02-21734. 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 12, 2002, from 8 a.m. to 5:30 p.m.

Location: Hilton Silver Spring Hotel, Maryland Ballroom, 8727 Colesville Rd., Silver Spring, MD 20910.

Contact Person: Linda A. Smallwood, Center for Biologics Evaluation and Research (HFM-302), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 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 12, 2002, the following committee updates are tentatively scheduled: (1) Consideration of the Clinical Laboratory Improvement Act (CLIA) waivers for rapid human immunodeficiency virus (HIV) tests; (2) implementation of HIV, type 1/hepatitis C virus nucleic acid testing algorithm; (3) summary of Public Health Service Advisory Committee on Blood Safety and Availability meeting held on September 5, 2002; (4) summary of the workshop on pathogen inactivation held on August 7 and 8, 2002; and (5) blood establishment registration—electronic submissions. In the morning, the committee will hear discussion and provide recommendations on the topic of self-administration of the uniform donor history questionnaire: first time donors. In the afternoon, the committee will hear an informational presentation on testing for Chagas disease, and a presentation on window period for HIV cases and current estimates of residual risk.

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 August 30, 2002. Oral presentations from the public will be scheduled between approximately 11 a.m. and 11:30 a.m., and 3:45 p.m. and 4:30 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before August 30, 2002, 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.

Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets.

FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Linda A. Smallwood or Pearline K. Muckelvene at 301-827-1281 at least 7 days in advance of the meeting.

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

Dated: August 20, 2002.

Linda Arey Skladany,

Senior Associate Commissioner for External Relations.