[Federal Register Volume 65, Number 170 (Thursday, August 31, 2000)]
[Notices]
[Pages 53017-53018]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-22463]


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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). At least one 
portion of the meeting will be closed 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 14, 2000, 8 
a.m. to 5 p.m. and September 15, 2000, 8 a.m. to 4 p.m.
    Location: Hilton, 620 Perry Pkwy., Gaithersburg, MD.
    Contact Person: Linda A. Smallwood, Center for Biologics Evaluation 
and Research (HFM-302), 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 September 14, 2000, the following committee updates are 
tentatively scheduled: (1) Summary of the Public Health Service 
Advisory Committee on Blood Safety and Availability meeting, (2) 
Hepatitis C virus lookback, (3) factor VIII and von Willebrand factor 
standards, and (4) shortage issues (blood components and recombinant 
factor VIII). In the morning, the committee will hear presentations, 
and discuss and make recommendations on the human immunodeficency virus 
(HIV) p24 antigen testing of plasma for fractionation (potential 
criteria for discontinuation). In the afternoon, the committee will 
hear presentations, and discuss and make recommendations on deferral, 
as blood or plasma donors, of males who have had sex with males. On 
September 15, 2000, the following updates of recent meetings and 
workshops are tentatively scheduled regarding: (1) Successful practices 
of recruiting blood donors, (2) cord blood, (3) tissue meeting on bone 
products, and (4) the joint meeting of the Transmissible Spongiform 
Encephalopathies Advisory Committee and the Vaccine and Related 
Biological Products Advisory Committee meeting. In the morning, the 
committee will hear presentations, and discuss and make recommendations 
on the current utility of screening blood donors for syphilis. In the 
afternoon, the committee will sit as a medical device panel for the 
classification of human leukocyte antigens (HLA) devices, and will hear 
the report of the intramural site visit of the Laboratory of Molecular 
Virology, Division of Emerging and Transfusion Transmitted Diseases, 
Office of Blood Research and Review (OBRR).
    Procedure: On September 14, 2000, from 8 a.m. to 5 p.m. and on 
September 15, 2000, from 8 a.m. to 3:30 p.m., the meeting is open to 
the public. 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 1, 2000. 
Oral presentations from the public will be scheduled from approximately 
9:30 a.m. to 11:45 a.m. and 3:30 p.m. to 4 p.m. on September 14, 2000; 
and from 11 a.m. to 11:30 a.m. and 1:45 p.m. to 2:15 p.m. on September 
15, 2000. Time allotted for each presentation may be limited. Those 
desiring to make formal oral presentations should notify the contact 
person before August 28, 2000, and submit arguments they wish to 
present, the names and addresses of proposed participants, and an 
indication of the approximate time requested to make their 
presentation.
    FDA regrets that it was unable to publish this notice 15 days prior 
to the September 14 and 15, 2000, Blood Products Advisory Committee 
meeting. Because the agency believes there is some urgency to bring 
these issues to public discussion and qualified members of the Blood 
Products Advisory Committee were available at this time, the 
Commissioner of Food and Drugs concluded that it was in the public 
interest to hold this meeting even if there was not sufficient time for 
the customary 15-day public notice.
    Closed Committee Deliberations: On September 15, 2000, from 3:30 
p.m. to 4 p.m., the meeting will be closed to permit discussion where 
disclosure would constitute a clearly unwarranted invasion of personal 
privacy (5 U.S.C. 552b(c)(6)). The committee will discuss reports of 
the review of individual

[[Page 53018]]

research programs in the Division of Emerging and Transfusion 
Transmitted Diseases, OBRR, Center for Biologics Evaluation and 
Research.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: August 24, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-22463 Filed 8-29-00; 2:17 pm]
BILLING CODE 4160-01-F