05-2452. 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 March 17, 2005, from 8 a.m. to 5:30 p.m., and on March 18, 2005, from 8:30 a.m. to 2:30 p.m.

Location: Holiday Inn Gaithersburg, 2 Montgomery Village Ave., Gaithersburg, MD.

Contact Person: William Freas or Pearline K. Muckelvene, Center for Biologics Evaluation and Research (HFM-71), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-0314, 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 March 17, 2005, the committee will hear updates on the following topics: Summary of the Department of Health and Human Services Advisory Committee on Blood Safety and Availability meeting, summary of the Transmissible Spongiform Encephalopathies Advisory Committee meeting, update on West Nile Virus guidance, and summaries of the Critical Path Initiative workshop. In the morning, the committee will also discuss and provide recommendations on the safety of albumin. In the afternoon, the committee will hear additional updates on the following topics: International agreements, and a presentation on sharing information with the public. Additionally, the committee will hear presentations, and discuss and provide recommendations on rapid freezing of plasma for transfusion. On the morning of March 18, 2005, the committee will hear presentations, and discuss and provide recommendations on the study design for the abbreviated uniform donor history questionnaire. The committee also will hear presentations related to the review of the site visit report for the Laboratory of Molecular Virology, Division of Emerging and Transfusion Transmitted Diseases, Office of Blood Research and Review.

Procedure: On March 17, 2005, from 8 a.m. to 5:30 p.m., and on March 18, 2005, from 8:30 a.m. to 12:30 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 February 25, 2005. Oral presentations from the public will be scheduled between approximately 11 a.m. and 12 noon, and 3:30 p.m. and 4:45 p.m. on March 17, 2005, and between approximately 9:30 a.m. and 10 a.m. on March 18, 2005. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before March 9, 2005, 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.

Closed Committee Deliberations: On March 18, 2005, between 1:30 p.m. and 2:30 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 the site visit report for the Laboratory of Molecular Virology, Division of Emerging and Transfusion Transmitted Diseases, Office of Blood Research and Review, Center for Biologics Evaluation and Research.

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 William Freas or Pearline K. Muckelvene 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: February 1, 2005.

Sheila Dearybury Walcoff,

Associate Commissioner for External Relations.