Agency: Food and Drug Administration
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[FR Doc E9-18416] 101. Seafood Hazard Analysis and Critical Control Points Alliance for Education
The Food and Drug Administration (FDA) is announcing its intention to receive and consider a single source application for the award of a cooperative agreement in fiscal year 2009 (FY09) to the University of Florida for the support of the Seafood Hazard Analysis and Critical Control Points (HACCP) Alliance for Education and Training. The goal of
Published: 2009-08-03 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-18354] 102. Agency Information Collection Activities; Submission for Office of Management
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.
Published: 2009-07-31 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-18227] 103. International Conference on Harmonisation; Draft Guidance on E16 Genomic
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``E16 Genomic Biomarkers Related to Drug Response: Context, Structure, and Format of Qualification Submissions.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for
Published: 2009-07-30 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-17978] 104. Agency Information Collection Activities; Submission for Office of Management
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.
Published: 2009-07-29 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-17963] 105. Applications for Food and Drug Administration Approval To Market a New Drug;
The Food and Drug Administration (FDA) is amending its regulations to require that the holder of a new drug application (NDA) submit certain information regarding authorized generic drugs in an annual report. We are taking this action as part of our implementation of the Food and Drug Administration Amendments Act of 2007 (FDAAA). FDAAA requires
Published: 2009-07-28 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-17621] 106. Agency Information Collection Activities; Announcement of Office of
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``General Administrative Procedures: Citizen Petitions; Petition for Reconsideration or Stay of Action; Advisory Opinions'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Published: 2009-07-24 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-17332] 107. Agency Information Collection Activities; Announcement of Office of
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Food Contact Substances Notification System'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Published: 2009-07-22 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-17394] 108. Agency Information Collection Activities; Submission for Office of Management
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 (the PRA).
Published: 2009-07-22 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-17356] 109. New Animal Drugs; Change of Sponsor
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for three new animal drug applications (NADAs) and one abbreviated new animal drug application (ANADA) from Virbac AH, Inc., to Cross Vetpharm Group Ltd.
Published: 2009-07-22 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-17329] 110. Agency Information Collection Activities; Announcement of Office of
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Notice of Participation'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Published: 2009-07-22 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-17330] 111. Agency Information Collection Activities; Announcement of Office of
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Published: 2009-07-22 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-17331] 112. Agency Information Collection Activities; Announcement of Office of
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Export of Food and Drug Administration Regulated Products: Export Certificates'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Published: 2009-07-22 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-17218] 113. Advisory Committee; Risk Communication Advisory Committee; Termination and
The Food and Drug Administration (FDA) is announcing the termination and the recharter of the Risk Communication Advisory Committee (the committee). These actions are needed to implement the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Food and Drug Administration Amendments Act of 2007, to change the committee from a
Published: 2009-07-21 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-17094] 114. Agency Information Collection Activities; Announcement of Office of
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Record Retention Requirements for the Soy Protein and Coronary Heart Disease Health Claim'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Published: 2009-07-20 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-16869] 115. Agency Information Collection Activities; Proposed Collection; Comment
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each
Published: 2009-07-15 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-16334] 116. Agency Information Collection Activities; Proposed Collection; Comment
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each
Published: 2009-07-10 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-15682] 117. Guidance for Industry on Updating Labeling for Susceptibility Test
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices.'' The Food and Drug Administration Amendments Act of 2007 (FDAAA) includes a requirement that FDA
Published: 2009-07-02 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-15549] 118. Regulation of Tobacco Products; Request for Comments
The Food and Drug Administration (FDA) is establishing a public docket to obtain information on the implementation of the Family Smoking Prevention and Tobacco Control Act. FDA is establishing this docket in order to provide an opportunity for all interested parties to provide information and share views on the implementation of the new law.
Published: 2009-07-01 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-15403] 119. Organ-Specific Warnings; Internal Analgesic, Antipyretic, and Antirheumatic
The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of April 29, 2009. The document requires important new organspecific warnings and related labeling for overthecounter (OTC) internal analgesic, antipyretic, and antirheumatic drug products. The new labeling informs consumers about the risk of
Published: 2009-06-30 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-15202] 120. Draft Guidance for Industry on Measures to Address the Risk for Contamination
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Guidance for Industry: Measures to Address the Risk for Contamination by Salmonella Species in Food Containing a PistachioDerived Product as an Ingredient'' (draft guidance). The draft guidance, when finalized, is intended to clarify
Published: 2009-06-29 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-14981] 121. Beverages: Bottled Water; Correction
The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of Friday, May 29, 2009 (74 FR 25651). The final rule was published with an inadvertent error in the ``Analysis of Impacts'' section. This document corrects that error.
Published: 2009-06-25 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-14904] 122. Convener of Active Medical Product Surveillance Discussion (U13)
The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of a neutral, independent institution and/or organization that proposes appropriate methods and processes for convening a broad range of stakeholders with relevant expertise to manage and support conferences and meetings. The focus of the
Published: 2009-06-24 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-14501] 123. Agency Information Collection Activities; Proposed Collection; Comment
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days
Published: 2009-06-22 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-14436] 124. Clinical Trials Transformation Initiative (U19)
The Food and Drug Administration (FDA) is announcing the availability of grant funds to support the Clinical Trials Transformation Initiative (CTTI). The goal of CTTI is to support modernization of the clinical trial enterprise by identifying practices that will enhance human subject protection, boost the quality of information derived from
Published: 2009-06-19 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E9-14212] 125. Agency Information Collection Activities; Submission for Office of Management
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.
Published: 2009-06-17 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
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