[Federal Register: February 18, 2005 (Volume 70, Number 33)]
[Page 8377]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

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 
    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.
[FR Doc. 05-3180 Filed 2-17-05; 8:45 am]