Sample records for recommendations draft guidance
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-08-26
...] (Formerly Docket No. 2007D-0168) Draft Guidance for Industry on Bioequivalence Recommendations for... industry entitled ``Draft Guidance on Risperidone.'' The guidance provides specific recommendations on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-02-13
... (rifaximin-550). The recommendations provide specific guidance on the design of bioequivalence (BE) studies... studies to support ANDAs for rifaximin-200 (Draft Rifaximin-200 BE Recommendations). FDA is now issuing a...] Draft Guidance for Industry on Bioequivalence Recommendations for Rifaximin Tablets; Availability AGENCY...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-09-10
...] Draft Guidance for Industry on Bioequivalence Recommendations for Fluticasone Propionate; Salmeterol... ``Bioequivalence Recommendations for Fluticasone Propionate; Salmeterol Xinafoate.'' The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-09-11
...] Draft Guidance for Industry on Recommendations for Preparation and Submission of Animal Food Additive...) entitled ``Recommendations for Preparation and Submission of Animal Food Additive Petitions.'' This draft... guidance for industry (GFI 221) entitled ``Recommendations for Preparation and Submission of Animal Food...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-03-28
...] Draft Guidance for Industry on Bioequivalence Recommendations for Iron Sucrose Injection; Availability... Recommendations for Iron Sucrose.'' The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for iron sucrose injection. DATES...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-02-13
... though we have not requested comparative in vitro studies, in vitro studies outlined in the 2002 guidance.... The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support... draft guidance for industry on the Agency's recommendations for BE studies to support ANDAs for...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-11-06
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0369] Draft Guidance for Industry on Bioequivalence Recommendations for Iron Sucrose; Availability AGENCY... guidance, FDA recommended an in vivo fasting BE study with pharmacokinetic endpoints and in vitro studies...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-08-02
... Recommendations for Mesalamine.'' The recommendations provide specific guidance on the design of bioequivalence... suppositories: A fasting BE study with pharmacokinetic endpoints and comparative in vitro studies (melting point...). The draft guidance, when finalized, will represent the Agency's current thinking on the design of BE...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-11-20
...] Draft Guidance for Industry: Recommendations for Premarket Notification (510(k)) Submissions for Nucleic... ``Guidance for Industry: Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid... submitters and FDA reviewers in preparing and reviewing 510(k) submissions for nucleic acid-based HLA test...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-11-06
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0433; (formerly Docket No. 2007D-0169)] Draft Guidance for Industry on Bioequivalence Recommendation for...) Acceptable fasting and fed bioequivalence studies on the 25 mg strength, (2) proportional similarity of the...
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78 FR 56718 - Draft Guidance for Industry on Bioanalytical Method Validation; Availability
Federal Register 2010, 2011, 2012, 2013, 2014
2013-09-13
...] Draft Guidance for Industry on Bioanalytical Method Validation; Availability AGENCY: Food and Drug... availability of a draft guidance for industry entitled ``Bioanalytical Method Validation.'' The draft guidance is intended to provide recommendations regarding analytical method development and validation for the...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-07-23
... Texts for Use in the International Conference on Harmonisation Regions; Annex 13 on Bulk Density and... availability of a draft guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-08-06
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0395] Draft Guidance for Industry and Food and Drug Administration Staff; Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays; Availability AGENCY: Food and Drug Administration, HHS...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-12-10
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0928] Draft Guidance for Industry on Recommendations for Preparation and Submission of Animal Food Additive... Preparation and Submission of Animal Food Additive Petitions.'' DATES: Submit either electronic or written...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-02-26
... components, including Source Plasma. The guidance announced in this notice replaces the draft guidance... before it begins work on the final version of the guidance, submit either electronic or written comments... the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-03-11
... Product Container Is Not Made With Natural Rubber Latex.'' The purpose of this draft guidance is to make recommendations on the appropriate language to include in the labeling of a medical product to convey that natural... Products To Inform Users That the Product or Product Container Is Not Made With Natural Rubber Latex...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-09-14
... Bioequivalence Recommendations; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY... draft product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-19
...] Draft Guidance for Industry on Self-Selection Studies for Nonprescription Drug Products; Availability...) is announcing the availability of a draft guidance for industry entitled ``Self-Selection Studies for Nonprescription Drug Products.'' The draft guidance is intended to provide recommendations to industry on the...
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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
...The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled ``Draft Guidance for Industry and Food and Drug Administration Staff: The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Low Glucose Suspend (LGS) Device Systems.'' This draft guidance document provides industry and Agency staff with recommendations that are intended to improve the safety and effectiveness of LGS Device Systems. This draft guidance is not final nor is it in effect at this time.
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-05-31
..., including Source Plasma, with recommendations intended to assist with determining which reporting mechanism... final version of the guidance, submit either electronic or written comments on the draft guidance by... INFORMATION section for electronic access to the draft guidance document. Submit electronic comments on the...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-02-21
...] Draft Guidance for Industry on Providing Submissions in Electronic Format--Standardized Study Data... Submissions in Electronic Format--Standardized Study Data.'' This draft guidance establishes FDA's recommendation that sponsors and applicants submit nonclinical and clinical study data in a standardized...
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New FDA draft guidance on immunogenicity.
Parenky, Ashwin; Myler, Heather; Amaravadi, Lakshmi; Bechtold-Peters, Karoline; Rosenberg, Amy; Kirshner, Susan; Quarmby, Valerie
2014-05-01
A "Late Breaking" session was held on May 20 at the 2013 American Association of Pharmaceutical Scientists-National Biotech Conference (AAPS-NBC) to discuss the US Food and Drug Administration's (FDA) 2013 draft guidance on Immunogenicity Assessment for Therapeutic Protein Products. The session was initiated by a presentation from the FDA which highlighted several key aspects of the 2013 draft guidance pertaining to immunogenicity risk, the potential impact on patient safety and product efficacy, and risk mitigation. This was followed by an open discussion on the draft guidance which enabled delegates from biopharmaceutical companies to engage the FDA on topics that had emerged from their review of the draft guidance. The multidisciplinary audience fostered an environment that was conducive to scientific discussion on a broad range of topics such as clinical impact, immune mitigation strategies, immune prediction and the role of formulation, excipients, aggregates, and degradation products in immunogenicity. This meeting report highlights several key aspects of the 2013 draft guidance together with related dialog from the session.
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DOE Office of Scientific and Technical Information (OSTI.GOV)
Posas, Paula J., E-mail: pjposas@gmail.co
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,more » 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.« less
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75 FR 48973 - Draft Guidance for Industry: Prevention of Salmonella
Federal Register 2010, 2011, 2012, 2013, 2014
2010-08-12
...] Draft Guidance for Industry: Prevention of Salmonella Enteritidis in Shell Eggs During Production... entitled ``Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation'' (the draft guidance). The draft guidance, when finalized, will provide guidance to egg producers...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-09-18
...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products--Content and Format.'' The recommendations in the draft guidance are intended to help ensure that the labeling is clear, useful, informative, and to the extent possible, consistent in content and format.
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-11-29
... document describes FDA's recommendations concerning 510(k) submissions for various types of in vitro.... SUPPLEMENTARY INFORMATION: I. Background This draft guidance includes recommendations concerning 510(k...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-04-15
...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk.'' 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 emphasizes considerations of both safety and quality risk management in establishing levels of mutagenic impurities that are expected to pose negligible carcinogenic risk. It outlines recommendations for assessment and control of mutagenic impurities that reside or are reasonably expected to reside in a final drug substance or product, taking into consideration the intended conditions of human use. The draft guidance is intended to provide guidance for new drug substances and new drug products during their clinical development and subsequent applications for marketing.
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-11-20
... such as Internet promotion, social media, emails, CD-ROMs, and DVDs. Following issuance of the guidance... materials. The recommendations in the draft guidance pertain to product names in traditional print media...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-02-03
... in order to be excluded from the organic certification requirements of Part 205. The NOSB recommended... handling operations that are or are not excluded from organic certification. The draft guidance proposes... excluded from certification and, therefore, must be certified organic operations. \\1\\ NOSB Recommendation...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-05-02
...] Draft Guidance for Industry and FDA Staff: Processing/ Reprocessing Medical Devices in Health Care... Devices in Health Care Settings: Validation Methods and Labeling.'' The recommendations in this guidance... Staff: Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-04-13
... or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions With GFI 209; Availability AGENCY: Food and Drug... availability of a draft guidance for industry (draft GFI 213) entitled ``New Animal Drugs and New Animal Drug...
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Hukkanen, Renee R; Halpern, Wendy G; Vidal, Justin D
2016-10-01
In July 2015, the U.S. Food and Drug Administration (FDA) posted a new draft guidance entitled "Testicular Toxicity: Evaluation during Drug Development Guidance for Industry," with a 90-day public comment period. As the nonclinical assessment of testicular toxicity often relies on the expert interpretation of pathology affecting the male reproductive tract, this draft guidance is considered directly relevant to the toxicologic pathology community. Therefore, a working group was formed through the Scientific and Regulatory Policy Committee of the Society of Toxicologic Pathologists (STPs) to provide a detailed review of the draft guidance. Specific comments on the guidance were submitted to the FDA by the STP. The draft guidance and all comments received are currently under review with the FDA. This commentary provides a summary of the components of the draft guidance and the comments submitted by the STP with acknowledgment of different perspectives reflected in comments from other respondents. © The Author(s) 2016.
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-11-05
...The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Use of Donor Screening Tests to Test Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) for Infection with Treponema pallidum (Syphilis),'' dated October 2013. The draft guidance document provides establishments that make donor eligibility determinations for donors of HCT/Ps (HCT/P Establishments), with updated recommendations concerning donor testing for evidence of Treponema pallidum (T. pallidum) infection, the etiologic agent of syphilis. HCT/P Establishments must, as required under Federal regulations, test a donor specimen for evidence of T. pallidum infection using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, unless an exception to this requirement applies. The draft guidance clarifies that FDA does not consider diagnostic tests or pre-amendment devices (which have not been licensed, approved, or cleared) to be adequate for use in donor testing for T. pallidum infection under the criteria specified in Federal regulations. The recommendations in this guidance, when finalized, will supersede those recommendations for testing HCT/P donors for evidence of T. pallidum infection contained in the document entitled ``Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps),'' dated August 2007.
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-12-10
...] Draft Guidance for Industry on Size, Shape, and Other Physical Attributes of Generic Tablets and... ``Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules.'' This guidance discusses FDA recommendations for the size, shape, and other physical attributes of generic tablets intended to...
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78 FR 53792 - Draft Guidance for Reciprocity
Federal Register 2010, 2011, 2012, 2013, 2014
2013-08-30
... NUCLEAR REGULATORY COMMISSION [NRC-2013-0186] Draft Guidance for Reciprocity AGENCY: Nuclear... Commission (NRC) is revising its licensing guidance for reciprocity. The NRC is requesting public comment on... Work in Agreement State Jurisdiction (Reciprocity).'' The document has been updated from the previous...
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A review of the FDA draft guidance document for software validation: guidance for industry.
Keatley, K L
1999-01-01
A Draft Guidance Document (Version 1.1) was issued by the United States Food and Drug Administration (FDA) to address the software validation requirement of the Quality System Regulation, 21 CFR Part 820, effective June 1, 1997. The guidance document outlines validation considerations that the FDA regards as applicable to both medical device software and software used to "design, develop or manufacture" medical devices. The Draft Guidance is available at the FDA web site http:@www.fda.gov/cdrh/comps/swareval++ +.html. Presented here is a review of the main features of the FDA document for Quality System Regulation (QSR), and some guidance for its implementation in industry.
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-12-05
... Paliperidone Palmitate Extended-Release Injectable Suspension; Availability AGENCY: Food and Drug...) studies to support abbreviated new drug applications (ANDAs) for paliperidone palmitate extended-release... the availability of revised draft BE recommendations for paliperidone palmitate extended-release...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-10-14
...] Draft Guidance for Industry: Early Clinical Trials With Live Biotherapeutic Products: Chemistry...: Chemistry, Manufacturing, and Control Information'' dated September 2010. The draft guidance provides... Products: Chemistry, Manufacturing, and Control Information'' dated September 2010. The draft guidance...
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US Food and Drug Administration draft recommendations on radioactive contamination of food
DOE Office of Scientific and Technical Information (OSTI.GOV)
Thompson, D.L.
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 radiationmore » 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.« less
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-11-20
...] Draft Guidance for Industry on Electronic Source Data in Clinical Investigations; Availability AGENCY... announcing the availability of a draft guidance for industry entitled ``Electronic Source Data in Clinical... in Clinical Investigations.'' This revised draft document provides guidance to sponsors, contract...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-02-28
...] Draft Guidance for Industry on Medication Guides--Distribution Requirements and Inclusion of Medication... a draft guidance for industry entitled ``Medication Guides--Distribution Requirements and Inclusion... Inclusion of Medication Guides in Risk Evaluation and Mitigation Strategies (REMS).'' This draft guidance is...
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77 FR 14402 - Draft Guidance on Classifying Significant Postmarket Drug Safety Issues; Availability
Federal Register 2010, 2011, 2012, 2013, 2014
2012-03-09
....'' This draft guidance describes FDA's current approach to classifying a significant postmarket drug... elevating some priority TSIs to an ``emergency'' status. The draft guidance was developed in connection with... guidance describes CDER's current approach to determining whether a significant postmarket drug safety...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-03-29
... Metronidazole Vaginal Gel; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The... entitled ``Bioequivalence Recommendations for Metronidazole Vaginal Gel.'' The guidance provides specific...) for metronidazole vaginal gel. DATES: Although you can comment on any guidance at any time (see 21 CFR...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-12-19
... inspection by FDA during the review of marketing applications. This draft guidance describes a recommended... associated with marketing applications. The summary level clinical site dataset: Contains data from all... represent the Agency's current thinking on this topic. It does not create or confer any rights for or on any...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-04-25
...] Draft Guidance for Industry: Safety of Nanomaterials in Cosmetic Products; Availability AGENCY: Food and... Cosmetic Products.'' The draft guidance, when finalized, will represent FDA's current thinking on the safety assessment of nanomaterials in cosmetic products. This guidance is intended to assist industry in...
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78 FR 68852 - Draft Guidance for Industry on Acrylamide in Foods; Availability
Federal Register 2010, 2011, 2012, 2013, 2014
2013-11-15
... high-temperature cooking. The draft guidance is intended to suggest a range of possible approaches to... during certain types of high-temperature cooking, and is a concern because it can cause cancer in... placing preparation and cooking instructions on frozen French fry packages. Lastly, the draft guidance is...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-09-20
... Polysulfate Sodium Capsule; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY... entitled ``Bioequivalence Recommendations for Pentosan Polysulfate Sodium.'' The recommendations provide... (ANDAs) for pentosan polysulfate sodium capsule. DATES: Although you can comment on any guidance at any...
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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...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-12-04
... facilities. The draft guidance discusses the process for registration of outsourcing facilities. The draft... outsourcing facilities that will participate in the process. Estimated reporting burden until September 30...] Draft Guidance for Industry on Registration for Human Drug Compounding Outsourcing Facilities Under...
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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...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-09-24
...] Global Unique Device Identification Database; Draft Guidance for Industry; Availability AGENCY: Food and... the availability of the draft guidance entitled ``Global Unique Device Identification Database (GUDID... manufacturer) will interface with the GUDID, as well as information on the database elements that must be...
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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
...The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled ``Draft Guidance for Industry and FDA Staff: The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems.'' This draft guidance document provides industry and the Agency staff with guidelines for developing premarket submissions for artificial pancreas device systems, in particular, the Control-to-Range (CTR) and Control-to-Target (CTT) device systems. This draft guidance is not final nor is it in effect at this time.
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-11-06
...] Draft Guidance for Industry on Pulmonary Tuberculosis: Developing Drugs for Treatment; Availability...) is announcing the availability of a draft guidance for industry entitled ``Pulmonary Tuberculosis... of antimycobacterial drugs for the treatment of pulmonary tuberculosis. This guidance applies to the...
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75 FR 59268 - Draft Guidance for Industry: Acidified Foods; Availability
Federal Register 2010, 2011, 2012, 2013, 2014
2010-09-27
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0434] Draft Guidance for Industry: Acidified Foods; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-01-13
....gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ProposedRegulationsandDraftGuidances/default...] Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: IRB Continuing Review After Clinical Investigation Approval; Availability AGENCY: Food and Drug Administration, HHS...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-02-23
... COUNCIL ON ENVIRONMENTAL QUALITY National Environmental Policy Act (NEPA) Draft Guidance...: Council on Environmental Quality. ACTION: Notice of Availability, Draft Guidance, ``Establishing, Applying... February 18, 2010, the Council on Environmental Quality (CEQ) announced four steps to modernize...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-07-05
...] Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and Related... ``Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.'' The draft guidance, when finalized, will assist industry in deciding when a premarket safety notification for a dietary supplement...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-06-29
...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Q11 Development and Manufacture of Drug Substances.'' 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 approaches to developing process and drug substance understanding and provides guidance on what information should be provided in certain sections of the Common Technical Document (CTD). The draft guidance is intended to harmonize the scientific and technical principles relating to the description and justification of the development and manufacturing process of drug substances (both chemical entities and biotechnological/biological entities) to enable a consistent approach for providing and evaluating this information across the three regions.
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77 FR 74852 - Draft Guidance for Industry on Certification of Designated Medical Gases; Availability
Federal Register 2010, 2011, 2012, 2013, 2014
2012-12-18
... the availability of a draft guidance for industry entitled ``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...
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75 FR 60129 - Draft Guidance for Industry and Investigators on Safety Reporting Requirements for...
Federal Register 2010, 2011, 2012, 2013, 2014
2010-09-29
... with the new requirements in the final rule entitled ``Investigational New Drug Safety Reporting...] Draft Guidance for Industry and Investigators on Safety Reporting Requirements for Investigational New... the agency considers your comment on this draft guidance before it begins work on the final version of...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-02-19
...] Draft Guidance for Industry and Food and Drug Administration Staff; Providing Information About... Guidance for Industry and Food and Drug Administration Staff: Providing Information About Pediatric Uses of...ComplianceRegulatoryInformation/default.htm . To receive ``Draft Guidance for Industry and Food and Drug...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-06-20
...] Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance... availability of the draft guidance entitled ``Class II Special Controls Guidance Document: Implanted Blood... blood access devices may comply with the requirement of special controls for class II devices. This...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-09-07
...] Draft Guidance for Industry: Bar Code Label Requirements-- Questions and Answers (Question 12 Update... Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Bar... guidance provides you, manufacturers of a licensed vaccine, with advice concerning compliance with the bar...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-11-20
...://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ProposedRegulationsandDraftGuidances...] Draft Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities for Reviewing the... IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities for Reviewing the Qualifications of...
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78 FR 17943 - Draft Program-Specific Guidance About Fixed Gauge Licenses
Federal Register 2010, 2011, 2012, 2013, 2014
2013-03-25
... is requesting public comment on draft NUREG-1556, Volume 4, Revision 1, ``Consolidated Guidance About... sensitive information, and changes in regulatory policies and practices. This document is intended for use...-415- 4737, or by email to [email protected] . The draft NUREG-1556, Volume 4, Revision 1, is...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-05-24
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-1999-D-0792] (Formerly FDA-1999-D-0792) Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial.... SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-11-07
...: In Vitro Diagnostic Devices for Yersinia Species Detection; Availability AGENCY: Food and Drug... availability of a draft guidance entitled ``Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Yersinia Species Detection.'' This draft guidance document describes a means by which in vitro...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-03-26
.... FDA-2013-D-0269] Draft Guidance for Industry on Purchasing Reef Fish Species Associated With the Hazard of Ciguatera Fish Poisoning; Availability AGENCY: Food and Drug Administration, HHS. ACTION... availability of a draft guidance entitled ``Guidance for Industry: Purchasing Reef Fish Species Associated With...
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75 FR 4400 - Draft Guidance for Industry on Assessment of Abuse Potential of Drugs; Availability
Federal Register 2010, 2011, 2012, 2013, 2014
2010-01-27
... comments on the draft guidance by March 29, 2010. ADDRESSES: Submit written requests for single copies of...] Draft Guidance for Industry on Assessment of Abuse Potential of Drugs; Availability AGENCY: Food and... psychoactive effects such as sedation, euphoria, or mood change. DATES: Although you can comment on any...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-12-13
... document, which addresses safety achieved through drug product design, is the first in a series of planned...] Draft Guidance for Industry on Safety Considerations for Product Design To Minimize Medication Errors... Considerations for Product Design to Minimize Medication Errors.'' The draft guidance provides sponsors of...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-09
...] Draft Guidance for Industry: Submission of Warning Plans for Cigarettes and Smokeless Tobacco Products... the availability of a draft guidance for industry entitled ``Submission of Warning Plans for... submitting warning plans to FDA under the Comprehensive Smokeless Tobacco Health Education Act, as amended by...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-04-01
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0286] Draft Guidance for Industry on Formal Meetings Between FDA and Biosimilar Biological Product Sponsors or... Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-02-23
...] Draft Guidance for Industry: Food and Drug Administration Records Access Authority Under the Federal... industry entitled ``FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug...). This updated draft guidance is intended to provide individuals in the human and animal food industries...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-06-10
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0281] Draft Guidance for Industry and Food and Drug Administration Staff; ```Harmful and Potentially Harmful... Food, Drug, and Cosmetic Act.'' This draft guidance provides written guidance to industry and FDA staff...
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Siegfried, Elaine C; Jaworski, Jennifer C; Eichenfield, Lawrence F; Paller, Amy; Hebert, Adelaide A; Simpson, Eric L; Altman, Emily; Arena, Charles; Blauvelt, Andrew; Block, Julie; Boguniewicz, Mark; Chen, Suephy; Cordoro, Kelly; Hanna, Diane; Horii, Kimberly; Hultsch, Thomas; Lee, James; Leung, Donald Y; Lio, Peter; Milner, Joshua; Omachi, Theodore; Schneider, Christine; Schneider, Lynda; Sidbury, Robert; Smith, Timothy; Sugarman, Jeffrey; Taha, Sharif; Tofte, Susan; Tollefson, Megha; Tom, Wynnis L; West, Dennis P; Whitney, Lucinda; Zane, Lee
2018-05-01
Atopic dermatitis is the most common chronic skin disease, and it primarily affects children. Although atopic dermatitis (AD) has the highest effect on burden of skin disease, no high-level studies have defined optimal therapy for severe disease. Corticosteroids have been used to treat AD since the 1950s and remain the only systemic medication with Food and Drug Administration approval for this indication in children, despite published guidelines of care that recommend against this option. Several clinical trials with level 1 evidence have supported the use of topical treatments for mild to moderate atopic dermatitis in adults and children, but these trials have had little consistency in protocol design. Consensus recommendations will help standardize clinical development and trial design for children. The Food and Drug Administration issues guidance documents for industry as a source for "the Agency's current thinking on a particular subject." Although they are nonbinding, industry considers these documents to be the standard for clinical development and trial design. Our consensus group is the first to specifically address clinical trial design in this population. We developed a draft guidance document for industry, Developing Drugs for Treatment of Atopic Dermatitis in Children (≥3 months to <18 years of age). This draft guidance has been submitted to the Food and Drug Administration based on a provision in the Federal Register (Good Guidance Practices). © 2018 Wiley Periodicals, Inc.
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Draft Updates to the Planning for Natural Disaster Debris Guidance and to Related Documents
EPA is requesting comment on the draft update of the Planning for Natural Disaster Debris Guidance, along with two other documents. This Guidance is an update of the Planning for Natural Disaster Debris guidance that EPA published in March 2008.
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-04-26
...] Draft Guidance for Industry and Food and Drug Administration Staff; Total Product Life Cycle: Infusion... the draft guidance document entitled ``Total Product Life Cycle: Infusion Pump--Premarket Notification... this issue of the Federal Register, FDA is announcing a public meeting regarding external infusion...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-05-10
...] Draft Guidance for Industry and Food and Drug Administration Staff; Pediatric Information for X-Ray... guidance entitled ``Pediatric Information for X-ray Imaging Device Premarket Notifications.'' This draft... premarket notifications for x-ray imaging devices with indications for use in pediatric populations. FDA...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-08-17
...; formerly Docket No. 2007D-0290] Draft Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells; Withdrawal of Draft Guidance...: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-07-15
...] Draft Guidance for Industry on Pediatric Study Plans: Content of and Process for Submitting Initial... a draft guidance for industry entitled ``Pediatric Study Plans: Content of and Process for... Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-08-15
... availability of the draft guidance document entitled ``Factors to Consider When Making Benefit-Risk... versus its probable risk. This draft guidance sets out the factors FDA considers when making this... factors to consider when making benefit-risk determinations in medical device premarket review. It does...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-09
...] Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and Related...; Dietary Supplements: New Dietary Ingredient Notifications and Related Issues; Availability,'' that... Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and Related Issues...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-07
... the Draft Guidance of Applying Quantitative Data To Develop Data-Derived Extrapolation Factors for.... SUMMARY: EPA is announcing that Eastern Research Group, Inc. (ERG), a contractor to the EPA, will convene an independent panel of experts to review the draft document, ``Guidance for Applying Quantitative...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-11-12
...] Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters... a draft guidance for industry and FDA staff entitled ``Dear Health Care Provider Letters: Improving Communication of Important Safety Information.'' Dear Health Care Provider (DHCP) Letters are correspondence...
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78 FR 33848 - Draft Guidance for Industry on Human Immunodeficiency Virus-1 Infection: Developing...
Federal Register 2010, 2011, 2012, 2013, 2014
2013-06-05
...] Draft Guidance for Industry on Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs... entitled ``Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment.'' The... guidance for industry entitled ``Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-01-07
...] Draft Guidance for Industry on Electronic Source Documentation in Clinical Investigations; Availability... Documentation in Clinical Investigations.'' This document provides guidance to sponsors, contract research organizations (CROs), data management centers, and clinical investigators on capturing, using, and archiving...
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76 FR 55068 - Mobile Medical Applications Draft Guidance; Public Workshop; Correction
Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-06
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0530] Mobile Medical Applications Draft Guidance; Public Workshop; Correction AGENCY: Food and Drug... announced a public workshop entitled ``Mobile [[Page 55069
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76 FR 16425 - Draft Guidance for Industry: Testing for Salmonella
Federal Register 2010, 2011, 2012, 2013, 2014
2011-03-23
... draft guidance does not apply to egg producers and other persons who are covered by FDA's final rule ``Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation.'' The... eggs) and direct-human-contact animal foods, and the interpretation of test results, when the presence...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-06-25
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0283] Draft Guidance for Industry on Chemistry, Manufacturing, and Controls Postapproval Manufacturing Changes... guidance describes chemistry, manufacturing, and controls (CMC) postapproval manufacturing changes that FDA...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-11-29
...] Draft Guidance for Industry on Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment; Availability AGENCY: Food and Drug Administration, HHS. ACTION... guidance for industry entitled ``Hospital- Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-06-17
...] Draft Guidance for Industry on Clinical Trial Endpoints for the Approval of Non-Small Cell Lung Cancer... entitled ``Clinical Trial Endpoints for the Approval of Non-Small Cell Lung Cancer Drugs and Biologics... draft guidance for industry entitled ``Clinical Trial Endpoints for the Approval of Non-Small Cell Lung...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-06-11
... by Blood and Blood Products,'' Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice...CJD) by Blood and Blood Products'' dated May 2010 (2010 CJD/vCJD guidance). When finalized, the... Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products' '' dated April 2012. The draft...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-02-23
... COUNCIL ON ENVIRONMENTAL QUALITY National Environmental Policy Act (NEPA) Draft Guidance, ``NEPA Mitigation and Monitoring.'' AGENCY: Council On Environmental Quality. ACTION: Notice of Availability, Draft... Quality (CEQ) announced four steps to modernize, reinvigorate, and ease the use and increase the...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-11-15
... NUCLEAR REGULATORY COMMISSION [NRC-2011-0254] Common-Cause Failure Analysis in Event and Condition Assessment: Guidance and Research, Draft Report for Comment; Correction AGENCY: Nuclear Regulatory Commission. ACTION: Draft NUREG; request for comment; correction. SUMMARY: This document corrects a notice appearing...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-09-09
...] Draft Guidance for Industry on Suicidality: Prospective Assessment of Occurrence in Clinical Trials...: Prospective Assessment of Occurrence in Clinical Trials.'' The purpose of this guidance is to assist sponsors in prospectively assessing the occurrence of treatment-emergent suicidality in clinical trials of...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-12-04
...] Draft Guidance for Industry on Interim Product Reporting for Human Drug Compounding Outsourcing... Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' The draft... human drug compounders that choose to register as outsourcing facilities (outsourcing facilities). DATES...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-04-25
... things, dated copies of advertisements, dated catalog pages, and dated promotional material. II. Significance of Guidance This draft guidance is being issued consistent with FDA's good guidance practices... manufacturer provide evidence that may include, among other things, dated copies of advertisements, dated...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-05-18
... Controls Guidance Document: In Vitro Diagnostic Devices for Bacillus Species Detection AGENCY: Food and... Guidance Document: In Vitro Diagnostic Devices for Bacillus spp. Detection.'' This draft guidance document describes means by which in vitro diagnostic devices for Bacillus species (spp.) detection may comply with...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-07-15
... Guidance for Industry on Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug... Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled... Administration Safety and Innovation Act (FDASIA) added a new provision to the Food, Drug, and Cosmetic Act (FD&C...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-08-31
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0431] Draft Guidance for Food and Drug Administration Staff and Tobacco Retailers on Civil Money Penalties and... guidance entitled ``Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers.'' This guidance...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-07-14
... Texts for Use in the International Conference on Harmonisation Regions; Annex 13 on Bulk Density and... guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions... evaluation of the Bulk Density and Tapped Density of Powders General Chapter harmonized text from each of the...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-07-06
... of the revised draft High Winds Guidance document, the EPA identifies example technical analyses that... identified analyses and any additional technical analyses that air agencies could use to demonstrate that the... Web site at http://www.epa.gov/ttn/analysis/exevents.htm for additional details on the draft non...
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78 FR 40199 - Draft Spent Fuel Storage and Transportation Interim Staff Guidance
Federal Register 2010, 2011, 2012, 2013, 2014
2013-07-03
... NUCLEAR REGULATORY COMMISSION [NRC-2013-0140] Draft Spent Fuel Storage and Transportation Interim... Spent Fuel Storage and Transportation Interim Staff Guidance No. 24 (SFST-ISG-24), Revision 0, ``The Use of a Demonstration Program as Confirmation of Integrity for Continued Storage of High Burnup Fuel...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-07-24
... Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and... Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation (Layers with Outdoor Access)'' (the draft guidance). The document provides guidance to egg producers on...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-08-13
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0880] Draft Guidance for Industry on Frequently Asked Questions About Medical Foods; Second Edition... guidance for industry entitled ``Frequently Asked Questions About Medical Foods; Second Edition.'' This...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-07-28
... Physical Medicine Device Guidance Document; Reopening of Comment Period AGENCY: Food and Drug... for 11 neurological and physical medicine devices. FDA is reopening the comment period to allow... announcing the availability of draft special controls guidance documents for 11 neurological and physical...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-10-23
...] Draft Guidance for Industry on Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral... entitled ``Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment... antiviral (DAA) drugs for the treatment of chronic hepatitis C. This guidance revises and replaces a...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-07-15
... Level for Arsenic in Apple Juice; A Quantitative Assessment of Inorganic Arsenic in Apple Juice... Arsenic in Apple Juice'' (the draft supporting document) and ``A Quantitative Assessment of Inorganic... document entitled ``A Quantitative Assessment of Inorganic Arsenic in Apple Juice.'' The draft guidance...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-06-18
...The Environmental Protection Agency (EPA or agency) is announcing a public meeting to discuss draft permitting guidance the agency has developed on the use of diesel fuels in oil and gas hydraulic fracturing and to solicit input during the public comment period. The meeting is open to all interested parties. The agency requests input on the following technical aspects of the draft permitting guidance: Diesel fuels description; diesel fuels usage information; permit duration and well closure; area of review; information submitted with the permit application; and monitoring.
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77 FR 69619 - Draft Recommendations of Joint Outreach Team
Federal Register 2010, 2011, 2012, 2013, 2014
2012-11-20
... Team AGENCY: Western Area Power Administration, DOE. ACTION: Notice of Availability of draft recommendations of Western/DOE Joint Outreach Team. SUMMARY: The Western Area Power Administration (Western), a... recommendations of the Western/DOE Joint Outreach Team (JOT) for review and comment by Western's customers, Tribes...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-04-08
... Recommendations; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-06-14
... Recommendations; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-03-22
... Recommendations; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-04-24
... container labels and carton labeling design, is the second in a series of three planned guidance documents...] Draft Guidance for Industry on Safety Considerations for Container Labels and Carton Labeling Design To... entitled ``Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-04-05
... Physical Medicine Device Guidance Documents; Availability AGENCY: Food and Drug Administration, HHS. ACTION... controls guidance documents for 11 neurological and physical medicine devices. FDA has developed a draft... stimulator device achieves ``aesthetic effects through physical change to the structure of the body'' as well...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-12-27
... Guidance for Assessing the Effects of Anthropogenic Sound on Marine Mammals--Acoustic Threshold Levels for.... SUMMARY: The National Marine Fisheries Service (NMFS) on behalf of NMFS and the National Ocean Service... availability of draft guidance for assessing the effects of anthropogenic sound on marine mammal species under...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-06-26
... approval, and priority review designation. DATES: Although you can comment on any guidance at any time (see... designation, (3) accelerated approval, and (4) priority review designation. The draft guidance describes... (the FD&C Act) (Enhancement of Accelerated Approval Access to New Medical Treatments) within 1 year of...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-03-07
... FEDERAL ACCOUNTING STANDARDS ADVISORY BOARD Notice of Issuance of Exposure Draft on Implementation Guidance on General Property, Plant, and Equipment Cost Accumulation, Assignment, and Allocation AGENCY... Guidance on General Property, Plant, and Equipment Cost Accumulation, Assignment, and Allocation. The...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-10-17
...: External Pacemaker Pulse Generator; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... entitled ``Class II Special Controls Guidance Document: External Pacemaker Pulse Generator.'' This draft guidance document describes a means by which external pacemaker pulse generators may comply with the...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-08-30
... your comment on this draft guidance before it begins work on the final version of the guidance, submit... Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm... Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm...
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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.
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-03-23
...] Draft Guidance for Industry on Irritable Bowel Syndrome--Clinical Evaluation of Products for Treatment... topics regarding irritable bowel syndrome (IBS) sign and symptom assessment for IBS with diarrhea (IBS-D... IBS. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-01-05
... electronic or written comments on the draft guidance by April 5, 2011. ADDRESSES: Submit written requests for... INFORMATION section for information on electronic access to the guidance. Submit electronic comments on the..., plasma, and blood. These devices are used to aid in the diagnosis of Lyme disease. This document does not...
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EPA is requesting comment on the draft Planning for Natural Disaster Debris Guidance, and two other documents. The Guidance is an update of the Planning for Natural Disaster Debris guidance that EPA published in March 2008.
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Bower, Joseph; Fast, Douglas; Garofolo, Fabio; Gouty, Dominique; Hayes, Roger; Lowes, Steve; Nicholson, Robert; LeLacheur, Richard; Bravo, Jennifer; Shoup, Ronald; Dumont, Isabelle; Carbone, Mary; Zimmer, Jennifer; Ortuno, Jordi; Caturla, Maria Cruz; Datin, Jim; Lansing, Tim; Fatmi, Saadya; Struwe, Petra; Sheldon, Curtis; Islam, Rafiqul; Yu, Mathilde; Hulse, Jim; Kamerud, John; Lin, John; Doughty, John; Kurylak, Kai; Tang, Daniel; Buonarati, Mike; Blanchette, Alexandre; Levesque, Ann; Gagnon-Carignan, Sofi; Lin, Jenny; Ray, Gene; Liu, Yanseng; Khan, Masood; Xu, Allan; El-Sulayman, Gibran; DiMarco, Chantal; Bouhajib, Mohammed; Tacey, Dick; Jenkins, Rand; der Strate, Barry van; Briscoe, Chad; Karnik, Shane; Rhyne, Paul; Garofolo, Wei; Schultz, Gary; Roberts, Andrew; Redrup, Mike; DuBey, Ira; Conliffe, Phyllis; Pekol, Teri; Hantash, Jamil; Cojocaru, Laura; Allen, Mike; Reuschel, Scott; Watson, Andrea; Farrell, Colin; Groeber, Elizabeth; Malone, Michele; Nowatzke, William; Fang, Xinping
2014-01-01
The 8th GCC Closed Forum for Bioanalysis was held in Baltimore, MD, USA on 5 December 2013, immediately following the 2013 AAPS Workshop (Crystal City V): Quantitative Bioanalytical Methods Validation and Implementation--The 2013 Revised FDA Guidance. This GCC meeting was organized to discuss the contents of the draft revised FDA Guidance on bioanalytical method validation that was published in September 2013 and consolidate the feedback of the GCC members. In attendance were 63 senior-level participants, from seven countries, representing 46 bioanalytical CRO companies/sites. This event represented a unique opportunity for CRO bioanalytical experts to share their opinions and concerns regarding the draft FDA Guidance, and to build unified comments to be provided to the FDA.
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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.
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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
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-07-02
...] Draft Guidance for Industry on Antibacterial Therapies for Patients With Unmet Medical Need for the... guidance for industry entitled ``Antibacterial Therapies for Patients With Unmet Medical Need for the... development of new antibacterial drugs to treat serious bacterial diseases, particularly in areas of unmet...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-02-08
...] Draft Guidance for Industry on Alzheimer's Disease: Developing Drugs for the Treatment of Early Stage Disease; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and... ``Alzheimer's Disease: Developing Drugs for the Treatment of Early Stage Disease.'' This guidance outlines FDA...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-02-08
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1083] Draft Guidance for Industry and Food and Drug Administration Staff; Civil Money Penalties for Tobacco... guidance for industry entitled ``Civil Money Penalties for Tobacco Retailers: Responses to Frequently Asked...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-12-19
...] Draft Guidance for Industry and Food and Drug Administration Staff; Evaluation of Sex Differences in... entitled ``Evaluation of Sex Differences in Medical Device Clinical Studies.'' This document provides guidance on the study and evaluation of sex differences in medical device clinical trials, with a specific...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-09-28
... method comparison section and the sample selection inclusion and exclusion criteria section. The... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0428] Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-07-02
..., choosing a study population, using a control group and blinding, dose selection, treatment plans...] Draft Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of Cellular... document entitled ``Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-20
... nuclear power plants. In response to a request from the Nuclear Energy Institute (NEI), the NRC is... NUCLEAR REGULATORY COMMISSION [NRC-2011-0191] Draft License Renewal Interim Staff Guidance LR-ISG-2011-05; Ongoing Review of Operating Experience AGENCY: Nuclear Regulatory Commission. ACTION: Draft...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-03-14
...] Revised Draft Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological... entitled ``User Fee Waivers, Reductions, and Refunds for Drug and Biological Products.'' This revised draft... industry entitled ``User Fee Waivers, Reductions, and Refunds for Drug and Biological Products.'' This...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-03-14
...] Draft Guidance for Industry on Chemistry, Manufacturing, and Controls Information--Fermentation-Derived... Controls (CMC) Information-- Fermentation-Derived Intermediates, Drug Substances, and Related Drug Products... documentation to submit to support the CMC information for fermentation-derived intermediates, drug substances...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-12-19
... Draft Recommendations of the Healthcare Personnel Influenza Vaccination Subgroup for Consideration by... Influenza Vaccination in Healthcare Personnel AGENCY: Department of Health and Human Services, Office of the... ASH has charged the NVAC with developing recommended strategies for annually achieving 90% influenza...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-10-24
...] Draft Guidance for Industry: Implementation of Acceptable Abbreviated Donor History Questionnaire and... Acceptable Abbreviated Donor History Questionnaire and Accompanying Materials for Use in Screening Frequent... abbreviated donor history questionnaire and accompanying materials (aDHQ documents), version 1.3 dated August...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-06-12
... the Agency considers your comment on this draft guidance before it begins work on the final version of... the regulated entities under FDA's and OHRP's jurisdiction. The Agencies wish to stress, however, that... other entities involved in the study oversight transfer process. FDA and OHRP will continue to work...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-12-30
... evolution and reversibility of morphologic changes. Because of the many variations in the practice of..., and other forms of information technology. This draft guidance refers to previously approved...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-12-12
... humans. ``Fungistats'' are antimicrobial pesticides intended for aesthetic or cosmetic purposes and only... to improve protection of public health through proper use of mold-related pesticides. III. Do PR... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPP-2010-0539; FRL-9362-3] Pesticides; Draft Guidance for...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-04-25
...] Draft Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes... Substances, Including Food Ingredients That Are Color Additives; Availability AGENCY: Food and Drug... Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-01-16
... with pesticide labeling requirements and thereby protecting human health and the environment from... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPP-2012-0906; FRL-9374-4] Pesticides; Draft Guidance for Pesticide Registrants on Web- Distributed Labeling for Pesticide Products AGENCY: Environmental Protection...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-11-10
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0790] Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff; Food and Drug Administration Decisions for Investigational Device Exemption Clinical...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-01-05
... Methicillin-Resistant Staphylococcus aureus and Staphylococcus aureus; Availability AGENCY: Food and Drug...-Resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA).'' The draft guidance document... and differentiation of methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-12-16
... FEDERAL ACCOUNTING STANDARDS ADVISORY BOARD Issuance of Exposure Drafts on Implementation Guidance on the Accounting for the Disposal of G-PP&E and Implementation Guidance for Estimating the Historical Cost of G-PP&E AGENCY: Federal Accounting Standards Advisory Board. ACTION: Notice. Board Action...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-11-13
... Additive Manufacturing showed great promise for the defense, energy, space and commercial sectors of the Nation. In August, 2012, the selection of the National Additive Manufacturing Innovation Institute (NAMII...-01] Draft Guidance on Intellectual Property Rights for the National Network for Manufacturing...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-02-14
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0081] 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...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-08-19
... assist the office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic... considerations for standardization of image acquisition, image interpretation methods, and other procedures to help ensure imaging data quality. The draft guidance describes two categories of image acquisition and...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-07-05
...] Draft Guidance for Industry on Organ-Specific Warnings: Internal Analgesic, Antipyretic, and... Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use... enforcement discretion with regard to the liver warning required in the labeling. DATES: Although you can...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-05-31
...] Draft Guidance for Industry on Rheumatoid Arthritis: Developing Drug Products for Treatment... support the approval of drug products for the treatment of patients with rheumatoid arthritis (RA). It... Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA),'' published in...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-05-28
... documenting the responsibilities of all parties involved in drug manufacturing, testing, or other support... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0558] Draft Guidance for Industry on Contract Manufacturing Arrangements for Drugs: Quality Agreements...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-08-24
...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Neglected Tropical Diseases of the Developing World: Developing Drugs for Treatment or Prevention.'' The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment or prevention of neglected diseases of the developing world. Specifically, this guidance addresses FDA's current thinking regarding the overall drug development program for the treatment or prevention of neglected tropical diseases (NTDs), including clinical trial designs and internal review standards to support approval of drugs.
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78 FR 54949 - Major Project Financial Plan Guidance
Federal Register 2010, 2011, 2012, 2013, 2014
2013-09-06
...'' (GA-090-751). That report recommended that Financial Plans include the cost of financing the project... Project Financial Plan Guidance AGENCY: Federal Highway Administration (FHWA), DOT. ACTION: Notice; Request for comments. SUMMARY: This notice requests comments on draft Major Project Financial Plan...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-04-09
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0258] Molecular Diagnostic Instruments With Combined Functions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-03-09
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2005-D-0339] Draft Guidance on Drug Safety Information--FDA's Communication to the Public; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-08-13
... 510(k)s reviewed in the Center for Devices and Radiological Health (CDRH) and the Center for Biologics... applicable to all devices reviewed through the 510(k) notification process in CDRH and CBER and have been... draft guidance may do so by using the Internet. A search capability for all CDRH guidance documents is...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-10-17
... Radiological Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver... request, or fax your request to CDRH at 301-847-8149. The draft guidance may also be obtained by mail by... using the Internet. A search capability for all CDRH guidance documents is available at http://www.fda...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-06-06
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-1999-D-0742 (formerly Docket No. 1999D-4396)] Draft Guidance for Clinical Investigators, Industry, and FDA Staff...: Notice; correction. SUMMARY: The Food and Drug Administration (FDA) is correcting a notice that appeared...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-10-14
... obtain approval from the Office of Management and Budget (OMB) for each collection of information they... information before submitting the collection to OMB for approval. To comply with this requirement, FDA is... VIII of the draft guidance, ``Process for Addressing Inquiries Concerning the Application of the IND...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-04-02
... Classification of Materials and Materials for Organic Crop Production AGENCY: Agricultural Marketing Service... organic crop production, livestock production, and handling. The second set of draft guidance documents, NOP 5034, provides clarification regarding materials for use in organic crop production. These...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-09-25
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0938] Draft Guidance for Industry on Abbreviated New Drug Applications: Stability Testing of Drug Substances... their complexity, the FDA is considering standardizing stability testing policies by adopting...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-09-17
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0881] Draft Guidance for Industry on Self-Identification of Generic Drug Facilities, Sites, and Organizations... ``Self-Identification of Generic Drug Facilities, Sites, and Organizations.'' The document was published...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-08-16
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0514] Draft Guidance for Industry and Food and Drug Administration Staff; Procedures for Handling Section 522 Postmarket Surveillance Studies; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-06-17
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0490] Draft Guidance for Industry and FDA Staff: Investigational New Drug Applications for Minimally... Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-12-13
..., is a fundamental tool used to harmonize our environmental, economic, and social aspirations and is a... COUNCIL ON ENVIRONMENTAL QUALITY Draft Guidance on Improving the Process for Preparing Efficient and Timely Environmental Reviews under the National Environmental Policy Act AGENCY: Council on...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-01-25
...] Draft Guidance for Industry: Questions and Answers Regarding Implementation of the Menu Labeling...: Questions and Answers Regarding Implementation of the Menu Labeling Provisions of Section 4205 of the... Implementation of the Menu Labeling Provisions of Section 4205 of the Patient Protection and Affordable Care Act...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-10-13
... Production (NOP 5021); Wild Crop Harvesting (NOP 5022); Outdoor Access for Organic Poultry (NOP 5024); Commingling and Contamination Prevention in Organic Production and Handling (NOP 5025); and The Use of Chlorine Materials in Organic Production and Handling (NOP 5026). These draft guidance documents are...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-10-02
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1010] Draft Guidance for Industry on Initial Completeness Assessments for Type II Active Pharmaceutical... certain drug master files, namely, Type II active pharmaceutical ingredient (API) drug master files (DMFs...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-09
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0147] Draft Guidance for Industry and Food and Drug Administration Staff; Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions; Availability AGENCY: Food and...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-03-02
... Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6340, Silver... the review of 351(k) applications and general scientific principles in conducting comparative analyses... specific, on the scientific considerations, Q&A, and quality considerations draft guidances. For example...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-11-23
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0784] Draft Guidance for Industry on Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing Animals; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-07-09
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0743] Medical Device Reporting for Manufacturers; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-05-25
...] Draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established.... The agency is also seeking comments from industry on the Reportable Food Registry requirements, and... the implementation of the Reportable Food Registry on September 8, 2009, and informs industry about...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-08-27
...] Draft Guidance for Industry on Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for... ``Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for Treatment.'' The purpose of... antimicrobial drugs for the treatment of acute bacterial skin and skin structure infections (ABSSSI), impetigo...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-08-17
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-1999-D-2955] (formerly Docket No. 1999D-4071) Draft Revised Guidance for Industry on Residual Solvents in New Veterinary...) entitled ``Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-06-01
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0305] Draft Guidance for Industry and FDA Staff: Commercially Distributed In Vitro Diagnostic Products Labeled...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-02-27
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0080... Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``FDA... that address nearly all aspects of the FDA approval and surveillance processes, including application...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-09-14
...] Draft Guidance for Industry on Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral... entitled ``Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Agents for Treatment... antiviral agents (DAAs), defined as agents that interfere with specific steps in the hepatitis C virus (HCV...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-05-09
... a more transparent process by increasing awareness and knowledge of expanded access programs and the... regulations. Consistent with the goal of making expanded access processes more transparent, FDA is providing... (IRB) review and approval required for individual patient expanded access?'' In the draft guidance, FDA...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-05-10
... authority. The draft guidance includes EPA's interpretation of the Safe Drinking Water Act (SDWA) and...., Washington, DC 20460. Hand Delivery: Office of Water (OW) Docket, EPA/DC, EPA West, Room 3334, 1301... Injection Control Program, Drinking Water Protection Division, Office of Ground Water and Drinking Water (MC...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-08-27
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0938] Draft Guidance for Industry on Abbreviated New Drug Applications: Stability Testing of Drug Substances... Products, Questions and Answers.'' Because of increases in the number and complexity of ANDAs and FDA's...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-04-02
... Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6340, Silver Spring, MD... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0618] Draft Guidances Relating to the Development of Biosimilar Products; Public Hearing; Request for Comments...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-06-09
... External Review Draft of the Guidance for Applying Quantitative Data To Develop Data-Derived Extrapolation... Applying Quantitative Data to Develop Data-Derived Extrapolation Factors for Interspecies and Intraspecies... Applying Quantitative Data to Develop Data-Derived Extrapolation Factors for Interspecies and Intraspecies...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-02-24
... abnormalities of the urinary tract, but are also considered to be a subset of cUTI. Different types of bacteria can cause cUTI, but Gram-negative bacteria are most often associated with cUTI. This draft guidance..., based on resolution of clinical symptoms and eradication of bacteria from the urinary tract, was derived...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-02-11
... availability of a draft Navigation and Vessel Inspection Circular (NVIC) that sets forth the Coast Guard's... guidance to the maritime industry, Coast Guard marine inspectors, and other affected parties on how the... and Coast Guard marine inspectors on how the Coast Guard intends to implement this new voluntary...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-06-21
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0429] Draft Guidances for Industry and Food and Drug Administration Staff: Classification of Products as Drugs... Action'' in the Definition of Device Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-01-07
... copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research..., Silver Spring, MD 20993- 0002, 301-796-8510. Regarding human drug products: Solomon Iyasu, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-05-10
... Draft Recommendations of the Vaccine Safety Working Group for Consideration by the National Vaccine Advisory Committee on the Federal Vaccine Safety System AGENCY: National Vaccine Program Office, Office of.... ACTION: Notice. SUMMARY: The National Vaccine Advisory Committee (NVAC) was established in 1987 to comply...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-28
... Tobacco Control Act amends the FD&C Act and grants FDA authority to regulate the manufacture, marketing... (PMTA) under section 910(b) of the FD&C Act and receive a marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act prior to marketing the product. The draft guidance is intended to...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-02-23
..., ``Consideration of the Effects of Climate Change and Greenhouse Gas Emissions.'' AGENCY: Council On Environmental Quality. ACTION: Notice of Availability, Draft Guidance, ``Consideration of the Effects of Climate Change... Effects of Climate Change and Greenhouse Gas Emissions'' should be submitted electronically to GCC...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-02-03
...] Draft Guidance for Industry on ``Target Animal Safety and Effectiveness Protocol Development and...) entitled ``Target Animal Safety and Effectiveness Protocol Development and Submission.'' The purpose of... Center for Veterinary Medicine (CVM), Office of New Animal Drug Evaluation (ONADE), to reduce the time to...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-12-30
... indication and risk information, post-marketing submission requirements) in their internet and social media... requests for off-label information, including those that firms may encounter on emerging electronic media...] Draft Guidance for Industry on Responding to Unsolicited Requests for Off-Label Information About...
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[International trend of guidance for nanomaterial risk assessment].
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.
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-08-15
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0585] 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...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-07-22
... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-ORD-2009-0694; FRL-9442-8] Notice of Availability of the External Review Draft of the Guidance for Applying Quantitative Data to Develop Data-Derived Extrapolation... Quantitative Data to Develop Data-Derived Extrapolation Factors for Interspecies and Intraspecies Extrapolation...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-06-28
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0749] Implanted Blood Access Devices for Hemodialysis; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-12-13
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0847] 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...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-08-19
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0215] Draft Guidance for Industry and Food and Drug Administration Staff on In Vitro Companion Diagnostic Devices; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; extension...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-06-22
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0469] Draft Guidance for Industry and Food and Drug Administration Staff: Applying Human Factors and Usability Engineering To Optimize Medical Device Design; Availability AGENCY: Food and Drug Administration, HHS. ACTION...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-03-05
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0147] Draft Guidance for Industry and Food and Drug Administration Staff; Types of Communication During the Review of Medical Device Submissions; Availability AGENCY: Food and Drug Administration, HHS. ACTION...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-11-14
... Radiological Health (CDRH) for qualification of medical device development tools (MDDT) for use in device.... Background The draft guidance describes the framework and process for the voluntary CDRH qualification of... science; and (4) more quickly and more clearly communicate with CDRH stakeholders about important advances...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-04-03
...] Draft Guidance for Industry and Food and Drug Administration Staff; Glass Syringes for Delivering Drug... and FDA staff entitled ``Glass Syringes for Delivering Drug and Biological Products: Technical... supplemental data are necessary for FDA to ensure the safe and effective use of glass syringes that comply with...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-02-16
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0057] Draft Guidance for Industry and Food and Drug Administration Staff on Best Practices for Conducting and...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-04-13
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0164] Draft Guidance for Industry on Safety Labeling Changes; Implementation of the Federal Food, Drug, and Cosmetic Act; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-07-14
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0215] Draft Guidance for Industry and FDA Staff on In Vitro Companion Diagnostic Devices; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...
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Turning point or tipping point: new FDA draft guidances and the future of DTC advertising.
Pitts, Peter J
2004-01-01
According to Food and Drug Administration (FDA) research, direct-to-consumer (DTC) drug ads are not as empowering as they were even three years ago. How will the FDA's new draft guidances reverse this trend and affect the future of DTC advertising? Will they be a turning point, resulting in pharmaceutical companies' embracing an educational public health imperative, or a tipping point with politicians and the public zeroing in on aggressively targeted DTC ads as the postimportation pharmaceutical bête noire? The FDA believes that its new guidances strengthen the strategic argument that a better-informed consumer lays the groundwork for a better potential customer.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-12-28
... ``Center for Devices and Radiological Health (CDRH) Appeals Processes.'' This document describes the processes available to outside stakeholders to request additional review of decisions and actions by CDRH... submit related requests to CDRH and FDA. This draft guidance is not final nor is it in effect at this...
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The New US Preventive Services Task Force "C" Draft Recommendation for Prostate Cancer Screening.
Cooperberg, Matthew R
2017-09-01
The US Preventive Services Task Force has issued a new draft guideline, with a "C" recommendation that men aged 55-69 yr should be informed about the benefits and harms of screening for prostate cancer, and offered prostate-specific antigen testing if they choose it. For men aged ≥70 yr, the recommendation remains "D", or "do not screen." This draft represents substantial progress in the right direction towards offering men a fair opportunity to discuss the risks and benefits of screening with their primary care providers. However, the evidence review underlying the draft remains fundamentally inadequate, leading to biased presentations of both benefits and harms of screening. The final guideline and future revisions should reflect formal engagement with subject matter experts to optimize the advise given to men and their physicians. Copyright © 2017 European Association of Urology. Published by Elsevier B.V. All rights reserved.
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-04-22
...] (formerly Docket No. 02D-0049) Draft Guidance for the Public, Food and Drug Administration Advisory Committee Members, and Food and Drug Administration Staff: Public Availability of Advisory Committee Members... and Drug Administration Amendments Act of 2007, Public Law No. 110-85), and section 701 (21 U.S.C. 371...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-01-19
... can be sprinkled on soft foods and swallowed without chewing as an alternative administration... parameters are considered in this draft guidance as they relate to drug products labeled for sprinkle: (1... size differences between reference listed drugs and ANDAs and meet bioavailability (BA) or...
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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…
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-02-10
... clinical investigations in determining the amounts and types of safety data to collect in trials conducted... types of safety data that should be collected during late-stage premarket and postmarket clinical...] Draft Guidance for Industry on Determining the Extent of Safety Data Collection Needed in Late Stage...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-09-10
... public and reduce costs to industry. GDUFA enables FDA to assess user fees to support critical and... assess user fees to support critical and measurable enhancements to FDA's generic drugs program. GDUFA...). The draft guidance, when finalized, will represent the Agency's current thinking on ``Generic Drug...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-02-27
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0140] Draft Guidance for Industry on Notification to Food and Drug Administration of Issues That May Result in a Prescription Drug Shortage; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-08-07
... Health's (CDRH) proposed approach on the safety of toy laser products. This draft guidance is not final... products, FDA headquarters and field personnel, and the public of CDRH's proposed approach on the safety of... limits. While this rulemaking process is ongoing, CDRH encourages manufacturers to keep children's toy...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-30
...-2011-02; Aging Management Program for Steam Generators AGENCY: Nuclear Regulatory Commission. ACTION... License Renewal Interim Staff Guidance (LR-ISG), LR-ISG-2011-02, ``Aging Management Program for Steam... using Revision 3 of NEI 97-06 to manage steam generator aging. The Draft LR-ISG revises the NRC staff's...
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Lance, Philip T; Greenaway, Ruth V; Edwards, Brian
2018-01-01
The US Food and Drug Administration (FDA) put out a call for comments on new draft guidance for industry "Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA." This call for comments elicited 7 submissions from various organizations in the field of health care products. This article reports on a review conducted on these 7 submissions. The purpose of this review was to identify any commonalities across the different submissions and determine if there was consensus on any point or aspect of the draft guidance. To identify any commonalities, a heat map plotting the lines of the draft guidance that had raised a comment/suggestion was produced. Also, a thematic analysis was conducted on the comments/suggestions. In total the 7 submissions produced 137 suggestions. The heat map revealed that these suggestions did not focus on any single part of the guidance but were spread throughout the guidance. The thematic analysis conducted on the suggestions found a number of distinct trends. These trends were grouped into 10 primary themes, each with a number of subthemes. It was concluded that guidance from the FDA on this matter is warranted and would be appreciated. However, it was also concluded that based on the distinct trends identified in the suggestions, there are issues that the FDA may wish to consider before publishing their final guidance.
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Sheehan, David V; Giddens, Jennifer M; Sheehan, Kathy Harnett
2014-09-01
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. 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. 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. 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.
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-04-08
...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Providing Postmarket Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report).'' This guidance is intended to inform applicants of the conditions under which FDA will exercise its waiver authority to permit applicants to submit an International Conference on Harmonisation (ICH) E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER) in place of the ICH E2C(R1) Periodic Safety Update Report (PSUR), U.S. periodic adverse drug experience report (PADER), or U.S. periodic adverse experience report (PAER), to satisfy the periodic safety reporting requirements in FDA regulations. The guidance describes the steps applicants can take to submit the PBRER, and discusses the format, content, submission deadline, and frequency of reporting for the PBRER.
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-11-29
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0584... Products.'' This guidance updates recommendations regarding degradation products and updates the draft... information on listing of degradation products, setting acceptance criteria, and qualifying degradation...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-11-07
... provides recommendations for the design of clinical trials for cancer vaccines conducted under an IND to... in this notice finalizes the draft guidance of the same title dated September 2009. DATES: Submit...), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-12-27
...The Food and Drug Administration (FDA) is extending the comment period for the notice that appeared in the Federal Register of Thursday, November, 10, 2011 (76 FR 70151). In the notice, FDA requested comments on the draft guidance that has been developed to promote the initiation of clinical investigations to evaluate the medical devices under FDA's Investigational Device Exemptions (IDE) regulations. The Agency is taking this action to allow interested persons additional time to submit comments.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-10-12
...The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products--Content and Format.'' This guidance is intended to assist applicants and reviewers in drafting the ``Warnings and Precautions, Contraindications, and Boxed Warning'' sections of labeling for human prescription drug and biological products. The recommendations in this guidance will help ensure that the labeling is clear, useful, informative, and to the extent possible, consistent in content and format.
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-01-07
... Recommended Interim Preliminary Remediation Goals for Dioxin in Soil at CERCLA and RCRA Sites AGENCY... Recommended Interim Preliminary Remediation Goals for Dioxin in Soil at Comprehensive Environmental Response... interim PRGs for dioxin in soil. These draft recommended interim PRGs were calculated using existing, peer...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-07-19
...) protect the head, neck and spine of all children transported in ground ambulances. By ensuring that these... transport (newborn with Mother, multiple children, etc.). The full text of the recommendations and the draft...
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Alexander, Paul E; Gionfriddo, Michael R; Li, Shelly-Anne; Bero, Lisa; Stoltzfus, Rebecca J; Neumann, Ignacio; Brito, Juan P; Djulbegovic, Benjamin; Montori, Victor M; Norris, Susan L; Schünemann, Holger J; Thabane, Lehana; Guyatt, Gordon H
2016-02-01
Many strong recommendations issued by the World Health Organization (WHO) are based on low- or very low-quality (low certainty) evidence (discordant recommendations). Many such discordant recommendations are inconsistent with the Grading of Recommendations Assessment, Development and Evaluation (GRADE) guidance. We sought to understand why WHO makes discordant recommendations inconsistent with GRADE guidance. We interviewed panel members involved in guidelines approved by WHO (2007-2012) that included discordant recommendations. Interviews, recorded and transcribed, focused on use of GRADE including the reasoning underlying, and factors contributing to, discordant recommendations. Four themes emerged: strengths of GRADE, challenges and barriers to GRADE, strategies to improve GRADE application, and explanations for discordant recommendations. Reasons for discordant recommendations included skepticism about the value of making conditional recommendations; political considerations; high certainty in benefits (sometimes warranted, sometimes not) despite assessing evidence as low certainty; and concerns that conditional recommendations will be ignored. WHO panelists make discordant recommendations inconsistent with GRADE guidance for reasons that include limitations in their understanding of GRADE. Ensuring optimal application of GRADE at WHO and elsewhere likely requires selecting panelists who have a commitment to GRADE principles, additional training of panelists, and formal processes to maximize adherence to GRADE principles. Copyright © 2016 Elsevier Inc. All rights reserved.
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Twelve recommendations for integrating existing systematic reviews into new reviews: EPC guidance.
Robinson, Karen A; Chou, Roger; Berkman, Nancy D; Newberry, Sydne J; Fu, Rongwei; Hartling, Lisa; Dryden, Donna; Butler, Mary; Foisy, Michelle; Anderson, Johanna; Motu'apuaka, Makalapua; Relevo, Rose; Guise, Jeanne-Marie; Chang, Stephanie
2016-02-01
As time and cost constraints in the conduct of systematic reviews increase, the need to consider the use of existing systematic reviews also increases. We developed guidance on the integration of systematic reviews into new reviews. A workgroup of methodologists from Evidence-based Practice Centers developed consensus-based recommendations. Discussions were informed by a literature scan and by interviews with organizations that conduct systematic reviews. Twelve recommendations were developed addressing selecting reviews, assessing risk of bias, qualitative and quantitative synthesis, and summarizing and assessing body of evidence. We provide preliminary guidance for an efficient and unbiased approach to integrating existing systematic reviews with primary studies in a new review. Copyright © 2016 Elsevier Inc. All rights reserved.
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Code of Federal Regulations, 2010 CFR
2010-07-01
... agencies find guidance on appealing GSA's decisions and recommendations concerning delineated areas? 102-83... System (Continued) FEDERAL MANAGEMENT REGULATION REAL PROPERTY 83-LOCATION OF SPACE Location of Space... recommendations concerning delineated areas? GSA's PBS provides guidance in its Customer Guide to Real Property on...
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Final OSWER Vapor Intrusion Guidance
EPA is preparing to finalize its guidance on assessing and addressing vapor intrusion, which is defined as migration of volatile constituents from contaminated media in the subsurface (soil or groundwater) into the indoor environment. In November 2002, EPA issued draft guidance o...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-07-13
..., Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation... Eggs During Production, Storage, and Transportation'' (the draft guidance). The draft guidance provides guidance to egg producers and other persons who are covered by FDA's final rule entitled ``Prevention of...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-12-15
... Buildings) is available at: http://www1.eere.energy.gov/femp/pdfs/draft_EISA_project_guidance.pdf DATES... at: http://www1.eere.energy.gov/femp/pdfs/draft_EISA_project_guidance.pdf . DOE will accept comments...
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Rodrigues, A M; Canhão, H; Marques, A; Ambrósio, C; Borges, J; Coelho, P; Costa, L; Fernandes, S; Gonçalves, I; Gonçalves, M; Guerra, M; Marques, M L; Pimenta, S; Pinto, P; Sequeira, G; Simões, E; Teixeira, L; Vaz, C; Vieira-Sousa, E; Vieira, R; Alvarenga, F; Araújo, F; Barcelos, A; Barcelos, F; Barros, R; Bernardes, M; Canas da Silva, J; Cordeiro, A; Costa, M; Cunha-Miranda, L; Cruz, M; Duarte, A C; Duarte, C; Faustino, A; Figueiredo, G; Fonseca, J E; Furtado, C; Gomes, J; Lopes, C; Mourão, A F; Oliveira, M; Pimentel-Santos, F M; Ribeiro, A; Sampaio da Nóvoa, T; Santiago, M; Silva, C; Silva-Dinis, A; Sousa, S; Tavares-Costa, J; Terroso, G; Vilar, A; Branco, J C; Tavares, V; Romeu, J C; da Silva, Jap
2018-01-01
Advances in osteoporosis (OP)case definition, treatment options, optimal therapy duration and pharmacoeconomic evidence in the national context motivated the Portuguese Society of Rheumatology (SPR) to update the Portuguese recommendations for the diagnosis and management of osteoporosis published in 2007. SPR bone diseases' working group organized meetings involving 55 participants (rheumatologists, rheumatology fellows and one OP specialist nurse) to debate and develop the document. First, the working group selected 11 pertinent clinical questions for the diagnosis and management of osteoporosis in standard clinical practice. Then, each question was investigated through literature review and draft recommendations were built through consensus. When insufficient evidence was available, recommendations were based on experts' opinion and on good clinical practice. At two national meetings, the recommendations were discussed and updated. A draft of the recommendations full text was submitted to critical review among the working group and suggestions were incorporated. A final version was circulated among all Portuguese rheumatologists before publication and the level of agreement was anonymously assessed using an online survey. The 2018 SPR recommendations provide comprehensive guidance on osteoporosis prevention, diagnosis, fracture risk assessment, pharmacological treatment initiation, therapy options and duration of treatment, based on the best available evidence. They attained desirable agreement among Portuguese rheumatologists. As more evidence becomes available, periodic revisions will be performed. Target audience and patient population: The target audience for these guidelines includes all clinicians. The target patient population includes adult Portuguese people. Intended use: These recommendations provide general guidance for typical cases. They may not be appropriate in all situations - clinicians are encouraged to consider this information together with
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-11-07
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-1295] Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products; Draft Guidance for... draft guidance entitled ``Regulatory Requirements for Hearing Aid Devices and Personal Sound...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-06-14
...The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.'' This guidance identifies cybersecurity issues that manufacturers should consider in preparing premarket submissions for medical devices in order to maintain information confidentiality, integrity, and availability. This draft guidance is not final nor is it in effect at this time.
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Pre-Publication to the Planning for Natural Disaster Debris Guidance
EPA is requesting comment on the draft update of the Planning for Natural Disaster Debris Guidance, along with two other documents. This Guidance is an update of the Planning for Natural Disaster Debris guidance that EPA published in March 2008.
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78 FR 72122 - Draft Emergency Preparedness Frequently Asked Questions
Federal Register 2010, 2011, 2012, 2013, 2014
2013-12-02
... NUCLEAR REGULATORY COMMISSION [NRC-2013-0262] Draft Emergency Preparedness Frequently Asked... of guidance documents related to the development and maintenance of emergency preparedness program... the interpretation or applicability of emergency preparedness guidance issued or endorsed by the NRC...
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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 comments.
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-10-23
...] International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts... Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on... evaluation of the Bacterial Endotoxins Test General Chapter harmonized text from each of the three...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-12-15
... that underlie many complex diseases, such as cancer, cardiovascular disease, and infectious diseases... used in combination to treat a disease or condition. This guidance provides recommendations and advice...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-12-05
... systemic exposure measures is suitable for documenting BE. The guidance will be especially useful when..., delayed) release drug products, and to non-orally administered drug products in which reliance on systemic... revises recommendations related to (1) the use of systemic exposure measures and (2) considerations for...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-09-03
...] International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts... Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 11: Capillary... text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-04-12
...] International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts... Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 10: Polyacrylamide... Electrophoresis General Chapter harmonized text from each of the three pharmacopoeias (United States, European...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-09-02
...] International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts... and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 12: Analytical Sieving... provides the results of the ICH Q4B evaluation of the Analytical Sieving General Chapter harmonized text...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-05-28
...] International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts... ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on... evaluation of the Bulk Density and Tapped Density of Powders General Chapter harmonized text from each of the...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-04-05
...] International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts... Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 7: Dissolution Test General Chapter... results of the ICH Q4B evaluation of the Dissolution Test General Chapter harmonized text from each of the...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-04-05
...] International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts... Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 9: Tablet Friability General Chapter... results of the ICH Q4B evaluation of the Tablet Friability General Chapter harmonized text from each of...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-05-18
... NUCLEAR REGULATORY COMMISSION [NRC-2010-0080] NUREG-0654/FEMA-REP-1, Rev. 1, Supplement 3...: ``NUREG-0654/FEMA-REP-1, Rev. 1, Supplement 3, Guidance for Protective Action Recommendations for General... the existing guidance contained in Supplement 3 to NUREG- 0654/FEMA-REP-1, Rev. 1, ``Criteria for...
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Chamberlain, Charlotte A; Martin, Richard M; Busby, John; Gilbert, Rebecca; Cahill, David J; Hollingworth, William
2013-02-06
National Institute for Health and Clinical Excellence (NICE) clinical guidelines and subsequent NICE issued 'recommendation reminders' advocate discontinuing two fertility procedures and caesarean sections in women with hepatitis. We assess whether NICE guidance in 2004 and recommendation reminders were associated with a change in the rate of clinical procedures performed. Routine inpatient Hospital Episode Statistics (HES) data were extracted from the HES database for 1st April 1998 to 31st March 2010 using OPCS procedure codes for varicocele operations in infertile men, endometrial biopsies in infertile women and caesarean sections in women with hepatitis B or C. We used Joinpoint regression to identify points in time when the trend in procedure rates changed markedly, to identify any influence of the release of NICE guidance. Between 1998-2010, planned caesarean sections in women with and without hepatitis B or C increased yearly (annual percentage change (APC) 4.9%, 95% CI 2.1% to 7.7%) in women with hepatitis, compared with women without (APC 4.0% [95% CI 2.7% to 5.3%] up to 2001, APC -0.6% [95% CI -2.8% to 1.8%] up to 2004 and 1.3% [95% CI 0.8% to 1.8%] up to 2010). In infertile women under 40 years of age, endometrial biopsies for investigation of infertility increased, APC 6.0% (95% CI 3.6% to 8.4%) up to 2003, APC 1.5% (95% CI -4.3% to 7.7%) to 2007 followed by APC 12.8% (95% CI 1.0% to 26.0%) to 2010. Varicocele procedures remained relatively static between 1998 and 2010 (APC -0.5%, 95% CI -2.3% to 1.3%). There was no decline in use of the three studied procedures, contrary to NICE guidance, and no change in uptake associated with the timing of NICE guidance or recommendation reminders. 'Do not do' recommendation reminders may be ineffective at improving clinical practice or achieving disinvestment.
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2013-01-01
Background National Institute for Health and Clinical Excellence (NICE) clinical guidelines and subsequent NICE issued ‘recommendation reminders’ advocate discontinuing two fertility procedures and caesarean sections in women with hepatitis. We assess whether NICE guidance in 2004 and recommendation reminders were associated with a change in the rate of clinical procedures performed. Methods Routine inpatient Hospital Episode Statistics (HES) data were extracted from the HES database for 1st April 1998 to 31st March 2010 using OPCS procedure codes for varicocele operations in infertile men, endometrial biopsies in infertile women and caesarean sections in women with hepatitis B or C. We used Joinpoint regression to identify points in time when the trend in procedure rates changed markedly, to identify any influence of the release of NICE guidance. Results Between 1998-2010, planned caesarean sections in women with and without hepatitis B or C increased yearly (annual percentage change (APC) 4.9%, 95% CI 2.1% to 7.7%) in women with hepatitis, compared with women without (APC 4.0% [95% CI 2.7% to 5.3%] up to 2001, APC -0.6% [95% CI -2.8% to 1.8%] up to 2004 and 1.3% [95% CI 0.8% to 1.8%] up to 2010). In infertile women under 40 years of age, endometrial biopsies for investigation of infertility increased, APC 6.0% (95% CI 3.6% to 8.4%) up to 2003, APC 1.5% (95% CI -4.3% to 7.7%) to 2007 followed by APC 12.8% (95% CI 1.0% to 26.0%) to 2010. Varicocele procedures remained relatively static between 1998 and 2010 (APC -0.5%, 95% CI -2.3% to 1.3%). Conclusions There was no decline in use of the three studied procedures, contrary to NICE guidance, and no change in uptake associated with the timing of NICE guidance or recommendation reminders. ‘Do not do’ recommendation reminders may be ineffective at improving clinical practice or achieving disinvestment. PMID:23388377
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76 FR 44049 - Guidance for Fuel Cycle Facility Change Processes
Federal Register 2010, 2011, 2012, 2013, 2014
2011-07-22
... NUCLEAR REGULATORY COMMISSION [NRC-2009-0262] Guidance for Fuel Cycle Facility Change Processes...-issued Draft Regulatory Guide, DG- 3037, ``Guidance for Fuel Cycle Facility Change Processes'' in the...-3037 from August 12, 2011 to September 16, 2011. DG-3037 describes the types of changes for fuel cycle...
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76 FR 79168 - U.S. Department of Energy Audit Guidance: For-Profit Recipients
Federal Register 2010, 2011, 2012, 2013, 2014
2011-12-21
... Federal eRulemaking Portal at http:[sol][sol]www.regulations.gov. Follow the instructions for submitting... access the guidance at: http:[sol][sol]energy.gov/management/downloads/ draft-profit-audit-guidance-fy...
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Alexander, Paul E; Brito, Juan P; Neumann, Ignacio; Gionfriddo, Michael R; Bero, Lisa; Djulbegovic, Benjamin; Stoltzfus, Rebecca; Montori, Victor M; Norris, Susan L; Schünemann, Holger J; Guyatt, Gordon H
2016-04-01
In 2007 the World Health Organization (WHO) adopted the GRADE system for development of public health guidelines. Previously we found that many strong recommendations issued by WHO are based on evidence for which there is only low or very low confidence in the estimates of effect (discordant recommendations). GRADE guidance indicates that such discordant recommendations are rarely appropriate but suggests five paradigmatic situations in which discordant recommendations may be warranted. We sought to provide insight into the many discordant recommendations in WHO guidelines. We examined all guidelines that used the GRADE method and were approved by the WHO Guideline Review Committee between 2007 and 2012. Teams of reviewers independently abstracted data from eligible guidelines and classified recommendations either into one of the five paradigms for appropriately-formulated discordant recommendations or into three additional categories in which discordant recommendations were inconsistent with GRADE guidance: 1) the evidence warranted moderate or high confidence (a misclassification of evidence) rather than low or very low confidence; 2) good practice statements; or 3) uncertainty in the estimates of effect would best lead to a conditional (weak) recommendation. The 33 eligible guidelines included 160 discordant recommendations, of which 98 (61.3%) addressed drug interventions and 132 (82.5%) provided some rationale (though not entirely explicit at times) for the strong recommendation. Of 160 discordant recommendations, 25 (15.6%) were judged consistent with one of the five paradigms for appropriate recommendations; 33 (21%) were based on evidence warranting moderate or high confidence in the estimates of effect; 29 (18%) were good practice statements; and 73 (46%) warranted a conditional, rather than a strong recommendation. WHO discordant recommendations are often inconsistent with GRADE guidance, possibly threatening the integrity of the process. Further training
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SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials
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
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SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials.
Chan, An-Wen; Tetzlaff, Jennifer M; Gøtzsche, Peter C; Altman, Douglas G; Mann, Howard; Berlin, Jesse A; Dickersin, Kay; Hróbjartsson, Asbjørn; Schulz, Kenneth F; Parulekar, Wendy R; Krleza-Jeric, Karmela; Laupacis, Andreas; Moher, David
2013-01-08
High quality protocols facilitate proper conduct, reporting, and external review of clinical trials. However, the completeness of trial protocols is often inadequate. To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol. This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations. For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance. We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. A website of resources is also available (www.spirit-statement.org). The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols. Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders.
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-06-22
...] (formerly Docket No. 2005D-0106) Guidance for Industry on Systemic Lupus Erythematosus--Developing Medical... entitled ``Systemic Lupus Erythematosus--Developing Medical Products for Treatment.'' This guidance... medical devices for the treatment of systemic lupus erythematosus (SLE). This guidance finalizes the draft...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-11-01
... Draft Microbial Risk Assessment Guideline: Pathogenic Microorganisms With Focus on Food and Water AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: The Agency is announcing that Eastern Research... Water. EPA previously announced the release of the draft guidance for a 60 day comment period (76 FR...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-29
... process includes submitting a time and extent application (TEA) to determine whether a condition is..., submitting safety and effectiveness data. This guidance is designed to clarify the TEA process and what happens after a TEA is submitted. This guidance finalizes the draft guidance for industry entitled ``Time...
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78 FR 4150 - Update of NIOSH Nanotechnology Strategic Plan for Research and Guidance
Federal Register 2010, 2011, 2012, 2013, 2014
2013-01-18
...; NIOSH-134-B] Update of NIOSH Nanotechnology Strategic Plan for Research and Guidance AGENCY: National... Nanotechnology Strategic Plan for Research and Guidance. SUMMARY: The National Institute for Occupational Safety... NIOSH FY2013-FY2016 nanotechnology strategic plan. This draft strategic plan (Protecting the...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-04-12
... Products (VICH). This draft VICH guidance document is intended to provide study design recommendations... Products; Draft Guidance for Industry on Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Marker Residue Depletion Studies to Establish Product Withdrawal...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-02-22
... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-SFUND-2009-0907; FRL-9114-6] RIN 2050-ZA05 Guidance on Recommended Interim Preliminary Remediation Goals for Dioxin in Soil at CERCLA and RCRA Sites; Extension of... Interim Preliminary Remediation Goals for Dioxin in Soil at Comprehensive Environmental Response...
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DOE Office of Scientific and Technical Information (OSTI.GOV)
Finley, C; Dave, J
Purpose: To evaluate implementation of AAPM TG-150’s draft recommendations via a parameter study for testing the performance of digital image receptors. Methods: Flat field images were acquired from 9 calibrated digital image receptors associated with 9 new portable digital radiography systems (Carestream Health, Inc.) based on the draft recommendations and manufacturer-specified calibration conditions (set of 4 images at input detector air kerma ranging from 1 to 25 µGy). Effects of exposure response function (linearized and logarithmic), ‘Presentation Intent Type’ (‘For Processing’ and ‘For Presentation’), detector orientation with respect to the anode-cathode axis (4 orientations; 900 rotations per iteration), different ROImore » sizes (5×5–40×40 mm{sup 2}) and elimination of varying dimensions of image border (0 mm i.e., without boundary elimination to 150 mm) on signal, noise, signal-to-noise ratio (SNR) and the associated nonuniformities were evaluated. Images were analyzed in Matlab and quantities were compared using ANOVA. Results: Signal, noise and SNR values averaged over 9 systems with default parameter values in draft recommendations were 4837.2±139.4, 19.7±0.9 and 246.4±10.1 (mean ± standard deviation), respectively (at input detector air kerma: 12.5 µGy). Signal, noise and SNR showed characteristic dependency on exposure response function and on ‘Presentation Intent Type’. These values were not affected by ROI size and detector orientation, but analysis showed that eliminating the edge pixels along the boundary was required for the noise parameter (coefficient of variation range for noise: 72%–106% and 3%–4% without and with boundary elimination; respectively). Local and global nonuniformities showed a similar dependence on the need for boundary elimination. Interestingly, computed non-uniformities showed agreement with manufacturer-reported values except for noise non-uniformities in two units; artifacts were seen in
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Safety assessment guidance in the International Atomic Energy Agency RADWASS Program
DOE Office of Scientific and Technical Information (OSTI.GOV)
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 safetymore » 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.« less
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77 FR 14047 - Guidance for Decommissioning Planning During Operations
Federal Register 2010, 2011, 2012, 2013, 2014
2012-03-08
...)-4014, ``Decommissioning Planning During Operations.'' This action is necessary to correct the NRC's... NUCLEAR REGULATORY COMMISSION [NRC-2011-0286] Guidance for Decommissioning Planning During Operations AGENCY: Nuclear Regulatory Commission. ACTION: Draft regulatory guide; correction. SUMMARY: The U...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-10-24
...] Guidance for Industry: Necessity of the Use of Food Product Categories in Food Facility Registrations and... industry entitled ``Necessity of the Use of Food Product Categories in Food Facility Registrations and... made available a draft guidance entitled ``Guidance for Industry: Necessity of the Use of Food [[Page...
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76 FR 23845 - Draft Regulatory Guide: Issuance, Availability
Federal Register 2010, 2011, 2012, 2013, 2014
2011-04-28
... draft guide in the agency's ``Regulatory Guide'' series. This series was developed to describe and make... approach that the staff of the NRC considers acceptable for use in developing an appropriate surveillance... steel. The recommendations described in this draft regulatory guide are an approach acceptable to the...
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Federal Guidance for Radiation Protection
EPA produces federal guidance technical reports, which standardize dose and risk assessment and issues radiation protection guidance to federal agencies. This page provides links to federal guidance policy recommendations and technical reports.
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PRN 2002-X Draft: False or Misleading Pesticide Product Brand Name
This notice provides guidance to registrants and distributors on pesticide product brand names that may be false or misleading, either by themselves or in association with particular company names or trademarks. It is a draft.
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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.
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-10-24
... Virus From Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Availability AGENCY... to Reduce the Risk of Transmission of West Nile Virus From Donors of Human Cells, Tissues, and... testing for West Nile Virus (WNV) using an FDA-licensed donor screening test. The guidance recommends the...
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Weightman, Alison; Urquhart, Christine; Spink, Siân; Thomas, Rhian
2009-03-01
Previous impact tool-kits for UK health libraries required updating to reflect recent evidence and changes in library services. The National Knowledge Service funded development of updated guidance. Survey tools were developed based on previous impact studies and a systematic review. The resulting draft questionnaire survey was tested at four sites, and the interview schedule was investigated in a fifth area. A literature search in ASSIA, Google Scholar, INTUTE, LISA, LISTA, SCIRUS, Social Sciences Citation Index (Web of Knowledge), and the major UK University and National Libraries Catalogue (COPAC), identified ways to improve response rates. Other expert advice contributed to the guidance. The resulting guidance contains evidence-based advice and a planning pathway for conducting an impact survey as a service audit. The survey tools (critical incident questionnaire and interview schedule) are available online. The evidence-based advice recommends personalizing the request, assuring confidentiality, and using follow-up reminders. Questionnaires should be brief, and small incentives, such as a lottery draw should be considered. Bias is minimized if the survey is conducted and analysed by independent researchers. The guidance is a starting point for a pragmatic survey to assess the impact of health library services.
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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. Copyright © 2012 S. Karger AG, Basel.
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-01-24
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0847] Guidance for Industry and Food and Drug Administration Staff; Humanitarian Use Device (HUD) Designations... public comment ``Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian Use...
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76 FR 55390 - Guidance on Exculpatory Language in Informed Consent, Draft
Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-07
...://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm , is intended to assist... , http://www.hhs.gov/ohrp/newsroom/rfc/index.html , or http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm . III. Request for Comments OHRP and FDA are making their joint draft...
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78 FR 3023 - Draft Policy on Donations, Fundraising, and Solicitation
Federal Register 2010, 2011, 2012, 2013, 2014
2013-01-15
... ethical considerations of all types of donations, as opposed to our Fish and Wildlife Service Manual (FW) guidance, 342 FW 5, Non-Purchase Acquisition, which covers the acquisition of real property rights by methods other than purchase, including donation. If finalized, this draft policy would establish...
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Hobbs, Fd Richard; Taylor, Clare J; Jan Geersing, Geert; Rutten, Frans H; Brouwer, Judith R
2016-03-01
Atrial fibrillation affects 1-2% of the general population and 10% of those over 75, and is responsible for around a quarter of all strokes. These strokes are largely preventable by the use of anticoagulation therapy, although many eligible patients are not treated. Recent large clinical trials have added to the evidence base on stroke prevention and international clinical guidelines have been updated. Consensus practical recommendations from primary care physicians with an interest in vascular disease and vascular specialists. A focussed all-day meeting, with presentation of summary evidence under each section of this guidance and review of European guidelines on stroke prevention in atrial fibrillation, was used to generate a draft document, which then underwent three cycles of revision and debate before all panel members agreed with the consensus statements. Six areas were identified that included how to identify patients with atrial fibrillation, how to determine their stroke risk and whether to recommend modification of this risk, and what management options are available, with practical recommendations on maximising benefit and minimising risk if anticoagulation is recommended and the reasons why antiplatelet therapy is no longer recommended. The summary evidence is presented for each area and simple summary recommendations are highlighted, with areas of remaining uncertainty listed. Atrial fibrillation-related stroke is a major public health priority for most health systems. This practical guidance can assist generalist community physicians to translate the large evidence base for this cause of preventable stroke and implement this at a local level. © The European Society of Cardiology 2015.
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Taylor, Clare J; Jan Geersing, Geert; Rutten, Frans H; Brouwer, Judith R
2015-01-01
Background Atrial fibrillation affects 1–2% of the general population and 10% of those over 75, and is responsible for around a quarter of all strokes. These strokes are largely preventable by the use of anticoagulation therapy, although many eligible patients are not treated. Recent large clinical trials have added to the evidence base on stroke prevention and international clinical guidelines have been updated. Design Consensus practical recommendations from primary care physicians with an interest in vascular disease and vascular specialists. Methods A focussed all-day meeting, with presentation of summary evidence under each section of this guidance and review of European guidelines on stroke prevention in atrial fibrillation, was used to generate a draft document, which then underwent three cycles of revision and debate before all panel members agreed with the consensus statements. Results Six areas were identified that included how to identify patients with atrial fibrillation, how to determine their stroke risk and whether to recommend modification of this risk, and what management options are available, with practical recommendations on maximising benefit and minimising risk if anticoagulation is recommended and the reasons why antiplatelet therapy is no longer recommended. The summary evidence is presented for each area and simple summary recommendations are highlighted, with areas of remaining uncertainty listed. Conclusions Atrial fibrillation-related stroke is a major public health priority for most health systems. This practical guidance can assist generalist community physicians to translate the large evidence base for this cause of preventable stroke and implement this at a local level. PMID:25701017
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Roundabout geometric design guidance.
DOT National Transportation Integrated Search
2007-06-01
This research report is intended to examine the geometric standards, guidelines, and practices used nationally and by other states to develop recommendations on roundabout design guidance for California. This research serves as a guidance tool in sup...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-07-19
... Texts for Use in the International Conference on Harmonisation Regions; Annex 14 on Bacterial Endotoxins... ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 14... Endotoxins Test General Chapter harmonized text from each of the three pharmacopoeias (United States...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-03-17
... Groundwater and Soils (Subsurface Vapor Intrusion Guidance) AGENCY: Environmental Protection Agency (EPA... Pathway from Contaminated Groundwater and Soil (Subsurface Vapor Intrusion Guidance). A draft of the... Evaluating Vapor Intrusion to Indoor Air Pathway from Contaminated Groundwater and Soil (Subsurface Vapor...
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Draft project management update to the Iowa DOT Project Development Manual : final report.
DOT National Transportation Integrated Search
2016-08-01
This work supported drafting project management guidance for the Iowa Department of Transportation (DOT). The goal is to : incorporate a greater focus on project management in their project development process. : A technical advisory committee (TAC) ...
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All-Ages Lead Model (Aalm) Version 1.05 (External Draft Report)
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...
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PRN 2001-X Draft: Spray and Dust Drift Label Statements for Pesticide Products
This Notice sets forth the U.S. Environmental Protection Agency's (EPA or Agency) draft guidance for labeling statements for controlling spray drift and dust drift from application sites and for implementing these statements for risk mitigation.
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76 FR 66925 - Guidance for 1-Hour SO2
Federal Register 2010, 2011, 2012, 2013, 2014
2011-10-28
... making decisions concerning each document. The draft of the guidance document is available online at http... instructions for submitting comments. Email: [email protected] . Attention Docket ID No. EPA-HQ-OAR-2010-1059. Fax: (202) 566-9744. Attention Docket ID No. EPA-HQ-OAR- 2010-1059. Mail: Air Docket, Attention...
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Predicted percentage dissatisfied with ankle draft.
Liu, S; Schiavon, S; Kabanshi, A; Nazaroff, W W
2017-07-01
Draft is unwanted local convective cooling. The draft risk model of Fanger et al. (Energy and Buildings 12, 21-39, 1988) estimates the percentage of people dissatisfied with air movement due to overcooling at the neck. There is no model for predicting draft at ankles, which is more relevant to stratified air distribution systems such as underfloor air distribution (UFAD) and displacement ventilation (DV). We developed a model for predicted percentage dissatisfied with ankle draft (PPD AD ) based on laboratory experiments with 110 college students. We assessed the effect on ankle draft of various combinations of air speed (nominal range: 0.1-0.6 m/s), temperature (nominal range: 16.5-22.5°C), turbulence intensity (at ankles), sex, and clothing insulation (<0.7 clo; lower legs uncovered and covered). The results show that whole-body thermal sensation and air speed at ankles are the dominant parameters affecting draft. The seated subjects accepted a vertical temperature difference of up to 8°C between ankles (0.1 m) and head (1.1 m) at neutral whole-body thermal sensation, 5°C more than the maximum difference recommended in existing standards. The developed ankle draft model can be implemented in thermal comfort and air diffuser testing standards. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
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Schneider, Lon S
2014-03-01
The February 2013 Food and Drug Administration (FDA) draft guidance for developing drugs for early-stage Alzheimer's disease (AD) creates certain challenges as they guide toward the use of one cognitive outcome to gain accelerated marketing approval for preclinical AD drugs, and a composite clinical scale - the Clinical Dementia Rating Scale in particular - for the primary outcome for prodromal AD clinical trials. In light of the developing knowledge regarding early stage diagnoses and clinical trials outcomes, we recommend that FDA describe its requirements for validating preclinical AD diagnoses for drug development purposes, maintain the principle for requiring coprimary outcomes, and encourage the advancement of outcomes for early stage AD trials. The principles for drug development for early stage AD should not differ from those for clinical AD, especially as the diagnoses of prodromal and early AD impinge on each other. The FDA should not recommend that a composite scale be used as a sole primary efficacy outcome to support a marketing claim unless it requires that the cognitive and functional components of such a scale are demonstrated to be individually meaningful. The current draft guidelines may inadvertently constrain efforts to better assess the clinical effects of new drugs and inhibit innovation in an area where evidence-based clinical research practices are still evolving. Copyright © 2014 The Alzheimer's Association. Published by Elsevier Inc. All rights reserved.
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-05-27
... Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products... Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products'' dated January 2002 (2002 guidance), and the...CJD) by Blood and Blood Products''' dated August 2006 (2006 draft guidance). DATES: Submit electronic...
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Methodological recommendations for comparative research on the treatment of chronic wounds.
Sonnad, S S; Goldsack, J C; Mohr, P; Tunis, S
2013-09-01
To provide specific recommendations to product developers and clinical researchers on the design of comparative effectiveness studies for the treatment of chronic wounds, specifically those pertaining to arterial and venous-disease related ulcers, diabetic foot ulcers, pressure ulcers and burn wounds. The recommendations were developed based on a process defined by the Center for Medical Technology Policy (CMTP). After selecting the subject area, semi-structured phone interviews were conducted by one of the authors (SSS) with representatives of payers, manufacturers, clinicians, clinician/researchers and patient advocates. Next, a broad range of stakeholders participated in a meeting convened by CMTP to determine their needs. A technical working group comprising key stakeholders then participated in clarifying recommendations developed by CMTP staff and adding important considerations for their implementation. The resulting draft document was finalised based on public and solicited comment from individual manufacturers; a consortium of product developers and manufacturers; and an alliance of physicians, providers, manufacturers and patient organisations. This article is a summary of the full effectiveness guidance document. To address the needs of patients, clinicians, guideline developers, payers and other post-regulatory decision makers, this work makes ten recommendations to guide comparative effectiveness research for chronic wound care. These recommendations fall into four categories: study design, population, comparators and outcomes. This paper suggests that using the recommendations outlined to conduct comparative effectiveness research on treatments for chronic wound therapies would facilitate trials that provide patients, clinicians, and payers with the information they need to make optimal treatment decisions. These recommendations focus on design changes that would have the largest impact in improving the usability of the results by decision makers and
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75 FR 6064 - Draft Emergency Action Level Frequently Asked Questions; Request for Comment
Federal Register 2010, 2011, 2012, 2013, 2014
2010-02-05
... provide clarification of endorsed Nuclear Energy Institute (NEI) guidance related to the development of... NUCLEAR REGULATORY COMMISSION [NRC-2010-0034] Draft Emergency Action Level Frequently Asked Questions; Request for Comment AGENCY: Nuclear Regulatory Commission. ACTION: Notice of availability and...
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75 FR 47856 - Draft Emergency Action Level Frequently Asked Questions; Request for Comment
Federal Register 2010, 2011, 2012, 2013, 2014
2010-08-09
... provide clarification of guidance submitted by the Nuclear Energy Institute (NEI) and endorsed by the NRC... NUCLEAR REGULATORY COMMISSION [NRC-2010-0273] Draft Emergency Action Level Frequently Asked Questions; Request for Comment AGENCY: Nuclear Regulatory Commission. ACTION: Notice of availability and...
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Brazilian recommendations of mechanical ventilation 2013. Part 2
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
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Brazilian recommendations of mechanical ventilation 2013. Part I
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
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Brazilian recommendations of mechanical ventilation 2013. Part 2
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
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Brazilian recommendations of mechanical ventilation 2013. Part I
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
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Aetiological diagnosis of child deafness: CODEPEH recommendations.
Núñez-Batalla, Faustino; Jáudenes-Casaubón, Carmen; Sequí-Canet, Jose Miguel; Vivanco-Allende, Ana; Zubicaray-Ugarteche, Jose; Cabanillas-Farpón, Rubén
Important progress in the fields of molecular genetics (principally) and diagnostic imaging, together with the lack of a consensus protocol for guiding the diagnostic process after confirming deafness by neonatal screening, have led to this new work document drafted by the Spanish Commission for the Early Detection of Child Deafness (Spanish acronym: CODEPEH). This 2015 Recommendations Document, which is based on the most recent scientific evidence, provides guidance to professionals to support them in making decisions regarding aetiological diagnosis. Such diagnosis should be performed without delay and without impeding early intervention. Early identification of the causes of deafness offers many advantages: it prevents unnecessary trouble for the families, reduces health system expenses caused by performing different tests, and provides prognostic information that may guide therapeutic actions. Copyright © 2016 Elsevier España, S.L.U. and Sociedad Española de Otorrinolaringología y Cirugía de Cabeza y Cuello. All rights reserved.
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-02-25
...--Conducting and Submitting Virology Studies to the Agency: Guidance for Submitting Hepatitis C Virus... sponsors in submitting hepatitis C virus (HCV) clinical virology data, which are important for supporting...
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Guidance for Reviewing OCSPP 850.2100 Avian Oral Toxicity Studies Conducted with Passerine Birds
Guidance based on comparison of results from the TG223 validation studies to results from avian acute oral studies previously submitted to EPA for two test chemicals following EPA's 850.2100 (public draft) guidelines.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-03-15
... and recommendations could be found on the Web at http://www.hhs.gov/nvpo/nvac/subgroups/adultimmunization . The Web address where the draft report and recommendations can be found is http://www.hhs.gov...) The draft report and recommendations are available on the Web at http://www.hhs.gov/nvpo/nvac...
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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
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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...
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Functional Drafting, Drafting--Intermediate: 9255.02.
ERIC Educational Resources Information Center
Dade County Public Schools, Miami, FL.
The course consists of six instructional blocks totaling 135 clock hours: (1) functional drafting, (2) threads and fasteners, (3) pictorial drawings, (4) introduction to electronic drafting, (5) introduction to piping drafting, and (6) Quinmester posttest. Mastery of skills indicated in Drafting-Basic--9255.01 is a prerequisite. In the functional…
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-02-14
....S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone: 301-415-0694, e-mail: Lisa... Accession Number for the draft Part 40 implementation guidance. FOR FURTHER INFORMATION CONTACT: Lisa...
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In Brief: Geoengineering draft statement
NASA Astrophysics Data System (ADS)
Showstack, Randy
2009-04-01
The American Meteorological Society (AMS) has prepared a draft policy statement on geoengineering the climate system, which the AMS Council is considering for approval. The statement notes, “Geoengineering will not substitute for either aggressive mitigation or proactive adaptation. It could contribute to a comprehensive risk management strategy to slow climate change and alleviate its negative impacts, but the potential for adverse and unintended consequences implies a need for adequate research, appropriate regulation, and transparent consideration.” The statement, if adopted, indicates that AMS recommends enhanced research on the scientific and technological potential for geoengineering the climate system; additional study of the historical, ethical, legal, political, and societal aspects of the geoengineering issues; and the development and analysis of policy options to promote transparency and international cooperation in exploring geoengineering options along with restrictions on reckless efforts to manipulate the climate system. AMS is accepting comments on the draft statement until 23 April. For more information, visit http://ametsoc.org/policy/draftstatements/index.html#draft.
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McCulloch, Karen L; Goldman, Sarah; Lowe, Lynn; Radomski, Mary Vining; Reynolds, John; Shapiro, Rita; West, Therese A
2015-01-01
Previously published mild traumatic brain injury (mTBI) management guidelines provide very general recommendations to return individuals with mTBI to activity. This lack of specific guidance creates variation in military rehabilitation. The Office of the Army Surgeon General in collaboration with the Defense and Veterans Brain Injury Center, a component center of the Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury, convened an expert working group to review the existing literature and propose clinical recommendations that standardize rehabilitation activity progression following mTBI. A Progressive Activity Working Group consisted of 11 Department of Defense representatives across all service branches, 7 Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury representatives, and 8 academic/research/civilian experts with experience assessing and treating individuals with mTBI for return to activity. An expert working group meeting included the Progressive Activity Working Group and 15 additional subject matter experts. In February 2012, the Progressive Activity Working Group was established to determine the need and purpose of the rehabilitation recommendations. Following literature review, a table was created on the basis of the progression from the Zurich consensus statement on concussion in sport. Issues were identified for discussion with a meeting of the larger expert group during a July 2012 conference. Following development of rehabilitation guidance, the Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury coordinated a similar process for military primary care providers. End products for rehabilitation and primary care providers include specific recommendations for return to activity after concussion. A 6-stage progression specifies activities in physical, cognitive, and balance/vestibular domains and allows for resumption of activity for those with low-level or
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Guidance based on comparison of results from the TG223 validation studies to results from avian acute oral studies previously submitted to EPA for two test chemicals following EPA's 850.2100 (public draft) guidelines.
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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…
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A TIERED APPROACH TO PERFORMING UNCERTAINTY ANALYSIS IN CONDUCTING EXPOSURE ANALYSIS FOR CHEMICALS
The WHO/IPCS draft Guidance Document on Characterizing and Communicating Uncertainty in Exposure Assessment provides guidance on recommended strategies for conducting uncertainty analysis as part of human exposure analysis. Specifically, a tiered approach to uncertainty analysis ...
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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:
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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;…
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1981-04-01
east of Arcola Creek. The Interim Report gave a favorable recommendation for the harbor project and the results were published in House Document No. 91...Draft Reformulation Phase I GDM Re]port (Draft Stage 3 Report) The purpi se of this )rf t Stag. 3 Report Is to present the results of the Stage 3...Iirements for a small-boat harbor at Geneva State Park. Results of the bathymetric survey and sediment sampling program are presented in Appendix A. (3
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2010-01-01
Background Influenza vaccination in infants and children with existing health complications is current practice in many countries, but healthy children are also susceptible to influenza, sometimes with complications. The under-recognised burden of disease in young children is greater than in elderly populations and the number of paediatric influenza cases reported does not reflect the actual frequency of influenza. Discussion Vaccination of healthy children is not widespread in Europe despite clear demonstration of the benefits of vaccination in reducing the large health and economic burden of influenza. Universal vaccination of infants and children also provides indirect protection in other high-risk groups in the community. This paper contains the Central European Vaccination Advisory Group (CEVAG) guidance statement on recommendations for the vaccination of infants and children against influenza. The aim of CEVAG is to encourage the efficient and safe use of vaccines to prevent and control infectious diseases. Summary CEVAG recommends the introduction of universal influenza vaccination for all children from the age of 6 months. Special attention is needed for children up to 60 months of age as they are at greatest risk. Individual countries should decide on how best to implement this recommendation based on their circumstances. PMID:20546586
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-11-13
... October 15, 2013. The Nuclear Energy Institute (NEI) submitted a letter on September 17, 2013 (Agencywide... NUCLEAR REGULATORY COMMISSION [NRC-2013-0212: NRC-2013-0211] Environmental Issues Associated With... AGENCY: Nuclear Regulatory Commission. ACTION: Draft interim staff guidance; re-opening of comment period...
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The World Health Organization's safe abortion guidance document.
Van Look, Paul F A; Cottingham, Jane
2013-04-01
We discuss the history of the World Health Organization's (WHO's) development of guidelines for governments on providing safe abortion services, which WHO published as Safe Abortion: Technical and Policy Guidance for Health Systems in 2003 and updated in 2012. We show how the recognition of the devastating impact of unsafe abortion on women's health and survival, the impetus of the International Conference on Population and Development and its five-year follow-up, and WHO's progressive leadership at the end of the century enabled the organization to elaborate guidance on providing safe abortion services. Guideline formulation involved extensive review of published evidence, an international technical expert meeting to review the draft document, and a protracted in-house review by senior WHO management.
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-11-29
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1038.... DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that... guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The...
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Jünger, Saskia; Payne, Sheila A; Brine, Jenny; Radbruch, Lukas; Brearley, Sarah G
2017-09-01
The Delphi technique is widely used for the development of guidance in palliative care, having impact on decisions with relevance for patient care. To systematically examine the application of the Delphi technique for the development of best practice guidelines in palliative care. A methodological systematic review was undertaken using the databases PubMed, CINAHL, Web of Science, Academic Search Complete and EMBASE. Original articles (English language) were included when reporting on empirical studies that had used the Delphi technique to develop guidance for good clinical practice in palliative care. Data extraction included a quality appraisal on the rigour in conduct of the studies and the quality of reporting. A total of 30 empirical studies (1997-2015) were considered for full-text analysis. Considerable differences were identified regarding the rigour of the design and the reporting of essential process and outcome parameters. Furthermore, discrepancies regarding the use of terms for describing the method were observed, for example, concerning the understanding of a 'round' or a 'modified Delphi study'. Substantial variation was found concerning the quality of the study conduct and the transparency of reporting of Delphi studies used for the development of best practice guidance in palliative care. Since credibility of the resulting recommendations depends on the rigorous use of the Delphi technique, there is a need for consistency and quality both in the conduct and reporting of studies. To allow a critical appraisal of the methodology and the resulting guidance, a reporting standard for Conducting and REporting of DElphi Studies (CREDES) is proposed.
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Consensus of recommendations guiding comparative effectiveness research methods.
Morton, Jacob B; McConeghy, Robert; Heinrich, Kirstin; Gatto, Nicolle M; Caffrey, Aisling R
2016-12-01
Because of an increasing demand for quality comparative effectiveness research (CER), methods guidance documents have been published, such as those from the Agency for Healthcare Research and Quality (AHRQ) and the Patient-Centered Outcomes Research Institute (PCORI). Our objective was to identify CER methods guidance documents and compare them to produce a summary of important recommendations which could serve as a consensus of CER method recommendations. We conducted a systematic literature review to identify CER methods guidance documents published through 2014. Identified documents were analyzed for methods guidance recommendations. Individual recommendations were categorized to determine the degree of overlap. We identified nine methods guidance documents, which contained a total of 312 recommendations, 97% of which were present in two or more documents. All nine documents recommended transparency and adaptation for relevant stakeholders in the interpretation and dissemination of results. Other frequently shared CER methods recommendations included: study design and operational definitions should be developed a priori and allow for replication (n = 8 documents); focus on areas with gaps in current clinical knowledge that are relevant to decision-makers (n = 7); validity of measures, instruments, and data should be assessed and discussed (n = 7); outcomes, including benefits and harms, should be clinically meaningful, and objectively measured (n = 7). Assessment for and strategies to minimize bias (n = 6 documents), confounding (n = 6), and heterogeneity (n = 4) were also commonly shared recommendations between documents. We offer a field-consensus guide based on nine CER methods guidance documents that will aid researchers in designing CER studies and applying CER methods. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-10-01
.... A wide variety of bacterial pathogens are responsible for cIAIs, including Gram-negative aerobic bacteria, Gram-positive bacteria, and anaerobic bacteria, and there are also mixed infections. This draft...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-12-28
... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPPT-2010-0877; FRL-8858-9] Endocrine Disruptor Screening Program (EDSP); Announcing the Availability of a Draft for Weight-of-Evidence Guidance Document..., Endocrine disruptors, Screening assays, Weight-of-evidence. Dated: December 20, 2010. Stephen A. Owens...
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2016-07-19
The Food and Drug Administration (FDA or Agency) is announcing the availability of guidances for industry entitled ``E2C(R2) Periodic Benefit-Risk Evaluation'' (E2C(R2) guidance) and ``E2C(R2) Periodic Benefit-Risk Evaluation Report--Questions and Answers'' (E2C(R2) Q&A guidance). These guidances were prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The E2C(R2) draft guidance, issued April 11, 2012, updated and combined two ICH guidances, ``E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs'' (E2C guidance) and ``Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs'' (addendum to the E2C guidance). The E2C(R2) guidance is intended to describe the format, content, and timing of a Periodic Benefit-Risk Evaluation Report (PBRER) for an approved drug or biologic, and it finalizes the draft guidance. The E2C(R2) Q&A guidance is a supplementary guidance that is intended to clarify key issues in the E2C(R2) guidance.
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Dauer, Lawrence T; Ainsbury, Elizabeth A; Dynlacht, Joseph; Hoel, David; Klein, Barbara E K; Mayer, Don; Prescott, Christina R; Thornton, Raymond H; Vano, Eliseo; Woloschak, Gayle E; Flannery, Cynthia M; Goldstein, Lee E; Hamada, Nobuyuki; Tran, Phung K; Grissom, Michael P; Blakely, Eleanor A
2016-02-01
Previous National Council on Radiation Protection and Measurements (NCRP) publications have addressed the issues of risk and dose limitation in radiation protection and included guidance on specific organs and the lens of the eye. NCRP decided to prepare an updated commentary intended to enhance the previous recommendations provided in earlier reports. The NCRP Scientific Committee 1-23 (SC 1-23) is charged with preparing a commentary that will evaluate recent studies on the radiation dose response for the development of cataracts and also consider the type and severity of the cataracts as well as the dose rate; provide guidance on whether existing dose limits to the lens of the eye should be changed in the United States; and suggest research needs regarding radiation effects on and dose limits to the lens of the eye. A status of the ongoing work of SC 1-23 was presented at the Annual Meeting, "Changing Regulations and Radiation Guidance: What Does the Future Hold?" The following represents a synopsis of a few main points in the current draft commentary. It is likely that several changes will be forthcoming as SC 1-23 responds to subject matter expert review and develops a final document, expected by mid 2016.
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Gysels, Marjolein; Evans, Catherine J; Lewis, Penney; Speck, Peter; Benalia, Hamid; Preston, Nancy J; Grande, Gunn E; Short, Vicky; Owen-Jones, Eleanor; Todd, Chris J; Higginson, Irene J
2013-12-01
There is little guidance on the particular ethical concerns that research raises with a palliative care population. To present the process and outcomes of a workshop and consensus exercise on agreed best practice to accommodate ethical issues in research on palliative care. Consultation workshop using the MORECare Transparent Expert Consultation approach. Prior to workshops, participants were sent overviews of ethical issues in palliative care. Following the workshop, nominal group techniques were used to produce candidate recommendations. These were rated online by participating experts. Descriptive statistics were used to analyse agreement and consensus. Narrative comments were collated. Experts in ethical issues and palliative care research were invited to the Cicely Saunders Institute in London. They included senior researchers, service providers, commissioners, researchers, members of ethics committees and policy makers. The workshop comprised 28 participants. A total of 16 recommendations were developed. There was high agreement on the issue of research participation and high to moderate agreement on applications to research ethics committees. The recommendations on obtaining and maintaining consent from patients and families were the most contentious. Nine recommendations were refined on the basis of the comments from the online consultation. The culture surrounding palliative care research needs to change by fostering collaborative approaches between all those involved in the research process. Changes to the legal framework governing the research process are required to enhance the ethical conduct of research in palliative care. The recommendations are relevant to all areas of research involving vulnerable adults.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-01-28
... 3150-AI64 [NRC-2010-0340] Draft NUREG-0561, Revision 2; Physical Protection of Shipments of Irradiated...-0561, ``Physical Protection of Shipments of Irradiated Reactor Fuel.'' This document provides guidance on implementing the provisions of proposed 10 CFR Part 73.37, ``Requirements for Physical Protection...
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Barratt, Christopher L R; Björndahl, Lars; De Jonge, Christopher J; Lamb, Dolores J; Osorio Martini, Francisco; McLachlan, Robert; Oates, Robert D; van der Poel, Sheryl; St John, Bianca; Sigman, Mark; Sokol, Rebecca; Tournaye, Herman
2017-11-01
Herein, we describe the consensus guideline methodology, summarize the evidence-based recommendations we provided to the World Health Organization (WHO) for their consideration in the development of global guidance and present a narrative review of the diagnosis of male infertility as related to the eight prioritized (problem or population (P), intervention (I), comparison (C) and outcome(s) (O) (PICO)) questions. Additionally, we discuss the challenges and research gaps identified during the synthesis of this evidence. The aim of this paper is to present an evidence-based approach for the diagnosis of male infertility as related to the eight prioritized PICO questions. Collating the evidence to support providing recommendations involved a collaborative process as developed by WHO, namely: identification of priority questions and critical outcomes; retrieval of up-to-date evidence and existing guidelines; assessment and synthesis of the evidence; and the formulation of draft recommendations to be used for reaching consensus with a wide range of global stakeholders. For each draft recommendation the quality of the supporting evidence was then graded and assessed for consideration during a WHO consensus. Evidence was synthesized and recommendations were drafted to address the diagnosis of male infertility specifically encompassing the following: What is the prevalence of male infertility and what proportion of infertility is attributable to the male? Is it necessary for all infertile men to undergo a thorough evaluation? What is the clinical (ART/non ART) value of traditional semen parameters? What key male lifestyle factors impact on fertility (focusing on obesity, heat and tobacco smoking)? Do supplementary oral antioxidants or herbal therapies significantly influence fertility outcomes for infertile men? What are the evidence-based criteria for genetic screening of infertile men? How does a history of neoplasia and related treatments in the male impact on (his and
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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.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-02-03
... holders, and other stakeholders on a draft guidance document entitled ``Weapons Safety Assessment'' (WSA... weapons under the NRC's proposed rule titled ``Enhanced Weapons, Firearms Background Checks, and Security.... You should not include any site-specific security information in your comments. Federal rulemaking Web...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-04-03
... appropriate scientific and medical experts, on the design and conduct of studies required for the assessment... functions, including the design and conduct of research, the oversight of specific studies, and the... any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft...
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Older Adults Need Guidance to Meet Nutritional Recommendations
Foote, Janet A.; Giuliano, Anna R.; Harris, Robin B.
2009-01-01
Objective The purpose of this study was to compare the diet of healthy, free-living senior volunteers to the dietary reference intakes (DRIs) and Food Guide Pyramid recommendations. Methods This study was a cross-sectional assessment of dietary habits, as measured using a standardized food frequency questionnaire, among 1740 healthy Southwestern U.S. adults, aged 51 to 85 years. Assessment of independently-living volunteers to chemoprevention trials provides an efficient mechanism to profile typical dietary habits among the older adult population. Results Daily estimated macronutrient intakes exceeded recommended proportions of protein and fat. In contrast, more than 60% of this senior population reported dietary vitamin D, vitamin E, folate and calcium intakes below estimated average requirements (EAR). Based on the Food Guide Pyramid recommendations, fewer than 10% of the older adults consumed the recommended daily dairy and grain servings. More females than males consumed recommended vegetable (49% versus 40%) and fruit (53% versus 48%) servings (p <, 0.05). More males consumed recommended grain (11% versus 7%) and protein (78% versus 73%) servings (p <, 0.05) than females. Conclusions Mean micronutrient intakes compared well with DRIs, although fewer than one-half of these older adults consumed recommended levels for vitamin D, vitamin E, folate, and calcium or daily food servings of dairy, grains, vegetables or fruits. Since the beneficial aspects of foods are not limited to essential nutrients, nutrition recommendations to older adults may be improved by emphasizing daily servings of nutrient-dense choices within the Food Pyramid. PMID:11022877
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-03-19
...; Class II Special Controls Guidance Document: Nucleic Acid-Based In Vitro Diagnostic Devices for the... Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document... II Special Controls Guidance Document: Nucleic Acid-Based In Vitro Diagnostic Devices for the...
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The World Health Organization’s Safe Abortion Guidance Document
Van Look, Paul F. A.; Cottingham, Jane
2013-01-01
We discuss the history of the World Health Organization’s (WHO’s) development of guidelines for governments on providing safe abortion services, which WHO published as Safe Abortion: Technical and Policy Guidance for Health Systems in 2003 and updated in 2012. We show how the recognition of the devastating impact of unsafe abortion on women’s health and survival, the impetus of the International Conference on Population and Development and its five-year follow-up, and WHO’s progressive leadership at the end of the century enabled the organization to elaborate guidance on providing safe abortion services. Guideline formulation involved extensive review of published evidence, an international technical expert meeting to review the draft document, and a protracted in-house review by senior WHO management. PMID:23409886
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-03-23
...The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products--Content and Format.'' This guidance is one of a series of guidance documents intended to assist applicants in drafting prescription drug labeling in which prescribing information is clear and accessible and in complying with the requirements in the final rule on the content and format of labeling for prescription drug and biological products. This guidance is intended to help applicants select information for inclusion in the ``Dosage and Administration'' section of labeling and to help them organize that information.
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DOE Office of Scientific and Technical Information (OSTI.GOV)
NONE
1995-08-01
This draft Control Techniques Guidelines (CTG) provides necessary guidance for development of regulations to limit emissions of volatile organic compounds (VOC`s) from wood furniture finishing and cleaning operations. This guidance includes emission limits for specific wood furniture finishing steps and work pratices to reduce waste and evaporation through pollution prevention methods; these represent reasonably available control technology for wood furniture finishing and cleaning operations. This document is intended to provide State and local air pollution authorities with an information base for proceeding with their own analyses of RACT to meet statutory requirements.
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Guidance based on comparison of results from the TG223 validation studies to results from avian acute oral studies previously submitted to EPA for two test chemicals following EPA's 850.2100 (public draft) guidelines.
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Quieter pavements guidance document
DOT National Transportation Integrated Search
2013-02-01
This report provides guidance and better practice recommendations to the National Park : Service for selecting pavement surfaces to minimize tire-pavement noise. The report : contains an overview of common technologies and methods for quieter pavemen...
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This draft notice provides guidance to registrants of EPA-registered antimicrobial products whose labels bear general directions related to hard, non-porous or porous surfaces, but which are not but which are not specifically registered for HVAC uses.
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-04-01
...-based assessment approaches and quality by design principles. These efforts will also be considered part... processes being referenced. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g... on the final version of the guidance and on any other part of the SUPAC guidance series, submit...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-06-07
... production is accounted for in API's certification program and that the follow-up audit program is showing... Selective Catalytic Reduction Technology AGENCY: Environmental Protection Agency (EPA). ACTION: Request for... reduction (SCR) technology to meet emission standards for oxides of nitrogen (NO X ). This draft guidance...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-08-06
... for Physical Protection of Byproduct Material; Category 1 and Category 2 Quantities of Radioactive... on the draft implementation guidance for proposed 10 CFR part 37 Physical Protection of Byproduct... proposed 10 CFR part 37, Physical Protection of Byproduct Material, specifically Category 1 and Category 2...
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Gade, Anne Lill; Ovrebø, Steinar; Hylland, Ketil
2008-07-01
The goal of REACH is the safe use of chemicals. This study examines the efficiency and usefulness of two draft technical guidance notes in the REACH Interim Project 3.2-2 for the development of the chemical safety report and exposure scenarios. A case study was carried out for a paint system for protection of structural steel. The focuses of the study were risk assessment of preparations based on Derived No Effect Level (DNEL) and Predicted No Effect Concentrations (PNEC) and on effective and accurate communication in the supply chain. Exposure scenarios and generic descriptions of uses, risk management measures, and exposure determinants were developed. The study showed that communication formats, software tools, and guidelines for chemical risk assessment need further adjustment to preparations and real-life situations. Web platforms may simplify such communication. The downstream formulator needs basic substance data from the substance manufacturer during the pre-registration phase to develop exposure scenarios for preparations. Default values need to be communicated in the supply chain because these were critical for the derivation of applicable risk management demands. The current guidelines which rely on the available toxicological knowledge are insufficient to advise downstream users on how to develop exposure scenarios for preparations.
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Schaper, N C; Van Netten, J J; Apelqvist, J; Lipsky, B A; Bakker, K
2017-02-01
Foot problems complicating diabetes are a source of major patient suffering and societal costs. To prevent, or at least reduce, the adverse effects of foot problems in diabetes, the International Working Group on the Diabetic Foot (IWGDF; www.iwgdf.org) was founded in 1996, consisting of experts from almost all the disciplines involved in the care of patients with diabetes and foot problems. An important output of the IWGDF is the international consensus guidance, continuously updated since 1999. To date, the publications have been translated into 26 languages, and more than 100,000 copies have been distributed globally. The "Summary Guidance for Daily Practice" summarises the essentials of prevention and management of foot problems in persons with diabetes for clinicians who work with these patients on a daily basis. This guidance is the result of a long and careful process that started with the empaneling in 2013 of five working groups consisting of 49 international experts. These experts performed seven targeted systematic reviews to provide the evidence supporting the five chapters of the IWGDF Guidance on prevention; footwear and offloading; diagnosis, prognosis and management of peripheral artery disease; diagnosis and management of foot infections; interventions to enhance healing. In total almost 80,000 studies were detected by our literature review. After review of the title and abstract the reviewers of the different working groups selected only studies that fulfilled a minimal set of quality criteria and ended up with 429 articles for complete quality analysis. The GRADE system was used to translate the evidence from the studies into recommendations for daily clinical practice. The rating of each recommendation takes into account both the strength and the quality of the evidence. The IWGDF Guidance 2015 makes a total of 77 recommendations on prevention and management of foot problems in diabetes. These recommendations were condensed by the editorial
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78 FR 9054 - Issuance of Final Guidance Publication
Federal Register 2010, 2011, 2012, 2013, 2014
2013-02-07
... NIOSH-144] Issuance of Final Guidance Publication AGENCY: National Institute for Occupational Safety and... Services (HHS). ACTION: Notice of issuance of final guidance publication. SUMMARY: The National Institute...), announces the availability of the following publication: ``NIOSH Criteria for a Recommended Standard...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-06-17
... Pesticide Registrants on False or Misleading Pesticide Product Brand Names; Extension of Comment Period... Pesticide Product Brand Names.'' This document extends the comment period for 60 days, from June 18, 2010... draft Pesticide Registration Notice (PR Notice) entitled ``False or Misleading Pesticide Product Brand...
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46 CFR 97.40-10 - Draft marks and draft indicating systems.
Code of Federal Regulations, 2013 CFR
2013-10-01
... 46 Shipping 4 2013-10-01 2013-10-01 false Draft marks and draft indicating systems. 97.40-10... VESSELS OPERATIONS Markings on Vessels § 97.40-10 Draft marks and draft indicating systems. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or...
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46 CFR 196.40-10 - Draft marks and draft indicating systems.
Code of Federal Regulations, 2012 CFR
2012-10-01
... 46 Shipping 7 2012-10-01 2012-10-01 false Draft marks and draft indicating systems. 196.40-10... VESSELS OPERATIONS Markings on Vessels § 196.40-10 Draft marks and draft indicating systems. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or...
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46 CFR 97.40-10 - Draft marks and draft indicating systems.
Code of Federal Regulations, 2010 CFR
2010-10-01
... 46 Shipping 4 2010-10-01 2010-10-01 false Draft marks and draft indicating systems. 97.40-10... VESSELS OPERATIONS Markings on Vessels § 97.40-10 Draft marks and draft indicating systems. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or...
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46 CFR 97.40-10 - Draft marks and draft indicating systems.
Code of Federal Regulations, 2012 CFR
2012-10-01
... 46 Shipping 4 2012-10-01 2012-10-01 false Draft marks and draft indicating systems. 97.40-10... VESSELS OPERATIONS Markings on Vessels § 97.40-10 Draft marks and draft indicating systems. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or...
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46 CFR 196.40-10 - Draft marks and draft indicating systems.
Code of Federal Regulations, 2013 CFR
2013-10-01
... 46 Shipping 7 2013-10-01 2013-10-01 false Draft marks and draft indicating systems. 196.40-10... VESSELS OPERATIONS Markings on Vessels § 196.40-10 Draft marks and draft indicating systems. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or...
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46 CFR 97.40-10 - Draft marks and draft indicating systems.
Code of Federal Regulations, 2014 CFR
2014-10-01
... 46 Shipping 4 2014-10-01 2014-10-01 false Draft marks and draft indicating systems. 97.40-10... VESSELS OPERATIONS Markings on Vessels § 97.40-10 Draft marks and draft indicating systems. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or...
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46 CFR 196.40-10 - Draft marks and draft indicating systems.
Code of Federal Regulations, 2011 CFR
2011-10-01
... 46 Shipping 7 2011-10-01 2011-10-01 false Draft marks and draft indicating systems. 196.40-10... VESSELS OPERATIONS Markings on Vessels § 196.40-10 Draft marks and draft indicating systems. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or...
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46 CFR 97.40-10 - Draft marks and draft indicating systems.
Code of Federal Regulations, 2011 CFR
2011-10-01
... 46 Shipping 4 2011-10-01 2011-10-01 false Draft marks and draft indicating systems. 97.40-10... VESSELS OPERATIONS Markings on Vessels § 97.40-10 Draft marks and draft indicating systems. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or...
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46 CFR 196.40-10 - Draft marks and draft indicating systems.
Code of Federal Regulations, 2010 CFR
2010-10-01
... 46 Shipping 7 2010-10-01 2010-10-01 false Draft marks and draft indicating systems. 196.40-10... VESSELS OPERATIONS Markings on Vessels § 196.40-10 Draft marks and draft indicating systems. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or...
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46 CFR 196.40-10 - Draft marks and draft indicating systems.
Code of Federal Regulations, 2014 CFR
2014-10-01
... 46 Shipping 7 2014-10-01 2014-10-01 false Draft marks and draft indicating systems. 196.40-10... VESSELS OPERATIONS Markings on Vessels § 196.40-10 Draft marks and draft indicating systems. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or...
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46 CFR 78.50-10 - Draft marks and draft indicating systems.
Code of Federal Regulations, 2013 CFR
2013-10-01
... 46 Shipping 3 2013-10-01 2013-10-01 false Draft marks and draft indicating systems. 78.50-10... OPERATIONS Markings on Vessels § 78.50-10 Draft marks and draft indicating systems. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or rudderpost or any place...
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46 CFR 78.50-10 - Draft marks and draft indicating systems.
Code of Federal Regulations, 2010 CFR
2010-10-01
... 46 Shipping 3 2010-10-01 2010-10-01 false Draft marks and draft indicating systems. 78.50-10... OPERATIONS Markings on Vessels § 78.50-10 Draft marks and draft indicating systems. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or rudderpost or any place...
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46 CFR 78.50-10 - Draft marks and draft indicating systems.
Code of Federal Regulations, 2014 CFR
2014-10-01
... 46 Shipping 3 2014-10-01 2014-10-01 false Draft marks and draft indicating systems. 78.50-10... OPERATIONS Markings on Vessels § 78.50-10 Draft marks and draft indicating systems. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or rudderpost or any place...
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46 CFR 78.50-10 - Draft marks and draft indicating systems.
Code of Federal Regulations, 2012 CFR
2012-10-01
... 46 Shipping 3 2012-10-01 2012-10-01 false Draft marks and draft indicating systems. 78.50-10... OPERATIONS Markings on Vessels § 78.50-10 Draft marks and draft indicating systems. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or rudderpost or any place...
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46 CFR 78.50-10 - Draft marks and draft indicating systems.
Code of Federal Regulations, 2011 CFR
2011-10-01
... 46 Shipping 3 2011-10-01 2011-10-01 false Draft marks and draft indicating systems. 78.50-10... OPERATIONS Markings on Vessels § 78.50-10 Draft marks and draft indicating systems. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or rudderpost or any place...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-11-10
... proof of principle and initial clinical safety data before the device design is finalized. This draft... to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm.... Early feasibility studies allow for early clinical evaluation of devices to provide proof of principle...
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75 FR 14604 - Guidance for Industry on Anesthetics for Companion Animals; Availability
Federal Register 2010, 2011, 2012, 2013, 2014
2010-03-26
...] Guidance for Industry on Anesthetics for Companion Animals; Availability AGENCY: Food and Drug... availability of Guidance for Industry 192 entitled ``Anesthetics for Companion Animals.'' This guidance makes recommendations for the development of anesthetic new animal drug products for companion animals. The guidance...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-06-01
... consider comments and recommendations on the draft guidebook, which is available at: http://www1.eere... draft guidebook is available at: http://www1.eere.energy.gov/femp/pdfs/largereguide.pdf . DOE will... DATES section. More information on DOE's FEMP is available at: http://www1.eere.energy.gov/femp...
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Orlewska, Ewa; Mierzejewski, Piotr
2004-01-01
Financial analysis (budget impact analysis, BIA) is increasingly required by decision-makers to ascertain the macroeconomic consequences of new product reimbursement in addition to proof of cost-effectiveness. Poland is in the process of drafting country-specific guidelines for BIA, positioned as complementary to economic evaluation in decision-making The aim of this article is to present the Polish project and compare it with currently available guidance. A checklist was developed that focuses on issues that are unique to BIA. An analysis of the differences between different national guidelines and their Polish counterparts was subsequently undertaken. The Polish project of BIA guidelines is composed of two sections. The first section presents the objective, the use of BIA, the responsibility for the preparation, and the target audience. The second section presents important methodological aspects that researchers should keep in mind when carrying out BIA. In comparison to existing guidance the Polish project appears to be more detailed. It includes more precise recommendations on perspective, time horizon, and reliability of data sources; reporting of results; rates of adoption of new therapies; and the probability of redeploying resources. Although there is an increased demand for BIA, there is only limited guidance on how such studies should be undertaken. It is hoped that the Polish guidelines can contribute to the development of such analyses and deliver benefit for Polish health-care decision-makers and beyond.
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Health system guidance appraisal--concept evaluation and usability testing.
Ako-Arrey, Denis E; Brouwers, Melissa C; Lavis, John N; Giacomini, Mita K
2016-01-05
Health system guidance (HSG) provides recommendations aimed to address health system challenges. However, there is a paucity of methods to direct, appraise, and report HSG. Earlier research identified 30 candidate criteria (concepts) that can be used to evaluate the quality of HSG and guide development and reporting requirements. The objective of this paper was to describe two studies aimed at evaluating the importance of these 30 criteria, design a draft HSG appraisal tool, and test its usability. This study involved a two-step survey process. In step 1, respondents rated the 30 concepts for appropriateness to, relevance to, and priority for health system decisions and HSG. This led to a draft tool. In step 2, respondents reviewed HSG documents, appraised them using the tool, and answered a series of questions. Descriptive analyses were computed. Fifty participants were invited in step 1, and we had a response rate of 82 %. The mean response rates for each concept within each survey question were universally favorable. There was also an overall agreement about the need for a high-quality tool to systematically direct the development, appraisal, and reporting of HSG. Qualitative feedback and a consensus process by the team led to refinements to some of the concepts and the creation of a beta (draft) version of the HSG tool. In step 2, 35 participants were invited and we had a response rate of 74 %. Exploratory analyses showed that the quality of the HSGs reviewed varied as a function of the HSG item and the specific document assessed. A favorable consensus was reached with participants agreeing that the HSG items were easy to understand and easy to apply. Moreover, the overall agreement was high for the usability of the tool to systematically direct the development (85 %), appraisal (92 %), and reporting (81 %) of HSG. From this process, version 1.0 of the HSG appraisal tool was generated complete with 32 items (and their descriptions) and 4 domains. The final
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The revised HSE fatigue guidance
DOE Office of Scientific and Technical Information (OSTI.GOV)
Stacey, A.; Sharp, J.V.
1995-12-31
Fatigue cracking has been a principal cause of damage to North Sea structures and consequently considerable attention has been given to the development of guidance for the prediction of fatigue performance. The fatigue guidance of the Offshore Safety Division of the Health and Safety Executive (HSE) was recently revised and published, following a significant offshore industry review in the period 1987 to 1990, and is based on the results of a considerable amount of research and development work on the fatigue behavior of welded tubular and plated joints. As a result of this review, the revised fatigue guidance incorporates severalmore » new clauses and recommendations. The revised recommendations apply to joint classification, basic design S-N curves for welded joints and cast or forged steel components, the thickness effect, the effects of environment and the treatment of low and high stress ranges. Additionally, a new appendix on the derivation of stress concentration factors is included. The new clauses cover high strength steels, bolts and threaded connectors, moorings, repaired joints and the use of fracture mechanics analysis. This paper presents an overview of the revisions to the fatigue guidance, the associated background technical information and aspects of the fatigue behavior of offshore structures which are considered to require further investigation. 67 refs., 7 figs., 8 tabs.« less
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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…
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-09-10
... for Use To Diagnose, Cure, Mitigate, Treat, or Prevent Disease in Dogs and Cats; Availability AGENCY..., Treat, or Prevent Disease in Dogs and Cats.'' This draft CPG is intended to provide guidance to FDA... marketing of dog and cat food products that are labeled and/or marketed as intending to diagnose, cure...
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This is a draft of the recommendations that that Assumable Waters Subcommittee will present to NACEPT on May 10. It should be considered a draft until it is approved and transmitted to the EPA by NACEPT
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-11-23
... entitled ``Vaginal Microbicides: Development for the Prevention of HIV Infection.'' The purpose of this... human immunodeficiency virus (HIV) infection. The guidance outlines the types of nonclinical studies and...: Development for the Prevention of HIV Infection.'' This guidance addresses nonclinical development, early...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-06-13
... Stock in Organic Crop Production (NOP 5029)''; and ``Evaluating Allowed Ingredients and Sources of... finalized, these guidance documents will be available from the NOP through ``The Program Handbook: Guidance... ``Seeds, Annual Seedlings, and Planting Stock in Organic Crop Production (NOP 5029)'', and ``Evaluating...
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77 FR 26562 - Mobile Offshore Drilling Unit Dynamic Positioning Guidance
Federal Register 2010, 2011, 2012, 2013, 2014
2012-05-04
... regarding a draft policy letter on Dynamic Positioning (DP) Systems, Emergency Disconnect Systems, Blowout... Coast Guard, NOSAC issued the report ``Recommendations for Dynamic Positioning System Design and... DEPARTMENT OF HOMELAND SECURITY Coast Guard [USCG-2011-1106] Mobile Offshore Drilling Unit Dynamic...
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WISE recommendations to ensure the safety of injections in diabetes.
Strauss, K
2012-01-01
Injections and fingersticks administered to patients with diabetes in health care settings present a risk of blood exposure to the injector as well as other workers in potential contact with sharps. Such exposures could lead to transmission of bloodborne pathogens such as hepatitis and HIV. A recent EU Directive requires that where such risks have been identified, processes and devices must be put in place to reduce or eliminate the risk. The aim of this paper is to provide formal guidelines on the application of this Directive to diabetes care settings. These evidence-based recommendations were written and vetted by a large group of international safety experts. A systematic literature search was conducted for all peer-reviewed studies and publications which bear on sharps safety in diabetes. Initially a group of experts reviewed this literature and drafted the recommendations. These were then presented for review, debate and revision to 57 experts from 14 countries at the WISE workshop in October, 2011. After the WISE meeting, the revised Recommendations were circulated electronically to attendees on three occasions, each time in a new iteration with revisions. Each recommendation was graded by the weight it should have in daily practice and by its degree of support in the medical literature. The topics covered include Risks of Sharps Injury and Muco-cutaneous Exposure, The EU Directive, Device Implications, Injection Technique Implications, Education and Training (Creating a "Safety Culture"), Value, Awareness and Responsibility. These safety recommendations provide practical guidance and fill an important gap in diabetes management. If followed, they should help ensure safe, effective and largely injury-free injections and fingersticks. They will serve as the roadmap for applying the new EU Directive to diabetes care. Copyright © 2012 Elsevier Masson SAS. All rights reserved.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-06-15
... human specimens or bacterial growth detected by continuous monitoring blood culture systems. This draft... versus SA in either human specimens or bacterial growth detected by continuous monitoring blood culture... devices that detect MRSA by growth in culture media or those devices that test for the protein, penicillin...
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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.…
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National Recommended Water Quality Criteria
The National Recommended Water Quality Criteria is a compilation of national recommended water quality criteria for the protection of aquatic life and human health in surface water for approximately 150 pollutants. These criteria provide guidance for states and tribes to use in adopting water quality standards.
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-12-13
... for Devices and Radiological Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave... INFORMATION CONTACT: For information concerning the guidance as it relates to devices regulated by CDRH: Mary... Internet. A search capability for all CDRH guidance documents is available at http://www.fda.gov/Medical...
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46 CFR 32.05-1 - Draft marks and draft indicating systems-TB/ALL.
Code of Federal Regulations, 2014 CFR
2014-10-01
... 46 Shipping 1 2014-10-01 2014-10-01 false Draft marks and draft indicating systems-TB/ALL. 32.05-1..., MACHINERY, AND HULL REQUIREMENTS Markings § 32.05-1 Draft marks and draft indicating systems—TB/ALL. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or...
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46 CFR 32.05-1 - Draft marks and draft indicating systems-TB/ALL.
Code of Federal Regulations, 2011 CFR
2011-10-01
... 46 Shipping 1 2011-10-01 2011-10-01 false Draft marks and draft indicating systems-TB/ALL. 32.05-1..., MACHINERY, AND HULL REQUIREMENTS Markings § 32.05-1 Draft marks and draft indicating systems—TB/ALL. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or...
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46 CFR 32.05-1 - Draft marks and draft indicating systems-TB/ALL.
Code of Federal Regulations, 2010 CFR
2010-10-01
... 46 Shipping 1 2010-10-01 2010-10-01 false Draft marks and draft indicating systems-TB/ALL. 32.05-1..., MACHINERY, AND HULL REQUIREMENTS Markings § 32.05-1 Draft marks and draft indicating systems—TB/ALL. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or...
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46 CFR 32.05-1 - Draft marks and draft indicating systems-TB/ALL.
Code of Federal Regulations, 2013 CFR
2013-10-01
... 46 Shipping 1 2013-10-01 2013-10-01 false Draft marks and draft indicating systems-TB/ALL. 32.05-1..., MACHINERY, AND HULL REQUIREMENTS Markings § 32.05-1 Draft marks and draft indicating systems—TB/ALL. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or...
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46 CFR 32.05-1 - Draft marks and draft indicating systems-TB/ALL.
Code of Federal Regulations, 2012 CFR
2012-10-01
... 46 Shipping 1 2012-10-01 2012-10-01 false Draft marks and draft indicating systems-TB/ALL. 32.05-1..., MACHINERY, AND HULL REQUIREMENTS Markings § 32.05-1 Draft marks and draft indicating systems—TB/ALL. (a) All vessels must have draft marks plainly and legibly visible upon the stem and upon the sternpost or...
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78 FR 23289 - Public Review of Draft National Shoreline Data Content Standard
Federal Register 2010, 2011, 2012, 2013, 2014
2013-04-18
...The Federal Geographic Data Committee (FGDC) is conducting a public review of the draft National Shoreline Data Content Standard. The FGDC has developed a draft National Shoreline Data Content Standard that provides a framework for shoreline data development, sharing of data, and shoreline data transformation and fusion. The FGDC Coastal and Marine Spatial Data Subcommittee, chaired by the National Oceanic and Atmospheric Administration (NOAA), sponsored development of the draft standard. The FGDC Coordination Group, comprised of representatives of Federal agencies, has approved releasing this draft standard for public review and comment. The draft National Shoreline Data Content Standard defines attributes or elements that are common for shoreline data development and provides suggested domains for the elements. The functional scope includes definition of data models, schemas, entities, relationships, definitions, and crosswalks to related standards. The draft National Shoreline Data Content Standard is intended to enhance the shoreline framework by providing technical guidance on shoreline semantics, data structures and their relationships to builders and users of shoreline data. The geographical scope of the draft standard comprises all shorelines of navigable waters within the United States and its territories. The primary intended users of the National Shoreline Data Content Standard are the mapping, shoreline engineering, coastal zone management, flood insurance, and natural resource management communities. The FGDC invites all stakeholders to comment on this draft standard to ensure that it meets their needs. The draft National Shoreline Data Content Standard may be downloaded from https://www.fgdc.gov/standards/projects/FGDC-standards- projects/shoreline-data-content/ revisedDraftNationalShorelineDataContentStandard. Comments shall be submitted using the content template at http://www.fgdc.gov/standards/ process
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Assay Characterization Guidance Documents | Office of Cancer Clinical Proteomics Research
CPTAC characterized assays are defined as those that meet the criteria described in the Assay Characterization Guidance Document. This guidance document aligns with recommendations by the research community as “fit-for-purpose” validation requirements of targeted proteomics assays.
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-07-13
... hazardous substances (EHSs) and to provide the public, local agencies, fire departments, and other emergency... submitted to the SERC, LEPC and the local fire department. The implementing regulations for sections 311 and... burden for SERCs, LEPCs and fire departments in the form of draft guidance in the preamble to the June 8...
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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…
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-10-03
... all CDRH guidance documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationand...),'' from CDRH you may either send an e-mail request to [email protected] to receive an electronic copy of... guidance describes how FDA's Center for Devices and Radiological Health (CDRH) and Center for Biologics...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-01-03
... medical devices regulated by the Center for Devices and Radiological Health (CDRH) and the Center for... assist that office in processing your request, or fax your request to CDRH at (301) 847-8149. The draft... parts 862 through 892)) have been the basis for the CDRH's Classification Product Code structure and...
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Beulke, Sabine; van Beinum, Wendy; Suddaby, Laura
2015-04-01
First-tier regulatory exposure assessments for pesticides assume that pesticide sorption is instantaneous and fully reversible. In European Union (EU) regulatory guidance, an increase in sorption over time ("aged sorption") can be considered at the higher tier to refine predicted environmental concentrations in groundwater. Research commissioned by the UK Chemicals Regulation Directorate (CRD), funded by the Department for Environment Food & Rural Affairs (Defra), formed the basis of a draft regulatory guidance document proposing 1) a protocol on how to measure aged sorption of parent compounds in laboratory studies, 2) procedures to fit kinetic models to the experimental data, 3) criteria to test the reliability of the parameters, and 4) procedures for use of the parameters in the groundwater exposure assessment. The draft guidance was revised after feedback from stakeholders and testing of the guidance was performed against real data sets by an independent consultancy. The Chemicals Regulation Directorate submitted the revised document to the European Food Safety Authority (EFSA) for scrutiny. This article gives an overview of the draft guidance and explains the reasoning behind the recommendations made. 2015 Crown Copyright; Published 2015 SETAC.
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Ultrasound Guidance for Botulinum Neurotoxin Chemodenervation Procedures.
Alter, Katharine E; Karp, Barbara I
2017-12-28
Injections of botulinum neurotoxins (BoNTs) are prescribed by clinicians for a variety of disorders that cause over-activity of muscles; glands; pain and other structures. Accurately targeting the structure for injection is one of the principle goals when performing BoNTs procedures. Traditionally; injections have been guided by anatomic landmarks; palpation; range of motion; electromyography or electrical stimulation. Ultrasound (US) based imaging based guidance overcomes some of the limitations of traditional techniques. US and/or US combined with traditional guidance techniques is utilized and or recommended by many expert clinicians; authors and in practice guidelines by professional academies. This article reviews the advantages and disadvantages of available guidance techniques including US as well as technical aspects of US guidance and a focused literature review related to US guidance for chemodenervation procedures including BoNTs injection.
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-06-12
... jurisdiction. The agencies wish to stress, however, that our intent was to provide harmonized guidance to IRBs.... FDA and OHRP will continue to work closely in the development of final guidance and appreciate...
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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:…
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NRC ARDC Guidance Support Status Report
DOE Office of Scientific and Technical Information (OSTI.GOV)
Holbrook, Mark R.
This report provides a summary that reflects the progress and status of proposed regulatory design criteria for advanced non-light water reactor (LWR) designs in accordance with the Level 3 milestone M3AT-17IN2001013 in work package AT-17IN200101. These criteria have been designated as advanced reactor design criteria (ARDC) and they provide guidance to future applicants for addressing the general design criteria (GDC) that are currently applied specifically to LWR designs. This report provides a summary of Phase 2 activities related to the various tasks associated with ARDC development and the subsequent development of ARDC regulatory guidance for sodium fast reactor (SFR) andmore » modular high-temperature gas-cooled reactor (HTGR) designs. Status Report Organization: Section 2 discusses the origin of the GDC and their application to LWRs. Section 3 addresses the objective of this initiative and how it benefits the advanced non-LWR reactor vendors. Section 4 discusses the scope and structure of the initiative. Section 5 provides background on the U.S. Department of Energy (DOE) ARDC team’s original development of the proposed ARDC that were submitted to the NRC for consideration. Section 6 provides a summary of recent ARDC Phase 2 activities. Appendices A through E document the DOE ARDC team’s public comments on various sections of the NRC’s draft regulatory guide DG–1330, “Guidance for Developing Principal Design Criteria for Non-Light Water Reactors.”« less
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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;…
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46 CFR 167.55-1 - Draft marks and draft indicating systems.
Code of Federal Regulations, 2013 CFR
2013-10-01
... Section 167.55-1 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) NAUTICAL SCHOOLS PUBLIC NAUTICAL SCHOOL SHIPS Special Markings Required § 167.55-1 Draft marks and draft indicating systems. (a... are of uniform height equal to the vertical spacing between consecutive marks. (f) Draft marks must be...
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46 CFR 167.55-1 - Draft marks and draft indicating systems.
Code of Federal Regulations, 2011 CFR
2011-10-01
... Section 167.55-1 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) NAUTICAL SCHOOLS PUBLIC NAUTICAL SCHOOL SHIPS Special Markings Required § 167.55-1 Draft marks and draft indicating systems. (a... are of uniform height equal to the vertical spacing between consecutive marks. (f) Draft marks must be...
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46 CFR 167.55-1 - Draft marks and draft indicating systems.
Code of Federal Regulations, 2014 CFR
2014-10-01
... Section 167.55-1 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) NAUTICAL SCHOOLS PUBLIC NAUTICAL SCHOOL SHIPS Special Markings Required § 167.55-1 Draft marks and draft indicating systems. (a... are of uniform height equal to the vertical spacing between consecutive marks. (f) Draft marks must be...
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46 CFR 167.55-1 - Draft marks and draft indicating systems.
Code of Federal Regulations, 2012 CFR
2012-10-01
... Section 167.55-1 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) NAUTICAL SCHOOLS PUBLIC NAUTICAL SCHOOL SHIPS Special Markings Required § 167.55-1 Draft marks and draft indicating systems. (a... are of uniform height equal to the vertical spacing between consecutive marks. (f) Draft marks must be...
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46 CFR 167.55-1 - Draft marks and draft indicating systems.
Code of Federal Regulations, 2010 CFR
2010-10-01
... Section 167.55-1 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) NAUTICAL SCHOOLS PUBLIC NAUTICAL SCHOOL SHIPS Special Markings Required § 167.55-1 Draft marks and draft indicating systems. (a... are of uniform height equal to the vertical spacing between consecutive marks. (f) Draft marks must be...
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Nace, David A; Archbald-Pannone, Laurie R; Ashraf, Muhammad S; Drinka, Paul J; Frentzel, Elizabeth; Gaur, Swati; Mahajan, Dheeraj; Mehr, David R; Mercer, William C; Sloane, Philip D; Jump, Robin L P
2017-02-01
Efforts at preventing pneumococcal disease are a national health priority, particularly in older adults and especially in post-acute and long-term care settings The Advisory Committee on Immunization Practices recommends that all adults ≥65 years of age, as well as adults 18-64 years of age with specific risk factors, receive both the recently introduced polysaccharide-protein conjugate vaccine against 13 pneumococcal serotypes as well as the polysaccharide vaccine against 23 pneumococcal serotypes. Nursing facility licensure regulations require facilities to assess the pneumococcal vaccination status of each resident, provide education regarding pneumococcal vaccination, and administer the appropriate pneumococcal vaccine when indicated. Sorting out the indications and timing for 13 pneumococcal serotypes and 23 pneumococcal serotypes administration is complex and presents a significant challenge to healthcare providers. Here, we discuss the importance of pneumococcal vaccination for older adults, detail AMDA-The Society for Post-Acute and Long-Term Care Medicine (The Society)'s recommendations for pneumococcal vaccination practice and procedures, and offer guidance to postacute and long-term care providers supporting the development and effective implementation of pneumococcal vaccine policies. Copyright © 2016 AMDA – The Society for Post-Acute and Long-Term Care Medicine. All rights reserved.
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Linthorst, Gabor E; Burlina, Alessandro P; Cecchi, Franco; Cox, Timothy M; Fletcher, Janice M; Feldt-Rasmussen, Ulla; Giugliani, Roberto; Hollak, Carla E M; Houge, Gunnar; Hughes, Derralynn; Kantola, Iikka; Lachmann, Robin; Lopez, Monica; Ortiz, Alberto; Parini, Rossella; Rivera, Alberto; Rolfs, Arndt; Ramaswami, Uma; Svarstad, Einar; Tondel, Camilla; Tylki-Szymanska, Anna; Vujkovac, Bojan; Waldek, Steven; West, Michael; Weidemann, F; Mehta, Atul
2013-01-01
The interruption of the manufacturing process of agalsidase beta has led to a worldwide shortage of this drug. In the EU, nearly all patients initially reduced their agalsidase beta dose, and many of these switched to agalsidase alfa (Replagal Shire HGT). The clinical consequences of this period of drug shortage need to be further evaluated. A gradual increase of agalsidase beta supply is now expected. This implies that patients could resume or even commence agalsidase beta treatment. Guidance for prioritization of patients is needed to support equitable distribution of agalsidase beta to EU member states. To achieve this, in absence of level I clinical evidence, a draft consensus proposal was initiated and distributed. No full consensus was achieved, as there is disagreement regarding the indications for switching patients from agalsidase alfa to agalsidase beta. Some physicians support the concept that the 1.0 mg/kg EOW dose of agalsidase beta is more effective than agalsidase alfa at 0.2 mg/kg EOW, while others believe that at recommended dose, the preparations are equivalent. In light of these difficulties and the uncertainties with respect to supply of agalsidase beta, recommendations were agreed upon by a subgroup of physicians. These current recommendations focus on prioritization of criteria indicative of disease progression.
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-07-13
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0530... Program and Meetings With FDA Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-08-03
... DEPARTMENT OF THE INTERIOR Bureau of Reclamation Draft Resource Management Plan/General Plan Draft... Recreation Area, Merced County, California AGENCY: Bureau of Reclamation, Interior. ACTION: Notice of... California Department of Parks and Recreation was given the responsibility to plan, design, construct...
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This document shares the guidance developed by the Interagency Working Group which was formed to develop guidance to reduce unnecessary radiation exposures from the use of x-rays in the healing arts in Federal health care facilities.
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Code of Federal Regulations, 2012 CFR
2012-10-01
... 46 Shipping 4 2012-10-01 2012-10-01 false Drafts. 131.220 Section 131.220 Shipping COAST GUARD... Drafts. (a) Each vessel must have the drafts of the vessel plainly and legibly marked upon the stem and... easy observance. The bottom of each mark must indicate the draft. (b) Each draft must be taken from the...
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Code of Federal Regulations, 2010 CFR
2010-10-01
... 46 Shipping 4 2010-10-01 2010-10-01 false Drafts. 131.220 Section 131.220 Shipping COAST GUARD... Drafts. (a) Each vessel must have the drafts of the vessel plainly and legibly marked upon the stem and... easy observance. The bottom of each mark must indicate the draft. (b) Each draft must be taken from the...
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Code of Federal Regulations, 2013 CFR
2013-10-01
... 46 Shipping 4 2013-10-01 2013-10-01 false Drafts. 131.220 Section 131.220 Shipping COAST GUARD... Drafts. (a) Each vessel must have the drafts of the vessel plainly and legibly marked upon the stem and... easy observance. The bottom of each mark must indicate the draft. (b) Each draft must be taken from the...
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Code of Federal Regulations, 2011 CFR
2011-10-01
... 46 Shipping 4 2011-10-01 2011-10-01 false Drafts. 131.220 Section 131.220 Shipping COAST GUARD... Drafts. (a) Each vessel must have the drafts of the vessel plainly and legibly marked upon the stem and... easy observance. The bottom of each mark must indicate the draft. (b) Each draft must be taken from the...
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Code of Federal Regulations, 2014 CFR
2014-10-01
... 46 Shipping 4 2014-10-01 2014-10-01 false Drafts. 131.220 Section 131.220 Shipping COAST GUARD... Drafts. (a) Each vessel must have the drafts of the vessel plainly and legibly marked upon the stem and... easy observance. The bottom of each mark must indicate the draft. (b) Each draft must be taken from the...
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75 FR 9228 - Draft Guidance for Industry on Non-Inferiority Clinical Trials; Availability
Federal Register 2010, 2011, 2012, 2013, 2014
2010-03-01
... guidance provides sponsors and review staff in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) with the agency's interpretation of the underlying principles involved in the use of non-inferiority (NI) study designs to provide evidence of the effectiveness...
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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…
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Report #13-P-0057, November 27, 2012. EPA has taken a number of actions to address findings and recommendations from the OIG’s 2008 report, including developing the GAP Online database, drafting a GAP guidebook, and revising GAP guidance.
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Quality assurance and quality control in mammography: a review of available guidance worldwide.
Reis, Cláudia; Pascoal, Ana; Sakellaris, Taxiarchis; Koutalonis, Manthos
2013-10-01
Review available guidance for quality assurance (QA) in mammography and discuss its contribution to harmonise practices worldwide. Literature search was performed on different sources to identify guidance documents for QA in mammography available worldwide in international bodies, healthcare providers, professional/scientific associations. The guidance documents identified were reviewed and a selection was compared for type of guidance (clinical/technical), technology and proposed QA methodologies focusing on dose and image quality (IQ) performance assessment. Fourteen protocols (targeted at conventional and digital mammography) were reviewed. All included recommendations for testing acquisition, processing and display systems associated with mammographic equipment. All guidance reviewed highlighted the importance of dose assessment and testing the Automatic Exposure Control (AEC) system. Recommended tests for assessment of IQ showed variations in the proposed methodologies. Recommended testing focused on assessment of low-contrast detection, spatial resolution and noise. QC of image display is recommended following the American Association of Physicists in Medicine guidelines. The existing QA guidance for mammography is derived from key documents (American College of Radiology and European Union guidelines) and proposes similar tests despite the variations in detail and methodologies. Studies reported on QA data should provide detail on experimental technique to allow robust data comparison. Countries aiming to implement a mammography/QA program may select/prioritise the tests depending on available technology and resources. •An effective QA program should be practical to implement in a clinical setting. •QA should address the various stages of the imaging chain: acquisition, processing and display. •AEC system QC testing is simple to implement and provides information on equipment performance.
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-05-20
... Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) are implementing this... search capability for all CDRH guidance documents is available at http://www.fda.gov/cdrh/guidance.html... CDRH and CBER are implementing this provision of the law and providing public notice as required. The...
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[Development process of Evidence-based "Return-to-work Guidance in Occupational Health 2017"].
Kojimahara, Noriko; Fukumoto, Masakatsu; Yoshikawa, Etsuko; Shinada, Kayoko; Tsuiki, Hirokazu
2018-06-05
Objective"Return-to-work Guidance in Occupational Health 2017 (RTW Guidance 2017) " is the first occupational health guide in Japan that evaluates the quality of evidence and offers recommendations based on results of the systematic review of randomized controlled trials. Details of the systematic review of each review question (RQs) will be described separately. This article presents an overview of the method and process of developing the "RTW Guidance 2017."Materials and MethodsThe guidance was developed following the previously-published "Method for developing evidence based occupational health guidance," which included the composition of a highly-transparent guidance developing group as well as the recruitment and selection of RQs. Using the Cochrane Library, PubMed, and Ichushi-Web, a literature search for the six RQs was conducted in January 2016 by partly modifying the search terms of the existing systematic review. Articles were selected according to the inclusion criteria, and the quality of evidence was evaluated using the GRADE approach. Meta-analysis was conducted for RQ2 and RQ4, and a qualitative systematic review was conducted for RQ5, RQ6, and cost-effectiveness. Recommendations were subsequently made after a thorough consideration for feasibility in Japan by examining the costs and available resources.ResultsBased on a comprehensive literature search, eleven RQ2, four RQ4, one RQ5, and three RQ6 were selected. Support program for returning to work, such as "Re-work" for those who are temporarily not working due to musculoskeletal disorders or mental health disorder, was recommended based on moderate evidence (RQ2). For RQ4, the collaboration between occupational health practice and clinical practice was weakly recommended based on low evidence. For RQ5 that evaluated the usefulness of social support, intervention by the manager/co-worker was proposed as a "best practice statement" without indicating it as a recommendation. Work accommodation was
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USGEO DMWG Cloud Computing Recommendations
NASA Astrophysics Data System (ADS)
de la Beaujardiere, J.; McInerney, M.; Frame, M. T.; Summers, C.
2017-12-01
The US Group on Earth Observations (USGEO) Data Management Working Group (DMWG) has been developing Cloud Computing Recommendations for Earth Observations. This inter-agency report is currently in draft form; DMWG hopes to have released the report as a public Request for Information (RFI) by the time of AGU. The recommendations are geared toward organizations that have already decided to use the Cloud for some of their activities (i.e., the focus is not on "why you should use the Cloud," but rather "If you plan to use the Cloud, consider these suggestions.") The report comprises Introductory Material, including Definitions, Potential Cloud Benefits, and Potential Cloud Disadvantages, followed by Recommendations in several areas: Assessing When to Use the Cloud, Transferring Data to the Cloud, Data and Metadata Contents, Developing Applications in the Cloud, Cost Minimization, Security Considerations, Monitoring and Metrics, Agency Support, and Earth Observations-specific recommendations. This talk will summarize the recommendations and invite comment on the RFI.
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-08-03
...] Guidance for Industry on Label Comprehension Studies for Nonprescription Drug Products; Availability AGENCY... announcing the availability of a guidance for industry entitled ``Label Comprehension Studies for Nonprescription Drug Products.'' The guidance provides recommendations on the design of label comprehension...
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Surface Water Treatment Rules State Implementation Guidance
These documents provide guidance to states, tribes and U.S. EPA Regions exercising primary enforcement responsibility under the Safe Drinking Water Act. The documents contain EPA’s recommendations for implementation of the Surface Water Treatment Rules.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-07-15
...] Draft Environmental Impact Statement and Draft Habitat Conservation Plan for Oncor Electric Delivery..., announce the availability of the draft environmental impact statement and the draft Oncor Electric Delivery... Oncor Electric Delivery Company, LLC (Applicant; Oncor), and (2) That the Applicant has developed a...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-04-29
... office in processing your request, or fax your request to CDRH to 301-847-8149. See the SUPPLEMENTARY... guidance you are requesting. A search capability for all CDRH guidance documents is available at http://www... Response Responses Response Total Hours CDRH 110 1 110 12 1,320 CBER 4 1 4 12 48 Total 1,368 \\1\\ There are...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-08-24
...- 2011-0191. Address questions about NRC dockets to Carol Gallagher, telephone: 301-492-3668; e-mail...): Publicly available documents created or received at the NRC are available online in the NRC Library at http...-800-397-4209, 301-415-4737, or by e-mail to [email protected] . The draft LR-ISG proposes to revise...
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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.
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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…
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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…
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-27
...] Draft Environmental Impact Statement and Draft Habitat Conservation Plan for Oncor Electric Delivery... availability of the draft environmental impact statement (DEIS) and the draft Oncor Electric Delivery Company... announced that Oncor Electric Delivery Company, LLC, has applied under section 10(a)(1)(B) of the Endangered...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-04-11
... recommendations regarding study design, study conduct, and final reporting of self-selection studies. The guidance...] Guidance for Industry on Self-Selection Studies for Nonprescription Drug Products; Availability AGENCY... announcing the availability of a guidance for industry entitled ``Self-Selection Studies for Nonprescription...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-02-11
... Pesticide Registrants on Antimicrobial Pesticide Products With Mold-Related Label Claims; Notice of... Register issue of December 12, 2012, requesting comments on Guidance for Antimicrobial Pesticide Products... CONTACT: Melba S. Morrow, Antimicrobials Division (7510P), Office of Pesticide Programs, Environmental...
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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.
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Schwartz, Jennifer A T; Pearson, Steven D
2013-06-24
Despite increasing concerns regarding the cost of health care, the consideration of costs in the development of clinical guidance documents by physician specialty societies has received little analysis. To evaluate the approach to consideration of cost in publicly available clinical guidance documents and methodological statements produced between 2008 and 2012 by the 30 largest US physician specialty societies. Qualitative document review. Whether costs are considered in clinical guidance development, mechanism of cost consideration, and the way that cost issues were used in support of specific clinical practice recommendations. Methodological statements for clinical guidance documents indicated that 17 of 30 physician societies (57%) explicitly integrated costs, 4 (13%) implicitly considered costs, 3 (10%) intentionally excluded costs, and 6 (20%) made no mention. Of the 17 societies that explicitly integrated costs, 9 (53%) consistently used a formal system in which the strength of recommendation was influenced in part by costs, whereas 8 (47%) were inconsistent in their approach or failed to mention the exact mechanism for considering costs. Among the 138 specific recommendations in these guidance documents that included cost as part of the rationale, the most common form of recommendation (50 [36%]) encouraged the use of a specific medical service because of equal effectiveness and lower cost. Slightly more than half of the largest US physician societies explicitly consider costs in developing their clinical guidance documents; among these, approximately half use an explicit mechanism for integrating costs into the strength of recommendations. Many societies remain vague in their approach. Physician specialty societies should demonstrate greater transparency and rigor in their approach to cost consideration in documents meant to influence care decisions.
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75 FR 67987 - Guidance for Industry: Cellular Therapy for Cardiac Disease; Availability
Federal Register 2010, 2011, 2012, 2013, 2014
2010-11-04
...] Guidance for Industry: Cellular Therapy for Cardiac Disease; Availability AGENCY: Food and Drug... availability of a document entitled ``Guidance for Industry: Cellular Therapy for Cardiac Disease'' dated... treatment of cardiac disease with recommendations on the design of preclinical and clinical studies and on...
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The 2009 schizophrenia PORT psychosocial treatment recommendations and summary statements.
Dixon, Lisa B; Dickerson, Faith; Bellack, Alan S; Bennett, Melanie; Dickinson, Dwight; Goldberg, Richard W; Lehman, Anthony; Tenhula, Wendy N; Calmes, Christine; Pasillas, Rebecca M; Peer, Jason; Kreyenbuhl, Julie
2010-01-01
The Schizophrenia Patient Outcomes Research Team (PORT) psychosocial treatment recommendations provide a comprehensive summary of current evidence-based psychosocial treatment interventions for persons with schizophrenia. There have been 2 previous sets of psychosocial treatment recommendations (Lehman AF, Steinwachs DM. Translating research into practice: the Schizophrenia Patient Outcomes Research Team (PORT) treatment recommendations. Schizophr Bull. 1998;24:1-10 and Lehman AF, Kreyenbuhl J, Buchanan RW, et al. The Schizophrenia Patient Outcomes Research Team (PORT): updated treatment recommendations 2003. Schizophr Bull. 2004;30:193-217). This article reports the third set of PORT recommendations that includes updated reviews in 7 areas as well as adding 5 new areas of review. Members of the psychosocial Evidence Review Group conducted reviews of the literature in each intervention area and drafted the recommendation or summary statement with supporting discussion. A Psychosocial Advisory Committee was consulted in all aspects of the review, and an expert panel commented on draft recommendations and summary statements. Our review process produced 8 treatment recommendations in the following areas: assertive community treatment, supported employment, cognitive behavioral therapy, family-based services, token economy, skills training, psychosocial interventions for alcohol and substance use disorders, and psychosocial interventions for weight management. Reviews of treatments focused on medication adherence, cognitive remediation, psychosocial treatments for recent onset schizophrenia, and peer support and peer-delivered services indicated that none of these treatment areas yet have enough evidence to merit a treatment recommendation, though each is an emerging area of interest. This update of PORT psychosocial treatment recommendations underscores both the expansion of knowledge regarding psychosocial treatments for persons with schizophrenia at the same time as
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33 CFR 401.29 - Maximum draft.
Code of Federal Regulations, 2012 CFR
2012-07-01
... 33 Navigation and Navigable Waters 3 2012-07-01 2012-07-01 false Maximum draft. 401.29 Section 401... TRANSPORTATION SEAWAY REGULATIONS AND RULES Regulations Seaway Navigation § 401.29 Maximum draft. (a) The draft...) The draft of a vessel shall not, in any case, exceed 79.2 dm or the maximum permissible draft...
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33 CFR 401.29 - Maximum draft.
Code of Federal Regulations, 2011 CFR
2011-07-01
... 33 Navigation and Navigable Waters 3 2011-07-01 2011-07-01 false Maximum draft. 401.29 Section 401... TRANSPORTATION SEAWAY REGULATIONS AND RULES Regulations Seaway Navigation § 401.29 Maximum draft. (a) The draft...) The draft of a vessel shall not, in any case, exceed 79.2 dm or the maximum permissible draft...
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33 CFR 401.29 - Maximum draft.
Code of Federal Regulations, 2010 CFR
2010-07-01
... 33 Navigation and Navigable Waters 3 2010-07-01 2010-07-01 false Maximum draft. 401.29 Section 401... TRANSPORTATION SEAWAY REGULATIONS AND RULES Regulations Seaway Navigation § 401.29 Maximum draft. (a) The draft...) The draft of a vessel shall not, in any case, exceed 79.2 dm or the maximum permissible draft...
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Qaseem, Amir; Snow, Vincenza; Owens, Douglas K; Shekelle, Paul
2010-08-03
The American College of Physicians (ACP) established its evidence-based clinical practice guidelines program in 1981. The ACP's Guidelines Committee and the staff of the Clinical Programs and Quality of Care Department develop the clinical recommendations. The ACP develops 2 different types of clinical recommendations: clinical practice guidelines and clinical guidance statements. The ACP clinical practice guidelines and guidance statements follow a multistep development process that includes a systematic review of the evidence, deliberation of the evidence by the committee, summary recommendations, and evidence and recommendation grading. All ACP clinical practice guidelines and clinical guidance statements, if not updated, are considered automatically withdrawn or invalid 5 years after publication or once an update has been issued.
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Working, Welding and Structural Drafting, Drafting--Intermediate: 9255.03.
ERIC Educational Resources Information Center
Dade County Public Schools, Miami, FL.
The course introduces the student to working welding drawings, both detail and assembly, as related to all fields of drafting and structural drafting, and provides him with the opportunity to work with various types of tools and equipment. Prior to entry in this course, the vocational student must display mastery of the skills indicated in…
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Mindell, J; Sheridan, L; Joffe, M; Samson-Barry, H; Atkinson, S
2004-03-01
To increase the positive and mitigate the negative health impacts of the mayor's draft transport strategy for London. A rapid prospective health impact assessment (HIA) of the penultimate draft of the strategy, using a review commissioned by the regional director of public health; an appraisal of congestion charging; and a participatory workshop. Two audits of changes were performed to assess the impact on policy of the HIA process. Regional government policy development. Recommendations from the rapid HIA were fed back into the drafting process. Changes (a) between the penultimate draft and the draft for public consultation and (b) between that and the final mayoral strategy. The draft transport strategy published for consultation differed in a number of respects from the previous version. Almost all the recommendations from the HIA were incorporated into the final strategy. Significant changes included promoting sustainable travel plans for workplaces and schools; giving priority to infrastructure and services that benefit London's deprived communities; increased emphasis on promoting walking and cycling and reducing reliance on private cars; and a commitment to track the health impacts of the final strategy and its implementation. Specific additions included re-allocating road space. HIA was successful in influencing the transport strategy for London, resulting in several improvements from a health viewpoint. HIA is an effective method both for bringing about significant change in policy proposals and in increasing policy makers' understanding of determinants of health and hence in changing attitudes of policy makers.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-16
... Availability of Draft Resource Management Plan and Draft Environmental Impact Statement for the Colorado River... prepared a Draft Resource Management Plan (RMP) and Draft Environmental Impact Statement (EIS) for the... alternative) seeks to allocate limited resources among competing human interests, land uses, and conservation...
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Heckel, Maria; Stiel, Stephanie; Herbst, Franziska A; Tiedtke, Johanna M; Sturm, Alexander; Adelhardt, Thomas; Bogdan, Christian; Sieber, Cornel; Schöffski, Oliver; Lang, Frieder R; Ostgathe, Christoph
2018-03-16
Palliative care professionals are frequently confronted with patients colonized or infected with MDRO. One major challenge is how to balance necessary isolation measures and social inclusion as one of the main principles of palliative and end-of-life care. To date, MDRO-specific policies and protocols vary widely between institutions. provide empirical recommendations on how to deal with hospitalized MDRO patients in end-of-life care. Recommendations were developed based on (i) initial results of face-to-face interviews and focus groups, (ii) impartial experts' comments and consensus on the draft via online survey and (iii) a face-to-face meeting with consortium members to finalize recommendations. Findings of 158 interviews and six focus groups (39 participants) with patients, family caregivers, staff members and institutional stakeholders contributed to the recommendations. The assessments of 17 experts were considered. In total, 21 recommendations were approved. The recommended strategy in dealing with MDRO at the end of life allows case-based application of protection and isolation measures. MDRO diagnostics and therapy involve screening at admission. The recommendations suggest consideration of required accommodation facilities, provided material as well as staff and time resources. The recommendations further highlight the importance of providing for strategies enabling the patient's social inclusion and provision of verbal and written information about MDRO for patients and family caregivers, transparent medical documentation, and staff member training. The recommendations summarize the perspectives of individuals and groups affected by MDRO at the end of life and provide practical guidance for clinical routine. Further dissemination and implementation requirements are discussed and should contain the evaluation of the knowledge, views, worries, and anxieties of the target groups.
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McAlindon, T E; Driban, J B; Henrotin, Y; Hunter, D J; Jiang, G-L; Skou, S T; Wang, S; Schnitzer, T
2015-05-01
The goal of this document is to update the original OARSI recommendations specifically for the design, conduct, and reporting of clinical trials that target symptom or structure modification among individuals with knee osteoarthritis (OA). To develop recommendations for the design, conduct, and reporting of clinical trials for knee OA we initially drafted recommendations through an iterative process. Members of the working group included representatives from industry and academia. After the working group members reviewed a final draft, they scored the appropriateness for recommendations. After the members voted we calculated the median score among the nine members of the working group who completed the score. The document includes 25 recommendations regarding randomization, blocking and stratification, blinding, enhancing accuracy of patient-reported outcomes (PRO), selecting a study population and index knee, describing interventions, patient-reported and physical performance measures, structural outcome measures, biochemical biomarkers, and reporting recommendations. In summary, the working group identified 25 recommendations that represent the current best practices regarding clinical trials that target symptom or structure modification among individuals with knee OA. These updated recommendations incorporate novel technologies (e.g., magnetic resonance imaging (MRI)) and strategies to address the heterogeneity of knee OA. Copyright © 2015 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.
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Coons, Stephen Joel; Gwaltney, Chad J; Hays, Ron D; Lundy, J Jason; Sloan, Jeff A; Revicki, Dennis A; Lenderking, William R; Cella, David; Basch, Ethan
2009-06-01
Patient-reported outcomes (PROs) are the consequences of disease and/or its treatment as reported by the patient. The importance of PRO measures in clinical trials for new drugs, biological agents, and devices was underscored by the release of the US Food and Drug Administration's draft guidance for industry titled "Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims." The intent of the guidance was to describe how the FDA will evaluate the appropriateness and adequacy of PRO measures used as effectiveness end points in clinical trials. In response to the expressed need of ISPOR members for further clarification of several aspects of the draft guidance, ISPOR's Health Science Policy Council created three task forces, one of which was charged with addressing the implications of the draft guidance for the collection of PRO data using electronic data capture modes of administration (ePRO). The objective of this report is to present recommendations from ISPOR's ePRO Good Research Practices Task Force regarding the evidence necessary to support the comparability, or measurement equivalence, of ePROs to the paper-based PRO measures from which they were adapted. The task force was composed of the leadership team of ISPOR's ePRO Working Group and members of another group (i.e., ePRO Consensus Development Working Group) that had already begun to develop recommendations regarding ePRO good research practices. The resulting task force membership reflected a broad array of backgrounds, perspectives, and expertise that enriched the development of this report. The prior work became the starting point for the Task Force report. A subset of the task force members became the writing team that prepared subsequent iterations of the report that were distributed to the full task force for review and feedback. In addition, review beyond the task force was sought and obtained. Along with a presentation and discussion period at an ISPOR meeting
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ERIC Educational Resources Information Center
Mississippi Research and Curriculum Unit for Vocational and Technical Education, State College.
This document, which is intended for use by community and junior colleges throughout Mississippi, contains curriculum frameworks for the two course sequences of the state's postsecondary-level drafting and design technology program: architectural drafting technology and drafting and design technology. Presented first are a program description and…
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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)
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Waugh, Norman; Sharma, Pawana; Sculpher, Mark; Walker, Andrew
2012-01-01
Objectives To compare the timelines and recommendations of the Scottish Medicines Consortium (SMC) and National Institute of Health and Clinical Excellence (NICE), in particular since the single technology assessment (STA) process was introduced in 2005. Design Comparative study of drug appraisals published by NICE and SMC. Setting NICE and SMC. Participants All drugs appraised by SMC and NICE, from establishment of each organisation until August 2010, were included. Data were gathered from published reports on the NICE website, SMC annual reports and European Medicines Agency website. Primary and secondary outcome measures Primary outcome was time from marketing authorisation until publication of first guidance. The final outcome for each drug was documented. Drug appraisals by NICE (before and after the introduction of the STA process) and SMC were compared. Results NICE and SMC appraised 140 drugs, 415 were appraised by SMC alone and 102 by NICE alone. NICE recommended, with or without restriction, 90% of drugs and SMC 80%. SMC published guidance more quickly than NICE (median 7.4 compared with 21.4 months). Overall, the STA process reduced the average time to publication compared with multiple technology assessments (median 16.1 compared with 22.8 months). However, for cancer medications, the STA process took longer than multiple technology assessment (25.2 compared with 20.0 months). Conclusions Proportions of drugs recommended for NHS use by SMC and NICE are similar. SMC publishes guidance more quickly than NICE. The STA process has improved the time to publication but not for cancer drugs. The lengthier time for NICE guidance is partly due to measures to provide transparency and the widespread consultation during the NICE process. PMID:22290398
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Overcoming consumer inertia to dietary guidance.
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. © 2015 American Society for Nutrition.
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2016-11-25
CDC has released updated guidance online for U.S. laboratory testing for Zika virus infection. The guidance is available at https://www.cdc.gov/zika/laboratories/lab-guidance.html. Frequently asked questions are addressed at https://www.cdc.gov/zika/laboratories/lab-guidance-faq.html. This guidance updates recommendations for testing of specimens by U.S. laboratories for possible Zika virus infection. Major updates to the guidance with clinical implications for health care providers include the following.
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How to Develop a Better Guidance Program.
ERIC Educational Resources Information Center
Lawrence, William W.
Designed for school board members, superintendents, administrators, counselors, and teachers, the paper outlines steps toward the systematic development of a guidance program. Following a rationale and introduction, the paper recommends a specific process for program development: (1) the identification of student needs through formal needs…
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78 FR 57450 - State Rail Plan Guidance
Federal Register 2010, 2011, 2012, 2013, 2014
2013-09-18
... development of State rail plans, as appropriate. A commenter recommended that the FRA Regional Manager be... integration of State rail plan development within the statewide/nonmetropolitan transportation planning... Guidance is to describe the processes for the development, submission, and acceptance of State rail plans...
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Kleinmann, Jean-François; Tubach, Florence; Le Guern, Véronique; Mathian, Alexis; Richez, Christophe; Saadoun, David; Sacre, Karim; Sellam, Jérémie; Seror, Raphaèle; Amoura, Zahir; Andres, Emmanuel; Audia, Sylvain; Bader-Meunier, Brigitte; Blaison, Gilles; Bonnotte, Bernard; Cacoub, Patrice; Caillard, Sophie; Chiche, Laurent; Chosidow, Olivier; Costedoat-Chalumeau, Nathalie; Daien, Claire; Daugas, Eric; Derdèche, Nairouz; Doria, Andrea; Fain, Olivier; Fakhouri, Fadi; Farge, Dominique; Gabay, Cem; Guillo, Sylvie; Hachulla, Eric; Hajjaj-Hassouni, Najia; Hamidou, Mohamed; Houssiau, Frédéric A; Jourde-Chiche, Noémie; Koné-Paut, Isabelle; Ladjouz-Rezig, Aïcha; Lambotte, Olivier; Lipsker, Dan; Mariette, Xavier; Martin-Silva, Nicolas; Martin, Thierry; Maurier, François; Meckenstock, Roderich; Mékinian, Arsène; Meyer, Olivier; Mohamed, Shirine; Morel, Jacques; Moulin, Bruno; Mulleman, Denis; Papo, Thomas; Poindron, Vincent; Puéchal, Xavier; Punzi, Leonardo; Quartier, Pierre; Sailler, Laurent; Smail, Amar; Soubrier, Martin; Sparsa, Agnès; Tazi-Mezalek, Zoubida; Zakraoui, Leith; Zuily, Stéphane; Sibilia, Jean; Gottenberg, Jacques-Eric
2017-06-01
Despite conventional immunosuppressants, active and steroid-dependent systemic lupus erythematosus (SLE) represents a therapeutic challenge. Only one biologic, belimumab, has been approved, but other biologics are sometimes used off-label. Given the lack of evidence-based data in some clinical situations encountered in real life, we developed expert recommendations for the use of biologics for SLE. The recommendations were developed by a formal consensus method. This method aims to formalize the degree of agreement among experts by identifying, through iterative ratings with feedback, the points on which experts agree, disagree or are undecided. Hence, the recommendations are based on the agreed-upon points. We gathered the opinion of 59 French-speaking SLE experts from 3 clinical networks dedicated to systemic autoimmune diseases (FLEUR, IMIDIATE, FAI2R) from Algeria, Belgium, France, Italy, Morocco, Switzerland and Tunisia. Represented medical specialities were internal medicine (49%), rheumatology (34%), nephrology (7%), dermatology (5%), pediatrics (3%) and cardiology (2%). Two methodologists and 3 strictly independent SLE expert groups contributed to developing these recommendations: a steering group (SG) (n=9), an evaluation group (EG) (n=28) and a reading group (RG) (n=22). Preliminary recommendations were drafted by the SG, then proposed to the EG. Each EG member rated the degree of agreement from 1 to 9 (1: lowest; 9: strongest) for each recommendation. After 2 rating rounds, the SG submitted a new version of the recommendations to the RG. With comments from the RG, the SG finalised the recommendations. A total of 17 final recommendations were formulated by the SG, considering all agreement scores and comments by the EG and RG members and the two methodologists. These recommendations define the subset of patients who require a biologic; the type of biologics to use (belimumab, rituximab, etc.) depending on the organ involvement and associated co
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Draft Guidance on EPA’s Section 8(a) Information Gathering Rule on Nanomaterials in Commerce
This guidance provides answers to questions the Agency has received from manufacturers (includes importers) and processors of certain chemical substances when they are manufactured or processed at the nanoscale as described in the final rule.
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-08-06
...] (formerly 2003D-0571) Guidance for Industry on Drug Substance Chemistry, Manufacturing, and Controls... Substance Chemistry, Manufacturing, and Controls Information.'' This guidance provides recommendations on the chemistry, manufacturing, and controls (CMC) information for drug substances that should be...
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Balen, Adam H; Morley, Lara C; Misso, Marie; Franks, Stephen; Legro, Richard S; Wijeyaratne, Chandrika N; Stener-Victorin, Elisabet; Fauser, Bart C J M; Norman, Robert J; Teede, Helena
2016-11-01
Here we describe the consensus guideline methodology, summarise the evidence-based recommendations we provided to the World Health Organisation (WHO) for their consideration in the development of global guidance and present a narrative review on the management of anovulatory infertility in women with polycystic ovary syndrome (PCOS). The aim of this paper was to present an evidence base for the management of anovulatory PCOS. The evidence to support providing recommendations involved a collaborative process for: (i) identification of priority questions and critical outcomes, (ii) retrieval of up-to-date evidence and exiting guidelines, (iii) assessment and synthesis of the evidence and (iv) the formulation of draft recommendations to be used for reaching consensus with a wide range of global stakeholders. For each draft recommendation, the methodologist evaluated the quality of the supporting evidence that was then graded as very low, low, moderate or high for consideration during consensus. Evidence was synthesized and we made recommendations across the definition of PCOS including hyperandrogenism, menstrual cycle regulation and ovarian assessment. Metabolic features and the impact of ethnicity were covered. Management includes lifestyle changes, bariatric surgery, pharmacotherapy (including clomiphene citrate (CC), aromatase inhibitors, metformin and gonadotropins), as well as laparoscopic surgery. In-vitro fertilization (IVF) was considered as were the risks of ovulation induction and of pregnancy in PCOS. Approximately 80% of women who suffer from anovulatory infertility have PCOS. Lifestyle intervention is recommended first in women who are obese largely on the basis of general health benefits. Bariatric surgery can be considered where the body mass index (BMI) is ≥35 kg/m 2 and lifestyle therapy has failed. Carefully conducted and monitored pharmacological ovulation induction can achieve good cumulative pregnancy rates and multiple pregnancy rates can be
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Mundt, Kenneth A; Gentry, P Robinan; Dell, Linda D; Rodricks, Joseph V; Boffetta, Paolo
2018-02-01
Shortly after the International Agency for Research on Cancer (IARC) determined that formaldehyde causes leukemia, the United States Environmental Protection Agency (EPA) released its Draft IRIS Toxicological Review of Formaldehyde ("Draft IRIS Assessment"), also concluding that formaldehyde causes leukemia. Peer review of the Draft IRIS Assessment by a National Academy of Science committee noted that "causal determinations are not supported by the narrative provided in the draft" (NRC 2011). They offered recommendations for improving the Draft IRIS assessment and identified several important research gaps. Over the six years since the NRC peer review, significant new science has been published. We identify and summarize key recommendations made by NRC and map them to this new science, including extended analysis of epidemiological studies, updates of earlier occupational cohort studies, toxicological experiments using a sensitive mouse strain, mechanistic studies examining the role of exogenous versus endogenous formaldehyde in bone marrow, and several critical reviews. With few exceptions, new findings are consistently negative, and integration of all available evidence challenges the earlier conclusions that formaldehyde causes leukemia. Given formaldehyde's commercial importance, environmental ubiquity and endogenous production, accurate hazard classification and risk evaluation of whether exposure to formaldehyde from occupational, residential and consumer products causes leukemia are critical. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.
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EPA scientific integrity policy draft
NASA Astrophysics Data System (ADS)
Showstack, Randy
2011-08-01
The U.S. Environmental Protection Agency (EPA) issued its draft scientific integrity policy on 5 August. The draft policy addresses scientific ethical standards, communications with the public, the use of advisory committees and peer review, and professional development. The draft policy was developed by an ad hoc group of EPA senior staff and scientists in response to a December 2010 memorandum on scientific integrity from the White House Office of Science and Technology Policy. The agency is accepting public comments on the draft through 6 September; comments should be sent to osa.staff@epa.gov. For more information, see http://www.epa.gov/stpc/pdfs/draft-scientific-integrity-policy-aug2011.pdf.
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Vertical Motion Simulator Experiment on Stall Recovery Guidance
NASA Technical Reports Server (NTRS)
Schuet, Stefan; Lombaerts, Thomas; Stepanyan, Vahram; Kaneshige, John; Shish, Kimberlee; Robinson, Peter; Hardy, Gordon H.
2017-01-01
A stall recovery guidance system was designed to help pilots improve their stall recovery performance when the current aircraft state may be unrecognized under various complicating operational factors. Candidate guidance algorithms were connected to the split-cue pitch and roll flight directors that are standard on large transport commercial aircraft. A new thrust guidance algorithm and cue was also developed to help pilots prevent the combination of excessive thrust and nose-up stabilizer trim. The overall system was designed to reinforce the current FAA recommended stall recovery procedure. A general transport aircraft model, similar to a Boeing 757, with an extended aerodynamic database for improved stall dynamics simulation fidelity was integrated into the Vertical Motion Simulator at NASA Ames Research Center. A detailed study of the guidance system was then conducted across four stall scenarios with 30 commercial and 10 research test pilots, and the results are reported.
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Lowson, Karin; Jenks, Michelle; Filby, Alexandra; Carr, Louise; Campbell, Bruce; Powell, John
2015-06-30
In the UK, NHS hospitals receive large amounts of evidence-based recommendations for care delivery from the National Institute for Health and Care Excellence (NICE) and other organisations. Little is known about how NHS organisations implement such guidance and best practice for doing so. This study was therefore designed to examine the dissemination, decision-making, and monitoring processes for NICE interventional procedures (IP) guidance and to investigate the barriers and enablers to the implementation of such guidance. A cross-sectional survey questionnaire was developed and distributed to individuals responsible for managing the processes around NICE guidance in all 181 acute NHS hospitals in England, Scotland, Wales and Northern Ireland. A review of acute NHS hospital policies for implementing NICE guidance was also undertaken using information available in the public domain and from organisations' websites. The response rate to the survey was 75 % with 135 completed surveys received. Additionally, policies from 25 % of acute NHS hospitals were identified and analysed. NHS acute hospitals typically had detailed processes in place to implement NICE guidance, although organisations recognised barriers to implementation including organisational process barriers, clinical engagement and poor targeting with a large number of guidance issued. Examples of enablers to, and good practice for, implementation of guidance were found, most notably the value of shared learning experiences between NHS hospitals. Implications for NICE were also identified. These included making improvements to the layout of guidance, signposting on the website and making better use of their shared learning platform. Most organisations have robust processes in place to deal with implementing guidance. However, resource limitations and the scope of guidance received by organisations create barriers relating to organisational processes, clinician engagement and financing of new procedures
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Atkinson, Thomas M; Mendoza, Tito R; Sit, Laura; Passik, Steven; Scher, Howard I; Cleeland, Charles; Basch, Ethan
2010-03-01
In 2006, the United States Food and Drug Administration (FDA) released a draft Guidance for Industry on the use of patient-reported outcomes (PRO) Measures in Medical Product Development to Support Labeling Claims. This draft guidance outlines psychometric aspects that should be considered when designing a PRO measure, including conceptual framework, content validity, construct validity, reliability, and the ability to detect clinically meaningful score changes. When finalized, it may provide a blueprint for evaluations of PRO measures that can be considered by sponsors and investigators involved in PRO research and drug registration trials. In this review we examine the short form of the Brief Pain Inventory (BPI) and particularly the "pain at its worst in the last 24 hours" item in the context of the FDA draft guidance, to assess its utility in clinical trials that include pain as a PRO endpoint. After a systematic evaluation of the psychometric aspects of the BPI, we conclude that the BPI and its "pain at its worst in the last 24 hours" item generically satisfy most key recommendations outlined in the draft guidance for assessing a pain-reduction treatment effect. Nonetheless, when the BPI is being considered for assessment of pain endpoints in a registration trial, sponsors and investigators should consult with the appropriate FDA division early during research design to discuss whether there is sufficient precedent to use the instrument in the population of interest or whether additional evaluations of measurement properties are advisable.
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Code of Federal Regulations, 2014 CFR
2014-10-01
... 49 Transportation 4 2014-10-01 2014-10-01 false Draft system. 229.61 Section 229.61 Transportation... TRANSPORTATION RAILROAD LOCOMOTIVE SAFETY STANDARDS Safety Requirements Draft System § 229.61 Draft system. (a) A... absorbed by friction devices or draft gears that exceeds one-half inches. (5) A broken or cracked coupler...
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Code of Federal Regulations, 2012 CFR
2012-10-01
... 49 Transportation 4 2012-10-01 2012-10-01 false Draft system. 229.61 Section 229.61 Transportation... TRANSPORTATION RAILROAD LOCOMOTIVE SAFETY STANDARDS Safety Requirements Draft System § 229.61 Draft system. (a) A... absorbed by friction devices or draft gears that exceeds one-half inches. (5) A broken or cracked coupler...
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Code of Federal Regulations, 2013 CFR
2013-10-01
... 49 Transportation 4 2013-10-01 2013-10-01 false Draft system. 229.61 Section 229.61 Transportation... TRANSPORTATION RAILROAD LOCOMOTIVE SAFETY STANDARDS Safety Requirements Draft System § 229.61 Draft system. (a) A... absorbed by friction devices or draft gears that exceeds one-half inches. (5) A broken or cracked coupler...
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ASCCP Colposcopy Standards: Colposcopy Quality Improvement Recommendations for the United States.
Mayeaux, Edward J; Novetsky, Akiva P; Chelmow, David; Garcia, Francisco; Choma, Kim; Liu, Angela H; Papasozomenos, Theognosia; Einstein, Mark H; Massad, L Stewart; Wentzensen, Nicolas; Waxman, Alan G; Conageski, Christine; Khan, Michelle J; Huh, Warner K
2017-10-01
The American Society for Colposcopy and Cervical Pathology (ASCCP) Colposcopy Standards recommendations address the role of and approach to colposcopy and biopsy for cervical cancer prevention in the United States. The recommendations were developed by an expert working group appointed by ASCCP's Board of Directors. The ASCCP Quality Improvement Working Group developed evidence-based guidelines to promote best practices and reduce errors in colposcopy and recommended indicators to measure colposcopy quality. The working group performed a systematic review of existing major society and national guidelines and quality indicators. An initial list of potential quality indicators was developed and refined through successive iterative discussions, and draft quality indicators were proposed. The draft recommendations were then reviewed and commented on by the entire Colposcopy Standards Committee, posted online for public comment, and presented at the International Federation for Cervical Pathology and Colposcopy 2017 World Congress for further comment. All comments were considered, additional adjustments made, and the final recommendations approved by the entire Task Force. Eleven quality indicators were selected spanning documentation, biopsy protocols, and time intervals between index screening tests and completion of diagnostic evaluation. The proposed quality indicators are intended to serve as a starting point for quality improvement in colposcopy at a time when colposcopy volume is decreasing and individual procedures are becoming technically more difficult to perform.
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Code of Federal Regulations, 2014 CFR
2014-07-01
... 32 National Defense 6 2014-07-01 2014-07-01 false Draft EIS. 989.19 Section 989.19 National... ENVIRONMENTAL IMPACT ANALYSIS PROCESS (EIAP) § 989.19 Draft EIS. (a) Preliminary draft. The EPF supports the proponent in preparation of a preliminary draft EIS (PDEIS) (40 CFR 1502.9) based on the scope of issues...
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Code of Federal Regulations, 2012 CFR
2012-07-01
... 32 National Defense 6 2012-07-01 2012-07-01 false Draft EIS. 989.19 Section 989.19 National... ENVIRONMENTAL IMPACT ANALYSIS PROCESS (EIAP) § 989.19 Draft EIS. (a) Preliminary draft. The EPF supports the proponent in preparation of a preliminary draft EIS (PDEIS) (40 CFR 1502.9) based on the scope of issues...
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Code of Federal Regulations, 2013 CFR
2013-07-01
... 32 National Defense 6 2013-07-01 2013-07-01 false Draft EIS. 989.19 Section 989.19 National... ENVIRONMENTAL IMPACT ANALYSIS PROCESS (EIAP) § 989.19 Draft EIS. (a) Preliminary draft. The EPF supports the proponent in preparation of a preliminary draft EIS (PDEIS) (40 CFR 1502.9) based on the scope of issues...
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Mechnical Drawing/Drafting Curriculum Guide.
ERIC Educational Resources Information Center
Gregory, Margaret R.; Benson, Robert T.
This curriculum guide consists of materials for teaching a course in mechanical drawing and drafting. Addressed in the individual units of the guide are the following topics: the nature and scope of drawing and drafting, visualization and spatial relationships, drafting tools and materials, linework, freehand lettering, geometric construction,…
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Implementing AORN recommended practices for a safe environment of care.
Hughes, Antonia B
2013-08-01
Providing a safe environment for every patient undergoing a surgical or other invasive procedure is imperative. AORN's "Recommended practices for a safe environment of care" provides guidance on a wide range of topics related to the safety of perioperative patients and health care personnel. The recommendations are intended to provide guidance for establishing best practices and implementing safety measures in all perioperative practice settings. Perioperative nurses should be aware of risks related to musculoskeletal injuries, fire, equipment, latex, and chemicals, among others, and understand strategies for reducing the risks. Evidence-based recommendations can give practitioners the tools to guide safe practice. Copyright © 2013 AORN, Inc. Published by Elsevier Inc. All rights reserved.
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-11-27
...), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-8465. SUPPLEMENTARY... in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be...
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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.
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-06-08
... has been proposed by these two agencies to address emergency planning and preparedness for Nuclear..., to measure the adequacy of emergency preparedness plans of Nuclear Power Plant (NPP) owners and... changes proposed in FEMA's draft Radiological Emergency Preparedness Program Manual and Supplement 4 to...
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Chapter 10: Management recommendations
Deborah M. Finch; Janie Agyagos; Tracy McCarthey; Robert M. Marshall; Scott H. Stoleson; Mary J. Whitfield
2000-01-01
This chapter was developed over a series of meetings using a group-consensus process. Our recommendations are based on published results, on information compiled in the previous chapters, on expert opinion, and on unpublished data of conservation team members. This chapter is available as temporary guidance until the Recovery Plan for the southwestern willow flycatcher...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-16
... Availability of Draft Resource Management Plan and Draft Environmental Impact Statement for the Kremmling Field... Management Act of 1976 (FLPMA), as amended, the Bureau of Land Management (BLM) has prepared a Draft Resource... alternatives for future [[Page 57760
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The need for national mandatory guidance on CSTDs.
Meade, Elizabeth; Simons, Alison; Toland, Samantha
2017-09-06
Closed system transfer devices play a vital role in reducing health professionals' risk of exposure to hazardous drugs. Although recommended as a first line of defence against contamination, they are not widely used. Clear mandatory national guidance is needed to address this.
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Automatic draft reading based on image processing
NASA Astrophysics Data System (ADS)
Tsujii, Takahiro; Yoshida, Hiromi; Iiguni, Youji
2016-10-01
In marine transportation, a draft survey is a means to determine the quantity of bulk cargo. Automatic draft reading based on computer image processing has been proposed. However, the conventional draft mark segmentation may fail when the video sequence has many other regions than draft marks and a hull, and the estimated waterline is inherently higher than the true one. To solve these problems, we propose an automatic draft reading method that uses morphological operations to detect draft marks and estimate the waterline for every frame with Canny edge detection and a robust estimation. Moreover, we emulate surveyors' draft reading process for getting the understanding of a shipper and a receiver. In an experiment in a towing tank, the draft reading error of the proposed method was <1 cm, showing the advantage of the proposed method. It is also shown that accurate draft reading has been achieved in a real-world scene.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-11-07
... and Radiological Health (CDRH) guidance documents is available at http://www.fda.gov/MedicalDevices... ``De Novo Classification Process (Evaluation of Automatic Class III Designation)'' from CDRH you may...
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Updated recommendations for isolation of persons with mumps.
2008-10-10
Mumps, an acute vaccine-preventable viral illness transmitted by respiratory droplets and saliva, has an incubation period most commonly of 16-18 days. The classic clinical presentation of mumps is parotitis, which can be preceded by several days of nonspecific prodromal symptoms; however, mumps also can be asymptomatic, especially in young children. Mumps transmission can occur from persons with subclinical or clinical infections and during the prodromal or symptomatic phases of illness. In 2006, during a mumps resurgence in the United States, the latest national recommendations from CDC and the American Academy of Pediatrics (AAP) stipulated that persons with mumps be maintained in isolation with standard precautions and droplet precautions for 9 days after onset of parotitis. However, the existence of conflicting guidance (i.e., that the infectious period of mumps extended through the fourth day after parotitis onset) led to confusion regarding the appropriate length of isolation. In addition, during the 2006 resurgence, compliance with recommendations for isolation in university settings was substantially lower for 9 days (65%) compared with 4-5 days (86%). In 2007, after a review of the evidence supporting the 9-day isolation guidance by AAP and CDC, AAP changed its isolation guidance for health-care workers in ambulatory settings from 9 days to 5 days. In February 2008, after review of data on mumps in health-care settings, mumps viral load, and mumps virus isolation, the Healthcare Infection Control Practices Advisory Committee (HICPAC) approved changes in its recommendations related to mumps in in-patient settings. As a result, CDC, AAP, and HICPAC all now recommend a 5-day period after onset of parotitis, both for isolation of persons with mumps in either community or health-care settings and for use of standard precautions and droplet precautions. This report summarizes the scientific basis for these changes in mumps isolation guidance.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-06-14
... Nanotechnology; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and... ``Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology''. This guidance is... nanomaterials or otherwise involve the application of nanotechnology. The points to consider are intended to be...
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[Function of the present systematic evaluation in establishment of guidance for clinical practice].
Yang, Jin-Hong; Hu, Jing; Yang, Feng-Chun; Zhang, Ning; Wang, Bing; Li, Xin
2012-07-01
Treatment of insomnia with acupuncture is taken as an example to explore the significance and problems existed in the present systematic evaluation in establishment of guidance for clinical practice. Fifteen articles on systematic evaluation of both English and Chinese were retrieved and studied carefully, their basic information was analyzed. Through study on the establishing process of the guidance of clinical practice, researches were focused on the possible significance of the articles to the guidance as well as the notes in the reuse of those articles since problem still existed. It is held that the systematic evaluation has great significance on the establishment of the guidance from the aspects of applicable people, recommended standards of diagnosis and therapeutic evaluation, extended recommendation and methodology. Great importance should also be attached to the direct application of the research result and understanding of the evaluation result. The data should be rechecked when necessary. Great guiding function can be found on the systematic evaluation of articles to the guidance. Moreover, if information needed to be taken into a full play, specific analysis should also be done on the concrete research targets.
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Nogawa, Kazuhiro; Kojimahara, Noriko
2018-05-31
We conducted a systematic review to determine whether work accommodation at the time of return-to-work (RTW) following a period of sick leave would improve work-related outcomes. Using a Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach, we developed recommendations applicable to the field of occupational health in Japan. We approached our review question for "Evidence-based Return-to-work Guidance in Occupational Health 2017 (RTW 2017) " using a PICO framework (P: workers on sick leave; I: work accommodation; C: usual care; O: improvement of work-related outcomes, such as shortened sick leave period or lower rate of sick leave recurrence). To identify relevant intervention studies about work accommodation at the time of RTW, for example, modified work or partial RTW, we searched Cochrane Library, PubMed, and ICHUSHI Web using keywords/phrases such as workplace accommodation, partial RTW, rehabilitation, and modified work. Although we found no systematic reviews, we did identify 632 randomized controlled trials and cohort studies. Two researchers screened them independently using selection and exclusion criteria defined by the RTW guidance committee in the scope. For intervention studies, we extracted PICO and evaluated risk of bias using RevMan 5.3. For cohort studies, we applied the Newcastle-Ottawa scale for evaluation of risk of bias. We then evaluated the body of evidence based on risk of bias, indirectness, inconsistency, imprecision, and publication bias using GRADEPro GDT. Finally, we adopted Evidence to Decision from GRADE and developed recommendations based on anonymous panels' votes. We identified three relevant studies, which were one randomized controlled trial and two cohort studies, on Partial RTW or modified work for musculoskeletal disorders. Although we could not conduct a meta-analysis, our qualitative systematic review of these studies led us to conclude that partial RTW could shorten the period of sick leave
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-04-02
... Management Plan (EIS/GMP) for Fort Raleigh National Historic Site, North Carolina. The draft describes and... announce the dates, times, and locations of public meetings on the draft EIS/GMP through the NPS Planning... delivery to the above address. Electronic copies of the Draft EIS/GMP will be available online at http...
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Do Community Recommendations Improve Metadata?
NASA Astrophysics Data System (ADS)
Gordon, S.; Habermann, T.; Jones, M. B.; Leinfelder, B.; Mecum, B.; Powers, L. A.; Slaughter, P.
2016-12-01
Complete documentation of scientific data is the surest way to facilitate discovery and reuse. What is complete metadata? There are many metadata recommendations from communities like the OGC, FGDC, NASA, and LTER, that can provide data documentation guidance for discovery, access, use and understanding. Often, the recommendations that communities develop are for a particular metadata dialect. Two examples of this are the LTER Completeness recommendation for EML and the FGDC Data Discovery recommendation for CSDGM. Can community adoption of a recommendation ensure that what is included in the metadata is understandable to the scientific community and beyond? By applying quantitative analysis to different LTER and USGS metadata collections in DataOne and ScienceBase, we show that community recommendations can improve the completeness of collections over time. Additionally, by comparing communities in DataOne that use the EML and CSDGM dialects, but have not adopted the recommendations to the communities that have, the positive effects of recommendation adoption on documentation completeness can be measured.
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Draft PSD Guidance for Impacts of the North County Resource Recovery PSD Remand
This document may be of assistance in applying the New Source Review (NSR) air permitting regulations including the Prevention of Significant Deterioration (PSD) requirements. This document is part of the NSR Policy and Guidance Database. Some documents in the database are a scanned or retyped version of a paper photocopy of the original. Although we have taken considerable effort to quality assure the documents, some may contain typographical errors. Contact the office that issued the document if you need a copy of the original.
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Report of Programme Commission II (Natural Sciences), Annex - Recommendations.
ERIC Educational Resources Information Center
United Nations Educational, Scientific, and Cultural Organization, Paris (France). General Conference.
As the second part of the report of the Programme Commission II, a summary of recommendations on plans for natural sciences and their applications is presented in this document. Resolutions and budgetary appropriations are two major concerns in the document. The topics are related to the 1973-74 draft program and budget, the 1973-78 draft…
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-11-28
... recommendations for studies to establish the performance characteristics of in vitro diagnostic devices (IVDs... issuing this guidance to provide industry and Agency staff with recommendations for studies to establish...
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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…
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This document describes the updated draft testing protocol recommended by the EPA to support the registration of copper-containing surface products (such as door knobs, or other items that are not intended for food contact) that bear sanitizer claims.
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Overcoming Consumer Inertia to Dietary Guidance12
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
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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
...-847-8149 to receive a hard copy. Please use the document number (1607). CDRH maintains an entry on the... personal computer with Internet access. Updated on a regular basis, the CDRH home page includes device... capability for all CDRH guidance documents is available at http://www.fda.gov/medicaldevices...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-10-01
... kind of omissions that can lead to a refuse-to-receive determination. The guidance is intended to... unless it contains the information required under section 505(j) of the Federal Food, Drug, and Cosmetic...
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Code of Federal Regulations, 2011 CFR
2011-01-01
... 10 Energy 2 2011-01-01 2011-01-01 false Distribution of draft environmental impact statement and supplement to draft environmental impact statement; news releases. 51.74 Section 51.74 Energy NUCLEAR... environmental impact statement; news releases. (a) A copy of the draft environmental impact statement will be...
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Code of Federal Regulations, 2012 CFR
2012-01-01
... 10 Energy 2 2012-01-01 2012-01-01 false Distribution of draft environmental impact statement and supplement to draft environmental impact statement; news releases. 51.74 Section 51.74 Energy NUCLEAR... environmental impact statement; news releases. (a) A copy of the draft environmental impact statement will be...
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Code of Federal Regulations, 2014 CFR
2014-01-01
... 10 Energy 2 2014-01-01 2014-01-01 false Distribution of draft environmental impact statement and supplement to draft environmental impact statement; news releases. 51.74 Section 51.74 Energy NUCLEAR... environmental impact statement; news releases. (a) A copy of the draft environmental impact statement will be...
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Code of Federal Regulations, 2013 CFR
2013-01-01
... 10 Energy 2 2013-01-01 2013-01-01 false Distribution of draft environmental impact statement and supplement to draft environmental impact statement; news releases. 51.74 Section 51.74 Energy NUCLEAR... environmental impact statement; news releases. (a) A copy of the draft environmental impact statement will be...
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Code of Federal Regulations, 2010 CFR
2010-01-01
... 10 Energy 2 2010-01-01 2010-01-01 false Distribution of draft environmental impact statement and supplement to draft environmental impact statement; news releases. 51.74 Section 51.74 Energy NUCLEAR... environmental impact statement; news releases. (a) A copy of the draft environmental impact statement will be...
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EPA guidance on cultural competence training.
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. Copyright © 2015 Elsevier Masson SAS. All rights reserved.
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ERIC Educational Resources Information Center
Ozkan, Aysen; Yildirim, Kemal
2016-01-01
Problem Statement: Drafting course is essential for students in the design disciplines for becoming more organized and for complying with standards in the educational system. Drafting knowledge is crucial, both for comprehension of the issues and for the implementation phase. In any design project, drafting performance and success are as important…
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Towards viable, useful and usable human factors design guidance.
Burns, C M; Vicente, K J; Christoffersen, K; Pawlak, W S
1997-01-01
This paper investigates the factors relevant to producing effective human factors design guidance, using the Engineering Data Compendium (EDC) as a research vehicle. A series of three exploratory experiments focusing on the factors that affect the usability, usefulness and viability of human factors handbooks was conducted. The results of these studies were interpreted in the context of the process by which the EDC was developed, leading to the following recommendations: (a) human factors guidance should be organized in a manner that is stepped in context; (b) human factors guidance should be based on an explicit requirements analysis; (c) the calibration of designers' perceptions of the cost of obtaining human factors information must be improved; (d) organizational policies must be changed to induce more effective information search behaviour.
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Competency Reference for Computer Assisted Drafting.
ERIC Educational Resources Information Center
Oregon State Dept. of Education, Salem. Div. of Vocational Technical Education.
This guide, developed in Oregon, lists competencies essential for students in computer-assisted drafting (CAD). Competencies are organized in eight categories: computer hardware, file usage and manipulation, basic drafting techniques, mechanical drafting, specialty disciplines, three dimensional drawing/design, plotting/printing, and advanced CAD.…
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Articulated Instruction Objectives Guide for Drafting. Final Document for Articulation of Drafting.
ERIC Educational Resources Information Center
Henderson, Wm. Edward, Jr.
Intended for use in competency-based and criterion-referenced vocational programs, this articulated, performance-based instruction objectives guide for Drafting I is designed for reference use in the articulation of drafting programs at the secondary and postsecondary levels. It consists of a description of the development of the guide, 14…
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-05-05
...] Guidance for Industry on Documenting Statistical Analysis Programs and Data Files; Availability AGENCY... Programs and Data Files.'' This guidance is provided to inform study statisticians of recommendations for documenting statistical analyses and data files submitted to the Center for Veterinary Medicine (CVM) for the...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-07-01
...Pursuant to the Resources and Ecosystems Sustainability, Tourist Opportunities, and Revived Economies of the Gulf States Act (RESTORE Act), the Secretary of Commerce, as Chair of the Gulf Coast Ecosystem Restoration Council (Council), announces the extension of the public comment period for the Draft Initial Comprehensive Plan (Draft Plan) to restore and protect the Gulf Coast region and the Draft Programmatic Environmental Assessment (Draft PEA) for the Draft Plan. Council Members also have compiled preliminary lists of ecosystem restoration projects that are ``authorized but not yet commenced'' and the full Council is in the process of evaluating these lists; the Council announces the availability of these preliminary lists. If you previously submitted comments, please do not resubmit them because the Council has already incorporated them into the public record and will fully consider them.
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32 CFR Appendix A to Part 152 - Guidance to the Joint Service Committee (JSCA)
Code of Federal Regulations, 2010 CFR
2010-07-01
... to the Code Committee established by Article 146 of the UCMJ, with an invitation to submit comments. (4) The draft of the annual review shall set forth any specific recommendations for changes to the... Committee for its consideration under Article 146, UCMJ. (d) Public Notice and Meeting. (1) Proposals to...
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46 CFR 151.03-35 - Limiting draft.
Code of Federal Regulations, 2010 CFR
2010-10-01
... 46 Shipping 5 2010-10-01 2010-10-01 false Limiting draft. 151.03-35 Section 151.03-35 Shipping... BULK LIQUID HAZARDOUS MATERIAL CARGOES Definitions § 151.03-35 Limiting draft. Maximum allowable draft to which a barge may be loaded. Limiting draft is a function of hull type and cargo specific gravity...
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46 CFR 151.03-35 - Limiting draft.
Code of Federal Regulations, 2012 CFR
2012-10-01
... 46 Shipping 5 2012-10-01 2012-10-01 false Limiting draft. 151.03-35 Section 151.03-35 Shipping... BULK LIQUID HAZARDOUS MATERIAL CARGOES Definitions § 151.03-35 Limiting draft. Maximum allowable draft to which a barge may be loaded. Limiting draft is a function of hull type and cargo specific gravity...
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46 CFR 151.03-35 - Limiting draft.
Code of Federal Regulations, 2013 CFR
2013-10-01
... 46 Shipping 5 2013-10-01 2013-10-01 false Limiting draft. 151.03-35 Section 151.03-35 Shipping... BULK LIQUID HAZARDOUS MATERIAL CARGOES Definitions § 151.03-35 Limiting draft. Maximum allowable draft to which a barge may be loaded. Limiting draft is a function of hull type and cargo specific gravity...