03-21229. 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 18, 2003, from 8 a.m. to 6 p.m.

Location: Gaithersburg Hilton Hotel, 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, 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 18, 2003, the following committee updates are tentatively scheduled: (1) Announcement of appointment of the new Director, Division of Hematology, Office of Blood Research and Review, Center for Biologics Evaluation and Research; (2) summary of Public Health Service Advisory Committee on Blood Safety and Availability; (3) summary of National Heart, Lung and Blood Institute workshop on pathogen reduction and blood component safety; (4) approval of human immune deficiency virus, type 1 (HIV-1) group “O” sensitive assays; (5) revised guidance on Severe Acute Respiratory Syndrome; (6) updated donor travel survey; and (7) labeling and storage: Blood and blood components (proposed regulation). In the morning, the committee will also hear informational presentations on: (1) An overview of counterterrorism exercise; and (2) the current status of West Nile Virus safety. In the afternoon, the committee will hear presentations, discuss and provide recommendations on the topic of supplemental testing for HIV-1 and hepatitis C virus.

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 8, 2003. Oral presentations from the public will be scheduled between approximately 10 a.m. and 10:15 a.m., 11:30 a.m. and 12:30 p.m., and 4:15 p.m. and 4:45 p.m. on September 18, 2003. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before September 8, 2003, 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 13, 2003.

Peter J. Pitts,

Associate Commissioner for External Relations.