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Center | Date | Time | Location |
---|---|---|---|
CBER | March 9, 2006 March 10, 2006 |
8:00 a.m. - 5:00
p.m. 8:30 a.m. - 4:30 p.m. |
Hilton Hotel Washington
DC North |
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 (NA T) 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, Center for Biologics Evaluation and Research (CBER), 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, Division of Hematology, Office of Blood Research and Review, CBER and in closed session discuss the report from the laboratory site visit of October 6, 2005.
Background material and meeting information will become available no later than one business day before each meeting day (Simply scroll down to the appropriate committee heading).
Closed Committee Deliberations:
On March 10, 2006, from 3:15 p.m. 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)) 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, CBER. In addition, the committee will discuss
the site visit report for the Laboratory of Biochemistry and Vascular Biology
and Laboratory of Cellular Hematology, Division of Hematology, Office of Blood
Research and Review, CBER. Following this closed session, the committee will
provide summarized comments regarding the Office Site Visit Report in an open
public session.
Procedure:
On March 9, 2006, the meeting is open to the public. On March 10, 2006, from
8:30 a.m. to 3:15 p.m. and again from 4:15 p.m. to 4:30 p.m., the meeting is
open to the public. Interested persons may present data, information, or views,
orally or in writing, on issues pending before the committee. Written submissions
may be made to the contact person by February 28, 2006. Oral presentations from
the public will be scheduled on March 9, 2006, between approximately 9:45 a.m.
to 11:30 a.m. and 2:30 p.m. to 3:30 p.m. On March 10, 2006, oral presentations
from the public will be scheduled between approximately 9:30 a.m. to 10:30 a.m.
and 2:45 p.m. to 2:55 p.m. Time allotted for each presentation may be limited.
Those desiring to make formal oral presentations should notify the contact person
before February 28, 2006, and submit a brief statement of the general nature
of the evidence or arguments they wish to present, the names and addresses of
proposed participants, and an indication of the approximate time requested to
make their presentation. Persons attending FDA's advisory committee meetings
are advised that the agency is not responsible for providing access to electrical
outlets.
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 contact Donald W. Jehn or Pearline K. Muckelvene at least 7 days in advance
of the meeting.
Contact Person:
Donald W. Jehn, or Pearline K. Muckelvene, Center for Biologics
Evaluation and Research (HFM-71), Food and Drug Administration, 1401 Rockville
Pike, Rockville, MD 20852, 301-827-0314.
Advisory Committee Telephone Information Line:
Please call the Information Line for up-to-date information on this
meeting, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014519516.