Vaccines and Related Biological Products Advisory Committee
January 25, 2007 Meeting
Date and Time:
The meeting will be held on January 25, 2007 from 8:00 a.m. to 5:00 p.m.
Location:
Doubletree Hotel, 8120 Wisconsin Ave., Bethesda, MD. 20814, 301-652-2000.
Contact Persons:
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:
In Session I, the committee will hear presentations and make recommendations on the safety and immunogenicity of Diphtheria & Tetanus Toxoids & Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine Combined (DTaP-IPV/Hib), PENTACEL, manufactured by Sanofi Pasteur Limited and in Session II, will hear an overview of the research programs in the Office of Vaccines Research and Review, CBER. In closed session, the committee will discuss the report of the Office of Vaccines Research and Review Office Site Visit of May 19, 2006.
Oral Presentations:
Oral presentations from the public will be scheduled between approximately 11:15 a.m. to 11:45 a.m. and 3:55 p.m. to 4:25 p.m. Those desiring to make formal oral presentations should notify the contact person on or before January 11, 2007.
Closed Committee Deliberations:
On January 25, 2007 from 4:25 p.m. to 5:00 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)). The committee will discuss the report of the May 19, 2006 review of internal research programs in the Office of Vaccines Research and Review, Division of Viral Products and Division of Bacterial Parasitic & Allergenic Products, Center for Biologics Evaluation and Research.