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Amended Notice
To reflect cancellation of the closed portion of the meeting and changes in
the Date and Time, Agenda, Procedure, and Closed Committee
Deliberations portions of the meeting.
Center | Date | Time | Location |
---|---|---|---|
CBER | March 3, 2005 March 4, 2005 |
8 a.m. - 6 p.m. 8 a.m. - 5 p.m. |
Quality Suites |
Background material and meeting information will become available no later than one business day before each meeting day (Simply scroll down to the appropriate committee link).
Notice:
The Food and Drug Administration (FDA) is announcing an amendment to the notice
of the meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee
(formerly the Biological Response Modifiers Advisory Committee). This meeting
was announced in the Federal Register of January 27, 2005 (70 FR 3934). The
amendment is being made to reflect the cancellation of the closed portion of
the meeting and the following portions of the document: Date and Time,
Agenda, Procedure, and Closed Committee Deliberations.
There are no other changes.
Supplementary Information:
In the Federal Register of January 27, 2005, FDA
announced that a meeting of the Cellular, Tissue, and Gene Therapies Advisory
Committee (formerly the Biological Response Modifiers Advisory Committee) would
be held on March 3 and 4, 2005. On page 3935, in the first column, the introductory
paragraph, Date and Time, Agenda, and Procedure
portions of the document are amended to read as follows:
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.
Date and Time:
The meeting will be held on March 3, 2005, from 8 a.m. to approximately 6 p.m.
and on March 4, 2005, from 8 a.m. to approximately 5 p.m.
Agenda:
On March 3, 2005, all day and on March 4, 2005, in the morning, the committee
will discuss cellular therapies for repair and regeneration of joint surfaces.
Additionally, on
March 4, 2005, the committee will discuss safety issues related to retroviral
vector-mediated tumorigenesis in gene transfer clinical trials.
Procedure:
On March 3, 2005, from 8 a.m. to approximately 6 p.m. and on March 4, 2005,
from 8 a.m. to approximately 5 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 23, 2005. Oral presentations from the public will be scheduled
on March 3, 2005, between approximately 11 a.m. and 11:30 a.m. and on March
4, 2005, between approximately 12 noon and 12:30 p.m. Time allotted for each
presentation may be limited. Those desiring to make formal oral presentations
should notify the contact person before February 23, 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.
On page 3935, in the second column, the Closed Committee Deliberations portion of the document is deleted to reflect the cancellation of the closed portion of the meeting on March 3, 2005.
Contact Person:
Gail Dapolito or Rosanna L. Harvey, 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 3014512389. Please call the Information Line
for up-to-date information on this meeting.