05-17470. 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 September 29, 2005, from 8 a.m. to 5 p.m.

Location: Food and Drug Administration, conference room 1066, 5630 Fishers Lane, Rockville, MD.

Contact Person: Donald W. Jehn 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 September 29, 2005, the committee will discuss new drug application (NDA) 21-882 proposed trade name EXJADE (deferasirox) Tablets for Oral Suspension, Novartis Pharmaceutical Corp., proposed for the indication of the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis). Following this discussion, the committee will hear an overview of the research programs in the Laboratory of Hemostasis and the Laboratory of Plasma Derivatives, Division of Hematology, Office of Blood Research and Review, Center for Biologics Evaluation and Research (CBER), and in closed session will discuss the report from the laboratory site visit of February 25, 2005.

Procedure: On September 29, 2005, from 8 a.m. to 4:15 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 September 22, 2005. Oral presentations from the public will be scheduled between approximately 11:15 a.m. and 12:15 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before September 22, 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 September 29, 2005, from approximately 4:15 p.m. to 5 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 a review of internal research programs in the Division of Hematology, 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 Donald Jehn 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: August 26, 2005.

Scott Gottlieb,

Deputy Commissioner for Policy.