[Federal Register Volume 65, Number 44 (Monday, March 6, 2000)]
[Notices]
[Pages 11785-11786]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-5394]


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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 March 16, 2000, from 8 
a.m. to 6 p.m. and on March 17, 2000, from 8 a.m. to 3:30 p.m.
    Location: Holiday Inn, 8777 Georgia Ave., Kennedy Grand Ballroom, 
Silver Spring, MD 20910.
    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 March 16, 2000, the following committee updates are 
tentatively scheduled: (1) Summaries of recent workshops on bacterial 
contamination of platelets, (2) criteria for safety and efficacy 
evaluation of oxygen therapeutics as red cell substitutes, (3) 
implementation of universal leukoreduction, and (4) the National 
Institutes of Health Workshop on Parvovirus B19. In the morning, the 
committee will hear presentations, and discuss and make recommendations 
on a submitted proposal to revise the interpretation of indeterminate 
human immunodeficiency virus-1 Western Blots with only nonviral bands. 
In the afternoon, the committee will hear presentations, and discuss 
and make recommendations on the topics of a history of hepatitis in 
blood and plasma

[[Page 11786]]

donors and hepatitis B virus nucleic acid testing. On March 17, the 
committee will hear updates on the following topics: (1) Summary of the 
January 2000 Public Health Service Advisory Committee Meeting on Blood 
Safety and Availability, (2) Creutzfeld-Jacob Disease policy, (3) 
hepatitis C virus lookback guidance, (4) postdonation information 
algorithm, and (5) immune globulin intravenous clinical endpoints. In 
the morning, the committee will hear an informational presentation on 
the blood action plan and supply issues, and discuss and make 
recommendations on donor deferral issues related to 
xenotransplantation. In the afternoon, the committee will be briefed on 
research programs in the Laboratory of Plasma Derivatives, Division of 
Hematology, Center for Biologics Evaluation and Research (CBER).
    Procedure: On March 16, 2000, from 8 a.m. to 6 p.m. and on March 
17, 2000, from 8 a.m. to 3 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 March 7, 2000. Oral presentations 
from the public will be scheduled between approximately 10:30 a.m. and 
11 a.m., 2:30 p.m. and 3 p.m., and 4:30 p.m. and 5 p.m. on March 16, 
2000; and between approximately 9:30 a.m. and 10 a.m., and 11:30 a.m. 
and 12 noon on March 17, 2000. Time allotted for each presentation may 
be limited. Those desiring to make formal oral presentations should 
notify the contact person before March 7, 2000, 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.
    Closed Committee Deliberations: On March 17, 2000, from 3 p.m. to 
3:30 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 research programs in the Division of 
Hematology, CBER.
    FDA regrets that it was unable to publish this notice 15 days prior 
to the March 16 and 17, 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.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: February 28, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-5394 Filed 3-1-00; 4:26 pm]
BILLING CODE 4160-01-F