03-4974. 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 March 13, 2003, from 8 a.m. to 6 p.m., and March 14, 2003, from 8:30 a.m. to 4 p.m.

Location: Hilton DC North—Gaithersburg, Grand Ballrooms A, B, C, and D, 620 Perry Pkwy., Gaithersburg, MD.

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

Agenda: On March 13, 2003, the following committee updates are tentatively scheduled: FDA consolidation, Medical Device User Fee and Modernization Act, Clinical Laboratory Improvement Amendments waiver for human immunodeficiency, type 1 human immunodeficiency virus-1 (HIV-1) rapid tests, and the Trans Net pilot program. The committee will hear presentations, discuss, and provide recommendations on the topic of West Nile Virus testing. On March 14, 2003, the following committee updates are tentatively scheduled: Limitations on validation of anticoagulant and additive solutions to permit freezing and irradiation of red cells, and particulates in blood bags. The committee will hear presentations, discuss, and provide recommendations on the topic of extensions of the dating period for pooled platelets.

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 March 7, 2003. Oral presentations from the public will be scheduled between approximately 9:15 a.m. and 9:45 a.m.; and 3 p.m. and 4:30 p.m. on March 13, 2003, and between approximately 9 a.m. and 9:30 a.m.; and 10:50 a.m. and noon on March 14, 2003. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before March 7, 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.

FDA regrets that was unable to publish this notice 15 days prior to the March 13 and 14, 2003, 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.

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

Dated: February 26, 2003.

William K. Hubbard,

Associate Commissioner for Policy and Planning.