E8-2824. Anti-Infective Drugs Advisory Committee; 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 January 11, 2008 (73 FR 2055). The amendment is being made to reflect a change in the Date and Time and Agenda portions of the document. 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, Rockville, MD 20857, 301-827-7001, 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 January 11, 2008, FDA announced that a meeting of the Anti-Infective Drugs Advisory Committee would be held on February 27 and 28, 2008. On page 2056, in the first column, the Date and Time and Agenda portions are amended to read as follows:

Date and Time: The meeting will be held on February 27, 2008, from 8 a.m. to 5 p.m.

Agenda: On February 27, 2008, the committee will discuss new drug application (NDA) 022-110, telavancin powder for reconstitution and intravenous administration, Theravance, Inc., proposed for the treatment of complicated skin and skin structure infection.

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

Dated: February 11, 2008.

Randall W. Lutter,

Deputy Commissioner for Policy.