[Federal Register Volume 62, Number 225 (Friday, November 21, 1997)]
[Notices]
[Pages 62323-62324]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-30615]


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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 December 11, 1997, 8 
a.m. to 6 p.m., and December 12, 1997, 8 a.m. to 3:30 p.m.
    Location: DoubleTree Hotel, Plazas 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 12388. Please call the Information Line for up-to-date 
information on this meeting.
    Agenda: On December 11, 1997, the committee will discuss and 
provide recommendations on the issue of FDA's donor deferral policy 
regarding men who have had sex with another man even one time since 
1977.
    On the morning of December 12, 1997, the committee will sit as a 
medical device panel and make recommendations on the issue of in vitro 
diagnostic detection of human immunodeficiency virus (HIV) viral load, 
sponsor, Roche Molecular Systems. In the afternoon, the Committee will 
hear an informational presentation on hepatitis C virus (HCV) risk in 
sexual partners of positive individuals.
    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 December 1, 
1997. Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 4:30 p.m., on December 11, 1997, and between 
approximately 10 a.m. and 11 a.m. and 2 p.m. and 3 p.m., on December 
12, 1997. Time allotted for each presentation may be limited. Those 
desiring to make formal oral presentations should notify the contact 
person before December 1, 1997, 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

[[Page 62324]]

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 14, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-30615 Filed 11-20-97; 8:45 am]
BILLING CODE 4160-01-F