[Federal Register Volume 66, Number 165 (Friday, August 24, 2001)]
[Notices]
[Pages 44637-44638]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-21361]


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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 September 20, 2001, from 
8 a.m. to 5 p.m., and on September 21, 2001, from 8 a.m. to 3:30 p.m.
    Location: Hilton DC North--Gaithersburg, 620 Perry Pkwy., 
Gaithersburg, MD.
    Contact: Linda A. Smallwood, Center for Biologics Evaluation and 
Research

[[Page 44638]]

(HFM-302), 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 September 20, 2001, the following committee updates are 
tentatively scheduled: (1) Transmissible spongiform encephalopathies 
guidance; hepatitis B surface antigen lot release guidance; human 
immunodeficiency virus (HIV) and hepatitis C virus nucleic acid 
testing; Clinical Laboratory Improvement Act waiver for HIV rapid 
tests; and (2) compliance quality control oversight. In the morning, 
the committee will hear presentations, discuss and make recommendations 
on potential concerns for simian foamy virus transmission by blood and 
blood products. In the afternoon, the committee will hear 
presentations, discuss and make recommendations on the leukocyte 
reduction guidance. On September 21, 2001, the committee will hear 
presentations, discuss and make recommendations on human cells, tissues 
and cellular and tissue-based products: risk factors for semen 
donation.
    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 September 4, 
2001. Oral presentations from the public will be scheduled between 
approximately 12 noon and 12:30 p.m., and 3:45 p.m. and 4:45 p.m. on 
September 20, 2001; and between approximately 11:30 a.m. and 1 p.m. on 
September 21, 2001. Time allotted for each presentation may be limited. 
Those desiring to make formal oral presentations should notify the 
contact person before September 4, 2001, 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: August 16, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 01-21361 Filed 8-23-01; 8:45 am]
BILLING CODE 4160-01-S