[Federal Register Volume 63, Number 222 (Wednesday, November 18, 1998)]
[Notices]
[Pages 64092-64093]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-30749]
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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 10, 1998, 8
a.m. to 5:30 p.m. and December 11, 1998, 8 a.m. to 3 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 20852-1448, 301-827-3514, or FDA Advisory Committee
Information Line, 1-800-741-8138
[[Page 64093]]
(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 10, 1998, the committee will: (1) Hear updates
on the Hepatitis C Virus (HCV) Lookback Guidance, malaria deferral, and
supply issues regarding plasma derivatives; (2) hear informational
summaries on the Donor Suitability Workshop and the Pilot Program for
Streamlining the Licensure of Blood and Blood Components Workshop; and
(3) discuss the topic of Hepatitis B Anti-Core (Anti-HBc) Re-entry. In
the afternoon, the committee will discuss and provide recommendations
on end user notification initiatives for plasma derivatives. On
December 11, 1998, the committee will discuss and provide
recommendations on the topic of inadvertent contamination of plasma
pools for fractionation and recombinant B-Domain-Deleted Antihemophilic
factor, sponsor: Genetics Institute.
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 November 30,
1998. Oral presentations from the public will be scheduled from
approximately 9 a.m. to 9:30 a.m.; 11:30 a.m. to 12 m.; and 3 p.m. to
3:30 p.m. on December 10, 1998, and from approximately 9 a.m. to 9:30
a.m. and 12 m. to 12:30 p.m. on December 11, 1998. Time allotted for
each presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before November 30,
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: November 9, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-30749 Filed 11-17-98; 8:45 am]
BILLING CODE 4160-01-F
