[Federal Register Volume 64, Number 34 (Monday, February 22, 1999)]
[Notices]
[Page 8577]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-4215]


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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 March 25, 1999, 8 a.m. 
to 5:30 p.m., and March 26, 1999, 8 a.m. to 2:30 p.m.
    Location: Ramada Inn, Embassy Ballroom, 8400 Wisconsin Ave., 
Bethesda, 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 (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 25, 1999, in the morning, the committee will hear, 
discuss, and provide comments on an informational presentation on 
Nucleic Acid Testing of Whole Blood. In the afternoon, the committee 
will discuss and provide comments on Human Immunodeficiency Virus (HIV) 
p24 Antigen Testing and Validation of Donor History Questions. On March 
26, 1999, the committee will discuss and provide comment on an 
informational presentation on Clinical Trial Endpoints for Immune 
Globulin Intravenous and will discuss and provide recommendations on 
algorithms to address Inadvertent Contamination (with HIV, HBsAg, and/
or HCV) of Plasma Pools for Fractionation.
    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 15, 
1999. Oral presentations from the public will be scheduled between 
approximately 10:30 a.m. and 11 a.m.; 1:30 p.m. and 2 p.m.; and 4:30 
p.m. and 5 p.m. on March 25, 1999, and between 8:45 a.m. and 9:15 a.m., 
and 11:30 a.m. and 12 m. on March 26, 1999. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before March 15, 1999, 
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, 1999.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 99-4215 Filed 2-19-99; 8:45 am]
BILLING CODE 4160-01-F