Department of Health and Human Services August 2009 – Federal Register Recent Federal Regulation Documents
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Revision of the Requirements for Publication of License Revocation; Confirmation of Effective Date
The Food and Drug Administration (FDA) is confirming the effective date of September 17, 2009, for the direct final rule that appeared in the Federal Register of May 5, 2009 (74 FR 20583). The direct final rule amends the biologics regulations to clarify the regulatory procedures for notifying the public about the revocation of a biologics license. The rule provides that FDA will publish a notice in the Federal Register following revocation of a biologics license under FDA regulations and will include a statement of the specific grounds for the revocation. This document confirms the effective date of the direct final rule.
Draft Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Tomatoes; Availability; Correction
The Food and Drug Administration is correcting a notice that appeared in the Federal Register of August 3, 2009 (74 FR 38438). The document announced the availability of a draft guidance entitled ``Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Tomatoes.'' The document was published with an incorrect date for submitting written or electronic comments on the draft guidance. This document corrects that error.
Draft Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Melons; Availability; Correction
The Food and Drug Administration is correcting a notice that appeared in the Federal Register of August 3, 2009 (74 FR 38437). The document announced the availability of a draft guidancet entitled ``Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Melons.'' The document was published with an incorrect date for submitting written or electronic comments on the draft guidance. This document corrects that error.
Draft Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Leafy Greens; Availability; Correction
The Food and Drug Administration is correcting a notice that appeared in the Federal Register of August 3, 2009 (74 FR 38439). The document announced the availability of a draft guidance entitled ``Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Leafy Greens.'' The document was published with an incorrect date for submitting written or electronic comments on the draft guidance. This document corrects that error.
Clinical Investigator Training Course
The Food and Drug Administration's (FDA's) Office of Critical Path Programs and the Clinical Trials Transformation Initiative (CTTI) are co-sponsoring a 3-day training course for clinical investigators on scientific, ethical, and regulatory aspects of clinical trials. This training course is intended to provide investigators with expertise in the design, conduct, and analysis of clinical trials; improve the quality of clinical trials; and enhance the safety of trial participants. Senior FDA staff will communicate directly with clinical investigators on issues of greatest importance for successful clinical research.
Prescription Drug User Fee Act IV Information Technology Assessment
In the last decade, the Food and Drug Adminstration (FDA) has achieved great success in reforming and modernizing its regulatory processes and responsibilities as a result of changes and improvements driven by the requirements of the Prescription Drug User Fee Act (PDUFA), the 1997 FDA Modernization Act (FDAMA), and other legislation. PDUFA was reauthorized by the Food and Drug Administration Amendments Act of 2007, Title I, Prescription Drug User Fee Amendments of 2007 (PDUFA IV). FDA plans to make even greater progress during the PDUFA IV timeframe (Fiscal Years 2008 through 2012), building on the foundation established in previous years. The additional resources provided by user fees, when combined with appropriations, have enabled the FDA to modernize its information technology infrastructure and begin a monumental transformation from a paper-based to an electronic work environment.
Medical Device Reporting: Electronic Submission Requirements
The Food and Drug Administration (FDA) is proposing to amend its postmarket medical device reporting regulation to require that manufacturers, importers, and user facilities submit mandatory reports of individual medical device adverse events, also known as medical device reports (MDRs) to the agency in an electronic format that FDA can process, review, and archive. Mandatory electronic reporting would improve the agency's process for collecting and analyzing postmarket medical device adverse event information. The proposed regulatory changes would provide the agency with a more efficient data entry process that would allow for timely access to medical device adverse event information and identification of emerging public health issues. Elsewhere in this issue of the Federal Register, FDA is also announcing a draft guidance document that provides recommendations on how to prepare and submit electronic MDRs to FDA in a manner that satisfies the requirements of this proposed regulation. The proposal also includes modifications to the regulations specifying the content of required MDRs to better track information already solicited on the FDA Form 3500A.
Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements
The Food and Drug Administration (FDA) is proposing to amend its postmarketing safety reporting regulations for human drug and biological products to require that persons subject to mandatory reporting requirements submit safety reports in an electronic format that FDA can process, review, and archive. FDA is taking this action to improve the agency's systems for collecting and analyzing postmarketing safety reports. The proposed change would help the agency to more rapidly review postmarketing safety reports, identify emerging safety problems, and disseminate safety information in support of FDA's public health mission. In addition, the proposed amendments would be a key element in harmonizing FDA's postmarketing safety reporting regulations with international standards for the electronic submission of safety information.
Draft Guidance for Industry, User Facilities, and Food and Drug Administration Staff; eMDR-Electronic Medical Device Reporting; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``eMDRElectronic Medical
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``2010-2011 Medical Expenditure Panel Survey Insurance Component.'' In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on this proposed information collection.
Meeting of the AHRQ National Advisory Council for Healthcare Research and Quality Subcommittee on Quality Measures for Children's Healthcare in Medicaid and Children's Health Insurance Programs
In accordance with section 10(a) of the Federal Advisory Committee Act, 5 U.S.C. App. 2, this notice announces a meeting of the National Advisory Council for Healthcare Research and Quality Subcommittee on Quality Measures for Children's Healthcare in Medicaid and Children's Health Insurance Programs (CHIP).
Educating the Public About Removal of Essential-Use Designation for Epinephrine; Public Workshop; Request for Comments
The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Educating the Public About Removal of Essential-Use Designation for Epinephrine.'' The currently approved over-the-counter (OTC) epinephrine metered-dose inhalers (MDIs) contain chlorofluorocarbons (CFCs) and cannot be marketed after December 31, 2011. This 1-day public workshop is intended to seek input from key stakeholders in the asthma community, the pharmaceutical industry, experts in health care communication, and the public on strategies to educate consumers about the decision to remove epinephrine MDIs from the market and transition consumers to therapeutic alternatives that do not contain CFCs or other ozone-depleting substances (ODSs). The agency encourages individuals, patient advocates, industry, consumer groups, health care professionals, researchers, and other interested persons to attend this public workshop.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; MedWatch: Food and Drug Administration Medical Products Reporting Program
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``MedWatch: Food and Drug Administration Medical Products Reporting Program'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Investigational New Drug Regulations
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Investigational New Drug Regulations'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
AHRQ Intent To Publish Grant and Contract Solicitations for Comparative Effectiveness Research (CER) Projects With Funds From the American Recovery and Reinvestment Act (ARRA)
AHRQ is announcing the Agency's intention to support new CER projects, with funding from the American Recovery and Reinvestment Act (ARRA). The ARRA appropriated $300 million to AHRQ for support of CER. ARRA funding will focus, initially, on 14 priority conditions established by the Secretary of the Department of Health and Human Services under Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. These priority conditions were identified through a process involving discussion with, and extensive input from, the public as well as Federal agencies. The list of priority conditions is relevant to the Medicare, Medicaid, and State Children's Health Insurance Program (SCHIP) programs, and can be found at: https://effectivehealthcare.ahrq.gov/ aboutUs.cfm?abouttype=program#Conditions.
Possession, Use, and Transfer of Select Agents and Toxins-Chapare virus
We are proposing to add Chapare virus to the list of HHS select agents and toxins. We are proposing this action because Chapare virus has been phylogenetically identified as a Clade B arenavirus and is closely related to other currently regulated South American arenaviruses that cause haemorrhagic fever, particularly Sabia virus.
Methodologies for Post-Approval Studies of Medical Devices; Public Workshop
The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Methodologies for Post-Approval Studies of Medical Devices.'' The purpose of the workshop is to facilitate discussion among FDA, industry, academia, professional societies, clinical investigators and other interested parties on issues related to methodologies for post-approval studies of medical devices. The target audiences for this workshop are Epidemiologists, Statisticians, Clinicians and Regulatory Affairs Specialists.
Findings of Research Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) and the Assistant Secretary for Health have taken final action in the following case:
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Financial Disclosure by Clinical Investigators
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Financial Disclosure by Clinical Investigators'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Mental Models Study of Farmers' Understanding and Implementation of Good Agricultural Practices
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Mental Models Study of Farmers' Understanding and Implementation of Good Agricultural Practices'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Recommendations for Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Recommendations for Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Study: Toll-Free Number for Consumer Reporting of Drug Product Side Effects in Direct-to-Consumer Television Advertisements for Prescription Drugs
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Development of Antiviral Products for Treatment of Smallpox and Related Poxvirus Infections; Public Workshop
The Food and Drug Administration (FDA) is announcing a public workshop regarding scientific issues in clinical development of antiviral drug products for treatment of smallpox and related poxvirus infections. This public workshop is intended to provide information for and gain perspective from health care providers, academia, and industry on various aspects of antiviral product development for smallpox and related poxvirus infections, including the status of clinical understanding of smallpox from pre-eradication experience, current epidemiology of naturally occurring poxvirus infections, potential effect of antiviral treatment for smallpox and related poxvirus infections, and issues pertaining to animal models for smallpox and related poxvirus infections. The input from this public workshop will help in developing topics for further discussion.
Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2010; Correction
The Food and Drug Administration is correcting a notice entitled that appeared in the Federal Register of August 3, 2009 (74 FR 38429). The document announced the Fiscal Year 2010 fee rates for the Animal Drug User Fee Act. The document was published with a typographical error. This document corrects that error.
Food and Drug Administration Transparency Task Force; Reopening of Comment Period
The Food and Drug Administration (FDA) is reopening until November 6, 2009, the comment period for the notice of public meeting and request for comments that appeared in the Federal Register of June 3, 2009 (74 FR 26712). In the notice of public meeting and request for comments, FDA's Transparency Task Force requested comments on ways in which FDA can make useful and understandable information about FDA activities and decision making more readily available to the public. The agency is taking this action because the agency is planning a second public meeting this fall and is reopening the comment period to allow interested persons additional time to submit comments.
New Animal Drugs for Use in Animal Feeds; Semduramicin; Virginiamycin
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Phibro Animal Health. The NADA provides for use of single-ingredient Type A medicated articles containing semduramyicin (as semduramicin sodium biomass) and virginiamycin to manufacture 2-way combination drug Type C medicated feeds for use in broiler chickens.
Office of the Commissioner Reorganization; Statement of Organizations, Functions, and Delegations of Authority
The Food and Drug Administration (FDA) has reorganized the Office of the Commissioner (OC). This reorganization includes the organizations and their substructure components as listed in this document. This reorganization includes the re-alignment of four Deputy- level offices within the Office of the Commissioner: the Office of the Chief Scientist; the Office of Administration (formerly titled the Office of Operations); the Office of Foods; and the Office of Policy, Planning and Budget (formerly titled the Office of Policy, Planning and Preparedness).
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Irradiation in the Production, Processing, and Handling of Food
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Irradiation in the Production, Processing, and Handling of Food'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of Federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of Federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
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