce the recommended annual lens of the eye occupational dose limit from an equivalent dose of 150 mSv to an absorbed dose of 50 mGy. Significant additional research is still needed in the following areas: comprehensive evaluation of the overall effects of ionizing radiation on the eye, dosimetry methodology and dose-sparing optimization techniques, additional high quality epidemiology studies, and a basic understanding of the mechanisms of cataract development.

  17. Pneumococcal Vaccination Guidance for Post-Acute and Long-Term Care Settings: Recommendations From AMDA's Infection Advisory Committee.

    PubMed

    Nace, David A; Archbald-Pannone, Laurie R; Ashraf, Muhammad S; Drinka, Paul J; Frentzel, Elizabeth; Gaur, Swati; Mahajan, Dheeraj; Mehr, David R; Mercer, William C; Sloane, Philip D; Jump, Robin L P

    2017-02-01

    Efforts at preventing pneumococcal disease are a national health priority, particularly in older adults and especially in post-acute and long-term care settings The Advisory Committee on Immunization Practices recommends that all adults ≥65 years of age, as well as adults 18-64 years of age with specific risk factors, receive both the recently introduced polysaccharide-protein conjugate vaccine against 13 pneumococcal serotypes as well as the polysaccharide vaccine against 23 pneumococcal serotypes. Nursing facility licensure regulations require facilities to assess the pneumococcal vaccination status of each resident, provide education regarding pneumococcal vaccination, and administer the appropriate pneumococcal vaccine when indicated. Sorting out the indications and timing for 13 pneumococcal serotypes and 23 pneumococcal serotypes administration is complex and presents a significant challenge to healthcare providers. Here, we discuss the importance of pneumococcal vaccination for older adults, detail AMDA-The Society for Post-Acute and Long-Term Care Medicine (The Society)'s recommendations for pneumococcal vaccination practice and procedures, and offer guidance to postacute and long-term care providers supporting the development and effective implementation of pneumococcal vaccine policies.

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

    PubMed

    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.

  19. 78 FR 69690 - Draft Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-20

    ... of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; Extension of Comment Period... and Gene Therapy Products'' that appeared in the Federal Register of July 2, 2013 (78 FR 39736). The... (CT) and gene therapy (GT) products (referred to collectively as CGT products) with recommendations to...

  20. 76 FR 72950 - Draft Guidance for Industry: Use of Nucleic Acid Tests on Pooled and Individual Samples From...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-28

    ..., to Reduce the Risk of Transmission of Hepatitis B Virus AGENCY: Food and Drug Administration, HHS... Leukocytes) to Adequately and Appropriately Reduce the Risk of Transmission of Hepatitis B Virus (HBV), and... recommendations on the use of FDA-licensed nucleic acid tests (NAT) to screen blood donors for hepatitis B virus...

  1. Guidance on How to Move from Current Practice to Recommended Practice in Life Cycle Impact Assessment (UNEP/SETAC Life Cycle Initiative Publication)

    EPA Science Inventory

    The report provides guidance on how to move from current practice to recommended practice in Life Cycle Impact Assessment. It is composed of three complementary parts elaborated in the first task force (TFI) of the LCIA programme, with contribution of the other three task forces:

  2. Guidance on How to Move from Current Practice to Recommended Practice in Life Cycle Impact Assessment (UNEP/SETAC Life Cycle Initiative Publication)

    EPA Science Inventory

    The report provides guidance on how to move from current practice to recommended practice in Life Cycle Impact Assessment. It is composed of three complementary parts elaborated in the first task force (TFI) of the LCIA programme, with contribution of the other three task forces:

  3. 75 FR 78231 - Management of Energy and Water Efficiency in Federal Buildings: Availability of Guidance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-15

    ...://www1.eere.energy.gov/femp/pdfs/draft_EISA_project_guidance.pdf DATES: Comments, data, and information..._project_guidance.pdf . DOE will accept comments, data, and information regarding the draft guidance no...

  4. Feedback on the FDA's February 2006 draft guidance on Patient Reported Outcome (PRO) measures from a developer of PRO measures.

    PubMed

    Bradley, Clare

    2006-10-09

    I believe that the FDA guidelines have already had an impact in encouraging good practice in the use of PROs. There are, however, important improvements that need to be made to the guidelines, particularly in the use of health status and quality of life terminology. It is essential to distinguish between health status and quality of life and to use both terms. Nothing is to be gained and a great deal will be lost if the term quality of life (which has been misused as an umbrella term in the past) is abandoned and replaced with the term health status. Patients want us to consider their quality of life as well as their health. To abandon the term would be to forget about their quality of life and focus only on their health. Patients are well able to tell us what quality of life means to them and to rate the impact of a condition on their quality of life if we use individualised quality of life measures and individualised condition-specific quality of life measures to allow them to do so. Although my experience with PRO measures would support many of the recommendations in the guidelines there are others that I would not fully agree with or would contradict on the basis of my own research evidence. I have provided references to that research and hope that the FDA will feel able to do the same when they finalize their guidelines.

  5. Recommendations

    ERIC Educational Resources Information Center

    Brazelton, G. Blue; Renn, Kristen A.; Stewart, Dafina-Lazarus

    2015-01-01

    In this chapter, the editors provide a summary of the information shared in this sourcebook about the success of students who have minoritized identities of sexuality or gender and offer recommendations for policy, practice, and further research.

  6. Recommendations

    ERIC Educational Resources Information Center

    Brazelton, G. Blue; Renn, Kristen A.; Stewart, Dafina-Lazarus

    2015-01-01

    In this chapter, the editors provide a summary of the information shared in this sourcebook about the success of students who have minoritized identities of sexuality or gender and offer recommendations for policy, practice, and further research.

  7. Refining the role of pegfilgrastim (a long-acting G-CSF) for prevention of chemotherapy-induced febrile neutropenia: consensus guidance recommendations.

    PubMed

    Aapro, Matti; Boccia, Ralph; Leonard, Robert; Camps, Carlos; Campone, Mario; Choquet, Sylvain; Danova, Marco; Glaspy, John; Hus, Iwona; Link, Hartmut; Sliwa, Thamer; Tesch, Hans; Valero, Vicente

    2017-08-25

    Chemotherapy-induced febrile neutropenia (FN) causes treatment delays and interruptions and can have fatal consequences. Current guidelines provide recommendations on granulocyte colony-stimulating factors (G-CSF) for prevention of FN, but guidance is unclear regarding use of short- vs long-acting G-CSF (e.g., filgrastim vs pegfilgrastim/lipegfilgrastim, respectively). An international panel of experts convened to develop guidance on appropriate use of pegfilgrastim for prevention of chemotherapy-induced FN. Guidance recommendations were developed following a literature review, survey, evaluation of current practice, and an expert meeting. Consensus was established using an anonymous Delphi-based approach. Guidance recommendations for prevention of treatment-associated FN were as follows: for treatment with curative intent, maintenance of dose intensity using G-CSF to prevent dose delays/reduction should be standard of care; for treatment-associated FN risk ≥ 20%, short-acting G-CSF/pegfilgrastim should be given from cycle 1 onwards; and for treatment-associated FN risk < 20%, short-acting G-CSF/pegfilgrastim should be given if factors suggest overall risk (including treatment-related and patient-related risk factors) is ≥ 20%. It was agreed that pegfilgrastim and 11 days' filgrastim have similar efficacy and safety and that pegfilgrastim is preferred to < 11 days' filgrastim (and may be preferred to ≥ 11 days' filgrastim based on adherence and convenience); pegfilgrastim is not appropriate in weekly chemotherapy; in split-dose chemotherapy, pegfilgrastim is recommended 24 h after last chemotherapy dose; and during palliative chemotherapy, patient adherence and convenience may favor pegfilgrastim. In this era of targeted therapies, additional trials with G-CSF are still required. These recommendations should be used with existing guidelines to optimize pegfilgrastim use in clinical practice.

  8. Draft genome sequence of Bradyrhizobium sp. strain BR 3262, an effective microsymbiont recommended for cowpea inoculation in Brazil.

    PubMed

    Simões-Araújo, Jean Luiz; Leite, Jakson; Marie Rouws, Luc Felicianus; Passos, Samuel Ribeiro; Xavier, Gustavo Ribeiro; Rumjanek, Norma Gouvêa; Zilli, Jerri Édson

    The strain BR 3262 was isolated from nodule of cowpea (Vigna unguiculata L. Walp) growing in soil of the Atlantic Forest area in Brazil and it is reported as an efficient nitrogen fixing bacterium associated to cowpea. Firstly, this strain was assigned as Bradyrhizobium elkanii, however, recently a more detailed genetic and molecular characterization has indicated it could be a Bradyrhizobium pachyrhizi species. We report here the draft genome sequence of B. pachyrhizi strain BR 3262, an elite bacterium used as inoculant for cowpea. The whole genome with 116 scaffolds, 8,965,178bp and 63.8% of C+G content for BR 3262 was obtained using Illumina MiSeq sequencing technology. Annotation was added by the RAST prokaryotic genome annotation service and shown 8369 coding sequences, 52 RNAs genes, classified in 504 subsystems. Published by Elsevier Editora Ltda.

  9. Draft genome sequence of Bradyrhizobium sp. strain BR 3267, an elite strain recommended for cowpea inoculation in Brazil.

    PubMed

    Simões-Araújo, Jean Luiz; Leite, Jakson; Passos, Samuel Ribeiro; Xavier, Gustavo Ribeiro; Rumjanek, Norma Gouvêa; Zilli, Jerri Édson

    The strain BR 3267 is a nitrogen-fixing symbiotic bacteria isolated from soil of semi-arid area of Brazilian Northeast using cowpea as the trap plant. This strain is used as commercial inoculant for cowpea and presents high efficient in nitrogen fixation as consequence of its adaptation potential to semi-arid conditions. We report here the draft genome sequence of Bradyrhizobium sp. strain BR 3267, an elite bacterium used as inoculant for cowpea. Whole genome sequencing of BR 3267 using Illumina MiSeq sequencing technology has 55 scaffolds with a total genome size of 7,904,309bp and C+G 63%. Annotation was added by the RAST prokaryotic genome annotation service and has shown 7314 coding sequences and 52 RNA genes. Published by Elsevier Editora Ltda.

  10. Guidance on submitting quality system information.

    PubMed

    Donawa, Maria E

    2004-03-01

    The Food and Drug Administration's final guidance document on the type of quality system information that should be submitted in some types of premarket submissions was published in February 2003. The final guidance replaces previous draft guidance. This article discusses the final guidance document.

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

    PubMed

    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.

  12. Federal Guidance for Radiation Protection

    EPA Pesticide Factsheets

    EPA produces federal guidance technical reports, which standardize dose and risk assessment and issues radiation protection guidance to federal agencies. This page provides links to federal guidance policy recommendations and technical reports.

  13. Draft Guidance on EPA's New Penalty Order Authority Against Federal Facilities Under the Safe Drinking Water Act Amendments (SDWA) of 1996

    EPA Pesticide Factsheets

    The purpose of this memorandum is to explain new provisions of the Safe Drinking Water Act (SDWA) Amendments of 1996 and to provide guidance on the use of the Agency's authority to issue penalty orders against Federal facilities.

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

    SciTech Connect

    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.

  15. International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 14 on Bacterial Endotoxins Test General Chapter; availability. Notice.

    PubMed

    2013-10-23

    The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 14: Bacterial Endotoxins Test General Chapter.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides the results of the ICH Q4B evaluation of the Bacterial Endotoxins Test General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. The guidance is in the form of an annex to the core guidance on the Q4B process entitled "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions (core ICH Q4B guidance).

  16. International Conference on Harmonisation; guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 6 on Uniformity of Dosage Units General Chapter; availability. Notice.

    PubMed

    2014-06-16

    The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 6: Uniformity of Dosage Units General Chapter.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides the results of the ICH Q4B evaluation of the Uniformity of Dosage Units General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. The guidance is in the form of an annex to the core guidance on the Q4B process entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions'' (core ICH Q4B guidance).

  17. International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 13 on Bulk Density and Tapped Density of Powders General Chapter; availability. Notice.

    PubMed

    2013-05-28

    The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 13: Bulk Density and Tapped Density of Powders General Chapter.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides the results of the ICH Q4B evaluation of the Bulk Density and Tapped Density of Powders General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. The guidance is in the form of an annex to the core guidance on the Q4B process entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions (core ICH Q4B guidance).

  18. International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 9 on Tablet Friability General Chapter; availability. Notice.

    PubMed

    2010-04-05

    The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 9: Tablet Friability General Chapter." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides the results of the ICH Q4B evaluation of the Tablet Friability General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. This guidance is in the form of an annex to the core guidance on the Q4B process entitled "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions" (core ICH Q4B guidance).

  19. International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 7 on Dissolution Test General Chapter; availability. Notice.

    PubMed

    2010-04-05

    The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 7: Dissolution Test General Chapter." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides the results of the ICH Q4B evaluation of the Dissolution Test General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. This guidance is in the form of an annex to the core guidance on the Q4B process entitled "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions" (core ICH Q4B guidance).

  20. International Conference on Harmonisation; guidance on Q4B Evaluation and Recommendation of Pharmacopoeial texts for use in the International Conference on Harmonisation Regions; Annex 12 on Analytical Sieving General Chapter; availability. Notice.

    PubMed

    2010-09-02

    The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 12: Analytical Sieving General Chapter." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides the results of the ICH Q4B evaluation of the Analytical Sieving General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. This guidance is in the form of an annex to the core guidance on the Q4B process entitled "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions" (the core ICH Q4B guidance).

  1. CDER photosafety guidance for industry.

    PubMed

    Jacobs, Abigail C; Brown, Paul C; Chen, Conrad; Ellis, Amy; Farrelly, James; Osterberg, Robert

    2004-01-01

    In the Federal Register of January 10, 2000 (65 FR 1399), FDA published a draft guidance entitled "Photosafety Testing." The notice gave interested persons an opportunity to submit comments. As a result of the comments, certain sections of the guidance were reworded to improve clarity. A final guidance was published in May 2003. The final guidance further emphasizes that a flexible approach can be used to address adverse photoeffects and that specific assays are not required. Moreover, it encourages the development of methods that can efficiently be used to evaluate human safety. The guidance describes a consistent, science-based approach for testing of topically and systemically administered drug products.

  2. Official Position of the American Academy of Clinical Neuropsychology Social Security Administration Policy on Validity Testing: Guidance and Recommendations for Change.

    PubMed

    Chafetz, M D; Williams, M A; Ben-Porath, Y S; Bianchini, K J; Boone, K B; Kirkwood, M W; Larrabee, G J; Ord, J S

    2015-01-01

    The milestone publication by Slick, Sherman, and Iverson (1999) of criteria for determining malingered neurocognitive dysfunction led to extensive research on validity testing. Position statements by the National Academy of Neuropsychology and the American Academy of Clinical Neuropsychology (AACN) recommended routine validity testing in neuropsychological evaluations. Despite this widespread scientific and professional support, the Social Security Administration (SSA) continued to discourage validity testing, a stance that led to a congressional initiative for SSA to reevaluate their position. In response, SSA commissioned the Institute of Medicine (IOM) to evaluate the science concerning the validation of psychological testing. The IOM concluded that validity assessment was necessary in psychological and neuropsychological examinations (IOM, 2015 ). The AACN sought to provide independent expert guidance and recommendations concerning the use of validity testing in disability determinations. A panel of contributors to the science of validity testing and its application to the disability process was charged with describing why the disability process for SSA needs improvement, and indicating the necessity for validity testing in disability exams. This work showed how the determination of malingering is a probability proposition, described how different types of validity tests are appropriate, provided evidence concerning non-credible findings in children and low-functioning individuals, and discussed the appropriate evaluation of pain disorders typically seen outside of mental consultations. A scientific plan for validity assessment that additionally protects test security is needed in disability determinations and in research on classification accuracy of disability decisions.

  3. International Conference on Harmonisation; guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 4A on Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests General Chapter; availability. Notice.

    PubMed

    2009-04-08

    The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 4A: Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests General Chapter." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides the results of the ICH Q4B evaluation of the Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. In the Federal Register of February 21, 2008 (73 FR 9575), FDA made available a guidance on the Q4B process entitled "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions."

  4. International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 8 on Sterility Test General Chapter; availability. Notice.

    PubMed

    2009-12-22

    The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 8: Sterility Test General Chapter.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides the results of the ICH Q4B evaluation of the Sterility Test General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. In the Federal Register of February 21, 2008 (73 FR 9575), FDA made available a guidance on the Q4B process entitled "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions."

  5. International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 10 on Polyacrylamide Gel Electrophoresis General Chapter; availability. Notice.

    PubMed

    2010-04-12

    The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 10: Polyacrylamide Gel Electrophoresis General Chapter. The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides the results of the ICH Q4B evaluation of the Polyacrylamide Gel Electrophoresis General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. In the Federal Register of February 21, 2008 (73 FR 9575), FDA made available a guidance on the Q4B process entitled "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions."

  6. International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 5 on Disintegration Test General Chapter; availability. Notice.

    PubMed

    2009-12-23

    The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 5: Disintegration Test General Chapter." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides the results of the ICH Q4B evaluation of the Disintegration Test General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. In the Federal Register of February 21, 2008 (73 FR 9575), FDA made available a guidance on the Q4B process entitled "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions."

  7. Investigations on non-inferiority--the Food and Drug Administration draft guidance on treatments for nosocomial pneumonia as a case for exact tests for binomial proportions.

    PubMed

    Röhmel, Joachim; Kieser, Meinhard

    2013-06-30

    This paper addresses statistical issues in non-inferiority trials where the primary outcome is a fatal event. The investigations are inspired by a recent Food and Drug Administration (FDA) draft guideline on treatments for nosocomial pneumonia. The non-inferiority margin suggested in this guideline for the endpoint all-cause mortality is defined on different distance measures (rate difference and odds ratio) and is discontinuous. Furthermore, the margin enables considerable power for the statistical proof of non-inferiority at alternatives that might be regarded as clinically unacceptable, that is, even if the experimental treatment is harmful as compared with the control. We investigated the appropriateness of the proposed non-inferiority margin as well as the performance of possible test statistics to be used for the analysis. A continuous variant of the margin proposed in the FDA guideline together with the unconditional exact test according to Barnard showed favorable characteristics with respect to type I error rate control and power. To prevent harmful new treatments from being declared as non-inferior, we propose to add a 'second hurdle'. We discuss examples and explore power characteristics when requiring both statistical significance and overcoming the second hurdle.

  8. International Conference on Harmonisation; final recommendation for the revision of the permitted daily exposure for the solvent cumene according to the maintenance procedures for the guidance Q3C Impurities: Residual Solvents; availability. Notice.

    PubMed

    2012-02-23

    The Food and Drug Administration (FDA) is announcing the availability of a final recommendation for the revision of the permitted daily exposure (PDE) for the solvent cumene according to the maintenance procedures for the guidance for industry entitled ``Q3C Impurities: Residual Solvents.'' The recommendation was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

  9. Architectural Drafting.

    ERIC Educational Resources Information Center

    Davis, Ronald; Yancey, Bruce

    Designed to be used as a supplement to a two-book course in basic drafting, these instructional materials consisting of 14 units cover the process of drawing all working drawings necessary for residential buildings. The following topics are covered in the individual units: introduction to architectural drafting, lettering and tools, site…

  10. Civil Drafting.

    ERIC Educational Resources Information Center

    Schertz, Karen; Kellum, Mary, Ed.

    This curriculum guide contains a course in civil drafting to train entry-level workers for jobs in the field. The module contains 12 instructional units that cover the following topics: (1) introduction to civil drafting; (2) map scales and measurement; (3) standard symbols and abbreviations; (4) interpretation of surveyor's notations; (5) legal…

  11. Mechanical Drafting.

    ERIC Educational Resources Information Center

    McClain, Gerald R.

    This publication, the third in a series on drafting, is intended to strengthen students' competence in the specialized field of mechanical drafting. The text consists of instructional materials for both teacher and students, written in terms of student performance using measurable objectives. The course includes 11 units. Each instructional unit…

  12. 75 FR 35492 - Guidance for Industry on Lupus Nephritis Caused By Systemic Lupus Erythematosus-Developing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-22

    ... availability of a guidance for industry entitled ``Lupus Nephritis Caused By Systemic Lupus Erythematosus... nephritis (LN) caused by systemic lupus erythematosus (SLE). This guidance finalizes the parts of the draft guidance entitled ``Systemic Lupus Erythematosus--Developing Drugs for Treatment'' (the draft...

  13. 77 FR 23275 - Notice of Availability of the Draft enXco Desert Harvest Solar Farm Project Environmental Impact...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-18

    ... Environmental Impact Statement, Riverside County, CA and the Draft California Desert Conservation Area Plan... Draft Environmental Impact Statement (Draft EIS) for the enXco Desert Harvest Solar Farm Project and... required based on guidance in the BLM Land Use Planning Handbook (H-1601-1). The Draft EIS Analyzes...

  14. 76 FR 72005 - NUREG-1556, Volume 2, Revision 1, “Consolidated Guidance About Materials Licenses Program...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-21

    ... COMMISSION NUREG-1556, Volume 2, Revision 1, ``Consolidated Guidance About Materials Licenses Program... Guidance About Materials Licenses: Program- Specific Guidance About Industrial Radiography Licenses, Draft Report for Comment.'' The document has been updated to include safety culture, security of...

  15. Corporate information management guidance

    SciTech Connect

    1997-08-01

    At the request of the Department of Energy`s (DOE) Information Management (IM) Council, IM representatives from nearly all Headquarters (HQ) organizations have been meeting over the past year as the Corporate Guidance Group (CGG) to develop useful and sound corporate information management (IM) guidance. The ability of the Department`s IM community to develop such unified guidance continues to be critical to the success of future Departmental IM planning processes and the establishment of a well-coordinated IM environment between Headquarters and field organizations. This report, with 26 specific corporate IM guidance items documented and unanimously agreed to, as well as 12 items recommended for further development and 3 items deferred for future consideration, represents a highly successful effort by the IM community. The effort has proven that the diverse DOE organizations can put aside individual preferences and work together towards a common and mutually beneficial goal. In examining most areas and issues associated with information management in the Department, they have developed specific, far-reaching, and useful guidance. The IM representatives recommend that the documented guidance items provided in this report and approved by the DOE IM Council be followed by all IM organizations. The representatives also strongly recommend that the guidance process developed by the CGG be the single process for developing corporate IM guidance.

  16. Drafting Fundamentals. Drafting Module 1. Instructor's Guide.

    ERIC Educational Resources Information Center

    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. The guide contains a cross-reference table of instructional materials. Ten units cover drafting fundamentals: (1) introduction to drafting; (2) general safety;…

  17. Guidance and Counseling Curricula and Programs Which Prepare Adolescent Females for the World of Work: Recommendations for the School-to-Work Initiative. Review of Literature.

    ERIC Educational Resources Information Center

    Vote, Carol J.

    A literature review examined the legislation to eliminate sex bias and stereotyping in education and the guidance and counseling curricula and programs that are integral components of the legislation. Six questions guided the preparation of the review: (1) How have legislative initiatives intended to reform education, affected the career…

  18. 78 FR 79328 - Amendments to Material Control and Accounting Regulations and Proposed Guidance for Fuel Cycle...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-30

    ... weather and extending the public comment period for a proposed rule and draft guidance on material control... rule and proposed guidance on December 10, 2013. Due to inclement weather, this public meeting has been...

  19. 75 FR 73108 - Guidance for Industry on Abbreviated New Drug Applications: Impurities in Drug Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-29

    ... degradation products and updates the draft guidance ``ANDAs: Impurities in Drug Products'' announced in... final guidance to: (1) Update information on listing of degradation products, setting acceptance criteria, and qualifying degradation products (thresholds and procedures) in abbreviated new...

  20. Bioequivalence Demonstration for Ω-3 Acid Ethyl Ester Formulations: Rationale for Modification of Current Guidance.

    PubMed

    Maki, Kevin C; Johns, Colleen; Harris, William S; Puder, Mark; Freedman, Steven D; Thorsteinsson, Thorsteinn; Daak, Ahmed; Rabinowicz, Adrian L; Sancilio, Frederick D

    2017-02-08

    The US Food and Drug Administration (FDA) draft guidance for establishing bioequivalence (BE) of ω-3 acid ethyl esters (containing both eicosapentaenoic acid [EPA] and docosahexaenoic acid [DHA] as ethyl esters), used to treat severe hypertriglyceridemia, recommends the conduct of 2 studies: one with participants in the fasting state and one with participants in the fed state. For the fasting study, the primary measures of BE are baseline-adjusted EPA and DHA levels in total plasma lipids. For the fed study, the primary measures of BE are EPA and DHA ethyl esters in plasma. This guidance differs from that established for icosapent ethyl (EPA ethyl esters) in which the primary measure of BE is baseline-adjusted total EPA in plasma lipids for both the fasting and fed states. The FDA guidance for ω-3 acid ethyl esters is not supported by their physiologic characteristics and triglyceride-lowering mechanisms because EPA and DHA ethyl esters are best characterized as pro-drugs. This article presents an argument for amending the FDA draft guidance for ω-3 acid ethyl esters to use baseline-adjusted EPA and DHA in total plasma lipids as the primary measures of BE for both fasting and fed conditions. This change would harmonize the approaches for demonstration of BE for ω-3 acid ethyl esters and icosapent ethyl (EPA ethyl esters) products for future development programs and is the most physiologically rational approach to BE testing.

  1. Recommendations for managing missing data, attrition and response shift in palliative and end-of-life care research: part of the MORECare research method guidance on statistical issues.

    PubMed

    Preston, Nancy J; Fayers, Peter; Walters, Stephen J; Pilling, Mark; Grande, Gunn E; Short, Vicky; Owen-Jones, Eleanor; Evans, Catherine J; Benalia, Hamid; Higginson, Irene J; Todd, Chris J

    2013-12-01

    Statistical analysis in palliative and end-of-life care research can be problematic due to high levels of missing data, attrition and response shift as disease progresses. To develop recommendations about managing missing data, attrition and response shift in palliative and end-of-life care research data. We used the MORECare Transparent Expert Consultation approach to conduct a consultation workshop with experts in statistical methods in palliative and end-of-life care research. Following presentations and discussion, nominal group techniques were used to produce recommendations about attrition, missing data and response shift. These were rated online by experts and analysed using descriptive statistics for consensus and importance. In total, 20 participants attended the workshop and 19 recommendations were subsequently ranked. There was broad agreement across recommendations. The top five recommendations were as follows: A taxonomy should be devised to define types of attrition. Types and amount of missing data should be reported with details of imputation methods. The pattern of missing data should be investigated to inform the imputation approach. A statistical analysis plan should be pre-specified in the protocol. High rates of attrition should be assumed when planning studies and specifying analyses. The leading recommendation for response shift was for more research. When designing studies in palliative and end-of-life care, it is recommended that high rates of attrition should not be seen as indicative of poor design and that a clear statistical analysis plan is in place to account for missing data and attrition.

  2. 77 FR 14047 - Guidance for Decommissioning Planning During Operations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-08

    ... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY COMMISSION Guidance for Decommissioning Planning During Operations AGENCY: Nuclear Regulatory Commission... public comment period for Draft Regulatory Guide (DG)-4014, ``Decommissioning Planning During...

  3. 77 FR 60126 - Guidance for Industry on Acute Bacterial Otitis Media: Developing Drugs for Treatment; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-02

    ...; Formerly 2008N-0004] Guidance for Industry on Acute Bacterial Otitis Media: Developing Drugs for Treatment... Media: Developing Drugs for Treatment.'' This guidance addresses FDA's current thinking regarding the... treatment of acute bacterial otitis media (ABOM). This guidance finalizes the revised draft guidance of...

  4. Aetiological diagnosis of child deafness: CODEPEH recommendations.

    PubMed

    Núñez-Batalla, Faustino; Jáudenes-Casaubón, Carmen; Sequí-Canet, Jose Miguel; Vivanco-Allende, Ana; Zubicaray-Ugarteche, Jose; Cabanillas-Farpón, Rubén

    Important progress in the fields of molecular genetics (principally) and diagnostic imaging, together with the lack of a consensus protocol for guiding the diagnostic process after confirming deafness by neonatal screening, have led to this new work document drafted by the Spanish Commission for the Early Detection of Child Deafness (Spanish acronym: CODEPEH). This 2015 Recommendations Document, which is based on the most recent scientific evidence, provides guidance to professionals to support them in making decisions regarding aetiological diagnosis. Such diagnosis should be performed without delay and without impeding early intervention. Early identification of the causes of deafness offers many advantages: it prevents unnecessary trouble for the families, reduces health system expenses caused by performing different tests, and provides prognostic information that may guide therapeutic actions. Copyright © 2016 Elsevier España, S.L.U. and Sociedad Española de Otorrinolaringología y Cirugía de Cabeza y Cuello. All rights reserved.

  5. 77 FR 67013 - Draft Compliance Policy Guide Sec. 550.050 Canned Ackee, Frozen Ackee, and Other Ackee Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-08

    ..., Frozen Ackee, and Other Ackee Products--Hypoglycin A Toxin; Availability AGENCY: Food and Drug..., Frozen Ackee, and Other Ackee Products--Hypoglycin A Toxin (the draft CPG).'' The draft CPG, when... Other Ackee Products--Hypoglycin A Toxin.'' The draft CPG is intended to provide guidance for FDA staff...

  6. Responses to Tribal Comments on the November 16, 2012 Consultation Draft “Indian Environmental General Assistance Program Guidance on the Award and Management of General Assistance Agreements for Tribes and Intertribal Consortia”

    EPA Pesticide Factsheets

    EPA's responses to comments received between November 16, 2012, and February 22, 2013, during the second round of consultation and coordination with tribal governments on EPA’s proposed new Indian Environmental General Assistance Program Guidance.

  7. Treatment and triage recommendations for pediatric emergency mass critical care.

    PubMed

    Christian, Michael D; Toltzis, Philip; Kanter, Robert K; Burkle, Frederick M; Vernon, Donald D; Kissoon, Niranjan

    2011-11-01

    This paper will outline the Task Force recommendations regarding treatment during pediatric emergency mass critical care, issues related to the allocation of scarce resources, and current challenges in the development of pediatric triage guidelines. In May 2008, the Task Force for Mass Critical Care published guidance on provision of mass critical care to adults. Acknowledging that the critical care needs of children during disasters were unaddressed by this effort, a 17-member Steering Committee, assembled by the Oak Ridge Institute for Science and Education with guidance from members of the American Academy of Pediatrics, convened in April 2009 to determine priority topic areas for pediatric emergency mass critical care recommendations.Steering Committee members established subcommittees by topic area and performed literature reviews of MEDLINE and Ovid databases. The Steering Committee produced draft outlines through consensus-based study of the literature and convened October 6-7, 2009, in New York, NY, to review and revise each outline. Eight draft documents were subsequently developed from the revised outlines as well as through searches of MEDLINE updated through March 2010.The Pediatric Emergency Mass Critical Care Task Force, composed of 36 experts from diverse public health, medical, and disaster response fields, convened in Atlanta, GA, on March 29-30, 2010. Feedback on each manuscript was compiled and the Steering Committee revised each document to reflect expert input in addition to the most current medical literature. Recommendations are divided into three operational sections. The first section provides pediatric emergency mass critical care recommendations for hospitals that normally provide care to pediatric patients. The second section provides recommendations for pediatric emergency mass critical care at hospitals that do not routinely provide care to pediatric patients. The final section provides a discussion of issues related to developing

  8. Policy & Guidance

    EPA Pesticide Factsheets

    Policy documents represent EPA's official interpretation or view of specific issues. Guidance documents are published to further clarify regulations and to assist in implementation of environmental regulations.

  9. Review of the Draft 2014 Science Mission Directorate Science Plan

    NASA Technical Reports Server (NTRS)

    2013-01-01

    At the request of NASA's Science Mission Directorate (SMD), the National Research Council's (NRC's) Space Studies Board (SSB) initiated a study to review a draft of the SMD's 2014 Science Plan. The request for this review was made at a time when NASA is engaged in the final stages of a comprehensive, agency-wide effort to develop a new strategic plan and at a time when NASA's budget is under considerable stress. SMD's Science Plan serves to provide more detail on its four traditional science disciplines-astronomy and astrophysics, solar and space physics (also called heliophysics), planetary science, and Earth remote sensing and related activities-than is possible in the agency-wide Strategic Plan. In conducting its review of the draft Science Plan, the Committee on the Assessment of the NASA Science Mission Directorate 2014 Science Plan was charged to comment on the following specific areas: (1) Responsiveness to the NRC's guidance on key science issues and opportunities in recent NRC reports; (2) Attention to interdisciplinary aspects and overall scientific balance; (3) Identification and exposition of important opportunities for partnerships as well as education and public outreach; (4) Integration of technology development with the science program; (5) Clarity on how the plan aligns with SMD's strategic planning process; (6) General readability and clarity of presentation; and (7) Other relevant issues as determined by the committee. The main body of the report provides detailed findings and recommendations relating to the draft Science Plan. The highest-level, crosscutting issues are summarized here, and more detail is available in the main body of the report.

  10. Review of the Draft 2014 Science Mission Directorate Science Plan

    NASA Technical Reports Server (NTRS)

    2013-01-01

    At the request of NASA's Science Mission Directorate (SMD), the National Research Council's (NRC's) Space Studies Board (SSB) initiated a study to review a draft of the SMD's 2014 Science Plan. The request for this review was made at a time when NASA is engaged in the final stages of a comprehensive, agency-wide effort to develop a new strategic plan and at a time when NASA's budget is under considerable stress. SMD's Science Plan serves to provide more detail on its four traditional science disciplines-astronomy and astrophysics, solar and space physics (also called heliophysics), planetary science, and Earth remote sensing and related activities-than is possible in the agency-wide Strategic Plan. In conducting its review of the draft Science Plan, the Committee on the Assessment of the NASA Science Mission Directorate 2014 Science Plan was charged to comment on the following specific areas: (1) Responsiveness to the NRC's guidance on key science issues and opportunities in recent NRC reports; (2) Attention to interdisciplinary aspects and overall scientific balance; (3) Identification and exposition of important opportunities for partnerships as well as education and public outreach; (4) Integration of technology development with the science program; (5) Clarity on how the plan aligns with SMD's strategic planning process; (6) General readability and clarity of presentation; and (7) Other relevant issues as determined by the committee. The main body of the report provides detailed findings and recommendations relating to the draft Science Plan. The highest-level, crosscutting issues are summarized here, and more detail is available in the main body of the report.

  11. Practical Recommendations for Long-term Management of Modifiable Risks in Kidney and Liver Transplant Recipients: A Guidance Report and Clinical Checklist by the Consensus on Managing Modifiable Risk in Transplantation (COMMIT) Group.

    PubMed

    Neuberger, James M; Bechstein, Wolf O; Kuypers, Dirk R J; Burra, Patrizia; Citterio, Franco; De Geest, Sabina; Duvoux, Christophe; Jardine, Alan G; Kamar, Nassim; Krämer, Bernhard K; Metselaar, Herold J; Nevens, Frederik; Pirenne, Jacques; Rodríguez-Perálvarez, Manuel L; Samuel, Didier; Schneeberger, Stefan; Serón, Daniel; Trunečka, Pavel; Tisone, Giuseppe; van Gelder, Teun

    2017-04-01

    Short-term patient and graft outcomes continue to improve after kidney and liver transplantation, with 1-year survival rates over 80%; however, improving longer-term outcomes remains a challenge. Improving the function of grafts and health of recipients would not only enhance quality and length of life, but would also reduce the need for retransplantation, and thus increase the number of organs available for transplant. The clinical transplant community needs to identify and manage those patient modifiable factors, to decrease the risk of graft failure, and improve longer-term outcomes.COMMIT was formed in 2015 and is composed of 20 leading kidney and liver transplant specialists from 9 countries across Europe. The group's remit is to provide expert guidance for the long-term management of kidney and liver transplant patients, with the aim of improving outcomes by minimizing modifiable risks associated with poor graft and patient survival posttransplant.The objective of this supplement is to provide specific, practical recommendations, through the discussion of current evidence and best practice, for the management of modifiable risks in those kidney and liver transplant patients who have survived the first postoperative year. In addition, the provision of a checklist increases the clinical utility and accessibility of these recommendations, by offering a systematic and efficient way to implement screening and monitoring of modifiable risks in the clinical setting.

  12. The Draft and Counseling.

    ERIC Educational Resources Information Center

    Kincaid, Marylou

    A rationale is presented for why counselors need to become involved in draft counseling. The author discusses five basic reasons why draft counseling should be offered and then considers a number of examples which indicate the kinds of problems which young draft-age men face: anxiety, moral dilemma, family pressures, self image, etc. The…

  13. The Draft and Counseling

    ERIC Educational Resources Information Center

    Kincaid, John; Kincaid, Marylou

    1970-01-01

    Professional counselors have a crucial role to play in draft counseling by helping to establish a Draft Information Center, by training and supervising students and faculty as draft counselors, and by serving as a referral source for individuals needing further counseling. (Author)

  14. Competencies for Articulation: Drafting.

    ERIC Educational Resources Information Center

    Southeast Community Coll., Lincoln, NE.

    Designed to help articulate vocational education student progress from one level of training to another and to employment, this drafting guide lists competencies for a core curriculum prerequisite to all drafting areas and competencies for machine, architectural, and civil drafting. The format for each competency is task statement, list of…

  15. Image Guidance

    EPA Pesticide Factsheets

    Guidance that explains the process for getting images approved in One EPA Web microsites and resource directories. includes an appendix that shows examples of what makes some images better than others, how some images convey meaning more than others

  16. PRN 2001-X Draft: Spray and Dust Drift Label Statements for Pesticide Products

    EPA Pesticide Factsheets

    This Notice sets forth the U.S. Environmental Protection Agency's (EPA or Agency) draft guidance for labeling statements for controlling spray drift and dust drift from application sites and for implementing these statements for risk mitigation.

  17. 78 FR 66940 - Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products; Draft...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-07

    ... HUMAN SERVICES Food and Drug Administration Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

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

    EPA Pesticide Factsheets

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-22

    ... HUMAN SERVICES Food and Drug Administration Distinguishing Medical Device Recalls From Product Enhancements; Reporting Requirements; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

  20. International Conference on Harmonisation; guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 4B on Microbiological Examination of nonsterile products: Tests for Specified Microorganisms General Chapter; availability. Notice.

    PubMed

    2009-04-08

    The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 4B: Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms General Chapter." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides the results of the ICH Q4B evaluation of the Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. In the Federal Register of February 21, 2008 (73 FR 9575), FDA made available a guidance on the Q4B process entitled "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions."

  1. International Conference on Harmonisation; guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for use in the International Conference on Harmonisation Regions; Annex 4C on Microbiological Examination of Nonsterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter; availability. Notice.

    PubMed

    2009-04-08

    The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 4C: Microbiological Examination of Nonsterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides the results of the ICH Q4B evaluation of the Microbiological Examination of Nonsterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. In the Federal Register of February 21, 2008 (73 FR 9575), FDA made available a guidance on the Q4B process entitled "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions."

  2. A manual of recommended practices for hydrogen energy systems

    SciTech Connect

    Hoagland, W.; Leach, S.

    1997-12-31

    Technologies for the production, distribution, and use of hydrogen are rapidly maturing and the number and size of demonstration programs designed to showcase emerging hydrogen energy systems is expanding. The success of these programs is key to hydrogen commercialization. Currently there is no comprehensive set of widely-accepted codes or standards covering the installation and operation of hydrogen energy systems. This lack of codes or standards is a major obstacle to future hydrogen demonstrations in obtaining the requisite licenses, permits, insurance, and public acceptance. In a project begun in late 1996 to address this problem, W. Hoagland and Associates has been developing a Manual of Recommended Practices for Hydrogen Systems intended to serve as an interim document for the design and operation of hydrogen demonstration projects. It will also serve as a starting point for some of the needed standard-setting processes. The Manual will include design guidelines for hydrogen procedures, case studies of experience at existing hydrogen demonstration projects, a bibliography of information sources, and a compilation of suppliers of hydrogen equipment and hardware. Following extensive professional review, final publication will occur later in 1997. The primary goal is to develop a draft document in the shortest possible time frame. To accomplish this, the input and guidance of technology developers, industrial organizations, government R and D and regulatory organizations and others will be sought to define the organization and content of the draft Manual, gather and evaluate available information, develop a draft document, coordinate reviews and revisions, and develop recommendations for publication, distribution, and update of the final document. The workshop, Development of a Manual of Recommended Practices for Hydrogen Energy Systems, conducted on March 11, 1997 in Alexandria, Virginia, was a first step.

  3. Modelling polymer draft gears

    NASA Astrophysics Data System (ADS)

    Wu, Qing; Yang, Xiangjian; Cole, Colin; Luo, Shihui

    2016-09-01

    This paper developed a new and simple approach to model polymer draft gears. Two types of polymer draft gears were modelled and compared with experimental data. Impact characteristics, in-train characteristics and frequency responses of these polymer draft gears were studied and compared with those of a friction draft gear. The impact simulations show that polymer draft gears can withstand higher impact speeds than the friction draft gear. Longitudinal train dynamics simulations show that polymer draft gears have significantly longer deflections than friction draft gears in normal train operations. The maximum draft gear working velocities are lower than 0.2 m/s, which are significantly lower than the impact velocities during shunting operations. Draft gears' in-train characteristics are similar to their static characteristics but are very different from their impact characteristics; this conclusion has also been reached from frequency response simulations. An analysis of gangway bridge plate failures was also conducted and it was found that they were caused by coupler angling behaviour and long draft gear deflections.

  4. 75 FR 53724 - Notice of Availability and Opportunity for Comment on Draft Division of Safety Systems Interim...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-01

    ... Guidance Regarding the Nuclear Criticality Safety Analysis for Spent Fuel Pools AGENCY: Nuclear Regulatory...-2010-01, ``Staff Guidance Regarding the Nuclear Criticality Safety Analysis for Spent Fuel Pools... comments on the draft DSS-ISG-2010-01, ``Staff Guidance Regarding the Nuclear Criticality Safety...

  5. An Interim Report on NASA's Draft Space Technology Roadmaps

    NASA Technical Reports Server (NTRS)

    2011-01-01

    NASA has developed a set of 14 draft roadmaps to guide the development of space technologies under the leadership of the NASA Office of the Chief Technologist (OCT). Each of these roadmaps focuses on a particular technology area (TA). The roadmaps are intended to foster the development of advanced technologies and concepts that address NASA's needs and contribute to other aerospace and national needs. OCT requested that the National Research Council conduct a study to review the draft roadmaps, gather and assess relevant community input, and make recommendations and suggest priorities to inform NASA's decisions as it finalizes its roadmaps. The statement of task states that "based on the results of the community input and its own deliberations, the steering committee will prepare a brief interim report that addresses high-level issues associated with the roadmaps, such as the advisability of modifying the number or technical focus of the draft NASA roadmaps." This interim report, which does not include formal recommendations, addresses that one element of the study charge. NASA requested this interim report so that it would have the opportunity to make an early start in modifying the draft roadmaps based on feedback from the panels and steering committee. The final report will address all other tasks in the statement of task. In particular, the final report will include a prioritization of technologies, will describe in detail the prioritization process and criteria, and will include specific recommendations on a variety of topics, including many of the topics mentioned in this interim report. In developing both this interim report and the final report to come, the steering committee draws on the work of six study panels organized by technical area, loosely following the organization of the 14 roadmaps, as follows: A Panel 1: Propulsion and Power TA01 Launch Propulsion Systems TA02 In-Space Propulsion Technologies TA03 Space Power and Energy Storage Systems TA13

  6. An Interim Report on NASA's Draft Space Technology Roadmaps

    NASA Technical Reports Server (NTRS)

    2011-01-01

    NASA has developed a set of 14 draft roadmaps to guide the development of space technologies under the leadership of the NASA Office of the Chief Technologist (OCT). Each of these roadmaps focuses on a particular technology area (TA). The roadmaps are intended to foster the development of advanced technologies and concepts that address NASA's needs and contribute to other aerospace and national needs. OCT requested that the National Research Council conduct a study to review the draft roadmaps, gather and assess relevant community input, and make recommendations and suggest priorities to inform NASA's decisions as it finalizes its roadmaps. The statement of task states that "based on the results of the community input and its own deliberations, the steering committee will prepare a brief interim report that addresses high-level issues associated with the roadmaps, such as the advisability of modifying the number or technical focus of the draft NASA roadmaps." This interim report, which does not include formal recommendations, addresses that one element of the study charge. NASA requested this interim report so that it would have the opportunity to make an early start in modifying the draft roadmaps based on feedback from the panels and steering committee. The final report will address all other tasks in the statement of task. In particular, the final report will include a prioritization of technologies, will describe in detail the prioritization process and criteria, and will include specific recommendations on a variety of topics, including many of the topics mentioned in this interim report. In developing both this interim report and the final report to come, the steering committee draws on the work of six study panels organized by technical area, loosely following the organization of the 14 roadmaps, as follows: A Panel 1: Propulsion and Power TA01 Launch Propulsion Systems TA02 In-Space Propulsion Technologies TA03 Space Power and Energy Storage Systems TA13

  7. Draft air deflecting device

    SciTech Connect

    Riley, J.E.

    1982-05-18

    A draft air deflecting device is mountable proximate to a window contained in a firebox and serves as a conduit which directs draft air across the inner surface of the window prior to its supporting combustion of the fuel in the firebox. In this respect , the draft air deflecting device is formed as a box which communicates with draft air holes located in the firebox and which includes a forwardly extending lip serving to define a nozzle for both increasing the velocity and directing the incoming draft air across the firebox window. The incoming draft air is thus utilized to cool and to prevent soot, creosote and other particulates from accumulating on the window.

  8. 76 FR 41157 - Guidance for Industry: Questions and Answers Regarding the Final Rule, Prevention of Salmonella...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-13

    ... Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production... Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation'' (the draft guidance... rule entitled ``Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and...

  9. Guidance for Use When Regurgitation is Observed in Avian Acute Toxicity Studies with Passerine Species

    EPA Pesticide Factsheets

    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. 76 FR 8314 - Implementation Guidance for Distribution of Source Material to Exempt Persons and to General...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-14

    ... necessary to correct the ADAMS Accession Number for the draft Part 40 implementation guidance. FOR FURTHER... Register, on page 1101, the first paragraphs in both the second and third columns, the ADAMS accession...

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

    EPA Pesticide Factsheets

    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.

  12. 78 FR 3023 - Draft Policy on Donations, Fundraising, and Solicitation

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-15

    ... Fish and Wildlife Service RIN 1018-AY36 Draft Policy on Donations, Fundraising, and Solicitation AGENCY..., and provides general guidance on fundraising by non-Federal entities on the Service's behalf. It also..., fundraising, and solicitation. While donations can be a means to further our mission, not all donations...

  13. 75 FR 8698 - Extension of Request for Scientific Views for Draft 2009 Update Aquatic Life Ambient Water...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-25

    ... AGENCY Extension of Request for Scientific Views for Draft 2009 Update Aquatic Life Ambient Water Quality... availability of draft national recommended water quality criteria for ammonia for the ] protection of aquatic life entitled ``Draft 2009 Update Aquatic Life Ambient Water Quality Criteria for Ammonia--Freshwater...

  14. Assay Characterization Guidance Documents | Office of Cancer Clinical Proteomics Research

    Cancer.gov

    CPTAC characterized assays are defined as those that meet the criteria described in the Assay Characterization Guidance Document. This guidance document aligns with recommendations by the research community as “fit-for-purpose” validation requirements of targeted proteomics assays.

  15. DRAFT of Final Report of the Assumable Waters Subcommittee Submitted to the National Advisory Council for Environmental Policy and Technology (NACEPT)

    EPA Pesticide Factsheets

    This is a draft of the recommendations that that Assumable Waters Subcommittee will present to NACEPT on May 10. It should be considered a draft until it is approved and transmitted to the EPA by NACEPT

  16. 77 FR 62247 - Dynamic Positioning Operations Guidance for Vessels Other Than Mobile Offshore Drilling Units...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-12

    ...] Dynamic Positioning Operations Guidance for Vessels Other Than Mobile Offshore Drilling Units Operating on... voluntary guidance titled ``Mobile Offshore Drilling Unit Dynamic Positioning Guidance''. The notice recommended owners and operators of Mobile Offshore Drilling Units (MODUs) follow Marine Technology...

  17. Decision for the Draft.

    ERIC Educational Resources Information Center

    Chambers, John Whiteclay, II

    2002-01-01

    Discusses why U.S. President Woodrow Wilson decided to institute the military draft. Provides background information on when Wilson changed from insisting on using volunteers in the military to his resolve for instituting the draft, due to a challenge of power by former U.S. President Theodore Roosevelt. (CMK)

  18. Basic Drafting: Book One.

    ERIC Educational Resources Information Center

    Davis, Ronald; And Others

    The first of a two-book course in drafting, this manual consists of 13 topics in the following units: introduction to drafting, general safety, basic tools and lines, major equipment, applying for a job, media, lettering, reproduction, drawing sheet layout, architect's scale usage, civil engineer's scale usage, mechanical engineer's scale usage,…

  19. 75 FR 13766 - Guidance for Industry on the Content and Format of the Dosage and Administration Section of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-23

    ...The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products--Content and Format.'' This guidance is one of a series of guidance documents intended to assist applicants in drafting prescription drug labeling in which prescribing information is clear......

  20. Smoking prevention and cessation in the Africa and Middle East region: a consensus draft guideline for healthcare providers--executive summary.

    PubMed

    Ali, Ahmed Yousif M; Safwat, Tarek; Onyemelukwe, Geoffrey; Otaibi, Moh'd Amin Al; Amir, Ashraf A; Nawas, Yousef N; Aouina, Hichem; Afif, Moulay Hicham; Bolliger, Chris T

    2012-01-01

    Despite the abundance of scientific evidence confirming the health consequences of smoking and other forms of tobacco use, the tobacco epidemic remains an important public health problem and by 2030 it is predicted that more than 80% of tobacco deaths will be in developing countries. In Africa and the Middle East, many local factors contribute to the initiation and maintenance of tobacco use. Although efforts to reduce the mortality and morbidity associated with smoking and tobacco dependence are underway, there is a need for guidance on how to utilize appropriate tobacco control policies and psychology- and pharmacology-based therapies to counter tobacco dependence as recommended by the Framework Convention on Tobacco Control (FCTC). A group of tobacco cessation experts from public health services and/or academic institutions in Africa and the Middle East participated in a series of four meetings held in Cairo, Cape Town, and Dubai between May 2008 and February 2011 to develop a draft guideline tailored to their region. This article provides the background to the development of this draft smoking cessation guideline and discusses how the recommendations can be implemented and progress monitored to promote both primary prevention and cessation of tobacco use within our countries. The draft guideline for Africa and the Middle East provides an important resource in combating the devastating effects of tobacco use in these regions which can be further localized through engagement with local stakeholders in the countries of the region.

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

    EPA Pesticide Factsheets

    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.

  2. Consensus standard requirements and guidance

    SciTech Connect

    Putman, V.L.

    1995-12-01

    This report presents information from the ANS Criticality Alarm System Workshop relating to the consensus standard requirements and guidance. Topics presented include: definition; nomenclature; requirements and recommendations; purpose of criticality alarms; design criteria; signal characteristics; reliability, dependability and durability; tests; and emergency preparedness and planning.

  3. Elementary School Guidance Work Conference. Conference Report.

    ERIC Educational Resources Information Center

    Herr, Edwin L.; Hershberger, James K.

    In October, 1967, 100 invited participants representing all aspects of guidance, education, school administration, counselor education, psychology, and interested government agencies in Pennsylvania met for three days to listen, think, discuss, and hopefully develop some recommendations for those who want a better program of elementary guidance.…

  4. Career Directions for Drafting CAD Technicians.

    ERIC Educational Resources Information Center

    Moore, Pam

    2002-01-01

    Provides information careers for drafting/computer-assisted drafting technicians, including salaries, responsibilities, employment outlook, working conditions, skills needed, and career advancement opportunities. Lists professional drafting organizations. (JOW)

  5. Drafting distance in swimming.

    PubMed

    Chatard, Jean-Claude; Wilson, Barry

    2003-07-01

    This study investigates the effect of the distance separating the lead and draft swimmers on the metabolic and hydrodynamic responses of the draft swimmer. A nondrafting swim of 4 min at 95% of the best 1500-m pace for 11 swimmers was compared with swimming in a drafting position at four different distances directly behind another swimmer (0, 50, 100, and 150 cm). Swimming performance was assessed by stroke rate and stroke length; the metabolic response by oxygen uptake, heart rate, and blood lactate; and the rating of perceived exertion by the Borg scale. Passive drag was assessed at these drafting distances by passive towing. Then, passive drag was measured in six swimmers towed in six lateral drafting positions, with swimmers separated by approximately 40 cm, and then measured in two positions at the rear of the lead swimmer with a reduced lateral distance between swimmers of 50 and 0 cm. Oxygen uptake, heart rate, blood lactate, rating of perceived exertion, and stroke rate were significantly reduced and stroke length was significantly increased in all drafting positions compared with the nondrafting position. For drag, the most advantageous drafting distances were 0 and 50 cm back from the toes of the lead swimmer. Drag was reduced by 21% and 20%, respectively. In lateral drafting, drag was significantly reduced by 6% and 7%, respectively, at 50 and 100 cm back from the hands of the lead swimmer. Swimming behind another swimmer at a distance between 0 and 50 cm back from the toes was the most advantageous, whereas in lateral drafting the optimal distance was 50-100 cm back from the hands of the lead swimmer.

  6. Surface Water Treatment Rules State Implementation Guidance

    EPA Pesticide Factsheets

    These documents provide guidance to states, tribes and U.S. EPA Regions exercising primary enforcement responsibility under the Safe Drinking Water Act. The documents contain EPA’s recommendations for implementation of the Surface Water Treatment Rules.

  7. Cluster: Drafting. Course: Architectural Drafting. Research Project.

    ERIC Educational Resources Information Center

    Sanford - Lee County Schools, NC.

    The sequence of 10 units is designed for use with an instructor in architectural 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: architectural lettering…

  8. Aeronautical Drafting, Drafting 3: 9257.02.

    ERIC Educational Resources Information Center

    Dade County Public Schools, Miami, FL.

    Intended for students interested in the aircraft and missile field of engineering and drafting, the course covers fundamentals, working drawings, and auxiliary views and sections that are related to this field. Considered advanced training, a prerequisite for the course is mastery of the skills indicated in Electrical and Electronic…

  9. 78 FR 39253 - Notice of Extension of Comment Period for Draft Initial Comprehensive Plan and Draft...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-01

    ...] Notice of Extension of Comment Period for Draft Initial Comprehensive Plan and Draft Environmental... Public Comment Period. SUMMARY: Pursuant to the Resources and Ecosystems Sustainability, Tourist... region and the Draft Programmatic Environmental Assessment (Draft PEA) for the Draft Plan....

  10. 76 FR 81957 - Mobile Offshore Drilling Unit Guidance Policy

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-29

    ... SECURITY Coast Guard Mobile Offshore Drilling Unit Guidance Policy AGENCY: Coast Guard, DHS. ACTION: Notice... availability of a draft policy letter entitled, ``Dynamically Positioned Mobile Offshore Drilling Unit (MODU... emergency procedures are critical to the safety of a MODU actively engaged in drilling....

  11. PORTUGUESE RECOMMENDATIONS FOR THE USE OF BIOLOGICAL THERAPIES IN PATIENTS WITH PSORIATIC ARTHRITIS--2015 UPDATE.

    PubMed

    Vieira-Sousa, Elsa; Machado, Pedro M; Costa, José; Ribeiro, Ana; Aguiar, Renata; Cerqueira, Marcos; Neto, Adriano; Bernardo, Alexandra; Cordeiro, Ana; Duarte, Cátia; Vinagre, Filipe; Canhão, Helena; Santos, Helena; Neves, Joana Sousa; Cunha-Miranda, Luís; Silva, Margarida; Santos, Maria José; Bernardes, Miguel; Bogas, Mónica; Abreu, Pedro; Viana-Queiroz, Mário; Barros, Rita; Falcão, Sandra; Pimenta, Sofia; Teixeira, Vitor; Fonseca, João Eurico; Barcelos, Anabela

    2015-01-01

    To update recommendations for the treatment of psoriatic arthritis with biological therapies, endorsed by the Portuguese Society of Rheumatology (SPR). These treatment recommendations were formulated by Portuguese rheumatologists based on literature evidence and consensus opinion. At a national meeting the 16 recommendations included in this document were discussed and updated. The level of agreement among Portuguese Rheumatologists was assessed using an online survey. A draft of the full text of the recommendations was then circulated and suggestions were incorporated. A final version was again circulated before publication. A consensus was achieved regarding the initiation, assessment of response and switching biological therapies in patients with psoriatic arthritis (PsA). Specific recommendations were developed for several disease domains: peripheral arthritis, axial disease, enthesitis and dactylitis. These recommendations may be used for guidance in deciding which patients with PsA should be treated with biological therapies. They cover a rapidly evolving area of therapeutic intervention. As more evidence becomes available and more biological therapies are licensed, these recommendations will have to be updated.

  12. 76 FR 63303 - Guidance for Industry on Warnings and Precautions, Contraindications, and Boxed Warning Sections...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-12

    ...The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products--Content and Format.'' This guidance is intended to assist applicants and reviewers in drafting the ``Warnings and Precautions, Contraindications, and......

  13. 77 FR 21783 - Guidance on Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-11

    ... the Agency's current good manufacturing practice regulations for PET drugs. DATES: Submit either... good manufacturing practices for PET drugs (21 CFR part 212) regarding media fills. A draft guidance of... HUMAN SERVICES Food and Drug Administration Guidance on Media Fills for Validation of...

  14. 75 FR 62694 - Implementation Guidance for Physical Protection of Byproduct Material Category 1 and Category 2...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-13

    ... and Category 2 Quantities of Radioactive Material; Draft Guidance Document for Comment; Extension of... Category 2 quantities of radioactive material. The public comment period for this guidance was to have... use of Category 1 and Category 2 quantities of radioactive material into a new Part 37 of Title 10 of...

  15. Guidance for Classifying Studies Conducted Using the OECD Test Guideline 223 (TG223) (Acute Avian Oral Sequential Dose Study)

    EPA Pesticide Factsheets

    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.

  16. 75 FR 76482 - Notice of Web Availability and Opportunity for Public Comment on Updated Guidance for the Section...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-08

    ... the Section 202 Supportive Housing for the Elderly and Section 811 Supportive Housing for Persons With... of a draft notice updating HUD's guidance for the Section 202 Supportive Housing for the Elderly...

  17. National Recommended Water Quality Criteria

    EPA Pesticide Factsheets

    The National Recommended Water Quality Criteria is a compilation of national recommended water quality criteria for the protection of aquatic life and human health in surface water for approximately 150 pollutants. These criteria provide guidance for states and tribes to use in adopting water quality standards.

  18. Field-testing of guidance on the appropriate labelling of processed complementary foods for infants and young children in South Africa.

    PubMed

    Sweet, Lara; Jerling, Johann; Van Graan, Averalda

    2013-01-01

    There is a lack of formal guidance from international normative bodies on the appropriate marketing of processed complementary foods. Such guidance is necessary to protect and promote optimal infant and young child feeding practices. The aim of this study was to field-test, in South Africa, the interim guidance provided by the Maternal, Infant and Young Child Nutrition Working Group's Draft Guide for Marketing Complementary Foods as a potential tool for use by manufacturers and national governments for guiding the appropriate labelling (as a subset of appropriate marketing practices) of complementary foods. This guidance was used to develop a checklist of questions and criteria for each possible answer, which was tested using a comprehensive database of labels from products purchased in South Africa from June to August 2011. One hundred and sixty product labels of 35 manufacturers were analysed, none of which complied with all checklist criteria. Fifty-six (35%) labels did not provide an appropriate age of introduction while 37 (23%) used images of infants appearing younger than 6 months. Nineteen (12%) labels suggested a daily ration too large for a breastfed child, and 32 (20%) potentially promote the manufacturer's infant formula. Only 58 (36%) labels were easy to read. The majority (69% and 92%) of labels provided instructions for safe and appropriate preparation/use and storage, respectively. The Draft Guide for Marketing Complementary Foods was found to be a useful tool for guiding the appropriate labelling of complementary foods, although some changes and additions are recommended to improve understanding, ease of use and to minimise the subjective interpretation of the guidance.

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

    ERIC Educational Resources Information Center

    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.…

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

    SciTech Connect

    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.

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

    PubMed

    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.

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

    PubMed Central

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

    2013-01-01

    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. PMID:23303884

  3. Radiation Protection Guidance for Diagnostic and Interventional X-Ray Procedures; Federal Guidance Report No. 14

    EPA Science Inventory

    Federal Guidance Report No. 14 provides federal facilities that use diagnostic and interventional x-ray equipment with updated recommendations for keeping doses as low as reasonably achievable without compromising the quality of patient care, This guidance is an update of Federal...

  4. Radiation Protection Guidance for Diagnostic and Interventional X-Ray Procedures; Federal Guidance Report No. 14

    EPA Science Inventory

    Federal Guidance Report No. 14 provides federal facilities that use diagnostic and interventional x-ray equipment with updated recommendations for keeping doses as low as reasonably achievable without compromising the quality of patient care, This guidance is an update of Federal...

  5. Choice and validation of a near infrared spectroscopic application for the identity control of starting materials. practical experience with the EU draft Note for Guidance on the use of near infrared spectroscopy by the pharmaceutical industry and the data to be forwarded in part II of the dossier for a marketing authorization.

    PubMed

    Vredenbregt, M J; Caspers, P W J; Hoogerbrugge, R; Barends, D M

    2003-11-01

    Recently the CPMP/CVMP sent out for consultation the draft Note for Guidance (dNfG) on the use of near infrared spectroscopy (NIRS) by the pharmaceutical industry and the data to be forwarded in part II of the dossier for a marketing authorization. We explored the practicability of this dNfG with respect to the verification of the correct identity of starting materials in a generic tablet-manufacturing site. Within the boundaries of the dNfG, a release procedure was developed for 12 substances containing structurally related compounds and substances differing only in particle size. For the method development literature data were also taken into consideration. Good results were obtained with wavelength correlation (WC), applied on raw spectra or second derivative spectra both without smoothing. The defined threshold of 0.98 for raw spectra differentiated between all molecular structures. Both methods were found to be robust over a period of 1 year. For the differentiation between the different particle sizes a subsequent second chemometric technique had to be used. Soft independent modelling of class analogy (SIMCA) with a probability level of 0.01 proved suitable. Internal and external validation I according to the dNfG showed no incorrect rejections or false acceptances. External validation II according to the dNfG was carried out with 95 potentially interfering substances from which 46 were tested experimentally. Macrogol 400 was not distinguished from macrogol 300. For the complete verification of the identity of macrogol 300 test A of the European Pharmacopoeia is needed in addition to the NIRS application. A release procedure developed with WC applied on raw spectra and SIMCA as a second method, which is different from the preferred method of the dNfG, was tested in practice with good results. We conclude that the dNfG has good practicability and that deviations from the preferred methods of the dNfG can also give good differentiation.

  6. The plenary session on the ICRP recommendations for the 21st century at IRPA-11, Madrid.

    PubMed

    Webb, Geoffrey A M; Magnússon, Sigurdur M; Lacoste, Andre-Claude; Tsela, Simanga Alex; Jones, C Rick; Fujimoto, Kenzo; Loy, John; Coates, Roger

    2004-12-01

    During the IRPA-11 Congress in Madrid in May 2004, a technical panel session was devoted to the presentation and discussion of the draft 2005 recommendations of the ICRP. Panel members had been given privileged access to the new draft and had been asked to concentrate on specific areas. This memorandum summarises the initial presentation of the main ideas in the draft recommendations by the ICRP Chairman, Roger Clarke, and then presents the views of the six panellists.

  7. Brazilian recommendations of mechanical ventilation 2013. Part 2

    PubMed Central

    Barbas, Carmen Sílvia Valente; Ísola, Alexandre Marini; Farias, Augusto Manoel de Carvalho; Cavalcanti, Alexandre Biasi; Gama, Ana Maria Casati; Duarte, Antonio Carlos Magalhães; Vianna, Arthur; Serpa Neto, Ary; Bravim, Bruno de Arruda; Pinheiro, Bruno do Valle; Mazza, Bruno Franco; de Carvalho, Carlos Roberto Ribeiro; Toufen Júnior, Carlos; David, Cid Marcos Nascimento; Taniguchi, Corine; Mazza, Débora Dutra da Silveira; Dragosavac, Desanka; Toledo, Diogo Oliveira; Costa, Eduardo Leite; Caser, Eliana Bernadete; Silva, Eliezer; Amorim, Fabio Ferreira; Saddy, Felipe; Galas, Filomena Regina Barbosa Gomes; Silva, Gisele Sampaio; de Matos, Gustavo Faissol Janot; Emmerich, João Claudio; Valiatti, Jorge Luis dos Santos; Teles, José Mario Meira; Victorino, Josué Almeida; Ferreira, Juliana Carvalho; Prodomo, Luciana Passuello do Vale; Hajjar, Ludhmila Abrahão; Martins, Luiz Claudio; Malbouisson, Luis Marcelo Sá; Vargas, Mara Ambrosina de Oliveira; Reis, Marco Antonio Soares; Amato, Marcelo Brito Passos; Holanda, Marcelo Alcântara; Park, Marcelo; Jacomelli, Marcia; Tavares, Marcos; Damasceno, Marta Cristina Paulette; Assunção, Murillo Santucci César; Damasceno, Moyzes Pinto Coelho Duarte; Youssef, Nazah Cherif Mohamed; Teixeira, Paulo José Zimmermann; Caruso, Pedro; Duarte, Péricles Almeida Delfino; Messeder, Octavio; Eid, Raquel Caserta; Rodrigues, Ricardo Goulart; de Jesus, Rodrigo Francisco; Kairalla, Ronaldo Adib; Justino, Sandra; Nemer, Sergio Nogueira; Romero, Simone Barbosa; Amado, Verônica Moreira

    2014-01-01

    Perspectives on invasive and noninvasive ventilatory support for critically ill patients are evolving, as much evidence indicates that ventilation may have positive effects on patient survival and the quality of the care provided in intensive care units in Brazil. For those reasons, the Brazilian Association of Intensive Care Medicine (Associação de Medicina Intensiva Brasileira - AMIB) and the Brazilian Thoracic Society (Sociedade Brasileira de Pneumologia e Tisiologia - SBPT), represented by the Mechanical Ventilation Committee and the Commission of Intensive Therapy, respectively, decided to review the literature and draft recommendations for mechanical ventilation with the goal of creating a document for bedside guidance as to the best practices on mechanical ventilation available to their members. The document was based on the available evidence regarding 29 subtopics selected as the most relevant for the subject of interest. The project was developed in several stages, during which the selected topics were distributed among experts recommended by both societies with recent publications on the subject of interest and/or significant teaching and research activity in the field of mechanical ventilation in Brazil. The experts were divided into pairs that were charged with performing a thorough review of the international literature on each topic. All the experts met at the Forum on Mechanical Ventilation, which was held at the headquarters of AMIB in São Paulo on August 3 and 4, 2013, to collaboratively draft the final text corresponding to each sub-topic, which was presented to, appraised, discussed and approved in a plenary session that included all 58 participants and aimed to create the final document. PMID:25295817

  8. Brazilian recommendations of mechanical ventilation 2013. Part I

    PubMed Central

    2014-01-01

    Perspectives on invasive and noninvasive ventilatory support for critically ill patients are evolving, as much evidence indicates that ventilation may have positive effects on patient survival and the quality of the care provided in intensive care units in Brazil. For those reasons, the Brazilian Association of Intensive Care Medicine (Associação de Medicina Intensiva Brasileira - AMIB) and the Brazilian Thoracic Society (Sociedade Brasileira de Pneumologia e Tisiologia - SBPT), represented by the Mechanical Ventilation Committee and the Commission of Intensive Therapy, respectively, decided to review the literature and draft recommendations for mechanical ventilation with the goal of creating a document for bedside guidance as to the best practices on mechanical ventilation available to their members. The document was based on the available evidence regarding 29 subtopics selected as the most relevant for the subject of interest. The project was developed in several stages, during which the selected topics were distributed among experts recommended by both societies with recent publications on the subject of interest and/or significant teaching and research activity in the field of mechanical ventilation in Brazil. The experts were divided into pairs that were charged with performing a thorough review of the international literature on each topic. All the experts met at the Forum on Mechanical Ventilation, which was held at the headquarters of AMIB in São Paulo on August 3 and 4, 2013, to collaboratively draft the final text corresponding to each sub-topic, which was presented to, appraised, discussed and approved in a plenary session that included all 58 participants and aimed to create the final document. PMID:25210957

  9. Brazilian recommendations of mechanical ventilation 2013. Part I.

    PubMed

    Barbas, Carmen Sílvia Valente; Isola, Alexandre Marini; Farias, Augusto Manoel de Carvalho; Cavalcanti, Alexandre Biasi; Gama, Ana Maria Casati; Duarte, Antonio Carlos Magalhães; Vianna, Arthur; Serpa Neto, Ary; Bravim, Bruno de Arruda; Pinheiro, Bruno do Valle; Mazza, Bruno Franco; Carvalho, Carlos Roberto Ribeiro de; Toufen Júnior, Carlos; David, Cid Marcos Nascimento; Taniguchi, Corine; Mazza, Débora Dutra da Silveira; Dragosavac, Desanka; Toledo, Diogo Oliveira; Costa, Eduardo Leite; Caser, Eliana Bernardete; Silva, Eliezer; Amorim, Fabio Ferreira; Saddy, Felipe; Galas, Filomena Regina Barbosa Gomes; Silva, Gisele Sampaio; Matos, Gustavo Faissol Janot de; Emmerich, João Claudio; Valiatti, Jorge Luis Dos Santos; Teles, José Mario Meira; Victorino, Josué Almeida; Ferreira, Juliana Carvalho; Prodomo, Luciana Passuello do Vale; Hajjar, Ludhmila Abrahão; Martins, Luiz Cláudio; Malbouisson, Luiz Marcelo Sá; Vargas, Mara Ambrosina de Oliveira; Reis, Marco Antonio Soares; Amato, Marcelo Brito Passos; Holanda, Marcelo Alcântara; Park, Marcelo; Jacomelli, Marcia; Tavares, Marcos; Damasceno, Marta Cristina Paulette; Assunção, Murillo Santucci César; Damasceno, Moyzes Pinto Coelho Duarte; Youssef, Nazah Cherif Mohamad; Teixeira, Paulo José Zimmermann; Caruso, Pedro; Duarte, Péricles Almeida Delfino; Messeder, Octavio; Eid, Raquel Caserta; Rodrigues, Ricardo Goulart; Jesus, Rodrigo Francisco de; Kairalla, Ronaldo Adib; Justino, Sandra; Nemer, Sérgio Nogueira; Romero, Simone Barbosa; Amado, Verônica Moreira

    2014-01-01

    Perspectives on invasive and noninvasive ventilatory support for critically ill patients are evolving, as much evidence indicates that ventilation may have positive effects on patient survival and the quality of the care provided in intensive care units in Brazil. For those reasons, the Brazilian Association of Intensive Care Medicine (Associação de Medicina Intensiva Brasileira - AMIB) and the Brazilian Thoracic Society (Sociedade Brasileira de Pneumonia e Tisiologia - SBPT), represented by the Mechanical Ventilation Committee and the Commission of Intensive Therapy, respectively, decided to review the literature and draft recommendations for mechanical ventilation with the goal of creating a document for bedside guidance as to the best practices on mechanical ventilation available to their members. The document was based on the available evidence regarding 29 subtopics selected as the most relevant for the subject of interest. The project was developed in several stages, during which the selected topics were distributed among experts recommended by both societies with recent publications on the subject of interest and/or significant teaching and research activity in the field of mechanical ventilation in Brazil. The experts were divided into pairs that were charged with performing a thorough review of the international literature on each topic. All the experts met at the Forum on Mechanical Ventilation, which was held at the headquarters of AMIB in São Paulo on August 3 and 4, 2013, to collaboratively draft the final text corresponding to each sub-topic, which was presented to, appraised, discussed and approved in a plenary session that included all 58 participants and aimed to create the final document.

  10. Brazilian recommendations of mechanical ventilation 2013. Part I.

    PubMed

    2014-01-01

    Perspectives on invasive and noninvasive ventilatory support for critically ill patients are evolving, as much evidence indicates that ventilation may have positive effects on patient survival and the quality of the care provided in intensive care units in Brazil. For those reasons, the Brazilian Association of Intensive Care Medicine (Associação de Medicina Intensiva Brasileira - AMIB) and the Brazilian Thoracic Society (Sociedade Brasileira de Pneumologia e Tisiologia - SBPT), represented by the Mechanical Ventilation Committee and the Commission of Intensive Therapy, respectively, decided to review the literature and draft recommendations for mechanical ventilation with the goal of creating a document for bedside guidance as to the best practices on mechanical ventilation available to their members. The document was based on the available evidence regarding 29 subtopics selected as the most relevant for the subject of interest. The project was developed in several stages, during which the selected topics were distributed among experts recommended by both societies with recent publications on the subject of interest and/or significant teaching and research activity in the field of mechanical ventilation in Brazil. The experts were divided into pairs that were charged with performing a thorough review of the international literature on each topic. All the experts met at the Forum on Mechanical Ventilation, which was held at the headquarters of AMIB in São Paulo on August 3 and 4, 2013, to collaboratively draft the final text corresponding to each sub-topic, which was presented to, appraised, discussed and approved in a plenary session that included all 58 participants and aimed to create the final document.

  11. Brazilian recommendations of mechanical ventilation 2013. Part 2.

    PubMed

    Barbas, Carmen Sílvia Valente; Ísola, Alexandre Marini; Farias, Augusto Manoel de Carvalho; Cavalcanti, Alexandre Biasi; Gama, Ana Maria Casati; Duarte, Antonio Carlos Magalhães; Vianna, Arthur; Serpa Neto, Ary; Bravim, Bruno de Arruda; Pinheiro, Bruno do Valle; Mazza, Bruno Franco; de Carvalho, Carlos Roberto Ribeiro; Toufen Júnior, Carlos; David, Cid Marcos Nascimento; Taniguchi, Corine; Mazza, Débora Dutra da Silveira; Dragosavac, Desanka; Toledo, Diogo Oliveira; Costa, Eduardo Leite; Caser, Eliana Bernadete; Silva, Eliezer; Amorim, Fabio Ferreira; Saddy, Felipe; Galas, Filomena Regina Barbosa Gomes; Silva, Gisele Sampaio; de Matos, Gustavo Faissol Janot; Emmerich, João Claudio; Valiatti, Jorge Luis dos Santos; Teles, José Mario Meira; Victorino, Josué Almeida; Ferreira, Juliana Carvalho; Prodomo, Luciana Passuello do Vale; Hajjar, Ludhmila Abrahão; Martins, Luiz Claudio; Malbouisson, Luis Marcelo Sá; Vargas, Mara Ambrosina de Oliveira; Reis, Marco Antonio Soares; Amato, Marcelo Brito Passos; Holanda, Marcelo Alcântara; Park, Marcelo; Jacomelli, Marcia; Tavares, Marcos; Damasceno, Marta Cristina Paulette; Assunção, Murillo Santucci César; Damasceno, Moyzes Pinto Coelho Duarte; Youssef, Nazah Cherif Mohamed; Teixeira, Paulo José Zimmermann; Caruso, Pedro; Duarte, Péricles Almeida Delfino; Messeder, Octavio; Eid, Raquel Caserta; Rodrigues, Ricardo Goulart; de Jesus, Rodrigo Francisco; Kairalla, Ronaldo Adib; Justino, Sandra; Nemer, Sergio Nogueira; Romero, Simone Barbosa; Amado, Verônica Moreira

    2014-01-01

    Perspectives on invasive and noninvasive ventilatory support for critically ill patients are evolving, as much evidence indicates that ventilation may have positive effects on patient survival and the quality of the care provided in intensive care units in Brazil. For those reasons, the Brazilian Association of Intensive Care Medicine (Associação de Medicina Intensiva Brasileira - AMIB) and the Brazilian Thoracic Society (Sociedade Brasileira de Pneumologia e Tisiologia - SBPT), represented by the Mechanical Ventilation Committee and the Commission of Intensive Therapy, respectively, decided to review the literature and draft recommendations for mechanical ventilation with the goal of creating a document for bedside guidance as to the best practices on mechanical ventilation available to their members. The document was based on the available evidence regarding 29 subtopics selected as the most relevant for the subject of interest. The project was developed in several stages, during which the selected topics were distributed among experts recommended by both societies with recent publications on the subject of interest and/or significant teaching and research activity in the field of mechanical ventilation in Brazil. The experts were divided into pairs that were charged with performing a thorough review of the international literature on each topic. All the experts met at the Forum on Mechanical Ventilation, which was held at the headquarters of AMIB in São Paulo on August 3 and 4, 2013, to collaboratively draft the final text corresponding to each sub-topic, which was presented to, appraised, discussed and approved in a plenary session that included all 58 participants and aimed to create the final document.

  12. Brazilian recommendations of mechanical ventilation 2013. Part I

    PubMed Central

    Barbas, Carmen Sílvia Valente; Ísola, Alexandre Marini; Farias, Augusto Manoel de Carvalho; Cavalcanti, Alexandre Biasi; Gama, Ana Maria Casati; Duarte, Antonio Carlos Magalhães; Vianna, Arthur; Serpa, Ary; Bravim, Bruno de Arruda; Pinheiro, Bruno do Valle; Mazza, Bruno Franco; de Carvalho, Carlos Roberto Ribeiro; Toufen, Carlos; David, Cid Marcos Nascimento; Taniguchi, Corine; Mazza, Débora Dutra da Silveira; Dragosavac, Desanka; Toledo, Diogo Oliveira; Costa, Eduardo Leite; Caser, Eliana Bernardete; Silva, Eliezer; Amorim, Fabio Ferreira; Saddy, Felipe; Galas, Filomena Regina Barbosa Gomes; Silva, Gisele Sampaio; de Matos, Gustavo Faissol Janot; Emmerich, João Claudio; Valiatti, Jorge Luis dos Santos; Teles, José Mario Meira; Victorino, Josué Almeida; Ferreira, Juliana Carvalho; Prodomo, Luciana Passuello do Vale; Hajjar, Ludhmila Abrahão; Martins, Luiz Cláudio; Malbouisson, Luiz Marcelo Sá; Vargas, Mara Ambrosina de Oliveira; Reis, Marco Antonio Soares; Amato, Marcelo Brito Passos; Holanda, Marcelo Alcântara; Park, Marcelo; Jacomelli, Marcia; Tavares, Marcos; Damasceno, Marta Cristina Paulette; Assunção, Murillo Santucci César; Damasceno, Moyzes Pinto Coelho Duarte; Youssef, Nazah Cherif Mohamad; Teixeira, Paulo José Zimmermann; Caruso, Pedro; Duarte, Péricles Almeida Delfino; Messeder, Octavio; Eid, Raquel Caserta; Rodrigues, Ricardo Goulart; de Jesus, Rodrigo Francisco; Kairalla, Ronaldo Adib; Justino, Sandra; Nemer, Sérgio Nogueira; Romero, Simone Barbosa; Amado, Verônica Moreira

    2014-01-01

    Perspectives on invasive and noninvasive ventilatory support for critically ill patients are evolving, as much evidence indicates that ventilation may have positive effects on patient survival and the quality of the care provided in intensive care units in Brazil. For those reasons, the Brazilian Association of Intensive Care Medicine (Associação de Medicina Intensiva Brasileira - AMIB) and the Brazilian Thoracic Society (Sociedade Brasileira de Pneumologia e Tisiologia - SBPT), represented by the Mechanical Ventilation Committee and the Commission of Intensive Therapy, respectively, decided to review the literature and draft recommendations for mechanical ventilation with the goal of creating a document for bedside guidance as to the best practices on mechanical ventilation available to their members. The document was based on the available evidence regarding 29 subtopics selected as the most relevant for the subject of interest. The project was developed in several stages, during which the selected topics were distributed among experts recommended by both societies with recent publications on the subject of interest and/or significant teaching and research activity in the field of mechanical ventilation in Brazil. The experts were divided into pairs that were charged with performing a thorough review of the international literature on each topic. All the experts met at the Forum on Mechanical Ventilation, which was held at the headquarters of AMIB in São Paulo on August 3 and 4, 2013, to collaboratively draft the final text corresponding to each sub-topic, which was presented to, appraised, discussed and approved in a plenary session that included all 58 participants and aimed to create the final document. PMID:25028944

  13. Brazilian recommendations of mechanical ventilation 2013. Part 2

    PubMed Central

    2014-01-01

    Perspectives on invasive and noninvasive ventilatory support for critically ill patients are evolving, as much evidence indicates that ventilation may have positive effects on patient survival and the quality of the care provided in intensive care units in Brazil. For those reasons, the Brazilian Association of Intensive Care Medicine (Associação de Medicina Intensiva Brasileira - AMIB) and the Brazilian Thoracic Society (Sociedade Brasileira de Pneumologia e Tisiologia - SBPT), represented by the Mechanical Ventilation Committee and the Commission of Intensive Therapy, respectively, decided to review the literature and draft recommendations for mechanical ventilation with the goal of creating a document for bedside guidance as to the best practices on mechanical ventilation available to their members. The document was based on the available evidence regarding 29 subtopics selected as the most relevant for the subject of interest. The project was developed in several stages, during which the selected topics were distributed among experts recommended by both societies with recent publications on the subject of interest and/or significant teaching and research activity in the field of mechanical ventilation in Brazil. The experts were divided into pairs that were charged with performing a thorough review of the international literature on each topic. All the experts met at the Forum on Mechanical Ventilation, which was held at the headquarters of AMIB in São Paulo on August 3 and 4, 2013, to collaboratively draft the final text corresponding to each sub-topic, which was presented to, appraised, discussed and approved in a plenary session that included all 58 participants and aimed to create the final document. PMID:25410835

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

    PubMed

    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.

  15. 17 CFR Appendix A to Subpart H to... - Guidance on the Application of §§ 23.434 and 23.440 for Swap Dealers That Make Recommendations to...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... recommends a swap or trading strategy involving a swap to a counterparty, other than a swap dealer, major... trading strategy involving a swap—general suitability (§ 23.434(a)(1))—and have a reasonable basis to believe that the recommended swap or trading strategy involving a swap is suitable for the...

  16. 76 FR 27924 - Draft Regulatory Guide, Guidance for ITAAC Closure

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-13

    ..., Regulatory Guide Development Branch, Division of Engineering, Office of Nuclear Regulatory Research. BILLING.... Although a time limit is given, comments and suggestions in connection with items for inclusion in...

  17. FDA Issues Draft Guidance on Questions and Answers ...

    Center for Food Safety and Applied Nutrition (CFSAN)

    ... ¢â‚¬â„¢s final rule ÃÆ'¢â†šÂ¬Ã…“Prevention of Salmonella Enteritidis in Shell Eggs ...

  18. 76 FR 50231 - Mobile Medical Applications Draft Guidance; Public Workshop

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-12

    ... would be similar to an infusion pump stand, which is currently classified as a class I device because it supports the intended use of an infusion pump (class II medical device). A mobile medical app that...

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

    PubMed

    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.

  20. Caught in the Draft

    ERIC Educational Resources Information Center

    Edge, Ron

    2007-01-01

    We've all seen (in movies, newscasts, or perhaps in person) the violent effect of the downwash that occurs when a helicopter hovers over the ground. Leaves, grass, and debris are dramatically blown about. We've also sat in front of circulating room fans and felt a large draft, whereas there seems to be very little air movement behind the fan. The…

  1. Caught in the Draft

    ERIC Educational Resources Information Center

    Edge, Ron

    2007-01-01

    We've all seen (in movies, newscasts, or perhaps in person) the violent effect of the downwash that occurs when a helicopter hovers over the ground. Leaves, grass, and debris are dramatically blown about. We've also sat in front of circulating room fans and felt a large draft, whereas there seems to be very little air movement behind the fan. The…

  2. Drafting. Competency Based Curriculum.

    ERIC Educational Resources Information Center

    Everly, Al; And Others

    This competency based drafting curriculum is presented in seven specialization sections with units in each section containing a competency statement, performance objective, learning activities, evaluation, and quiz or problem sheets. Some units also contain answer sheets and/or handout sheets. Sections and number of units presented are (1) basic…

  3. Provision of Guidance, Information and Basic Criteria for Radiation Protection and Measurements.

    DTIC Science & Technology

    1984-02-27

    expected that the draft report will go to critical reviewers in 1984. Task Group 13 on Neptunium is examing the validity of the parameters and dosimetric...models used for neptumium- 237 and developing recommendations on metabolic parameters. The work is in the middle draft stage at this time. 7. Scientific

  4. 77 FR 65728 - Final Interim Staff Guidance Augmenting NUREG-1537, “Guidelines for Preparing and Reviewing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-30

    ... COMMISSION Final Interim Staff Guidance Augmenting NUREG-1537, ``Guidelines for Preparing and Reviewing... Staff Guidance (ISG), that augments NUREG- 1537, Part 1, ``Guidelines for Preparing and Reviewing... NRC published for public comment Chapters 1-6 of the draft ISG, that augments NUREG-1537, Part...

  5. 77 FR 64999 - Guidance for Industry: Necessity of the Use of Food Product Categories in Food Facility...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-24

    ... Pkwy., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in... fishery/seafood product categories. We also added the word ``nutritional'' to the pet supplements category... ``pet nutritional supplements.'' The guidance announced in this notice finalizes the draft guidance...

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

    SciTech Connect

    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.

  7. Progress report on the guidance for industry for statistical aspects of the design, analysis, and interpretation of chronic rodent carcinogenicity studies of pharmaceuticals.

    PubMed

    Lin, K K

    2000-11-01

    The U.S. Food and Drug Administration (FDA) is in the process of preparing a draft Guidance for Industry document on the statistical aspects of carcinogenicity studies of pharmaceuticals for public comment. The purpose of the document is to provide statistical guidance for the design of carcinogenicity experiments, methods of statistical analysis of study data, interpretation of study results, presentation of data and results in reports, and submission of electronic study data. This article covers the genesis of the guidance document and some statistical methods in study design, data analysis, and interpretation of results included in the draft FDA guidance document.

  8. 17 CFR Appendix A to Subpart H - Guidance on the Application of §§ 23.434 and 23.440 for Swap Dealers That Make Recommendations to...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... or trading strategy involving a swap to a counterparty, other than a swap dealer, major swap... strategy involving a swap—general suitability (§ 23.434(a)(1))—and have a reasonable basis to believe that the recommended swap or trading strategy involving a swap is suitable for the...

  9. 17 CFR Appendix A to Subpart H - Guidance on the Application of §§ 23.434 and 23.440 for Swap Dealers That Make Recommendations to...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... or trading strategy involving a swap to a counterparty, other than a swap dealer, major swap... strategy involving a swap—general suitability (§ 23.434(a)(1))—and have a reasonable basis to believe that the recommended swap or trading strategy involving a swap is suitable for the...

  10. High proportions of foods recommended for consumption by United States Dietary Guidance contain solid fats and added sugar: Results from the National Health and Nutrition Examination Survey (2007-2008)

    USDA-ARS?s Scientific Manuscript database

    The 2010 Dietary Guidelines for Americans (DGA) recommend that individuals older than one year reduce intakes of solid fats (SoF) and added sugars (AS; together SoFAS). MyPlate, illustrates the proportions of five major food groups to promote healthy eating (Vegetables, Grains, Protein Foods, Fruit...

  11. Guidance for performing preliminary assessments under CERCLA

    SciTech Connect

    1991-09-01

    EPA headquarters and a national site assessment workgroup produced this guidance for Regional, State, and contractor staff who manage or perform preliminary assessments (PAs). EPA has focused this guidance on the types of sites and site conditions most commonly encountered. The PA approach described in this guidance is generally applicable to a wide variety of sites. However, because of the variability among sites, the amount of information available, and the level of investigative effort required, it is not possible to provide guidance that is equally applicable to all sites. PA investigators should recognize this and be aware that variation from this guidance may be necessary for some sites, particularly for PAs performed at Federal facilities, PAs conducted under EPA`s Environmental Priorities Initiative (EPI), and PAs at sites that have previously been extensively investigated by EPA or others. The purpose of this guidance is to provide instructions for conducting a PA and reporting results. This guidance discusses the information required to evaluate a site and how to obtain it, how to score a site, and reporting requirements. This document also provides guidelines and instruction on PA evaluation, scoring, and the use of standard PA scoresheets. The overall goal of this guidance is to assist PA investigators in conducting high-quality assessments that result in correct site screening or further action recommendations on a nationally consistent basis.

  12. 46 CFR 131.220 - Drafts.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... Drafts. (a) Each vessel must have the drafts of the vessel plainly and legibly marked upon the stem and... stem or cutaway skeg, the keel does not extend forward or aft to the draft markings, the datum line...

  13. 77 FR 3777 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-25

    ... Mofetil N Naltrexone HCl Naproxen Naproxen Sodium Naproxen Sodium; Sumatriptan Succinate Nebivolol Niacin... RLDs) Minoxidil Morphine N Nebivolol Niacin Nilutamide Nitroglycerin O Omeprazole Orlistat...

  14. Demonstration of Concept (Draft)

    DTIC Science & Technology

    1994-08-03

    DemonWtratlon of Concept (DRAFT) August 3, 1994 Table of Contents (continued) SectionPage 4,0 Mathematical Model for Computing Delivery Time ................................. 4...for Computing Delivery Time ....................................... 4-1 Secure Solutions, Inc. Contract No. N00039-93-C-0099 Ili Detnonstration of...Authentication * * 0 0 Access Control *1 1 1 Non-repudiation * * The Phase I made the qualitative observation that the delivery time through a

  15. Unified powered flight guidance

    NASA Technical Reports Server (NTRS)

    Brand, T. J.; Brown, D. W.; Higgins, J. P.

    1973-01-01

    A complete revision of the orbiter powered flight guidance scheme is presented. A unified approach to powered flight guidance was taken to accommodate all phases of exo-atmospheric orbiter powered flight, from ascent through deorbit. The guidance scheme was changed from the previous modified version of the Lambert Aim Point Maneuver Mode used in Apollo to one that employs linear tangent guidance concepts. This document replaces the previous ascent phase equation document.

  16. 77 FR 2555 - Guidance for Industry: Preparation of Investigational Device Exemptions and Investigational New...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-18

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry: Preparation of Investigational Device... Cartilage; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and.... The guidance supplements recommendations regarding IDE and IND submissions contained in other FDA...

  17. All-Ages Lead Model (Aalm) Version 1.05 (External Draft Report)

    EPA Science Inventory

    The All-Ages Lead Model (AALM) Version 1.05, is an external review draft software and guidance manual. EPA released this software and associated documentation for public review and comment beginning September 27, 2005, until October 27, 2005. The public comments will be accepte...

  18. All-Ages Lead Model (Aalm) Version 1.05 (External Draft Report)

    EPA Science Inventory

    The All-Ages Lead Model (AALM) Version 1.05, is an external review draft software and guidance manual. EPA released this software and associated documentation for public review and comment beginning September 27, 2005, until October 27, 2005. The public comments will be accepte...

  19. 76 FR 5102 - Draft NUREG-0561, Revision 2; Physical Protection of Shipments of Irradiated Reactor Fuel...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-28

    ...; ] NUCLEAR REGULATORY COMMISSION 10 CFR Part 73 RIN 3150-AI64 Draft NUREG-0561, Revision 2; Physical...-0561, ``Physical Protection of Shipments of Irradiated Reactor Fuel.'' This document provides guidance on implementing the provisions of proposed 10 CFR Part 73.37, ``Requirements for Physical Protection...

  20. 78 FR 54655 - Center for Devices and Radiological Health: Draft Standard Operating Procedure for Level 1...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-05

    ... HUMAN SERVICES Food and Drug Administration Center for Devices and Radiological Health: Draft Standard Operating Procedure for Level 1, Immediately in Effect Guidance Documents on Premarket Data Issues; Availability and Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request...

  1. Accelerating Cleanup: Focus on 2006. Discussion draft

    SciTech Connect

    1997-06-01

    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).

  2. 76 FR 12117 - Call for Comments on the Draft Report of the Adult Immunization Working Group to the National...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-04

    ... HUMAN SERVICES Call for Comments on the Draft Report of the Adult Immunization Working Group to the... Immunization Working Group (AIWG) of NVAC has developed a draft report and recommendations for the... Adult Immunization Working Group, Telephone (202) 260-2325; Fax: (202) 690-4631; E-mail:...

  3. Drafting--Basic, Drafting--Intermediate: 9255.01.

    ERIC Educational Resources Information Center

    Dade County Public Schools, Miami, FL.

    The course has no prerequisites, offers instruction in basic drafting room techniques and procedures, and also covers job opportunities and industrial methods in engineering. The student is introduced to and asked to perform fundamental drafting problems with working drawings, using multiview and auxiliary views and sections. The course also…

  4. Computer Aided Drafting. Instructor's Guide.

    ERIC Educational Resources Information Center

    Henry, Michael A.

    This guide is intended for use in introducing students to the operation and applications of computer-aided drafting (CAD) systems. The following topics are covered in the individual lessons: understanding CAD (CAD versus traditional manual drafting and care of software and hardware); using the components of a CAD system (primary and other input…

  5. Industrial Education. Drafting. [Grade 9].

    ERIC Educational Resources Information Center

    Parma City School District, OH.

    Part of a series of curriculum guides dealing with industrial education in junior high schools, this guide provides a course on drafting to be used in the ninth grade. Thirteen goals are identified for the students to demonstrate: (1) a knowledge of the relationship between drafting and the work of designers, engineers, and architects; (2) an…

  6. Drafting. Instructor Guide. General Information.

    ERIC Educational Resources Information Center

    Seymour, James W.; And Others

    The curriculum described in this manual covers basic drafting skills and entry skills for architectural, civil, and machine drafting, for both secondary and postsecondary instruction. The manual describes how the program is organized and gives objectives and exit points for the total curriculum. All of the tasks and units are listed with their…

  7. High proportions of foods recommended for consumption by United States Dietary Guidance contain solid fats and added sugar: results from the National Health and Nutrition Examination Survey (2007-2008).

    PubMed

    Jahns, Lisa; Kranz, Sibylle

    2014-03-20

    The 2010 Dietary Guidelines for Americans (DGA) recommend that individuals age two years and older reduce intakes of solid fats (SoF) and added sugars (AS; together SoFAS). MyPlate illustrates the proportions of five major food groups to promote healthy eating (Vegetables, Grains, Protein Foods, Fruits and Dairy). To assess if the foods currently consumed by Americans are in concordance with the DGA, food consumption data from What We Eat In America, National Health and Nutrition Examination Survey (WWEIA-NHANES) 2007-2008 (n = 8 527) was used to estimate the proportion of foods that contained SoFAS and to report them by food group. Weighted analysis was conducted to be nationally representative. The Dairy group contained the highest proportion (93%) of either SoF or AS, followed by Grains (70% SoF; 70% AS; 50% both). Fruits contained the least SoFAS (7%). Results suggest that the high proportion of SoFAS in each recommended food group makes it challenging for Americans to reduce their intake of SoFAS.

  8. Announcement: Guidance for U.S. Laboratory Testing for Zika Virus Infection: Implications for Health Care Providers.

    PubMed

    2016-11-25

    CDC has released updated guidance online for U.S. laboratory testing for Zika virus infection. The guidance is available at https://www.cdc.gov/zika/laboratories/lab-guidance.html. Frequently asked questions are addressed at https://www.cdc.gov/zika/laboratories/lab-guidance-faq.html. This guidance updates recommendations for testing of specimens by U.S. laboratories for possible Zika virus infection. Major updates to the guidance with clinical implications for health care providers include the following.

  9. Draft 1992 Resource Program : Technical Report.

    SciTech Connect

    United States. Bonneville Power Administration.

    1992-01-01

    The 1992 Resource Program will propose actions to meet future loads placed on the Bonneville Power Administration (BPA). It will also discuss and attempt to resolve resource-related policy issues. The Resource Program assesses resource availability and costs, and analyzes resource requirements and alternative ways of meeting those requirements through both conservation and generation resources. These general resource conclusions are then translated to actions for both conservation and generation. The Resource Program recommends budgets for the Office of Energy Resources for Fiscal Years (FY) 1994 and 1995. BPA's Resource Program bears directly on an important BPA responsibility: the obligation under the Northwest Power Act{sup 3} to meet the power requirements of public and private utility and direct service industrial (DSI) customers according to their contractual agreements. BPA's Draft 1992 Resource Program is contained in four documents: (1) 1992 Resource Program Summary; (2) Technical Report; (3) Technical Assumptions Appendix; and, (4) Conservation Implementation Plan. This volume is the Draft 1992 Resource Program Technical Report, a comprehensive document that provides supporting data and analyses for Resource Program recommendations.

  10. Draft 1992 Resource Program : Technical Report.

    SciTech Connect

    United States. Bonneville Power Administration.

    1992-01-01

    The 1992 Resource Program will propose actions to meet future loads placed on the Bonneville Power Administration (BPA). It will also discuss and attempt to resolve resource-related policy issues. The Resource Program assesses resource availability and costs, and analyzes resource requirements and alternative ways of meeting those requirements through both conservation and generation resources. These general resource conclusions are then translated to actions for both conservation and generation. The Resource Program recommends budgets for the Office of Energy Resources for Fiscal Years (FY) 1994 and 1995. BPA`s Resource Program bears directly on an important BPA responsibility: the obligation under the Northwest Power Act{sup 3} to meet the power requirements of public and private utility and direct service industrial (DSI) customers according to their contractual agreements. BPA`s Draft 1992 Resource Program is contained in four documents: (1) 1992 Resource Program Summary; (2) Technical Report; (3) Technical Assumptions Appendix; and, (4) Conservation Implementation Plan. This volume is the Draft 1992 Resource Program Technical Report, a comprehensive document that provides supporting data and analyses for Resource Program recommendations.

  11. Guidance for Developing Principal Design Criteria for Advanced (Non-Light Water) Reactors

    SciTech Connect

    Holbrook, Mark; Kinsey, Jim

    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. Guidance for K-12 Administrators' Responses to Influenza

    ERIC Educational Resources Information Center

    Education Digest: Essential Readings Condensed for Quick Review, 2009

    2009-01-01

    This document provides guidance to help decrease the spread of flu among students and school staff during the 2009-2010 school year. It provides tools that school and health officials can choose from based on conditions in their area and recommends actions to take if CDC finds that the flu starts causing more severe disease. The guidance also…

  13. Critical Perspectives on Adolescent Vocational Guidance in Chile

    ERIC Educational Resources Information Center

    McWhirter, Ellen Hawley; McWhirter, Benedict T.

    2012-01-01

    In this article, the lens of critical psychology is applied to adolescent career development and vocational guidance in Chile. The authors describe and critique the status of adolescent vocational guidance in Chile, the reproduction of extant social inequities in Chilean education, and offer recommendations for enhancing vocational guidance…

  14. Guidance for K-12 Administrators' Responses to Influenza

    ERIC Educational Resources Information Center

    Education Digest: Essential Readings Condensed for Quick Review, 2009

    2009-01-01

    This document provides guidance to help decrease the spread of flu among students and school staff during the 2009-2010 school year. It provides tools that school and health officials can choose from based on conditions in their area and recommends actions to take if CDC finds that the flu starts causing more severe disease. The guidance also…

  15. Critical Perspectives on Adolescent Vocational Guidance in Chile

    ERIC Educational Resources Information Center

    McWhirter, Ellen Hawley; McWhirter, Benedict T.

    2012-01-01

    In this article, the lens of critical psychology is applied to adolescent career development and vocational guidance in Chile. The authors describe and critique the status of adolescent vocational guidance in Chile, the reproduction of extant social inequities in Chilean education, and offer recommendations for enhancing vocational guidance…

  16. Climate and Land Use Change Effects on Ecological Resources in Three Watersheds: A Synthesis Report (External Review Draft)

    EPA Science Inventory

    The purpose of this draft report is to provide a summary of climate change impacts to selected watersheds and recommendations for how to improve the process of conducting watershed assessments in the future.

  17. Climate and Land Use Change Effects on Ecological Resources in Three Watersheds: A Synthesis Report (External Review Draft)

    EPA Science Inventory

    The purpose of this draft report is to provide a summary of climate change impacts to selected watersheds and recommendations for how to improve the process of conducting watershed assessments in the future.

  18. Updated Draft Protocol for the Evaluation of Bactericidal Activity of Hard, Non-porous Copper Containing Surface Products

    EPA Pesticide Factsheets

    This document describes the updated draft testing protocol recommended by the EPA to support the registration of copper-containing surface products (such as door knobs, or other items that are not intended for food contact) that bear sanitizer claims.

  19. Physical activity recommendations for older Australians.

    PubMed

    Sims, Jane; Hill, Keith; Hunt, Susan; Haralambous, Betty

    2010-06-01

    The aim of this research was to produce evidence-based recommendations on physical activity designed to improve and maintain the health of older Australians. The authors reviewed existing guidelines and consensus statements, systematic reviews, meta-analyses and research articles. Draft recommendations were circulated to stakeholder agencies and to an expert advisory group. Final recommendations were then forwarded to the Commonwealth Department of Health and Ageing for Ministerial approval. The physical activity recommendations for older Australians complement the current National Physical Activity Guidelines for adults and the American College of Sports Medicine and American Heart Association recommendations for older adults. The recommendations provide advice developed specifically for older Australians. Although the recommendations may be manifested in different ways, according to specific populations or settings, they apply to older people across all levels of health and have application to community dwelling people and those in residential care accommodation.

  20. 78 FR 29159 - Electric Power Research Institute; Seismic Evaluation Guidance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-17

    ... Guidance: EPRI Guidance for the Resolution of Fukushima Near-Term Task Force Recommendation 2.1: Seismic... 2.1, 2.3, and 9.3, of the Near-Term Task Force Review of Insights from the Fukushima Dai-ichi... Recommendations 2.1, 2.3, and 9.3, of the Near-Term Task Force (NTTF) Review of Insights from the Fukushima...

  1. The CCSDS Proposed Draft Recommended Standard for Electronic Data Sheets

    NASA Astrophysics Data System (ADS)

    Melvin, R.; Perrotin, M.; Valverde, A.; Ahlendorf, F.; Durand, E.; Cornforth, J.

    2016-08-01

    Electronic Data Sheets (EDS) is a concept that has been proposed to allow the capture of the relevant information about a piece of equipment. This should capture the relevant aspects not just to enable an efficient exchange of information (easing its maintainability, enforcing consistency, etc.) but should also enable the development process to be partially automated.The Consultative Committee for Space Data Standards (CCSDS) has been active on these topics and focusing on interoperability, both on-board and on the ground segments. The CCSDSSpacecraft Onboard Interface Services (SOIS) [1] area is looking at the On-board communications architectures and how would it be possible to maximise reuse and minimise component integration efforts. SOIS Electronic Data Sheets (SEDS)[2] is the result of that effort; a proposed standard which allows specifying the data interfaces for a device or other onboard component in a standardised form.

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

    SciTech Connect

    Cole, P. C.; Halverson, M. A.

    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.

  3. 75 FR 47494 - Implementation Guidance for Physical Protection of Byproduct Material; Category 1 and Category 2...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-06

    ...; Category 1 and Category 2 Quantities of Radioactive Material; Meeting AGENCY: Nuclear Regulatory Commission... category 2 quantities of radioactive material. The NRC has prepared draft guidance to address..., specifically Category 1 and Category 2 quantities of radioactive material. It is intended for use by applicants...

  4. 76 FR 26177 - National Organic Program: Notice of Final Guidance for Accredited Certifying Agents and Certified...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-06

    ... Organic Production and Handling (NOP 5025)''; and ``The Use of Chlorine Materials in Organic Production... the use of chlorine materials. The five draft guidances can be viewed on-line at http://www.ams.usda... ``NOP 5026--The Use of Chlorine Materials in Organic Production and Handling''. Based upon the...

  5. 75 FR 14152 - Executive Order 13508; Chesapeake Bay Protection and Restoration Section 502; Guidance for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-24

    ... Land Management in the Chesapeake Bay Watershed AGENCY: Environmental Protection Agency (EPA). ACTION... draft Guidance for Federal land management in the Chesapeake Bay watershed describing proven, cost-effective tools and practices that reduce water pollution and requests public comment. The document was...

  6. 76 FR 50490 - Draft Comprehensive Conservation Plan and Draft Environmental Impact Statement, Arctic National...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-15

    ... Fish and Wildlife Service Draft Comprehensive Conservation Plan and Draft Environmental Impact... conservation plan (CCP) and draft environmental impact statement (DEIS) for the Arctic National Wildlife Refuge... Refuge System, consistent with sound principles of fish and wildlife management, conservation, legal...

  7. 46 CFR 78.50-10 - Draft marks and draft indicating systems.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... draft marks plainly and legibly visible upon the stem and upon the sternpost or rudderpost or any place... of the draft marks, due to raked stem or cut—away skeg, the datum line from which the draft shal be...

  8. 46 CFR 78.50-10 - Draft marks and draft indicating systems.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... draft marks plainly and legibly visible upon the stem and upon the sternpost or rudderpost or any place... of the draft marks, due to raked stem or cut—away skeg, the datum line from which the draft shal be...

  9. 46 CFR 167.55-1 - Draft marks and draft indicating systems.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ...) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or... aft to the location of the draft marks, due to a raked stem or cut away skeg, the draft must be...

  10. 46 CFR 78.50-10 - Draft marks and draft indicating systems.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... draft marks plainly and legibly visible upon the stem and upon the sternpost or rudderpost or any place... of the draft marks, due to raked stem or cut—away skeg, the datum line from which the draft shal be...

  11. STATUS OF NCRP SCIENTIFIC COMMITTEE 1-23 COMMENTARY ON GUIDANCE ON RADIATION DOSE LIMITS FOR THE LENS OF THE EYE

    PubMed Central

    Dauer, Lawrence T.; Ainsbury, Elizabeth A.; Dynlacht, Joseph; Hoel, David; Klein, Barbara E. K.; Mayer, Don; Prescott, Christina R.; Thornton, Raymond H.; Vano, Eliseo; Woloschak, Gayle E.; Flannery, Cynthia M.; Goldstein, Lee E.; Hamada, Nobuyuki; Tran, Phung K.; Grissom, Michael P.; Blakely, Eleanor A.

    2015-01-01

    Previous National Council on Radiation Protection and Measurements (NCRP) publications have addressed the issues of risk and dose limitation in radiation protection and included guidance on specific organs and the lens of the eye (NCRP 1987, 1989, 1993a, 1993b, 1995a, 1995b, 2000b, 2001b, 2010a, 2010b, 2013). NCRP decided to prepare an updated commentary intended to enhance the previous recommendations provided in these earlier reports. NCRP Scientific Committee 1-23 (SC 1-23) (NCRP 2015) is charged with preparing a commentary that will evaluate recent studies on the radiation dose response for the development of cataracts, and also consider the type and severity of the cataracts as well as the dose rate; provide guidance on whether existing dose limits to the lens of the eye should be changed in the United States; and suggest research needs regarding radiation effects on and dose limits to the lens of the eye. A status of the ongoing work of SC 1-23 was presented at the NCRP 2015 Annual Meeting, “Changing Regulations and Radiation Guidance: What Dose the Future Hold?” The following represents a synopsis of a few main points in the current draft commentary. It is likely that several changes will be forthcoming as SC 1-23 responds to subject matter expert review and develops a final document, expected later in 2015. PMID:26717175

  12. RH Packaging Program Guidance

    SciTech Connect

    Washington TRU Solutions, LLC

    2003-08-25

    The purpose of this program guidance document is to provide technical requirements for use, operation, inspection, and maintenance of the RH-TRU 72-B Waste Shipping Package and directly related components. This document complies with the requirements as specified in the RH-TRU 72-B Safety Analysis Report for Packaging (SARP), and Nuclear Regulatory Commission (NRC) Certificate of Compliance (C of C) 9212. If there is a conflict between this document and the SARP and/or C of C, the SARP and/or C of C shall govern. The C of C states: ''...each package must be prepared for shipment and operated in accordance with the procedures described in Chapter 7.0, ''Operating Procedures,'' of the application.'' It further states: ''...each package must be tested and maintained in accordance with the procedures described in Chapter 8.0, ''Acceptance Tests and Maintenance Program of the Application.'' Chapter 9.0 of the SARP tasks the Waste Isolation Pilot Plant (WIPP) Management and Operating (M&O) contractor with assuring the packaging is used in accordance with the requirements of the C of C. Because the packaging is NRC approved, users need to be familiar with 10 CFR {section} 71.11, ''Deliberate Misconduct.'' Any time a user suspects or has indications that the conditions of approval in the C of C were not met, the Carlsbad Field Office (CBFO) shall be notified immediately. CBFO will evaluate the issue and notify the NRC if required. This document details the instructions to be followed to operate, maintain, and test the RH-TRU 72-B packaging. This Program Guidance standardizes instructions for all users. Users shall follow these instructions. Following these instructions assures that operations are safe and meet the requirements of the SARP. This document is available on the Internet at: ttp://www.ws/library/t2omi/t2omi.htm. Users are responsible for ensuring they are using the current revision and change notices. Sites may prepare their own document using the word

  13. Aiding Vertical Guidance Understanding

    NASA Technical Reports Server (NTRS)

    Feary, Michael; McCrobie, Daniel; Alkin, Martin; Sherry, Lance; Polson, Peter; Palmer, Everett; McQuinn, Noreen

    1998-01-01

    A two-part study was conducted to evaluate modern flight deck automation and interfaces. In the first part, a survey was performed to validate the existence of automation surprises with current pilots. Results indicated that pilots were often surprised by the behavior of the automation. There were several surprises that were reported more frequently than others. An experimental study was then performed to evaluate (1) the reduction of automation surprises through training specifically for the vertical guidance logic, and (2) a new display that describes the flight guidance in terms of aircraft behaviors instead of control modes. The study was performed in a simulator that was used to run a complete flight with actual airline pilots. Three groups were used to evaluate the guidance display and training. In the training, condition, participants went through a training program for vertical guidance before flying the simulation. In the display condition, participants ran through the same training program and then flew the experimental scenario with the new Guidance-Flight Mode Annunciator (G-FMA). Results showed improved pilot performance when given training specifically for the vertical guidance logic and greater improvements when given the training and the new G-FMA. Using actual behavior of the avionics to design pilot training and FMA is feasible, and when the automated vertical guidance mode of the Flight Management System is engaged, the display of the guidance mode and targets yields improved pilot performance.

  14. Ascent Guidance Comparisons

    NASA Technical Reports Server (NTRS)

    Hanson, John M.; Shrader, M. Wade; Cruzen, Craig A.

    1995-01-01

    This paper contains results from ascent guidance studies conducted at the NASA Marshall Space Flight Center. The studies include investigation of different guidance schemes for a variety of potential launch vehicles. Criteria of a successful ascent guidance scheme are low operations cost, satisfaction of load indicator constraints, and maximization of performance. Results show that open-loop designs as a function of altitude or velocity are preferable to designs that are functions of time. Optimized open-loop trajectories can increase performance while maintaining load indicators within limits. Closed-loop atmospheric schemes that involve linear tangent steering or feedback of velocity terms for trajectory modification did not yield any improvement. Early release of vacuum closed-loop guidance, including use during solid rocket booster operation, yields some improvements. Evaluation of a closed-loop optimization scheme for flying through the atmosphere shows no advantages over open-loop optimization. Dispersion study results for several potential guidance schemes and launch vehicles are included in the paper and are not a discriminator between guidance schemes. The primary cost driver is mission operations philosophy, not choice of guidance scheme. More autonomous guidance schemes can help in movement towards a philosophy that would reduce operations costs.

  15. Shuttle entry guidance revisited

    NASA Technical Reports Server (NTRS)

    Mease, Kenneth D.; Kremer, Jean-Paul

    1992-01-01

    The Shuttle entry guidance concept is reviewed which is aimed at tracking a reference drag trajectory that leads to the specified range and velocity for the initiation of the terminal energy management phase. An approximate method of constructing the domain of attraction is proposed, and its validity is ascertained by simulation. An alternative guidance law yielding global exponential tracking in the absence of control saturation is derived using a feedback linearization method. It is noted that the alternative guidance law does not improve on the stability and performance of the current guidance law, for the operating domain and control capability of the Shuttle. It is suggested that the new guidance law with a larger operating domain and increased lift-to-drag capability would be superior.

  16. Shuttle entry guidance

    NASA Technical Reports Server (NTRS)

    Harpold, J. C.; Graves, C. A., Jr.

    1978-01-01

    This paper describes the design of the entry guidance for the Space Shuttle Orbiter. This guidance provides the steering commands for trajectory control from initial penetration of the earth's atmosphere until the terminal area guidance is activated at an earth-relative speed of 2500 fps. At this point, the Orbiter is at a distance of about 50 nmi from the runway threshold, and at an altitude of about 80,000 ft. The entry guidance design is based on an analytic solution of the equations of motion defining the drag acceleration profile that meets the terminal criteria of the entry flight while maintaining the flight within systems and operational constraints. Guidance commands, which are based on a control law that ensures damping of oscillatory type trajectory motion, are computed to steer the Orbiter to this drag acceleration profile.

  17. Shuttle entry guidance revisited

    NASA Astrophysics Data System (ADS)

    Mease, Kenneth D.; Kremer, Jean-Paul

    1992-08-01

    The Shuttle entry guidance concept is reviewed which is aimed at tracking a reference drag trajectory that leads to the specified range and velocity for the initiation of the terminal energy management phase. An approximate method of constructing the domain of attraction is proposed, and its validity is ascertained by simulation. An alternative guidance law yielding global exponential tracking in the absence of control saturation is derived using a feedback linearization method. It is noted that the alternative guidance law does not improve on the stability and performance of the current guidance law, for the operating domain and control capability of the Shuttle. It is suggested that the new guidance law with a larger operating domain and increased lift-to-drag capability would be superior.

  18. Shuttle entry guidance revisited

    NASA Technical Reports Server (NTRS)

    Mease, Kenneth D.; Kremer, Jean-Paul

    1992-01-01

    The Shuttle entry guidance concept is reviewed which is aimed at tracking a reference drag trajectory that leads to the specified range and velocity for the initiation of the terminal energy management phase. An approximate method of constructing the domain of attraction is proposed, and its validity is ascertained by simulation. An alternative guidance law yielding global exponential tracking in the absence of control saturation is derived using a feedback linearization method. It is noted that the alternative guidance law does not improve on the stability and performance of the current guidance law, for the operating domain and control capability of the Shuttle. It is suggested that the new guidance law with a larger operating domain and increased lift-to-drag capability would be superior.

  19. Draft Wetlands Rule Released

    NASA Astrophysics Data System (ADS)

    Zielinski, Sarah

    2006-04-01

    The U.S. Environmental Protection Agency (EPA) and the U.S. Army Corps of Engineers released on 28 March a draft of a new rule to guide compensatory mitigation for when wetlands are unavoidably lost due to development. However, whether the rule is successful in preventing a net loss in wetlands will depend largely on its implementation, according to two wetlands scientists who evaluated the issue for the U.S. National Research Council (NRC) in 2001. Under the federal Clean Water Act, developers who seek to build on wetlands must compensate for any wetlands loss if they are unable to avoid or minimize the loss. Such compensation is covered under the newly proposed compensatory mitigation rule. Benjamin Grumbles, EPA assistant administrator for water, called the rule an ``innovative new standard that will accelerate the pace of wetlands conservation and restoration.''

  20. National Environmenal Policy Act Contracting Reform Guidance: Phase 1

    SciTech Connect

    1995-08-01

    The NEPA Contracting Quality Improvement Team identified several contracting improvements to reduce the cost and time for the NEPA process. The team`s February 1995 report recommended a series of steps to achieve the improvements, including issuance of contracting guidance. The guidance will be issued in three phases. This Phase I guidance implements the team`s short-term recommendations. It provides model statements of work and a sample schedule of contractor deliverables, establishes a pilot program for evaluating performance of NEPA support contractors, and describes information resources available on the DOE NEPA Web.