Sample records for harmonisation draft guidance
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-07-23
... Texts for Use in the International Conference on Harmonisation Regions; Annex 13 on Bulk Density and... availability of a draft guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use...
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Federal Register 2010, 2011, 2012, 2013, 2014
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...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Q11 Development and Manufacture of Drug Substances.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use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 The draft guidance describes approaches to developing process and drug substance understanding and provides guidance on what information should be provided in certain sections of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 The draft guidance is intended to harmonize the scientific and technical principles relating to the description and justification of the development and manufacturing process of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
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...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use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 The draft guidance emphasizes considerations of both safety and quality risk management in establishing levels of mutagenic impurities that are expected to pose negligible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 The draft guidance is intended to provide guidance for new drug substances and new drug products during their clinical development and subsequent applications for marketing.
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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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Federal Register 2010, 2011, 2012, 2013, 2014
2010-04-12
... Products (VICH). This draft VICH guidance document is intended to provide study design recommendations... Products; Draft Guidance for Industry on Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Marker Residue Depletion Studies to Establish Product Withdrawal...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-07-14
... 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
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
2011-09-15
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0588] International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Draft Guidance for Industry on Pharmacovigilance of Veterinary Medicinal Products: Electronic...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-07-19
... Texts for Use in the International Conference on Harmonisation Regions; Annex 14 on Bacterial Endotoxins... ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 14... Endotoxins Test General Chapter harmonized text from each of the three pharmacopoeias (United States...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-02-04
... European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers Association; the Centers for Drug Evaluation and...
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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
2013-10-23
... appropriate limits for impurities, and emphasizes control of supply chains and risk assessments. It is... expectations for test requirements and regulatory filings, and a global policy for limiting elemental... written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-10-20
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0720... Forwards Compatibility; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-04-12
... a framework for metabolism testing, it is important that the design of the studies remains flexible... Products (VICH); Draft Guidance for Industry on Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Metabolism Study to Determine the Quantity and Identify the...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-04-08
...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Providing Postmarket Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report).'' This guidance is intended to inform applicants of the conditions under which FDA will exercise its waiver authority to permit applicants to submit an International Conference on Harmonisation (ICH) E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER) in place of the ICH E2C(R1) Periodic Safety Update Report (PSUR), U.S. periodic adverse drug experience report (PADER), or U.S. periodic adverse experience report (PAER), to satisfy the periodic safety reporting requirements in FDA regulations. The guidance describes the steps applicants can take to submit the PBRER, and discusses the format, content, submission deadline, and frequency of reporting for the PBRER.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-08-11
...] International Conference on Harmonisation; Guidance on E16 Biomarkers Related to Drug or Biotechnology Product... availability of a guidance entitled ``E16 Biomarkers Related to Drug or Biotechnology Product Development... development of drug or biotechnology products, including translational medicine approaches, pharmacokinetics...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-02-21
...] International Conference on Harmonisation; Guidance on E7 Studies in Support of Special Populations; Geriatrics... in Support of Special Populations: Geriatrics; Questions and Answers.'' The guidance was prepared... well as observers from the World Health Organization, Health Canada, and the European Free Trade Area...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-05-18
... Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals; Availability AGENCY: Food and Drug... availability of a guidance entitled ``S6 Addendum to Preclinical Safety Evaluation of Biotechnology-Derived... implementation of the ICH guidance [[Page 29666
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-10-23
...] International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts... Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on... evaluation of the Bacterial Endotoxins Test General Chapter harmonized text from each of the three...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-09-03
...] International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts... Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 11: Capillary... text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-04-12
...] International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts... Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 10: Polyacrylamide... Electrophoresis General Chapter harmonized text from each of the three pharmacopoeias (United States, European...
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2001-07-13
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "S7A Safety Pharmacology Studies for Human Pharmaceuticals." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides a definition, general principles, and recommendations for the nonclinical safety pharmacology studies. The guidance is intended to help protect clinical trial participants and patients receiving marketed products from potential adverse effects of pharmaceuticals, while avoiding unnecessary use of animals and other resources.
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2006-06-02
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q9 Quality Risk Management."' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides principles and examples of tools for quality risk management that can be applied to all aspects of pharmaceutical quality throughout the lifecycle of drug substances, drug products, and biological and biotechnological products. The guidance is intended to enable regulators and industry to make more effective and consistent risk-based decisions.
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-09-02
...] International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts... and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 12: Analytical Sieving... provides the results of the ICH Q4B evaluation of the Analytical Sieving General Chapter harmonized text...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-04-05
...] International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts... Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 7: Dissolution Test General Chapter... results of the ICH Q4B evaluation of the Dissolution Test General Chapter harmonized text from each of the...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-05-28
...] International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts... ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on... evaluation of the Bulk Density and Tapped Density of Powders General Chapter harmonized text from each of the...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-04-05
...] International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts... Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 9: Tablet Friability General Chapter... results of the ICH Q4B evaluation of the Tablet Friability General Chapter harmonized text from each of...
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2009-04-08
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q10 Pharmaceutical Quality System." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance describes a model for an effective quality management system for the pharmaceutical industry, referred to as the Pharmaceutical Quality System. The guidance is intended to provide a comprehensive approach to an effective pharmaceutical quality system that is based on International Organization for Standardization (ISO) concepts, includes applicable good manufacturing practice (GMP) regulations and complements ICH guidances on "Q8 Pharmaceutical Development" and "Q9 Quality Risk Management."
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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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2010-01-21
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance, which is a revision of an existing guidance, discusses the types of nonclinical studies, their scope and duration, and their relation to the conduct of human clinical trials and marketing authorization for pharmaceuticals. The guidance is intended to facilitate the timely conduct of clinical trials and reduce the unnecessary use of animals and other drug development resources.
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2012-02-21
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``E7 Studies in Support of Special Populations: Geriatrics; Questions and Answers.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The questions and answers (Q&A) guidance addresses special considerations for the design and conduct of clinical trials of drugs likely to have significant use in the elderly. The Q&As are intended to provide guidance on the use of geriatric data to adequately characterize and represent the safety and efficacy of a drug for a marketing application, including data collected postmarketing.
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2004-06-09
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "M4: The CTD--Quality: Questions and Answers/Location Issues." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). This guidance provides further clarification for preparing the quality components of an application file in the common technical document (CTD) format. The guidance addresses the relationship between linked sections for certain parameters (such as polymorphism and particle size), and it addresses location issues (by indicating the section in which to place requested information). The guidance is intended to ease the preparation of paper and electronic submissions, facilitate regulatory reviews, and simplify the exchange of regulatory information among regulatory authorities.
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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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2012-11-20
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q11 Development and Manufacture of Drug Substances.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance describes approaches to developing and understanding the manufacturing process of a drug substance and provides guidance on what information should be provided in certain sections of the Common Technical Document (CTD). The 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. The discussion of principles in the guidance is intended to apply only to the manufacture of drug substance, not the manufacture of finished drug products.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-15
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0165] International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Guidance for Industry on Studies To Evaluate the Metabolism and Residue Kinetics of Veterinary...
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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
2012-11-20
...] Draft Guidance for Industry on Electronic Source Data in Clinical Investigations; Availability AGENCY... announcing the availability of a draft guidance for industry entitled ``Electronic Source Data in Clinical... in Clinical Investigations.'' This revised draft document provides guidance to sponsors, contract...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-02-28
...] Draft Guidance for Industry on Medication Guides--Distribution Requirements and Inclusion of Medication... a draft guidance for industry entitled ``Medication Guides--Distribution Requirements and Inclusion... Inclusion of Medication Guides in Risk Evaluation and Mitigation Strategies (REMS).'' This draft guidance is...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-19
...] Draft Guidance for Industry on Self-Selection Studies for Nonprescription Drug Products; Availability...) is announcing the availability of a draft guidance for industry entitled ``Self-Selection Studies for Nonprescription Drug Products.'' The draft guidance is intended to provide recommendations to industry on the...
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76 FR 36542 - Draft Guidance for Industry and Food and Drug Administration Staff: The Content of...
Federal Register 2010, 2011, 2012, 2013, 2014
2011-06-22
...The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled ``Draft Guidance for Industry and Food and Drug Administration Staff: The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Low Glucose Suspend (LGS) Device Systems.'' This draft guidance document provides industry and Agency staff with recommendations that are intended to improve the safety and effectiveness of LGS Device Systems. This draft guidance is not final nor is it in effect at this time.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-15
... guidance document is intended to provide study design recommendations that will facilitate the universal... objective of this guidance is to provide study design recommendations that will facilitate the universal... Products; Guidance for Industry on Studies To Evaluate the Metabolism and Residue Kinetics of Veterinary...
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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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Hukkanen, Renee R; Halpern, Wendy G; Vidal, Justin D
2016-10-01
In July 2015, the U.S. Food and Drug Administration (FDA) posted a new draft guidance entitled "Testicular Toxicity: Evaluation during Drug Development Guidance for Industry," with a 90-day public comment period. As the nonclinical assessment of testicular toxicity often relies on the expert interpretation of pathology affecting the male reproductive tract, this draft guidance is considered directly relevant to the toxicologic pathology community. Therefore, a working group was formed through the Scientific and Regulatory Policy Committee of the Society of Toxicologic Pathologists (STPs) to provide a detailed review of the draft guidance. Specific comments on the guidance were submitted to the FDA by the STP. The draft guidance and all comments received are currently under review with the FDA. This commentary provides a summary of the components of the draft guidance and the comments submitted by the STP with acknowledgment of different perspectives reflected in comments from other respondents. © The Author(s) 2016.
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Federal Register 2010, 2011, 2012, 2013, 2014
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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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
2010-07-20
... carcinogenicity study performed by the National Toxicology Program. The new data suggest a positive systemic... alternative approach may be used if such approach satisfies the requirements of the applicable statutes and...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-08-26
...] (Formerly Docket No. 2007D-0168) Draft Guidance for Industry on Bioequivalence Recommendations for... industry entitled ``Draft Guidance on Risperidone.'' The guidance provides specific recommendations on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for...
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Federal Register 2010, 2011, 2012, 2013, 2014
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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Federal Register 2010, 2011, 2012, 2013, 2014
2012-11-20
... Document (CTD). The guidance is intended to harmonize the scientific and technical principles relating to... sections of the CTD. A summary of changes includes the following: (1) Revisions to the introduction and...
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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
2010-09-07
...] 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
2011-11-07
...: In Vitro Diagnostic Devices for Yersinia Species Detection; Availability AGENCY: Food and Drug... availability of a draft guidance entitled ``Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Yersinia Species Detection.'' This draft guidance document describes a means by which in vitro...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-05-31
..., 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
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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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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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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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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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
2012-12-13
... 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
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
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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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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Federal Register 2010, 2011, 2012, 2013, 2014
2010-04-12
... Veterinary Drugs in Food-Producing Animals: Comparative Metabolism Studies in Laboratory Animals (VICH GL47... Food-Producing Animals: Comparative Metabolism Studies in Laboratory Animals,'' VICH GL47. This draft... Food-Producing Animals: Comparative Metabolism Studies in Laboratory Animals,'' VICH GL47. In recent...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-06-24
... General Chapter'' (Q4B Annex 7). The revised guidance specifies additional dissolution apparatuses to... Canada consideration. This second revision, Q4B Annex 7(R2), specifies additional dissolution apparatuses to which interchangeability applies in the three ICH regions: The Basket Apparatus (Apparatus 1), the...
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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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Draft Updates to the Planning for Natural Disaster Debris Guidance and to Related Documents
EPA is requesting comment on the draft update of the Planning for Natural Disaster Debris Guidance, along with two other documents. This Guidance is an update of the Planning for Natural Disaster Debris guidance that EPA published in March 2008.
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-01-21
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-D-0470... Human Clinical Trials and Marketing Authorization for Pharmaceuticals; Availability AGENCY: Food and... the availability of a guidance entitled ``M3(R2) Nonclinical Safety Studies for the Conduct of Human...
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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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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
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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A review of the FDA draft guidance document for software validation: guidance for industry.
Keatley, K L
1999-01-01
A Draft Guidance Document (Version 1.1) was issued by the United States Food and Drug Administration (FDA) to address the software validation requirement of the Quality System Regulation, 21 CFR Part 820, effective June 1, 1997. The guidance document outlines validation considerations that the FDA regards as applicable to both medical device software and software used to "design, develop or manufacture" medical devices. The Draft Guidance is available at the FDA web site http:@www.fda.gov/cdrh/comps/swareval++ +.html. Presented here is a review of the main features of the FDA document for Quality System Regulation (QSR), and some guidance for its implementation in industry.
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-09-18
...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
2011-05-18
... Controls Guidance Document: In Vitro Diagnostic Devices for Bacillus Species Detection AGENCY: Food and... Guidance Document: In Vitro Diagnostic Devices for Bacillus spp. Detection.'' This draft guidance document describes means by which in vitro diagnostic devices for Bacillus species (spp.) detection may comply with...
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Federal Register 2010, 2011, 2012, 2013, 2014
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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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
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
2011-08-23
... Commission; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers Association; the Centers for Drug...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-03-08
... drugs and biotechnology derived products, intended to treat patients with advanced cancer. The... studies for the development of pharmaceuticals, including both drugs and biotechnology derived products...
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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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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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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
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
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
2013-07-15
... Level for Arsenic in Apple Juice; A Quantitative Assessment of Inorganic Arsenic in Apple Juice... Arsenic in Apple Juice'' (the draft supporting document) and ``A Quantitative Assessment of Inorganic... document entitled ``A Quantitative Assessment of Inorganic Arsenic in Apple Juice.'' The draft guidance...
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Federal Register 2010, 2011, 2012, 2013, 2014
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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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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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
2013-07-24
... Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and... Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation (Layers with Outdoor Access)'' (the draft guidance). The document provides guidance to egg producers on...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-11-20
...] 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
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
2011-05-02
...] 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
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
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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DOE Office of Scientific and Technical Information (OSTI.GOV)
Kruse, P.; Rojas-Palma, C.
2007-07-01
European national emergency response plans have long been focused on accidents at nuclear power plants. Recently, the possible threats by disaffected groups have shifted the focus to being prepared also for malevolent use of radiation that are aimed at creating disruption and panic in the society. The casualties will most likely be members of the public. According to the scenario, the number of affected people can vary from a few to mass casualties. The radiation exposure can range from very low to substantial, possibly combined with conventional injuries. There is a need to develop practicable tools for the adequate responsemore » to such acts and more specifically to address European guidelines for triage, monitoring and treatment of exposed people. Although European countries have developed emergency response plans for nuclear accidents they have not all made plans for handling malevolent use of radioactive material. Indeed, there is a need to develop practical guidance on emergency response and medical treatment of the public affected by malevolent acts. Generic guidance on this topic has been published by international organisations. They are, however, not operational documents to be used in emergency situations. The Triage, Monitoring and Treatment (TMT) Handbook aims to strengthen the European ability to efficiently respond to malevolent acts in terms of protecting and treating exposed people. Part of the Handbook is also devoted to public information and communication issues which would contribute to public reassurance in emergency situations. The Handbook will be drafted by European and international experts before it is circulated to all emergency response institutions in Europe that would be a part of the handling of malevolent acts using radioactive material. The institutions would be given a 6 months consultation time with encouragement to test the draft Handbook in national exercises. A workshop will allow feedback from these end users on the content, structure and usefulness of the Handbook before a final version is produced. In order to achieve the project's objectives a consortium has been drawn together including, Belgian Nuclear Research Centre, the Norwegian Radiation Protection Authority, Radiation and Nuclear Safety Authority of Finland, the UK Health Protection Agency, the Central Laboratory for Radiological Protection of Poland and the World Health Organisation. Enviros Consulting is acting as the technical secretariat for the project. The Handbook will aim to harmonise the approaches to handling malevolent acts across Europe. This harmonisation will have an added value on the public confidence in authorities since differing approaches in neighbouring countries could lead to public confusion and mistrust. (authors)« less
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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
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
2013-05-17
... 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
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
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
2013-12-10
... 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
2013-04-24
... 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
2013-12-10
...] 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
2010-04-05
... Physical Medicine Device Guidance Documents; Availability AGENCY: Food and Drug Administration, HHS. ACTION... controls guidance documents for 11 neurological and physical medicine devices. FDA has developed a draft... stimulator device achieves ``aesthetic effects through physical change to the structure of the body'' as well...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-07-02
..., choosing a study population, using a control group and blinding, dose selection, treatment plans...] Draft Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of Cellular... document entitled ``Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of...
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Federal Register 2010, 2011, 2012, 2013, 2014
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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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
2010-03-23
...] Draft Guidance for Industry on Irritable Bowel Syndrome--Clinical Evaluation of Products for Treatment... topics regarding irritable bowel syndrome (IBS) sign and symptom assessment for IBS with diarrhea (IBS-D... IBS. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-01-05
... electronic or written comments on the draft guidance by April 5, 2011. ADDRESSES: Submit written requests for... INFORMATION section for information on electronic access to the guidance. Submit electronic comments on the..., plasma, and blood. These devices are used to aid in the diagnosis of Lyme disease. This document does not...
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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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78 FR 72122 - Draft Emergency Preparedness Frequently Asked Questions
Federal Register 2010, 2011, 2012, 2013, 2014
2013-12-02
... NUCLEAR REGULATORY COMMISSION [NRC-2013-0262] Draft Emergency Preparedness Frequently Asked... of guidance documents related to the development and maintenance of emergency preparedness program... the interpretation or applicability of emergency preparedness guidance issued or endorsed by the NRC...
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76 FR 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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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
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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SSTAC/ARTS review of the draft Integrated Technology Plan (ITP). Volume 6: Controls and guidance
NASA Technical Reports Server (NTRS)
1991-01-01
Viewgraphs of briefings from the Space Systems and Technology Advisory Committee (SSTAC)/ARTS review of the draft Integrated Technology Plan (ITP) on controls and guidance are included. Topics covered include: strategic avionics technology planning and bridging programs; avionics technology plan; vehicle health management; spacecraft guidance research; autonomous rendezvous and docking; autonomous landing; computational control; fiberoptic rotation sensors; precision instrument and telescope pointing; microsensors and microinstruments; micro guidance and control initiative; and earth-orbiting platforms controls-structures interaction.
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-15
... Drugs in Food-Producing Animals: Comparative Metabolism Studies in Laboratory Animals; Availability...: Comparative Metabolism Studies in Laboratory Animals'' (VICH GL47). This guidance has been developed for... Metabolism and Residue Kinetics of Veterinary Drugs in Food- Producing Animals: Comparative Metabolism...
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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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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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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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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
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
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
2012-09-17
... 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
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
2013-05-28
... documenting the responsibilities of all parties involved in drug manufacturing, testing, or other support... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0558] Draft Guidance for Industry on Contract Manufacturing Arrangements for Drugs: Quality Agreements...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-12-13
..., 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
2010-10-13
... Production (NOP 5021); Wild Crop Harvesting (NOP 5022); Outdoor Access for Organic Poultry (NOP 5024); Commingling and Contamination Prevention in Organic Production and Handling (NOP 5025); and The Use of Chlorine Materials in Organic Production and Handling (NOP 5026). These draft guidance documents are...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-06-12
... 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
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
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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Menges, Klaus
2008-07-01
Assessing Rules for Marketing Authorisation Applications and the Common Technical Document provide the framework regarding data-related requirements and regarding the structural requirements of marketing authorisation application dossiers, similar to the structural levels and rooms of buildings on the one hand and their interior equipment on the other hand. Since the 1970s requirements about how to submit application dossiers and how to assess them have become increasingly harmonised, aiming for the use of a single format and identical rules for assessment. In regard of the format, harmonisation has been achieved beyond Europe by implementing the mandatory use of CTD in the three main regions of interests of the pharmaceutical industry, Japan, the United States of America and Europe. The assessment rules have been extensively harmonised throughout Europe in a way that the same rules apply to the marketing authorisation applications submitted in Germany as well as in other Member States. Different interpretations of the guidance documents, different understanding of the provided data or divergent conclusions drawn up may still occur. All stakeholders within the European network of Drug Regulatory Affairs will act on the level floor of the European and--apart from some exceptions--also nationally implemented legislation. This will not only serve the internationally acting pharmaceutical companies' interests but also consumer interests in obtaining consistent information on drug products based on transparent rules safeguarding the necessary pharmaceutical quality, efficacy and safety with respect to an adequate risk-benefit relationship.
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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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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
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
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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Federal Register 2010, 2011, 2012, 2013, 2014
2012-06-07
... standard genetic toxicology battery for prediction of potential human risks, and on interpreting results... followup testing and interpretation of positive results in vitro and in vivo in the standard genetic... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-D-0178...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-15
... recommends a framework for metabolism testing, it is important that the design of the studies remains... Products; Guidance for Industry on Studies To Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Metabolism Study To Determine the Quantity and Identify the Nature of...
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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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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
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
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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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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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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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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FixO3: Advancement towards Open Ocean Observatory Data Management Harmonisation
NASA Astrophysics Data System (ADS)
Behnken, Andree; Pagnani, Maureen; Huber, Robert; Lampitt, Richard
2015-04-01
Since 2002 there has been a sustained effort, supported as European framework projects, to harmonise both the technology and the data management of Open Ocean fixed observatories run by European nations. FixO3 started in September 2013, and for 3 more years will coordinate the convergence of data management best practice across a constellation of moorings in the Atlantic, in both hemispheres, and in the Mediterranean. To ensure the continued existence of these unique sources of oceanographic data as sustained observatories it is vital to improve access to the data collected, both in terms of methods of presentation, real-time availability, long-term archiving and quality assurance. The data management component of FixO3 improves access to marine observatory data by harmonising data management standards, formats and workflows covering the complete life cycle of data from real time data acquisition to long-term archiving. Legal and data policy aspects have been examined and discussed to identify transnational barriers to open-access to marine observatory data. As a result, a harmonised FixO3 data policy was drafted, which provides a formal basis for data exchange between FixO3 infrastructures, and also enables open access to data for the general public. FixO3 interacts with other European infrastructures such as EMODnet, SeaDataNet, PANGAEA, and especially aims to harmonise efforts with OceanSites and MyOcean. The project landing page (www.fixo3.eu) offers detailed information about every observatory as well as data visualisations and direct downloads. In addition to this, metadata for all FixO3 - relevant data are available from the searchable FixO3 metadata catalogue, which is also accessible from the project web page. This catalogue is hosted by PANGAEA and receives updates in regular intervals. The FixO3 Standards & Services registry ties in with the GEOSS Components and Services Registry (CSR) and provides additional observatory information. The data management efforts are central to FixO3. As a result of the procedural and technological harmonisation efforts undertaken in the project, the FixO3 network of observatories is accumulating unique, quality controlled data sets that will develop into a legacy repository of openly accessible oceanographic data.
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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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Federal Register 2010, 2011, 2012, 2013, 2014
2011-11-01
... Draft Microbial Risk Assessment Guideline: Pathogenic Microorganisms With Focus on Food and Water AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: The Agency is announcing that Eastern Research... Water. EPA previously announced the release of the draft guidance for a 60 day comment period (76 FR...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-29
... process includes submitting a time and extent application (TEA) to determine whether a condition is..., submitting safety and effectiveness data. This guidance is designed to clarify the TEA process and what happens after a TEA is submitted. This guidance finalizes the draft guidance for industry entitled ``Time...
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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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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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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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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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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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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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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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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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[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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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
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
2013-12-05
... 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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Geisler, I; Hofmann, H-P; Nickel, L
2005-02-01
Directive 2001/20/EC of the European Parliament and the Council of 4 April 2001 aims to harmonise national regulations governing clinical trials of medicinal products for human use in the European Union. This aim is to be achieved by harmonising the legal regulations and administrative provisions in force in the Member States, especially with respect to the requirements for starting and conducting clinical trials, taking into account international ethical and scientific standards (Good Clinical Practice). The goal is to further improve the protection of participants in clinical trials and to promote clinical research within the European Union. In Germany, the necessary transposition into the national Drug Law has taken place in the form of the 12th Law Amending the Drug Law of 30 July 2004 as well as complementary implementation provisions. The amendments to the German Drug Law affect in particular the official authorisation procedure, the involvement of ethics committees as well as the conduct of clinical trials on minors. The Directive's requirements have been transposed into German law while maintaining the high level of protection for the participants in clinical trials which had already existed in German legislation.
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Banholzer, Maria Longauer; Wandel, Christoph; Barrow, Paul; Mannino, Marie; Schmitt, Georg; Guérard, Melanie; Müller, Lutz; Greig, Gerard; Amemiya, Kenjie; Peck, Richard; Singer, Thomas; Doessegger, Lucette
2016-12-01
This is an update to our 2012 publication on clinical trial considerations on male contraception and collection of pregnancy information from female partner, after critical review of recent (draft) guidances released by the International Council for Harmonisation [ICH] the Clinical Trial Facilitation Group [CTFG] and the US Food & Drug Administration [FDA]. Relevant aspects of the new guidance documents are discussed in the context of male contraception and pregnancy reporting from female partner in clinical trials and the approach is updated accordingly. Genotoxicity The concept of a threshold is introduced using acceptable daily intake/permissible daily exposure to define genotoxicity requirements, hence highly effective contraception in order to avoid conception. The duration for highly effective contraception has been extended from 74 to 90 days from the end of relevant systemic exposure. Teratogenicity Pharmacokinetic considerations to estimate safety margins have been contextualized with regard to over- and underestimation of the risk of teratogenicity transmitted by a vaginal dose. The duration of male contraception after the last dose takes into account the end of relevant systemic exposure if measured, or a default period of five half-lives after last dose for small molecules and two half-lives for immunoglobulins (mAbs). Measures to prevent exposure of the conceptus via a vaginal dose apply to reproductively competent or vasectomized men, unless measurements fail to detect the compound in seminal fluid. Critical review of new guidance documents provides a comparison across approaches and resulted in an update of our previous publication. Separate algorithms for small molecules and monoclonal antibodies are proposed to guide the recommendations for contraception for male trial participants and pregnancy reporting from female partners. No male contraception is required if the dose is below a defined threshold for genotoxic concern applicable to small molecules. For men treated with teratogenic mAbs, condom use to prevent exposure of a potentially pregnant partner is unlikely to be recommended because of the minimal female exposure anticipated following a vaginal dose. The proposed safety margins for teratogenicity may evolve with further knowledge.
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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
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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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
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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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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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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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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New legal requirements for submission of product information to poisons centres in EU member states.
de Groot, Ronald; Brekelmans, Pieter; Desel, Herbert; de Vries, Irma
2018-01-01
In the past eight years, the European Association of Poisons Centres and Clinical Toxicologists (EAPCCT) has been intensively involved in a European Commission led process to develop EU legislation on the information of hazardous products that companies have to notify to EU Poisons Centres (or equivalent "appointed bodies"). As a result of this process, the Commission adopted Regulation (EU) No 2017/542, amending the CLP Regulation by adding an Annex on harmonised product submission requirements. Harmonised mixture information requirements: Detailed and consistent information on the composition of the hazardous product will become available to EU Poisons Centres (PC). The information will be submitted by companies to PCs (or equivalent "appointed bodies") using a web-based software application or in-house software. Two new important features are introduced. Firstly, to be able to rapidly identify the product formula, a Unique Formula Identifier (UFI) on the product label links to the submitted information. Secondly, for better comparability of reports on poisonings between EU member states, a harmonised Product Categorisation System will specify the intended use of a product. Rapid product identification and availability of detailed composition information will lead to timely and adequate medical intervention. This may lead to considerable reduction in healthcare costs. Additionally, for companies trading across the EU, costs of submission of this information will be reduced significantly. Next steps: From 2017, an implementation period has started, consisting of a three-year period for stakeholders to implement the new requirements, followed by a gradual applicability for consumer products (2020), professional products (2021) and industrial use-only products (2024). Technical tools to generate the electronic format and the UFI together with guidance documents are expected to be made available by the end of 2017 by the European Chemicals Agency (ECHA). Guidance on interpretation of legal text and ECHA helpdesk support are planned to be ready at the end of 2018.
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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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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
2010-05-20
... 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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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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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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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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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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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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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
2010-06-17
... 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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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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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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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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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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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
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
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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Protection from radon exposure at home and at work in the directive 2013/59/Euratom.
Bochicchio, F
2014-07-01
In recent years, international organisations involved in radiation protection and public health have produced new guidance, recommendations and requirements aiming better protection from radon exposure. These organisations have often worked in close collaboration in order to facilitate the establishment of harmonised standards. This paper deals with such standards and specifically with the new European Council Directive of 5 December 2013 on basic safety standards for protection against the dangers arising from exposure to ionising radiation (2013/59/Euratom). This new Directive has established a harmonised framework for the protection against ionising radiations, including protection from radon exposure. Requirements for radon in workplace are much more tightening than in previous Directive, and exposures to radon in dwellings are regulated for the first time in a Directive. Radon-related articles of this Directive are presented and discussed in this paper, along with some comparisons with other relevant international standards. © The Author 2014. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.
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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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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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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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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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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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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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Federal Register 2010, 2011, 2012, 2013, 2014
2010-04-29
... office in processing your request, or fax your request to CDRH to 301-847-8149. See the SUPPLEMENTARY... guidance you are requesting. A search capability for all CDRH guidance documents is available at http://www... Response Responses Response Total Hours CDRH 110 1 110 12 1,320 CBER 4 1 4 12 48 Total 1,368 \\1\\ There are...
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Federal Register 2010, 2011, 2012, 2013, 2014
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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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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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
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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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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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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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
2011-12-28
... 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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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
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
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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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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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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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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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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2016-06-23
The Food and Drug Administration (FDA) is announcing the availability of its FDA Adverse Event Reporting System (FAERS) Regional Implementation Specifications for the International Conference on Harmonisation (ICH) E2B(R3) Specification. FDA is making this technical specifications document available to assist interested parties in electronically submitting individual case safety reports (ICSRs) (and ICSR attachments) to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). This document, entitled "FDA Regional Implementation Specifications for ICH E2B(R3) Implementation: Postmarket Submission of Individual Case Safety Reports (ICSRs) for Drugs and Biologics, Excluding Vaccines" supplements the "E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation Guide--Data Elements and Message Specification" final guidance for industry and describes FDA's technical approach for receiving ICSRs, for incorporating regionally controlled terminology, and for adding region-specific data elements when reporting to FAERS.
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Gourmelon, Anne; Delrue, Nathalie
Ten years elapsed since the OECD published the Guidance document on the validation and international regulatory acceptance of test methods for hazard assessment. Much experience has been gained since then in validation centres, in countries and at the OECD on a variety of test methods that were subjected to validation studies. This chapter reviews validation principles and highlights common features that appear to be important for further regulatory acceptance across studies. Existing OECD-agreed validation principles will most likely generally remain relevant and applicable to address challenges associated with the validation of future test methods. Some adaptations may be needed to take into account the level of technique introduced in test systems, but demonstration of relevance and reliability will continue to play a central role as pre-requisite for the regulatory acceptance. Demonstration of relevance will become more challenging for test methods that form part of a set of predictive tools and methods, and that do not stand alone. OECD is keen on ensuring that while these concepts evolve, countries can continue to rely on valid methods and harmonised approaches for an efficient testing and assessment of chemicals.
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76 FR 9529 - Migratory Birds; Draft Eagle Conservation Plan Guidance
Federal Register 2010, 2011, 2012, 2013, 2014
2011-02-18
... maintenance of land-based, wind energy facilities in the United States. DATES: We must receive any comments or... electricity from wind turbines has increased dramatically in the range [[Page 9530
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Helder, Theo
2008-01-01
The conditions under which safety data may be accepted by regulatory authorities (RAs) in OECD Countries do not only include the obligation to apply the principles of good laboratory practice (GLP) while producing these data, but also must countries, partaking in the Organisation for Economic Cooperation and Development (OECD) system for mutual acceptance of data (MAD), establish a monitoring programme to ensure proper application of the GLP principles. Detailed guidance to this end is given in the OECD GLP documents No. 2 and 3. Nevertheless, this guidance permits countries quite some freedom where it concerns the organisation of their programmes. Monitoring programmes may be embedded in governmental as well as private structures. It appears that GLP compliance monitoring is increasingly charged to accreditation bodies. Inspectors may be full-time or part-time workers, and there are differences in scheduling and performing inspections and study audits. Also the financing of the monitoring programmes is diverging: in some countries the programme is fully or partly paid by the inspected test facilities (TFs), while in other countries the financing comes from the national treasury. Is there a need for harmonisation in this area, as there is and was in the interpretation of the GLP principles themselves? Over the years more than ten consensus and advisory documents have been published by the OECD working group on GLP. The very existence of these documents is however no guarantee that the interpretation of the GLP principles by inspectors is similar, let alone identical. The most important criterion is, in fact, that there be no harm for human health and the environment.
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Kassianos, George; Blank, Patricia; Falup-Pecurariu, Oana; Kuchar, Ernest; Kyncl, Jan; De Lejarazu, Raul Ortiz; Nitsch-Osuch, Aneta; van Essen, Gerrit A
2016-01-01
Currently there is no influenza vaccination guidance for European general practitioners. Furthermore, although the European Council recommends a target seasonal influenza vaccination rate of 75% in the elderly (65 years and above) and in anyone aged >6 months with a chronic medical condition, there remain wide discrepancies throughout Europe. A harmonised guideline regarding not only vaccination strategy but also for the consistent diagnosis of influenza across Europe is essential to support a common approach for the implementation of seasonal influenza vaccination across Europe. This document is based on pre-existing guidelines available in the UK and Netherlands and has been approved by a group of European experts for use throughout Europe. As well as providing a standardised influenza diagnosis, it also reviews the current recommendations for influenza vaccination, the types of vaccine available, the contraindications, vaccine use in special populations (in pregnancy, children, and in those with egg allergy), and concomitant administration with other vaccines. The effectiveness, safety, and timing of the seasonal influenza vaccine are also reviewed. A second section provides practical guidance for general practitioners for the implementation of a seasonal influenza vaccination program, including the selection and notification of those eligible for vaccination, as well as suggestions for the organisation of a vaccination programme. Finally, suggested responses to common patient misconceptions and frequently asked questions are included. The aim of this article is to harmonise the diagnosis of seasonal influenza and the approach of European general practitioners to seasonal influenza vaccination in order to better identify influenza outbreaks and to move towards reaching the target vaccination rate of 75% throughout Europe.
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Kassianos, George; Blank, Patricia; Falup-Pecurariu, Oana; Kuchar, Ernest; Kyncl, Jan; De Lejarazu, Raul Ortiz; Nitsch-Osuch, Aneta; van Essen, Gerrit A
2016-01-01
Currently there is no influenza vaccination guidance for European general practitioners. Furthermore, although the European Council recommends a target seasonal influenza vaccination rate of 75% in the elderly (65 years and above) and in anyone aged >6 months with a chronic medical condition, there remain wide discrepancies throughout Europe. A harmonised guideline regarding not only vaccination strategy but also for the consistent diagnosis of influenza across Europe is essential to support a common approach for the implementation of seasonal influenza vaccination across Europe. This document is based on pre-existing guidelines available in the UK and Netherlands and has been approved by a group of European experts for use throughout Europe. As well as providing a standardised influenza diagnosis, it also reviews the current recommendations for influenza vaccination, the types of vaccine available, the contraindications, vaccine use in special populations (in pregnancy, children, and in those with egg allergy), and concomitant administration with other vaccines. The effectiveness, safety, and timing of the seasonal influenza vaccine are also reviewed. A second section provides practical guidance for general practitioners for the implementation of a seasonal influenza vaccination program, including the selection and notification of those eligible for vaccination, as well as suggestions for the organisation of a vaccination programme. Finally, suggested responses to common patient misconceptions and frequently asked questions are included. The aim of this article is to harmonise the diagnosis of seasonal influenza and the approach of European general practitioners to seasonal influenza vaccination in order to better identify influenza outbreaks and to move towards reaching the target vaccination rate of 75% throughout Europe. PMID:27540408
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Quality assurance and quality control in mammography: a review of available guidance worldwide.
Reis, Cláudia; Pascoal, Ana; Sakellaris, Taxiarchis; Koutalonis, Manthos
2013-10-01
Review available guidance for quality assurance (QA) in mammography and discuss its contribution to harmonise practices worldwide. Literature search was performed on different sources to identify guidance documents for QA in mammography available worldwide in international bodies, healthcare providers, professional/scientific associations. The guidance documents identified were reviewed and a selection was compared for type of guidance (clinical/technical), technology and proposed QA methodologies focusing on dose and image quality (IQ) performance assessment. Fourteen protocols (targeted at conventional and digital mammography) were reviewed. All included recommendations for testing acquisition, processing and display systems associated with mammographic equipment. All guidance reviewed highlighted the importance of dose assessment and testing the Automatic Exposure Control (AEC) system. Recommended tests for assessment of IQ showed variations in the proposed methodologies. Recommended testing focused on assessment of low-contrast detection, spatial resolution and noise. QC of image display is recommended following the American Association of Physicists in Medicine guidelines. The existing QA guidance for mammography is derived from key documents (American College of Radiology and European Union guidelines) and proposes similar tests despite the variations in detail and methodologies. Studies reported on QA data should provide detail on experimental technique to allow robust data comparison. Countries aiming to implement a mammography/QA program may select/prioritise the tests depending on available technology and resources. •An effective QA program should be practical to implement in a clinical setting. •QA should address the various stages of the imaging chain: acquisition, processing and display. •AEC system QC testing is simple to implement and provides information on equipment performance.
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Taylor, Rod S; Hutton, John; Culyer, Anthony J
2002-01-01
One of the principal roles of the National Institute for Clinical Excellence (NICE) is to appraise selected existing and emerging healthcare technologies and, as a result, produce guidance for the National Health Service (NHS) in England and Wales. A central part of this appraisal is the potential for manufacturers and sponsors to make a data submission. This paper describes the process of development of the second edition of technical guidance to manufacturers and sponsors for submission to NICE. The revision process took place during the period May 2000 and January 2001 and involved a number of key steps -- establishment of a guidance steering committee, review of current international guidelines of clinical and cost effectiveness, drafting of the guidance, detailed consultation with stakeholders, revision of the guidance and, finally, publication. The lessons learnt from revision of the NICE guidance for manufacturers and sponsors and some main issues for its future development are discussed.
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-02-21
... and magnitude of drug-drug interactions for several reasons. Concomitant medications, dietary supplements, and some foods, such as grapefruit juice, may alter metabolism and/or drug transport abruptly in...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-09-23
... provides industry and agency staff with updated recommendations concerning 510(k) submissions for various... will be relevant for premarket notification (510(k)) submissions for these device types. Detection...
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GASB to Issue Proposals on Pensions.
ERIC Educational Resources Information Center
Gauthier, Stephen
1994-01-01
The Governmental Accounting Standards Board has released three exposure drafts addressing the proper accounting and financial reporting for pensions. If approved, the new guidance would affect both pension plans and employers offering pension benefits to their employees. (Author)
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-08-15
... Assessment (C-CASA) categories, along with definitions and explanations; (3) revises the advice on which... C-CASA categories eliminates the need for any additional coding; (7) provides multiple additional...
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76 FR 50231 - Mobile Medical Applications Draft Guidance; Public Workshop
Federal Register 2010, 2011, 2012, 2013, 2014
2011-08-12
... p.m. on September 9, 2011. For those without Internet access, please call the contact person to... will be posted, as it becomes available, on the Internet at http://www.fda.gov/MedicalDevices/News...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-02-07
... CONTACT: Subhas Malghan, Center for Devices and Radiological Health, Food and Drug Administration, 10903... respiratory ailments, and development of irritant dermatitis or Type IV allergy when glove powder is used on...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-11-27
...), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-8465. SUPPLEMENTARY... in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be...
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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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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
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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Federal Register 2010, 2011, 2012, 2013, 2014
2011-11-02
...: Song-Hua Shen, Division of Risk Analysis, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: (301) 251- 7571, email: Song-Hua.Shen@nrc.gov...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-02-06
... comments to: RADB at (301) 492-3446. FOR FURTHER INFORMATION CONTACT: Song-Hua Shen, Division of Risk...-0001; telephone: (301) 251- 7571, email: Song-Hua.Shen@nrc.gov . SUPPLEMENTARY INFORMATION: Submitting...
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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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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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Guidelines for Preparing Economic Analysis (2010, revised 2014)
The Guidelines for Preparing Economic Analyses: External Review Draft have been prepared for review by the EPA Science Advisory Board and are part of a continuing effort by the U.S. EPA to develop improved economic guidance to support decision making.
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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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Federal Register 2010, 2011, 2012, 2013, 2014
2011-04-13
... Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to... exploration and verification of drug effects under epidemic and pandemic conditions. A draft notice of...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-07-06
... scientific workshop. In addition, FDA is aware that dengue viruses are endemic in Quintana Roo and Jalisco. FDA is currently evaluating the risk of dengue virus infections in U.S. blood donors that are acquired...
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RESEARCH PLAN FOR ENDOCRINE DISRUPTORS (DRAFT)
This research strategy was developed to provide a roadmap for the EPA Office of Research and Developments program on endocrine disruptors. It was developed by a team of scientists representing all of ORDs National Laboratories and Centers and is intended to provide guidance to bo...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-02-03
... fludeoxyglucose (FDG) 18 injection, ammonia N 13 injection, and sodium fluoride F 18 injection used in PET imaging... assist the manufacturers of certain PET drugs--fludeoxyglucose (FDG) F 18 injection, ammonia N 13...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-08-03
... drug substance than what is intended to be delivered to the patient. This excess amount of drug... issue not only to the patient, but also to others including family members, caregivers, children, and...
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Guide for curing of Portland cement concrete pavements : volume II.
DOT National Transportation Integrated Search
2006-08-01
Information on the current state of knowledge of curing hydraulic-cement concrete and on current curing practice : was gathered by means of a literature review and a review of current standard guidance. From this information, a : draft guide for curi...
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77 FR 26562 - Mobile Offshore Drilling Unit Dynamic Positioning Guidance
Federal Register 2010, 2011, 2012, 2013, 2014
2012-05-04
... regarding a draft policy letter on Dynamic Positioning (DP) Systems, Emergency Disconnect Systems, Blowout... Coast Guard, NOSAC issued the report ``Recommendations for Dynamic Positioning System Design and... DEPARTMENT OF HOMELAND SECURITY Coast Guard [USCG-2011-1106] Mobile Offshore Drilling Unit Dynamic...
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75 FR 81675 - Notice of Issuance of Regulatory Guide
Federal Register 2010, 2011, 2012, 2013, 2014
2010-12-28
... Fuel Cycle Facilities.'' FOR FURTHER INFORMATION CONTACT: Mekonen M. Bayssie, Regulatory Guide... Materials in Liquid and Gaseous Effluents from Nuclear Fuel Cycle Facilities,'' was published as Draft... guidance is applicable to nuclear fuel cycle facilities, with the exception of uranium milling facilities...
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75 FR 35508 - Draft Regulatory Guide: Issuance, Availability
Federal Register 2010, 2011, 2012, 2013, 2014
2010-06-22
... Systems and Networks,'' requires licensees to develop cyber-security plans and programs to protect critical digital assets, including digital safety systems, from malicious cyber attacks. Regulatory Guide 5.71, ``Cyber Security Programs for Nuclear Facilities,'' provides guidance to meet the requirements of...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-07-21
... infusion pump stand, which is currently classified as a class I device because it supports the intended use of an infusion pump (class II medical device). A mobile medical app that simply supports the intended...
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Exposure Factors Handbook - Update (2009, External Review Draft)
The mission of National Center for Environmental Assessment (NCEA) of EPA's Office of Research and Development is to provide guidance and risk assessments aimed at protecting human health and the environment. To accomplish this mission, NCEA works to develop and improve the mode...
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Heng, K S; Hejar, A R; Rushdan, A Z; Loh, S P
2013-04-01
Metabolic syndrome (MetSyn) as defined by the latest Harmonised definition and the agreement between the Harmonised definition and other definitions is poorly studied among Malaysians. This study was conducted to determine and compare the prevalence of MetSyn according to the Harmonised, International Diabetes Federation (IDF) and National Cholesterol Education Program (NCEP ATPIII) definitions among Malay staff of Universiti Putra Malaysia (UPM). Subjects aged between 20 to 65 years were recruited by convenient sampling. Waist circumference, blood pressure, lipid profiles and fasting plasma glucose levels were assessed. The agreement between the Harmonised and other definitions was determined by Kappa statistics. A total of 227 subjects with a mean +/- SD age of 37.9 +/- 9.6 years participated in the study. The overall prevalence of MetSyn was 38.3%, 38.8% and 33.5% according to Harmonised, IDF and NCEP ATP III definitions, respectively. Generally, men had higher prevalence of MetSyn than women. The prevalence increased with age in both genders with a more progressive trend in women. Men in the age group of 20-39 years had a high prevalence of metabolic syndrome. A strong agreement was found between the Harmonised and the IDF definitions (Kappa index = 0.991), and between the Harmonised and the NCEP ATP III definitions (Kappa index = 0.857). Regardless of definitions used, the prevalence of metabolic syndrome in the study, especially in young men, was high and warrants further investigation. The Harmonised definition is suitable for diagnosing metabolic syndrome in any population with similar sociodemographic characteristics.
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[Animal Health Law-- the National Animal Health Act and the European Animal Health Law].
Bätza, Hans-Joachim; Mettenleiter, Thomas
2013-01-01
The Animal Health Act that replaces the Animal Disease Act, which is currently in force, creates a regulatory framework in order to not only, as has been the case so far, control animal diseases that had already broken out, but in order to already prevent in advance possible outbreaks of animal diseases by means of preventive measures. The instruments to this effect are described here. At European level, too, the idea of prevention is set to play a greater role in the future, with the draft EU legal instrument on animal health, that has to date only been discussed at Commission level, also contributing to a simplification and easier implementation by the persons subject to law by harmonising the currently fragmented Community law. It remains to be seen when the deliberations in the Council and European Parliament will begin.
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76 FR 28403 - National Registry of Certified Medical Examiners
Federal Register 2010, 2011, 2012, 2013, 2014
2011-05-17
... [Docket No. FMCSA-2008-0363] RIN 2126-AA97 National Registry of Certified Medical Examiners ACTION: Notice... by training providers in implementing the National Registry of Certified Medical Examiners (National... included minimum training requirements for medical examiners. The draft guidance announced by this notice...
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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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USEPA is developing alternative approaches to quantify improvements to impaired waterbodies (USEPA 303(d)/TMDL Draft Guidance). Tribal environmental programs are leading the way in the paradigm shift towards sustainability of natural resources. Resources such as wildlife, aquatic...
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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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Sexual Harassment on Campus: A Legal Compendium.
ERIC Educational Resources Information Center
Van Tol, Joan E., Ed.
Law review and journal articles on sexual harassment in higher education are presented along with policies and procedures from selected universities and organizations, guidance on drafting policies, and a selected bibliography. The following law review and journal articles are presented: "Recent Legal Developments in Sexual Harassment"…
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-12-26
..., Office of Planning & Informatics, Center for Drug Evaluation and Research, Food and Drug Administration... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0643...: Food and Drug Administration, HHS. ACTION: Notice; correction. [[Page 76050
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78 FR 66698 - Pesticides; Repellency Awareness Graphic; Notice of Availability
Federal Register 2010, 2011, 2012, 2013, 2014
2013-11-06
... information you consider to be Confidential Business Information (CBI) or other information whose disclosure... products for quick and easy identification by the consumer. Prototypes of this graphic were presented to... from several key stakeholder groups. Starting in May 2012, EPA presented the concept, draft guidance...
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IRIS Toxicological Review of Dichlorobenzenes (2004 External Review Draft)
The goal of this assessment is to evaluate both carcinogenic and non-cancer toxicity based on the proposed July 1999 Cancer Guidelines and other relevant guidance. This approach will provide a better understanding of the toxicity and will aid in making informed risk-based decisio...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-06-14
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0790] Food and Drug Administration Decisions for Investigational Device Exemption Clinical Investigations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug...
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78 FR 1574 - Regulatory Agenda
Federal Register 2010, 2011, 2012, 2013, 2014
2013-01-08
... Infusion Pumps. 281 Requirements for the 0910-AG59 Testing and Reporting of Tobacco Product Constituents... Use Devices: Issuance of Draft Special Controls Guidance for Infusion Pumps Legal Authority: 21 U.S.C... proposing to amend the classification of infusion pumps from class II (performance standards) to class II...
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CRYPTOSPORIDIUM LOG INACTIVATION CALCULATION METHODS
Appendix O of the Surface Water Treatment Rule (SWTR) Guidance Manual introduces the CeffT10 (i.e., reaction zone outlet C value and T10 time) method for calculating ozone CT value and Giardia and virus log inactivation. The LT2ESWTR Pre-proposal Draft Regulatory Language for St...
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21 CFR Appendix A to Subpart B of... - Relevant Legislation, Regulations, and Procedures.
Code of Federal Regulations, 2010 CFR
2010-04-01
... Federal Food, Drug and Cosmetic Act, 21 U.S.C. 321 et seq. b. The Public Health Service Act, 42 U.S.C. 201... Program, 63 FR 28392 (May 22, 1998). f. Draft Guidance for Staff, Industry and Third Parties, Third Party...
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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
2012-02-15
... information (e.g., characterization, adventitious agent safety, process controls, and specifications) for the... Manufacturing Process Assessment of Physiochemical Properties Functional Activities Receptor Binding and... 351(k) application. FDA will also seek OMB approval for this information collection. In addition, this...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-04-12
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0165] International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal... veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-04-04
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0288] International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal... been developed for veterinary use by the International Cooperation on Harmonisation of Technical...
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Kinuya, Seigo; Yoshinaga, Keiichiro; Higuchi, Tetsuya; Jinguji, Megumi; Kawamoto, Hiroshi; Kurihara, Hiroaki
2015-02-01
131I-MIBG radiotherapy has been used for unresectable nueroendocrine tumors including malignant pheochromocytomas and neuroblastomas in foreign countries since the '80s when clinical therapeutic trials were initiated. In Japan, 131I-MIBG radiotherapy has not been approved by Ministry of Health, Labor and Welfare, however, personally imported 131I-MIBG is now available in limited institutions for therapeutic purpose. This updated guideline draft aims to provide useful information concerning 131I-MIBG radiotherapy, to prevent side effects, and to protect physicians, nurses, other health care professionals, patients and their families from radiation exposure. The committee also provides appendices including practical guidance for attending physicians, patient management and referring physicians for their conveniences.
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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
2011-09-09
... of wetland, riparian, desert grassland, and shrub-steppe habitats, with emphasis on removing feral... primarily shrub-steppe uplands, but also include important springs and spring brooks, basalt cliffs and... reasonable, scientifically- grounded guidance for improving the Refuge's shrub-steppe, riparian, wetland, and...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-12-11
... DEPARTMENT OF TRANSPORTATION Federal Transit Administration [Docket Number: FTA-2013-0019] Notice... and Request for Comment AGENCY: Federal Transit Administration (FTA), DOT. ACTION: Notice of availability; request for comment. SUMMARY: The Federal Transit Administration (FTA) announces the availability...
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75 FR 80850 - Development of Strategic Plan 2011-2015
Federal Register 2010, 2011, 2012, 2013, 2014
2010-12-23
... intended for use as LSC embarks on its planning process. LSC anticipates publishing a draft Strategic Plan... process to develop a Strategic Plan for the years 2011-2015. Toward that end, LSC is soliciting... strategic planning efforts. In addition, Among other sources, LSC is considering the guidance provided by...
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DOT National Transportation Integrated Search
2009-04-01
This study details the development of a series of enhancements to the Trip Reduction Impacts of : Mobility Management Strategies (TRIMMS) model. TRIMMS allows quantifying the net social : benefits of a wide range of transportation demand management...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-03-23
... Cigarettes and Smokeless Tobacco To Protect Children and Adolescents; Availability AGENCY: Food and Drug... Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and... the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-12-27
... for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human Studies... feasibility studies of medical devices, using appropriate risk mitigation strategies, under the... comments on the key principles unique to the justification for, and design of, early feasibility studies...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-06-29
... (HFV-12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville..., Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: William T. Flynn, Center for Veterinary Medicine (HFV... Food-Producing Animals.'' Antimicrobial drugs have been widely used in human and veterinary medicine...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-09-20
... include the sex hormones (e.g., estrogen and androgen), the hypothalamic-pituitary-adrenal axis, the thyroid hormone, and the hormones involved in the feedback regulation of those components (e.g., gonadotropin releasing hormone and corticotropin). Changes in endocrine function can result in...
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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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Federal Register 2010, 2011, 2012, 2013, 2014
2011-05-11
... Characteristics of In Vitro Diagnostic Devices for Chlamydia Trachomatis and/or Neisseria Gonorrhoeae: Screening... entitled ``Establishing the Performance Characteristics of In Vitro Diagnostic Devices for Chlamydia... clinical performance of in vitro diagnostic devices (IVDs) intended for C. trachomatis and/or N...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-08-02
... either electronic or written comments on the collection of information by October 1, 2013. ADDRESSES: Submit electronic comments on the collection of information to http://www.regulations.gov . Submit... detecting antibodies to T. cruzi in plasma and serum samples from individual human donors, including donors...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-07-22
... and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0487... dated December 2010, as an acceptable mechanism that is consistent with FDA's requirements and...
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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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Federal Register 2010, 2011, 2012, 2013, 2014
2012-02-15
... reference product for the purpose of submitting a marketing application through an abbreviated licensure... submitting a marketing application through the abbreviated licensure pathway under section 351(k) of the... FDA will use to review applications for biosimilar products; and General scientific principles in...
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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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The identification and quantitation of non-method-specific target analytes have greater importance with respect to EPA's current combustion strategy. The risk associated with combustion process emissions must now be characterized. EPA has recently released draft guidance on pr...
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75 FR 5630 - Draft Regulatory Guide: Issuance, Availability
Federal Register 2010, 2011, 2012, 2013, 2014
2010-02-03
... specific parts of the NRC's regulations, techniques that the staff uses in evaluating specific problems or postulated accidents, and data that the staff needs in its review of applications for permits and licenses... in license applications and for monitoring and reporting effluent data by licensees. The guidance 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-2006-D-0157... Patients With Disorders Affecting the Hematopoietic System; Availability AGENCY: Food and Drug 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
2011-03-15
... appropriate steps during the manufacturing process to prevent cross-contamination of finished pharmaceuticals... implementing appropriate steps during the manufacturing process to prevent cross-contamination of finished... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0104...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-02-11
... for Therapeutic Protein Products.'' Therapeutic protein products may elicit immune responses, and... evaluate and mitigate immune responses that may adversely affect their safety and efficacy. DATES: Although... these factors that may reduce the likelihood that these products will generate an immune response. In...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-03-18
... Industry and FDA Staff; Total Product Life Cycle: Infusion Pump--Premarket Notification [510(k... for Industry and FDA Staff; Total Product Life Cycle: Infusion Pump--Premarket Notification [510(k... Staff; Total Product Life Cycle: Infusion Pump--Premarket Notification [510(k)] Submissions--0910-NEW...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-02-28
... Prescription Drug and Biological Products Labeling; Availability AGENCY: Food and Drug Administration, HHS... (BPCA) and the Pediatric Research Equity Act (PREA), as amended by the Food and Drug Administration... Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-11-25
... violations of access, advertising, and promotion restrictions of regulations promulgated under section 906(d... advertising and promotion of, cigarettes and smokeless tobacco products; (2) the health and economic effects... employees be notified both verbally and in writing of the importance of complying with laws prohibiting the...
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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
2013-01-03
...ApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm253101.htm , http://www.regulations.../Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm253101.htm , http...), in a format that FDA can process, review, and archive. Currently, the Agency can process, review, and...
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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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Harmonising Training and Development across an Industry: The Case of Australian Rail
ERIC Educational Resources Information Center
Short, Tom; Harris, Roger McL.
2017-01-01
Purpose: This paper aims to explore why harmonisation, given its potential, is so difficult to achieve. It analyses the issues and challenges in achieving harmonisation of training and development across an industry. Design/methodology/approach: The approach was a meta-analysis of six research projects undertaken in the Australian rail industry.…
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-02-04
... FURTHER INFORMATION CONTACT: Robert Temple, Center for Drug Evaluation and Research, Food and Drug... Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1145...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-03-13
... Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New... and Development (HFM-40), Center for Biologics Evaluation and Research, Food and Drug Administration..., Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-05-09
... Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD... Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852...: Colleen L. Locicero, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-06-08
... has been proposed by these two agencies to address emergency planning and preparedness for Nuclear..., to measure the adequacy of emergency preparedness plans of Nuclear Power Plant (NPP) owners and... changes proposed in FEMA's draft Radiological Emergency Preparedness Program Manual and Supplement 4 to...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-06-09
... Cigarettes and Smokeless Tobacco to Protect Children and Adolescents; Availability AGENCY: Food and Drug... Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and... restricting the sale and distribution of cigarettes and smokeless tobacco in order to protect children and...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-01-25
... Environmental Impact Statement for Tuolumne Wild and Scenic River Comprehensive Management Plan, Yosemite... Statement (DEIS) for the proposed Tuolumne Wild and Scenic River Comprehensive Management Plan (TRPCMP). The...), and will provide long-term guidance for management of the 54 miles of the Tuolumne River that flows...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-01-31
... intended for transfusion, including recommendations for validation and quality control monitoring of the..., including recommendations for validation and quality control monitoring of the leukocyte reduction process... control number 0910-0052; the collections of information in 21 CFR 606.100(b), 606.100(c), and 606.121...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-05-19
... Pesticide Registrants on False or Misleading Pesticide Product Brand Names AGENCY: Environmental Protection... Pesticide Product Brand Names.'' PR Notices are issued by the Office of Pesticide Programs (OPP) to inform... concerning pesticide product brand names that may be false or misleading, either by themselves or in...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-08-29
... risk-based approach to the oversight of clinical investigations. It does not create or confer any... a range of approaches to monitoring. FDA currently has OMB approval for the information collection... Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-02-18
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0082... effectiveness and adverse effects). Genetic variations can also influence the exposure- response (E/R... overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-03-22
... ``Confidential Business Information'' (``CBI''). If a person making comments wants EPA to base its decision on a... special arrangements should be made for deliveries of boxed information. On-Line Instructions for... http://www.regulations.gov , including any personal information provided, unless the comment includes...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-09-09
... that the staff uses in evaluating specific problems or postulated accidents, and data that the staff... turbine missiles. NUREG/CR 7004 is the technical basis for regulatory guidance on design-basis hurricane... hurricane wind speeds for new nuclear power plants. [[Page 54919
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Report #13-P-0057, November 27, 2012. EPA has taken a number of actions to address findings and recommendations from the OIG’s 2008 report, including developing the GAP Online database, drafting a GAP guidebook, and revising GAP guidance.
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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
2013-01-22
... intends to provide the underlying principles to determine the type of marketing submission that may be... industry and FDA staff on the underlying principles to determine the type of marketing submission that may... Modifications to a Combination Product Approved Under Certain Marketing Applications; Availability AGENCY: Food...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-07-09
... INFORMATION CONTACT: Sherri Comerford, Underground Injection Control (UIC) Program, Drinking Water Protection Division, Office of Ground Water and Drinking Water (MC-4606M), Environmental Protection Agency, 1200... Fracturing and the Safe Drinking Water Act Web site, http://water.epa.gov/type/groundwater/uic/class2...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-10-18
... requirements described in Sec. 211.100(b); and standard operating procedures should be reviewed and revised or..., and update. The draft guidance also encourages manufacturers to include a procedure in their Plan for... as which drug products will be manufactured under altered procedures, which products will have...
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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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Federal Register 2010, 2011, 2012, 2013, 2014
2010-08-25
...) requires certain chain restaurants and similar retail food establishments with 20 or more locations... operators'') to disclose calories for articles of food. Restaurants and similar retail food establishments... restaurants can help people make healthier choices (Refs. 1 and 2). Responding to this demand for information...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-07-12
... regard to enforcement of premarket notification (510(k)) requirements for certain in vitro diagnostic and... devices that have established safety and effectiveness profiles and for which it believes 510(k) review is... 510(k) requirement through rulemaking that would reclassify the Class II devices and amend the...
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75 FR 49913 - Draft Guidance, “Federal Greenhouse Gas Accounting and Reporting”
Federal Register 2010, 2011, 2012, 2013, 2014
2010-08-16
... an integrated strategy toward sustainability in the Federal Government and to make reduction of... agencies to measure, report, and reduce their GHG emissions. Section 9(a) of E.O. 13514 directed the... accurately account for and report GHG emissions. In particular, while a detailed approach to accepted and...
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75 FR 41452 - Draft Guidance, “Federal Greenhouse Gas Accounting and Reporting”
Federal Register 2010, 2011, 2012, 2013, 2014
2010-07-16
...) in order to establish an integrated strategy toward sustainability in the Federal Government and to... provisions, E.O. 13514 requires agencies to measure, report, and reduce their GHG emissions. Section 9(a) of... Government's overall ability to accurately account for and report GHG emissions. In particular, while a...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-05-28
... draft Technical Guidance for Assessing Environmental Justice in Regulatory Analysis. There will be a... public comment period, or to submit written public comments, is also Noon, Monday, June 10, 2013. DATES... like to be put on the list to provide public comment, and whether you are submitting written comments...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-03-22
... Design, Data Analysis, and Impact on Dosing and Labeling; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0133...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-02-15
... Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver... Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville... 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
2011-08-15
... medical device for its intended use. Evidence from one or more pivotal clinical studies generally serves... some cases, a PMA may include multiple studies designed to answer different scientific questions. The... studies intended to support premarket submissions for medical devices and for FDA staff who review those...
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Federal Register 2010, 2011, 2012, 2013, 2014
2013-11-20
... and Gene Therapy Products; Extension of Comment Period AGENCY: Food and Drug Administration, HHS...: Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products'' that... sponsors of Investigational New Drug Applications for cellular therapy (CT) and gene therapy (GT) products...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-04-03
... products for consumer use--cigarettes, smokeless tobacco, and roll-your-own tobacco--and not with respect...: Cigarette smoke, smokeless tobacco products, and roll-your- own tobacco and cigarette filler. To facilitate... for cigarette smoke and filler, smokeless tobacco, and roll-your-own tobacco. FDA has created forms to...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-04-03
... Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD... Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD... Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 4288, Silver Spring, MD...
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Federal Register 2010, 2011, 2012, 2013, 2014
2010-10-25
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0529...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is... framework for interactions between the Center for Drug Evaluation and Research (CDER) and DDT sponsors to...
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Federal Register 2010, 2011, 2012, 2013, 2014
2011-12-02
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0800... AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA... Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-06-20
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0419... who conduct studies using active controls and have a basic understanding of statistical principles... clinical investigators who conduct studies using active controls and have a basic understanding of...
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76 FR 41527 - Draft Regulatory Guide: Re-Issuance and Availability
Federal Register 2010, 2011, 2012, 2013, 2014
2011-07-14
... and methods that are acceptable to the NRC staff for implementing specific parts of the NRC's..., and fabrication of mixed-oxide fuel or fuel assemblies. DG-3037 provides guidance on how to meet the... publicly disclosed. You may submit comments by any one of the following methods: Federal Rulemaking Web...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-01-19
... traditional inspection methods to newly reflagged vessels, while at the same time apply a less stringent level... any one of the following methods: (1) Federal eRulemaking Portal: http://www.regulations.gov . (2) Fax... methods. See the ``Public Participation and Request for Comments'' portion of the SUPPLEMENTARY...
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78 FR 49782 - Interim Staff Guidance on Changes During Construction
Federal Register 2010, 2011, 2012, 2013, 2014
2013-08-15
... seven comments on the Draft ISG from the Nuclear Energy Institute (NEI) (ADAMS Accession No. ML12089A019... construction impacts evaluation and the 10 CFR 50.59- like review (including applicability determination..., the construction impacts evaluation and the 10 CFR 50.59 and 10 CFR 50-59-like evaluation (including...
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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...