Sample records for draft guidance document
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76 FR 36542 - Draft Guidance for Industry and Food and Drug Administration Staff: The Content of...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...The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled ``Draft Guidance for Industry and Food and Drug Administration Staff: The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Low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 This draft guidance document provides industry and Agency staff with recommendations that are intended to improve the safety and effectiveness of LGS Device Systems. This draft guidance is not final nor is it in effect at this time.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
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 availability of a draft guidance entitled ``Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Yersinia Species Detection.'' This draft guidance document describes a means by which in vitro...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
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 Draft Guidance for Industry on Electronic Source Documentation in Clinical Investigations; Availability...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76 FR 76166 - Draft Guidance for Industry and Food and Drug Administration Staff; the Content of...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...The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled ``Draft Guidance for Industry and FDA Staff: The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device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 This draft guidance document provides industry and the Agency staff with guidelines for developing premarket submissions for artificial pancreas device systems, in particular, the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 This draft guidance is not final nor is it in effect at this time.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
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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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
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
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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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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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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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
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
2010-07-28
... 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
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
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
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
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
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
2011-08-15
... 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
2011-09-07
... 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
2010-04-26
...] 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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Chimonas, Susan; Rothman, David J
2005-01-01
In October 2002 the federal government issued a draft "Compliance Program Guidance for Pharmaceutical Manufacturers." The draft Guidance questioned the legality of many arrangements heretofore left to the discretion of physicians and drug companies, including industry-funded educational and research grants, consultantcies, and gifts. Medical organizations and drug manufacturers proposed major revisions to the draft, arguing that current practices were in everyone's best interest. To evaluate the impact of their responses, we compare the draft, the changes requested by industry and organized medicine, and the final Guidance document (issued in April 2003). We also explore the implications--some intended, others unanticipated--of the final document.
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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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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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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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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
2011-06-29
...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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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
2013-07-24
... 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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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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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
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
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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Draft federal GHG accounting and reporting : technical support document
DOT National Transportation Integrated Search
2010-07-01
This is a technical support document (TSD) that accompanies the Federal Greenhouse Gas Accounting and Reporting Guidance (or Guidance). This document provides detailed information on the inventory reporting process and accepted calculation methodolog...
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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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Federal Register 2010, 2011, 2012, 2013, 2014
2013-05-17
... availability of the draft guidance entitled ``Center for Devices and Radiological Health (CDRH) Appeals Processes: Questions and Answers About 517A.'' This draft document provides CDRH's proposed interpretation... decisions and actions taken by CDRH. 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
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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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
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
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
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
2011-10-26
.../DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm253101.htm , http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm , or http...
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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
2012-09-17
... 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
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
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
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
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
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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Federal Register 2010, 2011, 2012, 2013, 2014
2010-09-03
... guidance document, and pilot monitoring study can be directed to Mr. Nealson Watkins at 919-541-5522 or watkins[email protected] . Availability of Meeting Materials: The EPA draft guidance documents are posted...
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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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Federal Register 2010, 2011, 2012, 2013, 2014
2013-08-07
...-related bloodstream infections, febrile neutropenia, gonorrhea, Lyme disease, streptococcal pharyngitis...--Developing Antimicrobial Drugs for Treatment''--issued July 1998. 9. ``Streptococcal Pharyngitis and...
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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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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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Federal Register 2010, 2011, 2012, 2013, 2014
2011-05-25
... Proposed Rule on Enhanced Weapons, Firearms Background Checks, and Security Event Notifications AGENCY... the proposed enhanced weapons rule, the two draft regulatory guides, and the draft weapons safety.... No formal comments on the proposed enhanced weapons rule or the draft guidance documents will be...
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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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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
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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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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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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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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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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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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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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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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Federal Register 2010, 2011, 2012, 2013, 2014
2011-11-08
... for Devices and Radiological Health (CDRH) guidance documents is available at http://www.fda.gov...'' from CDRH, you may either send an email request to [email protected] to receive an electronic copy of...
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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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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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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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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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[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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Comments on the Draft Permit for Conoco Coker and Sulfur Recovery
This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Policy and Guidance Database available at www2.epa.gov/title-v-operating-permits/title-v-operating-permit-policy-and-guidance-document-index. Some documents in the database are a scanned or retyped version of a paper photocopy of the original. Although we have taken considerable effort to quality assure the documents, some may contain typographical errors. Contact the office that issued the document if you need a copy of the original.
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-01-14
... section. This document corrects that error. FOR FURTHER INFORMATION CONTACT: May Nelson, Center for...-1717, May.Nelson@fda.hhs.gov . SUPPLEMENTARY INFORMATION: In FR Doc. E9-30657, appearing on page 68629...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-09-13
... Level for Arsenic in Apple Juice; A Quantitative Assessment of Inorganic Arsenic in Apple Juice... Juice,'' and a risk assessment document entitled ``A Quantitative Assessment of Inorganic Arsenic in...
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The purpose of this presentation is to present an overview of the quality control (QC) sections of a draft EPA document entitled, "Quality Assurance/Quality Control Guidance for Laboratories Performing PCR Analyses on Environmental Samples." This document has been prepared by th...
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75 FR 54627 - Best Management Practices for Unused Pharmaceuticals at Health Care Facilities
Federal Register 2010, 2011, 2012, 2013, 2014
2010-09-08
... at Health Care Facilities AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: EPA... Unused Pharmaceuticals at Health Care Facilities. The guidance is targeted at hospitals, medical clinics... drafted a guidance document for health care facilities, which describes: Techniques for reducing or...
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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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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
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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76 FR 59406 - Anti-Infective Drugs Advisory Committee; Notice of Meeting
Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-26
... development of antibacterials for the treatment of community-acquired bacterial pneumonia and the draft document entitled ``Guidance for Industry: Community-Acquired Bacterial Pneumonia: Developing Drugs for...
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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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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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VERTICAL PROFILING OF VOCS IN GROUNDWATER AND SOIL VAPORS TO EVALUATE THE RISK OF VAPOR INTRUSION
The Draft EPA Subsurface Vapor Intrusion Guidance Document was established to address the incremental increases in exposures and risks from subsurface contaminants that may be intruding into indoor air@. The document utilizes attenuation factors based on indoor air/soil gas or i...
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The Draft EPA Subsurface Vapor Intrusion Guidance Document was established to "address the incremental increases in exposures and risks from subsurface contaminants that my be intruding into indoor air". The document utilizes attenuation factors based on indoor air/soil gas or i...
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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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DOE Office of Scientific and Technical Information (OSTI.GOV)
Not Available
The Environmental Engineering Committee conducted a preliminary review of the above document in March 1986, and identified obvious errors or omissions which are explained in detail in its initial report. The Office of Solid Waste asked the Committee to review the final draft ACL guidance when it was ready for publications in the Federal Register. This report represents the Committee's review of the final draft which was found to be well-written and technically sound.
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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
2011-07-27
.... In August 2010, the Center for Devices and Radiological Health (CDRH) published two documents in.... These documents are titled ``CDRH Preliminary Internal Evaluations--Volume I: 510(k) Working Group Preliminary Report and Recommendations'' and ``CDRH Preliminary Internal Evaluations--Volume II: Task Force on...
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DOD Information Technology Standard Guidance (ITSG) Version 3.1
1997-04-07
from NGSBs later (e.g., OSFs Motif specification became the basis for IEEE 1295 . 1). Most consortia specifications are available now, do not overlap...Illumination) CIM Center for Information Management (DISA) CINC Conumnder in Chief CIS CASE Integration Services CJCS Chairman of the Joint Chiefs of...Compound Text Encoding CUA Common User Access DAC Discretionary Access Controls DAD Draft Addendum (ISO) DAM Draft Amendment (ISO) DAP Document
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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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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
2010-04-29
... request, or fax your request to CDRH to 301-847-8149. See the SUPPLEMENTARY INFORMATION section for... capability for all CDRH guidance documents is available at http://www.fda.gov/MedicalDevices/Device... Responses Response Total hours CDRH 3601 110 1 110 2 220 CBER 3601 4 1 4 2 8 Total Hours 228 \\1\\ There are...
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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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78 FR 48696 - Draft Revisions to the Marine Safety Manual, Volume III, Chapters 20-26
Federal Register 2010, 2011, 2012, 2013, 2014
2013-08-09
...) Updated provisions for vessel manning, including guidance for the issuing of safe manning documents; (2... Distress and Safety System (GMDSS), and the Principles of Minimum Safe Manning (IMO Resolution A.1047(27...
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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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Comments on the Draft Permit for Conoco Coker and Sulfur Recovery
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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NSR Workshop Manual (DRAFT October 1990)
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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Revised Draft Policy on Permit Modifications and Extensions
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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Federal Register 2010, 2011, 2012, 2013, 2014
2012-11-09
... approaches. The document does not apply to devices that are intended to screen donors of blood and blood components, and donors of human cells, tissues, and cellular and tissue-based products for communicable...
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76 FR 59405 - Anti-Infective Drugs Advisory Committee; Notice of Meeting
Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-26
... development of antibacterials for the treatment of hospital-acquired bacterial pneumonia, including ventilator-associated bacterial pneumonia, and the draft document entitled ``Guidance for Industry: Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment...
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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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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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Landfill and Wastewater Treatment RNG Chemical and Physical Profiling: Increasing the Database Set
DOT National Transportation Integrated Search
2011-08-15
The purpose of this USDOT PHMSA sponsored research project was to address the continued development of a draft guidance document for the safe introduction of renewable gas into natural gas pipelines. This project was designed to build upon previous s...
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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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ERIC Educational Resources Information Center
Skalski, Anastasia Kalamaros
2009-01-01
On March 6, 2009, the APA Model Licensure Act Task Force released its second draft of the policy document known as the proposed "Model Act for State Licensure of Psychologists". This policy document serves as guidance to state legislatures for how they should set up their psychology licensing laws. The general expectations promoted in the model…
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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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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
2013-11-06
...] 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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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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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
2012-04-25
...] 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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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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GROUND WATER SAMPLING OF VOCS IN THE WATER/CAPILLARY FRINGE AREA FOR VAPOR INTRUSION ASSESSMENT
Vapor intrusion has recently been considered a major pathway for increased indoor air contamination from certain volatile organic contaminants (VOCs). The recent Draft EPA Subsurface Vapor Intrusion Guidance Document states that ground water samples should be obtained from the u...
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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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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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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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76 FR 66286 - Notice of Final 2010 Effluent Guidelines Program Plan
Federal Register 2010, 2011, 2012, 2013, 2014
2011-10-26
... Coalbed Methane Extraction (CBM) industry and will develop pretreatments requirements for discharges of...) industry. EPA is also issuing the detailed study report for the Coalbed Methane Extraction and the... Methane Point Source Category: Detailed Study Report, EPA-820-R-10-022, DCN 09999; Draft Guidance Document...
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75 FR 67636 - Physical Protection of Shipments of Irradiated Reactor Fuel
Federal Register 2010, 2011, 2012, 2013, 2014
2010-11-03
...-2010-0340; Draft NUREG-0561, Revision 2] RIN 3150-AI64 Physical Protection of Shipments of Irradiated...- 0561, ``Physical Protection of Shipments of Irradiated Reactor Fuel.'' This document provides guidance to a licensee or applicant for implementation of proposed 10 CFR 73.37, ``Requirements for Physical...
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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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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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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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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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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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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
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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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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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
2013-09-24
...] 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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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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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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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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76 FR 27924 - Draft Regulatory Guide, Guidance for ITAAC Closure
Federal Register 2010, 2011, 2012, 2013, 2014
2011-05-13
... received on or before this date. Although a time limit is given, comments and suggestions in connection... are encouraged at any time. ADDRESSES: Please include Docket ID NRC-2011-0102 in the subject line of... comments to: RADB at 301-492-3446. You can access publicly available documents related to this notice using...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-09-25
... reference existing standard operating procedures (SOPs) or other documents. The draft guidance specifies that a monitoring plan may reference existing policies and procedures in order to minimize the burden... risk device studies are already required under Sec. 812.25(e) to submit and maintain written procedures...
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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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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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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
2012-02-23
...] 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
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
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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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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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
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
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
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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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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Federal Register 2010, 2011, 2012, 2013, 2014
2010-02-26
... the drug development process, it is particularly important to protect study blinding of an adaptive...) and including a description of the responsibilities of each entity involved in the process. Based on... that each SOP will take approximately 30 minutes to document and maintain. B. Perform Simulations and...
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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
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
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
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
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
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
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
2013-11-20
... 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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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
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
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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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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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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DOE Office of Scientific and Technical Information (OSTI.GOV)
Coleman, Justin Leigh; Kammerer, Annie M.; Whittaker, Andrew S.
Over the last decade, particularly since implementation of the certified design regulatory approaches outlined in 10 CFR 52, “Licenses, Certifications, and Approvals for Nuclear Power Plants,” interest has been increasing in the use of seismic isolation (SI) technology to support seismic safety in nuclear facilities. In 2009, the United States (U.S.) Nuclear Regulatory Commission (NRC) initiated research activities to develop new guidance targeted at isolated facilities because SI is being considered for nuclear power plants in the U.S. One product of that research, which was developed around a risk-informed regulatory approach, is a draft NRC NUREG series (NUREG/CR) report thatmore » investigates and discusses considerations for use of SI in otherwise traditionally founded large light water reactors (LWRs). A coordinated effort led to new provisions for SI of LWRs in the American Society of Civil Engineers standard ASCE/SEI 4-16, “Seismic Analysis of Safety Related Nuclear Structures.” The risk-informed design philosophy that underpinned development of the technical basis for these documents led to a set of proposed performance objectives and acceptance criteria intended to serve as the foundation for future NRC guidance on the use of SI and related technology. Although the guidance provided in the draft SI NUREG/CR report and ASCE/SEI 4 16 provides a sound basis for further development of nuclear power plant designs incorporating SI, these initial documents were focused on surface-founded or near-surface-founded LWRs and were, necessarily, limited in scope. For example, there is limited information in both the draft NUREG/CR report and ASCE/SEI 4-16 related to nonlinear analysis of soil-structure systems for deeply-embedded reactors, the isolation of components, and the use of vertical isolation systems. Also not included in the draft SI NUREG/CR report are special considerations for licensing of isolated facilities using the certified design approach in 10 CFR 52 and a detailed discussion of seismic probabilistic risk assessments for isolated facilities.« less
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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
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
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
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
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
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
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
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
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
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
2013-11-20
...] 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
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
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
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
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
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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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
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
2013-12-10
... Materials in Accordance With Draft Guidance for Industry on Providing Postmarket Periodic Safety Reports in... periodic safety reports as described in the guidance entitled ``Periodic Benefit-Risk Evaluation Report... described in the draft guidance entitled ``Providing Postmarket Periodic Safety Reports in the ICH E2C(R2...
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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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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
2010-12-16
... 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
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
2013-06-26
... 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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Flight Simulation Model Exchange. Volume 1
NASA Technical Reports Server (NTRS)
Murri, Daniel G.; Jackson, E. Bruce
2011-01-01
The NASA Engineering and Safety Center Review Board sponsored an assessment of the draft Standard, Flight Dynamics Model Exchange Standard, BSR/ANSI-S-119-201x (S-119) that was conducted by simulation and guidance, navigation, and control engineers from several NASA Centers. The assessment team reviewed the conventions and formats spelled out in the draft Standard and the actual implementation of two example aerodynamic models (a subsonic F-16 and the HL-20 lifting body) encoded in the Extensible Markup Language grammar. During the implementation, the team kept records of lessons learned and provided feedback to the American Institute of Aeronautics and Astronautics Modeling and Simulation Technical Committee representative. This document contains the results of the assessment.
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Flight Simulation Model Exchange. Volume 2; Appendices
NASA Technical Reports Server (NTRS)
Murri, Daniel G.; Jackson, E. Bruce
2011-01-01
The NASA Engineering and Safety Center Review Board sponsored an assessment of the draft Standard, Flight Dynamics Model Exchange Standard, BSR/ANSI-S-119-201x (S-119) that was conducted by simulation and guidance, navigation, and control engineers from several NASA Centers. The assessment team reviewed the conventions and formats spelled out in the draft Standard and the actual implementation of two example aerodynamic models (a subsonic F-16 and the HL-20 lifting body) encoded in the Extensible Markup Language grammar. During the implementation, the team kept records of lessons learned and provided feedback to the American Institute of Aeronautics and Astronautics Modeling and Simulation Technical Committee representative. This document contains the appendices to the main report.
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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
2011-08-30
... 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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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
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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2016 United Kingdom national guideline on the sexual health care of men who have sex with men.
Clutterbuck, Dan; Asboe, David; Barber, Tristan; Emerson, Carol; Field, Nigel; Gibson, Stuart; Hughes, Gwenda; Jones, Rachael; Murchie, Martin; Nori, Achyuta V; Rayment, Michael; Sullivan, Ann
2018-01-01
This guideline is intended for use in UK Genitourinary medicine clinics and sexual health services but is likely to be of relevance in all sexual health settings, including general practice and Contraception and Sexual Health (CASH) services, where men who have sex with men (MSM) seek sexual health care or where addressing the sexual health needs of MSM may have public health benefits. For the purposes of this document, MSM includes all gay, bisexual and all other males who have sex with other males and both cis and trans men. This document does not provide guidance on the treatment of particular conditions where this is covered in other British Association for Sexual Health and HIV (BASHH) Guidelines but outlines best practice in multiple aspects of the sexual health care of MSM. Where prevention of sexually transmitted infections including HIV can be addressed as an integral part of clinical care, this is consistent with the concept of combination prevention and is included. The document is designed primarily to provide guidance on the direct clinical care of MSM but also makes reference to the design and delivery of services with the aim of supporting clinicians and commissioners in providing effective services. Methodology This document was produced in accordance with the guidance set out in the BASHH CEG's document 'Framework for guideline development and assessment' published in 2010 at http://www.bashh.org/guidelines and with reference to the Agree II instrument. Following the production of the updated framework in April 2015, the GRADE system for assessing evidence was adopted and the draft recommendations were regraded. Search strategy (see also Appendix 1) Ovid Medline 1946 to December 2014, Medline daily update, Embase 1974 to December 2014, Pubmed NeLH Guidelines Database, Cochrane library from 2000 to December 2014. Search language English only. The search for Section 3 was conducted on PubMed to December 2014. Priority was given to peer-reviewed papers published in scientific journals, although for many issues evidence includes conference abstracts listed on the Embase database. In addition, for 'Identification of problematic recreational drug and alcohol use' section and 'Sexual problems and dysfunctions in MSM' section, searches included PsycINFO. Methods Article titles and abstracts were reviewed and if relevant the full text article was obtained. Priority was given to randomised controlled trial and systematic review evidence, and recommendations made and graded on the basis of best available evidence. Piloting and feedback The first draft of the guideline was circulated to the writing group and to a small group of relevant experts, third sector partners and patient representatives who were invited to comment on the whole document and specifically on particular sections. The revised draft was reviewed by the CEG and then reviewed by the BASHH patient/public panel and posted on the BASHH website for public consultation. The final draft was piloted before publication. Guideline update The guidelines will be reviewed and revised in five years' time, 2022.
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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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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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2006-10-11
This guidance describes how the FDA evaluates patient-reported outcome (PRO) instruments used as effectiveness endpoints in clinical trials. It also describes our current thinking on how sponsors can develop and use study results measured by PRO instruments to support claims in approved product labeling (see appendix point 1). It does not address the use of PRO instruments for purposes beyond evaluation of claims made about a drug or medical product in its labeling. By explicitly addressing the review issues identified in this guidance, sponsors can increase the efficiency of their endpoint discussions with the FDA during the product development process, streamline the FDA's review of PRO endpoint adequacy, and provide optimal information about the patient's perspective of treatment benefit at the time of product approval. A PRO is a measurement of any aspect of a patient's health status that comes directly from the patient (i.e., without the interpretation of the patient's responses by a physician or anyone else). In clinical trials, a PRO instrument can be used to measure the impact of an intervention on one or more aspects of patients' health status, hereafter referred to as PRO concepts, ranging from the purely symptomatic (response of a headache) to more complex concepts (e.g., ability to carry out activities of daily living), to extremely complex concepts such as quality of life, which is widely understood to be a multidomain concept with physical, psychological, and social components. Data generated by a PRO instrument can provide evidence of a treatment benefit from the patient perspective. For this data to be meaningful, however, there should be evidence that the PRO instrument effectively measures the particular concept that is studied. Generally, findings measured by PRO instruments may be used to support claims in approved product labeling if the claims are derived from adequate and well-controlled investigations that use PRO instruments that reliably 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
This guidance describes how the FDA evaluates patient-reported outcome (PRO) instruments used as effectiveness endpoints in clinical trials. It also describes our current thinking on how sponsors can develop and use study results measured by PRO instruments to support claims in approved product labeling (see appendix point 1). It does not address the use of PRO instruments for purposes beyond evaluation of claims made about a drug or medical product in its labeling. By explicitly addressing the review issues identified in this guidance, sponsors can increase the efficiency of their endpoint discussions with the FDA during the product development process, streamline the FDA's review of PRO endpoint adequacy, and provide optimal information about the patient's perspective of treatment benefit at the time of product approval. A PRO is a measurement of any aspect of a patient's health status that comes directly from the patient (i.e., without the interpretation of the patient's responses by a physician or anyone else). In clinical trials, a PRO instrument can be used to measure the impact of an intervention on one or more aspects of patients' health status, hereafter referred to as PRO concepts, ranging from the purely symptomatic (response of a headache) to more complex concepts (e.g., ability to carry out activities of daily living), to extremely complex concepts such as quality of life, which is widely understood to be a multidomain concept with physical, psychological, and social components. Data generated by a PRO instrument can provide evidence of a treatment benefit from the patient perspective. For this data to be meaningful, however, there should be evidence that the PRO instrument effectively measures the particular concept that is studied. Generally, findings measured by PRO instruments may be used to support claims in approved product labeling if the claims are derived from adequate and well-controlled investigations that use PRO instruments that reliably 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
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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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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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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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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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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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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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
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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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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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
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
2012-09-25
... 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
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
2012-12-12
... 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
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
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
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
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
2013-04-08
... 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
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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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
2013-05-31
...] 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
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
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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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
2012-11-06
... 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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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
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
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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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
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
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
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
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
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
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
2011-11-23
... 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
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
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
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
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
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
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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Federal Register 2010, 2011, 2012, 2013, 2014
2013-02-15
...] Accreditation and Reaccreditation Process for Firms Under the Third Party Review Program: Part I; Draft Guidance... announcing the availability of the draft guidance entitled ``Accreditation and Reaccreditation Process for... Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), requires FDA...
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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
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
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
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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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
2013-08-28
... research and marketing applications for medical devices. This draft guidance is not final nor is it in... FDA-regulated products (21 CFR 58.1). The draft guidance provides clarification on GLP terminology, the types of medical device research or marketing applications that are subject to the GLP regulation...
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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
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
2013-12-10
... 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
2011-11-16
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0720...; Draft Guidance on Implementation; Data Elements and Message Specification; Appendix on Backwards and...): Implementation Guide--Data Elements and Message Specification'' (the draft E2B(R3) implementation guidance) and...
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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
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
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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NASA Technical Reports Server (NTRS)
Trahan, W. H.; Odonnell, R. A.; Pietz, K. C.; Drapela, L. J.
1988-01-01
The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA effort first completed an analysis of the Guidance, Navigation, and Control System (GNC) hardware, generating draft failure modes and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. The IOA results were then compared to the NASA FMEA/CIL baseline with proposed Post 51-L updates included. A resolution of each discrepancy from the comparison is provided through additional analysis as required. The results of that comparison for the Orbiter GNC hardware is documented. The IOA product for the GNC analysis consisted of 141 failure mode worksheets that resulted in 24 potential critical items being identified. Comparison was made to the NASA baseline which consisted of 148 FMEAs and 36 CIL items. This comparison produced agreement on all but 56 FMEAs which caused differences in zero CIL items.
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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
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
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
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
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
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
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
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
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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NASA Astrophysics Data System (ADS)
Kondrateva, O. E.; Roslyakov, P. V.; Borovkova, A. M.; Loktionov, O. A.
2017-11-01
Over the past 3 years there have been significant changes in Russian environmental legislation related to the transition to technological regulation based on the principles of the best available technologies (BAT). These changes also imply control and accounting of the harmful impact of industrial enterprises on the environment. Therefore, a mandatory requirement for equipping automatic continuous emission monitoring systems (ACEMS) is established for all large TPPs. For a successful practical solution of the problem of introducing such systems in the whole country there is an urgent need to develop the governing regulatory document for the design and operation of systems for continuous monitoring of TPP emissions into the air, allowing within reasonable limits to unify these systems for their work with the state data fund of state environmental monitoring and make easier the process of their implementation at operating facilities for industrial enterprises. Based on the large amount of research in the field of creation of ACEMS, which conducted in National Research University “MPEI”, a draft guidance document was developed, which includes the following regulatory provisions: goals and objectives of ACEMS, the stages of their introduction rules of carrying out preliminary inspection of energy facilities, requirements to develop technical specifications, general requirements for the operation of ACEMS, requirements to the structure and elements of ACEMS, recommendations on selection of places of measuring equipment installation, rules for execution, commissioning and acceptance testing, continuous measurement method, method for determination of the current gross and specific emissions. The draft guidance document, developed by the National Research University “MPEI”, formed the basis of the Preliminary national standards PNST 187-2017 “Automatic systems for continuous control and metering of contaminants emissions from thermal electric power stations into the atmospheric air. General requirements”. [1
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Ema, Makoto; Fukui, Yoshihiro; Aoyama, Hiroaki; Fujiwara, Michio; Fuji, Junichiro; Inouye, Minoru; Iwase, Takayuki; Kihara, Takahide; Oi, Akihide; Otani, Hiroki; Shinomiya, Mitsuhiro; Sugioka, Kozo; Yamano, Tsunekazu; Yamashita, Keisuke H; Tanimura, Takashi
2007-06-01
In October 2006, a new revision of the draft guideline (OECD Guideline for the Testing of Chemicals, Proposal for a New Guideline 426. Developmental Neurotoxicity Study) and Draft Document of the Retrospective Performance Assessment (RPA) of the Draft Test Guideline 426 on Developmental Neurotoxicity were distributed following incorporation of the results of the Expert Consultation Meeting in Tokyo on May 24-26, 2005. The draft guideline consists of 50 paragraphs and an appendix with 102 references; and the draft RPA consists of 37 paragraphs with 109 references. National coordinators were requested to arrange for national expert reviews of these draft documents in their member countries. Members of the Developmental Neurotoxicology (DNT) Committee of the Japanese Teratology Society (JTS) reviewed, discussed, and commented on the draft Test Guideline Proposal. The DNT Committee of the JTS also commented on the draft document of the RPA. These comments were sent to the OECD Secretariat. The DNT Committee of the JTS expects the comments to be useful for the finalization of these draft documents.
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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
2013-03-11
... 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
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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Engineering Documentation and Data Control
NASA Technical Reports Server (NTRS)
Matteson, Michael J.; Bramley, Craig; Ciaruffoli, Veronica
2001-01-01
Mississippi Space Services (MSS) the facility services contractor for NASA's John C. Stennis Space Center (SSC), is utilizing technology to improve engineering documentation and data control. Two identified improvement areas, labor intensive documentation research and outdated drafting standards, were targeted as top priority. MSS selected AutoManager(R) WorkFlow from Cyco software to manage engineering documentation. The software is currently installed on over 150 desctops. The outdated SSC drafting standard was written for pre-CADD drafting methods, in other words, board drafting. Implementation of COTS software solutions to manage engineering documentation and update the drafting standard resulted in significant increases in productivity by reducing the time spent searching for documents.
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18 CFR 5.24 - Applications not requiring a draft NEPA document.
Code of Federal Regulations, 2013 CFR
2013-04-01
... requiring a draft NEPA document. 5.24 Section 5.24 Conservation of Power and Water Resources FEDERAL ENERGY... APPLICATION PROCESS § 5.24 Applications not requiring a draft NEPA document. (a) If the Commission determines... environmental impact statement and that a draft environmental assessment will not be required, the Commission...
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18 CFR 5.25 - Applications requiring a draft NEPA document.
Code of Federal Regulations, 2012 CFR
2012-04-01
... a draft NEPA document. 5.25 Section 5.25 Conservation of Power and Water Resources FEDERAL ENERGY... APPLICATION PROCESS § 5.25 Applications requiring a draft NEPA document. (a) If the Commission determines that a license application will be processed with an environmental impact statement, or a draft and final...
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18 CFR 5.25 - Applications requiring a draft NEPA document.
Code of Federal Regulations, 2013 CFR
2013-04-01
... a draft NEPA document. 5.25 Section 5.25 Conservation of Power and Water Resources FEDERAL ENERGY... APPLICATION PROCESS § 5.25 Applications requiring a draft NEPA document. (a) If the Commission determines that a license application will be processed with an environmental impact statement, or a draft and final...
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18 CFR 5.24 - Applications not requiring a draft NEPA document.
Code of Federal Regulations, 2012 CFR
2012-04-01
... requiring a draft NEPA document. 5.24 Section 5.24 Conservation of Power and Water Resources FEDERAL ENERGY... APPLICATION PROCESS § 5.24 Applications not requiring a draft NEPA document. (a) If the Commission determines... environmental impact statement and that a draft environmental assessment will not be required, the Commission...
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18 CFR 5.24 - Applications not requiring a draft NEPA document.
Code of Federal Regulations, 2014 CFR
2014-04-01
... requiring a draft NEPA document. 5.24 Section 5.24 Conservation of Power and Water Resources FEDERAL ENERGY... APPLICATION PROCESS § 5.24 Applications not requiring a draft NEPA document. (a) If the Commission determines... environmental impact statement and that a draft environmental assessment will not be required, the Commission...
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18 CFR 5.25 - Applications requiring a draft NEPA document.
Code of Federal Regulations, 2014 CFR
2014-04-01
... a draft NEPA document. 5.25 Section 5.25 Conservation of Power and Water Resources FEDERAL ENERGY... APPLICATION PROCESS § 5.25 Applications requiring a draft NEPA document. (a) If the Commission determines that a license application will be processed with an environmental impact statement, or a draft and final...
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Regulatory assessment of reproductive toxicology data.
Davidson, Elizabeth
2013-01-01
This chapter outlines a regulator's personal approach to the assessment of reproductive toxicology data in the context of the assessment of the overall nonclinical data package for pharmaceutical agents. Using as a framework the International Conference on Harmonisation Common Technical Document headings, guidance is provided on the expectations of regulators for the presentation and discussion of the data by the applicant to facilitate the risk assessment process. Consideration is given to the use of reproductive toxicology data in the assessment process for both clinical trial applications (CTAs) and marketing authorization applications (MAAs). Suggestions for some guiding principles in drafting of the various product information documents (for example the Investigator's Brochure (IB) for CTAs and the Nonclinical Overview and Summary of Product Characteristics for MAAs) are included.
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DEVELOPMENT OF HFE SECTIONS OF DG-1145.
DOE Office of Scientific and Technical Information (OSTI.GOV)
HIGGINS,J.C.; OHARA, J.M.; BONGARRA, J.
2007-03-26
For the licensing of the current fleet of commercial nuclear power plants (NPPs), the Nuclear Regulatory Commission (NRC) used two key documents, NUREG-0800 and Regulatory Guide (RG) 1.70. RG 1.70 provided guidance to applicants on the contents needed in their Safety Analysis Reports (SARs) submitted as part of their application to construct or operate an NPP. NUREG-0800, the NRC Standard Review Plan (SRP), provides guidance to the NRR staff reviewers on performing their safety reviews of these applications. As part of the preparation for a new wave of improved NPP designs the NRC is in the process of updating themore » SRP and is also developing a new RG designated as draft RG or DG-1145, ''Combined License Applications for Nuclear Power Plants (LWR Edition).'' This will eventually become RG 1.206 and will take the place of RG 1.70. This will provide guidance for combined license (COL) applicants, as well as for other 10CFR Part 52 variations that are permitted.« less
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-01-25
... Potassium (multiple RLDs) Aripiprazole Aspirin; Butalbital; Caffeine (multiple RLDs) Aspirin; Dipyridamole Aspirin; Oxycodone Aspirin; Butalbital; Caffeine; Codeine Phosphate Atovaquone Auranofin Azelaic Acid...
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75 FR 78798 - Airport Improvement Program: Proposed Changes to Benefit Cost Analysis (BCA) Threshold
Federal Register 2010, 2011, 2012, 2013, 2014
2010-12-16
...The Federal Aviation Administration (FAA) is issuing this Notice to advise that FAA has developed draft guidance modifying its policy requiring benefit cost analyses (BCA) for capacity projects when applying for Airport Improvement Program (AIP) grants for capacity projects at the discretion of the Secretary of Transportation. This modification proposes to raise the threshold at which BCAs are required, from $5 million to $10 million in AIP Discretionary funds. FAA invites airport sponsors and other interested parties to comment on the draft guidance. FAA will consider these comments in promulgating final BCA guidance for airport sponsors.
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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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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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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
2012-08-07
... ``its Draft Economic Incentives Program Guidance is relevant to this rulemaking.'' Sierra Club states... Economic Incentive Program Guidance and in program-specific guidance that more directly addresses specific... Economic Incentives Program Guidance. Comment: Sierra Club comments that, ``the emission limits proposed by...
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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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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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Tobacco industry's ITGA fights FCTC implementation in the Uruguay negotiations.
Assunta, Mary
2012-11-01
To illustrate how the tobacco industry' front group, the International Tobacco Growers Association (ITGA), mobilised tobacco farmers to influence the fourth session of the Conference of the Parties (COP4) negotiations and defeat the adoption of Framework Convention on Tobacco Control Articles 9 and 10 Guidelines and Articles 17 and 18 progress report. A review of COP4 documents on Articles 9, 10, 17 and 18 was triangulated with relevant information from tobacco industry reports, websites of British American Tobacco, Philip Morris International and ITGA, presentations by tobacco industry executives and internal industry documents from the Legacy Tobacco Documents Library website. Philip Morris International and British American Tobacco rejected Articles 9 and 10 draft Guidelines claiming that banning ingredients in cigarettes will render burley leaf less commercially viable making tobacco growers in many countries suffer economic consequences. They claimed the terms 'attractiveness' and 'palatability' are not appropriate regulatory standards. The ITGA launched a global campaign to mobilise farmers to reject the draft Guidelines at COP4 in Uruguay. Tobacco producers, Brazil, Philippines, Tanzania, Zambia, Malawi and Zimbabwe, sent large delegations to COP4 and participated actively in the negotiation on the draft Guidelines. Partial Guidelines on Articles 9 and 10 on product regulation and disclosure were adopted. COP4's work on Article 17 provides guidance on viable alternatives, but the ITGA is opposed to this and continues fight crop substitution. Despite ITGA's international campaign to thwart the Guidelines on Articles 9 and 10 and a strong representation from tobacco-growing countries at COP4, the outcome after intense negotiations was the adoption of Partial Guidelines and work on Articles 17 and 18 to proceed.
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Smischney, Nathan J; Onigkeit, James A; Hinds, Richard F; Nicholson, Wayne T
2015-01-01
U.S. federal regulations require that certain ethical elements be followed to protect human research subjects. The location and clinical circumstances of a proposed research study can differ substantially and can have significant implications for these ethical considerations. Both the location and clinical circumstances are particularly relevant for research in intensive care units (ICUs), where patients are often unable to provide informed consent to participate in a proposed research intervention. Our goal is to elaborate on the updated 2013 U.S. Food and Drug Administration (FDA) guidance document regarding an exemption from the requirement of obtaining informed consent from patients or their surrogates and to address certain elements within that document, thereby assisting clinicians in developing a framework for emergency research in accordance with the regulatory bodies at their own institutions and in the United States. Review of the 2011 and updated FDA guidance document on exemption from informed consent. The current process of obtaining informed consent within ICUs needs to be revisited, especially for research in which timely informed consent is not likely. In particular, the process of obtaining informed consent may not be appropriate or even ethical for critically ill patients in extremis who require an intervention for which there is no current acceptable standard of care and clinical equipoise exists. We provide clinicians with a viewpoint that further elaborates on the FDA guidance document. The viewpoints provided herein are those of the authors and are therefore inherently limited by the personal views of a selected few. Other clinicians or researchers may not interpret the FDA guidelines in a similar manner. Moreover, the discussion of a guideline document is a limitation in and of itself. The guidelines set forth by the FDA are precisely that-guidelines. Therefore, they may not be followed as outlined in the guidance document within one's own institution. Our goal is that, by elaborating on the guidelines for planned research involving human subjects in the ICU, institutional regulatory bodies may gain a better understanding in drafting their own document when faced with a clinician or a researcher who wishes to conduct planned research in an ICU. We believe that the interpretations provided will allow clinicians to safely undertake planned research in ICUs without endangering the main tenets of ethical research involving human participants. This research is needed for the advancement of care in the critically ill. Copyright 2015 The Journal of Clinical Ethics. All rights reserved.
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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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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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On March 31, 2010, the draft IRIS Toxicological Review of Dichloromethane (Methylene Chloride) external review draft document and the charge to external peer reviewers were released for public review and comment. The draft document and the charge to external peer reviewers were r...
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IRIS Toxicological Review of Inorganic Arsenic (Cancer) (Interagency Science Consultation Draft)
On February 19, 2010, the draft IRIS Toxicological Review of Inorganic Arsenic (Cancer) external review draft document and the charge to external peer reviewers were released for public review and comment. The draft document and the charge to external peer reviewers were reviewed...
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76 FR 26284 - Draft Integrated Science Assessment for Lead (Pb)
Federal Register 2010, 2011, 2012, 2013, 2014
2011-05-06
... ENVIRONMENTAL PROTECTION AGENCY [FRL-9302-5; Docket ID No. EPA-HQ-ORD-2011-0051] Draft Integrated... the availability of a document titled, ``First External Review Draft Integrated Science Assessment for Lead'' (EPA/600/R-10/075A). This draft document was prepared by the National Center for Environmental...
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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
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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Trevisi, R; Risica, S; D'Alessandro, M; Paradiso, D; Nuccetelli, C
2012-02-01
The authors set up a database of activity concentration measurements of natural radionuclides (²²⁶Ra, ²³²Th and ⁴⁰K) in building material. It contains about 10,000 samples of both bulk material (bricks, concrete, cement, natural- and phosphogypsum, sedimentary and igneous bulk stones) and superficial material (igneous and metamorphic stones) used in the construction industry in most European Union Member States. The database allowed the authors to calculate the activity concentration index I--suggested by a European technical guidance document and recently used as a basis for elaborating the draft Euratom Basic Safety Standards Directive--for bricks, concrete and phosphogypsum used in the European Union. Moreover, the percentage could be assessed of materials possibly subject to restrictions, if either of the two dose criteria proposed by the technical guidance were to be adopted. Copyright © 2011 Elsevier Ltd. All rights reserved.
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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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Human dignity in international policy documents: a useful criterion for public policy?
de Melo-Martín, Inmaculada
2011-01-01
Current developments in biomedicine are presenting us with difficult ethical decisions and raising complex policy questions about how to regulate these new developments. Particularly vexing for governments have been issues related to human embryo experimentation. Because some of the most promising biomedical developments, such as stem cell research and nuclear somatic transfer, involve such experimentation, several international bodies have drafted documents aimed to provide guidance to governments when developing biomedical science policy. Here I focus on two such documents: the Council of Europe's Convention for the Protection of Human Rights and Dignity of the Human Being and the Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being. I argue that by using human dignity as a criterion to determine the permissibility of particular human embryo research practices, these documents cannot aid in identifying research that would be contrary to human dignity. Thus, they fail to guide public policy on embryo experimentation. Their use of human dignity as a criterion makes their task of offering guidance unfeasible because the concept as used in these documents is too vague and is applied in contradictory ways. I discuss the main goals of these documents and their claims in relation to human embryo research. I then discuss how they have influenced public policy in several countries. Finally, I show that although these Council of Europe treaties attempt to serve as public policy guides in the area of embryo research, they fail to do so. © 2009 Blackwell Publishing Ltd.
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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 tool, named the Appraisal of Guidelines for Research and Evaluation for Health Systems (AGREE-HS) (version 1), defines expectations of HSG and facilitates informed decisions among policymakers on health system delivery, financial, and governance arrangements.
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-06-18
... Document--Draft DO-XXX, Minimum Aviation Performance Standards (MASPS) for an Enhanced Flight Vision System... Discussion (9:00 a.m.-5:00 p.m.) Provide Comment Resolution of Document--Draft DO-XXX, Minimum Aviation.../Approve FRAC Draft for PMC Consideration--Draft DO- XXX, Minimum Aviation Performance Standards (MASPS...
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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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75 FR 22162 - Draft NIJ Duty Holster Retention Standard for Law Enforcement
Federal Register 2010, 2011, 2012, 2013, 2014
2010-04-27
...In an effort to obtain comments from interested parties, the U.S. Department of Justice, Office of Justice Programs, National Institute of Justice will make available to the general public two draft documents: (1) A draft standard entitled, ``NIJ Duty Holster Retention Standard for Law Enforcement'' and (2) a draft companion document entitled, ``NIJ Duty Holster Retention Certification Program Requirements.'' The opportunity to provide comments on these two documents is open to industry technical representatives, law enforcement agencies and organizations, research, development and scientific communities, and all other stakeholders and interested parties. Those individuals wishing to obtain and provide comments on the draft documents under consideration are directed to the following Web site: http://www.justnet.org.
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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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ISO radiation sterilization standards
NASA Astrophysics Data System (ADS)
Lambert, Byron J.; Hansen, Joyce M.
1998-06-01
This presentation provides an overview of the current status of the ISO radiation sterilization standards. The ISO standards are voluntary standards which detail both the validation and routine control of the sterilization process. ISO 11137 was approved in 1994 and published in 1995. When reviewing the standard you will note that less than 20% of the standard is devoted to requirements and the remainder is guidance on how to comply with the requirements. Future standards developments in radiation sterilization are being focused on providing additional guidance. The guidance that is currently provided in informative annexes of ISO 11137 includes: device/packaging materials, dose setting methods, and dosimeters and dose measurement, currently, there are four Technical Reports being developed to provide additional guidance: 1. AAMI Draft TIR, "Radiation Sterilization Material Qualification" 2. ISO TR 13409-1996, "Sterilization of health care products — Radiation sterilization — Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches" 3. ISO Draft TR, "Sterilization of health care products — Radiation sterilization Selection of a sterilization dose for a single production batch" li]4. ISO Draft TR, "Sterilization of health care products — Radiation sterilization-Product Families, Plans for Sampling and Frequency of Dose Audits."
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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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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
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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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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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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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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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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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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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
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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Comparison of A-SMGCS Requirements with Observed Performance of an Integrated Airport CNS System
NASA Technical Reports Server (NTRS)
Young, Steven D.
1997-01-01
The International Civil Aviation Organization (ICAO) has recently drafted a reference document describing the operational requirements for Advanced Surface Movement Guidance and Control Systems (A-SMGCS). During the summer of 1997, NASA, the FAA, industry, and academia partners demonstrated a holistic system approach that has the potential to meet many of the proposed A-SMGCS requirements. An assessment of the field tested system and data resulting from the field testing is presented to determine its compliance with A-SMGCS requirements. In those areas where compliance was not demonstrated, a recommendation is presented suggesting further research or a modification of the system architecture.
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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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Paperless Contract Folder’s (PCF) DoD 5015.2 Certification
2010-06-01
Draft Version Controls ...........................................................11 i. Electronic Routing of Purchase Request (Funding) Documents...of electronic records, version control , robust search and retrieval, and automated disposition that is compliant with legal requirements. As shown...h. Draft Version Controls Draft and versioning controls track the changes to the documents once they are saved. Draft numbers (0.1, 0.2, 0.3
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Internal Federal Railroad Administration draft rulemaking document
DOT National Transportation Integrated Search
1993-03-08
THIS DOCUMENT IS A DRAFTOF THE RULE FOR PARTICULAR APPLICABILITY : FOR THE ORLANDO MAGLEV SYSTEM - IT IS STILL A WORKING DRAFT AND : IS BEING DISTRIBUTED SO THAT EVERYONE THAT IS PART OF DRAFTING : THIS RULE CAN HAVE ONE MORE OPPORTUNITY TO REVIEW BO...
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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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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
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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Federal Register 2010, 2011, 2012, 2013, 2014
2010-05-25
... filling out form FDA 1932, ``Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect... Drug Reaction, Lack of Effectiveness, Product Defect Report.'' II. Significance of Guidance This level...
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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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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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IRIS Toxicological Review of Naphthalene (2004, External Review Draft, Update)
[Update Jun 2004] This document contains revision of the inhalation cancer assessment and other selected text from the 1998 draft as indicated: Sections of this document pertaining to the inhalation cancer assessment are presented as draft for external peer review purposes only ...
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Code of Federal Regulations, 2011 CFR
2011-01-01
... 1 General Provisions 1 2011-01-01 2011-01-01 false Drafting. 21.1 Section 21.1 General Provisions ADMINISTRATIVE COMMITTEE OF THE FEDERAL REGISTER PREPARATION, TRANSMITTAL, AND PROCESSING OF DOCUMENTS PREPARATION OF DOCUMENTS SUBJECT TO CODIFICATION General § 21.1 Drafting. (a) Each agency that prepares a...
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Code of Federal Regulations, 2010 CFR
2010-01-01
... 1 General Provisions 1 2010-01-01 2010-01-01 false Drafting. 21.1 Section 21.1 General Provisions ADMINISTRATIVE COMMITTEE OF THE FEDERAL REGISTER PREPARATION, TRANSMITTAL, AND PROCESSING OF DOCUMENTS PREPARATION OF DOCUMENTS SUBJECT TO CODIFICATION General § 21.1 Drafting. (a) Each agency that prepares a...
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Code of Federal Regulations, 2013 CFR
2013-01-01
... 1 General Provisions 1 2013-01-01 2012-01-01 true Drafting. 21.1 Section 21.1 General Provisions ADMINISTRATIVE COMMITTEE OF THE FEDERAL REGISTER PREPARATION, TRANSMITTAL, AND PROCESSING OF DOCUMENTS PREPARATION OF DOCUMENTS SUBJECT TO CODIFICATION General § 21.1 Drafting. (a) Each agency that prepares a...
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Code of Federal Regulations, 2012 CFR
2012-01-01
... 1 General Provisions 1 2012-01-01 2012-01-01 false Drafting. 21.1 Section 21.1 General Provisions ADMINISTRATIVE COMMITTEE OF THE FEDERAL REGISTER PREPARATION, TRANSMITTAL, AND PROCESSING OF DOCUMENTS PREPARATION OF DOCUMENTS SUBJECT TO CODIFICATION General § 21.1 Drafting. (a) Each agency that prepares a...
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Code of Federal Regulations, 2014 CFR
2014-01-01
... 1 General Provisions 1 2014-01-01 2012-01-01 true Drafting. 21.1 Section 21.1 General Provisions ADMINISTRATIVE COMMITTEE OF THE FEDERAL REGISTER PREPARATION, TRANSMITTAL, AND PROCESSING OF DOCUMENTS PREPARATION OF DOCUMENTS SUBJECT TO CODIFICATION General § 21.1 Drafting. (a) Each agency that prepares a...
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18 CFR 5.25 - Applications requiring a draft NEPA document.
Code of Federal Regulations, 2010 CFR
2010-04-01
... a draft NEPA document. 5.25 Section 5.25 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY REGULATIONS UNDER THE FEDERAL POWER ACT INTEGRATED LICENSE... include for comment draft license articles, a preliminary determination of the consistency of each fish...
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18 CFR 5.25 - Applications requiring a draft NEPA document.
Code of Federal Regulations, 2011 CFR
2011-04-01
... a draft NEPA document. 5.25 Section 5.25 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY REGULATIONS UNDER THE FEDERAL POWER ACT INTEGRATED LICENSE... include for comment draft license articles, a preliminary determination of the consistency of each fish...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-11-15
...; Docket Number NIOSH 240-A] Draft Current Intelligence Bulletin ``Update of NIOSH Carcinogen... document for public comment entitled ``Current Intelligence Bulletin: Update of NIOSH Carcinogen... obtain comments on the draft document, ``Current Intelligence Bulletin: Update of NIOSH Carcinogen...
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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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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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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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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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18 CFR 5.24 - Applications not requiring a draft NEPA document.
Code of Federal Regulations, 2011 CFR
2011-04-01
... requiring a draft NEPA document. 5.24 Section 5.24 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY REGULATIONS UNDER THE FEDERAL POWER ACT INTEGRATED LICENSE... assessment issued pursuant to this paragraph must include draft license articles, a preliminary determination...
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18 CFR 5.24 - Applications not requiring a draft NEPA document.
Code of Federal Regulations, 2010 CFR
2010-04-01
... requiring a draft NEPA document. 5.24 Section 5.24 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY REGULATIONS UNDER THE FEDERAL POWER ACT INTEGRATED LICENSE... assessment issued pursuant to this paragraph must include draft license articles, a preliminary determination...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-07-19
... Review Draft. These two draft assessment documents describe the quantitative analyses the EPA is... NAAQS,\\3\\ the Agency is conducting quantitative assessments characterizing the: (1) Health risks... present the initial key results, observations, and related uncertainties associated with the quantitative...
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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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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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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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78 FR 11903 - Acceptability of Corrective Action Programs for Fuel Cycle Facilities
Federal Register 2010, 2011, 2012, 2013, 2014
2013-02-20
... Cycle Facilities AGENCY: Nuclear Regulatory Commission. ACTION: Draft NUREG; request for public comment... ``Acceptability of Corrective Action Programs for Fuel Cycle Facilities.'' The draft NUREG provides guidance to... a fuel cycle facility is acceptable. DATES: Comments may be submitted by April 22, 2013. Comments...
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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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Problems caused by regulatory delays and lack of regulation
NASA Astrophysics Data System (ADS)
Reamer, Lynne A.
1994-12-01
An FDA perspective on some of the problems encountered during the device review process is described. Emphasis is placed on the need for communication and teamwork among all parties to make the system work. Manufacturers are encouraged to `Do it right the first time.' Pertinent questions are asked of the manufacturers and proposed solutions are presented. Day to day reality at FDA is described and document workload is revealed. Lack of regulation, or more appropriately, when less regulation is appropriate is discussed. FDA has distributed to manufacturers a new draft guidance document to help in the decisionmaking process and when to submit a 510(k) when modifications are made to a device. This and other mechanisms are in place at the FDA to streamline the review process. Manufacturers are cautioned about their decisions and to seek advice from qualified persons. FDA emphasizes that help is available and that when in doubt, call.
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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
2010-01-26
... for public comment a second draft assessment document titled, Quantitative Health Risk Assessment for... quantitative analyses that are being conducted as part of the review of the national ambient air quality...-Focused Visibility Assessment--Second External Review Draft and Quantitative Health Risk Assessment for...
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On February 26, 2010, the draft Development of a Relative Potency Factor (RPF) Approach for Polycyclic Aromatic Hydrocarbon (PAH) Mixtures document and the charge to external peer reviewers were released for external peer review and public comment. The draft document and t...
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The role of the China Experts Advisory Committee on Immunization Program.
Zheng, Jingshan; Zhou, Yuqing; Wang, Huaqing; Liang, Xiaofeng
2010-04-19
The Experts Advisory Committee on Immunization Program (EACIP) of China was founded in 1982, and currently consists of 33 experts in immunization and related fields, selected by the Ministry of Health, to provide advice and guidance on the control of vaccine-preventable diseases. The main tasks of the EACIP are to advise on the national immunization schedule, to participate in the drafting and review of technical documents, and to participate in field supervision and staff training. In 2007, the EACIP used evidence-based methods to formulate a revised national immunization schedule. The EACIP has played and is playing an increasingly important role in guiding immunization policy in China. Copyright © 2010. Published by Elsevier Ltd.
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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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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
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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Current good manufacturing practice regulation and investigational new drugs. Direct final rule.
2006-01-17
The Food and Drug Administration (FDA) is amending its current good manufacturing practice (CGMP) regulations for human drugs, including biological products, to exempt most investigational "Phase 1" drugs from complying with the requirements in FDA's regulations. FDA will instead exercise oversight of production of these drugs under the agency's general statutory CGMP authority and investigational new drug application (IND) authority. In addition, FDA is making available simultaneously with the publication of this direct final rule, a guidance document setting forth recommendations on approaches to CGMP compliance for the exempted Phase 1 drugs. Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule, under FDA's usual procedure for notice-and-comment rulemaking, to provide a procedural framework to finalize the rule in the event the agency receives any significant adverse comments and withdraws this direct final rule. The companion proposed rule and direct final rule are substantively identical. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a draft guidance for industry entitled "INDs--Approaches to Complying With CGMP During Phase 1" to provide further guidance on the subject.
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Pottie, Kevin; Welch, Vivian; Morton, Rachael; Akl, Elie A; Eslava-Schmalbach, Javier H; Katikireddi, Vittal; Singh, Jasvinder; Moja, Lorenzo; Lang, Eddy; Magrini, Nicola; Thabane, Lehana; Stanev, Roger; Matovinovic, Elizabeth; Snellman, Alexandra; Briel, Matthias; Shea, Beverly; Tugwell, Peter; Schunemann, Holger; Guyatt, Gordon; Alonso-Coello, Pablo
2017-10-01
The aim of this paper is to provide detailed guidance on how to incorporate health equity within the GRADE (Grading Recommendations Assessment and Development Evidence) evidence to decision process. We developed this guidance based on the GRADE evidence to decision framework, iteratively reviewing and modifying draft documents, in person discussion of project group members and input from other GRADE members. Considering the impact on health equity may be required, both in general guidelines and guidelines that focus on disadvantaged populations. We suggest two approaches to incorporate equity considerations: (1) assessing the potential impact of interventions on equity and (2) incorporating equity considerations when judging or weighing each of the evidence to decision criteria. We provide guidance and include illustrative examples. Guideline panels should consider the impact of recommendations on health equity with attention to remote and underserviced settings and disadvantaged populations. Guideline panels may wish to incorporate equity judgments across the evidence to decision framework. This is the fourth and final paper in a series about considering equity in the GRADE guideline development process. This series is coming from the GRADE equity subgroup. Copyright © 2017 Elsevier Inc. All rights reserved.
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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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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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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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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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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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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
2013-11-06
... Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD...], Center for Drug Evaluation and Research (HFD-600), Food and Drug Administration, 7520 Standish Pl... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0369...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-06-20
... Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD...], Center for Drug Evaluation and Research (HFD-600), Food and Drug Administration, 7519 Standish Pl... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0369...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-02-22
... Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver..., Center for Drug Evaluation and Research (HFD-600), Food and Drug Administration, 7519 Standish Pl... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0369...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-12-17
... Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD...], Center for Drug Evaluation and Research (HFD-600), Food and Drug Administration, 7519 Standish Pl... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0369...
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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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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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Department of Defense Intelligence Information System (DoDIIS). Instructions 2000
2000-02-01
DIA, November 1993, DoDIIS Site Certifier’s Guide, SC-2610-143-93. e) DIA, June 1995, DoDIIS Security Architecture Guidance and Directions ( SAGD ), Draft...Plan S&T Scientific & Technical SAGD Security Architecture Guidance and Directions SBU Sensitive But Unclassified SCI Sensitive Compartmented
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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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EPA has released of the draft document solely for the purpose of pre-dissemination peer review under applicable Information Quality Guidelines (IQGs). This document has not been formally disseminated by EPA. It does not represent and should not be construed to represent any Agenc...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-07-29
... characters, any form of encryption, and be free of any defects or viruses. Docket: All documents in the... EPA's TTN website at: http://www.epa.gov/ttn/naaqs/standards/pm/s_pm_2007_pa.html . The draft document...
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76 FR 49526 - Environmental Impact Statement; Saint Louis County, MN
Federal Register 2010, 2011, 2012, 2013, 2014
2011-08-10
... environmental impacts of alternatives, including (1) No-build, (2) Purchasing title and possession of the.... The Scoping Document/Draft Scoping Decision Document is anticipated to be published in late 2011. A... Decision Document will be published after the public comment period has closed. A Draft EIS will be...
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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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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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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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The purpose of this memorandum is to explain new provisions of the Safe Drinking Water Act (SDWA) Amendments of 1996 and to provide guidance on the use of the Agency's authority to issue penalty orders against Federal facilities.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-16
... companion manual to provide agency-wide guidance for executing compliance with Executive Order 11988... procedures and guidance in accordance with specific sections of Executive Order 11988 and Executive Order.... ADDRESSES: Written comments should be sent to Emily Johannes, Senior Environmental Technical Advisor, NOAA...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-10-12
...: Draft Regulatory Guide DG-1237, ``Guidance on Making Changes to Emergency Plans for Nuclear Power Reactors,'' Interim Staff Guidance (ISG) NSIR/DPR-ISG-01, ``Emergency Planning for Nuclear Power Plants... NUCLEAR REGULATORY COMMISSION Advisory Committee on Reactor Safeguards (ACRS); Meeting of the ACRS...
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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
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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77 FR 33489 - Draft Offender Tracking System Standard
Federal Register 2010, 2011, 2012, 2013, 2014
2012-06-06
... Tracking System Standard AGENCY: National Institute of Justice. ACTION: Notice of Draft Offender Tracking System Standard, Selection and Application Guide, and Certification Program Requirements. SUMMARY: In an...) A draft standard entitled, ``Offender Tracking System Standard'' (2) a draft companion document...
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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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DOE Office of Scientific and Technical Information (OSTI.GOV)
NONE
1995-08-01
This document provides a listing of Guidance Documents from the RCRA/CERCLA Division for August 1995. Documents are listed under the following categories: RCRA Guidance Manuals; RCRA Information Briefs; CERCLA Guidance Manuals; CERCLA Regulatory Bulletins; RCRA/CERCLA Guidance Manuals; TSCA Guidance Manuals; TSCA Information Briefs; and, Cross Cut Manuals.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-03-11
... Comments on Draft Vehicular Digital Multimedia Evidence Recording System Certification Program Requirements for Law Enforcement and Draft Law Enforcement Vehicular Digital Multimedia Evidence Recording System... two draft documents: ``Vehicular Digital Multimedia Evidence Recording System Certification Program...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-03-30
... Documents You may download a copy of the IPHCP, IAs and related documents on the Internet at http://www.fws... copies of the Draft IPHCP, Draft EA, and/or Draft IAs, should contact the Service by telephone (see FOR..., February 4, 1994; 62 FR 3616, January 24, 1997). Section 9 of the Act (16 U.S.C. 1531 et seq.) and our...
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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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Federal Register 2010, 2011, 2012, 2013, 2014
2012-08-27
... as it prepares to meet the self- identification requirement. It explains who is required to self... describing how FDA will implement the self- identification requirement contained in GDUFA. As required by... industry as it prepares to meet the self-identification requirement. The guidance explains who is required...
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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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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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DOE Office of Scientific and Technical Information (OSTI.GOV)
Not Available
At the request of the Office of Solid Wastes (OSW), the SAB's Environmental Engineering Committee reviewed a draft Agency guidance for the establishment of Alternate Concentration Limits (ACL) for Resource Conservation and Recovery Act (RCRA) facilities, and two case studies demonstrating applications of the guidance. The Committee identified only obvious technical errors or omissions, which are explained in detail in the report.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-30
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0691... Drugs; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and... manufacturing practice regulations for PET drugs. DATES: Although you can comment on any guidance at any time...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-04-11
... electronic submission of individual case safety reports to regulatory authorities, automated data mining... 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...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-11-21
.... Discussion Uranium recovery facility licensees, including in-situ recovery facilities and conventional... Recovery Facility Surveys of Radon and Radon Progeny in Air and Demonstrations of Compliance AGENCY... Staff Guidance, ``Evaluations of Uranium Recovery Facility Surveys of Radon and Radon Progeny in Air and...
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75 FR 22400 - Draft Test Guidelines; Reopening of Comment Period
Federal Register 2010, 2011, 2012, 2013, 2014
2010-04-28
... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPP-2009-0681; FRL-8822-3] Draft Test Guidelines... draft test guidelines for product performance of public health uses of antimicrobial agents. EPA...-8437-2). In that document, EPA announced the availability of four draft test guidelines for product...
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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
2011-10-24
...] Draft Environmental Assessment and Draft Habitat Conservation Plan for Lower Colorado River Authority... of availability of documents and announcement of public hearings. SUMMARY: The Lower Colorado River... issuance of an incidental take permit (ITP) to Lower Colorado River Authority Transmission Services...
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Health Assessment Document for Diesel Emissions (SAB Review Draft February 1998)
The US. EPA has prepared a draft assessment of the possible health hazards from human exposure to diesel engine exhaust emissions. This 1998 draft assessment is an update of a December 1994 draft assessment that was reviewed in 1995 by the Agency's Clean Air Scientific Advisory C...
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10 CFR 51.117 - Draft environmental impact statement-notice of availability.
Code of Federal Regulations, 2012 CFR
2012-01-01
... 10 Energy 2 2012-01-01 2012-01-01 false Draft environmental impact statement-notice of...-Regulations Implementing Section 102(2) Public Notice of and Access to Environmental Documents § 51.117 Draft environmental impact statement—notice of availability. (a) Upon completion of a draft environmental impact...
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10 CFR 51.117 - Draft environmental impact statement-notice of availability.
Code of Federal Regulations, 2013 CFR
2013-01-01
... 10 Energy 2 2013-01-01 2013-01-01 false Draft environmental impact statement-notice of...-Regulations Implementing Section 102(2) Public Notice of and Access to Environmental Documents § 51.117 Draft environmental impact statement—notice of availability. (a) Upon completion of a draft environmental impact...
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10 CFR 51.117 - Draft environmental impact statement-notice of availability.
Code of Federal Regulations, 2014 CFR
2014-01-01
... 10 Energy 2 2014-01-01 2014-01-01 false Draft environmental impact statement-notice of...-Regulations Implementing Section 102(2) Public Notice of and Access to Environmental Documents § 51.117 Draft environmental impact statement—notice of availability. (a) Upon completion of a draft environmental impact...
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10 CFR 51.117 - Draft environmental impact statement-notice of availability.
Code of Federal Regulations, 2011 CFR
2011-01-01
... 10 Energy 2 2011-01-01 2011-01-01 false Draft environmental impact statement-notice of...-Regulations Implementing Section 102(2) Public Notice of and Access to Environmental Documents § 51.117 Draft environmental impact statement—notice of availability. (a) Upon completion of a draft environmental impact...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-09-20
... NUCLEAR REGULATORY COMMISSION [NRC-2012-0218] Comparative Environmental Evaluation of Alternatives... public comment the Draft Comparative Environmental Evaluation of Alternatives for Handling Low-Level.... Availability of Documents ADAMS Accession No. Document title ML12256A965 Draft Comparative Environmental...
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List of draft permit & supporting documentation for the Cape Wind Associates, LLC, Horseshoe Shoal, Nantucket Sound (Offshore Renewable Energy Project/OCS Air Permit: Massachusetts Plan Approval including nonattainment NSR Appendix A requirements).
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Hauschke, D; Steinijans, V W
2000-10-30
Generally, the motivation for switching from average bioequivalence to population and/or individual bio-equivalence is well recognized in the light of certain limitations of the concept of average bioequivalence. However, this switch still results in unresolved issues which should be addressed before the regulatory guidance is finalized.
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-07-31
... element(s). In order to enhance the consistency of our acceptance and filing decisions and to help... accepting and filing a PMA, thereby assuring the consistency of our acceptance and filing decisions. This... guidance and associated checklist clarify the necessary elements and contents of a complete PMA application...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-11-25
... Experience.'' This LR-ISG provides guidance and clarification concerning ongoing review of plant-specific and... plants. As noticed on September 20, 2011 (76 FR 58311), the public comment period was extended and, as of... to communicate insights and lessons learned and to address emergent issues not covered in license...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-12-28
... Memorandum titled ``Guidance on the CDRH Premarket Notification Review Program, 510(k) Memorandum K86-3,'' a... achieves its intended goals. In September 2009, FDA's Center for Devices and Radiological Health (CDRH... regarding the strengths and challenges associated with the 510(k) program. In August 2010, CDRH published...
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Neonatal and pediatric regionalized systems in pediatric emergency mass critical care
Barfield, Wanda D.; Krug, Steven E.; Kanter, Robert K.; Gausche-Hill, Marianne; Brantley, Mary D.; Chung, Sarita; Kissoon, Niranjan
2015-01-01
Introduction Improved health outcomes are associated with neonatal and pediatric critical care in well-organized, cohesive, regionalized systems that are prepared to support and rehabilitate critically ill victims of a mass casualty event. However, present systems lack adequate surge capacity for neonatal and pediatric mass critical care. In this document, we outline the present reality and suggest alternative approaches. Methods In May 2008, the Task Force for Mass Critical Care published guidance on provision of mass critical care to adults. Acknowledging that the critical care needs of children during disasters were unaddressed by this effort, a 17-member Steering Committee, assembled by the Oak Ridge Institute for Science and Education with guidance from members of the American Academy of Pediatrics, convened in April 2009 to determine priority topic areas for pediatric emergency mass critical care recommendations. Steering Committee members established subcommittees by topic area and performed literature reviews of MEDLINE and Ovid databases. The Steering Committee produced draft outlines through consensus-based study of the literature and convened October 6–7, 2009, in New York, NY, to review and revise each outline. Eight draft documents were subsequently developed from the revised outlines as well as through searches of MEDLINE updated through March 2010. The Pediatric Emergency Mass Critical Care Task Force, composed of 36 experts from diverse public health, medical, and disaster response fields, convened in Atlanta, GA, on March 29–30, 2010. Feedback on each manuscript was compiled and the Steering Committee revised each document to reflect expert input in addition to the most current medical literature. Task Force Recommendations States and regions (facilitated by federal partners) should review current emergency operations and devise appropriate plans to address the population-based needs of infants and children in large-scale disasters. Action at the state, regional, and federal levels should address legal, operational, and information systems to provide effective pediatric mass critical care through: 1) predisaster/mass casualty planning, management, and assessment with input from child health professionals; 2) close cooperation, agreements, public-private partnerships, and unique delivery systems; and 3) use of existing public health data to assess pediatric populations at risk and to model graded response plans based on increasing patient volume and acuity. PMID:22067921
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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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This external review draft report is a technical "best practices" document describing sensor deployment for and data collection of continuous temperature and flow at ungaged sites in wadeable streams. This document addresses questions related to equipment needs; configuration, pl...
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EVALUATION OF THE POTENTIAL CARCINOGENICITY OF ELECTROMAGNETIC FIELDS (EXTERNAL REVIEW DRAFT)
The U.S. Environmental Protection Agency (EPA or Agency) is posting on this web site a draft document related to the potential adverse human health effects resulting from exposure to electromagnetic fields (EMF). This document was never finalized after EPA activities were discon...
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List of draft permit & supporting documentation for the Northeast Gateway Energy Bridge Deepwater Port, Federal Waters of Massachusetts Bay (Modification to Existing Permit LNG Regasification Vessel/DWP Project).
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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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ERIC Educational Resources Information Center
Mississippi Research and Curriculum Unit for Vocational and Technical Education, State College.
This document, which reflects Mississippi's statutory requirement that instructional programs be based on core curricula and performance-based assessment, contains outlines of the instructional units required in local instructional management plans and daily lesson plans for two secondary-level courses in drafting: drafting I and II. Presented…
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-07-09
... the Draft Environmental Impact Statement for the Toledo Bend Hydroelectric Project On May 17, 2013, the Commission issued a Draft Environmental Impact Statement (draft EIS) for the Toledo Bend Hydroelectric Project No 2105-036 (Toledo Bend Project). The draft EIS documents the views of governmental...
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76 FR 65769 - Airport Improvement Program: Modifications to Benefit Cost Analysis (BCA) Threshold
Federal Register 2010, 2011, 2012, 2013, 2014
2011-10-24
...This document announces the publication of the final policy changes to the Federal Aviation Administration's policy requiring a benefit cost analysis (BCA) for capacity projects funded by Airport Improvement Program (AIP) discretionary funds. On December 16, 2010, the FAA issued a Notice of Availability of Draft Guidance and Request for Comments with regard to the modification of its policy requiring benefit cost analyses (BCA) for capacity projects, which was published in the Federal Register. (78 FR 78798-02, December 16, 2010). The FAA now is (1) Issuing the final policy modifying the threshold at which BCAs are required from $5 million to $10 million in Airport Improvement Program (AIP) Discretionary funds, and (2) responding to comments requested in the Notice on December 16, 2010.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-01-19
... document (TSD), Methods and Approaches for Deriving Numeric Criteria for Nitrogen/Phosphorus Pollution in Florida's Estuaries, Coastal Waters, and Southern Inland Flowing Waters. The draft TSD describes methods... discuss its draft report reviewing EPA's technical support document on development of numeric nutrient...
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Illinois Occupational Skill Standards: Mechanical Drafting Cluster.
ERIC Educational Resources Information Center
Illinois Occupational Skill Standards and Credentialing Council, Carbondale.
This document, which is intended as a guide for work force preparation program providers, details the Illinois occupational skill standards for programs preparing students for employment in occupations in the mechanical drafting cluster. The document begins with a brief overview of the Illinois perspective on occupational skill standards and…
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EPA has released this draft document solely for the purpose of pre-dissemination peer review under applicable information quality guidelines. This document has not been formally disseminated by EPA. It does not represent and should not be construed to represent any Agency policy ...
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AIR QUALITY CRITERIA FOR PARTICULATE MATTER DOCUMENT
A Planning Document was produced by NCEA/RTP and reviewed by the Clean Air Scientific Advisory Committee (CASAC) (62 FR 55201, October 23, 1997). In FY99, a workshop draft of the PM AQCD was completed, a peer input workshop held, and an External Review Draft released for public ...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-03-05
.... This draft document describes the quantitative analyses that are being conducted as part of the review... primary (health-based) CO NAAQS, the Agency is conducting qualitative and quantitative assessments... results, observations, and related uncertainties associated with the quantitative analyses performed. An...
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Illinois Occupational Skill Standards: Architectural Drafting Cluster.
ERIC Educational Resources Information Center
Illinois Occupational Skill Standards and Credentialing Council, Carbondale.
This document, which is intended as a guide for work force preparation program providers, details the Illinois occupational skill standards for programs preparing students for employment in occupations in the architectural drafting cluster. The document begins with a brief overview of the Illinois perspective on occupational skill standards and…
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75 FR 38109 - Notice of Availability of Draft Policy Document for Comment
Federal Register 2010, 2011, 2012, 2013, 2014
2010-07-01
... Availability of Draft Policy Document for Comment AGENCY: Health Resources and Services Administration (HRSA... policy source for information on FTCA for Health Center Program grantees funded under section 330 of the Public Health Service (PHS) Act (``section 330''). The Policy Manual is currently posted on the Internet...
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78 FR 64970 - New Deadlines for Public Comment on Draft Environmental Documents
Federal Register 2010, 2011, 2012, 2013, 2014
2013-10-30
... interested parties to contact Service personnel and Web sites for information about these draft documents. As..., fdsys/pkg/FR-2013- CO; Comprehensive Conservation 08-07/pdf/2013- Plan and Environmental Impact 19052.pdf. Statement; Two Ponds National Wildlife Refuge, Arvada, CO; Comprehensive Conservation Plan and...
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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
2010-07-14
... 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
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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75 FR 29537 - Draft Transportation Conformity Guidance for Quantitative Hot-spot Analyses in PM2.5
Federal Register 2010, 2011, 2012, 2013, 2014
2010-05-26
... Quantitative Hot- spot Analyses in PM 2.5 and PM 10 Nonattainment and Maintenance Areas AGENCY: Environmental... finalized, this guidance would help state and local agencies complete quantitative PM 2.5 and PM 10 hot-spot...), EPA stated that quantitative PM 2.5 and PM 10 hot-spot analyses would not be required until EPA...
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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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Federal Register 2010, 2011, 2012, 2013, 2014
2012-07-27
... effect at this time. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5... departments, and manufacturers of enteral feeding tubes regarding luer lock misconnections. FDA advised... for Enteral Applications,'' you may either send an email request to [email protected] to receive an...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-02-13
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0083... Quality; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and... contamination. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure...
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Draft Title V Operating Permit: Andeavor Field Services, LLC - Walker Hollow Compressor Station
Draft Title V Operating Permit, statement of basis, public notice bulletin, and the administrative permit docket (application and other supporting documents) for the Draft Part 71 Permit for Andeavor Field Services, LLC - Walker Hollow CS.
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75 FR 48179 - Comprehensive List of Guidance Documents at the Food and Drug Administration
Federal Register 2010, 2011, 2012, 2013, 2014
2010-08-09
...The Food and Drug Administration (FDA) is publishing a comprehensive list of all guidance documents currently in use at the agency. This list is being published under FDA's Good Guidance Practices (GGPs). It is intended to inform the public of the existence and availability of all of our current guidance documents. It also provides information on guidance documents that have been added or withdrawn in the past 5 years.
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76 FR 411 - Regulatory Guidance Concerning Electronic Signatures and Documents
Federal Register 2010, 2011, 2012, 2013, 2014
2011-01-04
... Concerning Electronic Signatures and Documents AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Notice of regulatory guidance. SUMMARY: FMCSA issues regulatory guidance concerning the... regulatory guidance concerning the use of electronic signatures and documents to comply with FMCSA...
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Culver, Bruce H; Graham, Brian L; Coates, Allan L; Wanger, Jack; Berry, Cristine E; Clarke, Patricia K; Hallstrand, Teal S; Hankinson, John L; Kaminsky, David A; MacIntyre, Neil R; McCormack, Meredith C; Rosenfeld, Margaret; Stanojevic, Sanja; Weiner, Daniel J
2017-12-01
The American Thoracic Society committee on Proficiency Standards for Pulmonary Function Laboratories has recognized the need for a standardized reporting format for pulmonary function tests. Although prior documents have offered guidance on the reporting of test data, there is considerable variability in how these results are presented to end users, leading to potential confusion and miscommunication. A project task force, consisting of the committee as a whole, was approved to develop a new Technical Standard on reporting pulmonary function test results. Three working groups addressed the presentation format, the reference data supporting interpretation of results, and a system for grading quality of test efforts. Each group reviewed relevant literature and wrote drafts that were merged into the final document. This document presents a reporting format in test-specific units for spirometry, lung volumes, and diffusing capacity that can be assembled into a report appropriate for a laboratory's practice. Recommended reference sources are updated with data for spirometry and diffusing capacity published since prior documents. A grading system is presented to encourage uniformity in the important function of test quality assessment. The committee believes that wide adoption of these formats and their underlying principles by equipment manufacturers and pulmonary function laboratories can improve the interpretation, communication, and understanding of test results.
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Drafting and Design Technology Curriculum Guide.
ERIC Educational Resources Information Center
Idaho State Dept. of Education, Boise. Div. of Vocational Education.
This document provides lists of tasks, performance objectives, and enabling objectives for 1,800 hours of postsecondary instruction or 900 hours of secondary instruction in the drafting and design technology program. Following a list of tasks and an explanation of the program, the bulk of the document consists of 25 modules, each of which is a…
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77 FR 67340 - National Fire Codes: Request for Comments on NFPA's Codes and Standards
Federal Register 2010, 2011, 2012, 2013, 2014
2012-11-09
... the process. The Code Revision Process contains four basic steps that are followed for developing new documents as well as revising existing documents. Step 1: Public Input Stage, which results in the First Draft Report (formerly ROP); Step 2: Comment Stage, which results in the Second Draft Report (formerly...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-04-04
... Plan (BIP). This document is intended to describe the priority activities to occur during fiscal years.... The target audience for the BIP is the Nation (individuals, families, communities including all... the draft BIP document which address (1) Strategic Objective 4, Foster Integrated, Scalable Health...
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IRIS Toxicological Review of Dichloromethane (Methylene ...
On March 31, 2010, the draft IRIS Toxicological Review of Dichloromethane (Methylene Chloride) external review draft document and the charge to external peer reviewers were released for public review and comment. The draft document and the charge to external peer reviewers were reviewed internally by EPA and by other federal agencies and White House Offices before public release. In the new IRIS process, introduced by the EPA Administrator, all written comments on IRIS assessments submitted by other federal agencies and White House Offices will be made publicly available. Accordingly, interagency comments and the interagency science consultation draft of the Toxicological Review of Dichloromethane (Methylene Chloride) and the charge to external peer reviewers are posted on this site. The draft Toxicological Review of Dichloromethane provides scientific support and rationale for the hazard and dose-response assessment pertaining to chronic exposure to dichloromethane.
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Health Assessment Document for Diesel Emissions (External Review Draft)
This revised draft assessment of the possible health hazards from human exposure to diesel engine exhaust emissions updates two earlier drafts (1998 and 1994) that were reviewed by the Agency's Science Advisory Board (SAB) Clean Air Scientific Advisory Committee (CASAC). The curr...
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Health Assessment Document for Diesel Exhaust (Revised External Review Draft)
This External Review Draft version of this assessment updates three earlier drafts (1999, 1998 and 1994) that were reviewed by the Clean Air Scientific Advisory Committee (CASAC) of the Agency's Science Advisory Board (SAB). The assessment characterizes the possible human healt...
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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 updated evidence and their best clinical judgment in individual cases.
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ANMCO/SIC Consensus Document: cardiology networks for outpatient heart failure care
Gulizia, Michele Massimo; Di Lenarda, Andrea; Mortara, Andrea; Battistoni, Ilaria; De Maria, Renata; Gabriele, Michele; Iacoviello, Massimo; Navazio, Alessandro; Pini, Daniela; Di Tano, Giuseppe; Marini, Marco; Ricci, Renato Pietro; Alunni, Gianfranco; Radini, Donatella; Metra, Marco; Romeo, Francesco
2017-01-01
Abstract Changing demographics and an increasing burden of multiple chronic comorbidities in Western countries dictate refocusing of heart failure (HF) services from acute in-hospital care to better support the long inter-critical out-of- hospital phases of HF. In Italy, as well as in other countries, needs of the HF population are not adequately addressed by current HF outpatient services, as documented by differences in age, gender, comorbidities and recommended therapies between patients discharged for acute hospitalized HF and those followed-up at HF clinics. The Italian Working Group on Heart Failure has drafted a guidance document for the organisation of a national HF care network. Aims of the document are to describe tasks and requirements of the different health system points of contact for HF patients, and to define how diagnosis, management and care processes should be documented and shared among health-care professionals. The document classifies HF outpatient clinics in three groups: (i) community HF clinics, devoted to management of stable patients in strict liaison with primary care, periodic re-evaluation of emerging clinical needs and prompt treatment of impending destabilizations, (ii) hospital HF clinics, that target both new onset and chronic HF patients for diagnostic assessment, treatment planning and early post-discharge follow-up. They act as main referral for general internal medicine units and community clinics, and (iii) advanced HF clinics, directed at patients with severe disease or persistent clinical instability, candidates to advanced treatment options such as heart transplant or mechanical circulatory support. Those different types of HF clinics are integrated in a dedicated network for management of HF patients on a regional basis, according to geographic features. By sharing predefined protocols and communication systems, these HF networks integrate multi-professional providers to ensure continuity of care and patient empowerment. In conclusion, This guidance document details roles and interactions of cardiology specialists, so as to best exploit the added value of their input in the care of HF patients and is intended to promote a more efficient and effective organization of HF services. PMID:28751837
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Normalized Legal Drafting and the Query Method.
ERIC Educational Resources Information Center
Allen, Layman E.; Engholm, C. Rudy
1978-01-01
Normalized legal drafting, a mode of expressing ideas in legal documents so that the syntax that relates the constituent propositions is simplified and standardized, and the query method, a question-asking activity that teaches normalized drafting and provides practice, are examined. Some examples are presented. (JMD)
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IRIS Toxicological Review of Mirex (2003 External Review Draft)
EPA is providing for public information a draft Toxicological Review, draft IRIS Summary, and charge to external peer reviewers for EPA's Health Assessment of Mirex. These documents are provided for public viewing during an external scientific peer review period. While EPA is not...
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A Thesaurus for Information Technology and Education. Occasional Paper ITE/6/86.
ERIC Educational Resources Information Center
Lewis, R.
Prepared for use by the Information Technology and Education (ITE) Programme of the Economic and Social Science Research Council (ESRC), this draft document is based on the 1984 EUDISED (European Documentation and Information System for Education) Thesaurus for Information Processing. This draft is a modified thesaurus which aims to keep as close…
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Addressing Needs of Rural Health Care Providers via Distance Learning. Draft.
ERIC Educational Resources Information Center
Adeyemi, Gloria; And Others
This document describes a distance learning program designed to meet the needs of rural health care providers. The program allows students to complete an Associate of Applied Science (AS) in the Meramec Physical Therapist Assistant (PTA) program through St. Louis Community College (SLCC). The first section of the document provides a draft of the…
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33 CFR Appendix A to Part 230 - Processing Corps NEPA Documents
Code of Federal Regulations, 2012 CFR
2012-07-01
... Appendix A to Part 230 Navigation and Navigable Waters CORPS OF ENGINEERS, DEPARTMENT OF THE ARMY, DEPARTMENT OF DEFENSE PROCEDURES FOR IMPLEMENTING NEPA Pt. 230, App. A Appendix A to Part 230—Processing... integrating the draft EIS or EA and draft FONSI (as appropriate), or a separate NEPA document and circulate it...
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33 CFR Appendix A to Part 230 - Processing Corps NEPA Documents
Code of Federal Regulations, 2011 CFR
2011-07-01
... Appendix A to Part 230 Navigation and Navigable Waters CORPS OF ENGINEERS, DEPARTMENT OF THE ARMY, DEPARTMENT OF DEFENSE PROCEDURES FOR IMPLEMENTING NEPA Pt. 230, App. A Appendix A to Part 230—Processing... integrating the draft EIS or EA and draft FONSI (as appropriate), or a separate NEPA document and circulate it...
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33 CFR Appendix A to Part 230 - Processing Corps NEPA Documents
Code of Federal Regulations, 2013 CFR
2013-07-01
... Appendix A to Part 230 Navigation and Navigable Waters CORPS OF ENGINEERS, DEPARTMENT OF THE ARMY, DEPARTMENT OF DEFENSE PROCEDURES FOR IMPLEMENTING NEPA Pt. 230, App. A Appendix A to Part 230—Processing... integrating the draft EIS or EA and draft FONSI (as appropriate), or a separate NEPA document and circulate it...
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33 CFR Appendix A to Part 230 - Processing Corps NEPA Documents
Code of Federal Regulations, 2014 CFR
2014-07-01
... Appendix A to Part 230 Navigation and Navigable Waters CORPS OF ENGINEERS, DEPARTMENT OF THE ARMY, DEPARTMENT OF DEFENSE PROCEDURES FOR IMPLEMENTING NEPA Pt. 230, App. A Appendix A to Part 230—Processing... integrating the draft EIS or EA and draft FONSI (as appropriate), or a separate NEPA document and circulate it...
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This is a draft document and as such has not been formally disseminated by the U.S. EPA; it does not represent - and should not be construed to represent - any U.S. EPA policy or determination. Under applicable information quality guidelines, the document is being released for a...
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Nanomaterial Case Studies: Nanoscale Titanium Dioxide (External Review Draft)
This draft document presents two case studies of nanoscale titanium dioxide (nano-TiO2) used (1) to remove arsenic from drinking water and (2) as an active ingredient in topical sunscreen. The draft case studies are organized around a comprehensive environmental asses...
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Transition to Postsecondary: New Documentation Guidance for Access to Accommodations
ERIC Educational Resources Information Center
Klotz, Mary Beth
2012-01-01
The Association on Higher Education and Disability (AHEAD) recently developed a conceptual framework that substantially revises its guidance for disability documentation for accommodations in higher education settings. This new document, "Supporting Accommodation Requests: Guidance on Documentation Practices," was written in response to the…
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IRIS Toxicological Review of Inorganic Arsenic (Cancer) ...
On February 19, 2010, the draft IRIS Toxicological Review of Inorganic Arsenic (Cancer) external review draft document and the charge to external peer reviewers were released for public review and comment. The draft document and the charge to external peer reviewers were reviewed internally by EPA and by other federal agencies and White House Offices before public release. In the new IRIS process, introduced by the EPA Administrator, all written comments on IRIS assessments submitted by other federal agencies and White House Offices will be made publicly available. Accordingly, interagency comments and the interagency science consultation draft of the Toxicological Review of Inorganic Arsenic and the charge to external peer reviewers are posted on this site. This draft IRIS health assessment addresses only cancer human health effects that may result from chronic exposure to this chemical. An assessment of noncancer health effects of inorganic arsenic will be released for external peer review and public comment at a later date.
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Tanks Focus Area Site Needs Assessment - FY 2001
DOE Office of Scientific and Technical Information (OSTI.GOV)
Allen, Robert W.; Josephson, Gary B.; Westsik, Joseph H.
2001-04-30
The TFA uses a systematic process for developing its annual program that draws from the tanks science and technology development needs expressed by the five DOE tank waste sites. TFA's annual program development process is iterative and involves the following steps: Collection of site needs; Needs analysis; Development of technical responses and initial prioritization; Refinement of the program for the next fiscal year; Formulation of the Corporate Review Budget (CRB); Preparation of Program Execution Guidance (PEG) for the next FY Revision of the Multiyear Program Plan (MYPP). This document describes the outcomes of the first phase of this process, frommore » collection of site needs to the initial prioritization of technical activities. The TFA received site needs in October - December 2000. A total of 170 site needs were received, an increase of 30 over the previous year. The needs were analyzed and integrated, where appropriate. Sixty-six distinct technical responses were drafted and prioritized. In addition, seven strategic tasks were approved to compete for available funding in FY 2002 and FY 2003. Draft technical responses were prepared and provided to the TFA Site Representatives and the TFA User Steering Group (USG) for their review and comment. These responses were discussed at a March 15, 2001, meeting where the TFA Management Team established the priority listing in preparation for input to the DOE Office of Science and Technology (OST) budget process. At the time of publication of this document, the TFA continues to finalize technical responses as directed by the TFA Management Team and clarify the intended work scopes for FY 2002 and FY 2003.« less
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78 FR 53791 - Draft Program-Specific Guidance About Irradiator Licenses
Federal Register 2010, 2011, 2012, 2013, 2014
2013-08-30
... CONTACT: Tomas Herrera, Office of Federal and State Materials and Environmental Management Programs; U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415- 7138; email: Tomas.Herrera...
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76 FR 60820 - Draft Integrated Science Assessment for Ozone and Related Photochemical Oxidants
Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-30
... Science Assessment for Ozone and Related Photochemical Oxidants AGENCY: Environmental Protection Agency... Review Draft Integrated Science Assessment for Ozone and Related Photochemical Oxidants'' (EPA/600/R-10... standards (NAAQS) for ozone. EPA is releasing this draft document to seek review by the Clean Air Scientific...
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Integrated Science Assessment (ISA) for Carbon Monoxide (Second External Review Draft, Sep 2009)
EPA announced that the Second External Review Draft of the Integrated Science Assessment (ISA) for Carbon Monoxide (CO) and related Annexes was made available for independent peer review and public review. This draft ISA document represents a concise synthesis and evaluation of t...
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Integrated Science Assessment (ISA) for Carbon Monoxide (First External Review Draft, Mar 2009)
EPA announced that the First External Review Draft of the Integrated Science Assessment (ISA) for Carbon Monoxide (CO) and related Annexes was made available for independent peer review and public review. This draft ISA document represents a concise synthesis and evaluation of th...
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Articulated, Performance-Based Instruction Guide for Drafting II. Final Document. Revised.
ERIC Educational Resources Information Center
Henderson, William Edward, Jr.
Developed during a project designed to provide continuous, performance-based vocational training at the secondary and postsecondary levels, this instructional guide is intended to help teachers implement a laterally and vertically articulated secondary level drafting II program. Introductory materials include a description of Drafting II,…
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EPA has announced that the Second External Review Draft of the Integrated Science Assessment (ISA) for Oxides of Nitrogen – Health Criteria has been made available for independent peer review and public review. This draft ISA document represents a concise synthesis and evaluation...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-12-21
... ENVIRONMENTAL PROTECTION AGENCY [EPA-OW-2011-0466; FRL-9609-3] Notice of Availability of Draft Recreational Water Quality Criteria and Request for Scientific Views AGENCY: Environmental Protection Agency... Environmental Protection Agency (EPA) is announcing the availability of the draft document Recreational Water...
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Integrated Science Assessment (ISA) for Particulate Matter (First External Review Draft, Dec 2008)
EPA has announced that the First External Review Draft of the Integrated Science Assessment (ISA) for Particulate Matter and related Annexes have been made available for independent peer review and public review. This draft ISA document represents a concise synthesis and e...
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1 CFR 19.2 - Routing and approval of drafts.
Code of Federal Regulations, 2014 CFR
2014-01-01
... 1 General Provisions 1 2014-01-01 2012-01-01 true Routing and approval of drafts. 19.2 Section 19.2 General Provisions ADMINISTRATIVE COMMITTEE OF THE FEDERAL REGISTER PREPARATION, TRANSMITTAL, AND PROCESSING OF DOCUMENTS EXECUTIVE ORDERS AND PRESIDENTIAL PROCLAMATIONS § 19.2 Routing and approval of drafts...
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1 CFR 19.2 - Routing and approval of drafts.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 1 General Provisions 1 2010-01-01 2010-01-01 false Routing and approval of drafts. 19.2 Section 19.2 General Provisions ADMINISTRATIVE COMMITTEE OF THE FEDERAL REGISTER PREPARATION, TRANSMITTAL, AND PROCESSING OF DOCUMENTS EXECUTIVE ORDERS AND PRESIDENTIAL PROCLAMATIONS § 19.2 Routing and approval of drafts...
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1 CFR 19.2 - Routing and approval of drafts.
Code of Federal Regulations, 2011 CFR
2011-01-01
... 1 General Provisions 1 2011-01-01 2011-01-01 false Routing and approval of drafts. 19.2 Section 19.2 General Provisions ADMINISTRATIVE COMMITTEE OF THE FEDERAL REGISTER PREPARATION, TRANSMITTAL, AND PROCESSING OF DOCUMENTS EXECUTIVE ORDERS AND PRESIDENTIAL PROCLAMATIONS § 19.2 Routing and approval of drafts...
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1 CFR 19.2 - Routing and approval of drafts.
Code of Federal Regulations, 2012 CFR
2012-01-01
... 1 General Provisions 1 2012-01-01 2012-01-01 false Routing and approval of drafts. 19.2 Section 19.2 General Provisions ADMINISTRATIVE COMMITTEE OF THE FEDERAL REGISTER PREPARATION, TRANSMITTAL, AND PROCESSING OF DOCUMENTS EXECUTIVE ORDERS AND PRESIDENTIAL PROCLAMATIONS § 19.2 Routing and approval of drafts...
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1 CFR 19.2 - Routing and approval of drafts.
Code of Federal Regulations, 2013 CFR
2013-01-01
... 1 General Provisions 1 2013-01-01 2012-01-01 true Routing and approval of drafts. 19.2 Section 19.2 General Provisions ADMINISTRATIVE COMMITTEE OF THE FEDERAL REGISTER PREPARATION, TRANSMITTAL, AND PROCESSING OF DOCUMENTS EXECUTIVE ORDERS AND PRESIDENTIAL PROCLAMATIONS § 19.2 Routing and approval of drafts...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-11-24
... review of EPA's ``Toxicological Review of Trichloroethylene'' on December 15, 2010 and (b) a quality... of Trichloroethylene'' (October 2009), and (2) a draft report peer reviewing EPA's draft document... draft assessment entitled ``Toxicological Review of Trichloroethylene'' (October 2009). EPA's Office of...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-05-25
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [Docket Number NIOSH-238] Draft Alert Entitled ``Preventing Occupational Respiratory Disease From Dampness in Office Buildings, Schools, and Other Nonindustrial Buildings;'' Correction A notice of draft document for public...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-04-01
... Review of the National Ambient Air Quality Standards for Particulate Matter AGENCY: Environmental... Review of the Particulate Matter National Ambient Air Quality Standards--First External Review Draft (75... Particulate Matter National Ambient Air Quality Standards--First External Review Draft (March 2010), please...
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EPA announced that the First External Review Draft of the Integrated Science Assessment for Ozone and Related Photochemical Oxidants has been made available for independent peer review and public review. This draft document represents a concise synthesis and evaluation of ...
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EPA has released the Integrated Science Assessment of Ozone and Related Photochemical Oxidants (Second External Review Draft) for independent peer review and public review. This draft document represents a concise synthesis and evaluation of the most policy-relevant scienc...
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EPA has released the Integrated Science Assessment of Ozone and Related Photochemical Oxidants (Third External Review Draft) for independent peer review and public review. This draft document represents a concise synthesis and evaluation of the most policy-relevant science...