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 June 15, 2000, from 8 a.m. to 5 p.m. and on June 16, 2000, from 9 a.m. to 12:30 p.m.

Location: Holiday Inn, 8777 Georgia Ave., Silver Spring, MD.

Contact Person: 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 15, 2000, the committee will hear updates on summaries of the Public Health Service Advisory Committee on Blood Safety and Availability meeting, April 25 and 26, 2000; FDA's Transmissible Spongiform Encephalopathies Advisory Committee meeting, June 1 and 2, 2000; the FDA-sponsored workshop on plasticizers, October 18, 1999; and a briefing on blood supply monitoring. The committee will also hear presentations and provide recommendations on plasma pool screening by nucleic acid tests for Hepatitis A virus and, in the afternoon, the committee will hear presentations and provide recommendations on the development of rapid human immunodeficiency virus (HIV) tests. On June 16, 2000, the committee will hear updates on the requirements for syphilis testing, the risk of Hepatitis C virus to sexual partners, and relative sensitivity of Hepatitis B surface antigen and Hepatitis B virus nucleic acid tests. Also, the committee will hear and discuss presentations on the proposed document entitled “FDA Guidance on Universal Leukoreduction: Current Thinking.”

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 Friday, June 2, 2000. Oral presentations from the public will be scheduled between approximately 11 a.m. to 11:30 a.m. and 2:30 p.m. to 3:30 p.m. on June 15, 2000, and between approximately 10:30 a.m. to 11:30 a.m. on June 16, 2000. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before Friday, June 9, 2000, 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).