[Federal Register: September 2, 2005 (Volume 70, Number 170)]
[Page 52399-52400]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

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 
    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).

[[Page 52400]]

    Dated: August 26, 2005.
Scott Gottlieb,
Deputy Commissioner for Policy.
[FR Doc. 05-17470 Filed 9-1-05; 8:45 am]