Meetings: Blood Products Advisory Committee,
FR, August 30, 1999 › Notices › Food and Drug Administration
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Federal Register: August 30, 1999 (Volume 64, Number 167)NoticesPage 47194From 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. 99-22480Filed8-27-99; 8:45 amBILLING CODE 4160-01-F
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