[Federal Register: November 23, 2001 (Volume 66, Number 226)]
[Notices]
[Page 58746]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23no01-61]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Blood Products Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
Name of Committee: Blood Products Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
Date and Time: The meeting will be held on December 13, 2001, from
8 a.m. to 5:30 p.m. and on December 14, 2001, from 8 a.m. to 3:30 p.m.
Location: Hilton Silver Spring Hotel, 8727 Colesville Rd., Silver
Spring, MD.
Contact: Linda A. Smallwood, Center for Biologics Evaluation and
Research (HFM-302), Food and Drug Administration, 1401 Rockville Pike,
Rockville, MD 20852, 301-827-3514, or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area), code 19516. Please call the Information Line for up-to-date
information on this meeting.
Agenda: On December 13, 2001, the following committee updates are
tentatively scheduled: Transmissible spongiform encephalopathies (TSE)
guidance, Centers for Disease Control and Prevention workshop on factor
VIII, update on disaster response, and compliance quality control
oversight. In the morning, the committee will hear presentations,
discuss and make recommendations on potential concerns for simian foamy
virus (SFV) transmission by blood and blood products. In the afternoon,
the committee will hear presentations, discuss and make recommendations
on the leukocyte reduction guidance. On December 14, 2001, the
committee will hear presentations and discuss and make recommendations
on human cells, tissues and cellular and tissue-based products: Risk
factors for semen donation.
Procedure: 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 December 3,
2001. Oral presentations from the public will be scheduled between
approximately 12 noon and 12:30 p.m., and between approximately 3:45
p.m. and 4:45 p.m. on December 13, 2001; and between approximately
11:30 a.m. and 1 p.m. on December 14, 2001. Time allotted for each
presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before December 3, 2001,
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.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: November 15, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 01-29226 Filed 11-21-01; 8:45 am]
BILLING CODE 4160-01-S