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 July 22, 2004, from 8 a.m. to 6 p.m. and on July 23, 2004, from 8 a.m. to 3 p.m.

Location: Holiday Inn Gaithersburg, Two Montgomery Village Ave., Gaithersburg, MD 20877.

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 3014519516. Please call the Information Line for up-to-date information on this meeting.

Agenda: On July 22, 2004, the committee will hear updates on: FDA current thinking on transfusion related acute lung inflammation (TRALI), and donor blood pressure determination. The committee will also discuss and provide recommendations on the dating of irradiated blood. In the afternoon, the committee will discuss and provide recommendations on the new standards for platelet evaluation and experience with monitoring of bacterial contamination of platelets. On July 23, 2004, the committee will hear an update on West Nile Virus. The committee will also hear presentations, discuss and provide recommendations on hepatitis B virus nucleic acid testing (HBV NAT) for mini-pools. In the afternoon, there will be an informational presentation on current trends in plasma product manufacturing.

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 July 12, 2004. Oral presentations from the public will be scheduled between approximately 8:35 a.m. and 9 a.m., 11 a.m. and 11:30 a.m., 2 p.m. and 2:30 p.m., and 4:30 p.m. and 5 p.m. on July 22, 2004; and between approximately 10:15 a.m. and 11:15 a.m. and 2 p.m. and 2:30 p.m. on July 23, 2004. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before July 12, 2004, 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).