[Federal Register Volume 70, Number 31 (Wednesday, February 16, 2005)]
[Notices]
[Pages 7949-7950]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-2920]


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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); Amendment of 
Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    The Food and Drug Administration (FDA) is announcing an amendment 
to the notice of 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.

FOR FURTHER INFORMATION CONTACT: 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.

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.
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.


[[Page 7950]]


    Dated: February 8, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-2920 Filed 2-15-05; 8:45 am]
BILLING CODE 4160-01-S