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Notice

Drug Safety and Risk Management Advisory Committee; Amendment of Notice

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Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Drug Safety and Risk Management Advisory Committee. This meeting was announced in the Federal Register of December 11, 2007 (72 FR 70336). The amendment is being made to reflect a change in the Agenda portion of the document. There are no other changes.

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FOR FURTHER INFORMATION CONTACT:

Teresa A. Watkins, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7001, FAX: 301-827-6776, e-mail: Teresa.Watkins@fda.hhs.gov, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington DC area), code 3014512535. Please call the Information Line for up-to-date information on this meeting.

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SUPPLEMENTARY INFORMATION:

In the Federal Register of December 11, 2007, FDA announced that a meeting of the Drug Safety and Risk Management Advisory Committee would be held on February 1, 2008. On page 70336, in the second column, the first paragraph of the Agenda portion of document is amended to read as follows:

Agenda: The committee will discuss the efficacy and safety of new drug application (NDA) 22-054, INJECTAFER (ferric carboxymaltose injection), Luitpold Pharmaceuticals Inc., used for the treatment of iron deficiency anemia in postpartum patients or iron deficiency anemia in patients with heavy uterine bleeding.

This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.

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Dated: January 7, 2008.

Randall W. Lutter,

Deputy Commissioner for Policy.

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[FR Doc. E8-490 Filed 1-14-08; 8:45 am]

BILLING CODE 4160-01-S