E9-20377. Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management 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 a meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. This meeting was announced in the Federal Register of August 11, 2009 (74 FR 40207). 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:

Kalyani Bhatt, 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), codes 3014512529 or 3014512535. Please call the Information Line for up-to-date information on this meeting.

SUPPLEMENTARY INFORMATION:

In the Federal Register of August 11, 2009, FDA announced that a meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee would be held on September 23, 2009, from 8 a.m. to 4:30 p.m. On page 40207, in the second column, the Agenda portion of the document is changed to read as follows:

Agenda: The committees will discuss new drug application (NDA) 21-217, EXALGO (hydromorphone HC1), Neuromed Pharmaceuticals, Inc., 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 the advisory committees.

Dated: August 19, 2009.

David Horowitz,

Assistant Commissioner for Policy.