[Federal Register: August 30, 1999 (Volume 64, Number 167)]
[Notices]               
[Page 47194]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30au99-75]                         

-----------------------------------------------------------------------

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