05-1474. Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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.

Name of Committee: Vaccines and Related Biological Products Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the agency on FDA's regulatory issues.

Date and Time: The meeting will be held on February 16, 2005, from 8:30 a.m. to approximately 5 p.m., and on February 17, 2005, from 8:30 a.m. to approximately 2:05 p.m.

Location: Holiday Inn Select Bethesda, 8120 Wisconsin Ave., Bethesda, MD.

Contact Person: Christine Walsh or Denise Royster, Center for Biologics Evaluation and Research (HFM-71), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-0314, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512391. Please call the Information Line for up-to-date information on this meeting.

Agenda: On February 16, 2005, the committee will review and discuss the selection of strains to be included in the influenza virus vaccine for the 2005-2006 season. On February 17, 2005, the committee will hear updates on FDA Critical Path Initiative and Research Programs in the Center for Biologics Evaluation and Research.

Procedure: On February 16, 2005, from 8:30 a.m. to 5 p.m. and on February 17, 2005, from 8:30 a.m. to 11:25 a.m., the meeting is open to the public. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person by February 9, 2005. Oral presentations from the public will be scheduled between approximately 1 p.m. and 1:30 p.m. on February 16, 2005, and approximately 8:45 a.m. and 9:15 a.m. on February 17, 2005. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before February 9, 2005, and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation.

Closed Committee Deliberations: On February 17, 2005, from approximately 12 noon to 2:05 p.m., the meeting will be closed to permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)) and to permit discussion and review of trade secret and/or confidential information (5 U.S.C. 552b(c)(4)). The committee will discuss individual Research Programs in the Center for Biologics Evaluation and Research and receive an update on a product under review.

Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets.

FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Christine Walsh or Denise Royster at 301-827-0314 at least 7 days in advance of the meeting.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

Dated: January 18, 2005.

Sheila Dearybury Walcoff,

Associate Commissioner for External Relations.