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). 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's regulatory issues.

Date and Time: The meeting will be held on September 14, 2000, 8 a.m. to 5 p.m. and September 15, 2000, 8 a.m. to 4 p.m.

Location: Hilton, 620 Perry Pkwy., Gaithersburg, 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 September 14, 2000, the following committee updates are tentatively scheduled: (1) Summary of the Public Health Service Advisory Committee on Blood Safety and Availability meeting, (2) Hepatitis C virus lookback, (3) factor VIII and von Willebrand factor standards, and (4) shortage issues (blood components and recombinant factor VIII). In the morning, the committee will hear presentations, and discuss and make recommendations on the human immunodeficency virus (HIV) p24 antigen testing of plasma for fractionation (potential criteria for discontinuation). In the afternoon, the committee will hear presentations, and discuss and make recommendations on deferral, as blood or plasma donors, of males who have had sex with males. On September 15, 2000, the following updates of recent meetings and workshops are tentatively scheduled regarding: (1) Successful practices of recruiting blood donors, (2) cord blood, (3) tissue meeting on bone products, and (4) the joint meeting of the Transmissible Spongiform Encephalopathies Advisory Committee and the Vaccine and Related Biological Products Advisory Committee meeting. In the morning, the committee will hear presentations, and discuss and make recommendations on the current utility of screening blood donors for syphilis. In the afternoon, the committee will sit as a medical device panel for the classification of human leukocyte antigens (HLA) devices, and will hear the report of the intramural site visit of the Laboratory of Molecular Virology, Division of Emerging and Transfusion Transmitted Diseases, Office of Blood Research and Review (OBRR).

Procedure: On September 14, 2000, from 8 a.m. to 5 p.m. and on September 15, 2000, from 8 a.m. to 3:30 p.m., the meeting is open to the public. 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 1, 2000. Oral presentations from the public will be scheduled from approximately 9:30 a.m. to 11:45 a.m. and 3:30 p.m. to 4 p.m. on September 14, 2000; and from 11 a.m. to 11:30 a.m. and 1:45 p.m. to 2:15 p.m. on September 15, 2000. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before August 28, 2000, and submit arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation.

FDA regrets that it was unable to publish this notice 15 days prior to the September 14 and 15, 2000, Blood Products Advisory Committee meeting. Because the agency believes there is some urgency to bring these issues to public discussion and qualified members of the Blood Products Advisory Committee were available at this time, the Commissioner of Food and Drugs concluded that it was in the public interest to hold this meeting even if there was not sufficient time for the customary 15-day public notice.

Closed Committee Deliberations: On September 15, 2000, from 3:30 p.m. to 4 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)). The committee will discuss reports of the review of individual research programs in the Division of Emerging and Transfusion Transmitted Diseases, OBRR, Center for Biologics Evaluation and Research.

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