03-20951. Anesthetic and Life Support Drugs Advisory Committee; Amendment of Notice

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 Anesthetic and Life Support Drugs Advisory Committee. This meeting was announced in the Federal Register of July 31, 2003 (68 FR 44955). The amendment is being made to reflect a change in the Agenda portion of the document. There are no other changes.

FOR FURTHER INFORMATION CONTACT:

Johanna M. Clifford, 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, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 12529. Please call the Information Line for up-to-date information on this meeting.

SUPPLEMENTARY INFORMATION:

In the Federal Register of July 31, 2003, FDA announced that a meeting of the Anesthetic and Life Support Drugs Advisory Committee would be held on September 9 and 10, 2003. On page 44956, in the first column, the Agenda portion of the meeting is amended to read as follows:

Agenda: On September 10, 2003, the committee will discuss the abuse liability of and Risk Management Plans for Palladone (Hydromorphone Hydrochloride) Purdue Pharma, LP, a modified-release hydromorphone drug product indicated for the treatment of moderate to severe pain in opioid tolerant patients.

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 12, 2003.

Peter J. Pitts,

Associate Commissioner for External Relations.