Science.gov

Sample records for recommendations draft guidance

  1. 78 FR 52777 - Draft Guidance for Industry on Bioequivalence Recommendations for Risperidone Injection...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-26

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 availability of a revised draft guidance for industry entitled ``Draft Guidance on Risperidone.''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

  2. 78 FR 66743 - Draft Guidance for Industry on Bioequivalence Recommendations for Iron Sucrose; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-06

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 The draft guidance is a revised version of a previously issued draft...

  3. 78 FR 70953 - Draft Guidance for Industry on Bioequivalence Recommendations for Fluticasone Propionate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-27

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 HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Bioequivalence...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

  4. 77 FR 66621 - Draft Guidance for Industry on Bioequivalence Recommendation for Lenalidomide Capsules; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-06

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 draft guidance, when finalized, will represent the Agency's current thinking on the design of BE studies...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

  5. 75 FR 47603 - Draft Guidance for Industry and Food and Drug Administration Staff; Recommendations for Premarket...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-06

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA... zonisamide assays. This draft guidance is not final nor is it in effect at this time. DATES: Although you...

  6. 75 FR 41871 - International Conference on Harmonisation; Draft Guidance on Q4B Evaluation and Recommendation of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-19

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

  7. 78 FR 46965 - Draft Guidance for Industry on Bioequivalence Recommendations for Mesalamine Rectal Suppositories...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-02

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

  8. 76 FR 6685 - Draft Guidance for Industry and Food and Drug Administration Staff; Recommended Warning for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-07

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

  9. 78 FR 19271 - Draft Guidance for Industry on Bioequivalence Recommendations for Metronidazole Vaginal Gel...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-29

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

  10. 77 FR 58399 - Draft Guidance for Industry on Bioequivalence Recommendations for Pentosan Polysulfate Sodium...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-20

    ... Recommendations for Pentosan Polysulfate Sodium Capsule; Availability AGENCY: Food and Drug Administration, HHS... guidance for industry entitled ``Bioequivalence Recommendations for Pentosan Polysulfate Sodium.'' The... drug applications (ANDAs) for pentosan polysulfate sodium capsule. DATES: Although you can comment...

  11. 77 FR 18827 - Draft Guidance for Industry on Bioequivalence Recommendations for Iron Sucrose Injection...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-28

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

  12. 78 FR 13069 - Draft Guidance for Industry: Recommendations for Screening, Testing, and, Management of Blood...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-26

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

  13. 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

    ... FDA's Center for Veterinary Medicine (CVM) recommends for inclusion in food additive petitions (FAPs... for single copies of the guidance to the Communications Staff (HFV-12), Center for Veterinary Medicine... CONTACT: Sharon Benz, Center for Veterinary Medicine (HFV-220), Food and Drug Administration,...

  14. 78 FR 73200 - Draft Guidance for Industry on Bioequivalence Recommendations for Paliperidone Palmitate Extended...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-05

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

  15. 77 FR 7585 - Draft Guidance for Industry on Bioequivalence Recommendations for Rifaximin Tablets; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-13

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

  16. 78 FR 74154 - Draft Guidance for Industry on Recommendations for Preparation and Submission of Animal Food...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-10

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

  17. 76 FR 53909 - Draft Guidance for Industry on Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-30

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

  18. 78 FR 53792 - Draft Guidance for Reciprocity

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-30

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

  19. 75 FR 43172 - International Conference on Harmonisation; Draft Guidance on Q4B Evaluation and Recommendation of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-23

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

  20. 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

    ... Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on... Pharmacopoeial Texts for Use in the ICH Regions; Annex 13: Bulk Density and Tapped Density of Powders General... General Chapter harmonized text from each of the three pharmacopoeias (United States, European,...

  1. 77 FR 12852 - Draft Guidance for Industry on Limiting the Use of Certain Phthalates as Excipients in Center for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-02

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

  2. 76 FR 58018 - Draft Guidance for Industry on Self-Selection Studies for Nonprescription Drug Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-19

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

  3. 75 FR 48973 - Draft Guidance for Industry: Prevention of Salmonella

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-12

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

  4. 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

    ... responsible for cIAIs, including Gram-negative aerobic bacteria, Gram-positive bacteria, and anaerobic bacteria, and there are also mixed infections. This draft guidance includes recommendations for an...

  5. 76 FR 35450 - Draft Guidance for Industry on Clinical Trial Endpoints for the Approval of Non-Small Cell Lung...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-17

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

  6. 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...

  7. 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...

  8. 77 FR 10536 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-22

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Draft and Revised Draft Guidances for Industry Describing...). The guidances represent the Agency's current thinking on product-specific design of BE studies...

  9. 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...

  10. 75 FR 59268 - Draft Guidance for Industry: Acidified Foods; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-27

    ... and in employing appropriate quality control procedures. Under the draft guidance, processors of non... safe manufacturing, processing, and packing processes and in employing appropriate quality control... Establishment-Specific Written Quality Control Plans and Recordkeeping for Acidified Foods, and...

  11. 77 FR 69632 - Draft Guidance for Industry on Electronic Source Data in Clinical Investigations; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-20

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

  12. 75 FR 49913 - Draft Guidance, “Federal Greenhouse Gas Accounting and Reporting”

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-16

    ... QUALITY Draft Guidance, ``Federal Greenhouse Gas Accounting and Reporting'' AGENCY: Council on... Federal agencies. Among other provisions, E.O. 13514 requires agencies to measure, report, and reduce... and accounting procedures. On April 5, 2010, DOE-FEMP submitted the final recommendations on...

  13. 75 FR 7591 - Guidance on Recommended Interim Preliminary Remediation Goals for Dioxin in Soil at CERCLA and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-22

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

  14. 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.

  15. 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...

  16. 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

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Medical Device Reporting for Manufacturers; Draft Guidance....115). The draft guidance, when finalized, will represent the Agency's current thinking on...

  17. 76 FR 60055 - Draft Guidance for Industry: Applications for Premarket Review of New Tobacco Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-28

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

  18. 77 FR 14402 - Draft Guidance on Classifying Significant Postmarket Drug Safety Issues; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-09

    ... ``Classifying Significant Postmarket Drug Safety Issues.'' This draft guidance describes FDA's current approach... ``Classifying Significant Postmarket Drug Safety Issues.'' This draft guidance describes CDER's current approach... Archiving, Reporting, and Regulatory Tracking System (DARRTS), a centralized data base that enables...

  19. 76 FR 31615 - Draft Guidance for Industry and FDA Staff: Commercially Distributed In Vitro Diagnostic Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-01

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and FDA Staff: Commercially... Asked 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...

  20. 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... a draft guidance for industry entitled ``Quality Considerations in Demonstrating Biosimilarity to a... reference product for the purpose of submitting a marketing application through an abbreviated...

  1. 76 FR 55927 - Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-09

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

  2. 75 FR 41452 - Draft Guidance, “Federal Greenhouse Gas Accounting and Reporting”

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-16

    ... QUALITY Draft Guidance, ``Federal Greenhouse Gas Accounting and Reporting'' AGENCY: Council on Environmental Quality. ACTION: Notice of Availability, Draft Guidance, ``Federal Greenhouse Gas Accounting and... (GHG) emissions a priority for Federal agencies. Among other provisions, E.O. 13514 requires...

  3. 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

    ... Quality.'' This draft guidance is intended to alert manufacturers of active pharmaceutical ingredients... to protect public health. FDA developed this draft guidance to alert manufacturers to the risks...

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

    PubMed

    Donawa, Maria E

    2005-01-01

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

  5. 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...

  6. 78 FR 49271 - Draft Guidance for Industry on Frequently Asked Questions About Medical Foods; Second Edition...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-13

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

  7. 78 FR 33848 - Draft Guidance for Industry on Human Immunodeficiency Virus-1 Infection: Developing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-05

    ... No. FDA-2013-D-0589] Draft Guidance for Industry on Human Immunodeficiency Virus-1 Infection... guidance for industry entitled ``Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs... guidance for industry entitled ``Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral...

  8. 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

    ... efficiency of the review process. This draft guidance is not final nor is it in effect at this time. DATES... review process between FDA and industry for specific medical device premarket submissions. Further... recommendations for MDUFA III, Title II of the Food and Drug Administration Safety and Innovation Act, Public...

  9. 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

    ....regulations.gov . The www.regulations.gov Web site is an ``anonymous access'' system, which means EPA will not... efficient consideration of comments. a. Diesel Fuels Description 1. The draft guidance recommends using six... Oil No. 2 Common Synonyms: Diesel fuel; Gas oil or diesel fuel or heating oil, light 2 Home...

  10. 78 FR 32667 - Draft Guidance for Industry on Rheumatoid Arthritis: Developing Drug Products for Treatment...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-31

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

  11. 78 FR 56718 - Draft Guidance for Industry on Bioanalytical Method Validation; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-13

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Bioanalytical Method Validation; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and... revising the guidance to reflect advancements in the science and technology of bioanalytical...

  12. 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...

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

    EPA Pesticide Factsheets

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

  14. 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...

  15. 77 FR 76049 - Draft Guidance for Industry on Electronic Source Data in Clinical Investigations; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-26

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

  16. 78 FR 20925 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-08

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

  17. 77 FR 35688 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-14

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

  18. 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...

  19. 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...

  20. 78 FR 52931 - Draft Guidance for Industry on Abbreviated New Drug Applications: Stability Testing of Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-27

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Abbreviated New Drug Applications: Stability Testing of Drug Substances and Products, Questions and Answers; Availability AGENCY... announcing the availability of a draft guidance for industry entitled ``ANDAs: Stability Testing of...

  1. 77 FR 74003 - Pesticides; Draft Guidance for Pesticide Registrants on Antimicrobial Pesticide Products With...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-12

    ... AGENCY Pesticides; Draft Guidance for Pesticide Registrants on Antimicrobial Pesticide Products With Mold.... SUMMARY: The Agency is announcing the availability of and seeking public comment on a draft Pesticide Registration Notice (PR Notice) titled ``Guidance on Antimicrobial Pesticide Products with Mold-Related...

  2. 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

    ... 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 Abbreviated New Drug... regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency's current...

  3. 76 FR 68767 - Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-07

    ... entitled ``Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification...] [FR Doc No: 2011-28766] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0689] Draft Guidance for Industry and Food and Drug Administration Staff; De...

  4. 75 FR 9228 - Draft Guidance for Industry on Non-Inferiority Clinical Trials; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-01

    ... ``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 Trials... clinical trials. It does not create or confer any rights for or on any person and does not operate to...

  5. 76 FR 10908 - Draft Guidance for Industry on Medication Guides-Distribution Requirements and Inclusion of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-28

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

  6. 76 FR 30175 - Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-24

    ... HUMAN SERVICES Food and Drug Administration (Formerly FDA-1999-D-0792) Draft Guidance for Clinical... comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug... http://www.regulations.gov . Submit written comments to the Division of Dockets Management...

  7. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration...; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug... for heart valves. This draft guidance document is not final, nor is it in effect at this time....

  8. 77 FR 67379 - Draft Guidance for Industry and Food and Drug Administration Staff; Highly Multiplexed...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-09

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

  9. 75 FR 57963 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-23

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

  10. 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...

  11. 76 FR 40921 - Draft Guidance for Industry and Food and Drug Administration Staff; Enforcement Policy for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-12

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

  12. 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

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

  13. 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

    ... Agricultural Marketing Service 7 CFR Part 205 National Organic Program; Notice of Draft Guidance for Accredited... Availability With Request For Comments. SUMMARY: The National Organic Program (NOP) is announcing the... operations. The draft guidance documents are entitled as follows: ``The Use of Kelp in Organic Livestock...

  14. 75 FR 62693 - National Organic Program: Notice of Draft Guidance for Accredited Certifying Agents and Certified...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-13

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

  15. 77 FR 14401 - Draft Guidance on Drug Safety Information-FDA's Communication to the Public; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-09

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

  16. 77 FR 19672 - Draft Guidances Relating to the Development of Biosimilar Products; Public Hearing; Request for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-02

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

  17. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... Marketing Applications; 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...

  18. 78 FR 22269 - International Conference on Harmonisation; Draft Guidance on M7 Assessment and Control of DNA...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-15

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

  19. 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

    ... Agricultural Marketing Service National Organic Program: Notice of Draft Guidance Concerning ``Made With 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...

  20. 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...

  1. 77 FR 16842 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-22

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

  2. 78 FR 66745 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-06

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

  3. 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

    ... Industry on Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients... comments of a draft revised guidance for industry ( 100) entitled ``Residual Solvents in New Veterinary... veterinary use by the International Cooperation on Harmonisation of Technical Requirements for...

  4. 76 FR 70151 - Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-10

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry, Clinical Investigators... determined, despite outstanding issues, that the information provided is sufficient to justify human clinical... maintaining appropriate subject protections. Staged approval or staged approval with conditions is most...

  5. 76 FR 1170 - Draft Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-07

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

  6. 76 FR 55068 - Mobile Medical Applications Draft Guidance; Public Workshop; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-06

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Mobile Medical Applications Draft Guidance; Public Workshop... FR 50231). The document announced a public workshop entitled ``Mobile ] Medical Applications...

  7. 77 FR 8885 - Draft Guidance for Industry on Biosimilars: Questions and Answers Regarding Implementation of the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-15

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

  8. 78 FR 68852 - Draft Guidance for Industry on Acrylamide in Foods; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-15

    ... form in some foods during certain types of high-temperature cooking. The draft guidance is intended to.... Acrylamide is a chemical that can form in some foods during certain types of high-temperature cooking, and...

  9. 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

    ... Staff; Medical Device Classification Product Codes; Availability AGENCY: Food and Drug Administration... of the draft guidance entitled ``Medical Device Classification Product Codes.'' The purpose of the... classification product codes for medical devices regulated by the Center for Devices and Radiological...

  10. 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...

  11. 78 FR 19637 - National Organic Program: Notice of Draft Guidance on Classification of Materials and Materials...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-02

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

  12. 75 FR 8045 - National Environmental Policy Act (NEPA) Draft Guidance, Establishing, Applying, and Revising...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-23

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

  13. 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

    ... COMMISSION Draft License Renewal Interim Staff Guidance LR-ISG-2011-05: Ongoing Review of Operating Experience AGENCY: Nuclear Regulatory Commission. ACTION: Revision of draft interim staff guidance; request.... Nuclear Regulatory Commission (NRC) requested public comments on Draft License Renewal Interim...

  14. 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

    ... AGENCY Pesticides; Draft Guidance for Pesticide Registrants on False or Misleading Pesticide Product... Agency is announcing the availability of and seeking public comment on a draft Pesticide Registration Notice (PR Notice) entitled ``False or Misleading Pesticide Product Brand Names.'' PR Notices are...

  15. 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...

  16. 76 FR 570 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-05

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

  17. 76 FR 36542 - Draft Guidance for Industry and Food and Drug Administration Staff: The Content of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-22

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

  18. 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

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

  19. 78 FR 55261 - Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-10

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

  20. 76 FR 70768 - Common-Cause Failure Analysis in Event and Condition Assessment: Guidance and Research, Draft...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-15

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

  1. 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...

  2. 76 FR 14024 - Draft Guidance for Industry on Non-Penicillin Beta-Lactam Risk Assessment: A CGMP Framework...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-15

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-14

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

  4. 78 FR 27116 - Draft Guidance for Industry on Charging for Investigational Drugs Under an Investigational New...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-09

    ..., to set forth criteria for charging for an investigational drug for the three types of expanded access... types of costs that can be recovered, FDA is providing a draft guidance in a question and answer format...ComplianceRegulatoryInformation/Guidances/default.htm ,...

  5. 78 FR 9688 - Pesticides; Draft Guidance for Pesticide Registrants on Antimicrobial Pesticide Products With...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-11

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

  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

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

  7. 78 FR 24211 - Draft Guidance for Industry on Safety Considerations for Container Labels and Carton Labeling...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-24

    ... Container Labels and Carton Labeling Design To Minimize Medication Errors; Availability AGENCY: Food and... Labels and Carton Labeling Design to Minimize Medication Errors.'' The draft guidance focuses on safety... use of the product to minimize medication errors. DATES: Although you can comment on any guidance...

  8. 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

    ... on this draft guidance before it begins work on the final version of the guidance, submit either... access under a treatment protocol or treatment investigational new drug application (IND). These... CFR part 56 (21 CFR 312.305(c)(4)). 21 CFR part 56 requires, among other things, that an IRB...

  9. 78 FR 16676 - Agency Information Collection Activities; Proposed Collection; Comment Request; Draft Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-18

    ... Pump--Premarket Notification Submissions AGENCY: Food and Drug Administration, HHS. ACTION: Notice... solicits comments on ``Guidance for Industry and FDA Staff; Total Product Life Cycle: Infusion Pump... technology. Draft Guidance for Industry and FDA Staff; Total Product Life Cycle: Infusion...

  10. 79 FR 19620 - Draft Guidance for Industry: Proper Labeling of Honey and Honey Products; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2014-04-09

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

  11. 77 FR 8883 - Draft Guidance for Industry on Scientific Considerations in Demonstrating Biosimilarity to a...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-15

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

  12. 76 FR 16424 - Draft Guidance for Industry: Compliance With Regulations Restricting the Sale and Distribution of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-23

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

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

    PubMed

    1998-06-12

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

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

    PubMed

    2006-10-11

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

  15. 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.

  16. 77 FR 34390 - Draft Guidance for Industry: Amendment to “Guidance for Industry: Revised Preventive Measures To...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-11

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

  17. 78 FR 69691 - Draft Guidance for Industry on Product Name Placement, Size, and Prominence in Advertising and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-20

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

  18. 77 FR 16123 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-19

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

  19. 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

    ... http://www.regulations.gov . Identify comments with the docket number found in brackets in the heading... Guidance This draft guidance is being issued consistent with FDA's good guidance practices regulation (21... receive a hard copy. Please use the document number 1709 to identify the guidance you are requesting....

  20. 78 FR 66366 - Draft Guidance for Industry: Use of Donor Screening Tests To Test Donors of Human Cells, Tissues...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-05

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

  1. 76 FR 33752 - Notice of Availability of the External Review Draft of the Guidance for Applying Quantitative...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-09

    ... To Develop Data-Derived Extrapolation Factors for Interspecies and Intraspecies Extrapolation AGENCY... Draft of ``Guidance for Applying Quantitative Data to Develop Data-Derived Extrapolation Factors for... information below. This draft Guidance for Data Derived Extrapolation Factors document outlines approaches...

  2. 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

    ... 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 Self-Identification of... announced a draft guidance for industry entitled ``Self-Identification of Generic Drug Facilities,...

  3. 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...) is announcing the availability of the draft guidance entitled ``Medical Device ISO 13485:2003... written requests for single copies of the draft guidance document entitled ``Medical Device ISO...

  4. 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....

  5. 75 FR 8046 - National Environmental Policy Act (NEPA) Draft Guidance, “Consideration of the Effects of Climate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-23

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

  6. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is... safety and effectiveness of these devices. This draft guidance is not final nor is it in effect at...

  7. 77 FR 41413 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices: The Pre...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-13

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is... draft guidance is not final nor is it in effect at this time. DATES: Although you can comment on...

  8. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing... adequately addressed in clinical trials. This draft guidance is not final nor is it in effect at this...

  9. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and FDA Staff: Processing...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is... with processing or reprocessing labeling. This draft guidance is not final; nor is it in effect at...

  10. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... Assays; 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 ``Class...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-10

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Determining the Extent of... Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Determining the... types of safety data to collect in trials conducted late in the development of a drug for...

  13. 77 FR 31858 - Draft Guidance for Industry on Pathologic Complete Response in Neoadjuvant Treatment of High-Risk...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-30

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Pathologic Complete Response... Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry... applicants in designing trials to support marketing approval of drugs to treat breast cancer in...

  14. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Alzheimer's Disease... a draft guidance for industry entitled ``Alzheimer's Disease: Developing Drugs for the Treatment of... demonstrate efficacy in clinical trials in patients in the early stages of Alzheimer's disease that...

  15. 76 FR 60847 - Draft Guidance on Media Fills for Validation of Aseptic Preparations for Positron Emission...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-30

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

  16. 77 FR 11553 - Draft Guidance on Food and Drug Administration Oversight of Positron Emission Tomography Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-27

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

  17. 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...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-12

    ... may vary. To enhance human subject protections and reduce regulatory burden, FDA and the Office for Human Research Protections (OHRP) have been actively working to harmonize the Agencies' regulatory... HUMAN SERVICES Food and Drug Administration Draft Guidance for Institutional Review Boards,...

  19. 75 FR 1790 - Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: IRB...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-13

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Institutional Review Boards, Clinical... Approval'' (September 1998, Office of Health Affairs, Food and Drug Administration). To enhance human subject protection and reduce regulatory burden, the Department of Health and Human Services, Office...

  20. 78 FR 44572 - Draft Guidance for Industry on Pre-Launch Activities Importation Requests; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-24

    ...) or an abbreviated new drug application (ANDA). This draft guidance also applies to biologics... circumstances under which the Agency intends to grant a PLAIR. An applicant who has an NDA, ANDA, or a BLA... the underlying NDA or ANDA within 6 months and the conditions of the PLAIR are otherwise met....

  1. 81 FR 35767 - Pesticides; Draft Guidance for Pesticide Registrants on Herbicide Resistance Management Labeling...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2016-06-03

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-20

    ... determine the potential for a drug to disrupt the endocrine system. This draft guidance also discusses... compounds that have the potential to interfere with some aspect of the endocrine system of an organism or its progeny. Any component of the endocrine system can be a target of endocrine disruptors,...

  3. 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

    ... amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), as well as FDA... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Review Staff on Pediatric...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA)...

  4. 76 FR 80948 - Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-27

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

  5. 78 FR 3418 - Pesticides; Draft Guidance for Pesticide Registrants on Web-Distributed Labeling for Pesticide...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-16

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

  6. 77 FR 74852 - Draft Guidance for Industry on Certification of Designated Medical Gases; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-18

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

  7. 76 FR 55923 - Draft Guidance for Industry: Submission of Warning Plans for Cigarettes and Smokeless Tobacco...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-09

    ... Cigarettes and Smokeless Tobacco Products; Availability; Agency Information Collection Activities; Proposed... ``Submission of Warning Plans for Cigarettes and Smokeless Tobacco Products.'' This draft guidance document is... Cigarette Labeling and Advertising Act, as amended by the Family Smoking Prevention and Tobacco Control...

  8. 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

    ...: Developing Drugs for Treatment; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... industry entitled ``Pulmonary Tuberculosis: Developing Drugs for Treatment.'' The purpose of the draft guidance is to assist sponsors in the development of antimycobacterial drugs for the treatment of...

  9. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Investigational New Drug Applications--Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug Application; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...

  10. 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 SERVICES Food and Drug Administration Draft Guidance for Industry on Interim Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic... Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Drug Quality and Security Act...

  11. 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

    ... HUMAN SERVICES Food and Drug Administration International Conference on Harmonisation; Draft Guidance on Q11 Development and Manufacture of Drug Substances; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability...

  12. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act... ``Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food,...

  13. 76 FR 39111 - Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-05

    ... written requests for single copies of this draft guidance to the Office of Nutrition, Labeling, and Dietary Supplements, Center for Food Safety and Applied Nutrition (HFS-850), Food and Drug Administration... for Food Safety and Applied Nutrition (HFS-850), Food and Drug Administration, 5100 Paint Branch...

  14. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... Trachomatis and/or Neisseria Gonorrhoeae: Screening and Diagnostic Testing; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-05

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-16

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

  17. 76 FR 43689 - Draft Guidance for Industry and Food and Drug Administration Staff; Mobile Medical Applications...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-21

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

  18. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA... Food, Drug, and Cosmetic Act (FD&C Act), also known as the de novo classification process. FDA...

  19. 75 FR 36421 - Draft Guidance for Industry on Chemistry, Manufacturing, and Controls Postapproval Manufacturing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-25

    ... adverse effect on the identity, strength, quality, purity, or potency of the drug product and, therefore... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Chemistry, Manufacturing, and... Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

  20. 75 FR 4400 - Draft Guidance for Industry on Assessment of Abuse Potential of Drugs; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-27

    ... abuse potential, and drugs that produce psychoactive effects such as sedation, euphoria, or mood change... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Assessment of Abuse Potential of Drugs; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...

  1. 76 FR 55927 - Draft Guidance for Industry and Food and Drug Administration Staff; Demonstrating the Substantial...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-09

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

  2. 76 FR 34999 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-15

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

  3. 75 FR 2145 - Draft Guidance for Industry on Tobacco Health Document Submission; Availability; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-14

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

  4. 77 FR 10753 - Draft Guidance for Industry: Food and Drug Administration Records Access Authority Under the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-23

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

  5. 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

    ... Development (HFM-40), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401... the FD&C Act, FDA is issuing this draft guidance, announcing its determination that submission types... Persons with access to the Internet may obtain the document at either...

  6. 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...

  7. 76 FR 50484 - Draft Guidance for Industry, Clinical Investigators, and Food and Drug Administration Staff...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-15

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

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

    PubMed

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

    2017-02-09

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

  9. 75 FR 54347 - Draft Guidance for Industry: Bar Code Label Requirements-Questions and Answers (Question 12...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-07

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Bar Code Label Requirements... document entitled ``Guidance for Industry: Bar Code Label Requirements--Questions and Answers (Question 12... advice concerning compliance with the bar code label requirements. In this guidance, FDA is proposing...

  10. 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

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

  11. 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....

  12. 76 FR 58311 - Draft License Renewal Interim Staff Guidance LR-ISG-2011-05; Ongoing Review of Operating Experience

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-20

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

  13. 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... Studies Using Electronic Healthcare Data Sets.'' The draft guidance is intended to describe best practices pertaining to conducting and documenting pharmacoepidemiologic safety studies using electronic...

  14. 78 FR 54899 - Draft Guidance for Industry on Specification of the Unique Facility Identifier System for Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-06

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Specification of the Unique Facility Identifier System for Drug Establishment Registration; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing...

  15. 78 FR 68459 - Medical Device Development Tools; Draft Guidance for Industry, Tool Developers, and Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-14

    ... HUMAN SERVICES Food and Drug Administration Medical Device Development Tools; Draft Guidance for Industry, Tool Developers, and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing...

  16. 78 FR 38994 - Implanted Blood Access Devices for Hemodialysis; Draft Guidance for Industry and Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-28

    ... HUMAN SERVICES Food and Drug Administration Implanted Blood Access Devices for Hemodialysis; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing...

  17. 75 FR 8046 - National Environmental Policy Act (NEPA) Draft Guidance, “NEPA Mitigation and Monitoring.”

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-23

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

  18. 78 FR 78822 - Draft Guidance for Assessing the Effects of Anthropogenic Sound on Marine Mammals-Acoustic...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-27

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

  19. 77 FR 36273 - Public Meeting on Draft Permitting Guidance for Oil and Gas Hydraulic Fracturing Activities Using...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-18

    ...The Environmental Protection Agency (EPA or agency) is announcing a public meeting to discuss draft permitting guidance the agency has developed on the use of diesel fuels in oil and gas hydraulic fracturing and to solicit input during the public comment period. The meeting is open to all interested parties. The agency requests input on the following technical aspects of the draft permitting......

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

    PubMed

    Pitts, Peter J

    2004-01-01

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

  1. 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.

  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

    ... Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on... ] availability of a guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the... published ICH guidance, ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the...

  3. 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...

  4. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Oversight of Clinical... overarching goal of this guidance is to enhance human subject protection and the quality of clinical trial... adequate protection of the rights, welfare, and safety of human subjects and the quality and integrity...

  5. 78 FR 72901 - Draft Guidance; Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-04

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance; Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Withdrawal of Guidances AGENCY: Food and... Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act''. The...

  6. 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

    ... and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: External Pacemaker Pulse Generator; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing...

  7. 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

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Bacillus Species Detection AGENCY: Food and Drug Administration, HHS. ACTION: Notice of...

  8. 76 FR 69040 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-07

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

  9. 76 FR 55384 - External Peer Review Meeting for the Draft Guidance of Applying Quantitative Data To Develop Data...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-07

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

  10. 76 FR 13629 - Revised Draft Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-14

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

  11. 75 FR 75482 - Draft Guidance for Industry on Residual Solvents in Animal Drug Products; Questions and Answers...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-03

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-13

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

  13. 77 FR 74669 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-17

    ... active ingredients: D Desmopressin acetate Diflunisal Dipyridamole H Hydrochlorothiazide; lisinopril...-specific BE recommendations for drug products containing the following active ingredients: A Abiraterone acetate Albendazole Amlodipine besylate, hydrochlorothiazide, and olmesartan medoxomil C...

  14. 78 FR 37230 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-20

    ...-specific BE recommendations for drug products containing the following active ingredients: A Apixaban Artemether; Lumefantrine Asenapine maleate B Balsalazide disodium C Cycloserine Cyclosporine E Eltrombopag olamine F Fluoxetine H Hydrochlorothiazide; Triamterene M Medroxyprogesterone (multiple reference...

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

    PubMed

    Wilcox, Stephen B; Drucker, Daniel

    2012-03-01

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-13

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

  17. 76 FR 69274 - Draft Guidance for Industry and Food and Drug Administration Staff; 510(k) Device Modifications...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-08

    ... Staff; 510(k) Device Modifications: Deciding When To Submit a 510(k) for a Change to an Existing Device... Administration Staff; 510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing... comment period to request comments on the draft guidance for industry and FDA staff entitled...

  18. 75 FR 53316 - Draft Guidance for Food and Drug Administration Staff and Tobacco Retailers on Civil Money...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-31

    ... Tobacco Retailers on Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers; Availability...) is announcing the availability of a draft guidance entitled ``Civil Money Penalties and No-Tobacco... policies with respect to civil money penalties and no-tobacco-sale orders for retailers who...

  19. 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... written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630... enhancements to FDA's generic drugs program. GDUFA will also significantly improve global supply...

  20. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Scale-Up and Post-Approval...: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a scale-up and... Oral Dosage Forms--Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In...

  1. 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

    ... and Research. This draft guidance is not final nor is it in effect at this time. DATES: Although you... Development (HFM-40), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401..., Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville...

  2. 78 FR 56719 - Draft Guidance for Industry on Arsenic in Apple Juice: Action Level; Supporting Document for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-13

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

  3. 78 FR 42086 - Draft Guidance for Industry on Arsenic in Apple Juice: Action Level; Supporting Document for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-15

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

  4. 77 FR 51814 - Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-27

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

  5. 77 FR 34949 - Draft Guidance on Considerations in Transferring a Previously-Approved Research Project to a New...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-12

    ... HUMAN SERVICES Draft Guidance on Considerations in Transferring a Previously- Approved Research Project to a New IRB or Research Institution AGENCY: Department of Health and Human Services (HHS), Office of the Secretary, Office of the Assistant Secretary for Health, Office for Human Research...

  6. 76 FR 3144 - Draft Guidance for Industry on Size of Beads in Drug Products Labeled for Sprinkle; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-19

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

  7. 77 FR 11550 - Draft Guidance for Industry on Notification to Food and Drug Administration of Issues That May...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-27

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Notification to Food and Drug..., directing FDA to use all available administrative tools to expand the Agency's efforts to combat the problem... required nutrition, or to address other serious medical conditions. Other shortages force providers...

  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

    ... to Develop Data-Derived Extrapolation Factors for Interspecies and Intraspecies Extrapolation... Review Draft of ``Guidance for Applying Quantitative Data to Develop Data-Derived Extrapolation Factors... and to provide information to the regulated community and other interested parties about deriving...

  9. 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 consistent... development of resistance. In settings in which combination therapy provides significant...

  10. 77 FR 9946 - Draft Guidance for Industry on Drug Interaction Studies-Study Design, Data Analysis, Implications...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-21

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

  11. 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... Historical Cost of G- PP&E. The Exposure Drafts are available on the FASAB home page http://www.fasab.gov... From the Federal Register Online via the Government Publishing Office FEDERAL ACCOUNTING...

  12. 75 FR 69449 - Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-12

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration...; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug... manufacturer or distributor of a human drug or biologic, or from FDA--intended to alert physicians and...

  13. 77 FR 14811 - Draft Guidance for Industry on Direct-to-Consumer Television Advertisements-the Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-13

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Direct-to-Consumer Television Advertisements--the Food and Drug Administration Amendments Act of 2007 Direct-to-Consumer Television Ad Pre-Dissemination Review Program; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice....

  14. 78 FR 60292 - Draft Guidance for Industry on Abbreviated New Drug Application Submissions-Refuse-to-Receive...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-01

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

  15. 76 FR 22903 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing That a Tobacco...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-25

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-08

    ... Doc No: 2010-87] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0568] Draft Guidance for Industry on Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products; Availability AGENCY: Food and Drug Administration,...

  18. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA... and Food and Drug Administration Staff: Applying Human Factors and Usability Engineering to...

  19. 76 FR 44935 - Draft Guidance for Industry and Food and Drug Administration Staff; 510(k) Device Modifications...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-27

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

  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

    ... FDA may no longer be adequate, as animal drug effects can change over time and less apparent effects... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Data Elements for Submission... and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA)...

  1. 77 FR 37058 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-20

    ...] [FR Doc No: 2012-15025] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA 2012-D-0304] Draft Guidance for Industry and Food and Drug Administration Staff; Class II...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA)...

  2. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration and Industry Procedures for Section 513(g) Requests for Information Under the Federal Food, Drug, and Cosmetic Act AGENCY: Food and Drug Administration, HHS. ACTION:...

  3. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration...; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug... regulations issued under the Federal Food, Drug, and Cosmetic Act (FD&C Act) relating to tobacco products...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-17

    ... 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...

  5. 76 FR 50483 - Draft Guidance for Industry and Food and Drug Administration Staff; Factors to Consider When...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-15

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

  6. 78 FR 38349 - Draft Guidance for Industry on Expedited Programs for Serious Conditions-Drugs and Biologics...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-26

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-26

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

  8. 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...

  9. 77 FR 40354 - Permitting Guidance for Oil and Gas Hydraulic Fracturing Activities Using Diesel Fuels-Draft

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-09

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

  10. 75 FR 54153 - International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-03

    ... Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 11... guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions... Electrophoresis General Chapter harmonized text from each of the three pharmacopoeias (United States,...

  11. 78 FR 63221 - International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-23

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

  12. 75 FR 17148 - International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-05

    ... Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on... availability of a guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the... Dissolution Test General Chapter harmonized text from each of the three pharmacopoeias (United...

  13. 75 FR 53973 - International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-02

    ... Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on... availability of a guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the... Sieving General Chapter harmonized text from each of the three pharmacopoeias (United States,...

  14. 75 FR 17147 - International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-05

    ... Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on... availability of a guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the... Friability General Chapter harmonized text from each of the three pharmacopoeias (United States,...

  15. 75 FR 33311 - Guidance for Industry on Bioequivalence Recommendations for Specific Products; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-11

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

  16. 78 FR 39736 - Draft Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-02

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

  17. 77 FR 11133 - Draft Guidance for Industry on Complicated Urinary Tract Infections: Developing Drugs for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-24

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

  18. 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...

  19. 78 FR 12759 - Draft Guidance for Industry on Attachment to Guidance on Antiviral Product Development-Conducting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-25

    ... Submitting Hepatitis C Virus Resistance Data; Availability AGENCY: Food and Drug Administration, HHS. ACTION... Submitting Virology Studies to the Agency: Guidance for Submitting HCV Resistance Data.'' The purpose of this... important for supporting clinical trials of products in development for the treatment of HCV. HCV...

  20. 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

    ... Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm..., will represent the Agency's current thinking on tablet size, shape, and other physical attributes of... collections recommended in this guidance that are new or that would represent material modifications to...

  1. 78 FR 63476 - Draft Guidance for Industry: Use of Nucleic Acid Tests To Reduce the Risk of Transmission of West...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-24

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

  2. 78 FR 56752 - Interim Staff Guidance Specific Environmental Guidance for Integral Pressurized Water Reactors...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-13

    ... COMMISSION Interim Staff Guidance Specific Environmental Guidance for Integral Pressurized Water Reactors Reviews AGENCY: Nuclear Regulatory Commission. ACTION: Draft Interim Staff Guidance; request for comment... comment on, draft Interim Staff Guidance (ISG) ESP/COL-ISG-027, ``Interim Staff Guidance...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-08

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

  4. 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,...

  5. 75 FR 27840 - NUREG-0654/FEMA-REP-1, Rev. 1, Supplement 3, Guidance for Protective Action Recommendations for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-18

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

  6. 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

    ... of Occurrence in Clinical Trials.'' The purpose of this guidance is to assist sponsors in.... Send one self-addressed adhesive label to assist that office in processing your requests. See the... Clinical Trials.'' The purpose of this guidance is to assist sponsors in prospectively assessing...

  7. 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…

  8. 78 FR 32668 - Draft Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-31

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

  9. 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

    ... guidance document provides advice to potential sponsors, such as cord blood banks, registries, transplant... New Drug Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood..., Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and...

  10. 76 FR 52958 - Draft Guidance for Industry on Neglected Tropical Diseases of the Developing World: Developing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-24

    ... developing world. Specifically, this guidance addresses FDA's current thinking regarding the overall drug... current thinking on this topic. It does not create or confer any rights for or on any person and does...

  11. 78 FR 58545 - Global Unique Device Identification Database; Draft Guidance for Industry; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-24

    ... our current thinking of how the GUDID will operate. The guidance includes both information about how... represent the Agency's current thinking on the GUDID. It does not create or confer any rights for or on...

  12. 78 FR 17943 - Draft Program-Specific Guidance About Fixed Gauge Licenses

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-25

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

  13. 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

    ... Staff; Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies... guidance, FDA intends to facilitate early feasibility studies of medical devices, using appropriate risk mitigation strategies, under the IDE requirements. Early feasibility studies allow for limited early...

  14. 76 FR 78659 - Solicitation of Written Comments on the Draft Report and Draft Recommendations of the Healthcare...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-19

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

  15. 78 FR 69693 - Draft Guidance for Industry: Recommendations for Premarket Notification (510(k)) Submissions for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-20

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

  16. 78 FR 55263 - Draft Guidance for Industry on Bioequivalence Recommendations for Fluticasone Propionate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-10

    ... bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for fluticasone propionate... New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed adhesive...; salmeterol xinafoate. Advair Diskus (fluticasone propionate; salmeterol xinafoate), new drug...

  17. 77 FR 40068 - Draft Guidance for Industry: Recommendations for Donor Questioning, Deferral, Reentry, and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-06

    ... scientific workshop. In addition, FDA is aware that dengue viruses are endemic in Quintana Roo and Jalisco. FDA is currently evaluating the risk of dengue virus infections in U.S. blood donors that are...

  18. 78 FR 15370 - Draft Guidance for Industry and Food and Drug Administration Staff: Recommendations for Labeling...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-11

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

  19. 77 FR 7586 - Draft Guidance for Industry on Bioequivalence Recommendation for Nitroglycerin Metered Spray...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-13

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

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

    PubMed

    O'Connell, P

    2006-01-01

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

  1. 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,...

  2. 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...

  3. 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... for Biologics Research and Evaluation (CBER), Office of Cellular, Tissue, and Gene Therapies (OCTGT). The product areas covered by this guidance are cellular therapy, gene therapy, therapeutic...

  4. 78 FR 20926 - Draft Guidance for Industry on Providing Postmarket Periodic Safety Reports in the International...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-08

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

  5. 76 FR 1173 - Draft Guidance for Industry on Electronic Source Documentation in Clinical Investigations...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-07

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

  6. 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.

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

    PubMed

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

    2015-06-24

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

  8. 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

  9. 77 FR 74195 - Draft Guidance for Industry and Food and Drug Administration Staff; Design Considerations for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-13

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

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

    EPA Pesticide Factsheets

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

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

    EPA Pesticide Factsheets

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

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

    EPA Pesticide Factsheets

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

  13. 78 FR 50421 - Guidance for Industry: Recommendations for Donor Questioning, Deferral, Reentry, and Product...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-19

    ... guidances at any time. ADDRESSES: Submit written requests for single copies of the guidance to the Office of... collected from a donor who should have been deferred due to possible malaria risk. Finally, the guidance... other terms used to assess a donor's risk of malaria based on history of travel or residence;...

  14. 78 FR 46954 - Agency Information Collection Activities; Proposed Collection; Comment Request; Draft Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-02

    ... recommendations for the FDA-approved serological test systems for the detection of antibodies to T. cruzi. The use... detecting antibodies to T. cruzi in plasma and serum samples from individual human donors, including donors... reactive by a licensed test for T. cruzi antibody. When establishments identify a donor who is...

  15. 76 FR 44013 - Draft Guidance for Industry: Implementation of Acceptable Full-Length and Abbreviated Donor...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-22

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

  16. 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...

  17. 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.

  18. 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.

  19. 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

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

    SciTech Connect

    Butler, J.R.

    1986-03-13

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

  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. General Drafting. Technical Manual.

    ERIC Educational Resources Information Center

    Department of the Army, Washington, DC.

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

  3. 77 FR 62247 - Dynamic Positioning Operations Guidance for Vessels Other Than Mobile Offshore Drilling Units...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-12

    ... recommended owners and operators of Mobile Offshore Drilling Units (MODUs) follow Marine Technology Society... draft guidance from the Marine Technology Society (MTS) DP Committee for Mobile Offshore Drilling Units...] Dynamic Positioning Operations Guidance for Vessels Other Than Mobile Offshore Drilling Units Operating...

  4. 77 FR 21782 - International Conference on Harmonisation; Draft Guidance for Industry on E2C(R2) Periodic...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-11

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

  5. 76 FR 67764 - Common-Cause Failure Analysis in Event and Condition Assessment: Guidance and Research, Draft...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-02

    ... and image files of the NRC's public documents. If you do not have access to ADAMS or if there are.... ] SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment a draft NUREG, NUREG... following methods: NRC's Public Document Room (PDR): The public may examine and have copied, for a...

  6. 75 FR 18509 - International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-12

    ... Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on... Texts for Use in the ICH Regions; Annex 10: Polyacrylamide Gel Electrophoresis General Chapter.'' The... ICH Q4B evaluation of the Polyacrylamide Gel Electrophoresis General Chapter harmonized text from...

  7. 78 FR 31944 - International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-28

    ... Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on... Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 13: Bulk Density and... Tapped Density of Powders General Chapter harmonized text from each of the three pharmacopoeias...

  8. 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

    ... enrichment. The guidance also discusses general clinical trial design considerations, provides examples of potential clinical trial designs, and discusses regulatory considerations when using enrichment strategies... Clinical Trials To Support Approval of Human Drugs and Biological Products; Extension of Comment...

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

    PubMed

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

    2017-02-01

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

  10. 76 FR 82303 - Draft Guidance for Industry on Responding to Unsolicited Requests for Off-Label Information About...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-30

    ... to stakeholder requests for specific guidance on FDA's current views on how manufacturers and... Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD... Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD...

  11. 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...

  12. 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

    ...--Clinical Evaluation of Products for Treatment; Availability AGENCY: Food and Drug Administration, HHS... guidance for industry entitled ``Irritable Bowel Syndrome--Clinical Evaluation of Products for Treatment... who are conducting new product development for the treatment of IBS. DATES: Although you can...

  13. 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

    ... Biological Products: Technical Information to Supplement International Organization for Standardization (ISO... glass syringes that comply with the ISO 11040-4 standard when connected to devices (``connecting devices'') that comply with the ISO 594-2 standard. ] DATES: Although you can comment on any guidance at any...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-22

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

  15. 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

    ... blood components intended for transfusion, including recommendations for validation and quality control... for transfusion, including recommendations for validation and quality control monitoring of the... have been approved under OMB control number 0910-0052; the collections of information in 21 CFR...

  16. 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.

  17. 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:

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

    PubMed

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

    2008-07-01

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-20

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

  20. 77 FR 22327 - Draft Guidance for Industry on New Animal Drugs and New Animal Drug Combination Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-13

    ... Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing... Drinking Water of Food- Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning... and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water...

  1. 76 FR 72950 - Draft Guidance for Industry: Use of Nucleic Acid Tests on Pooled and Individual Samples From...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-28

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

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

    PubMed

    Bradley, Clare

    2006-10-09

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

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

    PubMed

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

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

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

    PubMed

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

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

  5. 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

    ... antibodies to Trypanosoma cruzi. These tests are intended for use as donor screening tests to reduce the risk of transmission of T. cruzi infection by detecting antibodies to T. cruzi in plasma and serum samples... recommendations for HCT/P donor screening and testing for T. cruzi antibodies contained in the draft guidance...

  6. Federal Guidance for Radiation Protection

    EPA Pesticide Factsheets

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

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

    PubMed

    Hirose, Akihiko

    2013-01-01

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

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

    PubMed

    2010-04-05

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

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

    PubMed

    2013-10-23

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

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

    PubMed

    2014-06-16

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

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

    PubMed

    2013-05-28

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

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

    EPA Pesticide Factsheets

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

  13. 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.

  14. Final OSWER Vapor Intrusion Guidance

    EPA Science Inventory

    EPA is preparing to finalize its guidance on assessing and addressing vapor intrusion, which is defined as migration of volatile constituents from contaminated media in the subsurface (soil or groundwater) into the indoor environment. In November 2002, EPA issued draft guidance o...

  15. 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...

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

    PubMed

    2009-04-08

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

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

    PubMed

    2012-02-23

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

  18. 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.

  19. 78 FR 49782 - Interim Staff Guidance on Changes During Construction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-15

    ... COMMISSION Interim Staff Guidance on Changes During Construction AGENCY: Nuclear Regulatory Commission. ACTION: Draft interim staff guidance; request for comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is issuing this notice for use of, and to solicit public comment on the draft Interim...

  20. 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…

  1. 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…

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-21

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

  3. 77 FR 23275 - Notice of Availability of the Draft enXco Desert Harvest Solar Farm Project Environmental Impact...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-18

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

  4. 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...

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

    PubMed

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

    2017-02-08

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

  6. Aetiological diagnosis of child deafness: CODEPEH recommendations.

    PubMed

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

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

  7. 77 FR 14047 - Guidance for Decommissioning Planning During Operations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-08

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

  8. 77 FR 60126 - Guidance for Industry on Acute Bacterial Otitis Media: Developing Drugs for Treatment; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-02

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

  9. 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...; The Content of Investigational Device Exemption and Premarket Approval Applications for...

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

    EPA Pesticide Factsheets

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

  11. 21 CFR 10.115 - Good guidance practices.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... the regulatory activity covered by the guidance document. (7) If FDA agrees to draft or revise a... input from individuals or groups outside the agency. For example, FDA can do this by participating in or... “guidance,” (ii) Identify the center(s) or office(s) issuing the document, (iii) Identify the activity...

  12. 21 CFR 10.115 - Good guidance practices.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... the regulatory activity covered by the guidance document. (7) If FDA agrees to draft or revise a... input from individuals or groups outside the agency. For example, FDA can do this by participating in or... “guidance,” (ii) Identify the center(s) or office(s) issuing the document, (iii) Identify the activity...

  13. 21 CFR 10.115 - Good guidance practices.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... the regulatory activity covered by the guidance document. (7) If FDA agrees to draft or revise a... input from individuals or groups outside the agency. For example, FDA can do this by participating in or... “guidance,” (ii) Identify the center(s) or office(s) issuing the document, (iii) Identify the activity...

  14. 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.

  15. 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.

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

    PubMed

    2009-04-08

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

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

    PubMed

    2009-04-08

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

  18. 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

    ... Criteria for Ammonia--Freshwater AGENCY: Environmental Protection Agency (EPA). ACTION: Notice; extension... availability of draft national recommended water quality criteria for ammonia for the ] protection of aquatic life entitled ``Draft 2009 Update Aquatic Life Ambient Water Quality Criteria for...

  19. Image Guidance

    EPA Pesticide Factsheets

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

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

    EPA Pesticide Factsheets

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

  1. 78 FR 12329 - Distinguishing Medical Device Recalls From Product Enhancements; Reporting Requirements; Draft...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-22

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

  2. 78 FR 66940 - Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products; Draft...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-07

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

  3. 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 Cybersecurity in Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  4. Modelling polymer draft gears

    NASA Astrophysics Data System (ADS)

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

    2016-09-01

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

  5. 75 FR 53724 - Notice of Availability and Opportunity for Comment on Draft Division of Safety Systems Interim...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-01

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

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

    EPA Pesticide Factsheets

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

  7. 76 FR 8314 - Implementation Guidance for Distribution of Source Material to Exempt Persons and to General...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-14

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

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

    EPA Pesticide Factsheets

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

  9. 76 FR 41157 - Guidance for Industry: Questions and Answers Regarding the Final Rule, Prevention of Salmonella...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-13

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

  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. 76 FR 79176 - Notice of Availability of Draft Recreational Water Quality Criteria and Request for Scientific Views

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-21

    ... AGENCY Notice of Availability of Draft Recreational Water Quality Criteria and Request for Scientific... availability of the draft document Recreational Water Quality Criteria (RWQC). The document contains the EPA's draft ambient water quality criteria recommendations for protecting human health in ambient waters...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-15

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

  13. Draft air deflecting device

    SciTech Connect

    Riley, J.E.

    1982-05-18

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

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

    PubMed

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

    2012-01-01

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

  15. Consensus standard requirements and guidance

    SciTech Connect

    Putman, V.L.

    1995-12-01

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

  16. 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.…

  17. Surface Water Treatment Rules State Implementation Guidance

    EPA Pesticide Factsheets

    These documents provide guidance to states, tribes and U.S. EPA Regions exercising primary enforcement responsibility under the Safe Drinking Water Act. The documents contain EPA’s recommendations for implementation of the Surface Water Treatment Rules.

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

    EPA Pesticide Factsheets

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

  19. 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...

  20. 76 FR 81957 - Mobile Offshore Drilling Unit Guidance Policy

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-29

    ..., technicians, and inspectors should view these integrated systems holistically, but the myriad requirements...) Critical Systems, Personnel and Training.'' We request your comments on this draft guidance. DATES....). You may review a Privacy Act, system of records notice regarding our public dockets in the January...

  1. 77 FR 21783 - Guidance on Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-11

    ... the Agency's current good manufacturing practice regulations for PET drugs. DATES: Submit either... good manufacturing practices for PET drugs (21 CFR part 212) regarding media fills. A draft guidance of... HUMAN SERVICES Food and Drug Administration Guidance on Media Fills for Validation of...

  2. 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)

  3. 75 FR 76482 - Notice of Web Availability and Opportunity for Public Comment on Updated Guidance for the Section...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-08

    ... the Section 202 Supportive Housing for the Elderly and Section 811 Supportive Housing for Persons With... of a draft notice updating HUD's guidance for the Section 202 Supportive Housing for the Elderly...

  4. 78 FR 39253 - Notice of Extension of Comment Period for Draft Initial Comprehensive Plan and Draft...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-01

    ...] Notice of Extension of Comment Period for Draft Initial Comprehensive Plan and Draft Environmental... Public Comment Period. SUMMARY: Pursuant to the Resources and Ecosystems Sustainability, Tourist... region and the Draft Programmatic Environmental Assessment (Draft PEA) for the Draft Plan....

  5. 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.

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

    PubMed

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

    2013-01-08

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

  7. 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

  8. 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

  9. Brazilian recommendations of mechanical ventilation 2013. Part I.

    PubMed

    Barbas, Carmen Sílvia Valente; Isola, Alexandre Marini; Farias, Augusto Manoel de Carvalho; Cavalcanti, Alexandre Biasi; Gama, Ana Maria Casati; Duarte, Antonio Carlos Magalhães; Vianna, Arthur; Serpa Neto, Ary; Bravim, Bruno de Arruda; Pinheiro, Bruno do Valle; Mazza, Bruno Franco; Carvalho, Carlos Roberto Ribeiro de; Toufen Júnior, Carlos; David, Cid Marcos Nascimento; Taniguchi, Corine; Mazza, Débora Dutra da Silveira; Dragosavac, Desanka; Toledo, Diogo Oliveira; Costa, Eduardo Leite; Caser, Eliana Bernardete; Silva, Eliezer; Amorim, Fabio Ferreira; Saddy, Felipe; Galas, Filomena Regina Barbosa Gomes; Silva, Gisele Sampaio; Matos, Gustavo Faissol Janot de; Emmerich, João Claudio; Valiatti, Jorge Luis Dos Santos; Teles, José Mario Meira; Victorino, Josué Almeida; Ferreira, Juliana Carvalho; Prodomo, Luciana Passuello do Vale; Hajjar, Ludhmila Abrahão; Martins, Luiz Cláudio; Malbouisson, Luiz Marcelo Sá; Vargas, Mara Ambrosina de Oliveira; Reis, Marco Antonio Soares; Amato, Marcelo Brito Passos; Holanda, Marcelo Alcântara; Park, Marcelo; Jacomelli, Marcia; Tavares, Marcos; Damasceno, Marta Cristina Paulette; Assunção, Murillo Santucci César; Damasceno, Moyzes Pinto Coelho Duarte; Youssef, Nazah Cherif Mohamad; Teixeira, Paulo José Zimmermann; Caruso, Pedro; Duarte, Péricles Almeida Delfino; Messeder, Octavio; Eid, Raquel Caserta; Rodrigues, Ricardo Goulart; Jesus, Rodrigo Francisco de; Kairalla, Ronaldo Adib; Justino, Sandra; Nemer, Sérgio Nogueira; Romero, Simone Barbosa; Amado, Verônica Moreira

    2014-01-01

    Perspectives on invasive and noninvasive ventilatory support for critically ill patients are evolving, as much evidence indicates that ventilation may have positive effects on patient survival and the quality of the care provided in intensive care units in Brazil. For those reasons, the Brazilian Association of Intensive Care Medicine (Associação de Medicina Intensiva Brasileira - AMIB) and the Brazilian Thoracic Society (Sociedade Brasileira de Pneumonia e Tisiologia - SBPT), represented by the Mechanical Ventilation Committee and the Commission of Intensive Therapy, respectively, decided to review the literature and draft recommendations for mechanical ventilation with the goal of creating a document for bedside guidance as to the best practices on mechanical ventilation available to their members. The document was based on the available evidence regarding 29 subtopics selected as the most relevant for the subject of interest. The project was developed in several stages, during which the selected topics were distributed among experts recommended by both societies with recent publications on the subject of interest and/or significant teaching and research activity in the field of mechanical ventilation in Brazil. The experts were divided into pairs that were charged with performing a thorough review of the international literature on each topic. All the experts met at the Forum on Mechanical Ventilation, which was held at the headquarters of AMIB in São Paulo on August 3 and 4, 2013, to collaboratively draft the final text corresponding to each sub-topic, which was presented to, appraised, discussed and approved in a plenary session that included all 58 participants and aimed to create the final document.

  10. Brazilian recommendations of mechanical ventilation 2013. Part I.

    PubMed

    2014-01-01

    Perspectives on invasive and noninvasive ventilatory support for critically ill patients are evolving, as much evidence indicates that ventilation may have positive effects on patient survival and the quality of the care provided in intensive care units in Brazil. For those reasons, the Brazilian Association of Intensive Care Medicine (Associação de Medicina Intensiva Brasileira - AMIB) and the Brazilian Thoracic Society (Sociedade Brasileira de Pneumologia e Tisiologia - SBPT), represented by the Mechanical Ventilation Committee and the Commission of Intensive Therapy, respectively, decided to review the literature and draft recommendations for mechanical ventilation with the goal of creating a document for bedside guidance as to the best practices on mechanical ventilation available to their members. The document was based on the available evidence regarding 29 subtopics selected as the most relevant for the subject of interest. The project was developed in several stages, during which the selected topics were distributed among experts recommended by both societies with recent publications on the subject of interest and/or significant teaching and research activity in the field of mechanical ventilation in Brazil. The experts were divided into pairs that were charged with performing a thorough review of the international literature on each topic. All the experts met at the Forum on Mechanical Ventilation, which was held at the headquarters of AMIB in São Paulo on August 3 and 4, 2013, to collaboratively draft the final text corresponding to each sub-topic, which was presented to, appraised, discussed and approved in a plenary session that included all 58 participants and aimed to create the final document.

  11. Brazilian recommendations of mechanical ventilation 2013. Part 2.

    PubMed

    Barbas, Carmen Sílvia Valente; Ísola, Alexandre Marini; Farias, Augusto Manoel de Carvalho; Cavalcanti, Alexandre Biasi; Gama, Ana Maria Casati; Duarte, Antonio Carlos Magalhães; Vianna, Arthur; Serpa Neto, Ary; Bravim, Bruno de Arruda; Pinheiro, Bruno do Valle; Mazza, Bruno Franco; de Carvalho, Carlos Roberto Ribeiro; Toufen Júnior, Carlos; David, Cid Marcos Nascimento; Taniguchi, Corine; Mazza, Débora Dutra da Silveira; Dragosavac, Desanka; Toledo, Diogo Oliveira; Costa, Eduardo Leite; Caser, Eliana Bernadete; Silva, Eliezer; Amorim, Fabio Ferreira; Saddy, Felipe; Galas, Filomena Regina Barbosa Gomes; Silva, Gisele Sampaio; de Matos, Gustavo Faissol Janot; Emmerich, João Claudio; Valiatti, Jorge Luis dos Santos; Teles, José Mario Meira; Victorino, Josué Almeida; Ferreira, Juliana Carvalho; Prodomo, Luciana Passuello do Vale; Hajjar, Ludhmila Abrahão; Martins, Luiz Claudio; Malbouisson, Luis Marcelo Sá; Vargas, Mara Ambrosina de Oliveira; Reis, Marco Antonio Soares; Amato, Marcelo Brito Passos; Holanda, Marcelo Alcântara; Park, Marcelo; Jacomelli, Marcia; Tavares, Marcos; Damasceno, Marta Cristina Paulette; Assunção, Murillo Santucci César; Damasceno, Moyzes Pinto Coelho Duarte; Youssef, Nazah Cherif Mohamed; Teixeira, Paulo José Zimmermann; Caruso, Pedro; Duarte, Péricles Almeida Delfino; Messeder, Octavio; Eid, Raquel Caserta; Rodrigues, Ricardo Goulart; de Jesus, Rodrigo Francisco; Kairalla, Ronaldo Adib; Justino, Sandra; Nemer, Sergio Nogueira; Romero, Simone Barbosa; Amado, Verônica Moreira

    2014-01-01

    Perspectives on invasive and noninvasive ventilatory support for critically ill patients are evolving, as much evidence indicates that ventilation may have positive effects on patient survival and the quality of the care provided in intensive care units in Brazil. For those reasons, the Brazilian Association of Intensive Care Medicine (Associação de Medicina Intensiva Brasileira - AMIB) and the Brazilian Thoracic Society (Sociedade Brasileira de Pneumologia e Tisiologia - SBPT), represented by the Mechanical Ventilation Committee and the Commission of Intensive Therapy, respectively, decided to review the literature and draft recommendations for mechanical ventilation with the goal of creating a document for bedside guidance as to the best practices on mechanical ventilation available to their members. The document was based on the available evidence regarding 29 subtopics selected as the most relevant for the subject of interest. The project was developed in several stages, during which the selected topics were distributed among experts recommended by both societies with recent publications on the subject of interest and/or significant teaching and research activity in the field of mechanical ventilation in Brazil. The experts were divided into pairs that were charged with performing a thorough review of the international literature on each topic. All the experts met at the Forum on Mechanical Ventilation, which was held at the headquarters of AMIB in São Paulo on August 3 and 4, 2013, to collaboratively draft the final text corresponding to each sub-topic, which was presented to, appraised, discussed and approved in a plenary session that included all 58 participants and aimed to create the final document.

  12. Brazilian recommendations of mechanical ventilation 2013. Part I

    PubMed Central

    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 2

    PubMed Central

    2014-01-01

    Perspectives on invasive and noninvasive ventilatory support for critically ill patients are evolving, as much evidence indicates that ventilation may have positive effects on patient survival and the quality of the care provided in intensive care units in Brazil. For those reasons, the Brazilian Association of Intensive Care Medicine (Associação de Medicina Intensiva Brasileira - AMIB) and the Brazilian Thoracic Society (Sociedade Brasileira de Pneumologia e Tisiologia - SBPT), represented by the Mechanical Ventilation Committee and the Commission of Intensive Therapy, respectively, decided to review the literature and draft recommendations for mechanical ventilation with the goal of creating a document for bedside guidance as to the best practices on mechanical ventilation available to their members. The document was based on the available evidence regarding 29 subtopics selected as the most relevant for the subject of interest. The project was developed in several stages, during which the selected topics were distributed among experts recommended by both societies with recent publications on the subject of interest and/or significant teaching and research activity in the field of mechanical ventilation in Brazil. The experts were divided into pairs that were charged with performing a thorough review of the international literature on each topic. All the experts met at the Forum on Mechanical Ventilation, which was held at the headquarters of AMIB in São Paulo on August 3 and 4, 2013, to collaboratively draft the final text corresponding to each sub-topic, which was presented to, appraised, discussed and approved in a plenary session that included all 58 participants and aimed to create the final document. PMID:25410835

  14. 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

  15. Cluster: Drafting. Course: Architectural Drafting. Research Project.

    ERIC Educational Resources Information Center

    Sanford - Lee County Schools, NC.

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

  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. 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...

  18. 17 CFR Appendix A to Subpart H to... - Guidance on the Application of §§ 23.434 and 23.440 for Swap Dealers That Make Recommendations to...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... recommends a swap or trading strategy involving a swap to a counterparty, other than a swap dealer, major... trading strategy involving a swap—general suitability (§ 23.434(a)(1))—and have a reasonable basis to believe that the recommended swap or trading strategy involving a swap is suitable for the...

  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. 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...

  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.

  2. Provision of Guidance, Information and Basic Criteria for Radiation Protection and Measurements.

    DTIC Science & Technology

    1984-02-27

    expected that the draft report will go to critical reviewers in 1984. Task Group 13 on Neptunium is examing the validity of the parameters and dosimetric...models used for neptumium- 237 and developing recommendations on metabolic parameters. The work is in the middle draft stage at this time. 7. Scientific

  3. 76 FR 50231 - Mobile Medical Applications Draft Guidance; Public Workshop

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-12

    ... would be similar to an infusion pump stand, which is currently classified as a class I device because it supports the intended use of an infusion pump (class II medical device). A mobile medical app that...

  4. 76 FR 27924 - Draft Regulatory Guide, Guidance for ITAAC Closure

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-13

    ..., Regulatory Guide Development Branch, Division of Engineering, Office of Nuclear Regulatory Research. BILLING.... Although a time limit is given, comments and suggestions in connection with items for inclusion in...

  5. FDA Issues Draft Guidance on Questions and Answers ...

    Center for Food Safety and Applied Nutrition (CFSAN)

    ... ¢â‚¬â„¢s final rule ÃÆ'¢â†šÂ¬Ã…“Prevention of Salmonella Enteritidis in Shell Eggs ...

  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, 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...

  7. 17 CFR Appendix A to Subpart H - Guidance on the Application of §§ 23.434 and 23.440 for Swap Dealers That Make Recommendations to...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... or trading strategy involving a swap to a counterparty, other than a swap dealer, major swap... strategy involving a swap—general suitability (§ 23.434(a)(1))—and have a reasonable basis to believe that the recommended swap or trading strategy involving a swap is suitable for the...

  8. 77 FR 65728 - Final Interim Staff Guidance Augmenting NUREG-1537, “Guidelines for Preparing and Reviewing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-30

    ... COMMISSION Final Interim Staff Guidance Augmenting NUREG-1537, ``Guidelines for Preparing and Reviewing... Staff Guidance (ISG), that augments NUREG- 1537, Part 1, ``Guidelines for Preparing and Reviewing... NRC published for public comment Chapters 1-6 of the draft ISG, that augments NUREG-1537, Part...

  9. 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...

  10. 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.

  11. 75 FR 47604 - Guidance for Industry on Drug Substance Chemistry, Manufacturing, and Controls Information...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-06

    ... Substance Chemistry, Manufacturing, and Controls Information; Availability AGENCY: Food and Drug... availability of a guidance for industry 169 entitled ``Drug Substance Chemistry, Manufacturing, and Controls Information.'' This guidance provides recommendations on the chemistry, manufacturing, and controls...

  12. 78 FR 32237 - Draft Initial Comprehensive Plan and Draft Programmatic Environmental Assessment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-29

    ... Office of the Secretary Draft Initial Comprehensive Plan and Draft Programmatic Environmental Assessment... comments. SUMMARY: In accordance with the Resources and Ecosystems Sustainability, Tourist Opportunities... Environmental Assessment (Draft PEA) for the Draft Plan. These documents are available for public review...

  13. Progress report on the guidance for industry for statistical aspects of the design, analysis, and interpretation of chronic rodent carcinogenicity studies of pharmaceuticals.

    PubMed

    Lin, K K

    2000-11-01

    The U.S. Food and Drug Administration (FDA) is in the process of preparing a draft Guidance for Industry document on the statistical aspects of carcinogenicity studies of pharmaceuticals for public comment. The purpose of the document is to provide statistical guidance for the design of carcinogenicity experiments, methods of statistical analysis of study data, interpretation of study results, presentation of data and results in reports, and submission of electronic study data. This article covers the genesis of the guidance document and some statistical methods in study design, data analysis, and interpretation of results included in the draft FDA guidance document.

  14. 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.

  15. 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…

  16. 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.

  17. 76 FR 12117 - Call for Comments on the Draft Report of the Adult Immunization Working Group to the National...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-04

    ... HUMAN SERVICES Call for Comments on the Draft Report of the Adult Immunization Working Group to the... Immunization Working Group (AIWG) of NVAC has developed a draft report and recommendations for the... Adult Immunization Working Group, Telephone (202) 260-2325; Fax: (202) 690-4631; E-mail:...

  18. Announcement: Guidance for U.S. Laboratory Testing for Zika Virus Infection: Implications for Health Care Providers.

    PubMed

    2016-11-25

    CDC has released updated guidance online for U.S. laboratory testing for Zika virus infection. The guidance is available at https://www.cdc.gov/zika/laboratories/lab-guidance.html. Frequently asked questions are addressed at https://www.cdc.gov/zika/laboratories/lab-guidance-faq.html. This guidance updates recommendations for testing of specimens by U.S. laboratories for possible Zika virus infection. Major updates to the guidance with clinical implications for health care providers include the following.

  19. 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...

  20. 78 FR 54655 - Center for Devices and Radiological Health: Draft Standard Operating Procedure for Level 1...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-05

    ... HUMAN SERVICES Food and Drug Administration Center for Devices and Radiological Health: Draft Standard Operating Procedure for Level 1, Immediately in Effect Guidance Documents on Premarket Data Issues; Availability and Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request...

  1. 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...

  2. 77 FR 56851 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-14

    ... Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD... Dalteparin sodium E Estramustine phosphate sodium F Fentanyl citrate K Ketoconazole L Linagliptin M... persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or...

  3. 77 FR 3777 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-25

    ...; Butalbital; Caffeine (multiple RLDs) Acetaminophen; Hydrocodone Bitartrate (multiple RLDs) Acetaminophen... Aspirin; Butalbital; Caffeine (multiple RLDs) Aspirin; Dipyridamole Aspirin; Oxycodone Aspirin; Butalbital; Caffeine; Codeine Phosphate Atovaquone Auranofin Azelaic Acid (multiple RLDs) B Baclofen (multiple...

  4. 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

  5. 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…

  6. 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…

  7. 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).

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-17

    ... Guidance: EPRI Guidance for the Resolution of Fukushima Near-Term Task Force Recommendation 2.1: Seismic... 2.1, 2.3, and 9.3, of the Near-Term Task Force Review of Insights from the Fukushima Dai-ichi... Recommendations 2.1, 2.3, and 9.3, of the Near-Term Task Force (NTTF) Review of Insights from the Fukushima...

  9. Updated Draft Protocol for the Evaluation of Bactericidal Activity of Hard, Non-porous Copper Containing Surface Products

    EPA Pesticide Factsheets

    This document describes the updated draft testing protocol recommended by the EPA to support the registration of copper-containing surface products (such as door knobs, or other items that are not intended for food contact) that bear sanitizer claims.

  10. 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.

  11. 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…

  12. 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.

  13. 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.

  14. STATUS OF NCRP SCIENTIFIC COMMITTEE 1-23 COMMENTARY ON GUIDANCE ON RADIATION DOSE LIMITS FOR THE LENS OF THE EYE

    PubMed Central

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

    2015-01-01

    Previous National Council on Radiation Protection and Measurements (NCRP) publications have addressed the issues of risk and dose limitation in radiation protection and included guidance on specific organs and the lens of the eye (NCRP 1987, 1989, 1993a, 1993b, 1995a, 1995b, 2000b, 2001b, 2010a, 2010b, 2013). NCRP decided to prepare an updated commentary intended to enhance the previous recommendations provided in these earlier reports. NCRP Scientific Committee 1-23 (SC 1-23) (NCRP 2015) is charged with preparing a commentary that will evaluate recent studies on the radiation dose response for the development of cataracts, and also consider the type and severity of the cataracts as well as the dose rate; provide guidance on whether existing dose limits to the lens of the eye should be changed in the United States; and suggest research needs regarding radiation effects on and dose limits to the lens of the eye. A status of the ongoing work of SC 1-23 was presented at the NCRP 2015 Annual Meeting, “Changing Regulations and Radiation Guidance: What Dose the Future Hold?” The following represents a synopsis of a few main points in the current draft commentary. It is likely that several changes will be forthcoming as SC 1-23 responds to subject matter expert review and develops a final document, expected later in 2015. PMID:26717175

  15. Computer Aided Drafting. Instructor's Guide.

    ERIC Educational Resources Information Center

    Henry, Michael A.

    This guide is intended for use in introducing students to the operation and applications of computer-aided drafting (CAD) systems. The following topics are covered in the individual lessons: understanding CAD (CAD versus traditional manual drafting and care of software and hardware); using the components of a CAD system (primary and other input…

  16. National Environmenal Policy Act Contracting Reform Guidance: Phase 1

    SciTech Connect

    1995-08-01

    The NEPA Contracting Quality Improvement Team identified several contracting improvements to reduce the cost and time for the NEPA process. The team`s February 1995 report recommended a series of steps to achieve the improvements, including issuance of contracting guidance. The guidance will be issued in three phases. This Phase I guidance implements the team`s short-term recommendations. It provides model statements of work and a sample schedule of contractor deliverables, establishes a pilot program for evaluating performance of NEPA support contractors, and describes information resources available on the DOE NEPA Web.

  17. 75 FR 40756 - Implementation Guidance for Physical Protection of Byproduct Material; Category 1 and Category 2...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-14

    ...; Federal Register #0; #0; #0;This section of the FEDERAL REGISTER contains notices to the public of #0;the... Regulatory Commission. ACTION: Notice of availability of draft guidance for public comment. SUMMARY: The U. S... requirements for the use and transport of category 1 and category 2 quantities of radioactive material. The...

  18. 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.

  19. 76 FR 26177 - National Organic Program: Notice of Final Guidance for Accredited Certifying Agents and Certified...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-06

    ... Organic Production and Handling (NOP 5025)''; and ``The Use of Chlorine Materials in Organic Production... the use of chlorine materials. The five draft guidances can be viewed on-line at http://www.ams.usda... ``NOP 5026--The Use of Chlorine Materials in Organic Production and Handling''. Based upon the...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-26

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Anesthetics for Companion Animals... Administration (FDA) is announcing the availability of Guidance for Industry 192 entitled ``Anesthetics for Companion Animals.'' This guidance makes recommendations for the development of anesthetic new animal...

  2. 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

  3. 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.

  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. 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.

  6. 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.

  7. Shuttle entry guidance revisited

    NASA Astrophysics Data System (ADS)

    Mease, Kenneth D.; Kremer, Jean-Paul

    1992-08-01

    The Shuttle entry guidance concept is reviewed which is aimed at tracking a reference drag trajectory that leads to the specified range and velocity for the initiation of the terminal energy management phase. An approximate method of constructing the domain of attraction is proposed, and its validity is ascertained by simulation. An alternative guidance law yielding global exponential tracking in the absence of control saturation is derived using a feedback linearization method. It is noted that the alternative guidance law does not improve on the stability and performance of the current guidance law, for the operating domain and control capability of the Shuttle. It is suggested that the new guidance law with a larger operating domain and increased lift-to-drag capability would be superior.

  8. 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.

  9. Offsite dose calculation manual guidance: Standard radiological effluent controls for boiling 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 Effluent Technical Specifications (RETS) to be removed from the main body of the Technical Specifications and placed in the Offsite Dose Calculation Manual (ODCM). Guidance is provided for Standard Effluent Controls definitions, Controls for effluent monitoring instrumentation, Controls for effluent releases, Controls for radiological environmental monitoring, and the basis for Controls. Guidance on the formulation of RETS has been available in draft form for a number of years; the current effort simply recasts those RETS into Standard Radiological Effluent Controls for application to the ODCM. 11 tabs.

  10. 76 FR 50490 - Draft Comprehensive Conservation Plan and Draft Environmental Impact Statement, Arctic National...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-15

    ... Fish and Wildlife Service Draft Comprehensive Conservation Plan and Draft Environmental Impact... conservation plan (CCP) and draft environmental impact statement (DEIS) for the Arctic National Wildlife Refuge... Refuge System, consistent with sound principles of fish and wildlife management, conservation,...

  11. 46 CFR 78.50-10 - Draft marks and draft indicating systems.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... draft marks plainly and legibly visible upon the stem and upon the sternpost or rudderpost or any place... of the draft marks, due to raked stem or cut—away skeg, the datum line from which the draft shal...

  12. 46 CFR 78.50-10 - Draft marks and draft indicating systems.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... draft marks plainly and legibly visible upon the stem and upon the sternpost or rudderpost or any place... of the draft marks, due to raked stem or cut—away skeg, the datum line from which the draft shal...

  13. 46 CFR 78.50-10 - Draft marks and draft indicating systems.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... draft marks plainly and legibly visible upon the stem and upon the sternpost or rudderpost or any place... of the draft marks, due to raked stem or cut—away skeg, the datum line from which the draft shal...

  14. 46 CFR 167.55-1 - Draft marks and draft indicating systems.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ...) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or... aft to the location of the draft marks, due to a raked stem or cut away skeg, the draft must...

  15. The handling of causality in SEA guidance

    SciTech Connect

    Perdicoulis, A. . E-mail: tasso@utad.pt; Hanusch, M. . E-mail: marie.hanusch@ufz.de; Kasperidus, H.D. . E-mail: hans.kasperidus@ufz.de; Weiland, U. . E-mail: ulrike.weiland@ufz.de

    2007-03-15

    Causality, or the relation of cause and effect, is a fundamental notion in science, planning, and management. It is also a fundamental notion in impact assessment, as it relates action proposals with environmental impacts. Building on recent research about causality in impact assessment, this article turns to Strategic Environmental Assessment (SEA) and examines eleven guidance documents to see whether and how they handle causality. The findings of this research, in line with results from similar research in EIA, indicate a weak handling of causality with regards to instruction, obligation, and theoretical support. The recommendations are to investigate the reasons for the observed trend, as there is no evidence in the guidance documents themselves, and to have the fundamental premise of causality in impact assessment safeguarded in future SEA guidance.

  16. ACE3 Draft Indicators: Health

    EPA Pesticide Factsheets

    The page information was provided by EPA in conjunction with the opportunity for public comment on the draft indicators for ACE3, which ran from March 8 – April 21, 2011. The public comment period is now closed.

  17. ACE3 Draft Indicators: Biomonitoring

    EPA Pesticide Factsheets

    The page information was provided by EPA in conjunction with the opportunity for public comment on the draft indicators for ACE3, which ran from March 8 – April 21, 2011. The public comment period is now closed.

  18. Automatic draft reading based on image processing

    NASA Astrophysics Data System (ADS)

    Tsujii, Takahiro; Yoshida, Hiromi; Iiguni, Youji

    2016-10-01

    In marine transportation, a draft survey is a means to determine the quantity of bulk cargo. Automatic draft reading based on computer image processing has been proposed. However, the conventional draft mark segmentation may fail when the video sequence has many other regions than draft marks and a hull, and the estimated waterline is inherently higher than the true one. To solve these problems, we propose an automatic draft reading method that uses morphological operations to detect draft marks and estimate the waterline for every frame with Canny edge detection and a robust estimation. Moreover, we emulate surveyors' draft reading process for getting the understanding of a shipper and a receiver. In an experiment in a towing tank, the draft reading error of the proposed method was <1 cm, showing the advantage of the proposed method. It is also shown that accurate draft reading has been achieved in a real-world scene.

  19. Pollinator Risk Assessment Guidance

    EPA Pesticide Factsheets

    This Guidance is part of a long-term strategy to advance the science of assessing the risks posed by pesticides to honey bees, giving risk managers the means to further improve pollinator protection in our regulatory decisions.

  20. EPA Policy and Guidance

    EPA Pesticide Factsheets

    The policy establishes the principles for accessible Electronic and Information Technology (EIT) and complying with Section 508 requirements. The guidance defines EIT and the technical and functional performance criteria necessary for compliance.

  1. 77 FR 33489 - Draft Offender Tracking System Standard

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-06

    ... of Justice Programs Draft Offender Tracking System Standard AGENCY: National Institute of Justice. ACTION: Notice of Draft Offender Tracking System Standard, Selection and Application Guide, and... general public three draft documents: (1) A draft standard entitled, ``Offender Tracking System...

  2. 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.

  3. Socioeconomic Representativeness and the Draft

    DTIC Science & Technology

    1980-06-01

    l that the quality of recruits who enter the services ( especiall the Army) is of lover caliber than historically experienced. Proponents of...the "quality" of recruits who enter the services ( especially the Army) is of lower caliber than historically experienced. Proponents of conscription...draft, especially when considering peacetime conscrip- tion. The strength of the argument for the draft was held to be that all eligible men would serve

  4. 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

    ... Draft Weapons Safety Assessment on the Use of Enhanced Weapons; Notice of Availability and Request for... ``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 rule titled ``Enhanced...

  5. VMT forecasting and tracking guidance, Section 187

    SciTech Connect

    Not Available

    1992-01-01

    The guidance is required by Section 187 (a) of the Clean Air Act Amendments of 1990. It offers the Environmental Protection Agency's (EPA's) recommendations on how to forecast and track vehicle miles traveled (VMT) in Moderate and Serious carbon monoxide (CO) non-attainment areas with design values greater than 12.7 ppm at the time of classification. The purpose of the guidance is to help states prepare State Implementation Plan (SIP) revisions that EPA can readily propose to approve as meeting the requirements of the Clean Air Act Amendments. If a state adheres to the guidance, EPA will propose approval of its SIP. A state intending to depart from the guidance, however, should show that the alternative approach it proposes is technically sound and adequate to meet the requirements of the Clean Air Act Amendments. EPA will review SIP submittals from such states on a case-by-case basis to determine whether they do in fact comply with the Clean Air Act Amendment requirements. States are encouraged to obtain EPA approval before using methods other than those specified in the guidance, in order to avoid later problems.

  6. 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.

  7. 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.

  8. A Guidance Document for Kentucky's Oil and Gas Operators

    SciTech Connect

    Kentucky Division of Oil and Gas

    1999-10-28

    This report is a summary of the accomplishments toward completion of ''A Guidance Document for Kentucky's Oil and Gas Operators.'' During this quarter, the document received continued review and editing in an electronic format to satisfy the United States Department of Energy (DOE). Comments received from oil and gas operators reviewing this document prompted contact to be made with the United States Environmental Protection Agency (USEPA) to develop an addendum section to provide better explanation of USEPA requirements for Class II injection wells in Kentucky. During February of this year the consultant hired to develop the Class II, UIC addendum section to the Guidance Document met with the USEPA and state personnel responsible for regulation of the Class II, UIC program in Kentucky. At this meeting a review of the federal and state regulatory procedures used for administration of the UIC program was made. Emphasis was directed to summarizing the addendum section in a format usable b y the small oil and gas operators in Kentucky. A draft of the addendum section is underway incorporating the ideas and comments received during this meeting. During the next quarter, a meeting of the subcommittee and Region IV of the USEPA will be scheduled. A review of a draft of the addendum section of the document will be made and necessary revisions incorporated toward final completion of the Guidance Document.

  9. 77 FR 25226 - Proposed Recommendations on Obstructive Sleep Apnea

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-27

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration Proposed Recommendations on Obstructive Sleep Apnea AGENCY... withdrawing its proposed regulatory guidance for obstructive sleep apnea (OSA) and request for comment...

  10. 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.

  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. 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…

  13. 77 FR 47800 - Adoption of Recommendations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-10

    ... authority among agencies. The recommendation proposes some reforms aimed at improving coordination of agency... Policies on Families (Pub. L. 105-277, sec. 654), an agency might add an entry to the chart stating...-legislative rules (such as interpretive rules, policy statements, and guidance documents) as compared to...

  14. 46 CFR 196.40-10 - Draft marks and draft indicating systems.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 46 Shipping 7 2010-10-01 2010-10-01 false Draft marks and draft indicating systems. 196.40-10 Section 196.40-10 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) OCEANOGRAPHIC RESEARCH VESSELS OPERATIONS Markings on Vessels § 196.40-10 Draft marks and draft indicating systems. (a)...

  15. Anticipatory guidance through DVD.

    PubMed

    Franz, Sandra; McMahon, Pamela M; Calongne, Laurinda; Steele-Moses, Susan K

    2014-03-01

    The major purpose of the study was to determine if a 5-minute DVD is an effective method for communicating anticipatory guidance to parents at their child's 4-month well-child visit. A total of 84 caregivers were randomly assigned to receive anticipatory guidance through standard care (written anticipatory guidance handout and free talk) or DVD (DVD format + standard care). Participants completed a brief questionnaire immediately before and after their visit. As anticipated, knowledge scores improved significantly from pre-test to post-test. There was also a significant interaction between format used for anticipatory guidance and time. Specifically, there was greater improvement in knowledge over time for parents in the DVD group as compared with the standard care group. Additionally, the mean knowledge level of those in the DVD group as compared with those in the standard care group trended toward significance. Finally, visit length was shortened by nearly 3 minutes in the DVD group, and close to 100% of all respondents, regardless of anticipatory guidance format, indicated that they were very satisfied with their visit and amount of information learned.

  16. 70 FR 2656 - Drafting Machines From Japan

    Federal Register 2010, 2011, 2012, 2013, 2014

    2005-01-14

    ... From the Federal Register Online via the Government Publishing Office INTERNATIONAL TRADE COMMISSION Drafting Machines From Japan AGENCY: United States International Trade Commission. ACTION... determine whether revocation of the antidumping duty order on drafting machines from Japan would be...

  17. Ascaris suum draft genome.

    PubMed

    Jex, Aaron R; Liu, Shiping; Li, Bo; Young, Neil D; Hall, Ross S; Li, Yingrui; Yang, Linfeng; Zeng, Na; Xu, Xun; Xiong, Zijun; Chen, Fangyuan; Wu, Xuan; Zhang, Guojie; Fang, Xiaodong; Kang, Yi; Anderson, Garry A; Harris, Todd W; Campbell, Bronwyn E; Vlaminck, Johnny; Wang, Tao; Cantacessi, Cinzia; Schwarz, Erich M; Ranganathan, Shoba; Geldhof, Peter; Nejsum, Peter; Sternberg, Paul W; Yang, Huanming; Wang, Jun; Wang, Jian; Gasser, Robin B

    2011-10-26

    Parasitic diseases have a devastating, long-term impact on human health, welfare and food production worldwide. More than two billion people are infected with geohelminths, including the roundworms Ascaris (common roundworm), Necator and Ancylostoma (hookworms), and Trichuris (whipworm), mainly in developing or impoverished nations of Asia, Africa and Latin America. In humans, the diseases caused by these parasites result in about 135,000 deaths annually, with a global burden comparable with that of malaria or tuberculosis in disability-adjusted life years. Ascaris alone infects around 1.2 billion people and, in children, causes nutritional deficiency, impaired physical and cognitive development and, in severe cases, death. Ascaris also causes major production losses in pigs owing to reduced growth, failure to thrive and mortality. The Ascaris-swine model makes it possible to study the parasite, its relationship with the host, and ascariasis at the molecular level. To enable such molecular studies, we report the 273 megabase draft genome of Ascaris suum and compare it with other nematode genomes. This genome has low repeat content (4.4%) and encodes about 18,500 protein-coding genes. Notably, the A. suum secretome (about 750 molecules) is rich in peptidases linked to the penetration and degradation of host tissues, and an assemblage of molecules likely to modulate or evade host immune responses. This genome provides a comprehensive resource to the scientific community and underpins the development of new and urgently needed interventions (drugs, vaccines and diagnostic tests) against ascariasis and other nematodiases.

  18. 78 FR 35072 - Proposed Revision to Strategies and Guidance to Address Loss of Large Areas of the Plant Due to...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-11

    ... Explosions and Fires AGENCY: Nuclear Regulatory Commission. ACTION: Standard review plan-draft section... and Guidance to Address Loss of Large Areas of the Plant due to Explosions and Fires.'' The current... due to explosions and fires. DATES: Submit comments by July 11, 2013. Comments received after...

  19. Annual Compliance Certification Guidance

    EPA Pesticide Factsheets

    This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Policy and Guidance Database available at www2.epa.gov/title-v-operating-permits/title-v-operating-permit-policy-and-guidance-document-index. Some documents in the database are a scanned or retyped version of a paper photocopy of the original. Although we have taken considerable effort to quality assure the documents, some may contain typographical errors. Contact the office that issued the document if you need a copy of the original.

  20. Guidance publication proves timely.

    PubMed

    Baillie, Jonathan

    2011-05-01

    The importance of properly identifying, assessing, and managing risk in all areas of engineering practice, the fact that genuine innovation is almost impossible without a certain element of risk-taking, and the need to acknowledge and respond to public concerns, however much some may be ill-founded, over the risks inherent in technological and engineering advances, are highlighted in a new risk guidance document, Guidance on Risk for the Engineering Profession, published by the Engineering Council in London last month. HEJ editor Jonathan Baillie reports.

  1. Mechnical Drawing/Drafting Curriculum Guide.

    ERIC Educational Resources Information Center

    Gregory, Margaret R.; Benson, Robert T.

    This curriculum guide consists of materials for teaching a course in mechanical drawing and drafting. Addressed in the individual units of the guide are the following topics: the nature and scope of drawing and drafting, visualization and spatial relationships, drafting tools and materials, linework, freehand lettering, geometric construction,…

  2. Competency Reference for Computer Assisted Drafting.

    ERIC Educational Resources Information Center

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

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

  3. 29 CFR 1918.82 - Building drafts.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 29 Labor 7 2011-07-01 2011-07-01 false Building drafts. 1918.82 Section 1918.82 Labor Regulations...) SAFETY AND HEALTH REGULATIONS FOR LONGSHORING Handling Cargo § 1918.82 Building drafts. (a) Drafts shall be built or means shall be taken to prevent cargo from falling from them. (b) Buckets and tubs...

  4. 29 CFR 1918.82 - Building drafts.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 29 Labor 7 2010-07-01 2010-07-01 false Building drafts. 1918.82 Section 1918.82 Labor Regulations...) SAFETY AND HEALTH REGULATIONS FOR LONGSHORING Handling Cargo § 1918.82 Building drafts. (a) Drafts shall be built or means shall be taken to prevent cargo from falling from them. (b) Buckets and tubs...

  5. Performance testing of extremity dosimeters against a draft standard

    SciTech Connect

    Harty, R.; Reece, W.D.; Hooker, C.D.; McDonald, J.C.

    1990-09-01

    The assurance of worker radiation safety is directly related to the performance of personnel dosimetry. The US Department of Energy (DOE) has long recognized this critical relationship and has addressed this issue by instituting the DOE Laboratory Accreditation Program (DOELAP) which strives to improve the quality of personnel dosimetry through performance testing, dosimetry calibration, intercomparisons, evaluations and accreditations. One area of personnel dosimetry that has not been specifically addressed by DOELAP is extremity dosimeter testing. This task was directed at assessing the problems of implementing extremity dosimeter performance testing. A series of performance tests were made based on a draft standard written by the Health Physics Society Standards Committee (HPSSC) using extremity dosimeters currently in use at DOE and DOE contractor facilities. The results of this study indicate the need to incorporate performance testing of extremity dosimetry systems into DOELAP. Based on the results of this study, recommendations are made for improvements to the draft standard. 20 refs., 6 figs., 3 tabs.

  6. Evaluation of the Challenges in the Implementation of the Guidance and Counselling Programme in Baringo County Secondary Schools, Kenya

    ERIC Educational Resources Information Center

    Boitt, Monicah Lydia. J.

    2016-01-01

    The need for guidance and counselling services in all learning institutions cannot be overstated. In response to this demand, guidance and counselling programme has been implemented since 1971 and more emphasis on its services in 2001 through Legal Notice, No. 95 of the Kenya Gazette that recommended guidance and counseling departments be…

  7. The World Health Organization’s Safe Abortion Guidance Document

    PubMed Central

    Van Look, Paul F. A.; Cottingham, Jane

    2013-01-01

    We discuss the history of the World Health Organization’s (WHO’s) development of guidelines for governments on providing safe abortion services, which WHO published as Safe Abortion: Technical and Policy Guidance for Health Systems in 2003 and updated in 2012. We show how the recognition of the devastating impact of unsafe abortion on women’s health and survival, the impetus of the International Conference on Population and Development and its five-year follow-up, and WHO’s progressive leadership at the end of the century enabled the organization to elaborate guidance on providing safe abortion services. Guideline formulation involved extensive review of published evidence, an international technical expert meeting to review the draft document, and a protracted in-house review by senior WHO management. PMID:23409886

  8. 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.

  9. Guidance on lobbying restrictions

    EPA Pesticide Factsheets

    The purpose of this guidance is to remind nonprofit organizations, universities, and other non-government recipients of EPA grants that, with very limited exceptions, you may not use Federal grant funds or cost-sharing funds to conduct lobbying activities.

  10. Guidelines for Guidance Services.

    ERIC Educational Resources Information Center

    Manitoba Dept. of Education and Training, Winnipeg.

    The purpose of this booklet is to provide direction and assistance to school divisions as they develop responsive, effective, and accountable guidance services and programs at the school level. The guidelines presented provide a broad conceptual framework of definitions and goals and outline expectations for service standards. Models and…

  11. Foundations of Career Guidance.

    ERIC Educational Resources Information Center

    Ruff, Eldon E.

    The paper traces the evolution of career guidance from 1909 to the present. The predominant views before 1950 were almost entirely nondevelopmental, but in response to questions raised at a series of major national conferences in the 1960's and the national impact of the career education concept, the 1970's have seen a flurry of writings and…

  12. 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…

  13. PIV Logon Configuration Guidance

    SciTech Connect

    Lee, Glen Alan

    2016-03-04

    This document details the configurations and enhancements implemented to support the usage of federal Personal Identity Verification (PIV) Card for logon on unclassified networks. The guidance is a reference implementation of the configurations and enhancements deployed at the Los Alamos National Laboratory (LANL) by Network and Infrastructure Engineering – Core Services (NIE-CS).

  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. 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.

  16. 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.…

  17. Caught in the Draft

    NASA Astrophysics Data System (ADS)

    Edge, Ron

    2007-09-01

    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 cause of this is a delightful manifestation of Bernoulli's principle. The fan blades, or helicopter rotor blades, produce a pressure differential as air passes through them—let us say p1 before and p2 after, as shown in Fig. 1, with p2 greater than p1. If p0 is the ambient pressure, Bernoulli's equation gives p0=p1 +(1/2)ρv12, where v1 is the velocity of the air entering the fan. Continuity requires that v2 leaving the fan must equal v1 entering the fan for an incompressible fluid, approximately true here (Av1 = Av2, where A is the area swept out by the blades, the "rotor disk area"). However, some distance below the rotor (or in front of the fan) the velocity is vd (vdowndraft in the figure) and the pressure again p0, so Bernoulli gives us p2 + (1/2)ρv22 = (p1 + Δp) + (1/2) ρv12 = [p1 + (p2 - p1)] +(1/2) ρv12 = p2 + (1/2)ρv12 = p0 + (1/2) ρvd2.

  18. 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.

  19. 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.

  20. Venturia carpophila draft genome sequence

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Venturia carpophila causes peach scab, a disease that renders peach fruit unmarketable. We report a high-quality draft genome sequence (36.9 Mb) of V. carpophila from an isolate collected from a peach tree in central Georgia in the United States. The genome sequence described will be a useful resour...

  1. Drafting. Performance Objectives. Basic Course.

    ERIC Educational Resources Information Center

    Allen, Charles

    Several intermediate performance objectives and corresponding criterion measures are listed for each of 12 terminal objectives for a basic drafting course. The materials were developed for a two-semester course (2 hours daily). The organized classroom and shop experiences are designed to enable the student to develop general competencies in the…

  2. Fusicladium effusum draft genome sequence

    Technology Transfer Automated Retrieval System (TEKTRAN)

    The pecan scab fungus (Fusicladium effusum [G. Winter]) is an economically important pathogen of pecan (Carya illinoinensis [Wangenh]. K. Koch), on account of its impact on yield and quality of valuable nutmeats. We describe the first draft genome sequence of F. effusum, the characteristics of annot...

  3. Drafting. Occupational Competency Analysis Profile.

    ERIC Educational Resources Information Center

    Ohio State Univ., Columbus. Vocational Instructional Materials Lab.

    This Drafting Occupational Competency Analysis Profile (OCAP) is one of a series of competency lists, verified by expert workers, that have evolved from a modified DACUM (Developing a Curriculum) job analysis process involving business, industry, labor, and community agency representatives from throughout Ohio. This OCAP identifies the…

  4. Drafting with Design in Mind

    ERIC Educational Resources Information Center

    Daugherty, Michael K.; Carter, Vinson

    2011-01-01

    Design and drafting are subjects long taught in technology education, and subjects that retain high status in the profession. Admittedly, since the initial publication of Standards for Technological Literacy in 2000, design has taken on a larger role and meaning in the technology education profession. However, design continues to be delivered…

  5. Implementing AORN recommended practices for a safe environment of care.

    PubMed

    Hughes, Antonia B

    2013-08-01

    Providing a safe environment for every patient undergoing a surgical or other invasive procedure is imperative. AORN's "Recommended practices for a safe environment of care" provides guidance on a wide range of topics related to the safety of perioperative patients and health care personnel. The recommendations are intended to provide guidance for establishing best practices and implementing safety measures in all perioperative practice settings. Perioperative nurses should be aware of risks related to musculoskeletal injuries, fire, equipment, latex, and chemicals, among others, and understand strategies for reducing the risks. Evidence-based recommendations can give practitioners the tools to guide safe practice.

  6. A Guidance Document for Kentucky's Oil and Gas Operators

    SciTech Connect

    Bender Rick

    1999-10-28

    This technical report is a summary of the accomplishments toward completion of ''A Guidance Document for Kentucky's Oil and Gas Operators''. During this quarter, the document received continued review and editing in an electronic format to satisfy the United States Department of Energy (DOE). Comments received from oil and gas operators reviewing this document prompted contact to be made with the United States Environmental Protection Agency (U. S. EPA) to develop an addendum section to provide better explanation of U.S. EPA requirements for Class II injection wells in Kentucky. During May of this year the consultant hired to develop the Class II, UIC addendum section to the guidance document met a second time with the U.S. EPA and state personnel responsible for regulation of the Class II, UIC program in Kentucky, to review a draft of the document. This draft was discussed during the meeting with the U.S. EPA and will receive additional editing and comment during the next quarter.

  7. Vocational Guidance and Human Development.

    ERIC Educational Resources Information Center

    Herr, Edwin L., Ed.

    New knowledge and practices in the area of vocational guidance and human growth and development that have occurred since 1964 as well as future directions for guidance, both nationally and internationally, are covered in this second volume of a decennial volume series sponsored by the National Vocational Guidance Association to up-date the…

  8. When Instructional Guidance is Needed

    ERIC Educational Resources Information Center

    Chen, Ouhao; Kalyuga, Slava; Sweller, John

    2016-01-01

    Studying worked examples providing problem solutions to learners usually leads to better test performance than solving the equivalent problems without guidance, demonstrating the worked-example effect. The generation effect occurs when learners who generate answers without guidance learn better than those who read answers that provide guidance.…

  9. Interim final guidance package on funding CERCLA State-enforcement actions at NPL sites

    SciTech Connect

    Not Available

    1988-04-07

    The directive outlines requirements, conditions, and limitations for State funding under a CERCLA cooperative agreement of CERCLA enforcement actions at National Priorities List sites. The guidance is divided into four subcomponents: 9831.6 a, b, c, and d. The directive supersedes directive no. 9831.1-1a CERCLA Funding of State Oversight of Potentially Responsible Parties (PRPs), dated October 1, 1986, and directive no. 9831.3 dated October 1, 1986 CERCLA Funding of State Enforcement Activities at NPL Sites, - Interim Draft Guidance.

  10. Draft Transportation Institutional Plan

    SciTech Connect

    Not Available

    1985-09-01

    The Department of Energy recognizes that the success of its program to develop and implement a national system for nuclear waste management and disposal depends on broad-based public understanding and acceptance. While each program element has its particular sensitivity, the transportation of the waste may potentially affect the greatest number of people, and accordingly is highly visible and potentially issue-laden. Therefore, the Office of Civilian Radioactive Waste Management has developed this Transportation Institutional Plan to lay the foundation for interaction among all interested parties for the purpose of identifying and resolving issues of concern. The Plan is divided into four chapters. Chapter 1 provides bachground information and discusses the purpose of the Plan and the policy guidance for establishing the transportation system. Chapter 2 introduces the major participants who must interact to build both the system itself and the consensus philosophy that is essential for effective operations. Chapter 3 suggests mechanisms for interaction that will ensure wide participation in program planning and implementation. And, finally, Chapter 4 suggests a framework for managing and resolving the issues related to development and operation of the transportation system. A list of acronyms and a glossary are included for the reader's convenience. The Plan's appendices provide supporting material to assist the reader in understanding the roles of the involved institutions. 4 figs., 1 tab.

  11. Environmental guidance regulatory bulletin

    SciTech Connect

    1997-01-31

    This document describes the background on expanding public participation in the Resource Conservation and Recovery Act and DOE`s response. The bulletin also describes the changes made by the final rule to existing regulations, guidance provided by EPA in the preamble and in the revised RCRA Public Participation Manual, the relationship between public participation and environmental justice, and DOE`s recent public participation and environmental justice initiatives.

  12. Managing particulates in cell therapy: Guidance for best practice.

    PubMed

    Clarke, Dominic; Stanton, Jean; Powers, Donald; Karnieli, Ohad; Nahum, Sagi; Abraham, Eytan; Parisse, Jean-Sebastien; Oh, Steve

    2016-09-01

    The intent of this article is to provide guidance and recommendations to cell therapy product sponsors (including developers and manufacturers) and their suppliers in the cell therapy industry regarding particulate source, testing, monitoring and methods for control. This information is intended to help all parties characterize the processes that generate particulates, understand product impact and provide recommendations to control particulates generated during manufacturing of cell therapy products.

  13. Shuttle ascent guidance and control.

    NASA Technical Reports Server (NTRS)

    Lovingood, J. A.; Blair, J. C.; Geissler, E. O.

    1972-01-01

    The requirements of a unified optimal guidance scheme are discussed, giving attention to a general formulation, aspects of self-targeting, problems of optimum guidance within the atmosphere, and a unified concept for all flight phases. Since no previous guidance scheme meets these requirements, the shuttle demands a fundamentally new approach. A new unified optimal guidance scheme, called Mascot, was developed. The capabilities of Mascot include the real-time solution of general trajectory-optimization problems and the unification of guidance for all flight phases.

  14. Nitrogenase: A Draft Mechanism

    PubMed Central

    Hoffman, Brian M.; Lukoyanov, Dmitriy; Dean, Dennis R.; Seefeldt, Lance C.

    2013-01-01

    consideration of previous studies, imply a pathway in which (i) N2 binds at E4 with liberation of H2, (ii) N2 is promptly reduced to N2H2, (iii) the two N’s are hydrogenated alternately to form hydrazine-bound FeMo-co, and (iv) two NH3 are liberated in two further steps of reduction. This proposal identifies nitrogenase as following a ‘Prompt-Alternating (P-A)’ reaction pathway, and unifies the catalytic pathway with the LT kinetic framework. However, it does not incorporate one of the most puzzling aspects of nitrogenase catalysis: obligatory generation of H2 upon N2 binding that apparently ‘wastes’ two reducing equivalents and thus 25% of the total energy supplied by the hydrolysis of ATP. The finding that E4 stores its four accumulated reducing equivalents as two bridging hydrides, considered in the context of the organometallic chemistries of hydrides and dihydrogen, leads us to propose an answer to this puzzle. Namely, that H2 release upon N2 binding involves reductive elimination of two hydrides to yield N2 bound to doubly reduced Fe. Coupled delivery of the two available electrons and two activating protons yields cofactor-bound diazene, in keeping with the P-A scheme. This keystone completes a draft mechanism for nitrogenase that organizes the vast body of data upon which it is formulated, and is intended to serve as a basis for future experiments. PMID:23289741

  15. Environmental restoration value engineering guidance document

    SciTech Connect

    1995-07-01

    This document provides guidance on Value Engineering (VE). VE is an organized team effort led by a person trained in the methodology to analyze the functions of projects, systems, equipment, facilities, services, and processes for achieving the essential functions at the lowest life cycle cost while maintaining required performance, reliability, availability, quality, and safety. VE has proven to be a superior tool to improve up-front project planning, cut costs, and create a better value for each dollar spent. This document forms the basis for the Environmental Restoration VE Program, describes the VE process, and provides recommendations on when it can be most useful on ER projects.

  16. Opioids in palliative care: the NICE guidance.

    PubMed

    Swift, Amelia

    Many life-limiting and progressive disorders require effective pain-management strategies. The use of opioids is one facet of pain management and the National Institute for Health and Clinical Excellence Clinical has produced guidance on this. One of the primary messages from the guideline is the need for careful assessment and excellent communication. This article discusses the various recommendations included in the guideline, covering issues of correct dosage, understanding patients' expectations and fears, ongoing monitoring and management of the side-effects associated with opioids.

  17. Reinstatement Considerations Guidance

    EPA Pesticide Factsheets

    This may prove to be helpful to the Suspension and Debarment Division in developing its recommendation to the SDO on a reinstatement petition and to the Suspension and Debarment Official when determining whether a Petitioner has corrected.

  18. 75 FR 67987 - Guidance for Industry: Cellular Therapy for Cardiac Disease; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-04

    ... No. FDA-2009-D-0132] Guidance for Industry: Cellular Therapy for Cardiac Disease; Availability AGENCY... Disease'' dated October 2010. The guidance document provides sponsors who are developing cellular therapies for the treatment of cardiac disease with recommendations on the design of preclinical...

  19. 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

    ... Industry: Potency Tests for Cellular and Gene Therapy Products'' dated January 2011. The guidance document provides manufacturers of cellular and gene therapy (CGT) products with recommendations for developing... document entitled ``Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products''...

  20. 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

    ... 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 provide recommendations to industry involved in developing and conducting self-selection studies to support an...