Agency: Food and Drug Administration
Years: 20002001200220032004200520062007200820092010201120122013[FR Doc E8-26010] 101. Agency Information Collection Activities; Announcement of Office of
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Infant Formula Recall Regulations'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Published: 2008-10-31 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E8-25740] 102. Memorandum of Understanding With the U.S. Army Medical Research Institute of
SUMMARY: The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) with the U.S. Army Research Institute of Infectious Diseases (USAMRIID). This MOU identifies the terms of collaboration between FDA and USAMRIID in the area of emergency preparedness. Specifically this MOU provides for the sharing of
Published: 2008-10-29 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E8-25719] 103. Food Additives Permitted in Feed and Drinking Water of Animals; Methyl Esters
The Food and Drug Administration (FDA) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of methyl esters of conjugated linoleic acid (cis9, trans11 and trans10, cis12 octadecadienoic acids) as a source of fatty acids in swine diets. This action is in response to a food
Published: 2008-10-29 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E8-25791] 104. Agency Information Collection Activities; Announcement of Office of
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Substantiation for Dietary Supplement Claims Made Under the Federal Food, Drug, and Cosmetic Act'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Published: 2008-10-29 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E8-25741] 105. 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: 2008-10-29 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E8-25738] 106. Memorandum of Understanding With the National Heart, Lung, and Blood
The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA's Center for Biologics Evaluation and Research (CBER) and the National Heart, Lung, and Blood Institute (NHLBI), a part of the National Institutes of Health (NIH). This MOU outlines the terms of collaboration between CBER and NHLBI in
Published: 2008-10-29 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E8-25670] 107. Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug
The Food and Drug Administration (FDA) is issuing a final rule that confirms the interim final rule entitled ``TollFree Number for Reporting Adverse Events on Labeling for Human Drug Products'' (73 FR 402, January 3, 2008) (interim final rule) and responds to comments submitted in response to the request for comments in the proposed rule of the
Published: 2008-10-28 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E8-25588] 108. Label Requirement for Food That Has Been Refused Admission Into the United
The Food and Drug Administration (FDA) is correcting a proposed rule that appeared in the Federal Register of Thursday, September 18, 2008 (73 FR 54106). The document issued a proposed rule that would require owners or consignees to label imported food that is refused entry into the United States. The preamble to the proposed rule inadvertently
Published: 2008-10-27 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E8-25586] 109. Intrapartum Electronic Fetal Monitoring With Computer Assisted Diagnosis
The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Intrapartum Electronic Fetal Monitoring (EFM) With Computer Assisted Diagnosis (CAD)Exploring Methods of Evaluation.'' The objectives of this workshop are to gather ideas on how to identify and differentiate categories of EFM/CAD devices and the corresponding
Published: 2008-10-27 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E8-25471] 110. Amendments to the Current Good Manufacturing Practice Regulations for
The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of Monday, September 8, 2008 (73 FR 51919). The final rule was published with an inadvertent error in the ``Analysis of Impacts'' section. This document corrects that error.
Published: 2008-10-24 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E8-25472] 111. 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: 2008-10-24 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E8-25470] 112. Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting
This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.
Name of Committee: Dermatologic and Ophthalmic Drugs Advisory Committee.
General Function of the Committee: To provide advice and recommendations to the agency on FDA's regulatory
Published: 2008-10-24 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E8-25389] 113. Peripheral and Central Nervous System Drugs Advisory Committee; Notice of
This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.
Name of Committee: Peripheral and Central Nervous System Drugs Advisory Committee.
General Function of the Committee: To provide advice and recommendations to the agency on FDA's
Published: 2008-10-24 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E8-25386] 114. Joint Meeting of the Pulmonary-Allergy Drugs Advisory Committee, Drug Safety
This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.
Name of Committees: PulmonaryAllergy Drugs Advisory Committee, Drug Safety and Risk Management Advisory Committee, and the Pediatric Advisory Committee.
General Function of the
Published: 2008-10-24 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E8-25359] 115. Opportunity for Hearing on a Proposal to Withdraw Approval of Prescription
The Food and Drug Administration (FDA) is proposing to withdraw approval of the following abbreviated new drug applications (ANDAs) for drug products containing polyethylene glycol 3350 (PEG 3350) labeled for prescription only use: ANDA 76652 held by Schwarz Pharma, Inc.; ANDA 77736 held by Kali Laboratories, Inc.; ANDA 77706 held by Nexgen Pharma
Published: 2008-10-24 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E8-25211] 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 and to allow 60 days
Published: 2008-10-23 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E8-25336] 117. 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: 2008-10-23 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E8-25338] 118. 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: 2008-10-23 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E8-25346] 119. Substances Prohibited From Use in Animal Food or Feed; Correction
The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of April 25, 2008 (73 FR 22720). The document amended the agency's regulations to prohibit the use of certain cattle origin materials in the food or feed of all animals to further strengthen existing safeguards against bovine spongiform
Published: 2008-10-23 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E8-25091] 120. Agency Information Collection Activities; Announcement of Office of
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Premarket Notification for a New Dietary Ingredient'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Published: 2008-10-21 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E8-25062] 121. Authorization of Emergency Use of Doxycycline Hyclate Tablet Emergency Kits
The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for doxycycline hyclate tablet emergency kits for eligible United States Postal Service (USPS) participants in the Cities Readiness Initiative (CRI) and their household members. FDA is issuing this Authorization under the
Published: 2008-10-21 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E8-25034] 122. Preparation for International Conference on Harmonization Meetings in
The Food and Drug Administration (FDA) is announcing an amendment to the public meeting notice entitled ``Preparation for ICH meetings in Brussels, Belgium.'' This meeting was announced in the Federal Register of September 16, 2008 (73 FR 53428). The amendment is being made to reflect changes in the Location portion of the document. There are no
Published: 2008-10-21 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E8-24932] 123. Draft Guidance for Industry on Tropical Disease Priority Review Vouchers;
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Tropical Disease Priority Review Vouchers.'' There has been significant outside interest in FDA's interpretation of section 1102 of the Food and Drug Administration Amendments Act (FDAAA), which adds a new section 524 to the Federal
Published: 2008-10-20 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E8-24671] 124. Agency Information Collection Activities; Announcement of Office of
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Temporary Marketing Permit Applications'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Published: 2008-10-17 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
[FR Doc E8-24506] 125. FDA-Regulated Products that Contain Bisphenol-A; Request for Information
The Food and Drug Administration (FDA) is requesting assistance in the identification of types of FDAregulated products that contain Bisphenol A (BPA), whether as a component of the product or its packaging, and any information relating to the leaching of BPA from the packaging to the product and/or from the product from the product following
Published: 2008-10-15 DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration
Years: 20002001200220032004200520062007200820092010201120122013