[Federal Register Volume 66, Number 109 (Wednesday, June 6, 2001)]
[Notices]
[Pages 30470-30471]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-14286]


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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 June 14, 2001, 8:30 a.m. 
to 5:30 p.m. and June 15, 2001, 8:30 a.m. to 3:45 p.m.
    Location: Gaithersburg Hilton, 620 Perry Pkwy., Gaithersburg, MD 
20877.
    Contact: 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 June 14, 2001, the following committee updates are 
tentatively scheduled: (1) Summary of the Public Health Service 
Advisory Committee on Blood Safety and Availability meeting, and (2) 
current thinking on clinical trial design and performance standards for 
approval of rapid human immunodeficiency virus (HIV) tests. In the 
morning, the committee will hear presentations, and discuss and make 
recommendations on re-entry for donors deferred because of HIV or 
hepatitis C virus (HCV) nucleic acid testing (NAT) or serological test 
results. In the afternoon, the committee will hear presentations, and 
discuss and make recommendations on the Clinical Laboratory Improvement 
Act (CLIA) criteria for invitro diagnostic tests: (1) Applicability of 
waivers to HIV rapid tests, and (2) revision of the uniform

[[Page 30471]]

donor history questionnaire. On June 15, 2001, the following updates 
are tentatively scheduled: Summaries of the Office of Blood Research 
and Review, Center for Biologics Evaluation and Research (CBER), 
transmissible spongiform encephalopathy (TSE) and bovine spongiform 
encephalopathy (BSE) action plans. In the morning, the committee will 
hear an informational presentation, and discuss and make 
recommendations on transfusion-related acute lung injury. In the 
afternoon, the committee will hear presentations on studies on 
leukoreduction filtration failures.
    Procedure: On June 14, 2001, from 8:30 a.m. to 5:30 p.m. and on 
June 15, 2001, from 8:30 a.m. to 3:45 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 June 8, 2001. Oral 
presentations from the public will be scheduled between approximately 
10:15 a.m. and 10:45 a.m., 2:30 p.m. and 3 p.m., and 4:45 p.m. and 5 
p.m. on June 14, 2001; and between approximately 10:15 a.m. and 10:45 
a.m., and 1:45 p.m. and 2:15 p.m. on June 15, 2001. Time allotted for 
each presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before June 8, 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.
    Closed Committee Deliberations: On June 15, 2001, from 3:15 p.m. to 
3:45 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, Office of Blood Research and Review, CBER.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: May 25, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 01-14286 Filed 6-1-01; 4:12 pm]
BILLING CODE 4160-01-S