Blood Products Advisory Committee
Date and Time: The meeting will be held on July 13, 2006, 8:00 a.m. to 4:30 p.m.; and on July 14, 2006, 8 a.m. to 3:30 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 July 13, 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 meeting held May 9 & 10, 2006; (2) Summary of the workshop on Testing for Malarial Infections in Blood Donors to be held July 12 2006; (3) Committee report on the Office of Blood Research and Review Site Visit, Review of Intramural Research; (4) West Nile Virus Update;. (5) FDA acceptance criteria for in vivo red blood cell survival studies. The Committee will discuss the FDA review of Nabi Biopharmceuticals' Hepatitis B Immunoglobulin Intravenous (IGIV) for prevention of recurrent Hepatitis B Virus (HBV) Disease after othotopic liver transplantation. In the afternoon, the Committee will hear an overview of the research program of the Laboratory of Bacterial, Parasitic and Unconventional Agents, Division of Emerging and Transfusion Transmitted Diseases, OBRR, CBER. On July 14, 2006, from 8 a.m. to 3:30 p.m. the meeting will be closed to permit discussion and review of trade secret and/or confidential information (5 U.S.C. 552b(c)).
Oral Presentations: Between approximately 11 a.m. to 11:30 a.m. and 3 p.m. to 3:30 p.m., on July 13, 2006, oral presentations from the public will be scheduled. Those desiring to make formal oral presentations should notify the contact person before July 5, 2006.
Closed Committee Deliberations: On July 13, 2006, from 3:30 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)). The Committee will discuss a review of the individual research program.
The July 14, 2006, session has been cancelled.