05-3180. 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). The meeting will be open 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 March 15, 2005, from 8:30 a.m. to approximately 5:40 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: The committee will review safety and immunogenicity for two Tetanus Toxoid, Reduced Diptheria Toxoid and Acellular Pertussis Vaccine, Absorbed (Tdap) vaccines. In the morning the committee will review safety and immunogenicity data for a Tdap vaccine manufactured by GlaxoSmithKline Biologicals. In the afternoon the committee will review safety and immunogenicity data for a Tdap vaccine manufactured by Aventis Pasteur Ltd.

Procedure: 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 March 8, 2005. Oral presentations from the public will be scheduled between approximately 11:10 a.m. and 11:40 a.m., and approximately 4:10 p.m. and 4:40 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before March 8, 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.

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 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: February 10, 2005.

Sheila Dearybury Walcoff,

Associate Commissioner for External Relations.