[Federal Register Volume 64, Number 167 (Monday, August 30, 1999)]
[Notices]
[Page 47194]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-22480]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 16, 1999, 8
a.m. to 4:30 p.m. and September 17, 1999, from 8 a.m. to 12:30 p.m.
Location: Ramada Inn, Embassy Ballroom, 8400 Wisconsin Ave.,
Bethesda, 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 September 16, 1999, the following committee updates are
tentatively scheduled: (1) Summary of the August 26 to 27, 1999, Public
Health Service (PHS) Advisory Committee on Blood Safety and
Availability meeting; (2) summary of the July 21, 1999, Workshop on
Donor Suitability: Donor History of Hepatitis; and (3) guidance
document on revised precautionary measures to reduce the possible risk
of transmission of Creutzfeldt-Jakob Disease (CJD) and new variant
Creutzfeldt-Jakob Disease (nvCJD) by blood and blood products. Other
committee updates will be scheduled if the need arises. In the morning,
the committee will hear and discuss an informational presentation on
strategies for increasing the blood supply and discuss and provide
recommendations on nucleic acid testing of blood donors for human
parvovirus B-19. In the afternoon, the committee will hear an
informational presentation on antigen/antibody testing for malaria.
On September 17, 1999, the committee will sit as a medical device
panel for the reclassification of human immunodeficiency virus (HIV)
drug sensitivity assays.
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 7,
1999. Oral presentations from the public will be scheduled from
approximately 10 a.m. to 10:30 a.m.; 11:30 a.m. to 12 noon; and 3 p.m.
to 3:30 p.m. on September 16,1999, and from 9 a.m. to 11 a.m. on
September 17, 1999. Time allotted for each presentation may be limited.
Those desiring to make formal oral presentations should notify the
contact person before September 7, 1999, 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 22, 1999.
Linda A. Suydam
Senior Associate Commissioner
[FR Doc. 99-22480 Filed 8-27-99; 8:45 am]
BILLING CODE 4160-01-F
