Science.gov

Sample records for recommendations draft guidance

  1. 78 FR 15370 - Draft Guidance for Industry and Food and Drug Administration Staff: Recommendations for Labeling...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-11

    ...The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled ``Draft Guidance for Industry and FDA Staff: Recommendations for Labeling Medical Products To Inform Users That the Product or Product Container Is Not Made With Natural Rubber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 The purpose of this draft guidance is to make recommendations on the appropriate language to include......

  2. 77 FR 40068 - Draft Guidance for Industry: Recommendations for Donor Questioning, Deferral, Reentry, and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-06

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 The draft guidance document provides blood establishments that collect...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 This guidance replaces the draft guidance entitled ``Guidance for Industry: Recommendations...

  3. 78 FR 13069 - Draft Guidance for Industry: Recommendations for Screening, Testing, and, Management of Blood...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-26

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Recommendations for Screening, Testing, and Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis,'' dated March 2013. The draft guidance document provides revised recommendations for screening and testing of donors and management......

  4. 75 FR 47603 - Draft Guidance for Industry and Food and Drug Administration Staff; Recommendations for Premarket...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-06

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 This draft guidance is not final nor is it in effect at this time.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

  5. 78 FR 55263 - Draft Guidance for Industry on Bioequivalence Recommendations for Fluticasone Propionate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-10

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-05

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-27

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

  8. 75 FR 41871 - International Conference on Harmonisation; Draft Guidance on Q4B Evaluation and Recommendation of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-19

    ... Register of February 21, 2008 (73 FR 9575). Once finalized, the annex will provide guidance to assist... Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on... availability of a draft guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-06

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

  10. 78 FR 55727 - Draft Guidance for Industry on Recommendations for Preparation and Submission of Animal Food...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-11

    ... if an animal food ingredient is already the subject of an approved FAP. Who to contact for more... Preparation and Submission of Animal Food Additive Petitions; Availability AGENCY: Food and Drug... Submission of Animal Food Additive Petitions.'' This draft guidance describes the types of information...

  11. 78 FR 74154 - Draft Guidance for Industry on Recommendations for Preparation and Submission of Animal Food...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-10

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

  12. 78 FR 69693 - Draft Guidance for Industry: Recommendations for Premarket Notification (510(k)) Submissions for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-20

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-29

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-20

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-28

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

  16. 78 FR 66743 - Draft Guidance for Industry on Bioequivalence Recommendations for Iron Sucrose; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-06

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

  17. 77 FR 7585 - Draft Guidance for Industry on Bioequivalence Recommendations for Rifaximin Tablets; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-13

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

  18. 77 FR 7586 - Draft Guidance for Industry on Bioequivalence Recommendation for Nitroglycerin Metered Spray...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-13

    ... 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry, ``Bioequivalence... attack or prophylaxis of angina pectoris due to coronary artery disease. Nitromist (nitroglycerin lingual... attack or acute prophylaxis of angina pectoris due to coronary artery disease. Nitrolingual Pumpspray...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-02

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-26

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

  1. 76 FR 6685 - Draft Guidance for Industry and Food and Drug Administration Staff; Recommended Warning for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-07

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

  2. 76 FR 13629 - Revised Draft Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-14

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-22

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

  4. 78 FR 53792 - Draft Guidance for Reciprocity

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-30

    ... COMMISSION Draft Guidance for Reciprocity AGENCY: Nuclear Regulatory Commission. ACTION: Draft NUREG; request... for reciprocity. The NRC is requesting public comment on draft NUREG-1556, Volume 19, Revision 1...@nrc.gov . The draft NUREG-1556, Volume 19, Revision 1, is available under ADAMS Accession...

  5. 77 FR 67379 - Draft Guidance for Industry and Food and Drug Administration Staff; Highly Multiplexed...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-09

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

  6. 75 FR 52755 - Draft Guidance for Industry on Acute Bacterial Skin and Skin Structure Infections: Developing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-27

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-20

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-17

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

  9. 77 FR 58999 - Draft Guidance for Industry on Abbreviated New Drug Applications: Stability Testing of Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-25

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

  10. 77 FR 74195 - Draft Guidance for Industry and Food and Drug Administration Staff; Design Considerations for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-13

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

  11. 78 FR 73199 - Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-05

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

  12. 77 FR 34390 - Draft Guidance for Industry: Amendment to “Guidance for Industry: Revised Preventive Measures To...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-11

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

  13. 76 FR 5386 - Draft Guidance for Industry: Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-31

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-13

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

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

    EPA Science Inventory

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

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

    EPA Science Inventory

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

  17. 77 FR 69619 - Draft Recommendations of Joint Outreach Team

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-20

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-12

    ... notice of availability for the draft guidance (76 FR 43689, July 21, 2011): FDA's recently- issued draft... would be similar to an infusion pump stand, which is currently classified as a class I device because it supports the intended use of an infusion pump (class II medical device). A mobile medical app that...

  19. 78 FR 33848 - Draft Guidance for Industry on Human Immunodeficiency Virus-1 Infection: Developing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-05

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

  20. 76 FR 35450 - Draft Guidance for Industry on Clinical Trial Endpoints for the Approval of Non-Small Cell Lung...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-17

    .... This guidance does not address endpoints for drugs to prevent or decrease the incidence of lung cancer... the Approval of Non-Small Cell Lung Cancer Drugs and Biologics; Availability AGENCY: Food and Drug... Cell Lung Cancer Drugs and Biologics.'' This draft guidance provides recommendations to applicants...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-13

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

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

    SciTech Connect

    Posas, Paula J.

    2011-04-15

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

  3. 75 FR 17143 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-05

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-25

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-23

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-05

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-16

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

  8. 76 FR 72710 - Agency Information Collection Activities; Proposed Collection; Comment Request; Draft Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-25

    ... July 16, 2010 (75 FR 41498), FDA published a notice of availability of the draft guidance document... Collection; Comment Request; Draft Guidance for Tobacco Retailers on Tobacco Retailer Training Programs... collection provisions of the draft guidance entitled ``Tobacco Retailer Training Programs.'' DATES:...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-28

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

  10. 78 FR 41069 - Medical Device Reporting for Manufacturers; Draft Guidance for Industry and Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-09

    ...The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Medical Device Reporting for Manufacturers.'' This draft guidance describes and explains the current FDA regulation that addresses reporting and recordkeeping requirements applicable to manufacturers of medical devices for certain device-related adverse events. This draft guidance is intended......

  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

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

  12. 76 FR 38187 - International Conference on Harmonisation; Draft Guidance on Q11 Development and Manufacture of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-29

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

  13. 76 FR 51993 - Draft Guidance for Industry on Standards for Clinical Trial Imaging Endpoints; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-19

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

  14. 75 FR 9228 - Draft Guidance for Industry on Non-Inferiority Clinical Trials; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-01

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-12

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

  16. 76 FR 16425 - Draft Guidance for Industry: Testing for Salmonella

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-23

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-25

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

  18. 76 FR 44935 - Draft Guidance for Industry and Food and Drug Administration Staff; 510(k) Device Modifications...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-27

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

  19. 76 FR 72422 - Draft Guidance for Industry on Evaluating the Effectiveness of Anticoccidial Drugs in Food...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-23

    ...The Food and Drug Administration (FDA) is announcing the availability of draft guidance for industry 217 entitled ``Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing Animals.'' The draft guidance, when finalized, is intended to provide guidance to industry for designing and conducting clinical effectiveness studies, and describes criteria that the Center for......

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

    SciTech Connect

    Thompson, D.L.

    1995-12-31

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-14

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

  2. 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...

  3. 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...

  4. 77 FR 125 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Device Classification...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-03

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-22

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

  6. 78 FR 20925 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-08

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

  7. 78 FR 40199 - Draft Spent Fuel Storage and Transportation Interim Staff Guidance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-03

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

  8. 75 FR 3238 - Draft Guidance for Industry and Food and Drug Administration Staff; Heart Valves...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-20

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

  9. 78 FR 32668 - Draft Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-31

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-14

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

  12. 76 FR 55927 - Draft Guidance for Industry and Food and Drug Administration Staff; Demonstrating the Substantial...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-09

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

  13. 76 FR 80948 - Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-27

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

  14. 75 FR 60129 - Draft Guidance for Industry and Investigators on Safety Reporting Requirements for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-29

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

  15. 75 FR 63189 - Draft Guidance for Industry on Investigational New Drug Applications-Determining Whether Human...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-14

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-02

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

  17. 78 FR 310 - Draft Revision of Guidance for Industry on Providing Regulatory Submissions in Electronic Format...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-03

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-06

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

  19. 77 FR 14402 - Draft Guidance on Classifying Significant Postmarket Drug Safety Issues; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-09

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Classifying Significant Postmarket Drug Safety Issues.'' This draft guidance describes FDA's current approach to classifying a significant postmarket drug safety issue as a ``priority'' tracked safety issue (TSI) or a ``standard'' TSI, with the capability of elevating some priority TSIs to an......

  20. 76 FR 1170 - Draft Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-07

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

  1. 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...

  2. 78 FR 72899 - Draft Guidance for Industry on Registration for Human Drug Compounding Outsourcing Facilities...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-04

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-23

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-06

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

  5. 78 FR 2676 - Draft Guidance for Industry on Abuse-Deterrent Opioids-Evaluation and Labeling; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-14

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

  6. 77 FR 21782 - International Conference on Harmonisation; Draft Guidance for Industry on E2C(R2) Periodic...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-11

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-27

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

  8. 78 FR 52931 - Draft Guidance for Industry on Abbreviated New Drug Applications: Stability Testing of Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-27

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

  9. 76 FR 82306 - Draft Guidance for Industry on Use of Histology in Biomarker Qualification Studies; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-30

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Use of Histology in Biomarker Qualification Studies.'' This guidance is intended to assist sponsors that conduct biomarker qualification studies for which histology is a reference standard. This guidance discusses the processes that should be considered to ensure the quality and......

  10. 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 13686 - Draft Guidance for Industry and Review Staff on Pediatric Information Incorporated Into Human...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-28

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

  12. 76 FR 50740 - Draft Guidance for Industry and Food and Drug Administration Staff; Procedures for Handling...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-16

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-16

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-23

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

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

    PubMed

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

    2003-06-01

    States appreciate guidance for activities done infrequently or at only a few locations in the state. For many states, this is the case for decommissioning. Some states have reactors being decommissioned, some DOE sites undergoing cleanup, and some uranium mill or radium sites. Many, however, only occasionally do a small facility cleanup or, once in a great while, a large one. For this reason, most states participated in the readily available MARSSIM training and now recommend its use. For this same reason, the CRCPD Committee on Decontamination and Decommissioning (E24) developed a brief guidance document for state and licensee use. PMID:12792402

  16. 78 FR 53791 - Draft Program-Specific Guidance About Irradiator Licenses

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-30

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

  17. 78 FR 17943 - Draft Program-Specific Guidance About Fixed Gauge Licenses

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-25

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

  18. 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...

  19. 76 FR 16424 - Draft Guidance for Industry: Compliance With Regulations Restricting the Sale and Distribution of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-23

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-06

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

  1. 75 FR 984 - Draft Recommended Interim Preliminary Remediation Goals for Dioxin in Soil at CERCLA and RCRA Sites

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-07

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

  2. 75 FR 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...

  3. 75 FR 75482 - Draft Guidance for Industry on Residual Solvents in Animal Drug Products; Questions and Answers...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-03

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Residual Solvents in Animal... guidance for industry 211 entitled ``Residual Solvents in Animal Drug Products; Questions and Answers... availability of a draft guidance for industry 211 entitled ``Residual Solvents in Animal ] Drug...

  4. 76 FR 69040 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-07

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Yersinia Species Detection.'' This draft guidance document describes a means by which in vitro diagnostic devices for Yersinia species (spp.) detection may comply with the requirement of special controls for class II......

  5. 76 FR 64228 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-17

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

  6. 75 FR 45640 - Draft Guidance for Industry on Residual Drug in Transdermal and Related Drug Delivery Systems...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-03

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Residual Drug in Transdermal... guidance for industry entitled ``Residual Drug in Transdermal and Related Drug Delivery Systems.'' This... of a draft guidance for industry entitled ``Residual Drug in Transdermal and Related Drug...

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

    PubMed Central

    2006-01-01

    and validly measure the specific concepts at issue. The glossary defines many of the terms used in this guidance. In particular, the term instrument refers to the actual questions or items contained in a questionnaire or interview schedule along with all the additional information and documentation that supports the use of these items in producing a PRO measure (e.g., interviewer training and instructions, scoring and interpretation manual). The term conceptual framework refers to how items are grouped according to subconcepts or domains (e.g., the item walking without help may be grouped with another item, walking with difficulty, within the domain of ambulation, and ambulation may be further grouped into the concept of physical ability). FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidance documents describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance documents means that something is suggested or recommended but not required. First publication of the Draft Guidance by the Food and Drug Administration- February 2006. PMID:17034633

  8. 78 FR 4417 - Draft Guidance for Industry and Food and Drug Administration Staff; Submissions for Postapproval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-22

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

  9. 78 FR 24211 - Draft Guidance for Industry on Safety Considerations for Container Labels and Carton Labeling...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-24

    ... closure design (December 13, 2012, 77 FR 74196), and the third guidance will focus on minimizing risks... Container Labels and Carton Labeling Design To Minimize Medication Errors; Availability AGENCY: Food and... Labels and Carton Labeling Design to Minimize Medication Errors.'' The draft guidance focuses on...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-08

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Providing Postmarket Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report).'' This guidance is intended to inform applicants of the conditions under which FDA will exercise its waiver authority to permit applicants to submit an International......

  11. 78 FR 16676 - Agency Information Collection Activities; Proposed Collection; Comment Request; Draft Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-18

    ..., 2010 (75 FR 21632), FDA published a notice seeking comment on the proposed information collection... Collection; Comment Request; Draft Guidance for Industry and FDA Staff; Total Product Life Cycle: Infusion... solicits comments on ``Guidance for Industry and FDA Staff; Total Product Life Cycle: Infusion...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-15

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Suicidal Ideation and Behavior: Prospective Assessment of Occurrence in Clinical Trials.'' The purpose of this guidance is to assist sponsors in prospectively assessing the occurrence of treatment-emergent suicidal ideation and behavior in clinical trials of drug and biological......

  13. 77 FR 20025 - Draft Guidance for Industry on Compliance Policy for Reporting Drug Sample Distribution...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-03

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

  14. 77 FR 14401 - Draft Guidance on Drug Safety Information-FDA's Communication to the Public; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-09

    ... Federal Register of March 7, 2007 (72 FR 10224), FDA announced the availability of a guidance titled... HUMAN SERVICES Food and Drug Administration Draft Guidance on Drug Safety Information--FDA's Communication to the Public; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice....

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-07

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

  16. 78 FR 32667 - Draft Guidance for Industry on Rheumatoid Arthritis: Developing Drug Products for Treatment...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-31

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

  17. 75 FR 29350 - Draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-25

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

  18. 78 FR 27115 - Draft Guidance for Industry on Expanded Access to Investigational Drugs for Treatment Use...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-09

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

  19. 76 FR 70151 - Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-10

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

  20. 76 FR 1173 - Draft Guidance for Industry on Electronic Source Documentation in Clinical Investigations...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-07

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-13

    ... Good Guidance Practices (GGPs) (January 25, 2007, 72 FR 3432-3440). The purpose of GGPs is to ensure... Agricultural Marketing Service 7 CFR Part 205 National Organic Program; Notice of Draft Guidance for Accredited... Availability With Request For Comments. SUMMARY: The National Organic Program (NOP) is announcing...

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

    NASA Technical Reports Server (NTRS)

    1991-01-01

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-05

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

  4. 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 8968 - Draft Guidance for Industry on Adaptive Design Clinical Trials for Drugs and Biologics; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-26

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

  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

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

  7. 76 FR 50483 - Draft Guidance for Industry and Food and Drug Administration Staff; Factors to Consider When...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-15

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

  8. 77 FR 12852 - Draft Guidance for Industry on Limiting the Use of Certain Phthalates as Excipients in Center for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-02

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-19

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

  10. 75 FR 29537 - Draft Transportation Conformity Guidance for Quantitative Hot-spot Analyses in PM2.5

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-26

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-19

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

  13. 75 FR 73107 - Draft Guidance for Industry on Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-29

    ... this draft guidance is to assist clinical trial sponsors and investigators in the development of... bacterial pneumonia (VABP). The science of clinical trial design and our understanding of these diseases... Drugs for Treatment.'' The purpose of this draft guidance is to assist clinical trial sponsors...

  14. 76 FR 22903 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing That a Tobacco...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-25

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

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

    EPA Science Inventory

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

  16. 76 FR 569 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-05

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

  17. 77 FR 20026 - Draft Guidance for Industry: Modified Risk Tobacco Product Applications; Availability; Agency...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-03

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

  18. 76 FR 80947 - Draft Guidance for Industry and Food and Drug Administration Staff; Investigational Device...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-27

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

  19. 78 FR 19492 - Draft Guidance for Industry on Formal Meetings Between FDA and Biosimilar Biological Product...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-01

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

  20. 76 FR 9583 - Draft Guidance for Industry on Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-18

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

  1. 76 FR 32367 - Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-06

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-15

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Quality Considerations in... abbreviated licensure pathway under section 351(k) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(k... application (i.e., a facility in which the proposed biological product is ] manufactured, processed,...

  3. 76 FR 50484 - Draft Guidance for Industry, Clinical Investigators, and Food and Drug Administration Staff...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-15

    ... Food and Drug Administration Staff; Design Considerations for Pivotal Clinical Investigations for... and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Design... study design principles relevant to the development of medical device clinical studies that can be...

  4. 77 FR 60124 - Draft Guidance for Industry on Initial Completeness Assessments for Type II Active Pharmaceutical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-02

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

  5. 76 FR 61103 - Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-03

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

  6. 77 FR 10753 - Draft Guidance for Industry: Food and Drug Administration Records Access Authority Under the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-23

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

  7. 75 FR 44267 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-28

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

  8. 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...

  9. 78 FR 49271 - Draft Guidance for Industry on Frequently Asked Questions About Medical Foods; Second Edition...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-13

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

  10. 77 FR 19672 - Draft Guidances Relating to the Development of Biosimilar Products; Public Hearing; Request for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-02

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

  11. 78 FR 36194 - Draft Guidance for Industry and FDA Staff: Investigational New Drug Applications for Minimally...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-17

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

  12. 76 FR 55927 - Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-09

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

  13. 76 FR 77492 - Draft Guidance on Improving the Process for Preparing Efficient and Timely Environmental Reviews...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-13

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

  14. 77 FR 34958 - Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-12

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

  15. 78 FR 72897 - Draft Guidance for Industry on Interim Product Reporting for Human Drug Compounding Outsourcing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-04

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

  16. 78 FR 11654 - Draft Guidance for Industry and Food and Drug Administration Staff; Providing Information About...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-19

    ... Food, Drug, and Cosmetic Act; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act.'' FDA is... information required under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This draft guidance is...

  17. 78 FR 21128 - Molecular Diagnostic Instruments With Combined Functions; Draft Guidance for Industry and Food...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-09

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

  18. 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...

  19. 78 FR 48175 - Retrospective Review of Draft Guidance Documents Issued Before 2010; Withdrawal of Guidances

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-07

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

  20. 78 FR 69691 - Draft Guidance for Industry on Product Name Placement, Size, and Prominence in Advertising and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-20

    ... Federal Register of January 25, 2012 (77 FR 3779), FDA announced the availability of a guidance entitled..., and Prominence in Advertising and Promotional Labeling; Availability AGENCY: Food and Drug... Advertising and Promotional Labeling.'' When finalized, the draft guidance will replace the guidance of...

  1. 75 FR 54347 - Draft Guidance for Industry: Bar Code Label Requirements-Questions and Answers (Question 12...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-07

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

  2. 78 FR 60292 - Draft Guidance for Industry on Abbreviated New Drug Application Submissions-Refuse-to-Receive...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-01

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

  3. 78 FR 38994 - Implanted Blood Access Devices for Hemodialysis; Draft Guidance for Industry and Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-28

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

  4. 76 FR 81511 - Draft Guidance for Industry and Food and Drug Administration Staff; Center for Devices and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-28

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

  5. 75 FR 59726 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-28

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

  6. 76 FR 28688 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-18

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

  7. 77 FR 40354 - Permitting Guidance for Oil and Gas Hydraulic Fracturing Activities Using Diesel Fuels-Draft

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-09

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

  8. 76 FR 9529 - Migratory Birds; Draft Eagle Conservation Plan Guidance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-18

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

  9. 77 FR 10535 - Final Guidances for Industry Describing Product-Specific Bioequivalence Recommendations...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-22

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

  10. 76 FR 9027 - Draft Guidance for Industry and Food and Drug Administration Staff on Best Practices for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-16

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-15

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

  12. 78 FR 19495 - Draft Guidance for Industry on Scale-Up and Post-Approval Changes: Manufacturing Equipment...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-01

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

  13. 76 FR 58018 - Draft Guidance for Industry on Self-Selection Studies for Nonprescription Drug Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-19

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

  14. 78 FR 48172 - Minimizing Risk for Children's Toy Laser Products; Draft Guidance for Industry and Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-07

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

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

    NASA Technical Reports Server (NTRS)

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

    2011-01-01

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

  16. 75 FR 21632 - Draft Guidance for Industry and Food and Drug Administration Staff; Total Product Life Cycle...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-26

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

  17. 78 FR 78822 - Draft Guidance for Assessing the Effects of Anthropogenic Sound on Marine Mammals-Acoustic...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-27

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

  18. 76 FR 78670 - Draft Guidance for Industry and Food and Drug Administration Staff; Evaluation of Sex Differences...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-19

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

  19. 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...

  20. 76 FR 6143 - Draft Guidance for Industry on “Target Animal Safety and Effectiveness Protocol Development and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-03

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

  1. 77 FR 37059 - Draft Guidance for Industry on Active Controls in Studies To Demonstrate Effectiveness of a New...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-20

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

  2. 78 FR 14305 - Draft Guidance for Industry and Food and Drug Administration Staff; Types of Communication During...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-05

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

  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

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

  4. 76 FR 2328 - National Organic Program: Notice of Draft Guidance Concerning “Made With Organic (Specified...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-13

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

  5. 76 FR 41506 - Draft Guidance for Industry and FDA Staff on In Vitro Companion Diagnostic Devices; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-14

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and FDA Staff on In Vitro... entitled ``In Vitro Companion Diagnostic Devices.'' This guidance is intended to assist sponsors planning to develop a therapeutic product that depends on the use of an in vitro companion diagnostic...

  6. 77 FR 36273 - Public Meeting on Draft Permitting Guidance for Oil and Gas Hydraulic Fracturing Activities Using...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-18

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-14

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

  8. 75 FR 33311 - Guidance for Industry on Bioequivalence Recommendations for Specific Products; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-11

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

  9. 77 FR 35688 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-14

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

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

    ERIC Educational Resources Information Center

    California State Postsecondary Education Commission, Sacramento.

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

  11. 76 FR 52995 - Draft License Renewal Interim Staff Guidance LR-ISG-2011-05: Ongoing Review of Operating...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-24

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

  12. 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...

  13. 75 FR 28257 - Draft Guidance for Industry, Third Parties and Food and Drug Administration Staff; Medical Device...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-20

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

  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

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

  15. 76 FR 35665 - Draft Guidance for Industry on Enforcement Policy for Over-the-Counter Sunscreen Drug Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-17

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

  16. 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...

  17. 76 FR 6143 - Draft Guidance on Positron Emission Tomography Drug Applications-Content and Format for New Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-03

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

  18. 77 FR 7584 - Draft Guidance for Industry on Heparin for Drug and Medical Device Use; Monitoring Crude Heparin...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-13

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

  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 Generic Drug Facilities, Sites, and Organizations; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a...

  20. 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...

  1. 78 FR 9396 - Draft Guidance for Industry and Food and Drug Administration Staff; Civil Money Penalties for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-08

    ... Tobacco to Protect Children and Adolescents'' (75 FR 13225, March 19, 2010, codified at 21 CFR part 1140... Staff; Civil Money Penalties for Tobacco Retailers: Responses to Frequently Asked Questions... Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Civil...

  2. 77 FR 5857 - Common-Cause Failure Analysis in Event and Condition Assessment: Guidance and Research, Draft...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-06

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

  3. 78 FR 69690 - Draft Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-20

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

  4. 78 FR 20116 - Draft Guidance for Industry and Food and Drug Administration Staff; Glass Syringes for Delivering...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-03

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

  5. 75 FR 22601 - Draft Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-29

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

  6. 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...

  7. 78 FR 78366 - Draft Guidance for Industry on Naming of Drug Products Containing Salt Drug Substances; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-26

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

  8. 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...

  9. 78 FR 74154 - Draft Guidance for Industry on Size, Shape, and Other Physical Attributes of Generic Tablets and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-10

    ... Physical Attributes of Generic Tablets and Capsules; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Size, Shape, and Other Physical Attributes of Generic Tablets and...

  10. 77 FR 57094 - Draft Guidance for Industry on Self-Identification of Generic Drug Facilities, Sites, and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-17

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

  11. 78 FR 70953 - Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-27

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

  12. 78 FR 17660 - Draft Guidance for E85 Flexible Fuel Vehicle Weighting Factor for Model Years 2016-2019 Vehicles...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-22

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

  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

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

  14. 78 FR 56719 - Draft Guidance for Industry on Arsenic in Apple Juice: Action Level; Supporting Document for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-13

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-23

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

  16. 76 FR 24494 - Draft Guidance for Industry and FDA Staff: Processing/Reprocessing Medical Devices in Health Care...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-02

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

  17. 77 FR 27451 - Permitting Guidance for Oil and Gas Hydraulic Fracturing Activities Using Diesel Fuels-Draft...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-10

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

  18. 75 FR 22599 - Draft Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-29

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

  19. 77 FR 9946 - Draft Guidance for Industry on Drug Interaction Studies-Study Design, Data Analysis, Implications...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-21

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

  20. 78 FR 7784 - Draft Guidance for Industry on Enrichment Strategies for Clinical Trials To Support Approval of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-04

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-03

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-12

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-02

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

  4. 78 FR 50421 - Guidance for Industry: Recommendations for Donor Questioning, Deferral, Reentry, and Product...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-19

    ... deferral recommendations. In the Federal Register of July 6, 2012 (77 FR 40068), FDA announced the..., Deferral, Reentry, and Product Management To Reduce the Risk of Transfusion-Transmitted Malaria...-Transmitted Malaria'' dated August 2013. The guidance document provides blood establishments that...

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

    PubMed Central

    Giddens, Jennifer M.; Sheehan, Kathy Harnett

    2014-01-01

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

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

    SciTech Connect

    1986-01-01

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

  7. 75 FR 13765 - Draft Guidance for Industry on Irritable Bowel Syndrome-Clinical Evaluation of Products for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-23

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

  8. 75 FR 10524 - NUREG-0654/FEMA-REP-1, Rev. 1, Supplement 3, Guidance for Protective Action Recommendations for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-08

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

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

    SciTech Connect

    Not Available

    1989-06-01

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

  10. 77 FR 70167 - Draft Guidance for Industry on Vaginal Microbicides: Development for the Prevention of Human...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-23

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

  11. 75 FR 63188 - Draft Guidance for Industry: Early Clinical Trials With Live Biotherapeutic Products: Chemistry...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-14

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-22

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

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

    ERIC Educational Resources Information Center

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

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

  14. 77 FR 59928 - Draft Guidance for Industry on Complicated Intra-Abdominal Infections: Developing Drugs for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-01

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

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

    PubMed

    Barlas, Stephen

    2015-10-01

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

  16. 78 FR 9688 - Pesticides; Draft Guidance for Pesticide Registrants on Antimicrobial Pesticide Products With...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-11

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

  17. 75 FR 28012 - Pesticides; Draft Guidance for Pesticide Registrants on False or Misleading Pesticide Product...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-19

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

  18. 76 FR 27331 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-11

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

  19. 77 FR 2741 - Draft Guidance Regarding Inspection and Certification of Vessels Under the Maritime Security Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-19

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

  20. 77 FR 76049 - Draft Guidance for Industry on Electronic Source Data in Clinical Investigations; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-26

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

  1. 76 FR 70150 - Draft Guidance for Industry and Food and Drug Administration Staff; Investigational Device...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-10

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

  2. 78 FR 36196 - Draft Guidance for Industry: Biologics License Applications for Minimally Manipulated, Unrelated...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-17

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

  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... document entitled ``Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene... for Biologics Research and Evaluation (CBER), Office of Cellular, Tissue, and Gene Therapies...

  4. 78 FR 42387 - Draft Guidance for Industry on Circumstances That Constitute Delaying, Denying, Limiting, or...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-15

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

  5. 78 FR 7786 - International Conference on Harmonisation; Draft Guidance on S10 Photosafety Evaluation of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-04

    ... and marketing authorization for pharmaceuticals. DATES: Although you can comment on any guidance at... regarding assessment of photosafety to support clinical development and marketing authorization of... Clinical Trials and Marketing Authorization for Pharmaceuticals,'' available on the Internet at...

  6. 75 FR 27840 - NUREG-0654/FEMA-REP-1, Rev. 1, Supplement 3, Guidance for Protective Action Recommendations for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-18

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

  7. 75 FR 7591 - Guidance on Recommended Interim Preliminary Remediation Goals for Dioxin in Soil at CERCLA and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-22

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-17

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

  9. 75 FR 62693 - National Organic Program: Notice of Draft Guidance for Accredited Certifying Agents and Certified...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-13

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

  10. 76 FR 55390 - Guidance on Exculpatory Language in Informed Consent, Draft

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-07

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