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March 17-18, 2005 Meeting
Date and Time:
The meeting will be held on March 17, 2005, 8:00 am to 5:30 pm; and March 18, 2005, 8:30 am to 2:30 pm.
Location:
Holiday Inn Gaithersburg, 2 Montgomery Village Avenue, Gaithersburg, MD, 301-948-8900.
Contact Persons:
William Freas, Ph.D. or Pearline K. 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:
On March 17, 2005, the Committee will hear updates on the following topics: summary of the Department of Health and Human Services Advisory Committee on Blood Safety and Availability meeting; summary of the Transmissible Spongiform Encephalopathies Advisory Committee meeting; update on West Nile Virus guidance; and summaries of the Critical Path Initiative workshop. In the morning, the Committee will also discuss and provide recommendations on the safety of albumin. In the afternoon, the Committee will hear additional updates on the following topics: update on international agreements and a presentation on sharing information with the public. Additionally, the Committee will hear presentations, discuss and provide recommendations on rapid freezing of plasma for transfusion.
On the morning of March 18, 2005, the Committee will hear presentations, discuss and provide recommendations on the study design for the abbreviated uniform donor history questionnaire. The Committee also will hear presentations related to the review of the site visit report for the Laboratory of Molecular Virology, Division of Emerging and Transfusion Transmitted Diseases, Office of Blood Research and Review.
Oral Presentations:
Between approximately 11:00 am and 12:00 noon, and 3:30 and 4:45 pm on March 17, 2005; and 9:30 and 10:00 am on March 18, 2005, oral presentations from the public will be scheduled. Those desiring to make formal presentations should notify the contact person before March 9, 2005.
Closed Committee Deliberations:
On March 18, 2005, between 1:30 and 2:30 pm, 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 site visit report for the Laboratory of Molecular Virology, Division of Emerging Transfusion Transmitted Diseases, Office of Blood Research and Review, Center for Biologics Evaluation and Research.
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