[Federal Register: September 2, 2005 (Volume 70, Number 170)]
[Notices]
[Page 52399-52400]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02se05-74]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Blood Products Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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).
[[Page 52400]]
Dated: August 26, 2005.
Scott Gottlieb,
Deputy Commissioner for Policy.
[FR Doc. 05-17470 Filed 9-1-05; 8:45 am]
BILLING CODE 4160-01-S