[Federal Register Volume 63, Number 106 (Wednesday, June 3, 1998)]
[Notices]
[Pages 30241-30242]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-14760]


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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 regulatory issues.
    Date and Time: The meeting will be held on June 18, 1998, 8 a.m. to 
5:30 p.m., and on June 19, 1998, 8 a.m. to 3 p.m.
    Location: Doubletree Hotel, Plazas I and II, 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 20852-1448, 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 18, 1998, the committee will: (1) Hear updates on 
hepatitis C recipient notification and partner deferral of 
xenotransplantation recipients; (2) discuss information provided on the 
Blood Action Plan, Immune Globulin Intravenous supply issues, and 
Plasma Inventory Hold; and (3) discuss and make recommendations on 
standard testing for human immunodeficiency virus (HIV) variants. On 
June 19, 1998, the committee will: (1) Discuss and make recommendations 
on the review of clinical trial design for Alpha-1-Proteinase 
Inhibitor; and (2) review and discuss the draft report on the 
intramural site visit of the Laboratories of Hemostasis and Cellular 
Hematology, Division of Hematology, and the Laboratories of Hepatitis 
and Molecular Virology, Division of Transfusion Transmitted Diseases.
    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 June 9, 1998. 
Oral presentations from the public will be scheduled between 
approximately 2 p.m. and 3 p.m. on June 18, 1998, and between 10:45 
a.m. and 11:15 a.m. on June 19, 1998. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before June 9, 1998, 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 18, 1998, from 3 p.m. to 
3:30 p.m., and on June 19, 1998, from 10:15 a.m. to 10:45 a.m., the 
meeting will be closed to permit discussion and review of trade secret 
and/or confidential information (5 U.S.C. 552b(c)(4)). These portions 
of the meeting will be closed to discuss increased sensitivity of 
manufacturers' tests for HIV variants and review of clinical trial 
design for Alpha-1-Proteinase Inhibitor. On June 19, 1998, from 2 p.m. 
to 3 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)). This portion of the meeting will be 
closed to discuss the draft report of the intramural site visit.

[[Page 30242]]

    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: May 28, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-14760 Filed 6-2-98; 8:45 am]
BILLING CODE 4160-01-F