[Federal Register: January 27, 2005 (Volume 70, Number 17)]
[Notices]
[Page 3934-3935]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27ja05-58]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Cellular, Tissue and Gene Therapies Advisory Committee (formerly
the Biological Response Modifiers Advisory Committee); Notice of
Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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[[Page 3935]]
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: Cellular, Tissue and Gene Therapies Advisory
Committee (formerly the Biological Response Modifiers 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 3, 2005, from 8
a.m. to approximately 5:15 p.m. and on March 4, 2005, from 8 a.m. to
approximately 2:30 p.m.
Location: Quality Suites, 3 Research Court, Rockville, MD.
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.
Agenda: On March 3 and 4, 2005, the Committee will discuss cellular
therapies for repair and regeneration of joint surfaces. The Committee
will also receive the following updates: (1) On March 3, 2005, in the
afternoon, updates of research programs in the Center for Biologics
Evaluation and Research and the Center for Drug Evaluation and
Research; (2) on March 4, 2005, in the morning, update on the FDA
Critical Path Initiative.
Procedure: On March 3, 2005, from 8 a.m. to approximately 4:45 p.m.
and on March 4, 2005, from 8 a.m. to approximately 2:30 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 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 8:45 a.m. and 9:15 a.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.
Closed Committee Deliberations: On March 3, 2005, from
approximately 4:45 p.m. to 5:15 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 research programs in the Center for Biologics
Evaluation and Research and the Center for Drug 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 Gail Dapolito 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: January 19, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-1473 Filed 1-26-05; 8:45 am]
BILLING CODE 4160-01-S