[Federal Register: April 27, 2005 (Volume 70, Number 80)]
[Page 21799]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Cellular, Tissue and Gene Therapies Advisory Committee (Formerly 
Biological Response Modifiers Advisory Committee); Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


    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 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 May 20, 2005, from 2 
p.m. to approximately 4 p.m.
    Location: 5515 Security Lane, rm. 1113, Rockville, MD. This meeting 
will be held by teleconference. The public is welcome to attend the 
meeting at the specified location. A speakerphone will be provided at 
this location for public participation in the meeting.
    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: The committee will receive an update on individual research 
programs in the Division of Therapeutic Proteins, Center for Drug 
Evaluation and Research.
    Procedure: On May 20, 2005, from 2 p.m. to approximately 4 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 
May 13, 2005. Oral presentations from the public will be scheduled 
between approximately 3 p.m. and 4 p.m. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before May 13, 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 May 20, 2005, from approximately 
4 p.m. to 4:30 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 individual FDA research programs.
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
    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: April 18, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-8353 Filed 4-26-05; 8:45 am]