06-7310. Anti-Infective Drugs Advisory Committee Meeting; Amendment of Notice

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing an amendment to the notice of a meeting of the Anti-Infective Drugs Advisory Committee. This meeting was announced in the Federal Register of July 25, 2006 (71 FR 42096). The amendment is being made to reflect a change in the Date and Time and Agenda portions of the document. The meeting scheduled for September 11, 2006, has been cancelled. There are no other changes.

FOR FURTHER INFORMATION CONTACT:

Sohail Mosaddegh, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 301-827-7001, FAX: [phone], e-mail: [e-mail], or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington DC area), code 3014512530. Please call the Information Line for up-to-date information on this meeting.

SUPPLEMENTARY INFORMATION:

In the Federal Register of July 25, 2006 (71 FR 42096), FDA announced that a meeting of the Anti-Infective Drugs would be held on September 11 and 12, 2006. On page 42096, in the second column, the Date and Time portion of the meeting is amended to read as follows:

Date and Time: The meeting will held on September 12, 2006, from 8 a.m. to 5 p.m.

On page 42096, third column, the Agenda portion of the meeting is amended to read as follows:

Agenda: On September 12, 2006, the committee will discuss supplemental new drug application (sNDA) 21-158/S-006, FACTIVE (gemifloxacin mesylate) Tablets, submitted by Oscient Pharmaceuticals Corp., for the proposed treatment of acute baterial sinusitis.

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

Dated: August 25, 2006.

Randall W. Lutter,

Associate Commissioner for Policy and Planning.