Science.gov

Sample records for recommendations draft guidance

  1. 77 FR 40068 - Draft Guidance for Industry: Recommendations for Donor Questioning, Deferral, Reentry, and...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 The draft guidance document provides blood establishments that collect...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 This guidance replaces the draft guidance entitled ``Guidance for Industry: Recommendations...

  2. 78 FR 46965 - Draft Guidance for Industry on Bioequivalence Recommendations for Mesalamine Rectal Suppositories...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-02

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 HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Bioequivalence Recommendations for Mesalamine Rectal Suppositories; Availability AGENCY: Food and Drug Administration, HHS.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

  3. 78 FR 73200 - Draft Guidance for Industry on Bioequivalence Recommendations for Paliperidone Palmitate Extended...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-05

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Bioequivalence Recommendations for Paliperidone Palmitate Extended-Release Injectable Suspension; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

  4. 78 FR 52777 - Draft Guidance for Industry on Bioequivalence Recommendations for Risperidone Injection...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-26

    ... HUMAN SERVICES Food and Drug Administration (Formerly Docket No. 2007D-0168) Draft Guidance for Industry on Bioequivalence Recommendations for Risperidone Injection; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing...

  5. 78 FR 15370 - Draft Guidance for Industry and Food and Drug Administration Staff: Recommendations for Labeling...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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff: Recommendations for Labeling Medical Products To Inform Users That the Product or Product Container Is Not Made With Natural Rubber Latex; Availability AGENCY: Food and Drug Administration,...

  6. 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...

  7. 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...

  8. 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... INFORMATION: I. Background In the Federal Register of Wednesday, September 11, 2013 (78 FR 55727),...

  9. 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

    ... Register of June 26, 2003 (68 FR 38083), FDA announced the availability of the draft guidance entitled... Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Paul E. Levine, Jr.,...

  10. 78 FR 55263 - Draft Guidance for Industry on Bioequivalence Recommendations for Fluticasone Propionate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-10

    ... bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for fluticasone propionate...; salmeterol xinafoate. Advair Diskus (fluticasone propionate; salmeterol xinafoate), new drug application... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on...

  11. 77 FR 58399 - Draft Guidance for Industry on Bioequivalence Recommendations for Pentosan Polysulfate Sodium...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-20

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-11

    ... Preparation and Submission of Animal Food Additive Petitions; Availability AGENCY: Food and Drug... Submission of Animal Food Additive Petitions.'' This draft guidance describes the types of information that...) submitted for food additives intended for use in food for animals. It is intended to help the...

  13. 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... Recommendations for Iron Sucrose; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY... entitled ``Bioequivalence Recommendations for Iron Sucrose.'' The recommendations provide specific...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-28

    ... Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry... Recommendations for Iron Sucrose Injection; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... industry entitled ``Bioequivalence Recommendations for Iron Sucrose.'' The recommendations provide...

  15. 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

    ... quantitate the anti-seizure drugs lamotrigine and zonisamide in serum. The Therapeutic Drug Monitoring (TDM... TDM Roundtable recommendations. Some of the general concepts in this guidance may also be helpful...

  16. 78 FR 19271 - Draft Guidance for Industry on Bioequivalence Recommendations for Metronidazole Vaginal Gel...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-29

    ... abbreviated new drug applications (ANDAs) for metronidazole vaginal gel. DATES: Although you can comment on... Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD... the availability of draft BE recommendations for metronidazole vaginal gel. New drug...

  17. 78 FR 36196 - Draft Guidance for Industry: Biologics License Applications for Minimally Manipulated, Unrelated...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-17

    ... Hematopoietic System'' dated June 2013. The draft guidance document provides recommendations for manufacturers... Affecting the Hematopoietic System'' dated June 2013. The draft guidance document, when finalized, will... Patients with Disorders Affecting the Hematopoietic System.'' That draft guidance, when finalized,...

  18. 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...), approved by FDA on December 27, 2005, is a thalidomide analogue indicated for the treatment of:...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-13

    ... 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...

  20. 77 FR 35688 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-14

    ... HUMAN SERVICES Food and Drug Administration Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability...

  1. 75 FR 40843 - International Conference on Harmonisation; Draft Guidance on Q4B Evaluation and Recommendation of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-14

    ..., which was made available in the Federal Register of February 21, 2008 (73 FR 9575). DATES: Although you... Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on... Pharmacopoeial Texts for Use in the ICH Regions; Annex 13: Bulk Density and Tapped Density of Powders...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-23

    ... Administration (FDA) is correcting a notice that appeared in the Federal Register of July 14, 2010 (75 FR 40843...-0002, 301-796-9148. SUPPLEMENTARY INFORMATION: In FR Doc. 2010-17055, appearing on page 40843 in the... Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference...

  3. 76 FR 55927 - Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-09

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry; Dietary Supplements: New... notice entitled ``Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications... the draft guidance for industry entitled ``Draft Guidance for Industry; Dietary Supplements:...

  4. 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

    ... guidance for industry entitled ``Residual Drug in Transdermal and Related Drug Delivery Systems.'' This... Systems.'' This draft guidance provides recommendations to developers and manufacturers of TDDS, TMDS, and... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Residual Drug in...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-17

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

  6. 77 FR 8884 - Draft Guidance for Industry on Quality Considerations in Demonstrating Biosimilarity to a...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-15

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Quality Considerations in... a draft guidance for industry entitled ``Quality Considerations in Demonstrating Biosimilarity to a... pathway. This draft guidance provides an overview of FDA's approach to quality considerations...

  7. 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... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Prevention of Salmonella... availability of a draft guidance entitled ``Prevention of Salmonella Enteritidis in Shell Eggs...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-31

    ..., published in the Federal Register of August 7, 2001 (66 FR 41247). The draft guidance is being issued..., including Source Plasma, with recommendations intended to assist with determining which reporting mechanism..., including Source Plasma, with recommendations intended to assist with determining which reporting...

  9. 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...

  10. 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...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-13

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

  12. 78 FR 63476 - Draft Guidance for Industry: Use of Nucleic Acid Tests To Reduce the Risk of Transmission of West...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-24

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Use of Nucleic Acid Tests To... ``Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus From... donor screening test. The guidance recommends the use of an FDA-licensed nucleic acid test ] (NAT)...

  13. 78 FR 74154 - Draft Guidance for Industry on Size, Shape, and Other Physical Attributes of Generic Tablets and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-10

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Size, Shape, and Other... guidance for industry entitled ``Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules.'' This guidance discusses FDA recommendations for the size, shape, and other physical attributes...

  14. 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...

  15. 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

    ... guidance for industry entitled ``Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical Studies.'' The draft guidance is intended to assist the pharmaceutical industry and other investigators... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Clinical...

  16. 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

    ... 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 Under... availability of a draft guidance for industry entitled ``Compliance Policy on Reporting Drug...

  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

    ... tobacco smoke; Scientific evidence is not available and, using the best available scientific methods... application and the scientific evidence FDA recommends you submit to support your application. The draft... guidance (or any combination thereof) on the scientific evidence required for assessment and ongoing...

  18. 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.

  19. 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... Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference...

  20. 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...

  1. 75 FR 36421 - Draft Guidance for Industry on Chemistry, Manufacturing, and Controls Postapproval Manufacturing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-25

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

  2. 78 FR 13686 - Draft Guidance for Industry and Review Staff on Pediatric Information Incorporated Into Human...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-28

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Review Staff on Pediatric Information Incorporated Into Human Prescription Drug and Biological Products Labeling; Availability AGENCY... announcing the availability of a draft guidance for industry and review staff entitled...

  3. 77 FR 34958 - Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-12

    ... Investigators, and Sponsors: Considerations When Transferring Clinical Investigation Oversight to Another... ``Considerations When Transferring Clinical Investigation Oversight to Another IRB.'' The draft guidance discusses... IRB to another IRB. The draft guidance also addresses questions that have been previously...

  4. 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...

  5. 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

    ... Document: Transcutaneous Electrical Nerve Stimulator for Pain Relief; Draft Guidance for Industry and FDA... for Pain Relief Intended for Over the Counter Use; Draft Guidance for Industry and FDA Staff''; (5... Output for Pain Relief; Draft Guidance for Industry and FDA Staff''; (6) ``Class II Special...

  6. 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:...

  7. 76 FR 16425 - Draft Guidance for Industry: Testing for Salmonella

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-23

    ... human foods and direct-human-contact animal foods. It does not create or confer any rights for or on any... 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...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-27

    .... 0910-0037; 73 FR 11649 at 11650, March 4, 2008). In that analysis, we estimated that there are 8,950... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Acidified Foods; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration...

  9. 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... Cefaclor Cefadroxil; Cefadroxil Hemihydrate Cefditoren Pivoxil Cefixime Cefuroxime Axetil (multiple...

  10. 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...

  11. 78 FR 14305 - Draft Guidance for Industry and Food and Drug Administration Staff; Types of Communication During...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-05

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

  12. 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... Thalidomide Tretinoin (multiple RLDs and dosage forms) III. Drug Products for Which Revised Draft...

  13. 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.

  14. 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

    ... using a systems approach to minimize medication errors relating to product design. The draft guidance... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Safety Considerations for... guidance for industry entitled ``Safety Considerations for Product Design to Minimize Medication...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-30

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance on Media Fills for Validation of Aseptic... guidance entitled ``Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography... is announcing the availability of a draft guidance entitled ``Media Fills for Validation of...

  16. 76 FR 55390 - Guidance on Exculpatory Language in Informed Consent, Draft

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-07

    ... HUMAN SERVICES Guidance on Exculpatory Language in Informed Consent, Draft AGENCY: Office for Human... the availability of a draft guidance entitled, ``Guidance on Exculpatory Language in Informed Consent... Language in Informed Consent document to the Division of Policy and Assurances, Office for Human...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-25

    ... COMMISSION Draft Program-Specific Guidance About Fixed Gauge Licenses AGENCY: Nuclear Regulatory Commission... revising its licensing guidance for fixed gauge licenses. The NRC is requesting public comment on draft... Guidance About Fixed Gauge Licenses.'' The document has been updated from the previous revision to...

  18. 78 FR 16676 - Agency Information Collection Activities; Proposed Collection; Comment Request; Draft Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-18

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

  19. 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... transcripts of the meeting?'' This document corrects that error. FOR FURTHER INFORMATION CONTACT: Joyce...

  20. 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... guidance for industry entitled ``Frequently Asked Questions About Medical Foods; Second Edition.''...

  1. 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

    ... 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 Rheumatoid Arthritis... guidance for industry entitled ``Rheumatoid Arthritis: Developing Drug Products for Treatment.''...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-25

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

  3. 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

    ... draft guidance provides responses to questions FDA has received on the Family Smoking Prevention and... effect at this time. DATES: Although you can comment on any guidance at any time (see 21 CFR...

  4. 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,...

  5. 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... Risedronate sodium T Tacrolimus Thalidomide Tinidazole For a complete history of previously published...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-22

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

  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... drugs) Methyltestosterone ] Mirabegron S Sodium ferric gluconate T Timolol maleate Trientine III....

  8. 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...

  9. 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...

  10. 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

    ... Affecting the Hematopoietic System.'' That draft guidance, when finalized, is intended to supersede the... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and FDA Staff: Investigational... Hematopoietic System; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-24

    ... HUMAN SERVICES Food and Drug Administration Global Unique Device Identification Database; Draft Guidance... ``Global Unique Device Identification Database (GUDID).'' FDA is issuing this draft guidance to communicate... device labelers (in most instances, the device manufacturer) will interface with the GUDID, as well...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-27

    ... 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...-resistant Staphylococcus aureus. The definitions of ABSSSI and the designs of ABSSSI clinical trials...

  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 assist sponsors in the use of imaging endpoints in clinical trials of therapeutic drugs and...

  14. 75 FR 63188 - Draft Guidance for Industry: Early Clinical Trials With Live Biotherapeutic Products: Chemistry...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-14

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Early Clinical Trials With Live... availability of a draft document entitled ``Guidance for Industry: Early Clinical Trials with Live... submission of INDs for early clinical trials with live biotherapeutic products (LBPs). DATES: Although...

  15. 75 FR 9228 - Draft Guidance for Industry on Non-Inferiority Clinical Trials; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-01

    ... ``Non- Inferiority Clinical Trials.'' This draft guidance provides sponsors and review staff in the... announcing the availability of a draft guidance for industry entitled ``Non-Inferiority Clinical Trials... clinical trials. It does not create or confer any rights for or on any person and does not operate to...

  16. 76 FR 10908 - Draft Guidance for Industry on Medication Guides-Distribution Requirements and Inclusion of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-28

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Medication Guides... Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Medication Guides... healthcare professional for administration to a patient instead of being dispensed directly to the...

  17. 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... Administration (FDA) is announcing the availability of the draft guidance document entitled ``Heart...

  18. 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...

  19. 77 FR 24722 - Draft Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-25

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Assessing the Effects of... Additives; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and... Food Ingredients That Are Color Additives.'' The draft guidance, when finalized, will explain...

  20. 76 FR 16424 - Draft Guidance for Industry: Compliance With Regulations Restricting the Sale and Distribution of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-23

    ... Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents... Smokeless Tobacco to Protect Children and Adolescents.'' This revised draft guidance replaces the original draft guidance published in the Federal Register of June 9, 2010 (75 FR 32791). The original...

  1. 77 FR 11553 - Draft Guidance on Food and Drug Administration Oversight of Positron Emission Tomography Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-27

    ... availability of a draft guidance entitled ``FDA Oversight of PET Drug Products--Questions and Answers.'' The... draft guidance entitled ``FDA Oversight of PET Drug Products--Questions and Answers.'' In 1997, Congress... good manufacturing practices (CGMP) for PET drugs. The procedures were finalized and an...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-19

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Self-Selection Studies for Nonprescription Drug Products; 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...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-14

    ... 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...

  4. 78 FR 68852 - Draft Guidance for Industry on Acrylamide in Foods; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-15

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

  5. 78 FR 44572 - Draft Guidance for Industry on Pre-Launch Activities Importation Requests; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-24

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Pre-Launch Activities Importation Requests; 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...

  6. 75 FR 65495 - Draft Guidance for Industry on Qualification Process for Drug Development Tools; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-25

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Qualification Process for... entitled ``Qualification Process for Drug Development Tools.'' This draft guidance describes the qualification process for drug development tools (DDTs) intended for potential use, over time, in multiple...

  7. 78 FR 38994 - Implanted Blood Access Devices for Hemodialysis; Draft Guidance for Industry and Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-28

    ... HUMAN SERVICES Food and Drug Administration Implanted Blood Access Devices for Hemodialysis; Draft... availability of the draft guidance entitled ``Implanted Blood Access Devices for Hemodialysis.'' This guidance was developed to support the reclassification of the Implanted Blood Access Devices for...

  8. 76 FR 81510 - Draft Guidance for Industry and Food and Drug Administration Staff; the 510(k) Program...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-28

    ... Notifications .'' FDA developed this draft guidance document to provide a contemporary perspective on how FDA... This draft guidance serves to update FDA's perspective on the Agency's approach to the 510(k)...

  9. 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... Availability, Draft Guidance, ``Consideration of the Effects of Climate Change and Greenhouse Gas Emissions... the NEPA Draft Guidance ``Consideration of the Effects of Climate Change and Greenhouse Gas...

  10. 75 FR 22601 - Draft Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-29

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

  11. 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... previously conducted clinical trials with various effective antibiotics. The draft guidance also provides a... of information referred to in the guidance for clinical trial sponsors ``Establishment and...

  12. 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... Commission (NRC) is issuing for public comment draft Interim Staff Guidance, ``Evaluations of Uranium....1301.'' This Interim Staff Guidance provides guidance to the NRC staff for evaluating uranium...

  13. 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

    ... Special Controls Guidance Document: In Vitro Diagnostic Devices for Yersinia Species Detection... 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...

  14. Radiological health; evaluation of radiation exposure in diagnostic radiology examinations; availability of draft recommendations--FDA. Notice.

    PubMed

    1983-07-29

    The Food and Drug Administration (FDA) announces the availability for public review and comment of draft recommendations on evaluation of radiation exposure in diagnostic radiology examinations, prepared by FDA's National Center for Devices and Radiological Health (NCDRH). In addition to the draft recommendations, FDA is making available background information, rationale, and NCDRH's response to comments that were received on a notice of inquiry regarding the need for and content of such recommendations. FDA is also encouraging private groups and individuals to join in the research efforts needed to develop further technique/exposure guidance and suggests a number of principles to be followed in these efforts so all interested parties may achieve consistent and useful results. Final recommendations, when developed, will be published as a technical report in NCDRH's radiation recommendation series. PMID:10261489

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-23

    ... 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... Exclusions Under the National Environmental Policy Act.'' SUMMARY: On February 18, 2010, the Council...

  16. 75 FR 54889 - Draft Guidance for Industry on Suicidality: Prospective Assessment of Occurrence in Clinical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-09

    ... tretinoins, beta blockers (especially those entering the brain), reserpine, drugs for smoking cessation, and... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Suicidality: Prospective Assessment of Occurrence in Clinical Trials; Availability AGENCY: Food and Drug Administration, HHS....

  17. 76 FR 44013 - Draft Guidance for Industry: Implementation of Acceptable Full-Length and Abbreviated Donor...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-22

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Implementation of Acceptable Full- Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Source Plasma; Availability AGENCY: Food and Drug Administration, HHS. ACTION:...

  18. 76 FR 36542 - Draft Guidance for Industry and Food and Drug Administration Staff: The Content of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-22

    ... Staff: The Content of Investigational Device Exemption and Premarket Approval Applications for Low... document entitled ``Draft Guidance for Industry and Food and Drug Administration Staff: The Content of... Staff: The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA)...

  19. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry, Clinical Investigators, and Food and Drug Administration Staff; Design Considerations for Pivotal Clinical Investigations for Medical Devices; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-27

    ... Applications: Stability Testing of Drug Substances and Products, Questions and Answers; Availability AGENCY... announcing the availability of a draft guidance for industry entitled ``ANDAs: Stability Testing of Drug... to generic drug manufacturers to follow International Conference on Hamonisation (ICH)...

  1. 77 FR 8885 - Draft Guidance for Industry on Biosimilars: Questions and Answers Regarding Implementation of the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-15

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

  2. 77 FR 125 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Device Classification...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-03

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

  3. 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... AGENCY Pesticides; Draft Guidance for Pesticide Registrants on Antimicrobial Pesticide Products With Mold... for Antimicrobial Pesticide Products with Mold-Related Label Claims. This document extends the...

  4. 76 FR 65735 - Draft Guidance for Industry: Implementation of Acceptable Abbreviated Donor History Questionnaire...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-24

    ... The draft guidance refers to previously approved collections of information found in FDA regulations.... SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft document... donor history information from frequent donors of blood and blood components that is consistent with...

  5. 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...

  6. 78 FR 54899 - Draft Guidance for Industry on Specification of the Unique Facility Identifier System for Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-06

    ...) System for Drug Establishment Registration.'' This draft guidance specifies the UFI system for... guidance specifies the UFI system as follows. At this time, FDA's preferred UFI for a drug establishment is... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Specification of the...

  7. 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...

  8. 76 FR 14024 - Draft Guidance for Industry on Non-Penicillin Beta-Lactam Risk Assessment: A CGMP Framework...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-15

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

  9. 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...

  10. 78 FR 14791 - Notice of Issuance of Exposure Draft on Implementation Guidance on General Property, Plant, and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-07

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

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

    PubMed

    2006-10-11

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

  12. 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

  13. 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

    ... Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Document; Reopening of... for the notice that appeared in the Federal Register of April 5, 2010 (75 FR 17143). In the notice, FDA requested comments on draft guidance documents for 11 neurological and physical medicine...

  14. 75 FR 47604 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-06

    ... Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Document; Reopening of... July 28, 2010 (75 FR 44267). The document reopened the comment period for a notice of availability of draft guidance documents for 11 neurological and physical medicine devices. The document was...

  15. 76 FR 82306 - Draft Guidance for Industry on Use of Histology in Biomarker Qualification Studies; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-30

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

  16. 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

    ... food-producing animals. It does not create or confer any rights for or on any person and does not... of Anticoccidial Drugs in Food-Producing Animals; Availability AGENCY: Food and Drug Administration...-Producing Animals.'' The draft guidance, when finalized, is intended to provide guidance to industry...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-13

    ... Budget (OMB) Bulletin on Agency Good Guidance Practices (GGPs) (January 25, 2007, 72 FR 3432-3440). The... 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...

  18. 78 FR 19637 - National Organic Program: Notice of Draft Guidance on Classification of Materials and Materials...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-02

    ...) Bulletin on Agency Good Guidance Practices (GGPs) (January 25, 2007, 72 FR 3432-3440). The purpose of GGPs...; ] DEPARTMENT OF AGRICULTURE Agricultural Marketing Service National Organic Program: Notice of Draft Guidance on Classification of Materials and Materials for Organic Crop Production AGENCY:...

  19. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Safety Considerations for Container Labels and Carton Labeling Design To Minimize Medication Errors; Availability AGENCY: Food and... closure design (December 13, 2012, 77 FR 74196), and the third guidance will focus on minimizing...

  20. 77 FR 14401 - Draft Guidance on Drug Safety Information-FDA's Communication to the Public; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-09

    ... Communication to the Public; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY... ``Drug Safety Information-- FDA's Communication to the Public.'' This draft guidance updates and revises the March 2007 guidance entitled ``Drug Safety Information-- FDA's Communication to the Public.''...

  1. 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......

  2. 77 FR 34390 - Draft Guidance for Industry: Amendment to “Guidance for Industry: Revised Preventive Measures To...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-11

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

  3. 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.

  4. International Conference on Harmonisation; draft guidance on E2F Development Safety Update Report; availability. Notice.

    PubMed

    2008-08-01

    The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "E2F Development Safety Update 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 describes the format, content, and timing of a development safety update report (DSUR) for an investigational drug. The DSUR would serve as a harmonized, annual clinical trial safety report that would be standard among the three ICH regions. The DSUR could be submitted in the United States in place of an annual report for an investigational new drug application (IND). The harmonized DSUR is intended to promote a consistent approach to annual clinical safety reporting among the ICH regions and enhance efficiency by reducing the number of reports generated for submission to the regulatory authorities. PMID:18949880

  5. 77 FR 16123 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-19

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

  6. 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...

  7. 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

    ... COMMISSION Common-Cause Failure Analysis in Event and Condition Assessment: Guidance and Research, Draft...: 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...

  8. 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

    ... 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 Scale-Up and Post-Approval... post-approval changes (SUPAC) draft guidance for industry entitled ``SUPAC: Manufacturing...

  9. 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...

  10. 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

    ...The Food and Drug Administration (FDA) is reopening the comment period for the notice of availability entitled ``Draft Guidance for 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 comment on the draft guidance. FDA is reopening the comment......

  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. 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-- Evaluation and Labeling; 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...

  13. 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...

  14. 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....

  15. 76 FR 5386 - Draft Guidance for Industry: Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-31

    ... same title dated January 2001 (January 31, 2001, 66 FR 8410). The draft guidance, when finalized, will... of Whole Blood and Blood Components Intended for Transfusion; Availability AGENCY: Food and Drug... Blood and Blood Components Intended for Transfusion'' dated January 2011. The draft guidance...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-07

    ... AGENCY RIN 2050-ZA05 Draft Recommended Interim Preliminary Remediation Goals for Dioxin in Soil at CERCLA... announcing a 50-day public comment period for draft recommended interim preliminary remediation goals (PRGs) developed in the Draft Recommended Interim Preliminary Remediation Goals for Dioxin in Soil at...

  17. 76 FR 9529 - Migratory Birds; Draft Eagle Conservation Plan Guidance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-18

    ... development of facilities to generate electricity from wind turbines has increased dramatically in the range... wind turbines. Because of this risk, many of the current and planned wind facilities require permits... Fish and Wildlife Service 50 CFR Part 22 RIN 1018-AX53 Migratory Birds; Draft Eagle Conservation...

  18. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007... information to the industry in complying with the Reportable Food Registry requirements prescribed by the...

  19. 78 FR 68460 - Draft Guidance for Industry on Frequently Asked Questions About Medical Foods; Second Edition...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-14

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Frequently Asked Questions About Medical Foods; Second Edition; Reopening of the Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; reopening of the comment period. SUMMARY: The Food and Drug...

  20. 77 FR 12853 - Draft Guidances Relating to the Development of Biosimilar Products; Public Hearing; Request for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-02

    ... HUMAN SERVICES Food and Drug Administration Draft Guidances Relating to the Development of Biosimilar Products; Public Hearing; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public hearing; request for comments. SUMMARY: The Food and Drug Administration (FDA) is announcing a...

  1. 78 FR 44483 - Draft Guidance for Industry: Questions and Answers Regarding the Final Rule, Prevention of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-24

    .... Background In the Federal Register of July 9, 2009 (74 FR 33030), FDA issued a final rule requiring shell egg... HUMAN SERVICES Food and Drug Administration 21 CFR Part 118 Draft Guidance for Industry: Questions and Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During...

  2. 76 FR 55923 - Draft Guidance for Industry: Submission of Warning Plans for Cigarettes and Smokeless Tobacco...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-09

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

  3. 76 FR 76166 - Draft Guidance for Industry and Food and Drug Administration Staff; the Content of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-06

    ..., including CTR, CTT, and Low Glucose Suspend systems. On June 22, 2011 (76 FR 36542), FDA announced the... Staff; the Content of Investigational Device Exemption and Premarket Approval Applications for... document entitled ``Draft Guidance for Industry and FDA Staff: The Content of Investigational...

  4. 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

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Draft Guidance for Clinical Investigators, Industry, and FDA... notice that appeared in the Federal Register of May 24, 2011 (76 FR 30175). The document announced...

  5. 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

    ... 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 Electronic Source Data in... Register of Tuesday, November 20, 2012 (77 FR 69632). The document announced the availability of a...

  6. 78 FR 3418 - Pesticides; Draft Guidance for Pesticide Registrants on Web-Distributed Labeling for Pesticide...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-16

    ... end of 2010, EPA initiated a ``user acceptance pilot.'' (75 FR 51058, August 18, 2010; EPA-HQ-OPP-2010... comment on a number of these issues. (75 FR 82011, December 29, 2010; EPA-HQ-OPP-2010-0648). Based on its... AGENCY Pesticides; Draft Guidance for Pesticide Registrants on Web- Distributed Labeling for...

  7. 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...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-09

    ... (21 CFR part 312, subpart I) went into effect on October 13, 2009 (74 FR 40900). These regulations... implementation of its expanded access regulations. Therefore, FDA is providing this draft guidance in a question... Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring,...

  10. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification Process (Evaluation of Automatic Class III Designation); Availability; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; extension of...

  11. 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...

  12. 76 FR 60055 - Draft Guidance for Industry: Applications for Premarket Review of New Tobacco Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-28

    ... Review of New Tobacco Products; Availability; Agency Information Collection Activities; Proposed... ``Applications for Premarket Review of New Tobacco Products.'' The draft guidance is intended to assist persons submitting applications for new tobacco products under the Federal Food, Drug, and Cosmetic Act (the FD&C...

  13. 76 FR 70150 - Draft Guidance for Industry and Food and Drug Administration Staff; Investigational Device...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-10

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration..., Including Certain First in Human Studies; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a...

  14. 75 FR 63189 - Draft Guidance for Industry on Investigational New Drug Applications-Determining Whether Human...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-14

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Investigational New Drug Applications--Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug... ``Investigational New Drug Applications (INDs)--Determining Whether Human Research Studies Can Be Conducted...

  15. 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...

  16. 78 FR 57859 - Draft Guidance for Industry on Endocrine Disruption Potential of Drugs: Nonclinical Evaluation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-20

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

  17. 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

    ... stability, as well as enhance processability of the solid material inputs in drug product manufacture... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY:...

  18. 76 FR 570 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-05

    ..., plasma, and blood. These devices are used to aid in the diagnosis of Lyme disease. This document does not... detection of antibodies to Borrelia burgdorferi. These devices are used to aid in the diagnosis of Lyme disease. This draft guidance is not final nor is it in effect at this time. DATES: Although you...

  19. 75 FR 73106 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-29

    ... Clostridium difficile (C. difficile). This draft guidance is not final nor is it in effect at this time. DATES... Assisting in the Diagnosis of C. difficile Associated Disease'' issued on May 31, 1990. It is updated to... C. difficile nucleic acids (e.g., C. difficile toxin B gene by nucleic acid amplification...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-13

    ... Communication, Outreach and Development (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and... of February 3, 2006 (71 FR 5861), which describes FDA's intention to update the process for... draft guidance, when finalized, will represent FDA's current thinking on this topic. It does not...

  1. 75 FR 57963 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-23

    ... Helicobacter pylori; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food... detecting Helicobacter pylori (H. pylori). This draft guidance is not final nor is it in effect at this time... Detection of Antibodies to Helicobacter pylori,'' to suggest information that submitters provide that...

  2. 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 document is intended to assist manufacturers in designing and developing home use medical devices...

  3. 77 FR 74852 - Draft Guidance for Industry on Certification of Designated Medical Gases; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-18

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

  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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Initial Completeness Assessments for Type II Active Pharmaceutical Ingredient Drug Master Files Under the Generic Drug User Fee Amendments of 2012 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  5. 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.... 78, No. 135 / Monday, July 15, 2013 / Notices#0;#0; ] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Circumstances That Constitute Delaying,...

  6. 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 FD&C Act, FDA is issuing this draft guidance, announcing its determination that submission types... files and advertising and promotional labeling submissions. However, FDA accepts and strongly encourages the submission of master files and advertising and promotional labeling materials electronically,...

  7. 76 FR 28688 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-18

    ... 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...

  8. 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...

  9. 76 FR 9027 - Draft Guidance for Industry and Food and Drug Administration Staff on Best Practices for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-16

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... Electronic Healthcare Data Sets; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... industry and FDA staff entitled ``Best Practices for Conducting and Reporting Pharmacoepidemiologic...

  10. 76 FR 58311 - Draft License Renewal Interim Staff Guidance LR-ISG-2011-05; Ongoing Review of Operating Experience

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-20

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

  11. 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... Life Cycle: Infusion Pump-- Premarket Notification Submissions'' to the Division of Small...

  12. 77 FR 36273 - Public Meeting on Draft Permitting Guidance for Oil and Gas Hydraulic Fracturing Activities Using...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-18

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

  13. 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...

  14. 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

    ... guidance outlines the types of nonclinical studies and clinical trials recommended throughout the drug... 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...

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

    NASA Technical Reports Server (NTRS)

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

    2011-01-01

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

  16. 76 FR 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...

  17. 77 FR 45357 - Draft Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Review...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-31

    ... either electronic or written comments on the draft guidance by September 14, 2012. ADDRESSES: Submit... Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993-0002; or Office of Communication, Outreach and... section for information on electronic access to the guidance. Submit electronic comments on the...

  18. 77 FR 74670 - Draft Guidance for Industry on Enrichment Strategies for Clinical Trials to Support Approval of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-17

    ... Clinical Trials to Support Approval of Human Drugs and Biological Products; Availability AGENCY: Food and... the availability of a draft guidance for industry entitled ``Enrichment Strategies for Clinical Trials... provide guidance to industry on enrichment strategies that can be used in clinical trials intended...

  19. 78 FR 68459 - Medical Device Development Tools; Draft Guidance for Industry, Tool Developers, and Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-14

    ... guidance to FDA staff, industry, healthcare providers, researchers, and patient and consumer groups on a... HUMAN SERVICES Food and Drug Administration Medical Device Development Tools; Draft Guidance for Industry, Tool Developers, and Food and Drug Administration Staff; Availability AGENCY: Food and...

  20. 76 FR 67764 - Common-Cause Failure Analysis in Event and Condition Assessment: Guidance and Research, Draft...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-02

    ... COMMISSION Common-Cause Failure Analysis in Event and Condition Assessment: Guidance and Research, Draft...-xxxx, Revision 0, ``Common-Cause Failure Analysis in Event and Condition Assessment: Guidance and...-0254 in the subject line of your comments. For additional instructions on submitting comments...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-07

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

  3. 77 FR 34949 - Draft Guidance on Considerations in Transferring a Previously-Approved Research Project to a New...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-12

    ... HUMAN SERVICES Draft Guidance on Considerations in Transferring a Previously- Approved Research Project... on Considerations in Transferring a Previously-Approved Research Project to a New IRB or Research... Guidance on Considerations in Transferring a Previously-Approved Research Project to a New IRB or...

  4. 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...

  5. 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

    ... TV ads will be subject to a 45-calendar day review clock by FDA. DATES: Although you can comment on... on this draft guidance before it begins work on the final version of the guidance, submit either... table 1 of this document. There is a 45-day review clock for TV ads submitted under section 503B....

  6. 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

    ..., gonorrhea, Lyme disease, streptococcal pharyngitis and tonsillitis, uncomplicated urinary tract infections... Neutropenia--Developing Antimicrobial Drugs for Treatment''--issued July 1998. 7. ``Lyme Disease--Developing... ``Administrative Practices and Procedures; Good Guidance Practices'' (GGP) (65 FR 56468; September 19, 2000)....

  7. 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... hydrochloride (multiple reference listed drugs and dosage forms). C Cefixime. Celecoxib....

  8. Recommendations and Guidance for Practice in Youth Tobacco Cessation

    ERIC Educational Resources Information Center

    Milton, Micah H.; Maule, Catherine O.; Backinger, Cathy L.; Gregory, Dena M.

    2003-01-01

    Objectives: To summarize recommendations from Youth Tobacco Cessation: A Guide for Making Informed Decisions for careful consideration, selection, implementation, and evaluation of youth cessation interventions. Methods: Recommendations were developed from an evidence review and consensus from a multidisciplinary advisory panel. Results:…

  9. 77 FR 10536 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-22

    ... (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 January 25, 2012 (77 FR 3777... ingredients: A Alendronate Sodium Alendronate Sodium; Cholecalciferol B Benzoyl Peroxide;...

  10. 76 FR 50220 - Availability of Draft ICCVAM Recommendations on Using Fewer Animals to Identify Chemical Eye...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-12

    ...-animal tests that would provide eye hazard classification equivalent to testing conducted in accordance... testing is expected to adhere to the 3-animal procedure described in OECD Test Guideline 405 (OECD, 2002... HUMAN SERVICES Availability of Draft ICCVAM Recommendations on Using Fewer Animals to Identify...

  11. 78 FR 37242 - Draft Report and Recommendations Prepared by the Research Committee of the Scientific Working...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-20

    ... of Justice Programs Draft Report and Recommendations Prepared by the Research Committee of the Scientific Working Group on Medicolegal Death Investigation AGENCY: National Institute of Justice, DOJ..., the U.S. Department of Justice, Office of Justice Programs, National Institute of Justice,...

  12. Draft area recommendation report for the Crystalline Repository Project: Comments: Final technical report

    SciTech Connect

    Not Available

    1986-04-16

    The Mille Lacs Band conducted a review of the draft area recommendation report (ARR) and provided comments as outlined in the contract. It also had staff attending the necessary training and informational meeting established by the Department of Energy. This had met all the necessary objectives as outlined in the contract.

  13. 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... implementation of the National Environmental Policy Act (NEPA). Enacted in 1970, NEPA is a fundamental tool used to harmonize our economic, environmental, and social aspirations and is a cornerstone of our...

  14. 77 FR 63837 - Draft Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-17

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

  15. 78 FR 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...

  16. 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...

  17. 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

    ... Dispute Resolution: Appeals Above the Division Level; Availability AGENCY: Food and Drug Administration... a draft guidance for industry and review staff entitled ``Formal Dispute Resolution: Appeals Above... staff entitled ``Formal Dispute Resolution: Appeals Above the Division Level.'' In the course of...

  18. 77 FR 37058 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-20

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration...; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug... Manufacturers, International and Consumer Assistance, Center for Devices and Radiological Health, Food and...

  19. 76 FR 77542 - Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian Use Device...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-13

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

  20. 75 FR 78259 - Draft Guidance for Industry on Codevelopment of Two or More Unmarketed Investigational Drugs for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-15

    ... to apply to vaccines, gene or cellular therapies, blood products, or medical devices. DATES: Although... vaccines, gene or cellular therapies, or blood products. This draft guidance is being issued consistent... development of resistance. In settings in which combination therapy provides significant...

  1. 76 FR 51038 - Draft Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-17

    ... INFORMATION: In a notice published in the Federal Register of July 26, 2007 (72 FR 41080), FDA announced the... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells; Withdrawal...

  2. 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...

  3. 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...

  4. 76 FR 70768 - Common-Cause Failure Analysis in Event and Condition Assessment: Guidance and Research, Draft...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-15

    ... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY COMMISSION Common-Cause Failure Analysis in Event and Condition Assessment: Guidance and Research, Draft... November 2, 2011 (76 FR 67764). This action is necessary to correct an erroneous date for submission...

  5. 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...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-17

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Self-Identification of... notice that appeared in the Federal Register of Monday, August 27, 2012 (77 FR 51811). The...

  7. 75 FR 37450 - Draft Guidance: The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-29

    ... Antimicrobial Drugs in Food-Producing Animals; Availability AGENCY: Food and Drug Administration, HHS. ACTION... Animals.'' This draft guidance is intended to inform the public of FDA's current thinking on the use of medically important antimicrobial drugs in food-producing animals. DATES: Although you can comment on...

  8. 78 FR 38349 - Draft Guidance for Industry on Expedited Programs for Serious Conditions-Drugs and Biologics...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-26

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

  9. 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...

  10. 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...

  11. 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...

  12. 78 FR 55261 - Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-10

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers (Revision 1); Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability...

  13. 77 FR 51814 - Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-27

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of...

  14. 77 FR 75174 - Draft Guidance for Industry on Providing Submissions in Electronic Format-Summary Level Clinical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-19

    ... submitted to and reviewed by CDER as described in the Federal Register of June 26, 2003 (68 FR 38067....'' The draft guidance is intended to assist applicants in the voluntary submission of a clinical dataset... of the individual study site (summary level clinical site dataset). The summary level clinical...

  15. 77 FR 40354 - Permitting Guidance for Oil and Gas Hydraulic Fracturing Activities Using Diesel Fuels-Draft

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-09

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

  16. 78 FR 60292 - Draft Guidance for Industry on Abbreviated New Drug Application Submissions-Refuse-to-Receive...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-01

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Abbreviated New Drug... to assist applicants preparing to submit to FDA abbreviated new drug applications (ANDAs) and related... ANDAs and PASs to ANDAs for which the applicant is seeking approval of a new strength of the...

  17. 77 FR 27461 - Draft Guidance for Industry and Food and Drug Administration Staff; Pediatric Information for X...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-10

    ... Staff; Pediatric Information for X-Ray Imaging Device Premarket Notifications; Availability AGENCY: Food... announcing the availability of the draft guidance entitled ``Pediatric Information for X-ray Imaging Device... should be ] provided in premarket notifications for x-ray imaging devices with indications for use...

  18. 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

    ... design clinical trials (i.e., clinical, statistical, regulatory) call for special consideration, when to interact with FDA while planning and conducting adaptive design studies, what information to include in the... study. The draft guidance is intended to assist sponsors in planning and conducting adaptive...

  19. 78 FR 56719 - Draft Guidance for Industry on Arsenic in Apple Juice: Action Level; Supporting Document for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-13

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-15

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

  1. 75 FR 53316 - Draft Guidance for Food and Drug Administration Staff and Tobacco Retailers on Civil Money...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-31

    ...'' that were published by FDA in the Federal Register of March 19, 2010 (75 FR 13225) (21 CFR part 1140... Tobacco Retailers on Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers; Availability...) is announcing the availability of a draft guidance entitled ``Civil Money Penalties and...

  2. 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...

  3. 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...

  4. 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

    ...EPA is requesting comment on draft EPA guidance to auto manufacturers for weighting the greenhouse gas (GHG) emissions of a flexible fuel vehicle operating on E85 with the GHG emissions of the vehicle operating on conventional gasoline, when calculating the compliance value to use for EPA's GHG emissions standards. EPA also invites comment on the analysis used by EPA to determine the weighting......

  5. 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

    ... availability was published in the Federal Register on June 22, 2010 (75 FR 35510). The NRC staff has developed... Experience Request for Public Comment AGENCY: Nuclear Regulatory Commission (NRC). ACTION: Draft license... Interim Staff Guidance (LR-ISG), LR-ISG-2011-05, ``Ongoing Review of Operating Experience.'' This...

  6. 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...

  7. 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...

  8. 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...

  9. 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...

  10. 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...

  11. 75 FR 17147 - International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-05

    ... Federal Register of August 14, 2009 (74 FR 41144), FDA published a ] notice announcing the availability of... Register of February 21, 2008 (73 FR 9575). When implemented, the annex will provide guidance for industry... Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference...

  12. 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. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of...

  13. 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

  14. 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.

  15. 78 FR 21128 - Molecular Diagnostic Instruments With Combined Functions; Draft Guidance for Industry and Food...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-09

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

  16. 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,...

  17. Red Lake Band of Chippewa Indians response to the draft area recommendation report

    SciTech Connect

    Not Available

    1986-04-15

    The statement of Little Rock, a Chief of the Red Lake Band of Chippewa Indians, provides the genesis of the Red Lake Band of Chippewa Indian's response to the Department of Energy's efforts to establish a nuclear waste repository on lands ceded under the Treaty of 1863. Of paramount interest to the Red Lake Band of Chippewa Indians are the unresolved issues of hunting and fishing rights, promised in the Treaty negotiations of 1863 and still unresolved to the satisfaction of Tribal members. Comments pertaining to the draft Area Recommendation Report will address the potential impact of a high-level nuclear repository on the human and natural resources of the Red Lake Band of Chippewa Indians. Socio-cultural factors of economics and family displacement and traditional beliefs, combined with potential hazards to natural habitats of wildlife, will be analyzed and synthesized for applicable conclusions. 18 refs., 4 tabs.

  18. 76 FR 64353 - Request for Public Comment on Draft Document: “Criteria for a Recommended Standard: Occupational...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-18

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

  19. 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

    ... principles and concepts described in ICH guidances ``Q8 Pharmaceutical Development,'' ``Q9 Quality Risk Management,'' and ``Q10 Pharmaceutical Quality Systems'' as they pertain to the development and manufacture...ComplianceRegulatoryInformation/Guidances/default.htm , or...

  20. 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.

  1. 75 FR 13765 - Draft Guidance for Industry on Irritable Bowel Syndrome-Clinical Evaluation of Products for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-23

    ... of primary endpoints for IBS clinical trials, interim recommendations for IBS clinical trial design... clinical trials. This guidance is intended to assist the pharmaceutical industry and other investigators... subtype is the ideal primary efficacy assessment tool in clinical trials used to support labeling...

  2. Solicitation of information and recommendations for developing OIG compliance program guidance for the durable medical equipment industry--HHS. Notice.

    PubMed

    1998-08-01

    This Federal Register notice seeks the input and recommendations of interested parties into the OIG's development of a compliance program guidance for the durable medical equipment (DME) industry, its providers and suppliers. Many providers and provider organizations have expressed an interest in better protecting their operations from fraud and abuse. Previously, the OIG has developed compliance program guidances for hospitals, clinical laboratories and home health agencies. In order to provide clear and meaningful guidance to those segments of the health care industry involved in the supply and distribution of DME, we are soliciting comments, recommendations and other suggestions from concerned parties and organizations on how best to develop compliance program guidance and reduce fraud and abuse within the DME industry.

  3. 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…

  4. 75 FR 50771 - Draft Revised Guidance for Industry on Residual Solvents in New Veterinary Medicinal Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-17

    ... Federal Register of May 22, 2001 (66 FR 28182) (the 2001 final guidance), has been developed for... residual solvents in new animal drugs (referred to as pharmaceuticals or veterinary medicinal products in this guidance) for the safety of the target animal as well as for the safety of human consumers...

  5. 75 FR 41452 - Draft Guidance, “Federal Greenhouse Gas Accounting and Reporting”

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-16

    ... peer-reviewed life cycle methodologies is beyond the scope of the current version of this guidance... request comment on inclusion of life cycle methodologies in future versions of this Guidance document. CEQ... Leadership in Environmental, Energy, and Economic Performance (74 FR 52117) in order to establish...

  6. 75 FR 49913 - Draft Guidance, “Federal Greenhouse Gas Accounting and Reporting”

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-16

    ... peer-reviewed life cycle methodologies is beyond the scope of the current version of this guidance... request comment on inclusion of life cycle methodologies in future versions of this Guidance document. CEQ..., Energy, and Economic Performance (74 FR 52117) in order to establish an integrated strategy...

  7. 78 FR 68030 - Draft Guidance on Intellectual Property Rights for the National Network for Manufacturing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-13

    ... Register (77 FR 26509) and may be found at: http://www.gpo.gov/fdsys/pkg/FR-2012-05-04/pdf/2012-10809.pdf... National Network for Manufacturing Innovation and Draft Institute Performance Metrics for the National Network for Manufacturing Innovation AGENCY: National Institute of Standards and Technology, Department...

  8. 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...

  9. 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...

  10. 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

    ... Influenza Pandemic.'' In the Federal Register of December 16, 2008 (73 FR 76364), FDA published notice of... Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic; Availability AGENCY... for Medical Products and Dietary Supplements During an Influenza Pandemic.'' The draft...

  11. 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...

  12. Drafting.

    ERIC Educational Resources Information Center

    Hughes, Larry R.

    This guide to teaching drafting, one in a series of instructional materials for junior high industrial arts education, is designed to assist teachers as they plan and implement new courses of study and as they make revisions and improvements in existing courses in order to integrate classroom learning with real-life experiences. This drafting…

  13. 78 FR 56718 - Draft Guidance for Industry on Bioanalytical Method Validation; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-13

    ... (66 FR 28526), FDA issued the first version of this guidance. Since then, substantial scientific and... where needed, such as the sections on chromatography and ligand-binding assays. The changes...

  14. 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

    ... Arrangements for Drugs: Quality Agreements; Availability AGENCY: Food and Drug Administration, HHS. ACTION... guidance for industry entitled ``Contract Manufacturing Arrangements for Drugs: Quality Agreements.'' This... drugs can utilize Quality Agreements to delineate their responsibilities and assure drug quality,...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-20

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

  16. 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... as a cause of respiratory allergic reactions; (2) rhinitis, conjunctivitis, and dyspnea;...

  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

    ...' diarrhea caused by noninvasive strains of Escherichia coli. Xifaxan (rifaximin) 550-mg tablets, approved by.... Background In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of...

  18. 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...

  19. 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...

  20. 76 FR 78659 - Solicitation of Written Comments on the Draft Report and Draft Recommendations of the Healthcare...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-19

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

  1. 77 FR 48989 - Draft Guidance for Industry on Suicidal Ideation and Behavior: Prospective Assessment of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-15

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-24

    ... clinical trial designs to support approval of drugs. DATES: Although you can comment on any guidance at any... trial sponsors ``Establishment and Operation of Clinical Trial Data Monitoring Committees'' have been... margin based on historical observational data compared to the results of previously conducted...

  3. 76 FR 34715 - Draft Guidance for Industry; Considering Whether an FDA-Regulated Product Involves the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-14

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

  4. 75 FR 13562 - Revised Draft Guidance for Industry on Pharmacokinetics in Patients With Impaired Renal Function...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-22

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

  5. 77 FR 5415 - National Organic Program: Notice of Draft Guidance for Accredited Certifying Agents, Certified...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-03

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

  6. 76 FR 1173 - Draft Guidance for Industry on Electronic Source Documentation in Clinical Investigations...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-07

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

  7. 77 FR 20030 - Draft Guidance for Industry: Reporting Harmful and Potentially Harmful Constituents in Tobacco...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-03

    ... the HPHC list requirement (76 FR 5387, January 31, 2011). The guidance is available on the Internet at..., on August 12, 2011, FDA issued a document (the HPHC notice; 76 FR 50226) in the Federal Register... Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under the Federal Food, Drug,...

  8. 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

    ... accordance with ICH E2C (see 62 FR 27470 (May 19, 1997) and 69 FR 5551 (Feb. 5, 2004)) instead of a PADER... with an existing PSUR waiver to substitute the PBRER for the PSUR without submitting a new waiver...Information/Guidances/default.htm ,...

  9. 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... and Sources of Vitamins and Minerals For Organic Livestock Feed, Feed Supplements, and Feed Additives... (NOP 5029)'', and ``Evaluating Allowed Ingredients and Sources of Vitamins and Minerals For...

  10. Solicitation of information and recommendations for developing OIG compliance program guidance for certain Medicare+Choice organizations--OIG, HHS. Notice.

    PubMed

    1998-09-22

    This Federal Register notice seeks the input and recommendations of interested parties into the OIG's development of a compliance program guidance for Medicare+Choice organizations that offer coordinated care plans (M+CO/CCPs). The OIG has previously developed compliance program guidances for hospitals, clinical laboratories and home health agencies in order to provide clear and meaningful guidance to those segments of the health care industry. In an effort to provide similar guidance to certain M+C organizations, we are soliciting comments, recommendations and other suggestions from concerned parties and organizations on how best to develop compliance program guidance and reduce fraud and abuse within M+CO/CCPs.

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

    SciTech Connect

    1984-02-01

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

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

    SciTech Connect

    1997-04-01

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

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

    SciTech Connect

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

    2006-08-15

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

  14. 77 FR 28600 - Draft publication: Coal Dust Explosibility Meter Evaluation and Recommendations for Application

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-15

    ... Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC... HUMAN SERVICES Centers for Disease Control and Prevention Draft publication: Coal Dust Explosibility... comment. SUMMARY: The National Institute for Occupational Safety and Health (NIOSH) of the Centers...

  15. 77 FR 10535 - Final Guidances for Industry Describing Product-Specific Bioequivalence Recommendations...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-22

    ... FR 33311), FDA announced the availability of a guidance for industry, ``Bioequivalence... Meprobamate Methotrexate Sodium (multiple RLDs) Methylprednisolone Acetate Metoclopramide HCl N Nadolol... Tosylate T Tamoxifen Citrate Telbivudine Temazepam Terbinafine HCl Toremifene Citrate V Voriconazole...

  16. 78 FR 46954 - Agency Information Collection Activities; Proposed Collection; Comment Request; Draft Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-02

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

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

    PubMed Central

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

    2015-01-01

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

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

    NASA Astrophysics Data System (ADS)

    Streibel, Martin; Schoebel, Birgit

    2015-04-01

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

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

    SciTech Connect

    Not Available

    1993-03-01

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

  20. 75 FR 78705 - Issuance of Exposure Drafts on Implementation Guidance on the Accounting for the Disposal of G-PP...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-16

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

  1. 78 FR 63221 - International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-23

    ... FURTHER INFORMATION CONTACT: Regarding the guidance: Robert King, Sr., Center for Drug Evaluation and... 20993-0002, 301- 796-1242; or Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17... Organization, Health Canada, and the European Free Trade Area. In the Federal Register of July 19, 2010 (75...

  2. 78 FR 31944 - International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-28

    ... guidance: Robert King, Sr., Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 4150, Silver Spring, MD 20993-0002, 301-796-1242; or Stephen Ripley... Organization, Health Canada, and the European Free Trade Area. In the Federal Register of July 14, 2010 (75...

  3. 75 FR 75483 - Guidance for Industry: Recommendations for Blood Establishments: Training of Back-Up Personnel...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-03

    ... guidance, the H1N1 influenza pandemic has waned in the United States and disruptions in the blood supply..., and Preservation of the Blood Supply in Response to Pandemic (H1N1) 2009 Virus'' dated November 2009... in Response to Pandemic (H1N1) 2009 Virus'' (November 2009). At that time, we anticipated that...

  4. 75 FR 42098 - International Conference on Harmonisation; Draft Recommendation for the Revision of the Permitted...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-20

    ... Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers Association; the Centers for Drug... Federal Register of December 24, 1997 (62 FR 67377), FDA published the ICH guidance for industry entitled... February 12, 2002 (67 FR 6542), FDA briefly described the process for proposing future revisions to the...

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

    SciTech Connect

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

    2007-09-04

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

  6. 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

    ... Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC... recommendations for occupational standards, prevention and control. In recent years, including during the oil... HUMAN SERVICES Centers for Disease Control and Prevention (CDC) Criteria for a Recommended...

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

    SciTech Connect

    Butler, J.R.

    1986-03-13

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

  8. 76 FR 60937 - Draft License Renewal Interim Staff Guidance LR-ISG-2011-02; Aging Management Program for Steam...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-30

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

  9. 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... applicable to donors of Source Plasma. DATES: Submit either electronic or written comments on...

  10. 76 FR 37129 - International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-24

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

  11. General Drafting. Technical Manual.

    ERIC Educational Resources Information Center

    Department of the Army, Washington, DC.

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

  12. 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

    ... decompensated cirrhosis and those co-infected with human immunodeficiency virus (HIV). The guidance also... experienced, patients without cirrhosis, patients with compensated and decompensated cirrhosis, and...

  13. 78 FR 72901 - Draft Guidance; Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-04

    ... November 23, 1998 (63 FR 64723), FDA announced the availability of a guidance entitled ``Enforcement Policy... withdrawn. In a notice published in the Federal Register of June 7, 2002 (67 FR 39409), FDA announced the... Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Withdrawal of Guidances AGENCY: Food...

  14. 77 FR 44256 - Draft Guidance for Industry and Food and Drug Administration Staff; Safety Considerations for 510...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-27

    ... guidance is not final nor is it in effect at this time. DATES: Although you can comment on any guidance at... professionals, hospital purchasing departments, and manufacturers of enteral feeding tubes regarding luer lock... Misconnections With Small-Bore Connectors Intended for Enteral Applications,'' you may either send an...

  15. 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

    ... individual case safety reports to regulatory authorities, automated data mining techniques, more attention to... and combines two ICH guidances, ``E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs'' (E2C guidance) and ``Addendum to E2C Clinical Safety Data Management:...

  16. 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

    ... Guidance (October 5, 2006, 71 FR 58739). In this guidance, FDA is proposing to amend our response to... we believe that an alternative regulatory program, comprised of alternative technology such as two dimensional symbology, could render the use of linear bar codes unnecessary for patient safety and...

  17. 78 FR 39736 - Draft Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-02

    ... of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; Availability AGENCY: Food and... Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products'' dated July 2013. The draft... assist in designing early-phase clinical trials of CGT products. DATES: Although you can comment on...

  18. 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

    ... labeling and advertising for prescription human and animal drugs and biological products. The draft... prescription human and animal drug and biological products is important for the proper identification of such... proprietary and established names for human and animal prescription drug products are specified in...

  19. 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

    ... Commercially Marketed in the United States as of February 15, 2007.'' It does not create or confer any rights... Staff; Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February... Product Was Commercially Marketed in the United States as of February 15, 2007.'' This draft...

  20. 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

    ... From the Federal Register Online via the Government Publishing Office ] DEPARTMENT OF HEALTH AND... human health risks associated with exposure to dibutyl phthalate (DBP) and di(2-ethylhexyl) phthalate... potential human health risks associated with exposure to DBP and DEHP. In particular, the draft...

  1. 76 FR 72725 - Draft License Renewal Interim Staff Guidance LR-ISG-2011-05: Ongoing Review of Operating Experience

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-25

    ... for public comment. SUMMARY: On August 24, 2011, in the Federal Register (76 FR 52995), the U.S... 20, 2011 (76 FR 58311), the public comment period was extended and, as of October 23, 2011, is now... Register on June 22, 2010 (75 FR 35510). The NRC staff developed draft LR-ISG-2011-05 to clarify...

  2. Recommendations

    ERIC Educational Resources Information Center

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

    2015-01-01

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

  3. 75 FR 69449 - Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-12

    ... Means to Distribute Certain Product Information'' (71 FR 26102, May 3, 2006). That guidance referred to... information. \\1\\ Mazor K, S. Andrade, J. Auger, et al., ``Communicating Safety Information to Physicians:...

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

    EPA Science Inventory

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

  5. 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

    ... for review by the Center for Veterinary Medicine (CVM), Office of New Animal Drug Evaluation (ONADE... guidance to the Communications Staff (HFV-12), Center for Veterinary Medicine, Food and Drug Administration... Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855,...

  6. 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

    ... Clinical Trials To Support Approval of Human Drugs and Biological Products; Extension of Comment Period... entitled ``Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological... guidance to industry on enrichment strategies that can be used in clinical trials intended to...

  7. 78 FR 69690 - Draft Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-20

    ... of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; Extension of Comment Period... entitled ``Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of Cellular... assist in designing early-phase clinical trials of CGT products. In the notice, we requested comments...

  8. 76 FR 53683 - Draft Guidance for Industry on Oversight of Clinical Investigations: A Risk-Based Approach to...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-29

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

  9. 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

    ... in the final product may be produced using excluded methods (i.e., genetically modified organisms... (genetically modified organisms), sewage sludge, or ionizing radiation, but may be produced using synthetic... Management and Budget (OMB) Bulletin on Agency Good Guidance Practices (GGPs) (January 25, 2007, 72 FR...

  10. 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

    ... page number). Follow directions--The agency may ask you to respond to specific questions or organize... and receiving public input will ensure that the guidance adequately addresses remaining questions... No. 517; EINECS 232-366-4; EPA Pesticide Chemical Code 063501; Fuel oil No. 1; Fuels, kerosine;...

  11. 76 FR 72950 - Draft Guidance for Industry: Use of Nucleic Acid Tests on Pooled and Individual Samples From...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-28

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

  12. 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

    ... includes language for alternate administration via an enteral feeding tube. The recommendations in this... administration via an enteral feeding tube, and (3) how to address potential bead size differences between... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH...

  13. 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

    ... Staff; Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Review... When Making Benefit-Risk Determinations in Medical Device Premarket Review.'' The recommendations in... document entitled ``Factors to Consider When Making Benefit- Risk Determinations in Medical...

  14. 77 FR 22327 - Draft Guidance for Industry on New Animal Drugs and New Animal Drug Combination Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-13

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

  15. International Conference on Harmonisation; S10 Photosafety Evaluation of Pharmaceuticals; guidance for industry; availability. Notice.

    PubMed

    2015-01-27

    The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "S10 Photosafety Evaluation of Pharmaceuticals.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). This guidance outlines details on when photosafety testing is warranted and on possible assessment strategies; it should be read in conjunction with the ICH M3(R2) guidance, section XIV(14) Photosafety Testing. The purpose of the guidance is to recommend international standards for photosafety assessment and to harmonize such assessments that support human clinical trials and marketing authorization for pharmaceuticals. This guidance finalizes the draft guidance issued on February 4, 2013.

  16. 77 FR 68133 - Guidance for Industry: Use of Nucleic Acid Tests on Pooled and Individual Samples From Donors of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-15

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

  17. Recommendation for Short-Interval Follow-Up Examinations After a Probably Benign Assessment: Is Clinical Practice Consistent With BI-RADS Guidance?

    PubMed Central

    Aiello Bowles, Erin J.; Sickles, Edward A.; Miglioretti, Diana L.; Carney, Patricia A.; Elmore, Joann G.

    2010-01-01

    Objective American College of Radiology BI-RADS guidance suggests that women with a probably benign finding on mammography receive a management recommendation for short-interval follow-up; historically, radiologists in community practice have not consistently linked this assessment with short-interval follow-up. We evaluated predictors of discordance between probably benign assessments and short-interval follow-up recommendations. Materials and Methods We linked data on 196 radiologists who completed a survey on demographic and practice patterns to 15,515 diagnostic mammograms they interpreted with probably benign assessments between 2001 and 2006. Patient characteristics were collected at the time of the mammography. Using logistic regression, we examined whether patient and radiologist characteristics were associated with the odds of short-interval follow-up recommendations (relative to a recommendation for normal follow-up, additional imaging evaluation, or biopsy or surgical consultation). Results Overall, 90.9% of mammograms with probably benign findings were recommended for short-interval follow-up; 4.3% were recommended for normal follow-up, 3.0% for additional imaging, and 1.8% for biopsy or surgical consultation. Women with probably benign findings were less likely to receive a short-interval follow-up recommendation if they had extremely dense breasts versus almost entirely fatty breasts (odds ratio [OR], 0.61; 95% CI, 0.39–0.96) or had a breast lump versus no symptoms (OR, 0.55; 95% CI, 0.38–78). Radiologists were less likely to recommend short-interval follow-up if they had ≥ 20 years of experience versus < 10 years of experience (OR, 0.57; 95% CI, 0.36–0.90) but more likely if they practiced primarily at an academic medical center versus other institutions (OR, 2.66; 95% CI, 1.14–6.21). Conclusion In contrast to older studies, the majority of probably benign assessments are now recommended for short-interval follow-up, but the probability of

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

    PubMed

    2013-05-28

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

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

    PubMed

    2013-10-23

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

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

    PubMed

    2014-06-16

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

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

    PubMed

    2010-09-01

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

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

    PubMed

    Hirose, Akihiko

    2013-01-01

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

  3. 78 FR 35940 - Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; Draft...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-14

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

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

    PubMed

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

    2011-07-01

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

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

    SciTech Connect

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

    1986-03-01

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

  6. 77 FR 28519 - Test Procedure Guidance for Room Air Conditioners, Residential Dishwashers, and Residential...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-15

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

  7. RCRA (Resource Conservation and Recovery Act) personnel training guidance manual for owners or operators of hazardous-waste-management facilities. Draft report

    SciTech Connect

    Not Available

    1980-09-01

    The manual provides guidance to an audience consisting of owners or operators of hazardous waste-management facilities and also regulatory personnel responsible for facility permitting. Information is provided concerning general training strategies and program design, types of training, training modules pertinent to hazardous-waste management, suggested training module elements, and sources of information.

  8. 32 CFR 989.19 - Draft EIS.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

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

  9. 32 CFR 989.19 - Draft EIS.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

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

  10. 32 CFR 989.19 - Draft EIS.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

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

  11. 32 CFR 989.19 - Draft EIS.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

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

  12. 78 FR 56752 - Interim Staff Guidance Specific Environmental Guidance for Integral Pressurized Water Reactors...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-13

    ... comment on, draft Interim Staff Guidance (ISG) ESP/COL-ISG-027, ``Interim Staff Guidance Specific..., early site permits (ESPs), and combined licenses (COLs). DATES: Submit comments by October 15, 2013... issues ESP/COL-ISGs to facilitate timely implementation of current staff guidance and to...

  13. 76 FR 61098 - Guidance for 1-Hour SO2

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-03

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

  14. Corporate information management guidance

    SciTech Connect

    1997-08-01

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

  15. 76 FR 26177 - National Organic Program: Notice of Final Guidance for Accredited Certifying Agents and Certified...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-06

    ... on five draft guidance documents (75 FR 62693). The topics covered in the draft documents addressed... Guidance Practices (GGPs) (January 25, 2007, 72 FR 3432-3440). The purpose of GGPs is to ensure that... Service 7 CFR Part 205 National Organic Program: Notice of Final Guidance for Accredited Certifying...

  16. 76 FR 72951 - Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-28

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

  17. 77 FR 62247 - Dynamic Positioning Operations Guidance for Vessels Other Than Mobile Offshore Drilling Units...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-12

    ... recommended interim voluntary guidance titled ``Mobile Offshore Drilling Unit Dynamic Positioning Guidance''. The notice recommended owners and operators of Mobile Offshore Drilling Units (MODUs) follow Marine....'' The recommended interim voluntary guidance titled ``Mobile Offshore Drilling Unit (MODU)...

  18. Architectural Drafting.

    ERIC Educational Resources Information Center

    Davis, Ronald; Yancey, Bruce

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

  19. Civil Drafting.

    ERIC Educational Resources Information Center

    Schertz, Karen; Kellum, Mary, Ed.

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

  20. Mechanical Drafting.

    ERIC Educational Resources Information Center

    McClain, Gerald R.

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

  1. 76 FR 71577 - Guidance for Industry on Medication Guide Distribution Requirements and Inclusion of Medication...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-18

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

  2. 78 FR 33447 - Draft Applications for Sealed Source and Device Evaluation and Registration

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-04

    ... COMMISSION Draft Applications for Sealed Source and Device Evaluation and Registration AGENCY: Nuclear... Commission (NRC) is revising its licensing guidance for applications for sealed source and device evaluation..., ``Consolidated Guidance about Materials Licenses: Applications for Sealed Source and Device Evaluation...

  3. 78 FR 53773 - Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-30

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

  4. 78 FR 53792 - Draft Guidance for Reciprocity

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-30

    ... (Reciprocity).'' The document has been updated from the previous revision to include safety culture, security.... Brian J. McDermott, Director, Division of Materials Safety and State Agreements, Office of Federal...

  5. 77 FR 60126 - Guidance for Industry on Acute Bacterial Otitis Media: Developing Drugs for Treatment; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-02

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

  6. 75 FR 57469 - Guidance on Withdrawal of Subjects From Research: Data Retention and Other Related Issues

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-21

    ... HUMAN SERVICES Guidance on Withdrawal of Subjects From Research: Data Retention and Other Related Issues... Retention and Other Related Issues.'' The guidance document provides OHRP's first formal guidance on this... (73 FR 72804). OHRP received comments on the draft guidance document from 30 individuals...

  7. 77 FR 70168 - Guidance for Industry and Food and Drug Administration Staff; The Content of Investigational...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-23

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

  8. 78 FR 22887 - Guidance for Industry on Non-Penicillin Beta-Lactam Drugs: A Current Good Manufacturing Practices...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-17

    ... manufactured, and should have an independent air handling system. A draft version of this guidance was... practices regulation (21 CFR 10.115). The guidance represents the Agency's current thinking on...

  9. 77 FR 64999 - Guidance for Industry: Necessity of the Use of Food Product Categories in Food Facility...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-24

    ... Federal Register of August 15, 2012 (77 FR 48990), we made available a draft guidance entitled ``Guidance..., as added by section 305 of the Public Health Security and Bioterrorism Preparedness and Response...

  10. 78 FR 14097 - Pulse Oximeters-Premarket Notification Submissions [510(k)s]; Guidance for Industry and Food and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-04

    ... Federal Register of July 19, 2007 (72 FR 39631), FDA announced the availability of the draft guidance... developed this guidance document to assist industry in preparing a Premarket Notification (510(k)) for...

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

    ERIC Educational Resources Information Center

    Missouri Univ., Columbia. Instructional Materials Lab.

    This Missouri Vocational Instruction Management System instructor's drafting guide has been keyed to the drafting competency profile developed by state industry and education professionals. The guide contains a cross-reference table of instructional materials. Ten units cover drafting fundamentals: (1) introduction to drafting; (2) general safety;…

  12. A manual of recommended practices for hydrogen energy systems

    SciTech Connect

    Hoagland, W.; Leach, S.

    1997-12-31

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

  13. 75 FR 75809 - Guidance for Industry: Use of Serological Tests To Reduce the Risk of Transmission of Trypanosoma...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-06

    ... (74 FR 13211), FDA announced the availability of the draft guidance entitled ``Guidance for Industry... Health and Human Services Food and Drug Administration Guidance for Industry: Use of Serological Tests To... Management and Budget Review; Comment Request; Guidance for Industry: Use of Serological Tests To Reduce...

  14. 75 FR 53724 - Notice of Availability and Opportunity for Comment on Draft Division of Safety Systems Interim...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-01

    ... Systems Interim Staff Guidance, (DSS-ISG) DSS-ISG-2010-01, ``Staff Guidance Regarding the Nuclear... COMMISSION Notice of Availability and Opportunity for Comment on Draft Division of Safety Systems Interim Staff Guidance DSS-ISG-2010-01: Staff Guidance Regarding the Nuclear Criticality Safety Analysis...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-20

    ... (74 FR 68629), FDA announced the availability of a draft guidance entitled ``Tobacco Health Document... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Tobacco Health Document Submission... Administration (FDA) is announcing the availability of a guidance entitled ``Tobacco Health Document...

  16. 75 FR 81605 - Endocrine Disruptor Screening Program (EDSP); Announcing the Availability of a Draft for Weight...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-28

    ... public comment period established in the Federal Register notice of November 4, 2010 (75 FR 67963) (FRL...-Evidence Guidance Document: Evaluating Results of EDSP Tier 1 Screening To Identify Candidate Chemicals for... 4, 2010, concerning a draft guidance document titled, ``Weight-of-Evidence Guidance...

  17. 77 FR 26562 - Mobile Offshore Drilling Unit Dynamic Positioning Guidance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-04

    ... Guard is publishing this notice to recommend interim voluntary DP system guidance and recommend DP... concern are likely to be the subject of a future rulemaking. II. Interim Voluntary DP System Guidance On..._operations_guidance.cfm . It is particularly important they identify the DP System's Critical Activity...

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

    NASA Technical Reports Server (NTRS)

    2013-01-01

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

  19. Manual Drafting: A Skill for the 21st Century?

    ERIC Educational Resources Information Center

    Raudebaugh, Robert A.

    1996-01-01

    Discusses the advantages and disadvantages of teaching manual drafting and concludes that teaching manual drafting in technology education is no longer justified. Recommends teaching drawing in the context of the design process, including all types of drawing, and focusing on freehand techniques for ideation and communication. (JOW)

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-30

    ..., 2008 (73 FR 29519), FDA announced the availability of the draft guidance of the same title. FDA... electronic comments to http://www.regulations.gov . FOR FURTHER INFORMATION CONTACT: Paul E. Levine,...

  1. Guidelines for a Quality Career Guidance Program.

    ERIC Educational Resources Information Center

    Vocational Guidance Quarterly, 1979

    1979-01-01

    This position paper on quality career guidance programs outlines basic assumptions, guidelines, a comprehensive program development model, and recommended uses. Highlights of the program development model include management questions, information, and program standards. This represents NVGA/AVA Guidance Divisions efforts to establish standards for…

  2. 76 FR 35922 - Interim Staff Guidance Regarding the Environmental Report for Applications To Construct and/or...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-20

    ... COMMISSION Interim Staff Guidance Regarding the Environmental Report for Applications To Construct and/or... guidance; request for public comment. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) staff is requesting public comment on a proposed draft Interim Staff Guidance (ISG), NPR-ISG-2011-001,...

  3. 78 FR 24425 - Assay Migration Studies for In Vitro Diagnostic Devices; Guidance for Industry and Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-25

    ... studies on an old system. The draft of this guidance was issued on January 5, 2009 (74 FR 302). The... guidance is also applicable for some 510(k) cleared devices for which transition to a new system presents...; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and...

  4. Basic Drafting. Revised.

    ERIC Educational Resources Information Center

    Schertz, Karen

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

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

    NASA Technical Reports Server (NTRS)

    2011-01-01

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

  6. Modelling polymer draft gears

    NASA Astrophysics Data System (ADS)

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

    2016-09-01

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

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

    PubMed

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

    2012-01-01

    Despite the abundance of scientific evidence confirming the health consequences of smoking and other forms of tobacco use, the tobacco epidemic remains an important public health problem and by 2030 it is predicted that more than 80% of tobacco deaths will be in developing countries. In Africa and the Middle East, many local factors contribute to the initiation and maintenance of tobacco use. Although efforts to reduce the mortality and morbidity associated with smoking and tobacco dependence are underway, there is a need for guidance on how to utilize appropriate tobacco control policies and psychology- and pharmacology-based therapies to counter tobacco dependence as recommended by the Framework Convention on Tobacco Control (FCTC). A group of tobacco cessation experts from public health services and/or academic institutions in Africa and the Middle East participated in a series of four meetings held in Cairo, Cape Town, and Dubai between May 2008 and February 2011 to develop a draft guideline tailored to their region. This article provides the background to the development of this draft smoking cessation guideline and discusses how the recommendations can be implemented and progress monitored to promote both primary prevention and cessation of tobacco use within our countries. The draft guideline for Africa and the Middle East provides an important resource in combating the devastating effects of tobacco use in these regions which can be further localized through engagement with local stakeholders in the countries of the region. PMID:22487605

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

    PubMed

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

    2012-01-01

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

  9. 76 FR 81513 - Guidance for Industry: Prevention of Salmonella

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-28

    .... SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of July 9, 2009 (74 FR 33030), FDA issued a... September 8, 2009. In the Federal Register of August 12, 2010 (75 FR 48973), FDA made available a draft... HUMAN SERVICES Food and Drug Administration Guidance for Industry: Prevention of Salmonella...

  10. 76 FR 44049 - Guidance for Fuel Cycle Facility Change Processes

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-22

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

  11. 76 FR 81957 - Mobile Offshore Drilling Unit Guidance Policy

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-29

    ..., 2008, issue of the Federal Register (73 FR 3316). Background and Purpose Dynamic Positioning Systems...) Critical Systems, Personnel and Training.'' We request your comments on this draft guidance. DATES... Standards, Human Element and Ship Design Division (CG- 5211), United States Coast Guard; telephone (202)...

  12. 78 FR 57395 - Guidance for Industry on Electronic Source Data in Clinical Investigations; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-18

    ... accurate and complete data. In the Federal Register of November 20, 2012 (77 FR 69632), FDA issued a draft... FR 76049)). Most of the comments sought clarification on the topics discussed in the guidance. We... Clinical Investigations,'' as mentioned in the guidance, is discussed in the May 10, 2007 (72 FR...

  13. 76 FR 63303 - Guidance for Industry on Warnings and Precautions, Contraindications, and Boxed Warning Sections...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-12

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

  14. 75 FR 74734 - Guidance on Institutional Review Board Approval of Research With Conditions

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-01

    ... OHRP's first formal guidance on this topic. The document, which is available on OHRP's Web site at http... notice in the Federal Register on November 6, 2009 (74 FR 57486). OHRP received comments on the draft guidance document from 12 individuals and organizations, and those comments were considered as the...

  15. 78 FR 18353 - Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-26

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

  16. 75 FR 14604 - Guidance for Industry on Anesthetics for Companion Animals; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-26

    ... Federal Register of December 17, 2008, (73 FR 76657), FDA published the notice of availability for a draft... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Anesthetics for Companion Animals... Administration (FDA) is announcing the availability of Guidance for Industry 192 entitled ``Anesthetics...

  17. 75 FR 35492 - Guidance for Industry on Lupus Nephritis Caused By Systemic Lupus Erythematosus-Developing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-22

    ... Federal Register of March 29, 2005 (70 FR 15868), FDA announced the availability of a draft guidance... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Lupus Nephritis Caused By Systemic Lupus Erythematosus--Developing Medical Products for Treatment; Availability AGENCY: Food and...

  18. 76 FR 8314 - Implementation Guidance for Distribution of Source Material to Exempt Persons and to General...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-14

    ..., e-mail: Lisa.Dimmick@nrc.gov . SUPPLEMENTARY INFORMATION: On January 7, 2011, at 76 FR 1100, NRC...; ] NUCLEAR REGULATORY COMMISSION 10 CFR Part 40 RIN 3150-AH15 Implementation Guidance for Distribution of..., that announces the availability of draft implementation guidance for public comment. This action...

  19. 78 FR 54657 - Guidance for Tobacco Retailers on Tobacco Retailer Training Programs; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-05

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

  20. Radiation Protection Guidance for Diagnostic and Interventional X-Ray Procedures; Federal Guidance Report No. 14

    EPA Science Inventory

    Federal Guidance Report No. 14 provides federal facilities that use diagnostic and interventional x-ray equipment with updated recommendations for keeping doses as low as reasonably achievable without compromising the quality of patient care, This guidance is an update of Federal...

  1. Brazilian recommendations of mechanical ventilation 2013. Part I

    PubMed Central

    2014-01-01

    Perspectives on invasive and noninvasive ventilatory support for critically ill patients are evolving, as much evidence indicates that ventilation may have positive effects on patient survival and the quality of the care provided in intensive care units in Brazil. For those reasons, the Brazilian Association of Intensive Care Medicine (Associação de Medicina Intensiva Brasileira - AMIB) and the Brazilian Thoracic Society (Sociedade Brasileira de Pneumologia e Tisiologia - SBPT), represented by the Mechanical Ventilation Committee and the Commission of Intensive Therapy, respectively, decided to review the literature and draft recommendations for mechanical ventilation with the goal of creating a document for bedside guidance as to the best practices on mechanical ventilation available to their members. The document was based on the available evidence regarding 29 subtopics selected as the most relevant for the subject of interest. The project was developed in several stages, during which the selected topics were distributed among experts recommended by both societies with recent publications on the subject of interest and/or significant teaching and research activity in the field of mechanical ventilation in Brazil. The experts were divided into pairs that were charged with performing a thorough review of the international literature on each topic. All the experts met at the Forum on Mechanical Ventilation, which was held at the headquarters of AMIB in São Paulo on August 3 and 4, 2013, to collaboratively draft the final text corresponding to each sub-topic, which was presented to, appraised, discussed and approved in a plenary session that included all 58 participants and aimed to create the final document. PMID:25210957

  2. Brazilian recommendations of mechanical ventilation 2013. Part I

    PubMed Central

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

    2014-01-01

    Perspectives on invasive and noninvasive ventilatory support for critically ill patients are evolving, as much evidence indicates that ventilation may have positive effects on patient survival and the quality of the care provided in intensive care units in Brazil. For those reasons, the Brazilian Association of Intensive Care Medicine (Associação de Medicina Intensiva Brasileira - AMIB) and the Brazilian Thoracic Society (Sociedade Brasileira de Pneumologia e Tisiologia - SBPT), represented by the Mechanical Ventilation Committee and the Commission of Intensive Therapy, respectively, decided to review the literature and draft recommendations for mechanical ventilation with the goal of creating a document for bedside guidance as to the best practices on mechanical ventilation available to their members. The document was based on the available evidence regarding 29 subtopics selected as the most relevant for the subject of interest. The project was developed in several stages, during which the selected topics were distributed among experts recommended by both societies with recent publications on the subject of interest and/or significant teaching and research activity in the field of mechanical ventilation in Brazil. The experts were divided into pairs that were charged with performing a thorough review of the international literature on each topic. All the experts met at the Forum on Mechanical Ventilation, which was held at the headquarters of AMIB in São Paulo on August 3 and 4, 2013, to collaboratively draft the final text corresponding to each sub-topic, which was presented to, appraised, discussed and approved in a plenary session that included all 58 participants and aimed to create the final document. PMID:25028944

  3. Brazilian recommendations of mechanical ventilation 2013. Part 2

    PubMed Central

    2014-01-01

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

  4. Brazilian recommendations of mechanical ventilation 2013. Part 2

    PubMed Central

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

    2014-01-01

    Perspectives on invasive and noninvasive ventilatory support for critically ill patients are evolving, as much evidence indicates that ventilation may have positive effects on patient survival and the quality of the care provided in intensive care units in Brazil. For those reasons, the Brazilian Association of Intensive Care Medicine (Associação de Medicina Intensiva Brasileira - AMIB) and the Brazilian Thoracic Society (Sociedade Brasileira de Pneumologia e Tisiologia - SBPT), represented by the Mechanical Ventilation Committee and the Commission of Intensive Therapy, respectively, decided to review the literature and draft recommendations for mechanical ventilation with the goal of creating a document for bedside guidance as to the best practices on mechanical ventilation available to their members. The document was based on the available evidence regarding 29 subtopics selected as the most relevant for the subject of interest. The project was developed in several stages, during which the selected topics were distributed among experts recommended by both societies with recent publications on the subject of interest and/or significant teaching and research activity in the field of mechanical ventilation in Brazil. The experts were divided into pairs that were charged with performing a thorough review of the international literature on each topic. All the experts met at the Forum on Mechanical Ventilation, which was held at the headquarters of AMIB in São Paulo on August 3 and 4, 2013, to collaboratively draft the final text corresponding to each sub-topic, which was presented to, appraised, discussed and approved in a plenary session that included all 58 participants and aimed to create the final document. PMID:25295817

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

    PubMed

    2014-01-01

    Perspectives on invasive and noninvasive ventilatory support for critically ill patients are evolving, as much evidence indicates that ventilation may have positive effects on patient survival and the quality of the care provided in intensive care units in Brazil. For those reasons, the Brazilian Association of Intensive Care Medicine (Associação de Medicina Intensiva Brasileira - AMIB) and the Brazilian Thoracic Society (Sociedade Brasileira de Pneumologia e Tisiologia - SBPT), represented by the Mechanical Ventilation Committee and the Commission of Intensive Therapy, respectively, decided to review the literature and draft recommendations for mechanical ventilation with the goal of creating a document for bedside guidance as to the best practices on mechanical ventilation available to their members. The document was based on the available evidence regarding 29 subtopics selected as the most relevant for the subject of interest. The project was developed in several stages, during which the selected topics were distributed among experts recommended by both societies with recent publications on the subject of interest and/or significant teaching and research activity in the field of mechanical ventilation in Brazil. The experts were divided into pairs that were charged with performing a thorough review of the international literature on each topic. All the experts met at the Forum on Mechanical Ventilation, which was held at the headquarters of AMIB in São Paulo on August 3 and 4, 2013, to collaboratively draft the final text corresponding to each sub-topic, which was presented to, appraised, discussed and approved in a plenary session that included all 58 participants and aimed to create the final document. PMID:25210957

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

    PubMed

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

    2014-01-01

    Perspectives on invasive and noninvasive ventilatory support for critically ill patients are evolving, as much evidence indicates that ventilation may have positive effects on patient survival and the quality of the care provided in intensive care units in Brazil. For those reasons, the Brazilian Association of Intensive Care Medicine (Associação de Medicina Intensiva Brasileira - AMIB) and the Brazilian Thoracic Society (Sociedade Brasileira de Pneumonia e Tisiologia - SBPT), represented by the Mechanical Ventilation Committee and the Commission of Intensive Therapy, respectively, decided to review the literature and draft recommendations for mechanical ventilation with the goal of creating a document for bedside guidance as to the best practices on mechanical ventilation available to their members. The document was based on the available evidence regarding 29 subtopics selected as the most relevant for the subject of interest. The project was developed in several stages, during which the selected topics were distributed among experts recommended by both societies with recent publications on the subject of interest and/or significant teaching and research activity in the field of mechanical ventilation in Brazil. The experts were divided into pairs that were charged with performing a thorough review of the international literature on each topic. All the experts met at the Forum on Mechanical Ventilation, which was held at the headquarters of AMIB in São Paulo on August 3 and 4, 2013, to collaboratively draft the final text corresponding to each sub-topic, which was presented to, appraised, discussed and approved in a plenary session that included all 58 participants and aimed to create the final document. PMID:25028944

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

    PubMed

    2014-10-01

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

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

    PubMed

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

    2014-01-01

    Perspectives on invasive and noninvasive ventilatory support for critically ill patients are evolving, as much evidence indicates that ventilation may have positive effects on patient survival and the quality of the care provided in intensive care units in Brazil. For those reasons, the Brazilian Association of Intensive Care Medicine (Associação de Medicina Intensiva Brasileira - AMIB) and the Brazilian Thoracic Society (Sociedade Brasileira de Pneumologia e Tisiologia - SBPT), represented by the Mechanical Ventilation Committee and the Commission of Intensive Therapy, respectively, decided to review the literature and draft recommendations for mechanical ventilation with the goal of creating a document for bedside guidance as to the best practices on mechanical ventilation available to their members. The document was based on the available evidence regarding 29 subtopics selected as the most relevant for the subject of interest. The project was developed in several stages, during which the selected topics were distributed among experts recommended by both societies with recent publications on the subject of interest and/or significant teaching and research activity in the field of mechanical ventilation in Brazil. The experts were divided into pairs that were charged with performing a thorough review of the international literature on each topic. All the experts met at the Forum on Mechanical Ventilation, which was held at the headquarters of AMIB in São Paulo on August 3 and 4, 2013, to collaboratively draft the final text corresponding to each sub-topic, which was presented to, appraised, discussed and approved in a plenary session that included all 58 participants and aimed to create the final document. PMID:25295817

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

    PubMed Central

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

    2013-01-01

    High quality protocols facilitate proper conduct, reporting, and external review of clinical trials. However, the completeness of trial protocols is often inadequate. To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol. This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations. For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance. We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. A website of resources is also available (www.spirit-statement.org). The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols. Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders. PMID:23303884

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

    PubMed

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

    2013-01-01

    High quality protocols facilitate proper conduct, reporting, and external review of clinical trials. However, the completeness of trial protocols is often inadequate. To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol. This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations. For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance. We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. A website of resources is also available (www.spirit-statement.org). The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols. Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders. PMID:23303884

  11. 75 FR 22814 - Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-30

    ... (70 FR 43439), FDA announced the availability of the draft guidance of the same title. FDA received... INFORMATION CONTACT: Paul Levine, Center for Biologics Evaluation and Research (HFM-17), Food and...

  12. 75 FR 76482 - Notice of Web Availability and Opportunity for Public Comment on Updated Guidance for the Section...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-08

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

  13. 76 FR 59705 - Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-27

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

  14. Field-testing of guidance on the appropriate labelling of processed complementary foods for infants and young children in South Africa.

    PubMed

    Sweet, Lara; Jerling, Johann; Van Graan, Averalda

    2013-01-01

    There is a lack of formal guidance from international normative bodies on the appropriate marketing of processed complementary foods. Such guidance is necessary to protect and promote optimal infant and young child feeding practices. The aim of this study was to field-test, in South Africa, the interim guidance provided by the Maternal, Infant and Young Child Nutrition Working Group's Draft Guide for Marketing Complementary Foods as a potential tool for use by manufacturers and national governments for guiding the appropriate labelling (as a subset of appropriate marketing practices) of complementary foods. This guidance was used to develop a checklist of questions and criteria for each possible answer, which was tested using a comprehensive database of labels from products purchased in South Africa from June to August 2011. One hundred and sixty product labels of 35 manufacturers were analysed, none of which complied with all checklist criteria. Fifty-six (35%) labels did not provide an appropriate age of introduction while 37 (23%) used images of infants appearing younger than 6 months. Nineteen (12%) labels suggested a daily ration too large for a breastfed child, and 32 (20%) potentially promote the manufacturer's infant formula. Only 58 (36%) labels were easy to read. The majority (69% and 92%) of labels provided instructions for safe and appropriate preparation/use and storage, respectively. The Draft Guide for Marketing Complementary Foods was found to be a useful tool for guiding the appropriate labelling of complementary foods, although some changes and additions are recommended to improve understanding, ease of use and to minimise the subjective interpretation of the guidance. PMID:23167582

  15. 77 FR 20826 - Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-06

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

  16. 75 FR 32240 - Draft Tier II Environmental Impact Statement: Southeast High Speed Rail Corridor-Richmond, VA...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-07

    ... Quality NEPA implementing regulations, 40 CFR parts 1500-1508, and the FRA NEPA guidance, 64 FR 28545 (May... Federal Railroad Administration Draft Tier II Environmental Impact Statement: Southeast High Speed Rail... Draft Environmental Impact Statement and public hearings for the Southeast High Speed Rail, Richmond,...

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

    ERIC Educational Resources Information Center

    Peck, Greg

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

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

    SciTech Connect

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

    1997-05-01

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

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

    PubMed

    Schneider, Lon S

    2014-03-01

    The February 2013 Food and Drug Administration (FDA) draft guidance for developing drugs for early-stage Alzheimer's disease (AD) creates certain challenges as they guide toward the use of one cognitive outcome to gain accelerated marketing approval for preclinical AD drugs, and a composite clinical scale - the Clinical Dementia Rating Scale in particular - for the primary outcome for prodromal AD clinical trials. In light of the developing knowledge regarding early stage diagnoses and clinical trials outcomes, we recommend that FDA describe its requirements for validating preclinical AD diagnoses for drug development purposes, maintain the principle for requiring coprimary outcomes, and encourage the advancement of outcomes for early stage AD trials. The principles for drug development for early stage AD should not differ from those for clinical AD, especially as the diagnoses of prodromal and early AD impinge on each other. The FDA should not recommend that a composite scale be used as a sole primary efficacy outcome to support a marketing claim unless it requires that the cognitive and functional components of such a scale are demonstrated to be individually meaningful. The current draft guidelines may inadvertently constrain efforts to better assess the clinical effects of new drugs and inhibit innovation in an area where evidence-based clinical research practices are still evolving. PMID:24698029

  20. 17 CFR Appendix A to Subpart H - Guidance on the Application of §§ 23.434 and 23.440 for Swap Dealers That Make Recommendations to...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... swaps that are tailored to the particular needs or characteristics of the Special Entity. Thus, a swap dealer that recommends a swap to a Special Entity that is tailored to the particular needs or... involving a swap that is tailored to the particular needs or characteristics of the Special Entity. A...

  1. High proportions of foods recommended for consumption by United States Dietary Guidance contain solid fats and added sugar: Results from the National Health and Nutrition Examination Survey (2007-2008)

    Technology Transfer Automated Retrieval System (TEKTRAN)

    The 2010 Dietary Guidelines for Americans (DGA) recommend that individuals older than one year reduce intakes of solid fats (SoF) and added sugars (AS; together SoFAS). MyPlate, illustrates the proportions of five major food groups to promote healthy eating (Vegetables, Grains, Protein Foods, Fruit...

  2. FDA Recommends All Blood Donations Be Tested for Zika

    MedlinePlus

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

  3. Basic Drafting: Book Two.

    ERIC Educational Resources Information Center

    Davis, Ronald; And Others

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

  4. Mathematics for Drafting.

    ERIC Educational Resources Information Center

    Clary, Joseph R.; Nery, Karen P.

    This set of three modules was designed for use primarily to help teach and reinforce the basic mathematics skills in drafting classes. The modules are based on the needs of drafting students in beginning courses as determined by a survey of teachers across North Carolina. Each module consists of basic information and examples and problem sheets…

  5. Basic Drafting: Book One.

    ERIC Educational Resources Information Center

    Davis, Ronald; And Others

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

  6. 77 FR 2257 - Adoption of Recommendations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-17

    ...-Setting Organizations in Health and Safety Regulation, 44 FR 1,357 (Jan. 5, 1979) (recommending agencies...)(4); Nat'l Archives & Records Admin., Federal Register Document Drafting Handbook Sec. 6.4 (Jan. 2011... Health and Safety Regulation, 44 FR 1,357 (Jan. 5, 1979). 8. Agencies should not address...

  7. Recommender systems

    NASA Astrophysics Data System (ADS)

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

    2012-10-01

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

  8. Guidance for performing preliminary assessments under CERCLA

    SciTech Connect

    1991-09-01

    EPA headquarters and a national site assessment workgroup produced this guidance for Regional, State, and contractor staff who manage or perform preliminary assessments (PAs). EPA has focused this guidance on the types of sites and site conditions most commonly encountered. The PA approach described in this guidance is generally applicable to a wide variety of sites. However, because of the variability among sites, the amount of information available, and the level of investigative effort required, it is not possible to provide guidance that is equally applicable to all sites. PA investigators should recognize this and be aware that variation from this guidance may be necessary for some sites, particularly for PAs performed at Federal facilities, PAs conducted under EPA`s Environmental Priorities Initiative (EPI), and PAs at sites that have previously been extensively investigated by EPA or others. The purpose of this guidance is to provide instructions for conducting a PA and reporting results. This guidance discusses the information required to evaluate a site and how to obtain it, how to score a site, and reporting requirements. This document also provides guidelines and instruction on PA evaluation, scoring, and the use of standard PA scoresheets. The overall goal of this guidance is to assist PA investigators in conducting high-quality assessments that result in correct site screening or further action recommendations on a nationally consistent basis.

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

    SciTech Connect

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

    1995-12-31

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

  10. 76 FR 67437 - Draft Aquatic Life Ambient Water Quality Criteria for Carbaryl-2011

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-01

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

  11. 76 FR 2681 - Amended Environmental Impact Statement Filing System Guidance for Implementing 40 CFR 1506.9 and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-14

    ... AGENCY Amended Environmental Impact Statement Filing System Guidance for Implementing 40 CFR 1506.9 and... guidelines to implement its EIS filing responsibilities. The purpose of the EPA Filing System Guidelines is to provide guidance to Federal agencies on filing EISs, including draft, final, and supplemental...

  12. 77 FR 51530 - Amended Environmental Impact Statement Filing System Guidance for Implementing 40 CFR 1506.9 and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-24

    ... AGENCY Amended Environmental Impact Statement Filing System Guidance for Implementing 40 CFR 1506.9 and... guidelines to implement its EIS filing responsibilities. The purpose of the EPA Filing System Guidelines is to provide guidance to Federal agencies on filing EISs, including draft, final, and supplemental...

  13. 75 FR 6210 - Guidance for Industry on the Contents of a Complete Submission for the Evaluation of Proprietary...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-08

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

  14. 76 FR 22905 - Guidance for Food and Drug Administration Staff and Tobacco Retailers on Civil Money Penalties...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-25

    ..., 2010 (75 FR 13225) (21 CFR part 1140). The Tobacco Control Act also authorizes FDA to impose a no... Register of August 31, 2010 (75 FR 53316), FDA announced the availability of the draft guidance of the same... HUMAN SERVICES Food and Drug Administration Guidance for Food and Drug Administration Staff and...

  15. 76 FR 20689 - Guidance for Industry on Influenza: Developing Drugs for Treatment and/or Prophylaxis; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-13

    ....'' Because of the public health implications of both epidemic and pandemic influenza, the variable nature of... effects under epidemic and pandemic conditions. A draft notice of availability of this guidance was... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Influenza: Developing Drugs...

  16. 78 FR 72900 - Guidance for Industry and Food and Drug Administration Staff; Civil Money Penalties for Tobacco...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-04

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

  17. Unified powered flight guidance

    NASA Technical Reports Server (NTRS)

    Brand, T. J.; Brown, D. W.; Higgins, J. P.

    1973-01-01

    A complete revision of the orbiter powered flight guidance scheme is presented. A unified approach to powered flight guidance was taken to accommodate all phases of exo-atmospheric orbiter powered flight, from ascent through deorbit. The guidance scheme was changed from the previous modified version of the Lambert Aim Point Maneuver Mode used in Apollo to one that employs linear tangent guidance concepts. This document replaces the previous ascent phase equation document.

  18. 76 FR 6087 - Draft Weapons Safety Assessment on the Use of Enhanced Weapons; Notice of Availability and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-03

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

  19. Architectural Drafting, Drafting 2: 9255.04.

    ERIC Educational Resources Information Center

    Dade County Public Schools, Miami, FL.

    The course covers the basic fundamentals of architectural drafting and is not intended to delve into the more advanced phases of architecture. The student is presented with standards and procedures, and will become proficient in layout of floor plans, electrical plans, roof construction, foundation plans, typical wall construction, plot plans, and…

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

    ERIC Educational Resources Information Center

    Sanford - Lee County Schools, NC.

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

  1. Aeronautical Drafting, Drafting 3: 9257.02.

    ERIC Educational Resources Information Center

    Dade County Public Schools, Miami, FL.

    Intended for students interested in the aircraft and missile field of engineering and drafting, the course covers fundamentals, working drawings, and auxiliary views and sections that are related to this field. Considered advanced training, a prerequisite for the course is mastery of the skills indicated in Electrical and Electronic…

  2. Family planning methods: new guidance.

    PubMed

    1996-10-01

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

  3. Drafting: Current Trends and Future Practices

    ERIC Educational Resources Information Center

    Jensen, C.

    1976-01-01

    Various research findings are reported on drafting trends which the author feels should be incorporated into teaching drafting: (1) true position and geometric tolerancing, (2) decimal and metric dimensioning, (3) functional drafting, (4) automated drafting, and (5) drawing reproductions. (BP)

  4. Microfilming for Drafting Students

    ERIC Educational Resources Information Center

    Bass, Ronald E.

    1972-01-01

    If you have a 35mm camera, an enlarger or filmstrip projector, and developing equipment you can introduce your drafting students to one of the processes used in the newly emerging field of technical communication.'' (Editor)

  5. 76 FR 50231 - Mobile Medical Applications Draft Guidance; Public Workshop

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-12

    ..., therefore, FDA may limit the number of participants from each organization. If time and space permit, onsite... decision support. Date and Time: The public workshop will be held on September 12 and 13, 2011. Submit... urged to consolidate or coordinate their presentations, and request time for a joint presentation....

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

    Center for Food Safety and Applied Nutrition (CFSAN)

    ... ‚¬â„¢s final rule ÃÆ'¢â‚¬Å “Prevention of Salmonella Enteritidis in Shell Eggs During ...

  7. Critical Perspectives on Adolescent Vocational Guidance in Chile

    ERIC Educational Resources Information Center

    McWhirter, Ellen Hawley; McWhirter, Benedict T.

    2012-01-01

    In this article, the lens of critical psychology is applied to adolescent career development and vocational guidance in Chile. The authors describe and critique the status of adolescent vocational guidance in Chile, the reproduction of extant social inequities in Chilean education, and offer recommendations for enhancing vocational guidance…

  8. Guidance for K-12 Administrators' Responses to Influenza

    ERIC Educational Resources Information Center

    Education Digest: Essential Readings Condensed for Quick Review, 2009

    2009-01-01

    This document provides guidance to help decrease the spread of flu among students and school staff during the 2009-2010 school year. It provides tools that school and health officials can choose from based on conditions in their area and recommends actions to take if CDC finds that the flu starts causing more severe disease. The guidance also…

  9. 76 FR 23823 - Guidance for Industry on Fish and Fishery Products Hazards and Controls, Fourth Edition...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-28

    ... control recommendations are listed for the natural toxin action level for diarrhetic shellfish poisoning... the third edition to include ciguatera fish poisoning guidance for northern Gulf of Mexico...

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

    ERIC Educational Resources Information Center

    Missouri Univ., Columbia. Instructional Materials Lab.

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

  11. Guidance for Developing Principal Design Criteria for Advanced (Non-Light Water) Reactors

    SciTech Connect

    Holbrook, Mark; Kinsey, Jim

    2015-03-01

    In July 2013, the US Department of Energy (DOE) and US Nuclear Regulatory Commission (NRC) established a joint initiative to address a key portion of the licensing framework essential to advanced (non-light water) reactor technologies. The initiative addressed the “General Design Criteria for Nuclear Power Plants,” Appendix A to10 Code of Federal Regulations (CFR) 50, which were developed primarily for light water reactors (LWRs), specific to the needs of advanced reactor design and licensing. The need for General Design Criteria (GDC) clarifications in non-LWR applications has been consistently identified as a concern by the industry and varied stakeholders and was acknowledged by the NRC staff in their 2012 Report to Congress1 as an area for enhancement. The initiative to adapt GDC requirements for non-light water advanced reactor applications is being accomplished in two phases. Phase 1, managed by DOE, consisted of reviews, analyses and evaluations resulting in recommendations and deliverables to NRC as input for NRC staff development of regulatory guidance. Idaho National Laboratory (INL) developed this technical report using technical and reactor technology stakeholder inputs coupled with analysis and evaluations provided by a team of knowledgeable DOE national laboratory personnel with input from individual industry licensing consultants. The DOE national laboratory team reviewed six different classes of emerging commercial reactor technologies against 10 CFR 50 Appendix A GDC requirements and proposed guidance for their adapted use in non-LWR applications. The results of the Phase 1 analysis are contained in this report. A set of draft Advanced Reactor Design Criteria (ARDC) has been proposed for consideration by the NRC in the establishment of guidance for use by non-LWR designers and NRC staff. The proposed criteria were developed to preserve the underlying safety bases expressed by the original GDC, and recognizing that advanced reactors may take

  12. 78 FR 77027 - Overhead Clearance (Air-Draft) Accidents

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-20

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

  13. Overcoming consumer inertia to dietary guidance.

    PubMed

    Webb, Densie; Byrd-Bredbenner, Carol

    2015-07-01

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

  14. Overcoming Consumer Inertia to Dietary Guidance12

    PubMed Central

    Webb, Densie; Byrd-Bredbenner, Carol

    2015-01-01

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

  15. Overcoming consumer inertia to dietary guidance.

    PubMed

    Webb, Densie; Byrd-Bredbenner, Carol

    2015-07-01

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

  16. Aiding Vertical Guidance Understanding

    NASA Technical Reports Server (NTRS)

    Feary, Michael; McCrobie, Daniel; Alkin, Martin; Sherry, Lance; Polson, Peter; Palmer, Everett; McQuinn, Noreen

    1998-01-01

    A two-part study was conducted to evaluate modern flight deck automation and interfaces. In the first part, a survey was performed to validate the existence of automation surprises with current pilots. Results indicated that pilots were often surprised by the behavior of the automation. There were several surprises that were reported more frequently than others. An experimental study was then performed to evaluate (1) the reduction of automation surprises through training specifically for the vertical guidance logic, and (2) a new display that describes the flight guidance in terms of aircraft behaviors instead of control modes. The study was performed in a simulator that was used to run a complete flight with actual airline pilots. Three groups were used to evaluate the guidance display and training. In the training, condition, participants went through a training program for vertical guidance before flying the simulation. In the display condition, participants ran through the same training program and then flew the experimental scenario with the new Guidance-Flight Mode Annunciator (G-FMA). Results showed improved pilot performance when given training specifically for the vertical guidance logic and greater improvements when given the training and the new G-FMA. Using actual behavior of the avionics to design pilot training and FMA is feasible, and when the automated vertical guidance mode of the Flight Management System is engaged, the display of the guidance mode and targets yields improved pilot performance.

  17. Guidance for Total Development.

    ERIC Educational Resources Information Center

    Van Hoose, William H.

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

  18. 75 FR 73107 - Guidance for Industry and Food and Drug Administration Staff; Blood Lancet Labeling; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-29

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff... ``Guidance for Industry and Food and Drug Administration Staff; Blood Lancet Labeling.'' FDA is issuing this guidance with labeling recommendations because of concerns that both healthcare providers and patients...

  19. Detailed recommendations

    SciTech Connect

    1996-05-01

    The recommendations which have resulted from this workshop have come from several sources, including most importantly the break-out sessions, but also from discussions with other leaders in the field, some www discussions, and least of all the organization committee of the workshop. They may be divided into three sections, the ones which need immediate attention or should happen before the bulk of activities can take place, the priority items that will form the bulk of future research activities, and the important continuing items, that are ancillary to the main objective but help to nurture the field.

  20. Developing the revised NICE appraisal technical guidance to manufacturers and sponsors: opportunity or threat?

    PubMed

    Taylor, Rod S; Hutton, John; Culyer, Anthony J

    2002-01-01

    One of the principal roles of the National Institute for Clinical Excellence (NICE) is to appraise selected existing and emerging healthcare technologies and, as a result, produce guidance for the National Health Service (NHS) in England and Wales. A central part of this appraisal is the potential for manufacturers and sponsors to make a data submission. This paper describes the process of development of the second edition of technical guidance to manufacturers and sponsors for submission to NICE. The revision process took place during the period May 2000 and January 2001 and involved a number of key steps -- establishment of a guidance steering committee, review of current international guidelines of clinical and cost effectiveness, drafting of the guidance, detailed consultation with stakeholders, revision of the guidance and, finally, publication. The lessons learnt from revision of the NICE guidance for manufacturers and sponsors and some main issues for its future development are discussed. PMID:12456199

  1. 76 FR 82308 - Guidance for Industry: Current Good Tissue Practice and Additional Requirements for Manufacturers...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-30

    ... 16, 2009 (74 FR 3055), FDA announced the availability of the draft guidance of the same title dated... Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products... Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues,...

  2. 75 FR 18514 - Developing Guidance on Naming, Labeling, and Packaging Practices to Reduce Medication Errors...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-12

    ... constructive dialogue and information sharing among regulators, researchers, the pharmaceutical industry... used to develop draft guidance for industry on practices for naming, labeling, and packaging of drugs... http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm119243.htm ). In that letter,...

  3. 75 FR 35493 - Guidance for Industry on Systemic Lupus Erythematosus-Developing Medical Products for Treatment...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-22

    ... the Federal Register of March 29, 2005 (70 FR 15868), FDA announced the availability of a draft... Systemic Lupus Erythematosus--Developing Medical Products for Treatment; Availability AGENCY: Food and Drug... availability of a guidance for industry entitled ``Systemic Lupus Erythematosus--Developing Medical...

  4. 75 FR 36425 - Guidance for Industry and Food and Drug Administration Staff; In Vitro Diagnostic Studies...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-25

    ... the quality of the premarket submission. The draft of this guidance was issued October 25, 2007. DATES... Code of Federal Regulations, subchapter H. In the Federal Register of October 25, 2007 (72 FR 60682...://www.regulations.gov or the CBER Internet site at...

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

    SciTech Connect

    Cole, P. C.; Halverson, M. A.

    2013-09-01

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

  6. 78 FR 34392 - Guidance for Industry and Food and Drug Administration Staff: Technical Considerations for Pen...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-07

    ...) application for the injector alone. For a combination product that includes the injector, the marketing...) or a PMA application for the injector alone. For a combination product that includes the injector... Federal Register on April 27, 2009, (74 FR 19094), FDA announced the availability of the draft guidance...

  7. 76 FR 51038 - Guidance for Industry on Residual Drug in Transdermal and Related Drug Delivery Systems...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-17

    ... during product design and development--as well as during manufacturing and product life-cycle management... development--as well as during manufacturing and product life-cycle management--to ensure that the amount of... August 3, 2010 (75 FR 45640), FDA announced the availability of the draft version of this guidance....

  8. 78 FR 24754 - Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-26

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

  9. 76 FR 49773 - International Conference on Harmonisation; Guidance on E16 Biomarkers Related to Drug or...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-11

    ..., 2009 (74 FR 38033), FDA published a notice announcing the availability of a draft guidance entitled... Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of... Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format...

  10. 75 FR 62694 - Implementation Guidance for Physical Protection of Byproduct Material Category 1 and Category 2...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-13

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

  11. 75 FR 74734 - Guidance on Institutional Review Board Continuing Review of Research

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-01

    ... (74 FR 57487). OHRP received comments on the draft guidance document from 18 individuals and...) Lapses in IRB Approval; (8) Communicating the IRB's Continuing Review Determination to Investigators and... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH...

  12. 75 FR 8698 - Extension of Request for Scientific Views for Draft 2009 Update Aquatic Life Ambient Water...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-25

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

  13. All-Ages Lead Model (Aalm) Version 1.05 (External Draft Report)

    EPA Science Inventory

    The All-Ages Lead Model (AALM) Version 1.05, is an external review draft software and guidance manual. EPA released this software and associated documentation for public review and comment beginning September 27, 2005, until October 27, 2005. The public comments will be accepte...

  14. 76 FR 67439 - External Peer Review Meeting for Draft Microbial Risk Assessment Guideline: Pathogenic...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-01

    ... Microorganisms With Focus on Food and Water AGENCY: Environmental Protection Agency (EPA). ACTION: Notice...: Pathogenic Microorganisms with Focus on Food and Water. EPA previously announced the release of the draft guidance for a 60 day comment period (76 FR 44586-44587). The public comment period ended on September...

  15. 78 FR 66940 - Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products; Draft...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-07

    ... implemented to promote the prompt diagnosis of treatable medical conditions causing hearing loss. To ensure... HUMAN SERVICES Food and Drug Administration Regulatory Requirements for Hearing Aid Devices and Personal... Hearing Aid Devices and Personal Sound Amplification Products.'' This draft guidance clarifies...

  16. Drafting Lab Management Guide.

    ERIC Educational Resources Information Center

    Ohio State Univ., Columbus. Instructional Materials Lab.

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

  17. Drafting. Competency Based Curriculum.

    ERIC Educational Resources Information Center

    Everly, Al; And Others

    This competency based drafting curriculum is presented in seven specialization sections with units in each section containing a competency statement, performance objective, learning activities, evaluation, and quiz or problem sheets. Some units also contain answer sheets and/or handout sheets. Sections and number of units presented are (1) basic…

  18. Caught in the Draft

    ERIC Educational Resources Information Center

    Edge, Ron

    2007-01-01

    We've all seen (in movies, newscasts, or perhaps in person) the violent effect of the downwash that occurs when a helicopter hovers over the ground. Leaves, grass, and debris are dramatically blown about. We've also sat in front of circulating room fans and felt a large draft, whereas there seems to be very little air movement behind the fan. The…

  19. Drafting the Basics

    ERIC Educational Resources Information Center

    Lamb, Carol M.; Kurtanich, David G.

    2007-01-01

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

  20. Guidance for evaluating and recommending temperature regimes to protect fish

    USGS Publications Warehouse

    Armour, Carl L.

    1991-01-01

    Procedures are presented for evaluating temperature regimes for fish. Although examples pertain to spring chinook salmon (Oncorhynchus tshawytscha), the principles apply to other species. Basic temperature tolerance relationships for fish are explained and three options are described for comparing alternative temperature regimes. The options are to base comparisons on experimental temperature tolerance results, suitability of a simulated temperature regime for key life stages, or population statistics and predicated responses to simulated temperatures.

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

    NASA Technical Reports Server (NTRS)

    1984-01-01

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

  2. Serving size guidance for consumers: is it effective?

    PubMed

    Faulkner, G P; Pourshahidi, L K; Wallace, J M W; Kerr, M A; McCrorie, T A; Livingstone, M B E

    2012-11-01

    Larger portion sizes (PS) may be inciting over-eating and contributing to obesity rates. Currently, there is a paucity of data on the effectiveness of serving size (SS) guidance. The aims of the present review are to evaluate SS guidance; the understanding, usability and acceptability of such guidance, its impact on consumers and potential barriers to its uptake. A sample of worldwide SS guidance schemes (n 87) were identified using targeted and untargeted searches, overall these were found to communicate various inconsistent and often conflicting messages about PS selection. The available data suggest that consumers have difficulty in understanding terms such as 'portion size' and 'serving size', as these tend to be used interchangeably. In addition, discrepancies between recommended SS and those present on food labels add to the confusion. Consumers generally understand and visualise SS best when expressed in terms of household measures rather than actual weights. Only a limited number of studies have examined the direct impact of SS guidance on consumer behaviour with equivocal results. Although consumers recognise that guidance on selecting SS would be helpful, they are often unwilling to act on such guidance. The challenge of achieving consumer adherence to SS guidance is formidable due to several barriers including chronic exposure to larger PS, distorted consumption norms and perceptions, the habit of 'cleaning one's plate' and language barriers for ethnic minorities. In conclusion, the impact of SS guidance on consumers merits further investigation to ensure that future guidance resonates with consumers by being more understandable, usable and acceptable.

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

    SciTech Connect

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

    1991-04-01

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

  4. 46 CFR 131.220 - Drafts.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... Drafts. (a) Each vessel must have the drafts of the vessel plainly and legibly marked upon the stem and... stem or cutaway skeg, the keel does not extend forward or aft to the draft markings, the datum...

  5. Climate and Land Use Change Effects on Ecological Resources in Three Watersheds: A Synthesis Report (External Review Draft)

    EPA Science Inventory

    The purpose of this draft report is to provide a summary of climate change impacts to selected watersheds and recommendations for how to improve the process of conducting watershed assessments in the future.

  6. Accelerating Cleanup: Focus on 2006. Discussion draft

    SciTech Connect

    1997-06-01

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

  7. Decontaminating breast pump kits: new guidance.

    PubMed

    Oxtoby, Kathy

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

  8. Safety of magnetic fusion facilities: Guidance

    SciTech Connect

    1996-05-01

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

  9. Pupil Personnel Services: Material Review List Recommendations.

    ERIC Educational Resources Information Center

    Cardinale, Anthony

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

  10. Comprehensive Guidance Programs That Work.

    ERIC Educational Resources Information Center

    Gysbers, Norman C.; And Others

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

  11. Draft 1992 Resource Program : Technical Report.

    SciTech Connect

    United States. Bonneville Power Administration.

    1992-01-01

    The 1992 Resource Program will propose actions to meet future loads placed on the Bonneville Power Administration (BPA). It will also discuss and attempt to resolve resource-related policy issues. The Resource Program assesses resource availability and costs, and analyzes resource requirements and alternative ways of meeting those requirements through both conservation and generation resources. These general resource conclusions are then translated to actions for both conservation and generation. The Resource Program recommends budgets for the Office of Energy Resources for Fiscal Years (FY) 1994 and 1995. BPA`s Resource Program bears directly on an important BPA responsibility: the obligation under the Northwest Power Act{sup 3} to meet the power requirements of public and private utility and direct service industrial (DSI) customers according to their contractual agreements. BPA`s Draft 1992 Resource Program is contained in four documents: (1) 1992 Resource Program Summary; (2) Technical Report; (3) Technical Assumptions Appendix; and, (4) Conservation Implementation Plan. This volume is the Draft 1992 Resource Program Technical Report, a comprehensive document that provides supporting data and analyses for Resource Program recommendations.

  12. Draft 1992 Resource Program : Technical Report.

    SciTech Connect

    United States. Bonneville Power Administration.

    1992-01-01

    The 1992 Resource Program will propose actions to meet future loads placed on the Bonneville Power Administration (BPA). It will also discuss and attempt to resolve resource-related policy issues. The Resource Program assesses resource availability and costs, and analyzes resource requirements and alternative ways of meeting those requirements through both conservation and generation resources. These general resource conclusions are then translated to actions for both conservation and generation. The Resource Program recommends budgets for the Office of Energy Resources for Fiscal Years (FY) 1994 and 1995. BPA's Resource Program bears directly on an important BPA responsibility: the obligation under the Northwest Power Act{sup 3} to meet the power requirements of public and private utility and direct service industrial (DSI) customers according to their contractual agreements. BPA's Draft 1992 Resource Program is contained in four documents: (1) 1992 Resource Program Summary; (2) Technical Report; (3) Technical Assumptions Appendix; and, (4) Conservation Implementation Plan. This volume is the Draft 1992 Resource Program Technical Report, a comprehensive document that provides supporting data and analyses for Resource Program recommendations.

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

    ERIC Educational Resources Information Center

    Dade County Public Schools, Miami, FL.

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

  14. Drafting--Basic, Drafting--Intermediate: 9255.01.

    ERIC Educational Resources Information Center

    Dade County Public Schools, Miami, FL.

    The course has no prerequisites, offers instruction in basic drafting room techniques and procedures, and also covers job opportunities and industrial methods in engineering. The student is introduced to and asked to perform fundamental drafting problems with working drawings, using multiview and auxiliary views and sections. The course also…

  15. Recommendations and Resolutions: 1971 White House Conference on Youth.

    ERIC Educational Resources Information Center

    White House Conference on Youth, Washington, DC.

    This document includes the task force recommendations and the caucus statements of the White House Conference on Youth. The primary working units at the Conference were task forces arranged around the following issue areas: Draft, National Service and Alternatives; Drugs; Economy and Employment; Education; Environment; Foreign Relations; Legal…

  16. Final Report and Recommendations on Regional Computing Centre Development.

    ERIC Educational Resources Information Center

    Committee of Presidents of Universities of Ontario, Toronto.

    The Draft Report of the Joint Ad Hoc Subcommittee on Regional Computing Centres of the Committee of Presidents of Universities of Ontario made a tentative recommendation that a regional computer center should be developed for the use of Ontario universities. However, on further investigation it was found that such a computer center would be…

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

    ERIC Educational Resources Information Center

    Kann, Ulla

    1988-01-01

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

  18. IRIS Product Recommendations

    NASA Technical Reports Server (NTRS)

    Short, David A.

    2000-01-01

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

  19. Computer Aided Drafting. Instructor's Guide.

    ERIC Educational Resources Information Center

    Henry, Michael A.

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

  20. Industrial Education. Drafting. [Grade 9].

    ERIC Educational Resources Information Center

    Parma City School District, OH.

    Part of a series of curriculum guides dealing with industrial education in junior high schools, this guide provides a course on drafting to be used in the ninth grade. Thirteen goals are identified for the students to demonstrate: (1) a knowledge of the relationship between drafting and the work of designers, engineers, and architects; (2) an…

  1. 32 CFR 989.19 - Draft EIS.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... review of draft EIS (40 CFR 1502.19 and 1506.6): (1) The public comment period for the draft EIS is at... summary to the public with an attached list of locations (such as public libraries) where the entire draft... proponent in preparation of a preliminary draft EIS (PDEIS) (40 CFR 1502.9) based on the scope of...

  2. Computer Aided Drafting Workshop. Workshop Booklet.

    ERIC Educational Resources Information Center

    Goetsch, David L.

    This mini-course and article are presentations from a workshop on computer-aided drafting. The purpose of the mini-course is to assist drafting instructors in updating their occupational knowledge to include computer-aided drafting (CAD). Topics covered in the course include general computer information, the computer in drafting, CAD terminology,…

  3. Quality in Careers Guidance.

    ERIC Educational Resources Information Center

    Plant, Peter

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

  4. Vocational Development and Guidance.

    ERIC Educational Resources Information Center

    Tennyson, W. Wesley; And Others

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

  5. Regulatory guidance document

    SciTech Connect

    1994-05-01

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

  6. EPA guidance on cultural competence training.

    PubMed

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

    2015-03-01

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

  7. EPA guidance on cultural competence training.

    PubMed

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

    2015-03-01

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

  8. Guidance, Navigation, and Control Program

    NASA Technical Reports Server (NTRS)

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

    2011-01-01

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

  9. 46 CFR 169.755 - Draft marks and draft indicating systems.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... SCHOOL VESSELS Vessel Control, Miscellaneous Systems, and Equipment Markings § 169.755 Draft marks and... necessary for easy observance. The bottom of each mark must indicate the draft. (b) The draft must be...

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

    Code of Federal Regulations, 2013 CFR

    2013-10-01

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

  11. 46 CFR 167.55-1 - Draft marks and draft indicating systems.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

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

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

    Code of Federal Regulations, 2012 CFR

    2012-10-01

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

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

    Code of Federal Regulations, 2011 CFR

    2011-10-01

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

  14. Guidance for Environmental Mangement Science and Technology Roadmapping

    SciTech Connect

    Dixon, Brent Wayne

    2001-02-01

    Science and technology roadmapping is a planning process to help identify technical capabilities needed for both project- and program-level cleanup efforts, map them into technology alternatives, and develop plans to ensure that the required scientific knowledge and tools will be available when needed. Application of science and technology roadmapping within Invironmental Management (EM) requires significant flexibility to accommodate the variations between different projects and programs and the different levels of roadmapping application. The author has provided direct support to EM’s Office of Science and Technology (OST) in the development of draft guidance for science and technology roadmapping in EM. This paper provides a summary of this guidance and a synopsis of lessons learned from the application of roadmapping to a number of EM projects and programs.

  15. Enhancing Access to Vocational Guidance.

    ERIC Educational Resources Information Center

    Clayton, Pam

    1998-01-01

    Issues in vocational guidance for adults include lack of provision, especially for unemployed or disadvantaged people and the need to publicize existing excellent guidance services and demonstrate their usefulness to this population. (SK)

  16. 77 FR 18828 - Guidance for Industry and Food and Drug Administration Staff; Factors To Consider When Making...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-28

    ... FR 50483), FDA announced the availability of the draft guidance. Interested persons were invited to...; Factors To Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and de... entitled ``Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket...

  17. 76 FR 39101 - EPA and Army Corps of Engineers Guidance Regarding Identification of Waters Protected by the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-05

    ...) announced availability of draft guidance (76 FR 24479) that describes how the agencies will identify waters protected by the Federal Water Pollution Control Act Amendments of 1972 (Clean Water Act or CWA or Act) and... Water Act AGENCY: Environmental Protection Agency (EPA); and U.S. Army Corps of Engineers, Department...

  18. 76 FR 33309 - Guidance for Industry on Citizen Petitions and Petitions for Stay of Action Subject to Section...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-08

    ... (74 FR 3611), FDA announced the availability of a draft version of this guidance and provided... Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act; Availability... and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic...

  19. 78 FR 45930 - Guidance for Industry: Safety Labeling Changes-Implementation of Section 505(o)(4) of the Federal...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-30

    ... Register of April 13, 2011 (76 FR 20686), FDA announced the availability of a draft guidance for industry...--Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act; Availability AGENCY: Food and... new provisions to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) authorizing FDA to...

  20. 76 FR 11506 - Fisheries and Habitat Conservation and Migratory Birds Programs; Draft Land-Based Wind Energy...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-02

    ... a notice in the Federal Register on February 18, 2011 (76 FR 9590), announcing the availability for... Guidance. Correction In the Federal Register of February 18, 2011, in FR Doc. 2011-3699, on page 9590, in...; Draft Land-Based Wind Energy Guidelines; Correction AGENCY: Fish and Wildlife Service, Interior....