[Federal Register Volume 70, Number 17 (Thursday, January 27, 2005)]
[Notices]
[Pages 3934-3935]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-1473]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

[[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