[Federal Register Volume 63, Number 33 (Thursday, February 19, 1998)]
[Notices]
[Page 8461]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-4075]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 regulatory issues.
Date and Time: The meeting will be held on March 19, 1998, 8 a.m.
to 6 p.m., and March 20, 1998, 8 a.m. to 3:30 p.m.
Location: DoubleTree Hotel, Plaza I, II and III, 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 March 19, 1998, the Committee will hear an informational
summary of the emerging infections plan of action and discuss and
provide recommendations on the issue of the FDA proposal on plasma
inventory hold. The committee will also discuss the comparison of
infectious disease marker rates in paid versus volunteer donors. On
March 20, 1998, the Committee will discuss and make recommendations on
the issue of classification of blood bank software and the relative
safety of solvent detergent-treated pooled plasma and single-donor
plasma, donor retested. The meeting will conclude with an informational
presentation on the FDA proposal for donor deferrals related to
xenotransplantation.
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 March 9, 1998.
Oral presentations from the public will be scheduled between
approximately 10:30 a.m. and 11 a.m. and 4 p.m. and 5 p.m on March 19,
1998, and between approximately 9:30 a.m. and 10 a.m. and 1 p.m. and
1:30 p.m. on March 20, 1998. Time allotted for each presentation may be
limited. Those desiring to make formal oral presentations should notify
the contact person before March 9, 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: February 11, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-4075 Filed 2-18-98; 8:45 am]
BILLING CODE 4160-01-F
