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March 15, 2002 Meeting
Date and Time:
The meeting will be held on March 15, 2002, 8:00 a.m. to 4:15 p.m.
Location:
Holiday Inn-Bethesda, Versailles I and II, 8120 Wisconsin Avenue, Bethesda, MD 20814, 301-652-2000.
Contact Person:
William Freas, Ph.D. 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 12388. Please call the Information Line for up-to-date information on this meeting.
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please notify the contact persons listed above at least 7 days in advance of the meeting. Persons attending FDA advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets.
Agenda:
On March 15, 2002, the committee will hear updates on: personnel and lot release activities of the Laboratory of Immunobiochemistry (LIB), LIB research programs, particulates in allergen extracts, reduction of possible risk of exposure to TSE agents in allergen extracts, and the statistical power of clinical studies used to assess bioequivalence of allergen extracts. The committee will discuss: considerations for the regulation of recombinant allergens for the diagnosis and treatment of allergic disease, and glycerol in allergen extracts.
Oral Presentations:
Between approximately 11:30 a.m. and 12:00 noon, and between 2:45 and 3:15 p.m. oral presentations from the public will be scheduled. Those desiring to make formal oral presentations should notify the contact person before March 7, 2002.
Closed Committee Deliberations:
From approximately 3:15 to 4:15 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)). This portion of the meeting will be closed to permit discussion of the report of the site visit review of the Laboratory of Immunobiochemistry, in the Division of Bacterial, Parasitic & Allergenic Products, in the Office of Vaccines Research and Review, Center for Biologics Evaluation and Research.
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