Science.gov

Sample records for recommendations draft guidance

  1. 78 FR 15370 - Draft Guidance for Industry and Food and Drug Administration Staff: Recommendations for Labeling...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

    ...The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled ``Draft Guidance for Industry and FDA Staff: Recommendations for Labeling Medical Products To Inform Users That the Product or Product Container Is Not Made With Natural Rubber Latex.'' The purpose of this draft guidance is to make recommendations on the appropriate language to include......

  2. 77 FR 40068 - Draft Guidance for Industry: Recommendations for Donor Questioning, Deferral, Reentry, and...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 The draft guidance document provides blood establishments that collect...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 This guidance replaces the draft guidance entitled ``Guidance for Industry: Recommendations...

  3. 78 FR 13069 - Draft Guidance for Industry: Recommendations for Screening, Testing, and, Management of Blood...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

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft document 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 The draft guidance document provides revised recommendations for screening and testing of donors and management......

  4. 75 FR 47603 - Draft Guidance for Industry and Food and Drug Administration Staff; Recommendations for Premarket...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

    ... Staff; Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays; Availability... Staff; Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays.'' This draft... zonisamide assays. This draft guidance is not final nor is it in effect at this time. DATES: Although you...

  5. 78 FR 55263 - Draft Guidance for Industry on Bioequivalence Recommendations for Fluticasone Propionate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-10

    ... Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry... Propionate; Salmeterol Xinafoate.'' The recommendations provide specific guidance on the design of....115). The draft guidance, when finalized, will represent the Agency's current thinking on the...

  6. 78 FR 73200 - Draft Guidance for Industry on Bioequivalence Recommendations for Paliperidone Palmitate Extended...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-05

    ... the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for... for Paliperidone Palmitate.'' The guidance provides specific recommendations on the design of...). The draft guidance, when finalized, will represent the Agency's current thinking on the design of...

  7. 78 FR 70953 - Draft Guidance for Industry on Bioequivalence Recommendations for Fluticasone Propionate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-27

    ... the Federal Register of September 10, 2013 (78 FR 55263). In that notice, FDA requested public comment... FR 55263), FDA announced the notice of availability for the draft guidance entitled ``Draft Guidance... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on...

  8. 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

    ... Register of February 21, 2008 (73 FR 9575). Once finalized, the annex will provide guidance to assist... 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...

  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

    ... 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry, ``Bioequivalence... design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for... draft guidance, when finalized, will represent the Agency's current thinking on the design of BE...

  10. 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

    ... if an animal food ingredient is already the subject of an approved FAP. Who to contact for more... 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...

  11. 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

    ... Wednesday, September 11, 2013 (78 FR 55727), announcing the availability of the draft guidance for industry..., 7519 Standish Pl., Rockville, MD 20855, 240-453-6864, sharon.benz@fda.hhs.gov . SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of Wednesday, September 11, 2013 (78 FR 55727),...

  12. 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

    ... transplantation. The guidance provides detailed information on the types of studies FDA recommends for validation... information on the types of studies FDA recommends for validation of HLA test kits submitted as 510(k)s. The... designing and conducting studies for validation of nucleic acid-based HLA test kits and preparing a...

  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

    .... SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of June 11, 2010 (75 FR 33311; FDA-2007-D- 0433... guidance provides specific recommendations on the design of bioequivalence (BE) studies to support... finalized, will represent the Agency's current thinking on the design of BE studies to support ANDAs...

  14. 77 FR 58399 - Draft Guidance for Industry on Bioequivalence Recommendations for Pentosan Polysulfate Sodium...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-20

    .... SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of June 11, 2010 (75 FR 33311; FDA-2007-D- 0433... recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new... on the design of BE studies to support ANDAs for pentosan polysulfate sodium capsule. It does...

  15. 77 FR 18827 - Draft Guidance for Industry on Bioequivalence Recommendations for Iron Sucrose Injection...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-28

    ... Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry... guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs... current thinking on the design of BE studies to support ANDAs for iron sucrose injection. It does...

  16. 77 FR 7586 - Draft Guidance for Industry on Bioequivalence Recommendation for Nitroglycerin Metered Spray...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-13

    ... 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry, ``Bioequivalence... 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...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-06

    ... the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for... on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for..., will represent the Agency's current thinking on the design of BE studies to support ANDAs 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

    .... Background In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a... specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications... represent the Agency's current thinking on the design of BE studies to support ANDAs for rifaximin-200...

  19. 78 FR 46965 - Draft Guidance for Industry on Bioequivalence Recommendations for Mesalamine Rectal Suppositories...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-02

    ... INFORMATION: I. Background In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the..., density, and viscosity). FDA is no longer ] recommending a BE study with clinical endpoints...

  20. 78 FR 52777 - Draft Guidance for Industry on Bioequivalence Recommendations for Risperidone Injection...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-26

    ... INFORMATION: I. Background In the Federal Register of May 31, 2007 (72 FR 30388), FDA announced the... its availability in the Federal Register of June 11, 2010 (75 FR 33311). This notice announces the... provides specific recommendations on the design of bioequivalence (BE) studies to support abbreviated...

  1. 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

    ... of January 13, 1989 (54 FR 1602), FDA revoked the exemption for patient examination gloves from... requirements for patient examination gloves. On December 12, 1990 (55 FR 51254), FDA published regulations... Staff; Recommended Warning for Surgeon's Gloves and Patient Examination Gloves That Use...

  2. 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

    ..., Reductions, and Refunds for Drug and Biological Products; Availability AGENCY: Food and Drug Administration... and Biological Products.'' This revised draft guidance provides recommendations to applicants... Drug and Biological Products.'' This revised draft guidance provides recommendations for...

  3. 77 FR 10536 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-22

    ...The Food and Drug Administration (FDA) is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a......

  4. 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...@nrc.gov . The draft NUREG-1556, Volume 19, Revision 1, is available under ADAMS Accession...

  5. 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

    ...The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices.'' This draft guidance is to provide industry and Agency staff with recommendations for studies to establish the analytical and clinical performance of highly multiplexed......

  6. 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

    ... Treatment.'' The purpose of this draft guidance is to assist clinical trial sponsors and investigators in...: Developing Drugs for Treatment.'' The purpose of this draft guidance is to assist clinical trial sponsors and... definitions of ABSSSI and the recommendations for clinical drug development. DATES: Although you can...

  7. 78 FR 37230 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-20

    ... INFORMATION: I. Background In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the... FR 74669). This notice announces draft product-specific recommendations, either new or revised, that... provide product-specific guidance on the design of BE studies to support abbreviated new drug...

  8. 77 FR 74669 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-17

    ... INFORMATION: I. Background In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the... FR 56851). This notice announces draft product-specific recommendations, either new or revised, that... provide product-specific guidance on the design of BE studies to support abbreviated new drug...

  9. 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

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``ANDAs: Stability Testing of Drug Substances and Products.'' FDA is recommending that generic drug manufacturers follow the stability testing recommendations in the International Conference on Harmonisation (ICH) guidances Q1A(R2) through Q1E. The use of these ICH recommendations......

  10. 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

    ... Staff; Design Considerations for Devices Intended for Home Use; Availability AGENCY: Food and Drug... availability of the draft guidance entitled ``Design Considerations for Devices Intended for Home Use.'' This... should consider, especially during device design and development, and provides recommendations...

  11. 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

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA.'' This guidance provides recommendations to applicants planning to include bioequivalence (BE) information in abbreviated new drug applications (ANDAs) and ANDA supplements. The guidance......

  12. 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

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Amendment (revisions to labeling recommendations for potential risk of vCJD) to `Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and......

  13. 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

    ... same title dated January 2001 (January 31, 2001, 66 FR 8410). The draft guidance, when finalized, will... blood components intended for transfusion, including recommendations for validation and quality control... for transfusion, including recommendations for validation and quality control monitoring of...

  14. 76 FR 27924 - Draft Regulatory Guide, Guidance for ITAAC Closure

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-13

    ... COMMISSION 10 CFR Parts 2 and 52 RIN 3150-AI77 Draft Regulatory Guide, Guidance for ITAAC Closure AGENCY: Nuclear Regulatory Commission. ACTION: Draft regulatory guide; request for comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment Draft Regulatory Guide...

  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. 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...

  17. 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...

  18. 76 FR 50231 - Mobile Medical Applications Draft Guidance; Public Workshop

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-12

    ... notice of availability for the draft guidance (76 FR 43689, July 21, 2011): FDA's recently- issued draft... 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. 78 FR 33848 - Draft Guidance for Industry on Human Immunodeficiency Virus-1 Infection: Developing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-05

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Human Immunodeficiency Virus... availability of a draft guidance for industry entitled ``Human Immunodeficiency Virus-1 Infection: Developing... guidance for industry entitled ``Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral...

  20. 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

    .... This guidance does not address endpoints for drugs to prevent or decrease the incidence of lung cancer... 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...

  1. 78 FR 15955 - Draft Guidance for Industry and Review Staff on Formal Dispute Resolution: Appeals Above the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-13

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and review staff entitled ``Formal Dispute Resolution: Appeals Above the Division Level.'' This guidance is intended to provide recommendations for industry on the procedures in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) for......

  2. 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.

  3. 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

    ...) ``Class II Special Controls Guidance Document: Powered Muscle Stimulator for Rehabilitation; Draft Guidance for Industry and FDA Staff''; (9) ``Class II Special Controls Guidance Document: Powered Muscle... II Special Controls Guidance Document: Powered Muscle Stimulator for Muscle Conditioning;...

  4. 75 FR 36421 - Draft Guidance for Industry on Chemistry, Manufacturing, and Controls Postapproval Manufacturing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-25

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Chemistry, Manufacturing, and... reported in annual reports. Specifically, the draft guidance describes chemistry, manufacturing,...

  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...

  6. 76 FR 39111 - Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-05

    ... notification requirements for dietary supplements that contain an NDI (62 FR 49886, September 23, 1997). The... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry; Dietary Supplements: New... a draft guidance for industry entitled ``Dietary Supplements: New Dietary Ingredient...

  7. 75 FR 41452 - Draft Guidance, “Federal Greenhouse Gas Accounting and Reporting”

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-16

    ... Leadership in Environmental, Energy, and Economic Performance (74 FR 52117) in order to establish an... QUALITY Draft Guidance, ``Federal Greenhouse Gas Accounting and Reporting'' AGENCY: Council on Environmental Quality. ACTION: Notice of Availability, Draft Guidance, ``Federal Greenhouse Gas Accounting...

  8. 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

    ...The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Medical Device Reporting for Manufacturers.'' This draft guidance 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 is intended......

  9. 76 FR 72710 - Agency Information Collection Activities; Proposed Collection; Comment Request; Draft Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-25

    ... July 16, 2010 (75 FR 41498), FDA published a notice of availability of the draft guidance document... 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:...

  10. 76 FR 51993 - Draft Guidance for Industry on Standards for Clinical Trial Imaging Endpoints; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-19

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Standards for Clinical Trial... entitled ``Standards for Clinical Trial Imaging Endpoints.'' The purpose of this draft guidance is to... products. The draft guidance describes standards sponsors can use to ensure that clinical trial...

  11. 75 FR 9228 - Draft Guidance for Industry on Non-Inferiority Clinical Trials; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-01

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Non-Inferiority Clinical... ``Non- Inferiority Clinical Trials.'' This draft guidance provides sponsors and review staff in the... announcing the availability of a draft guidance for industry entitled ``Non-Inferiority Clinical...

  12. 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

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Electronic Source Data in Clinical Investigations.'' This document revises and updates the draft guidance entitled ``Electronic Source Documentation in Clinical Investigations.'' This revised draft document provides guidance to sponsors, contract research organizations (CROs), data......

  13. 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

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Medication Guides--Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS).'' This draft guidance addresses two topics pertaining to Medication Guides for drug and biological products. First, the draft guidance addresses when FDA intends to......

  14. 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

    ... Q11 Development and Manufacture of Drug Substances; Availability AGENCY: Food and Drug Administration... a draft guidance entitled ``Q11 Development and Manufacture of Drug Substances.'' The draft guidance... Manufacture of Drug Substances'' should be made available for public comment. The draft guidance is...

  15. 75 FR 48973 - Draft Guidance for Industry: Prevention of Salmonella

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-12

    ...-1493. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of July 9, 2009 (74 FR 33030... Enteritidis in Shell Eggs During Production, Storage, and Transportation; Availability AGENCY: Food and Drug... availability of a draft guidance entitled ``Prevention of Salmonella Enteritidis in Shell Eggs...

  16. 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...

  17. 77 FR 3777 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-25

    ... (ANDAs). In the Federal Register of May 31, 2007 (72 FR 30386), FDA announced the availability of a draft... FR 62793). This notice announces draft product- specific recommendations, either new or revised, that... RLDs) Choline Fenofibrate (multiple RLDs) Ciclopirox (multiple RLDs) Ciprofloxacin HCl (multiple...

  18. 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

    ... Staff; 510(k) Device Modifications: Deciding When To Submit a 510(k) for a Change to an Existing Device... Administration (FDA) is announcing the availability of the draft guidance entitled ``510(k) Device Modifications: Deciding When To Submit a 510(k) for a Change to an Existing Device.'' The recommendations in this...

  19. 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

    ...The Food and Drug Administration (FDA) is announcing the availability of draft guidance for industry 217 entitled ``Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing Animals.'' The 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......

  20. US Food and Drug Administration draft recommendations on radioactive contamination of food

    SciTech Connect

    Thompson, D.L.

    1995-12-31

    Recommendations on accidental radioactive contamination of human food were issued in 1982 by the Food and Drug Administration (FDA). The recommendations provided guidance to State and local government officials in the exercise of their respective authorities, and were applicable to emergency response planning and to the conduct of radiation protection activities associated with the production, processing, distribution, and use of human food accidentally contaminated with radioactive material. Review of the 1982 FDA recommendations, stimulated by the events following the 1986 accident at Chernobyl, indicated that it would be appropriate to update the recommendations to incorporate newer scientific information and radiation protection philosophy, to include experience gained since 1982, and to take into account international advances. This paper presents a brief outline of the FDA`s approach to its draft revision. the most recent draft was circulated for interagency review in November 1994. Modification made in response to the comments received are included in this paper. 20 refs., 6 tabs.

  1. 76 FR 65735 - Draft Guidance for Industry: Implementation of Acceptable Abbreviated Donor History Questionnaire...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-24

    ... Abbreviated Donor History Questionnaire and Accompanying Materials for Use in Screening Frequent Donors of... entitled ``Guidance for Industry: Implementation of Acceptable Abbreviated Donor History Questionnaire and.... The draft guidance document recognizes the abbreviated donor history questionnaire and...

  2. 76 FR 13629 - Draft Guidance for Industry on Chemistry, Manufacturing, and Controls Information-Fermentation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-14

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Chemistry, Manufacturing, and... 216 entitled ``Chemistry, Manufacturing, and Controls (CMC) Information-- Fermentation-Derived... guidance for industry 216 entitled ``Chemistry, Manufacturing, and Controls (CMC)...

  3. 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

    .... This draft guidance is not final nor is it in effect at this time. DATES: Although you can comment on... electronic radiation emitting products. The scope of the guidance document includes devices described in...

  4. 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...

  5. 78 FR 20925 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-08

    ... (ANDAs). In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a... INFORMATION: I. Background In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the... FR 74669). This notice announces draft product-specific recommendations, either new or revised,...

  6. 77 FR 16842 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-22

    ... INFORMATION: I. Background In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the... FR 3777). This notice announces draft product-specific recommendations, either new or revised, that... Clindamycin Phosphate (multiple RLDs), D Dalfampridine, Dexmethylphenidate HCl, Dextromethorphan...

  7. 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...

  8. 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

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Investigational New Drug Applications (INDs)--Determining Whether Human Research Studies Can Be Conducted Without an IND.'' This draft guidance is intended to assist clinical investigators, sponsors, and sponsor-investigators in determining whether planned human research studies......

  9. 76 FR 75551 - Draft Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-02

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Regulatory Classification of Pharmaceutical Co-Crystals.'' This draft guidance provides applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) with the Center for Drug Evaluation and Research's (CDER's) current thinking on the appropriate......

  10. 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

    ...The Food and Drug Administration (FDA) is announcing the availability of draft guidance for industry entitled ``Providing Regulatory Submissions in Electronic Format--Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications.'' The draft guidance announced in this notice is being issued in accordance with the Food and Drug Administration Safety and......

  11. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Pulmonary Tuberculosis... industry entitled ``Pulmonary Tuberculosis: Developing Drugs for Treatment.'' The purpose of the draft... tuberculosis. This guidance applies to the development of a single investigational drug as well as...

  12. 77 FR 14402 - Draft Guidance on Classifying Significant Postmarket Drug Safety Issues; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-09

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Classifying Significant Postmarket Drug Safety Issues.'' This draft guidance describes FDA's current approach 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......

  13. 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

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic.'' The draft guidance discusses FDA's intended approach to enforcement of adverse event reporting requirements for drugs, biologics, medical devices, and dietary......

  14. 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

    ... guidance practices regulation. FDA withdrew the 1994 draft on January 5, 2005 (70 FR 824) and is now... Staff; Heart Valves -- Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications... -- Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications.'' This draft guidance...

  15. 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

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

  16. 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

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

  17. 75 FR 2145 - Draft Guidance for Industry on Tobacco Health Document Submission; Availability; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-14

    ... Register of December 28, 2009 (74 FR 68629). The notice announced the availability of a draft guidance...., Rockville, MD 20850-3229, 240-276-1717, May.Nelson@fda.hhs.gov . SUPPLEMENTARY INFORMATION: In FR Doc. E9... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Tobacco Health...

  18. 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... Questions; 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...

  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

    ..., November, 10, 2011 (76 FR 70151). In the notice, FDA requested comments on the draft guidance that has been... (76 FR 70151), FDA published a notice announcing the availability of the draft guidance entitled ``FDA... Investigational Device Exemption (IDE) Clinical Investigations; Extension of Comment Period AGENCY: Food and...

  20. 75 FR 60129 - Draft Guidance for Industry and Investigators on Safety Reporting Requirements for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-29

    ..., 2003 (68 FR 12406), FDA published a proposed rule to revise its regulations governing pre- and... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Investigators on Safety... Administration (FDA) is announcing the availability of a draft guidance for industry and investigators...

  1. 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...

  2. 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...

  3. 75 FR 8046 - National Environmental Policy Act (NEPA) Draft Guidance, “NEPA Mitigation and Monitoring.”

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-23

    ... QUALITY National Environmental Policy Act (NEPA) Draft Guidance, ``NEPA Mitigation and Monitoring.'' AGENCY: Council On Environmental Quality. ACTION: Notice of Availability, Draft Guidance, ``NEPA Mitigation and Monitoring.'' SUMMARY: On February 18, 2010, the Council on Environmental Quality...

  4. 78 FR 66745 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-06

    ... INFORMATION: I. Background In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the... recommendations for comment. Recommendations were last announced in the Federal Register on June 20, 2013 (78 FR... provide product-specific guidance on the design of BE studies to support abbreviated new drug...

  5. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Abuse-Deterrent Opioids... Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry... availability of a draft guidance for industry entitled ``Abuse-Deterrent Opioids--Evaluation and...

  6. 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

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``E2C(R2) Periodic Benefit-Risk Evaluation Report.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance updates and combines two ICH......

  7. 78 FR 78962 - Criteria for a Recommended Standard; Occupational Exposure to Heat and Hot Environments; Draft...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-27

    ...; Occupational Exposure to Heat and Hot Environments; Draft Criteria Document Availability AGENCY: National... Recommended Standard: Occupational Exposure to Heat and Hot Environments for public comment. To view the... draft document, ``Criteria for a Recommended Standard: Occupational Exposure to Heat and...

  8. 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

    ... (77 FR 58999), FDA published a draft and on June 20, 2013 (78 FR 37231), published a final guidance... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND... guidances Q1A (R2) through Q1E. DATES: Although you can comment on any guidance at any time (see 21 CFR...

  9. 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

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``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 discusses the processes that should be considered to ensure the quality and......

  10. 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 Staff; Procedures for Handling Section 522 Postmarket Surveillance Studies; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA)...

  11. 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...

  12. 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

    ... Information Incorporated Into Human Prescription Drug and Biological Products Labeling; Availability AGENCY... Information Incorporated into Human Prescription Drug and Biological Products Labeling.'' This draft guidance... content of pediatric information in human prescription drug and biological products labeling in...

  13. 75 FR 49913 - Draft Guidance, “Federal Greenhouse Gas Accounting and Reporting”

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-16

    ..., Energy, and Economic Performance (74 FR 52117) in order to establish an integrated strategy toward... QUALITY Draft Guidance, ``Federal Greenhouse Gas Accounting and Reporting'' AGENCY: Council on Environmental Quality. ACTION: Notice: Extension of comment period. SUMMARY: This notice extends the...

  14. 75 FR 8045 - National Environmental Policy Act (NEPA) Draft Guidance, Establishing, Applying, and Revising...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-23

    ... QUALITY National Environmental Policy Act (NEPA) Draft Guidance, Establishing, Applying, and Revising Categorical Exclusions Under the National Environmental Policy Act AGENCY: Council on Environmental Quality... Environmental Quality (CEQ) announced four steps to modernize, reinvigorate, and ease the use and increase...

  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. PMID:12792402

  16. 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

    ... draft guidance published in the Federal Register of June 9, 2010 (75 FR 32791). The original draft... Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. L. 111-31; 123 Stat. 1776... the authority to regulate tobacco products. Section 102 of the Tobacco Control Act requires FDA...

  17. 78 FR 53791 - Draft Program-Specific Guidance About Irradiator Licenses

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-30

    .... ACTION: Draft NUREG; request for comments. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is... NUREG-1556, Volume 6, Revision 1, ``Consolidated Guidance about Materials Licenses: Program-Specific...- 4737, or by email to pdr.resource@nrc.gov . The draft NUREG-1556, Volume 6, Revision 1, is...

  18. 78 FR 17943 - Draft Program-Specific Guidance About Fixed Gauge Licenses

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-25

    .... ACTION: Draft NUREG; request for comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is... NUREG-1556, Volume 4, Revision 1, ``Consolidated Guidance About Materials Licenses: Program-Specific...- 4737, or by email to pdr.resource@nrc.gov . The draft NUREG-1556, Volume 4, Revision 1, is available...

  19. 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...

  20. 76 FR 55068 - Mobile Medical Applications Draft Guidance; Public Workshop; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-06

    ... FR 50231). The document announced a public workshop entitled ``Mobile ] Medical Applications Draft... HUMAN SERVICES Food and Drug Administration Mobile Medical Applications Draft Guidance; Public Workshop... Spring, MD 20993-0002, 301-796-9148. SUPPLEMENTARY INFORMATION: In FR Doc. 2011-20574, appearing on...

  1. 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...

  2. 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... availability of a draft guidance for industry 211 entitled ``Residual Solvents in Animal ] Drug...

  3. 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

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Class II Special Controls Guidance Document: In 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 requirement of special controls for class II......

  4. 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...

  5. 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...

  6. 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... guidance for industry entitled ``Residual Drug in Transdermal and Related Drug Delivery Systems.'' This... of a draft guidance for industry entitled ``Residual Drug in Transdermal and Related Drug...

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

    PubMed Central

    2006-01-01

    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. PMID:17034633

  8. 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

    ... Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 66, Rm. 1646, Silver Spring... the Internet. A search capability for all Center for Devices and Radiological Health (CDRH) guidance... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and......

  9. 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

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Rheumatoid Arthritis: Developing Drug Products for Treatment.'' This guidance outlines FDA's current thinking on the principles of clinical development relevant to dose-selection and assessment of efficacy and safety to support the approval of drug products for the treatment of......

  10. 75 FR 29350 - Draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-25

    ... 2007'' and gave interested parties an opportunity to submit comments by July 27, 2009 (74 FR 27803... FR 46434). This draft guidance is the second edition of that guidance entitled ``Questions and... Registry is to provide a ``reliable mechanism to track patterns of adulteration in food would...

  11. 78 FR 27115 - Draft Guidance for Industry on Expanded Access to Investigational Drugs for Treatment Use...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-09

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Expanded Access to Investigational Drugs for Treatment Use--Qs & As.'' This guidance is intended to provide information for industry, researchers, physicians, and patients about certain aspects of FDA's implementation of its regulations on expanded access to investigational drugs......

  12. 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

    ...The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations.'' This guidance document has been developed to promote the initiation of clinical investigations to evaluate medical devices under FDA's IDE regulations. In an effort to promote timely clinical investigations in......

  13. 78 FR 4417 - Draft Guidance for Industry and Food and Drug Administration Staff; Submissions for Postapproval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-22

    ... Under a BLA, NDA, or PMA.'' This draft guidance intends to provide the underlying principles to... new drug application (NDA), or a device premarket approval application (PMA). DATES: Although you can..., or PMA.'' This document provides guidance to industry and FDA staff on the underlying principles...

  14. 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

    ... closure design (December 13, 2012, 77 FR 74196), and the third guidance will focus on minimizing risks... 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...

  15. 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

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``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 exercise its waiver authority to permit applicants to submit an International......

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-18

    ..., 2010 (75 FR 21632), FDA published a notice seeking comment on the proposed information collection... 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...

  17. 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

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Suicidal Ideation and Behavior: Prospective Assessment 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 of drug and biological......

  18. 77 FR 20025 - Draft Guidance for Industry on Compliance Policy for Reporting Drug Sample Distribution...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-03

    ... (42 U.S.C. 1320a-7i). This new section requires the submission of certain drug sample information to... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Compliance Policy for... guidance for industry entitled ``Compliance Policy on Reporting Drug Sample Distribution Information...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-07

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Electronic Source Documentation in Clinical Investigations.'' This document provides guidance to sponsors, contract research organizations (CROs), data management centers, and clinical investigators on capturing, using, and archiving electronic data in FDA-regulated clinical......

  20. 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

    ... Federal Register of March 7, 2007 (72 FR 10224), FDA announced the availability of a guidance titled... 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....

  1. 76 FR 34180 - National Organic Program; Notice of Draft Guidance for Accredited Certifying Agents and Certified...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-13

    ... Good Guidance Practices (GGPs) (January 25, 2007, 72 FR 3432-3440). The purpose of GGPs is to ensure... 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...

  2. 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.

  3. 75 FR 17148 - International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-05

    ... 17, 2009 (74 FR 7447), FDA published a notice announcing the availability of a draft tripartite... guidance made available in the Federal Register of February 21, 2008 (73 FR 9575). When implemented, the..., European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance...

  4. 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

    ... begins work on the final version of the guidance, submit electronic or written comments on the draft... section for information on electronic access to the guidance. Submit electronic comments on the draft... the applicable statute and regulations. III. Electronic Access Persons interested in obtaining a...

  5. 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

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Limiting the Use of Certain Phthalates as Excipients in CDER-Regulated Products.'' This draft guidance provides the pharmaceutical industry with the Center for Drug Evaluation and Research's (CDER's) current thinking on the potential human health risks associated with exposure to......

  6. 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... of development of direct-acting antiviral (DAA) drugs for the treatment of chronic hepatitis C....

  7. 75 FR 8968 - Draft Guidance for Industry on Adaptive Design Clinical Trials for Drugs and Biologics; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-26

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Adaptive Design Clinical... entitled ``Adaptive Design Clinical Trials for Drugs and Biologics.'' The draft guidance provides sponsors... Evaluation and Research (CBER) with information regarding adaptive design clinical trials when used in...

  8. 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

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Size of Beads in Drug Products Labeled for Sprinkle.'' This draft guidance provides sponsors of new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics licensing applications (BLAs) the Center for Drug Evaluation and Research's (CDER's) current......

  9. 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... Drugs for Treatment.'' The purpose of this draft guidance is to assist clinical trial sponsors...

  10. 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

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007.'' This draft guidance provides information on how a manufacturer may demonstrate that a tobacco product was commercially marketed in the United States as of February 15, 2007. In this......

  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...

  12. 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

    ... Register of July 14, 2011 (76 FR 41506). In the notice, FDA requested comments on a draft guidance document... 14, 2011 (76 FR 41506), FDA published a notice announcing the availability of the draft guidance... Staff on In Vitro Companion Diagnostic Devices; Extension of Comment Period AGENCY: Food and...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-26

    ... (58 FR 62188) and has subsequently published several amendments. II. Background on the Draft Guidance.... In its March 10, 2006 final rule (71 FR 12468), EPA stated that quantitative PM 2.5 and PM 10 hot... its March 2006 final rule (71 FR 12502), this draft guidance was developed in coordination with...

  14. 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

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Providing Submissions in Electronic Format--Summary Level Clinical Site Data for CDER's Inspection Planning.'' The draft guidance is intended to assist applicants in the voluntary submission of a clinical dataset that describes and summarizes the characteristics and outcomes of......

  15. BENCHMARK DOSE TECHNICAL GUIDANCE DOCUMENT (EXTERNAL REVIEW DRAFT)

    EPA Science Inventory

    The purpose of this document is to provide guidance for the Agency on the application of the benchmark dose approach in determining the point of departure (POD) for health effects data, whether a linear or nonlinear low dose extrapolation is used. The guidance includes discussion...

  16. 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

    ...The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled ``Initial Completeness Assessments for Type II API DMFs Under GDUFA.'' Under the Generic Drug User Fee Amendments of 2012 (GDUFA), holders of certain drug master files, namely, Type II active pharmaceutical ingredient (API) drug master files (DMFs) that are referenced......

  17. 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

    ... Staff; De Novo Classification Process (Evaluation of Automatic Class III Designation); Availability...) is announcing the availability of the draft guidance entitled ``De Novo Classification Process... staff and industry on the process for the submission and review of petitions submitted under the...

  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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Food and Drug Administration Records Access Authority Under the Federal Food, Drug, and Cosmetic Act; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

  19. 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

    ... April 5, 2010 (75 FR 17093), FDA published a notice announcing the availability of draft special... for the notice that appeared in the Federal Register of April 5, 2010 (75 FR 17143). In the notice... Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Document; Reopening...

  20. 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...

  1. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Frequently Asked Questions About Medical Foods; Second Edition; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA or we) is announcing the availability of the...

  2. 77 FR 20026 - Draft Guidance for Industry: Modified Risk Tobacco Product Applications; Availability; Agency...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-03

    ... product; Sample product labels and labeling; All documents (including underlying scientific information... proposes to label and market the product, consumers will not be misled into believing that the product is... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Modified Risk Tobacco...

  3. 76 FR 80947 - Draft Guidance for Industry and Food and Drug Administration Staff; Investigational Device...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-27

    ..., 2011 (76 FR 70150). In the notice, FDA requested comments on the draft guidance that addresses the.... Background In the Federal Register of November 10, 2011 (76 FR 70150), FDA published a notice announcing the... mitigation strategies, under the investigational device exemption (IDE) requirements. The Agency is...

  4. 78 FR 19492 - Draft Guidance for Industry on Formal Meetings Between FDA and Biosimilar Biological Product...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-01

    ... during the development phase of a biosimilar biological product. This draft guidance describes the Agency... development and review of biosimilar biological products. \\1\\ See http://www.fda.gov/downloads/Drugs... between sponsors or applicants and FDA for biosimilar biological product development (BPD) programs. It...

  5. 76 FR 9583 - Draft Guidance for Industry on Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-18

    ..., metabolism, and excretion), and pharmacodynamics (i.e., all of the effects of the drug on various physiologic... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical Studies; Availability AGENCY: Food and Drug Administration,...

  6. 76 FR 32367 - Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-06

    ... notice that appeared in the Federal Register of May 24, 2011 (76 FR 30175). The document announced the...-0002, 301-796-9148. SUPPLEMENTARY INFORMATION: In FR Doc. 2011-12623, appearing on page 30175, in the... HUMAN SERVICES Food and Drug Administration Draft Guidance for Clinical Investigators, Industry, and...

  7. 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... abbreviated licensure pathway under section 351(k) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(k... application (i.e., a facility in which the proposed biological product is ] manufactured, processed,...

  8. 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... and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Design... study design principles relevant to the development of medical device clinical studies that can be...

  9. 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...

  10. 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...

  11. 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

    ... draft guidance document provides industry and Agency staff with FDA's current thinking on regulation of...-resistant Staphylococcus aureus, Hepatitis C virus, and genetic markers of cystic fibrosis. These types of... meant to communicate FDA's policy regarding molecular diagnostic instruments with combined...

  12. 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...

  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

    ... Administration (FDA) is correcting a notice that appeared in the Federal Register of March 2, 2012 (77 FR 12853...-3529, email: biosimilarspublicmtg@fda.hhs.gov . SUPPLEMENTARY INFORMATION: In FR Doc. 2012-5070... HUMAN SERVICES Food and Drug Administration Draft Guidances Relating to the Development of...

  14. 78 FR 36194 - Draft Guidance for Industry and FDA Staff: Investigational New Drug Applications for Minimally...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-17

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry and FDA Staff: Investigational New Drug Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System'' dated June 2013.......

  15. 76 FR 55927 - Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-09

    ... and Related Issues; Availability,'' that appeared in the Federal Register of July 5, 2011 (76 FR 39111... 5, 2011 (76 FR 39111), FDA published a notice with a 90-day comment period to request comments on... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry; Dietary Supplements:...

  16. 76 FR 77492 - Draft Guidance on Improving the Process for Preparing Efficient and Timely Environmental Reviews...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-13

    ...The Council on Environmental Quality (CEQ) is issuing its draft guidance on Improving the Process for Preparing Efficient and Timely Environmental Reviews under the National Environmental Policy Act for public review and comment. The National Environmental Policy Act (NEPA) and CEQ Regulations implementing NEPA provide numerous techniques for preparing efficient and timely environmental......

  17. 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

    ... Detection and Differentiation of Methicillin-Resistant Staphylococcus aureus (MRSA) and Staphylococcus... Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA). This draft guidance is not final nor is it in effect... for the Detection and Differentiation of Methicillin-Resistant Staphylococcus aureus (MRSA)...

  18. 77 FR 34958 - Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-12

    ....gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ProposedRegulationsandDraftGuidances/default... Drug Information, Center for Drug Evaluation and Research (CDER), Food and Drug Administration, 10903... and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville,...

  19. 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

    ... ``Administrative Practices and Procedures; Good Guidance Practices'' (GGP) (65 FR 56468; September 19, 2000). The... manufacturing practice (cGMP) compliance specific to manufacturing, processing, and dose unit sampling and... following guidances: 1. ``Manufacturing, Processing, or Holding Active Pharmaceutical...

  20. 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

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``ANDA Submissions--Refuse-to-Receive Standards.'' This guidance is intended to assist applicants preparing to submit to FDA abbreviated new drug applications (ANDAs) and related submissions (i.e., prior approval supplements (PASs) for new strengths). The guidance contains details on......

  1. 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

    ... the guidance, submit either electronic or written comments on the draft guidance by August 27, 2013... INFORMATION section for information on electronic access to the guidance. Submit electronic comments on the... approach satisfies the requirements of the applicable statute and regulations. III. Electronic...

  2. 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

    ... before it begins work on the final version of the guidance, submit either electronic or written comments... information on electronic access to the guidance. Submit electronic comments on the draft guidance to http... the requirements of the applicable statute and regulations. III. Electronic Access Persons...

  3. 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...

  4. 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

    ... Federal Register of January 25, 2012 (77 FR 3779), FDA announced the availability of a guidance entitled..., 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...

  5. 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

    ... regulations require that certain human drug and biological product labels contain a bar code (Sec. 201.25 (21... Guidance (October 5, 2006, 71 FR 58739). In this guidance, FDA is proposing to amend our response to... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Bar Code Label...

  6. 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

    ... Drug Administration Staff; Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for... entitled ``Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Bacillus spp. Detection.'' This draft guidance document describes means by which in vitro diagnostic devices for...

  7. 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

    ... AGENCY Permitting Guidance for Oil and Gas Hydraulic Fracturing Activities Using Diesel Fuels--Draft... published on May 10, 2012, Permitting Guidance for Oil and Gas Hydraulic Fracturing Activities Using Diesel....gov @epa.gov. Mail: Permitting Guidance for Oil and Gas Hydraulic Fracturing Activities Using...

  8. 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....

  9. 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...

  10. 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,...

  11. 75 FR 78259 - Draft Guidance for Industry on Codevelopment of Two or More Unmarketed Investigational Drugs for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-15

    ... to apply to vaccines, gene or cellular therapies, blood products, or medical devices. DATES: Although... vaccines, gene or cellular therapies, or blood products. This draft guidance is being issued...

  12. 77 FR 10535 - Final Guidances for Industry Describing Product-Specific Bioequivalence Recommendations...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-22

    ...The Food and Drug Administration (FDA) is announcing the availability of final product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry,......

  13. 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

    ... provide recommendations to industry on the design of self- selection studies for nonprescription drug... guidance discusses general concepts to be considered in the design and conduct of a self-selection...

  14. 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

    ... specifically address children's toy laser products. FDA recently issued a proposed rule (78 FR 37723) that... HUMAN SERVICES Food and Drug Administration Minimizing Risk for Children's Toy Laser Products; Draft... availability of the draft guidance entitled ``Minimizing Risk for Children's Toy Laser Products.'' This...

  15. 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.

  16. 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...

  17. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on ``Target Animal Safety and... guidance for industry ( 215) entitled ``Target Animal Safety and Effectiveness Protocol Development and... for review by the Center for Veterinary Medicine (CVM), Office of New Animal Drug Evaluation...

  18. 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

    ... Demonstrate Effectiveness of a New Animal Drug for Use in Companion Animals; Availability AGENCY: Food and... Demonstrate Effectiveness of a New Animal Drug for Use in Companion Animals.'' This draft guidance advises... of new animal drugs for use in companion animals. The intent of the guidance is to...

  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 Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Types of Communication During the Review of Medical Device Submissions.'' The purpose of this guidance is to update the Agency's approach to Interactive Review to reflect FDA's implementation of the Medical Device User Fee Act of 2007 (MDUFA II) Commitment Letters and of undertakings agreed......

  20. 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...

  1. 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

    ... Anthropogenic Sound on Marine Mammals--Acoustic Threshold Levels for Onset of Permanent and Temporary Threshold... the effects of anthropogenic sound on marine mammal species under NOAA's jurisdiction. The guidance... anthropogenic sound sources. NOAA solicits public comment on the draft guidance. DATES: Comments must...

  2. 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...

  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... entitled ``In Vitro Companion Diagnostic Devices.'' This guidance is intended to assist sponsors planning to develop a therapeutic product that depends on the use of an in vitro companion diagnostic...

  4. 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

    ... and achievable with the use of good manufacturing practices. It also describes FDA's intended sampling... to be protective of human health and to be achievable with the use of good manufacturing practices... with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized,...

  5. 76 FR 2328 - National Organic Program: Notice of Draft Guidance Concerning “Made With Organic (Specified...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-13

    ... Management and Budget (OMB) Bulletin on Agency Good Guidance Practices (GGPs) (January 25, 2007, 72 FR 3432... Organic (Specified Ingredients or Food Groups)'' Products: Product Composition and Use of Percentage...: This notice announces draft guidance for the organic industry to address the labeling, composition...

  6. 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

    ... AGENCY Public Meeting on Draft Permitting Guidance for Oil and Gas Hydraulic Fracturing Activities Using... agency has developed on the use of diesel fuels in oil and gas hydraulic fracturing and to solicit input... discuss ``Permitting Guidance for Oil and Gas Hydraulic Fracturing Activities Using Diesel...

  7. 77 FR 56851 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-14

    ... INFORMATION: I. Background In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the... recommendations for comment. Recommendations were last announced in the Federal Register of June 14, 2012 (77 FR... salmon Carbidopa; levodopa Carglumic acid Ciclesonide Ciprofloxacin; dexamethasone Cyclophosphamide...

  8. 77 FR 35688 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-14

    ... (ANDAs). In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a... comment. Recommendations were last announced in the Federal Register of March 28, 2012 (77 FR 18827). This... reference listed drugs (RLDs)) Cefprozil (multiple RLDs) Cetirizine HCl Ciprofloxacin HCl;...

  9. 75 FR 33311 - Guidance for Industry on Bioequivalence Recommendations for Specific Products; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-11

    ... HUMAN SERVICES Food and Drug Administration (formerly Docket No. 2007D-0169) Guidance for Industry on Bioequivalence Recommendations for Specific Products; Availability AGENCY: Food and Drug Administration, HHS... comment on those recommendations. In the Federal Register of May 31, 2007 (72 FR 30388), FDA announced...

  10. 76 FR 52995 - Draft License Renewal Interim Staff Guidance LR-ISG-2011-05: Ongoing Review of Operating...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-24

    ...The NRC requests public comment on Draft License Renewal Interim Staff Guidance (LR-ISG), LR-ISG-2011-05, ``Ongoing Review of Operating Experience.'' This LR-ISG provides guidance and clarification concerning ongoing review of plant-specific and industry-wide operating experience as an attribute of aging management programs used at nuclear power plants for compliance with Title 10 of the Code......

  11. Post Commission Final Draft: Recommendations of Interest to Commission.

    ERIC Educational Resources Information Center

    California State Postsecondary Education Commission, Sacramento.

    A brief overview is presented by a blue ribbon commission on the organization of elementary/secondary education and higher education in California, funding provided to community colleges, and recommendations of the California Postsecondary Education Commission regarding postsecondary education. In addition, an outline of issues facing…

  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

    ... Staff; Glass Syringes for Delivering Drug and Biological Products: Technical Information To Supplement... availability of draft guidance for industry and FDA staff entitled ``Glass Syringes for Delivering Drug and... glass syringes that comply with the ISO 11040-4 standard when connected to devices (``connecting...

  13. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g); Requests for Information; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability...

  14. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical Device Submissions; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability...

  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. 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...

  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

    ... 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 guidance for industry entitled ``Size, Shape, and Other Physical Attributes of Generic Tablets and...

  18. 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

    ... Generic Drug Facilities, Sites, and Organizations; Availability; Correction AGENCY: Food and Drug... notice that appeared in the Federal Register of Monday, August 27, 2012 (77 FR 51811). The document announced a draft guidance for industry entitled ``Self-Identification of Generic Drug Facilities,...

  19. 78 FR 70953 - Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-27

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Generic Drug User Fee... Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers (Revision 1)'', published in the Federal Register of September 10, 2013 (78 FR 55261). In that notice, FDA requested public...

  20. 78 FR 17660 - Draft Guidance for E85 Flexible Fuel Vehicle Weighting Factor for Model Years 2016-2019 Vehicles...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-22

    ... AGENCY Draft Guidance for E85 Flexible Fuel Vehicle Weighting Factor for Model Years 2016-2019 Vehicles... the weighting factor. DATES: Comments must be received on or before April 22, 2013. ADDRESSES: Submit.... Environmental Protection Agency, 2000 Traverwood Drive, Ann Arbor, MI 48105. Telephone: (734) 214-4380....

  1. 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

    ... advertisements (TV ads) provision of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). (The term ``pre... ``Prereview of Television Advertisements.'') The draft guidance describes which TV ads FDA intends to make... submit their TV ads to FDA for pre-dissemination review in compliance with the FD&C Act. These...

  2. 75 FR 28257 - Draft Guidance for Industry, Third Parties and Food and Drug Administration Staff; Medical Device...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-20

    ... Administration Staff; Medical Device ISO 13485:2003 Voluntary Audit Report Submission Program; Availability... Voluntary Audit Report Submission Program.'' This draft guidance is intended to provide information on the... Voluntary Audit Report Submission Program'' to the Division of Small Manufacturers, International,...

  3. 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

    ... HUMAN SERVICES Food and Drug Administration (formerly Docket No. 02D-0049) Draft Guidance for the Public, Food and Drug Administration Advisory Committee Members, and Food and Drug Administration Staff: Public...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA)...

  4. 76 FR 35665 - Draft Guidance for Industry on Enforcement Policy for Over-the-Counter Sunscreen Drug Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-17

    ... sunscreen final rule published in the Federal Register of May 21, 1999 (64 FR 27666) (the 1999 final rule) that was stayed before becoming effective (69 FR 53801, September 3, 2004); The draft guidance states... FR 27666 at 27689 through 27693) or a proposed rule that published in the Federal Register of...

  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

    ...: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans... Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study... draft guidance for industry entitled ``Pediatric Study Plans: Content of and Process for...

  6. 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

    ... Applications--Content and Format for New Drug Applications and Abbreviated New Drug Applications; Availability...) is announcing the availability of a draft guidance entitled ``PET Drug Applications-- Content and... Content and Format of New Drug Applications and Abbreviated New Drug Applications for Certain...

  7. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Heparin for Drug and Medical Device Use; Monitoring Crude Heparin for Quality; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a...

  8. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Self-Identification of Generic Drug Facilities, Sites, and Organizations; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a...

  9. 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...

  10. 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

    ... Tobacco to Protect Children and Adolescents'' (75 FR 13225, March 19, 2010, codified at 21 CFR part 1140... 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...

  11. 77 FR 5857 - Common-Cause Failure Analysis in Event and Condition Assessment: Guidance and Research, Draft...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-06

    ...: On November 2, 2011 (76 FR 67764), the U.S. Nuclear Regulatory Commission (NRC) published for public comment Draft NUREG, ``Common- Cause Failure Analysis in Event and Condition Assessment: Guidance and...-2011-0254. Discussion On November 2, 2011 (76 FR 67764), the NRC published for public comment...

  12. 78 FR 7784 - Draft Guidance for Industry on Enrichment Strategies for Clinical Trials To Support Approval of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-04

    ... Products'' that appeared in the Federal Register of December 17, 2012 (77 FR 74670). In the document, FDA... the Federal Register of December 17, 2012 (77 FR 74670), FDA announced the availability of this draft... enrichment. The guidance also discusses general clinical trial design considerations, provides examples...

  13. 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

    ... Under the Federal Food, Drug, and Cosmetic Act AGENCY: Food and Drug Administration, HHS. ACTION: Notice...) Requests for Information Under the Federal Food, Drug, and Cosmetic Act.'' This draft guidance is not final...) Requests for Information Under the Federal Food, Drug, and Cosmetic Act'' to the Division of...

  14. 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

    ... Federal Register of September 12, 2006 (71 FR 53696), FDA announced the availability of a draft guidance... in vivo studies of drug metabolism, drug transport, and drug-drug, or drug-therapeutic protein... metabolism and/or drug transport abruptly in individuals who previously had been receiving and tolerating...

  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

    ... protective of human health and achievable with the use of good manufacturing practices. It also describes FDA...: Action Level'' that appeared in the Federal Register of July 15, 2013 (78 FR 42086). The draft guidance...-1639. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of July 15, 2013 (78 FR...

  16. 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

    ... QUALITY National Environmental Policy Act (NEPA) Draft Guidance, ``Consideration of the Effects of Climate Change and Greenhouse Gas Emissions.'' AGENCY: Council On Environmental Quality. ACTION: Notice of....'' SUMMARY: On February 18, 2010, the Council on Environmental Quality (CEQ) announced four steps...

  17. 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...

  18. 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...

  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

    ... and Gene Therapy Products'' that appeared in the Federal Register of July 2, 2013 (78 FR 39736). The... 2, 2013 (78 FR 39736), FDA published a notice announcing the availability of a draft guidance... of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; Extension of Comment...

  20. 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

    ... AGENCY Permitting Guidance for Oil and Gas Hydraulic Fracturing Activities Using Diesel Fuels--Draft... oil- and gas-related hydraulic fracturing (HF) using diesel fuels where the U.S. Environmental... Safe Drinking Water Act (SDWA) and regulations regarding UIC permitting of oil and gas...

  1. 75 FR 54153 - International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-03

    .... In the Federal Register of December 17, 2009 (74 FR 66981), FDA published a notice announcing the... Federal Register of February 21, 2008 (73 FR 9575). When implemented, the annex will provide guidance for... Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference...

  2. 75 FR 18509 - International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-12

    ... 21, 2008 (73 FR 9575), FDA made available a guidance on the Q4B process entitled ``Q4B Evaluation and.... In the Federal Register of August 14, 2009 (74 FR 41143), FDA published a notice announcing the... Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference...

  3. 75 FR 53973 - International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-02

    .... In the Federal Register of December 17, 2009 (74 FR 66982), FDA published a notice announcing the... Register of February 21, 2008 (73 FR 9575). When implemented, the annex will provide guidance for industry... Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference...

  4. 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 recommendations. In the Federal Register of July 6, 2012 (77 FR 40068), FDA announced the..., 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...

  5. Current Assessment and Classification of Suicidal Phenomena using the FDA 2012 Draft Guidance Document on Suicide Assessment: A Critical Review

    PubMed Central

    Giddens, Jennifer M.; Sheehan, Kathy Harnett

    2014-01-01

    Objective: Standard international classification criteria require that classification categories be comprehensive to avoid type II error. Categories should be mutually exclusive and definitions should be clear and unambiguous (to avoid type I and type II errors). In addition, the classification system should be robust enough to last over time and provide comparability between data collections. This article was designed to evaluate the extent to which the classification system contained in the United States Food and Drug Administration 2012 Draft Guidance for the prospective assessment and classification of suicidal ideation and behavior in clinical trials meets these criteria. Method: A critical review is used to assess the extent to which the proposed categories contained in the Food and Drug Administration 2012 Draft Guidance are comprehensive, unambiguous, and robust. Assumptions that underlie the classification system are also explored. Results: The Food and Drug Administration classification system contained in the 2012 Draft Guidance does not capture the full range of suicidal ideation and behavior (type II error). Definitions, moreover, are frequently ambiguous (susceptible to multiple interpretations), and the potential for misclassification (type I and type II errors) is compounded by frequent mismatches in category titles and definitions. These issues have the potential to compromise data comparability within clinical trial sites, across sites, and over time. Conclusion: These problems need to be remedied because of the potential for flawed data output and consequent threats to public health, to research on the safety of medications, and to the search for effective medication treatments for suicidality. PMID:25520889

  6. 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.

  7. 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... guidance recommends interim strategies for IBS clinical trial design and endpoints, and discusses the...--Clinical Evaluation of Products for Treatment; Availability AGENCY: Food and Drug Administration,...

  8. 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,...

  9. 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

    ....'' This guidance addresses nonclinical development, early phases of clinical development, phase 3 trial... collections of information referred to in the guidance for clinical trial sponsors entitled ``Establishment and Operation of Clinical Trial Data Monitoring Committees'' have been approved under OMB...

  10. Supplemental risk-assessment guidance for the Superfund program. Part 1. Guidance for Public-Health Risk Assessments. Part 2. Guidance for ecological Risk Assessments. Draft report (Final)

    SciTech Connect

    Not Available

    1989-06-01

    This guidance manual was developed to address the practical aspects and issues pertaining to the Superfund risk-assessment process for both public health and environment concerns. Part 1, Guidance for Public Health Risk Assessments, supplements the Superfund Public Health Evaluation Manual and Superfund Exposure Assessment Manual and the Endangerment Assessment Handbook. Explicit guidance on technical matters which should be followed in developing public health risk assessments for EPA Region 1. The guidance addresses hazard identification, dose-response assessment, exposure assessment, risk characterization, and uncertainty/limitations. Part 2 of the manual, Guidance for Ecological Risk Assessments, addresses the collection of site-specific data needed to support an ecological risk assessment, describes a framework for conducting the assessments, and provides several specific approaches for assessing risks to systems exposed to chemical contamination in different media.

  11. 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

    ... Biotherapeutic Products: Chemistry, Manufacturing, and Control Information; Availability AGENCY: Food and Drug... Biotherapeutic Products: Chemistry, Manufacturing, and Control Information'' dated September 2010. The draft... Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information'' dated September...

  12. 76 FR 36543 - Draft Guidance for Industry and Food and Drug Administration Staff: Applying Human Factors and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-22

    ... Staff: Applying Human Factors and Usability Engineering To Optimize Medical Device Design; Availability... Medical Device Design.'' The recommendations in this guidance are intended to improve the safety and... Factors and Usability Engineering to Optimize Medical Device Design'' to the Division of...

  13. 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…

  14. 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

    ... clinical trial designs to support approval of drugs. DATES: Although you can comment on any guidance at any... endpoint and a non-inferiority trial design. The efficacy endpoint of clinical success represents the... of information referred to in the guidance for clinical trial sponsors ``Establishment and...

  15. Congress Likely to Rein In 340B Drug Discount Program: The HRSA's Draft Guidance and a Proposed Rule Give Legislators an Opening.

    PubMed

    Barlas, Stephen

    2015-10-01

    Congress may be about to rein in the 340B drug program, which lets safety-net hospitals and community clinics use outpatient prescription sales to generate revenue. The Health Resources and Services Administration, which runs the program, has published draft guidance to clarify issues raised by federal watchdog agencies. PMID:26535022

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-11

    ... (77 FR 74003) (FRL-9362-3). In that document, EPA requested comment on a draft PR notice that provided...-Related Label Claims; Notice of Availability; Extension of Comment Period AGENCY: Environmental Protection... for Antimicrobial Pesticide Products with Mold-Related Label Claims. This document extends the...

  18. 75 FR 28012 - Pesticides; Draft Guidance for Pesticide Registrants on False or Misleading Pesticide Product...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-19

    ... availability of this draft PR Notice for public comment (67 FR 14941; FRL-6809-9) on March 28, 2002 and... Brand Names AGENCY: Environmental Protection Agency (EPA). ACTION: Notice of availability. SUMMARY: The... Notice (PR Notice) entitled ``False or Misleading Pesticide Product Brand Names.'' PR Notices are...

  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

    ... Register of Tuesday, November 20, 2012 (77 FR 69632). The document announced the availability of a draft...: 301-847-8443. SUPPLEMENTARY INFORMATION: In FR Doc. 2012-28198, appearing on page 69632 in the Federal... Fitzmartin, Office of Planning & Informatics, Center for Drug Evaluation and Research, Food and...

  20. 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

    ... in the January 17, 2008, issue of the Federal Register (73 FR 3316). Background and Purpose Title VI... the MSP inspection process through the establishment of two levels of MSP inspection and oversight... vessels would utilize the process outlined in this draft NVIC to obtain a Coast Guard Certificate...

  1. 78 FR 42387 - Draft Guidance for Industry on Circumstances That Constitute Delaying, Denying, Limiting, or...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-15

    ... Drug Inspection.'' The Food and Drug Administration Safety and Innovation Act (FDASIA) added a new... adulterated. This guidance defines, by way of example, the circumstances that FDA would consider to...

  2. 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... regarding assessment of photosafety to support clinical development and marketing authorization of... Clinical Trials and Marketing Authorization for Pharmaceuticals,'' available on the Internet at...

  3. 76 FR 70150 - Draft Guidance for Industry and Food and Drug Administration Staff; Investigational Device...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-10

    ... guidance entitled ``Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical... mitigation strategies, under the IDE requirements. Early feasibility studies allow for limited early clinical... of an early feasibility study IDE application and explains the requirements applicable...

  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...

  5. 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

    ... Investigational Cellular and Gene Therapy Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION... document entitled ``Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene... for Biologics Research and Evaluation (CBER), Office of Cellular, Tissue, and Gene Therapies...

  6. 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

    ...: extension of comment period. SUMMARY: On March 8, 2010, (75 FR 10524), the Nuclear Regulatory Commission (NRC) published for public comment a document entitled: ``NUREG-0654/FEMA-REP-1, Rev. 1, Supplement 3... COMMISSION NUREG-0654/FEMA-REP-1, Rev. 1, Supplement 3, Guidance for Protective Action Recommendations...

  7. 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

    ... (75 FR 984), the deadline for the public to provide its comments was February 26, 2010. The purpose of... January 7, 2010 (75 FR 984), was for 50 days. Therefore, the new deadline will now be April 2, 2010. Dated... AGENCY RIN 2050-ZA05 Guidance on Recommended Interim Preliminary Remediation Goals for Dioxin in Soil...

  8. 78 FR 29159 - Electric Power Research Institute; Seismic Evaluation Guidance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-17

    ...The U.S. Nuclear Regulatory Commission (NRC) is issuing an endorsement letter of Electric Power Research Institute (EPRI) Report, ``Seismic Evaluation Guidance: EPRI Guidance for the Resolution of Fukushima Near-Term Task Force Recommendation 2.1: Seismic,'' Draft Report, hereafter referred to as the EPRI...

  9. 76 FR 55390 - Guidance on Exculpatory Language in Informed Consent, Draft

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-07

    ... Sheet Guidance Initiative, announced in the Federal Register of February 3, 2006 (71 FR 5861), which... instructions. Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]: Irene Stith-Coleman, PhD... . FOR FURTHER INFORMATION CONTACT: Irene Stith-Coleman, PhD, Office for Human Research Protections,...

  10. 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

    ... July 28, 2010 (75 FR 44267). The document reopened the comment period for a notice of availability of..., Silver Spring, MD 20993, 301-796-9148. SUPPLEMENTARY INFORMATION: In FR Doc. 2010-18406, appearing on... Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Document; Reopening...

  11. 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,...

  12. 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

    ...) Bulletin on Agency Good Guidance Practices (GGPs) (January 25, 2007, 72 FR 3432-3440). The purpose of GGPs... on Classification of Materials and Materials for Organic Crop Production AGENCY: Agricultural... materials used for organic crop production, livestock production, and handling. The second set of...

  13. 75 FR 50771 - Draft Revised Guidance for Industry on Residual Solvents in New Veterinary Medicinal Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-17

    ... Federal Register of May 22, 2001 (66 FR 28182) (the 2001 final guidance), has been developed for... requirements for the approval of human pharmaceutical and biological products among the European Union, Japan... medicinal products in the European Union, Japan, and the United States, and includes input from...

  14. 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...

  15. 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

    ... Budget (OMB) Bulletin on Agency Good Guidance Practices (GGPs) (January 25, 2007, 72 FR 3432-3440). The... 5024); Commingling and Contamination Prevention in Organic Production and Handling (NOP 5025); and The... specifically developed Commingling and Contamination Prevention in Organic Production and Handling (NOP...

  16. 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

    ... clinical trial designs to support approval of drugs. DATES: Although you can comment on any guidance at any... efficacy endpoint and noninferiority trial design. The efficacy endpoint, based on resolution of clinical... trial sponsors ``Establishment and Operation of Clinical Trial Data Monitoring Committees'' have...

  17. 75 FR 13562 - Revised Draft Guidance for Industry on Pharmacokinetics in Patients With Impaired Renal Function...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-22

    ... 15, 1998 (63 FR 27094), FDA announced the availability of a guidance entitled ``Pharmacokinetics in... its metabolites, changes in renal metabolism can also occur. Renal impairment can also adversely affect some pathways of hepatic and/or gut drug metabolism and has been associated with other...

  18. 77 FR 20030 - Draft Guidance for Industry: Reporting Harmful and Potentially Harmful Constituents in Tobacco...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-03

    ... the HPHC list requirement (76 FR 5387, January 31, 2011). The guidance is available on the Internet at..., on August 12, 2011, FDA issued a document (the HPHC notice; 76 FR 50226) in the Federal Register... publishing a notice announcing the established list of HPHCs as required by section 904(e) of the FD&C...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-11

    ... comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc..., 2008, issue of the Federal Register (73 FR 3316). Background and Purpose The 94th (Maritime) session of... force on August 20, 2013. The NVIC will provide guidance to the maritime industry, Coast Guard...

  20. 78 FR 56718 - Draft Guidance for Industry on Bioanalytical Method Validation; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-13

    ...)) regulated by the Center for Veterinary Medicine. This guidance was originally issued in 2001. FDA is...), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855... John Kadavil, Center for Veterinary Medicine (HFV-151), Food and Drug Administration, 7500 Standish...

  1. 77 FR 5415 - National Organic Program: Notice of Draft Guidance for Accredited Certifying Agents, Certified...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-03

    ... Budget (OMB) Bulletin on Agency Good Guidance Practices (GGPs) (January 25, 2007, 72 FR 3432-3440). The...; ] DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 205 National Organic Program: Notice of... Certified Organic Products AGENCY: Agricultural Marketing Service, USDA. ACTION: Notice of availability...

  2. 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.

  3. 75 FR 17147 - International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-05

    ... Federal Register of August 14, 2009 (74 FR 41144), FDA published a ] notice announcing the availability of... Register of February 21, 2008 (73 FR 9575). When implemented, the annex will provide guidance for industry..., and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance...

  4. 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.

  5. 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...

  6. Strong Public Health Recommendations from Weak Evidence? Lessons Learned in Developing Guidance on the Public Health Management of Meningococcal Disease.

    PubMed

    Hanquet, Germaine; Stefanoff, Pawel; Hellenbrand, Wiebke; Heuberger, Sigrid; Lopalco, Pierluigi; Stuart, James M

    2015-01-01

    The evidence underpinning public health policy is often of low quality, leading to inconsistencies in recommended interventions. One example is the divergence in national policies across Europe for managing contacts of invasive meningococcal disease. Aiming to develop consistent guidance at the European level, a group of experts reviewed the literature and formulated recommendations. The group defined eight priority research questions, searched the literature, and formulated recommendations using GRADE methodology. Five of the research questions are discussed in this paper. After taking into account quality of evidence, benefit, harm, value, preference, burden on patient of the intervention, and resource implications, we made four strong recommendations and five weak recommendations for intervention. Strong recommendations related not only to one question with very low quality of evidence as well as to two questions with moderate to high quality of evidence. The weak recommendations related to two questions with low and very low quality of evidence but also to one question with moderate quality of evidence. GRADE methodology ensures a transparent process and explicit recognition of additional factors that should be considered when making recommendations for policy. This approach can be usefully applied to many areas of public health policy where evidence quality is often low. PMID:26693485

  7. Strong Public Health Recommendations from Weak Evidence? Lessons Learned in Developing Guidance on the Public Health Management of Meningococcal Disease

    PubMed Central

    Hanquet, Germaine; Stefanoff, Pawel; Hellenbrand, Wiebke; Heuberger, Sigrid; Lopalco, Pierluigi; Stuart, James M.

    2015-01-01

    The evidence underpinning public health policy is often of low quality, leading to inconsistencies in recommended interventions. One example is the divergence in national policies across Europe for managing contacts of invasive meningococcal disease. Aiming to develop consistent guidance at the European level, a group of experts reviewed the literature and formulated recommendations. The group defined eight priority research questions, searched the literature, and formulated recommendations using GRADE methodology. Five of the research questions are discussed in this paper. After taking into account quality of evidence, benefit, harm, value, preference, burden on patient of the intervention, and resource implications, we made four strong recommendations and five weak recommendations for intervention. Strong recommendations related not only to one question with very low quality of evidence as well as to two questions with moderate to high quality of evidence. The weak recommendations related to two questions with low and very low quality of evidence but also to one question with moderate quality of evidence. GRADE methodology ensures a transparent process and explicit recognition of additional factors that should be considered when making recommendations for policy. This approach can be usefully applied to many areas of public health policy where evidence quality is often low. PMID:26693485

  8. 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

    ... end of 2010, EPA initiated a ``user acceptance pilot.'' (75 FR 51058, August 18, 2010; EPA-HQ-OPP-2010... comment on a number of these issues. (75 FR 82011, December 29, 2010; EPA-HQ-OPP-2010-0648). Based on its... portion of labeling. It recommends content, function, and security for the Web site associated with...

  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

    ... G-PP&E and Implementation Guidance for Estimating the Historical Cost of G-PP&E AGENCY: Federal... Guidance on the Accounting for the Disposal of G-PP&E and Implementation Guidance for Estimating...

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

    SciTech Connect

    Not Available

    1993-03-01

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

  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. PMID:26436642

  12. 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.

  13. 78 FR 31944 - International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-28

    ... Organization, Health Canada, and the European Free Trade Area. In the Federal Register of July 14, 2010 (75 FR... 21, 2008 (73 FR 9575). The annex will provide guidance to assist industry and regulators in the... Harmonisation Regions; Annex 13 on Bulk Density and Tapped Density of Powders General Chapter;...

  14. 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.

  15. 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

  16. Cornelia de Lange Syndrome: a case report with clinical review and recommended anticipatory guidance for the general practitioner.

    PubMed

    Theile, Anthony R; Gowans, Gordon

    2009-09-01

    Cornelia de Lange Syndrome is a rare congenital malformation syndrome with typical craniofacial abnormalities and can affect the musculoskeletal, cardiovascular, gastrointestinal, genitourinary, and central nervous systems. Not all the patients look alike as the phenotypic appearance is seen on a spectrum. A classic case of CdLS has been reviewed in this article and we have discussed diagnosis, management, and anticipatory guidance. Maintaining consistent health supervision visits and outpatient therapy is vital for these children. Referring the parents to a genetic counselor is recommended if the family desires to have more children. The CdLS foundation Webpage is www.cdlsusa.org. PMID:19813431

  17. 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

    ... Federal Register of December 24, 1997 (62 FR 67377), FDA published the ICH guidance for industry entitled... February 12, 2002 (67 FR 6542), FDA briefly described the process for proposing future revisions to the PDE... Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use...

  18. 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

  19. 75 FR 14604 - Guidance for Industry on Anesthetics for Companion Animals; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-26

    ... Federal Register of December 17, 2008, (73 FR 76657), FDA published the notice of availability for a draft... Companion Animals.'' This guidance makes recommendations for the development of anesthetic new animal drug products for companion animals. The guidance discusses the contents of the target animal...

  20. 75 FR 22813 - Guidance for Industry: Requalification Method for Reentry of Blood Donors Deferred Because of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-30

    ..., 2008 (73 FR 29519), FDA announced the availability of the draft guidance of the same title. FDA... Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti... Hepatitis B Core Antigen (Anti- HBc),'' dated May 2010. The guidance document provides recommendations...

  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...

  2. 76 FR 37129 - International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-24

    .... In the Federal Register of April 5, 2010 (75 FR 17148), FDA published a notice announcing the... available in the Federal Register of February 21, 2008 (73 FR 9575). When implemented, the annex will... Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference...

  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

    ... Organization, Health Canada, and the European Free Trade Area. In the Federal Register of July 19, 2010 (75 FR... ) made available in the Federal Register of February 21, 2008 (73 FR 9575). The annex will provide... Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference...

  4. 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

    ... November 2, 2011 (76 FR 67764). This action is necessary to correct an erroneous date for submission of... Report for Comment; Correction AGENCY: Nuclear Regulatory Commission. ACTION: Draft NUREG; request...

  5. 76 FR 50220 - Availability of Draft ICCVAM Recommendations on Using Fewer Animals to Identify Chemical Eye...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-12

    ...://iccvam.niehs.nih.gov/contact/FR_pubcomment.htm ) or via e-mail to niceatm@niehs.nih.gov . Written... Toxicological Methods (SACATM) at the June 17-18, 2010 meeting (75 FR 26757) when finalizing its recommendations... Methods (NICEATM), in collaboration with the Interagency Coordinating Committee on the Validation...

  6. 78 FR 14097 - Pulse Oximeters-Premarket Notification Submissions [510(k)s]; Guidance for Industry and Food and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-04

    ... Federal Register of July 19, 2007 (72 FR 39631), FDA announced the availability of the draft guidance... oxygen saturation (SpO 2 ) and pulse rate. This document supersedes the General Guidance Document... received with recommendations related to organization, terminology, references to standards, labeling,...

  7. 77 FR 32124 - Guidance for Industry on Irritable Bowel Syndrome-Clinical Evaluation of Drugs for Treatment...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-31

    ...) measures as primary endpoints for IBS clinical trials, and sets forth provisional endpoints and trial... endpoints and trial design recommendations set forth in the guidance. This guidance was published as a draft... for maintenance treatment to prevent sign or symptom recurrence. The section on trial endpoints...

  8. 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

    ... for Interspecies and Intraspecies Extrapolation'' for public comment (76 FR 33752-33753). With this... draft document solely for the purpose of seeking public comment prior to external peer review. The document will undergo independent peer review during an expert peer review meeting, which will be...

  9. 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.

  10. 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

    ... describes a means by which implanted blood access devices may comply with the requirement of special... identified in the guidance document or by some other means that provides equivalent assurances of safety...

  11. 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:

  12. 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

    ... Administration (FDA) is correcting a notice that appeared in the Federal Register of July 14, 2010 (75 FR 40843...-0002, 301-796-9148. SUPPLEMENTARY INFORMATION: In FR Doc. 2010-17055, appearing on page 40843 in the... Harmonisation Regions; Annex 13 on Bulk Density and Tapped Density of Powders General Chapter;...

  13. 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

    ..., which was made available in the Federal Register of February 21, 2008 (73 FR 9575). DATES: Although you... Harmonisation Regions; Annex 13 on Bulk Density and Tapped Density of Powders General Chapter; Availability... Pharmacopoeial Texts for Use in the ICH Regions; Annex 13: Bulk Density and Tapped Density of Powders...

  14. 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

    ... concerns regarding the development of antimicrobial resistance in human and animal bacterial pathogens when... those products consistent with FDA's GFI 209, ``The Judicious Use of Medically Important Antimicrobial... of a final guidance entitled ``The Judicious Use of Medically Important Antimicrobial Drugs in...

  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...

  16. 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

    ... Adolescents.'' When this guidance document is final, several provisions in the Family Smoking Prevention and... Products, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850-3229. Send one self... Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and...

  17. 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

    ... Products (HCT/Ps)'' dated April 2008 (April 28, 2008; 73 FR 22958), with respect to HCT/Ps. The testing... 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...

  18. 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

    ... Guidance (LR-ISG), LR-ISG-2011-05, ``Ongoing Review of Operating Experience.'' This LR-ISG provides... on how the ongoing review of operating experience should be used to ensure the effectiveness of the... their programmatic activities for operating experience reviews are appropriate for considering...

  19. 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

    ... clarify the criteria for accepting and filing a PMA, thereby assuring the consistency of our acceptance and filing decisions. This guidance is applicable to original PMAs and PMA panel-track supplements..., suite 200N, Rockville, MD 20852-1448, 301-827-6210. I. Background The PMA regulation (21 CFR...

  20. 75 FR 29352 - Draft Guidance for Industry on Data Elements for Submission of Veterinary Adverse Event Reports...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-25

    ... Reaction, Lack of Effectiveness, Product Defect Report,'' as required by FDA regulations. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency... FDA may no longer be adequate, as animal drug effects can change over time and less apparent...

  1. 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

    ... Act (21 U.S.C. 353a) and current enforcement policies relating to the compounding of human drug... directions for use); and (3) section 505 (21 U.S.C. 355) (concerning the approval of drugs under new drug... guidance announces the Agency's intention with regard to enforcement of the Federal Food, Drug,...

  2. 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

    ... overarching goal of this guidance is to enhance human subject protection and the quality of clinical trial... methods, responsibilities, and requirements for each clinical trial. The plan should provide those... plans to the appropriate CDER review division and request input from the division's clinical...

  3. 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

    ... guidance describes the importance of implementing appropriate steps during the manufacturing process to... manufacturing process to prevent cross-contamination of finished pharmaceuticals and APIs with non-penicillin... critical aspect of manufacturing non-penicillin beta-lactam drugs is preventing cross-contamination...

  4. 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

    ... before the onset of overt dementia. DATES: Although you can comment on any guidance at any time (see 21... patients in the early stages of Alzheimer's disease (AD) that occur before the onset of overt dementia.... The design of clinical trials that are specifically focused on the treatment of patients...

  5. 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

    ... (HBV) deoxyribonucleic acid (DNA) and recommendations for product testing and disposition, donor...- licensed NAT to screen blood donors for HBV DNA. FDA is also providing these blood establishments...

  6. 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

    ... clinical trial design, including product characteristics, manufacturing considerations and preclinical... document provides recommendations with respect to these products as to clinical trial design, including... of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; Availability AGENCY: Food...

  7. 77 FR 44256 - Draft Guidance for Industry and Food and Drug Administration Staff; Safety Considerations for 510...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-27

    ... provides recommendations to 510(k) submitters regarding the submission expectations regarding design and... 510(k) submitters (1) Design and test enteral connectors based on the Association for the Advancement... to prevent misconnections; and (3) perform risk assessments to demonstrate that the proposed...

  8. 77 FR 68133 - Guidance for Industry: Use of Nucleic Acid Tests on Pooled and Individual Samples From Donors of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-15

    ... November 28, 2011 (76 FR 72950), FDA announced the availability of the draft guidance of the same title...) deoxyribonucleic acid (DNA) and recommendations for product testing and disposition, donor management, methods for... screen blood donors for HBV DNA. FDA is also providing these blood establishments with...

  9. 78 FR 28228 - Guidance for Industry and Food and Drug Administration Staff on Best Practices for Conducting and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-14

    ... Federal Register of February 16, 2011 (76 FR 9027), FDA issued a draft version of this guidance entitled... includes recommendations for documenting the design, analysis, and results of such studies to optimize FDA... be prescriptive with regard to choice of study design or type of analysis and does not endorse...

  10. 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

    ...-Specific Guidance About Industrial Radiography Licenses;'' Draft Guidance for Comment AGENCY: Nuclear... Regulatory Commission (NRC) is revising its licensing guidance for industrial radiography licensees. The NRC... Guidance About Materials Licenses: Program- Specific Guidance About Industrial Radiography Licenses,...

  11. 78 FR 35940 - Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; Draft...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-14

    ... HUMAN SERVICES Food and Drug Administration Content of Premarket Submissions for Management of... Administration (FDA) is announcing the availability of the draft guidance entitled ``Content of Premarket... draft guidance document entitled ``Content of Premarket Submissions for Management of Cybersecurity...

  12. 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

    ... Sound Amplification Products; Draft Guidance for Industry and Food and Drug Administration Staff... Hearing Aid Devices and Personal Sound Amplification Products.'' This draft guidance clarifies the distinction between hearing aids and personal sound amplification products (PSAPs), as well as the...

  13. Guidance for substantiating the evidence for beneficial effects of probiotics: current status and recommendations for future research.

    PubMed

    Rijkers, Ger T; Bengmark, Stig; Enck, Paul; Haller, Dirk; Herz, Udo; Kalliomaki, Marko; Kudo, Satoshi; Lenoir-Wijnkoop, Irene; Mercenier, Annick; Myllyluoma, Eveliina; Rabot, Sylvie; Rafter, Joseph; Szajewska, Hania; Watzl, Bernhard; Wells, Jerry; Wolvers, Danielle; Antoine, Jean-Michel

    2010-03-01

    Probiotic bacteria are live microorganisms that, when administered in adequate amounts, confer a health benefit on the host. There is a growing interest in probiotics within the scientific community, with consumers, and in the food industry. The interactions between the gut and intestinal microbiota and between resident and transient microbiota define a new arena in physiology, an understanding of which would shed light on the "cross-talk" between humans and microbes. The different beneficial effects of specific probiotic strains may be translated into different health claims. However, there is a need for comprehensive and harmonized guidelines on the assessment of the characteristics and efficacy of probiotics and of foods containing them. An international expert group of ILSI has evaluated the published evidence of the functionality of different probiotics in 4 areas of (human) application: 1) metabolism, 2) chronic intestinal inflammatory and functional disorders, 3) infections, and 4) allergy. Based on the existing evidence, concrete examples of demonstration of benefits and gaps are listed, and guidelines and recommendations are defined that should help design the next generation of probiotic studies. PMID:20130080

  14. Committee report: Considerations and recommendations for national guidance regarding the retention and use of residual dried blood spot specimens after newborn screening.

    PubMed

    Therrell, Bradford L; Hannon, W Harry; Bailey, Donald B; Goldman, Edward B; Monaco, Jana; Norgaard-Pedersen, Bent; Terry, Sharon F; Johnson, Alissa; Howell, R Rodney

    2011-07-01

    Newborn screening programs are state based with variable policies. Guidance regarding the retention, storage, and use of portions of newborn screening dried blood spots that remain after screening (residual specimens) was first published in 1996. Since then, newborn screening programs have paid increased attention to specimen storage and usage issues. Standard residual specimen uses include quality assurance and program evaluation, treatment efficacy, test refinement, and result verification. In all cases, privacy and security are primary concerns. In general, two distinct state practices regarding the storage and use of residual newborn screening specimens exist: (1) short-term storage (<3 years), primarily for standard program uses and (2) long-term storage (>18 years), for standard program uses and possible important public health research uses. Recently, there have been concerns in some consumer communities regarding both the potential uses of residual specimens and patient (newborn and family) privacy. To assist in policy improvements that can protect the individual's privacy and allow for important public health uses of residual newborn screening specimens, the Secretary of Health and Human Services' Advisory Committee on Heritable Disorders in Newborns and Children has developed recommendations (with requested action by the Secretary where applicable). This report presents the Committee's recommendations and reviews the pertinent associated issues. PMID:21602691

  15. 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.

  16. 77 FR 28519 - Test Procedure Guidance for Room Air Conditioners, Residential Dishwashers, and Residential...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-15

    .... A link to the docket web page can be found at www.regulations.gov . The www.regulations.gov web page..., DOE launched a new Web site dedicated to DOE guidance: http://www1.eere.energy.gov/guidance/default... publishes guidance in draft form on the guidance Web site. DOE accepts public comment on the draft...

  17. 76 FR 61098 - Guidance for 1-Hour SO2

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-03

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

  18. 32 CFR 989.19 - Draft EIS.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... proponent in preparation of a preliminary draft EIS (PDEIS) (40 CFR 1502.9) based on the scope of issues... recommended in the CEQ regulations (40 CFR 1502.10 and 1502.11). The CEQ regulations indicate that EISs... review of draft EIS (40 CFR 1502.19 and 1506.6): (1) The public comment period for the draft EIS is...

  19. 32 CFR 989.19 - Draft EIS.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... proponent in preparation of a preliminary draft EIS (PDEIS) (40 CFR 1502.9) based on the scope of issues... recommended in the CEQ regulations (40 CFR 1502.10 and 1502.11). The CEQ regulations indicate that EISs... review of draft EIS (40 CFR 1502.19 and 1506.6): (1) The public comment period for the draft EIS is...

  20. 32 CFR 989.19 - Draft EIS.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... proponent in preparation of a preliminary draft EIS (PDEIS) (40 CFR 1502.9) based on the scope of issues... recommended in the CEQ regulations (40 CFR 1502.10 and 1502.11). The CEQ regulations indicate that EISs... review of draft EIS (40 CFR 1502.19 and 1506.6): (1) The public comment period for the draft EIS is...

  1. 32 CFR 989.19 - Draft EIS.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... proponent in preparation of a preliminary draft EIS (PDEIS) (40 CFR 1502.9) based on the scope of issues... recommended in the CEQ regulations (40 CFR 1502.10 and 1502.11). The CEQ regulations indicate that EISs... review of draft EIS (40 CFR 1502.19 and 1506.6): (1) The public comment period for the draft EIS is...

  2. 32 CFR 989.19 - Draft EIS.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... proponent in preparation of a preliminary draft EIS (PDEIS) (40 CFR 1502.9) based on the scope of issues... recommended in the CEQ regulations (40 CFR 1502.10 and 1502.11). The CEQ regulations indicate that EISs... review of draft EIS (40 CFR 1502.19 and 1506.6): (1) The public comment period for the draft EIS is...

  3. 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.

  4. 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. PMID:22991269

  5. 76 FR 72951 - Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-28

    ... (74 FR 46433), FDA announced the availability of the draft guidance. Comments on the draft guidance... Differentiation of Human Papillomaviruses; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Differentiation of Human Papillomaviruses.'' This guidance document provides industry and Agency staff...

  6. 77 FR 55510 - Guidance on Performing a Seismic Margin Assessment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-10

    ...The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment the draft Japan Lessons-Learned Project Directorate Interim Staff Guidance (JLD-ISG), JLD-ISG-2012-04, ``Guidance on Performing a Seismic Margin Assessment in response to the March 2012 Request for Information Letter.'' This draft JLD-ISG provides guidance on an acceptable method for licensees to carry out a Seismic......

  7. 76 FR 59142 - Guidance for Industry on Reproductive and Developmental Toxicities-Integrating Study Results To...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-23

    ... appropriate dose ranges. On November 13, 2001 (66 FR 56830), FDA issued a draft of this guidance. Comments... pharmacokinetic information, including absorption, distribution, metabolism, and elimination findings....

  8. 77 FR 14403 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-09

    ...: Norovirus Serological Reagents.'' This guidance document describes a means by which norovirus serological... by following the recommendations in the guidance document or by some other means that...

  9. 76 FR 48870 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-09

    ..., and ease of reading. The draft of this guidance issued on September 28, 2010 (75 FR 59726) and the... supersedes the guidance with the same name that issued on April 3, 2007 (72 FR 15888). II. Significance of...; Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological...

  10. 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...

  11. 76 FR 71577 - Guidance for Industry on Medication Guide Distribution Requirements and Inclusion of Medication...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-18

    ..., 2011 (76 FR 10908), FDA announced the availability of a draft guidance for industry entitled... inpatient setting or an outpatient setting such as a clinic or infusion center. This guidance is intended...

  12. 77 FR 14507 - Revision to Guidance, “Federal Greenhouse Gas Accounting and Reporting”

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-12

    ..., ``Federal Leadership in Environmental, Energy, and Economic Performance'' (74 FR 52117), in order to... QUALITY Revision to Guidance, ``Federal Greenhouse Gas Accounting and Reporting'' AGENCY: Council On Environmental Quality. ACTION: Notice of Availability, Draft Revised Guidance, ``Federal Greenhouse...

  13. 78 FR 68101 - Environmental Issues Associated With New Reactors and Specific Environmental Guidance for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-13

    ...On September 13, 2013, the U.S. Nuclear Regulatory Commission (NRC) published a request for public comment on draft Interim Staff Guidance (ISG) ESP/COL-ISG 026, ``Interim Staff Guidance on Environmental Issues Associated with New Reactors'' and draft ISG ESP/ COL-ISG-027, ``Interim Staff Guidance on Specific Environmental Guidance for iPWR Reviews.'' The purpose of this ISG is to clarify the......

  14. 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…

  15. 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…

  16. 78 FR 21611 - Guidance for Industry on Self-Selection Studies for Nonprescription Drug Products; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-11

    ... specific protocols. This guidance finalizes the draft guidance issued on September 19, 2011 (76 FR 58018... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Self-Selection Studies for... entitled ``Self-Selection Studies for Nonprescription Drug Products.'' This guidance is intended to...

  17. 75 FR 45641 - Guidance for Industry on Label Comprehension Studies for Nonprescription Drug Products; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-03

    ... the draft guidance published in the Federal Register of May 1, 2009 (74 FR 20322). This guidance is... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Label Comprehension Studies for... entitled ``Label Comprehension Studies for Nonprescription Drug Products.'' The guidance...

  18. 78 FR 53773 - Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-30

    ... nickel ion release testing. Based on the discussion at the workshop, this draft guidance updates a key... corrosion potential; Galvanic corrosion; Surface characterization; and Nickel ion release. This...

  19. GUIDANCE DOCUMENT ON ENVIRONMENTAL MODELS

    EPA Science Inventory

    This guidance provides recommendations intended to assist in the development, evaluation and application of high quality environmental models that the Environmental Protection Agency uses to address environmental problems and to support regulatory activities. These guidelines wi...

  20. Health Assessment Guidance Manual. Draft report

    SciTech Connect

    Not Available

    1990-07-01

    The document is directed to public health physicians, scientists, and engineers employed by The Agency for Toxic Substances and Disease Registry (ATSDR) and other State and Federal agencies who perform health assessments. It sets forth the health assessment process as defined by ATSDR and clarifies the methodologies and guidelines that will be used by ATSDR staff and agents of ATSDR in conducting these health assessments. The individual steps for performing a health assessment are discussed in Chapters 3 through 8 of the document. Chapter 9 discusses how the health assessment report should be written and the format in which it should be presented.

  1. 75 FR 57469 - Guidance on Withdrawal of Subjects From Research: Data Retention and Other Related Issues

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-21

    ... (73 FR 72804). OHRP received comments on the draft guidance document from 30 individuals and... Federal Register on December 1, 2008 (73 FR 72804). OHRP received comments on the draft guidance document...-402-2071. FOR FURTHER INFORMATION CONTACT: Irene Stith-Coleman, PhD, Office for Human...

  2. 77 FR 70168 - Guidance for Industry and Food and Drug Administration Staff; The Content of Investigational...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-23

    .... On June 22, 2011 (76 FR 36542), FDA announced the availability of the draft guidance document...) Device Systems.'' On December 6, 2011 (76 FR 76166), FDA announced the availability of the draft guidance... Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for...

  3. 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

    ... on five draft guidance documents (75 FR 62693). The topics covered in the draft documents addressed... Guidance Practices (GGPs) (January 25, 2007, 72 FR 3432-3440). The purpose of GGPs is to ensure that... Production (NOP 5021); Wild Crop Harvesting (NOP 5022)''; ``Commingling and Contamination Prevention...

  4. 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

    .... Specifically, the guidance addresses study population enrollment and efficacy endpoints for LN trials. In the Federal Register of March 29, 2005 (70 FR 15868), FDA announced the availability of a draft guidance..., efficacy endpoints, and response criteria in SLE. FDA received a number of comments on the draft...

  5. 78 FR 37231 - Guidance for Industry; Guidance on Abbreviated New Drug Applications: Stability Testing of Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-20

    ...The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance entitled ``ANDAs: Stability Testing of Drug Substances and Products.'' FDA is recommending generic drug manufacturers follow the stability testing recommendations in the International Conference on Harmonisation (ICH) guidances Q1A (R2) through Q1E. The use of these ICH recommendations will......

  6. Guidance Matters

    ERIC Educational Resources Information Center

    Gartrell, Dan

    2005-01-01

    In this column, the author shares and comments on early childhood educators' use of guidance to foster young children's development and learning. He defines guidance as the commitment a teacher makes to teaching children how to solve their problems, rather than punishing them for having problems they haven't yet learned how to solve. The focus of…

  7. Comprehensive Guidance Results-Based Evaluation: Developing a Practical Approach.

    ERIC Educational Resources Information Center

    Maliszewski, Stan J.; Mackiel, John J.

    Results-based evaluation and assessment of guidance and counseling is a difficult task. How to best evaluate whether the comprehensive guidance program was getting the intended results became an issue for Omaha Public Schools. They set about to draft a framework for measuring student behavior or learning resulting from activities associated with…

  8. 77 FR 71019 - Japan Lessons-Learned Project Directorate Interim Staff Guidance JLD-ISG-2012-04; Guidance on...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-28

    ... for public comment. On September 10, 2012 (77 FR 55510), the NRC requested public comments on draft... COMMISSION Japan Lessons-Learned Project Directorate Interim Staff Guidance JLD-ISG-2012-04; Guidance on...: Nuclear Regulatory Commission. ACTION: Japan Lessons-Learned Project Directorate Interim Staff...

  9. 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;…

  10. 78 FR 69992 - Guidance for Industry on Purchasing Reef Fish Species Associated With the Hazard of Ciguatera...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-22

    ..., 2013 (78 FR 18273), FDA made available a draft guidance entitled ``Guidance for Industry: Purchasing... Fish Species Associated With the Hazard of Ciguatera Fish Poisoning; Availability AGENCY: Food and Drug... announcing the availability of a guidance for industry entitled ``Guidance for Industry: Purchasing Reef...

  11. 75 FR 29768 - Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-27

    ... 16, 2002 (67 FR 2226), FDA announced the availability of a guidance entitled ``Guidance for Industry... the Federal Register of August 14, 2006 (71 FR 46484), FDA announced the availability of a draft... the revised 2002 guidance as a level 2 guidance document for immediate implementation (71 FR...

  12. 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.

  13. 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

    ... Staff Guidance DSS-ISG-2010-01: Staff Guidance Regarding the Nuclear Criticality Safety Analysis for... Criticality Safety Analysis for Spent Fuel Pools.'' This draft DSS-ISG provides updated guidance to the NRC....resource@nrc.gov . The Staff Guidance Regarding the Nuclear Criticality Safety Analysis Accompanying...

  14. 77 FR 22328 - Guidance for Industry on the Judicious Use of Medically Important Antimicrobial Drugs in Food...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-13

    ... Register of June 29, 2010 (75 FR 37450), FDA published the notice of availability for a draft guidance... thinking on the use of medically important antimicrobial drugs in animal agriculture. DATES: Submit either... announcing: (1) The availability of a draft guidance entitled ``New Animal Drugs and New Animal...

  15. 76 FR 82308 - Guidance for Industry: Current Good Tissue Practice and Additional Requirements for Manufacturers...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-30

    .... The guidance is intended for any HCT/P establishment that performs a manufacturing step and is... 1271, subpart E. The guidance is intended for any HCT/P establishment that performs a manufacturing... 16, 2009 (74 FR 3055), FDA announced the availability of the draft guidance of the same title...

  16. 76 FR 9028 - Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-16

    ..., 2008 (73 FR 59635), FDA announced the availability of the draft guidance of the same title. FDA... HUMAN SERVICES Food and Drug Administration Guidance for Industry: Potency Tests for Cellular and Gene... Industry: Potency Tests for Cellular and Gene Therapy Products'' dated January 2011. The guidance...

  17. Internet Guidance.

    ERIC Educational Resources Information Center

    Savage, Frank X.

    1999-01-01

    States that children need proper guidance and boundaries to reap the benefits of the Internet. Focuses on two issues: how parents can protect their children from the Internet's potential dangers and how they can help their children use the Internet to get work done. Includes suggestions for teachers to help parents meet these challenges. (VWC)

  18. GUIDANCE DOCUMENTS

    EPA Science Inventory

    Defn: Guidance Document - A peer-reviewed document stating overarching principles and practices to be followed (also includes handbook documents).

    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.

  19. 76 FR 51038 - Guidance for Industry on Residual Drug in Transdermal and Related Drug Delivery Systems...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-17

    ... August 3, 2010 (75 FR 45640), FDA announced the availability of the draft version of this guidance. The... prolonged pharmacological effect of the drug. Also, some children have died from inadvertent exposure...

    1. 78 FR 14557 - Guidance for Industry and Food and Drug Administration Staff: Investigational Device Exemption...

      Federal Register 2010, 2011, 2012, 2013, 2014

      2013-03-06

      ... higher brain areas such as the visual cortex or the lateral geniculate nucleus. In the Federal Register of April 17, 2009 (74 FR 17872), FDA announced the availability of the draft guidance. Comments...

    2. 78 FR 46588 - Solicitation of Written Comments on the Global Immunizations Working Group's Draft Report and...

      Federal Register 2010, 2011, 2012, 2013, 2014

      2013-08-01

      ... HUMAN SERVICES Solicitation of Written Comments on the Global Immunizations Working Group's Draft Report... Immunizations for Consideration by the National Vaccine Advisory Committee AGENCY: National Vaccine Program... Immunizations Working Group to assist in addressing these charges. A draft report and draft recommendations...

    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. 75 FR 74734 - Guidance on Institutional Review Board Approval of Research With Conditions

      Federal Register 2010, 2011, 2012, 2013, 2014

      2010-12-01

      ... notice in the Federal Register on November 6, 2009 (74 FR 57486). OHRP received comments on the draft... Register on November 6, 2009 (74 FR 57486). OHRP received comments on the draft guidance document from 12..., 1101 Wootton Parkway, Suite 200, Rockville, MD 20852. Send one self-addressed adhesive label to...

    5. 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... Device Recalls From Product Enhancements; Reporting Requirements.'' This draft guidance intends to clarify for industry when a potential change to a device is a medical device recall, distinguish...

    6. 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

      ... Federal Register of August 15, 2012 (77 FR 48990), we made available a draft guidance entitled ``Guidance... HUMAN SERVICES Food and Drug Administration Guidance for Industry: Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories; Availability AGENCY:...

    7. 75 FR 75809 - Guidance for Industry: Use of Serological Tests To Reduce the Risk of Transmission of Trypanosoma...

      Federal Register 2010, 2011, 2012, 2013, 2014

      2010-12-06

      ... (74 FR 13211), FDA announced the availability of the draft guidance entitled ``Guidance for Industry... of transmission of T. cruzi infection by detecting antibodies to T. cruzi in plasma and serum samples from individual human donors. The guidance document does not apply to the collection of source...

    8. 78 FR 48173 - Guidance for Industry on Oversight of Clinical Investigations-A Risk-Based Approach to Monitoring...

      Federal Register 2010, 2011, 2012, 2013, 2014

      2013-08-07

      ... guidance is to enhance human subject protection and the quality of clinical trial data by focusing sponsor..., 2011 (76 FR 53683), FDA announced the availability of the draft guidance entitled ``Oversight of... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Oversight of...

    9. 76 FR 67439 - External Peer Review Meeting for Draft Microbial Risk Assessment Guideline: Pathogenic...

      Federal Register 2010, 2011, 2012, 2013, 2014

      2011-11-01

      ... AGENCY External Peer Review Meeting for Draft Microbial Risk Assessment Guideline: Pathogenic... convene an independent panel of experts to review the draft document, Microbial Risk Assessment Guideline... guidance for a 60 day comment period (76 FR 44586-44587). The public comment period ended on September...

    10. 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

    11. 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...

    12. Basic Drafting. Revised.

      ERIC Educational Resources Information Center

      Schertz, Karen

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

    13. 76 FR 44049 - Guidance for Fuel Cycle Facility Change Processes

      Federal Register 2010, 2011, 2012, 2013, 2014

      2011-07-22

      ... COMMISSION Guidance for Fuel Cycle Facility Change Processes AGENCY: Nuclear Regulatory Commission. ACTION: Draft regulatory guide; extension of comment period. SUMMARY: On July 14, 2011 (76 FR 41527), the U.S...: Richard.Jervey@nrc.gov . SUPPLEMENTARY INFORMATION: On July 14, 2011 (76 FR 41527), the NRC published...

    14. 76 FR 60503 - Guidance for Industry on Target Animal Safety and Effectiveness Protocol Development and...

      Federal Register 2010, 2011, 2012, 2013, 2014

      2011-09-29

      ... Federal Register of February 3, 2011 (76 FR 6143), FDA published the notice of availability for a draft... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Target Animal Safety and... guidance for industry ( 215) entitled ``Target Animal Safety and Effectiveness Protocol Development...

    15. 75 FR 20606 - Guidance for Industry on Tobacco Health Document Submission; Availability

      Federal Register 2010, 2011, 2012, 2013, 2014

      2010-04-20

      ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Tobacco Health Document Submission; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug... (74 FR 68629), FDA announced the availability of a draft guidance entitled ``Tobacco Health...

    16. 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

      ... (71 FR 3999), FDA issued final guidances on the content and format of the ``Adverse Reactions'' and ``Clinical Studies'' sections of labeling. In the Federal Register of October 19, 2009 (74 FR 53507), FDA... Register of March 3, 2009 (74 FR 9250), FDA issued a draft guidance on the content and format of...

    17. 76 FR 49773 - International Conference on Harmonisation; Guidance on E16 Biomarkers Related to Drug or...

      Federal Register 2010, 2011, 2012, 2013, 2014

      2011-08-11

      ..., 2009 (74 FR 38033), FDA published a notice announcing the availability of a draft guidance entitled... HUMAN SERVICES Food and Drug Administration International Conference on Harmonisation; Guidance on E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format...

    18. 78 FR 54657 - Guidance for Tobacco Retailers on Tobacco Retailer Training Programs; Availability

      Federal Register 2010, 2011, 2012, 2013, 2014

      2013-09-05

      ... regulation restricting the sale and distribution of cigarettes and smokeless tobacco products (75 FR 13225... Register of July 16, 2010 (75 FR 41498), FDA announced the availability of a draft guidance entitled... HUMAN SERVICES Food and Drug Administration Guidance for Tobacco Retailers on Tobacco Retailer...

    19. 78 FR 18353 - Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility...

      Federal Register 2010, 2011, 2012, 2013, 2014

      2013-03-26

      ... the Federal Register of October 29, 2007 (72 FR 61171), FDA announced the availability of the draft... HUMAN SERVICES Food and Drug Administration Guidance for Industry: Blood Establishment Computer System... ``Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility'' dated...

    20. 76 FR 18558 - Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception From...

      Federal Register 2010, 2011, 2012, 2013, 2014

      2011-04-04

      ... be obtained. In the Federal Register of August 29, 2006 (71 FR 51198), FDA announced the availability of the draft guidance of the same title, dated July 2006. The same Federal Register (71 FR 51143... HUMAN SERVICES Food and Drug Administration (Formerly Docket No. 2006D-0331) Guidance for...

    1. 78 FR 57395 - Guidance for Industry on Electronic Source Data in Clinical Investigations; Availability

      Federal Register 2010, 2011, 2012, 2013, 2014

      2013-09-18

      ... ``Electronic Source Data in Clinical Investigations.'' This document provides guidance to sponsors, contract... accurate and complete data. In the Federal Register of November 20, 2012 (77 FR 69632), FDA issued a draft... FR 76049)). Most of the comments sought clarification on the topics discussed in the guidance....

    2. 78 FR 70307 - Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy...

      Federal Register 2010, 2011, 2012, 2013, 2014

      2013-11-25

      ... Federal Register of November 29, 2012 (77 FR 71194), FDA announced the availability of the draft guidance... Investigational Cellular and Gene Therapy Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION... entitled ``Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene...

    3. The revised HSE fatigue guidance

      SciTech Connect

      Stacey, A.; Sharp, J.V.

      1995-12-31

      Fatigue cracking has been a principal cause of damage to North Sea structures and consequently considerable attention has been given to the development of guidance for the prediction of fatigue performance. The fatigue guidance of the Offshore Safety Division of the Health and Safety Executive (HSE) was recently revised and published, following a significant offshore industry review in the period 1987 to 1990, and is based on the results of a considerable amount of research and development work on the fatigue behavior of welded tubular and plated joints. As a result of this review, the revised fatigue guidance incorporates several new clauses and recommendations. The revised recommendations apply to joint classification, basic design S-N curves for welded joints and cast or forged steel components, the thickness effect, the effects of environment and the treatment of low and high stress ranges. Additionally, a new appendix on the derivation of stress concentration factors is included. The new clauses cover high strength steels, bolts and threaded connectors, moorings, repaired joints and the use of fracture mechanics analysis. This paper presents an overview of the revisions to the fatigue guidance, the associated background technical information and aspects of the fatigue behavior of offshore structures which are considered to require further investigation. 67 refs., 7 figs., 8 tabs.

    4. 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

    5. 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

      2013-01-01

      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

    6. 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

      ... recommendations regarding any type of swap or trading strategy involving a swap, the “acts as an advisor rule” and... type of communications that they will make under the safe harbor, the Commission expects that...

    7. 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

      ... rule, which covers recommendations regarding any type of swap or trading strategy involving a swap, the... communications. To clarify the type of communications that they will make under the safe harbor, the...

    8. 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. PMID:23167582

    9. 77 FR 25504 - Draft Emergency Preparedness Frequently Asked Questions

      Federal Register 2010, 2011, 2012, 2013, 2014

      2012-04-30

      ... COMMISSION Draft Emergency Preparedness Frequently Asked Questions AGENCY: Nuclear Regulatory Commission... asked questions (EPFAQs). These EPFAQs will be used to provide clarification of guidance documents... Frequently Asked Questions is available electronically under ADAMS Accession Number ML12108A151, and it...

    10. 76 FR 59705 - Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological...

      Federal Register 2010, 2011, 2012, 2013, 2014

      2011-09-27

      ... clarification on related issues such as user fee exemptions for orphan drugs. In the Federal Register of March 14, 2011 (76 FR 13629), FDA announced the availability of a revised draft guidance entitled...

    11. 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

    12. 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

    13. 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

    14. 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

    15. 78 FR 56750 - Interim Staff Guidance on Environmental Issues Associated With New Reactors

      Federal Register 2010, 2011, 2012, 2013, 2014

      2013-09-13

      ...The U.S Nuclear Regulatory Commission (NRC) staff is issuing for use of, and to solicit public comment on, draft Interim Staff Guidance (ISG) ESP/COL-ISG-026, ``Interim Staff Guidance on Environmental Issues Associated with New Reactors.'' The purpose of this ISG is to clarify the NRC guidance and application of NUREG 1555, ``Standard Review Plans for Environmental Reviews for Nuclear Power......

    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

      ...Through this notice, HUD announces the availability on its Web site of a draft notice updating HUD's guidance for the Section 202 Supportive Housing for the Elderly and Section 811 Supportive Housing for Persons with Disabilities Programs. HUD's draft notice provides revised procedures relating to processing activities after selection of Section 202 and Section 811 applications for fund......

    17. 77 FR 20826 - Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration and...

      Federal Register 2010, 2011, 2012, 2013, 2014

      2012-04-06

      ..., 2010 (75 FR 22599), FDA announced the availability of the draft guidance. Comments on the draft... the Federal Food, Drug, and Cosmetic Act; Availability AGENCY: Food and Drug Administration, HHS... Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act.''...

    18. In Brief: Geoengineering draft statement

      NASA Astrophysics Data System (ADS)

      Showstack, Randy

      2009-04-01

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

    19. 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.

    20. 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 finalized, will provide guidance for FDA staff on our enforcement criteria for canned ackee, frozen...

    1. 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. PMID:24698029

    2. 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...

    3. 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)

      Technology Transfer Automated Retrieval System (TEKTRAN)

      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...

    4. 77 FR 8258 - Availability of ICCVAM Evaluation Report and Recommendations on the Usefulness and Limitations of...

      Federal Register 2010, 2011, 2012, 2013, 2014

      2012-02-14

      ... BRD and draft ICCVAM test method recommendations (76 FR 4113). Stakeholders from the public were... available to the public for review and comment (76 FR 28781). The draft test method recommendations, the... comments at its public meeting on June 16-17, 2011 (76 FR 23323). ICCVAM considered the peer review...

    5. Computer Aided Drafting Curriculum for Vocational Drafting. A Competency Based Unit of Instruction. Final Report.

      ERIC Educational Resources Information Center

      Peck, Greg

      This document contains (1) the final report of a project to develop a computer-aided drafting (CAD) curriculum and (2) a competency-based unit of instruction for use with the CADAPPLE system. The final report states the problem and project objective, presents conclusions and recommendations, and includes survey instruments. The unit is designed…

    6. FDA Recommends All Blood Donations Be Tested for Zika

      MedlinePlus

      ... FDA Recommends All Blood Donations Be Tested for Zika Updated guidance provides further protection for U.S. blood ... entire blood supply be routinely screened for the Zika virus. In February, the FDA recommended testing of ...

    7. 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.

    8. 76 FR 21752 - Guidance for Industry on How To Write a Request for Designation; Availability

      Federal Register 2010, 2011, 2012, 2013, 2014

      2011-04-18

      ... Write a Request for Designation (RFD).'' This guidance is intended to clarify the type of information... the type of information OCP recommends that a sponsor include in an RFD. The goal of this guidance...

    9. 76 FR 80946 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for...

      Federal Register 2010, 2011, 2012, 2013, 2014

      2011-12-27

      ... Collection; Comment Request; Guidance for Industry on Postmarketing Adverse Event Reporting for... solicits comments on the FDA guidance for industry on ``Postmarketing Adverse Event Reporting for... recommendations on postmarketing serious adverse event reporting for nonprescription (over-the-counter)...

    10. Elementary School Guidance Bibliography.

      ERIC Educational Resources Information Center

      Biasco, Frank

      This bibliography lists articles and books dealing with elementary school guidance. The bibliography is arranged alphabetically by author. No annotations are given. Approximately 70 titles are given, covering most phases of elementary guidance. (KJ)

    11. On Recommending.

      ERIC Educational Resources Information Center

      Furner, Jonathan

      2002-01-01

      Discusses recommendation, or preference ordering, in document retrieval systems that ranks documents in order of the likelihood with which they match the preferences of any person searching the system. Describes the ERIn (Evaluation-Recommendation-Information) model, a decision-theoretic framework for understanding information-related activity…

    12. 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.

    13. Functional Drafting, Drafting--Intermediate: 9255.02.

      ERIC Educational Resources Information Center

      Dade County Public Schools, Miami, FL.

      The course consists of six instructional blocks totaling 135 clock hours: (1) functional drafting, (2) threads and fasteners, (3) pictorial drawings, (4) introduction to electronic drafting, (5) introduction to piping drafting, and (6) Quinmester posttest. Mastery of skills indicated in Drafting-Basic--9255.01 is a prerequisite. In the functional…

    14. Recommender systems

      NASA Astrophysics Data System (ADS)

      Lü, Linyuan; Medo, Matúš; Yeung, Chi Ho; Zhang, Yi-Cheng; Zhang, Zi-Ke; Zhou, Tao

      2012-10-01

      The ongoing rapid expansion of the Internet greatly increases the necessity of effective recommender systems for filtering the abundant information. Extensive research for recommender systems is conducted by a broad range of communities including social and computer scientists, physicists, and interdisciplinary researchers. Despite substantial theoretical and practical achievements, unification and comparison of different approaches are lacking, which impedes further advances. In this article, we review recent developments in recommender systems and discuss the major challenges. We compare and evaluate available algorithms and examine their roles in the future developments. In addition to algorithms, physical aspects are described to illustrate macroscopic behavior of recommender systems. Potential impacts and future directions are discussed. We emphasize that recommendation has great scientific depth and combines diverse research fields which makes it interesting for physicists as well as interdisciplinary researchers.

    15. 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,…

    16. Basic Drafting: Book Two.

      ERIC Educational Resources Information Center

      Davis, Ronald; And Others

      The second of a two-book course in drafting, this manual consists of 12 topics in the following units: sketching techniques, geometric constructions, orthographic views, dimensioning procedures, basic tolerancing, auxiliary views, sectional views, inking tools and techniques, axonometrics, oblique, perspective, and computer-aided drafting.…

    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. 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.

    19. 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 Central

      2014-01-01

      Background 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). Methods 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. Results 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%). Conclusions Results suggest that the high proportion of SoFAS in each recommended food group makes it challenging for Americans to reduce their intake of SoFAS. PMID:24649969

    20. 78 FR 101 - Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Reviews for...

      Federal Register 2010, 2011, 2012, 2013, 2014

      2013-01-02

      ... Federal Register of July 31, 2012 (77 FR 45357), FDA announced the availability of the draft guidance... accepting and filing a PMA, thereby assuring the consistency of our acceptance and filing decisions. This guidance is applicable to original PMAs and PMA panel-track supplements reviewed in the Center for...

    1. 75 FR 6210 - Guidance for Industry on the Contents of a Complete Submission for the Evaluation of Proprietary...

      Federal Register 2010, 2011, 2012, 2013, 2014

      2010-02-08

      ... Register of November 24, 2008 (73 FR 71009), FDA announced the availability of a draft guidance for... Name Review'' (concept paper) (73 FR 58604, October 7, 2008). FDA acknowledges that information in the... HUMAN SERVICES Food and Drug Administration Guidance for Industry on the Contents of a...

    2. 75 FR 15440 - Guidance for Industry on Standards for Securing the Drug Supply Chain-Standardized Numerical...

      Federal Register 2010, 2011, 2012, 2013, 2014

      2010-03-29

      ... FR 3054), a draft version of this guidance was made available for public comment. On September 27... of an SNI by opening a docket to receive information (73 FR 14988, March 20, 2008). We received 59... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Standards for Securing the...

    3. 78 FR 72900 - Guidance for Industry and Food and Drug Administration Staff; Civil Money Penalties for Tobacco...

      Federal Register 2010, 2011, 2012, 2013, 2014

      2013-12-04

      ... 8, 2013 (78 FR 9396), FDA announced the availability of the draft guidance of the same title. FDA...; Civil Money Penalties for Tobacco Retailers: Responses to Frequently Asked Questions; Availability... (FDA) is announcing the availability of the guidance entitled ``Civil Money Penalties for...

    4. 78 FR 13071 - Guidance for Industry: Implementation of an Acceptable Full-Length and Abbreviated Donor History...

      Federal Register 2010, 2011, 2012, 2013, 2014

      2013-02-26

      ... (76 FR 44013), FDA announced the availability of the draft guidance of the same title dated July 2011...- Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening... ``Guidance for Industry: Implementation of an Acceptable Full-Length and Abbreviated Donor...

    5. 77 FR 14022 - Guidance for Industry: Testing for Salmonella Species in Human Foods and Direct-Human-Contact...

      Federal Register 2010, 2011, 2012, 2013, 2014

      2012-03-08

      ... 23, 2011 (76 FR 16425), FDA made available a draft guidance entitled ``Testing for Salmonella Species... Human Foods and Direct-Human-Contact Animal Foods; Availability AGENCY: Food and Drug Administration... Direct- Human-Contact Animal Foods.'' The document provides guidance to firms that manufacture,...

    6. Family planning methods: new guidance.

      PubMed

      1996-10-01

      Presented in this report are the recommendations of two expert groups, the Technical Guidance/Competence Working Group of the US Agency for International Development's Maximizing Access and Quality Initiative and the World Health Organization's Family Planning and Population Unit, regarding currently available family planning methods. The former group addressed key biomedical questions and formulated recommendations about 11 groups of family planning methods: combined oral contraceptives, progestin-only pills during breast feeding, progestin-only injectables, combined injectable contraceptives, Norplant implants, copper-bearing IUDs, tubal occlusion, vasectomy, lactational amenorrhea method, natural family planning, and barrier methods. A table presents the relative importance, by method, of procedures such as pelvic exam, blood pressure reading, breast exam, and screening for sexually transmitted diseases and cervical cancer. The medical eligibility recommendations for each method are also presented in tabular form, with four categories for temporary methods: 1) no restrictions on use, 2) advantages generally outweigh theoretical or proven risks, 3) theoretical or proven risks usually outweigh the advantages, and 4) unacceptable health risks. Included among the 41 conditions for which eligibility criteria are specified are age, smoking, thromboembolic disorder, headaches, irregular vaginal bleeding, family history of breast cancer, obesity, drug interactions, parity, breast feeding, postpartum, and postabortion. The new guidance presented in this report enables providers to give family planning clients expanded contraceptive choices while ensuring method safety and effectiveness. PMID:9342775

    7. 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. PMID:14602194

    8. 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)

    9. Recommended Paperbacks.

      ERIC Educational Resources Information Center

      Horn Book Magazine, 1980

      1980-01-01

      Lists recommended paperback books for children in the following categories: picture books; stories for younger, for intermediate, and for older readers; folklore, legend, and mythology; and nonfiction. Tells if and when the original editions were reviewed in this journal. (GT)

    10. 76 FR 6087 - Draft Weapons Safety Assessment on the Use of Enhanced Weapons; Notice of Availability and...

      Federal Register 2010, 2011, 2012, 2013, 2014

      2011-02-03

      ... COMMISSION 10 CFR Part 73 RIN 3150-AI49 Draft Weapons Safety Assessment on the Use of Enhanced Weapons... guidance document entitled ``Weapons Safety Assessment'' (WSA). This guidance would be used by licensees and certificate holders applying to the NRC to obtain enhanced weapons under the NRC's proposed...

    11. 76 FR 67437 - Draft Aquatic Life Ambient Water Quality Criteria for Carbaryl-2011

      Federal Register 2010, 2011, 2012, 2013, 2014

      2011-11-01

      ... AGENCY Draft Aquatic Life Ambient Water Quality Criteria for Carbaryl-- 2011 AGENCY: Environmental...) of the Clean Water Act (CWA), the Environmental Protection Agency (EPA) is announcing the availability of draft national recommended water quality criteria for the protection of aquatic life...

    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. Making Connections: Guidance and Career Education in the Middle Years.

      ERIC Educational Resources Information Center

      Levi, Marion; Ziegler, Suzanne

      This report is an examination of recommended and actual school-based guidance policies, programs, and practices for young adolescents. The information is drawn from Canadian and international publications, and from a survey of guidance and career education programs for grades 7-8 in Ontario boards of education and schools, called The 1990 Ontario…

    15. 75 FR 59268 - Draft Guidance for Industry: Acidified Foods; Availability

      Federal Register 2010, 2011, 2012, 2013, 2014

      2010-09-27

      .... 0910-0037; 73 FR 11649 at 11650, March 4, 2008). In that analysis, we estimated that there are 8,950... note that fermented dairy products, such as yogurt, belong to a separate category that is not...

    16. 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…

    17. 77 FR 33779 - Interim Staff Guidance JLD-ISG-2012-01; Compliance With Order EA-12-049, Order Modifying Licenses...

      Federal Register 2010, 2011, 2012, 2013, 2014

      2012-06-07

      ...The U.S. Nuclear Regulatory Commission (NRC or the Commission) is issuing the draft Japan Lessons-Learned Project Directorate Interim Staff Guidance (JLD-ISG), JLD-ISG-2012-01, ``Compliance with Order EA- 12-049, Order Modifying Licenses with Regard to Requirements for Mitigation Strategies for Beyond-Design-Basis External Events.'' This draft JLD-ISG provides guidance and clarification to......

    18. 77 FR 33780 - Interim Staff Guidance JLD-ISG-2012-03; Compliance with Order EA-12-051, Order Modifying Licenses...

      Federal Register 2010, 2011, 2012, 2013, 2014

      2012-06-07

      ...: Draft Japan Lessons-Learned Project Directorate guidance; request for comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC or the Commission) is issuing the draft Japan Lessons-Learned Project Directorate... this document. FOR FURTHER INFORMATION CONTACT: Mrs. Lisa M. Regner, Japan Lessons Learned...

    19. 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

    20. 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

    1. Stressor Identification Guidance Document

      EPA Science Inventory

      EPA has made availabile the Stressor Identification Guidance Document (EPA 822-B-00-025) published under the authority of Section 304(a)(2) of the Clean Water Act (CWA). This technical guidance doc...

    2. 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.

    3. Evaluating Guidance Activities.

      ERIC Educational Resources Information Center

      Sanborn, Marshall P.

      This report discusses one of the consistent problems in school counseling and guidance-that of furnishing concrete evidence concerning the effects of counseling and guidance activities on the development of children. The following causal factors are discussed: (1) the difficulty of pinning down abstractly stated goals in an operational manner at…

    4. 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.

    5. Guidance for Total Development.

      ERIC Educational Resources Information Center

      Van Hoose, William H.

      Elementary guidance, deriving much of its content from the developmental phenomena of middle childhood, is viewed as the maximization of human potentiality in the total range of the population. Included in the list of elementary school guidance objectives are (1) aiding academic development, (2) helping children develop health self-concepts, (3)…

    6. Overcoming consumer inertia to dietary guidance.

      PubMed

      Webb, Densie; Byrd-Bredbenner, Carol

      2015-07-01

      Despite 35 y of dietary guidance, there has been no substantial shift in consumer compliance. Consumers report that they seek information on nutrition and healthy eating, but most are not paying attention to dietary recommendations. For guidance to be effective, it must be realistic. Even with increasingly detailed nutrition information and evidence that diet affects health outcomes, convenience and taste remain the strongest determinants of food choices. It is up to health educators to clear up confusion and give consumers control with nutrition messages that are realistic, positive, easy to understand, and actionable without an expectation that consumers will surrender foods they love. PMID:26178023

    7. Overcoming Consumer Inertia to Dietary Guidance12

      PubMed Central

      Webb, Densie; Byrd-Bredbenner, Carol

      2015-01-01

      Despite 35 y of dietary guidance, there has been no substantial shift in consumer compliance. Consumers report that they seek information on nutrition and healthy eating, but most are not paying attention to dietary recommendations. For guidance to be effective, it must be realistic. Even with increasingly detailed nutrition information and evidence that diet affects health outcomes, convenience and taste remain the strongest determinants of food choices. It is up to health educators to clear up confusion and give consumers control with nutrition messages that are realistic, positive, easy to understand, and actionable without an expectation that consumers will surrender foods they love. PMID:26178023

    8. POTW sludge sampling and analysis guidance document

      SciTech Connect

      Not Available

      1989-08-01

      In view of the variability of municipal sludge quality, appropriate procedures must be followed to collect and analyze samples that accurately represent each POTW's sludge quality. The manual was developed to provide that guidance to POTW operators, engineers, managers, chemists and permit writers. It was intended to provide guidance in developing and implementing a sampling and analysis program, to gather information on sludge quality and determine compliance with permit conditions. The manual is based on current, state-of-the-art field and laboratory practices and therefore is recommended for all sludge sampling and analysis programs.

    9. 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.

    10. 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.

    11. 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.…

    12. Status of NCRP Scientific Committee 1-23 Commentary on Guidance on Radiation Dose Limits for the Lens of the Eye.

      PubMed

      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

      2016-02-01

      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 decided to prepare an updated commentary intended to enhance the previous recommendations provided in earlier reports. The NCRP Scientific Committee 1-23 (SC 1-23) 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 Annual Meeting, "Changing Regulations and Radiation Guidance: What Does 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 by mid 2016. PMID:26717175

    13. 78 FR 77027 - Overhead Clearance (Air-Draft) Accidents

      Federal Register 2010, 2011, 2012, 2013, 2014

      2013-12-20

      ... Federal Register (73 FR 3316). Description of Petition for Rulemaking In its Petition for Rulemaking dated... meeting notice (78 FR 49543, 49544, August 14, 2013) and copy of Task 13-10, Recommendation to Establish... SECURITY Coast Guard 33 CFR Parts 117, 161, and 164 46 CFR Part 4 Overhead Clearance (Air-Draft)...

    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

      ... the Code of Federal Regulations. The proposed rule was published on June 15, 2010 (75 FR 33902) and... searching on Docket ID: NRC-2010-0194. On July 14, 2010 (75 FR 40756), the NRC noticed the availability of... and Category 2 Quantities of Radioactive Material; Draft Guidance Document for Comment; Extension...

    15. 78 FR 24754 - Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals; Availability

      Federal Register 2010, 2011, 2012, 2013, 2014

      2013-04-26

      ... of the classification. On December 2, 2011 (76 FR 75551), FDA announced the availability of the draft... Pharmaceutical Co-Crystals; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The... ``Regulatory Classification of Pharmaceutical Co-Crystals.'' This guidance provides applicants of new...

    16. 77 FR 50372 - Guidance for Industry: Questions and Answers Regarding the Final Rule, Prevention of Salmonella...

      Federal Register 2010, 2011, 2012, 2013, 2014

      2012-08-21

      ..., 2009 (74 FR 33030), we issued a final rule requiring shell egg producers to implement measures to... the Federal Register of July 13, 2011 (76 FR 41157), we made available a draft guidance entitled... Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During...

    17. 78 FR 34392 - Guidance for Industry and Food and Drug Administration Staff: Technical Considerations for Pen...

      Federal Register 2010, 2011, 2012, 2013, 2014

      2013-06-07

      ... Federal Register on April 27, 2009, (74 FR 19094), FDA announced the availability of the draft guidance of... application would typically be a premarket notification submission (510(k)) or a premarket approval (PMA...) or a PMA application for the injector alone. For a combination product that includes the...

    18. 77 FR 39498 - Guidances for Industry and Food and Drug Administration Staff: Computer-Assisted Detection...

      Federal Register 2010, 2011, 2012, 2013, 2014

      2012-07-03

      ... Register of October 21, 2009 (74 FR 54053), FDA announced the availability of the draft guidance documents...-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data--Premarket Approval (PMA...-- Premarket Approval (PMA) and Premarket Notification (510(k)) Submissions'' to the Division of...

    19. 75 FR 74734 - Guidance on Institutional Review Board Continuing Review of Research

      Federal Register 2010, 2011, 2012, 2013, 2014

      2010-12-01

      ... (74 FR 57487). OHRP received comments on the draft guidance document from 18 individuals and... comment through a notice in the Federal Register on November 6, 2009 (74 FR 57487). OHRP received comments... for public comment through a notice in the Federal Register on January 13, 2010 (75 FR 1790),...

    20. 76 FR 32863 - Guidance for Industry and Investigators on Enforcement of Safety Reporting Requirements for...

      Federal Register 2010, 2011, 2012, 2013, 2014

      2011-06-07

      ... Requirements for Bioavailability and Bioequivalence Studies in Humans'' (75 FR 59935, September 29, 2010... Bioequivalence Studies in Humans'' (75 FR 59935) and issued related draft guidance ``Safety Reporting Requirements for INDs and BA/BE Studies'' (75 FR 60129, Docket No. FDA-2010-D-0482). The final rule amended...

    1. 77 FR 59929 - Guidance for Industry on Acute Bacterial Exacerbations of Chronic Bronchitis in Patients With...

      Federal Register 2010, 2011, 2012, 2013, 2014

      2012-10-01

      ... regarding the overall development program and clinical trial designs for drugs to support an indication for... August 22, 2008 (73 FR 49684), which in turn revised the draft guidance for industry entitled ``Acute... for clinical trial sponsors entitled ``Establishment and Operation of Clinical Trial Data...

    2. 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..., such as bacterial endotoxins. The media fill is the performance of an aseptic manufacturing...

    3. 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.

    4. Emergency Locator Transmitter (ELT) batteries guidance and recommendations

      NASA Technical Reports Server (NTRS)

      1984-01-01

      Batteries for use with Emergency locator transmitters are discussed. Types of batteries, real-time activation considerations, encapsulation of cells in a battery pack, cold storage to extend shelf life, and general requirements are among the topics covered.

    5. 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

      ... Commission. ACTION: Draft guidance document: Extension of comment period. SUMMARY: On November 3, 2010 (75 FR..., 2010 (75 FR 62695). The public comment period for this proposed rule was scheduled to expire on February 11, 2011; however, on January 10, 2011 (76 FR 1376), the public comment period for the...

    6. 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...

    7. 77 FR 26815 - Opportunity To Comment on the Draft Airport Design Advisory Circular 150/5300-13A

      Federal Register 2010, 2011, 2012, 2013, 2014

      2012-05-07

      ... Federal Aviation Administration Opportunity To Comment on the Draft Airport Design Advisory Circular 150... interested parties to review and comment on the Draft ``Airport Design'' Advisory Circular, AC 150/5300-13A. The Advisory Circular provides standards and recommendations for airport design. The FAA has...

    8. 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

      ... of the request for scientific views. SUMMARY: On December 30, 2009 (74 FR 69086), EPA announced the availability of draft national recommended water quality criteria for ammonia for the ] protection of aquatic... AGENCY Extension of Request for Scientific Views for Draft 2009 Update Aquatic Life Ambient Water...

    9. Safety of magnetic fusion facilities: Guidance

      SciTech Connect

      1996-05-01

      This document provides guidance for the implementation of the requirements identified in DOE-STD-6002-96, Safety of Magnetic Fusion Facilities: Requirements. This guidance is intended for the managers, designers, operators, and other personnel with safety responsibilities for facilities designated as magnetic fusion facilities. While the requirements in DOE-STD-6002-96 are generally applicable to a wide range of fusion facilities, this Standard, DOE-STD-6003-96, is concerned mainly with the implementation of those requirements in large facilities such as the International Thermonuclear Experimental Reactor (ITER). Using a risk-based prioritization, the concepts presented here may also be applied to other magnetic fusion facilities. This Standard is oriented toward regulation in the Department of Energy (DOE) environment as opposed to regulation by other regulatory agencies. As the need for guidance involving other types of fusion facilities or other regulatory environments emerges, additional guidance volumes should be prepared. The concepts, processes, and recommendations set forth here are for guidance only. They will contribute to safety at magnetic fusion facilities.

    10. Decontaminating breast pump kits: new guidance.

      PubMed

      Oxtoby, Kathy

      Various methods can be used to decontaminate breast pump milk collection kits and items related to infant feeding but they have some drawbacks and risks. In 2015, the Joint Working Group of the Healthcare Infection Society and Infection Prevention Society published guidance to support the safe decontamination of this equipment at home and in hospital. This article summarises its recommendations for health professionals to use and communicate to other groups, such as parents and carers. PMID:27400623

    11. Recommendations for Insulin Dose Calculator Risk Management

      PubMed Central

      2014-01-01

      Several studies have shown the usefulness of an automated insulin dose bolus advisor (BA) in achieving improved glycemic control for insulin-using diabetes patients. Although regulatory agencies have approved several BAs over the past decades, these devices are not standardized in their approach to dosage calculation and include many features that may introduce risk to patients. Moreover, there is no single standard of care for diabetes worldwide and no guidance documents for BAs, specifically. Given the emerging and more stringent regulations on software used in medical devices, the approval process is becoming more difficult for manufacturers to navigate, with some manufacturers opting to remove BAs from their products altogether. A comprehensive literature search was performed, including publications discussing: diabetes BA use and benefit, infusion pump safety and regulation, regulatory submissions, novel BAs, and recommendations for regulation and risk management of BAs. Also included were country-specific and international guidance documents for medical device, infusion pump, medical software, and mobile medical application risk management and regulation. No definitive worldwide guidance exists regarding risk management requirements for BAs, specifically. However, local and international guidance documents for medical devices, infusion pumps, and medical device software offer guidance that can be applied to this technology. In addition, risk management exercises that are algorithm-specific can help prepare manufacturers for regulatory submissions. This article discusses key issues relevant to BA use and safety, and recommends risk management activities incorporating current research and guidance. PMID:24876550

    12. Recommendations for Insulin Dose Calculator Risk Management.

      PubMed

      Rees, Christen

      2014-01-01

      Several studies have shown the usefulness of an automated insulin dose bolus advisor (BA) in achieving improved glycemic control for insulin-using diabetes patients. Although regulatory agencies have approved several BAs over the past decades, these devices are not standardized in their approach to dosage calculation and include many features that may introduce risk to patients. Moreover, there is no single standard of care for diabetes worldwide and no guidance documents for BAs, specifically. Given the emerging and more stringent regulations on software used in medical devices, the approval process is becoming more difficult for manufacturers to navigate, with some manufacturers opting to remove BAs from their products altogether. A comprehensive literature search was performed, including publications discussing: diabetes BA use and benefit, infusion pump safety and regulation, regulatory submissions, novel BAs, and recommendations for regulation and risk management of BAs. Also included were country-specific and international guidance documents for medical device, infusion pump, medical software, and mobile medical application risk management and regulation. No definitive worldwide guidance exists regarding risk management requirements for BAs, specifically. However, local and international guidance documents for medical devices, infusion pumps, and medical device software offer guidance that can be applied to this technology. In addition, risk management exercises that are algorithm-specific can help prepare manufacturers for regulatory submissions. This article discusses key issues relevant to BA use and safety, and recommends risk management activities incorporating current research and guidance. PMID:24876550

    13. Drafting the Basics

      ERIC Educational Resources Information Center

      Lamb, Carol M.; Kurtanich, David G.

      2007-01-01

      This paper outlines the work in progress undertaken by the School of Engineering Technology faculty to identify, assess, and develop a course to address the depth and breadth of drafting/plan preparation and plan reading skills required by the various engineering technology programs offered at Youngstown State University. The methodology used to…

    14. Drafting Lab Management Guide.

      ERIC Educational Resources Information Center

      Ohio State Univ., Columbus. Instructional Materials Lab.

      This manual was developed to guide drafting instructors and vocational supervisors in sequencing laboratory instruction and controlling the flow of work for a 2-year machine trades training program. The first part of the guide provides information on program management (program description, safety concerns, academic issues, implementation…

    15. 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…

    16. 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…

    17. Recommendations for Public Cholesterol Education and Screening Programs. Draft.

      ERIC Educational Resources Information Center

      Minnesota State Dept. of Health, St. Paul.

      This document provides guidelines for communities interested in developing public cholesterol education and screening programs. It contains information to use in considering a program and protocols to follow in conducting a program that meets standards established by the National Cholesterol Education Program. An introduction summarizes content.…

    18. Comprehensive Guidance Programs That Work.

      ERIC Educational Resources Information Center

      Gysbers, Norman C.; And Others

      This monograph describes how the comprehensive guidance model is transforming elementary-secondary school guidance and counseling programs in schools across the country. It incorporates the ideas and experiences of 12 guidance program developers in the actual use of the comprehensive guidance model in diverse school and cultural settings. The book…

    19. Pupil Personnel Services: Material Review List Recommendations.

      ERIC Educational Resources Information Center

      Cardinale, Anthony

      This list of materials provides recommendations to counselors and guidance personnel for the purchase of materials for pupil personnel services programs in the Department of Defense Dependents Schools (DDDS). The listing, based on staff reviews in each of the six DDDS regions, is divided into 10 content areas: (1) assessment and evaluation; (2)…

    20. Vocational Guidance and the Labour Market: Guidance to Transform or Guidance to Domesticate?

      ERIC Educational Resources Information Center

      Kann, Ulla

      1988-01-01

      Explores the conflict in guidance arising from the desire to consider the needs of society while guaranteeing individual freedom of choice. Discusses the theoretical basis of vocational guidance. Gives examples of "domestication" and "transformation" approaches to guidance and discusses the consequences of viewing guidance as a change strategy.(KO)

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

      SciTech Connect

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

      1991-04-01

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

    2. 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.

    3. 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).

    4. 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...

    5. IRIS Product Recommendations

      NASA Technical Reports Server (NTRS)

      Short, David A.

      2000-01-01

      This report presents the Applied Meteorology Unit's (AMU) evaluation of SIGMET Inc.'s Integrated Radar Information System (IRIS) Product Generator and recommendations for products emphasizing lightning and microburst tools. The IRIS Product Generator processes radar reflectivity data from the Weather Surveillance Radar, model 74C (WSR-74C), located on Patrick Air Force Base. The IRIS System was upgraded from version 6.12 to version 7.05 in late December 1999. A statistical analysis of atmospheric temperature variability over the Cape Canaveral Air Force Station (CCAFS) Weather Station provided guidance for the configuration of radar products that provide information on the mixed-phase (liquid and ice) region of clouds, between 0 C and -20 C. Mixed-phase processes at these temperatures are physically linked to electrification and the genesis of severe weather within convectively generated clouds. Day-to-day variations in the atmospheric temperature profile are of sufficient magnitude to warrant periodic reconfiguration of radar products intended for the interpretation of lightning and microburst potential of convectively generated clouds. The AMU also examined the radar volume-scan strategy to determine the scales of vertical gaps within the altitude range of the 0 C to -20 C isotherms over the Kennedy Space Center (KSC)/CCAFS area. This report present's two objective strategies for designing volume scans and proposes a modified scan strategy that reduces the average vertical gap by 37% as a means for improving radar observations of cloud characteristics in the critical 0 C to -20 C layer. The AMU recommends a total of 18 products, including 11 products that require use of the IRIS programming language and the IRIS User Product Insert feature. Included is a cell trends product and display, modeled after the WSR-88D cell trends display in use by the National Weather Service.

    6. 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.

    7. 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.

    8. Exploring Goals. Career Guidance.

      ERIC Educational Resources Information Center

      Mesa Public Schools, AZ.

      Materials contained in this career guidance unit are designed to enable senior high school students to relate their abilities scores from the Developed Abilities Performance (DAP) instrument to actual vocational areas and Long Range [occupational] Goals (LRG) for later indepth study. The length of the unit is six 55-minute periods. Instructional…

    9. Regulatory guidance document

      SciTech Connect

      1994-05-01

      The Office of Civilian Radioactive Waste Management (OCRWM) Program Management System Manual requires preparation of the OCRWM Regulatory Guidance Document (RGD) that addresses licensing, environmental compliance, and safety and health compliance. The document provides: regulatory compliance policy; guidance to OCRWM organizational elements to ensure a consistent approach when complying with regulatory requirements; strategies to achieve policy objectives; organizational responsibilities for regulatory compliance; guidance with regard to Program compliance oversight; and guidance on the contents of a project-level Regulatory Compliance Plan. The scope of the RGD includes site suitability evaluation, licensing, environmental compliance, and safety and health compliance, in accordance with the direction provided by Section 4.6.3 of the PMS Manual. Site suitability evaluation and regulatory compliance during site characterization are significant activities, particularly with regard to the YW MSA. OCRWM`s evaluation of whether the Yucca Mountain site is suitable for repository development must precede its submittal of a license application to the Nuclear Regulatory Commission (NRC). Accordingly, site suitability evaluation is discussed in Chapter 4, and the general statements of policy regarding site suitability evaluation are discussed in Section 2.1. Although much of the data and analyses may initially be similar, the licensing process is discussed separately in Chapter 5. Environmental compliance is discussed in Chapter 6. Safety and Health compliance is discussed in Chapter 7.

    10. Differentiating Classroom Guidance

      ERIC Educational Resources Information Center

      Akos, Patrick; Cockman, Caroline R.; Strickland, Cindy A.

      2007-01-01

      To differentiate is to make different, distinct, or specialized (Costello, 1994). Differentiation has become popular in education as an instructional philosophy aimed at equitably meeting the learning needs of all students in the classroom. Differentiated planning and delivery of classroom guidance is also necessary for appropriate school…

    11. The Counseling & Guidance Curriculum.

      ERIC Educational Resources Information Center

      Ediger, Marlow

      Counseling and guidance services are vital in any school curriculum. Counselors may themselves be dealing with students of diverse abilities and handicaps. Counselors may have to work with students affected by drug addiction, fetal alcohol syndrome, homelessness, poverty, Acquired Immune Deficiency Syndrome (AIDS) and divorce. Students may present…

    12. Primary Guidance Activities.

      ERIC Educational Resources Information Center

      Hauck, Ruth, Comp.

      Designed for the primary grades, the guidance activities in this document cover thirty-three topical areas: capabilities, changes, cooperation, criticism, differences, family, feelings, free time, friends, following directions, handicaps, honesty, improving environment, kindness, patience, paying attention, problem solving, rejection,…

    13. Developmental Guidance Program Implementation.

      ERIC Educational Resources Information Center

      Vernon, Ann; Strub, Richard

      This packet of materials was developed for workshops provided to teams of school counselors and administrators for the purpose of developing knowledge and competencies in the delivery of a comprehensive, sequential, developmental guidance program. Section I contains a rationale, definition, and description of program components. In section II…

    14. Quality in Careers Guidance.

      ERIC Educational Resources Information Center

      Plant, Peter

      This paper examines quality issues in career guidance, counseling, and information services in Europe and elsewhere from a range of different perspectives related to economic, ethical, and/or effectiveness criteria. Selected examples from the European Union member states, Canada, and the United States are used to illustrate how quality is…

    15. Vocational Development and Guidance.

      ERIC Educational Resources Information Center

      Tennyson, W. Wesley; And Others

      The vocational education volume considers questions of career development, the role of guidance in the school, vocational training, the relation of self-concept to vocational choice, and occupational information. Twenty-six papers deal with theories of vocational behavior, the success of vocational education programs, and testing information.…

    16. 78 FR 41853 - Safety Advisory Guidance: Heating Rail Tank Cars To Prepare Hazardous Material for Unloading or...

      Federal Register 2010, 2011, 2012, 2013, 2014

      2013-07-12

      ...This guidance provides safety precautions and recommended guidance for persons responsible for unloading or transloading \\1\\ hazardous materials from rail tank cars, specifically those persons heating a rail tank car to prepare its hazardous material contents for unloading or transloading. Further, this guidance reminds such persons of current regulatory requirements addressing this type of......

    17. EPA guidance on cultural competence training.

      PubMed

      Schouler-Ocak, Meryam; Graef-Calliess, Iris T; Tarricone, Ilaria; Qureshi, Adil; Kastrup, Marianne C; Bhugra, Dinesh

      2015-03-01

      The stress of migration as well as social factors and changes related to the receiving society may lead to the manifestation of psychiatric disorders in vulnerable individuals after migration. The diversity of cultures, ethnicities, races and reasons for migration poses a challenge for those seeking to understand how illness is experienced by immigrants whose backgrounds differ significantly from their clinicians. Cultural competence represents good clinical practice and can be defined as such that a clinician regards each patient in the context of the patient's own culture as well as from the perspective of the clinician's cultural values and prejudices. The EPA Guidance on cultural competence training outlines some of the key issues related to cultural competence and how to deal with these. It points out that cultural competence represents a comprehensive response to the mental health care needs of immigrant patients and requires knowledge, skills and attitudes which can improve the effectiveness of psychiatric treatment. To reach these aims, both individual and organizational competence are needed, as well as teaching competence in terms of educational leadership. The WPA Guidance on Mental Health and Mental Health Care for Migrants and the EPA Guidance on Mental Health Care for Migrants list a series of recommendations for policy makers, service providers and clinicians; these are aimed at improving mental health care for immigrants. The authors of this paper would like to underline these recommendations and, focusing on cultural competency and training, believe that they will be of positive value. PMID:25725596

    18. 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…

    19. Electrical and Electronic Drafting, Drafting 3: 9257.01.

      ERIC Educational Resources Information Center

      Dade County Public Schools, Miami, FL.

      The course covers the standards used in the electronic field, electrical drawings, electronic drafting, and parts of functional drafting. The student will become familiar with symbols used in these fields and become proficient with tools and reference material used in drawing schematics and mechanical details and in electrical and electronic…

    20. Guidance, Navigation, and Control Program

      NASA Technical Reports Server (NTRS)

      Hinkel, Heather; Tamblyn, Scott; Jackson, William L.; Foster, Chris; Brazzel, Jack; Manning, Thomas R.; Clark, Fred; Spehar, Pete; Barrett, Jim D.; Milenkovic, Zoran

      2011-01-01

      The Rendezvous and Proximity Operations Program (RPOP) is real-time guidance, navigation, and control (GN&C) domain piloting-aid software that provides 3D Orbiter graphics and runs on the Space Shuttle's Criticality-3 Payload and General Support Computer (PGSC) in the crew cockpit. This software provides the crew with Situational Awareness during the rendezvous and proximity operations phases of flight. RPOP can be configured from flight to flight, accounting for mission-specific flight scenarios and target vehicles, via initialization load (I-load) data files. The software provides real-time, automated, closed-loop guidance recommendations and the capability to integrate the crew s manual backup techniques. The software can bring all relative navigation sensor data, including the Orbiter's GPC (general purpose computer) data, into one central application to provide comprehensive situational awareness of the rendezvous and proximity operations trajectory. RPOP also can separately maintain trajectory estimates (past, current, and predicted) based on certain data types and co-plot them, in order to show how the various navigation solutions compare. RPOP s best estimate of the relative trajectory is determined by a relative Kalman filter processing data provided by the sensor suite s most accurate sensor, the trajectory control sensor (TCS). Integrated with the Kalman filter is an algorithm that identifies the reflector that the TCS is tracking. Because RPOP runs on PC laptop computers, the development and certification lifecycles are more agile, flexible, and cheaper than those that govern the Orbiter FSW (flight software) that runs in the GPC. New releases of RPOP can be turned around on a 3- to 6-month template, from new Change Request (CR) to certification, depending on the complexity of the changes.