[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]


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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 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