Blood Products Advisory Committee

Date and Time:

The meeting will be held on March 9, 2006, 8:00 a.m. to 5:00 p.m.; and on March 10, 2006, 8:30 a.m. to 4:30 p.m.

Location:

Hilton Hotel, 620 Perry Parkway, Gaithersburg, MD, 20879, 301-977-8900.

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 March 9, 2006, in the morning the Committee will hear updates on the following topics: (1) Summary of the Department of Health and Human Services Advisory Committee on Blood Safety and Availability January 2006 meeting; (2) current considerations for blood donor screening for West Nile Virus; (3) classification of transfusion recipient identification (ID) systems; and (4) summary of the workshop on behavior-based donor deferrals in the Nucleic Acid Test (NAT) era. The Committee will then discuss rapid tests for detection of bacterial contamination of platelets. In the afternoon, the Committee will discuss public comments on the "Guidance for Industry and FDA Review Staff: Collection of Platelets by Automated Methods (DRAFT)." On March 10, 2006, in the morning the Committee will discuss proposed studies to support the approval of over-the-counter (OTC) home-use human immunodeficiency virus (HIV) test kits. 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 during their site visit on July 22, 2005, and discuss a subcommittee report in closed session. Additionally, the Committee will hear an overview of the research programs in the Laboratory of Biochemistry and Vascular Biology and the Laboratory of Cellular Hematology, and in closed session discuss the report from the laboratory site visit of October 6, 2005.

Oral Presentations:

Between approximately 9:45 and 11:30 a.m., and 2:30 and 3:30 p.m., on March 9, 2006; and 9:30 and 10:30 a.m., and 2:45 and 2:55 p.m., on March 10, 2006, oral presentations from the public will be scheduled. Those desiring to make formal oral presentations should notify the contact person before February 28, 2006.

Closed Committee Deliberations:

On March 10, 2006, from 3:15 to 4:30 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 a subcommittee's report of the internal research programs in the Office of Blood Research and Review. In addition, the Committee will discuss the site visit report for the Laboratory of Biochemistry and Vascular Biology and Laboratory of Cellular Hematology.