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July 22, 2005 Meeting
Date and Time:
The meeting will be held on July 22, 2005; 8:00 a.m. to approximately 5:00 p.m.
Location:
Holiday Inn, 2 Montgomery Village Avenue, Gaithersburg, MD 20879; 301-948-8900.
Contact Persons:
William Freas, or Pearline Muckelvene, 301-827-0314, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014519516. Please call the Information Line for up-to-date information on this meeting.
Agenda:
The subcommittee will listen to presentations to further a dynamic, responsive, and cutting edge research program in the Office of Blood Research and Review, Center for Biologics Evaluation and Research (CBER), that facilitates development of safe and effective biological products. The subcommittee's recommendations will be publicly discussed at a future meeting of the Blood Products Advisory Committee. Information regarding CBER's scientific program is outlined in its Strategic Plan of 2004 and is available to the public on the internet at: http://www.fda.gov/cber/inside/mission.htm. Information regarding FDA's Critical Path to New Medical Products is available to the public on the internet at
http://www.fda.gov/oc/initiatives/criticalpath/.
Oral Presentations:
Between approximately 12:15 and 1:15 p.m. oral presentations from the public will be scheduled. Those desiring to make formal oral presentations should notify the contact person by July 14, 2005.
Closed Committee Deliberations:
From approximately 2:15 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)) and to permit discussion and review of trade secret and/or confidential information (5 U.S.C. 552b(c)(4)). The Committee will discuss the internal research programs in the Office of Blood Research and Review, CBER.
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