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November 3 - 4, 2005 Meeting
Date and Time:
The meeting will be held on November 3, 2005, 8:00 a.m. to 5:30 p.m.; and on November 4, 2005, from 8:00 a.m. to 3:30 p.m.
Location:
Holiday Inn Gaithersburg, 2 Montgomery Village Avenue, Gaithersburg, MD, 20879, 301-948-8900.
Contact Persons:
Donald W. Jehn 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:
On November 3, 2005, in the morning, the Committee will hear updates on the following topics: (1) West Nile Virus; (2) draft guidance on NAT for HIV-1 and HCV: testing, product disposition and donor deferral and re-entry; (3) summary of the Department of Health and Human Services Advisory Committee on Blood Safety and Availability meeting held on September 19-20, 2005; and (4) re-entry of donors deferred based on anti-HBc test results. The Committee will discuss approaches to over-the-counter (OTC) home-use HIV test kits the rest of the day. On November 4, 2005, in the morning, the Committee will hear information on serious adverse events resulting from interference with measurement of blood glucose following infusion of maltose-containing immune globulin intravenous (Human) and will discuss Alpha-1-Proteinase Inhibitor products. In the afternoon, the Committee will hear an overview of the research programs of the Office of Blood Research and Review, as presented to a subcommittee of the Blood Products Advisory Committee at their site visit on July 22, 2005, and discuss a subcommittee report.
Oral Presentations:
Between approximately 2:00 and 3:45 p.m., on November 3, 2005; and 10:30 and 11:00 a.m. on November 4, 2005, oral presentations from the public will be scheduled. Those desiring to make formal oral presentations should notify the contact person before October 25, 2005.
Closed Committee Deliberations:
On November 4, 2005, from 2:15 to 3:00 p.m., the meeting will be closed to the public. 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 a subcommittee’s report of the internal research programs in the Office of Blood Research and Review.
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