[Federal Register Volume 63, Number 163 (Monday, August 24, 1998)]
[Notices]
[Page 45074]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-22566]
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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 September 17, 1998, 8
a.m. to 6 p.m., and September 18, 1998, 8 a.m. to 3:30 p.m.
Location: DoubleTree Hotel, 1750 Rockville Pike, Rockville, MD.
Contact Person: Linda A. Smallwood, Center for Biologics Evaluation
and Research (HFM-350), 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 September 17, 1998, the committee will hear: (1) Updates
on HCV nucleic acid testing; (2) year 2000 computer software; (3)
recent review of albumin clinical trials; (4) informational summaries
on the Hematopoietic/Progenitor Cell Products Workshop, Granulocytes
for Transfusion Workshop, Nucleic Acid Testing for HCV and Other
Viruses in Blood Donors Workshop; and (5) an informational presentation
on TT virus and transfusion safety. In the afternoon, the committee
will discuss and make recommendations on the Abbott Laboratories PRISM
Detection Assay for HBsAg, Anti-HCV, and Anti-HTLV-I/II. On September
18, 1998, the committee will discuss and make recommendations on the
topic of routine leukoreduction of blood components.
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 September 4,
1998. On September 17, 1998, oral presentations from the public will be
scheduled between approximately 3:30 p.m. and 4 p.m. and on September
18, 1998, between approximately 11:15 a.m. and 1:30 p.m. Time allotted
for each presentation may be limited. Those desiring to make formal
oral presentations should notify the contact person before September 4,
1998, 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: August 12, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-22566 Filed 8-21-98; 8:45 am]
BILLING CODE 4160-01-F
