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Vaccines and Related Biological Products Advisory Committee

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February 16 - 17, 2005 Meeting

Date and Time:

The meeting will be held on February 16, 2005, 8:30 a.m. to 5:00 p.m.; and February 17, 2005, 8:30 a.m. to 2:05 p.m.

Location:

Holiday Inn - Select Bethesda, 8120 Wisconsin Avenue, Bethesda, MD (301) 652-2000.

Contact Persons:

Christine Walsh, R.N. or Denise Royster, 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.

Oral Presentations:

Between approximately 1:00 and 1:30 p.m. on February 16, 2005; and 8:45 and 9:15 a.m. on February 17, 2005, oral presentations from the public will be scheduled. Those desiring to make formal oral presentations should notify the contact person before February 9, 2005.

Closed Committee Deliberations:

On February 17, 2005, from 12:00 p.m. 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.

 

 
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