E8-8683. 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 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 March 27, 2008 (73 FR 16314). The amendment is being made to reflect changes in the introductory paragraph and to add a portion entitled “Closed Committee Deliberations.” There are no other changes.

FOR FURTHER INFORMATION CONTACT:

Teresa Watkins, 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 Washington, DC area), codes 3014512529 and 3014512535. Please call the Information Line for up-to-date information on this meeting.

SUPPLEMENTARY INFORMATION:

In the Federal Register of March 27, 2008, 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 May 5 and 6, 2008.

On page 16314, in the third column, the introductory paragraph of the document is amended to read as follows:

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). At least one portion of the meeting will be closed to the public.

On page 16315, the second column of the document is amended to add a portion entitled “Closed Committee Deliberations” to read as follows:

Closed Committee Deliberations: On May 5, 2008, from 8 a.m. to 9:15 a.m., the meeting will be closed to permit discussion and review of trade secret and/or confidential commercial information (5 U.S.C. 552b(c)(4)). During this session, the committee will discuss the details of a proprietary research report and protocol addressing characteristics of different formulations.

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: April 16, 2008.

Randall W. Lutter,

Deputy Commissioner for Policy.