[Federal Register: February 18, 2005 (Volume 70, Number 33)]
[Notices]
[Page 8377]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18fe05-80]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Vaccines and Related Biological Products Advisory Committee;
Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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.
[FR Doc. 05-3180 Filed 2-17-05; 8:45 am]
BILLING CODE 4160-01-S