[Federal Register: April 27, 2005 (Volume 70, Number 80)]
[Notices]
[Page 21799]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27ap05-103]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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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
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: April 18, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-8353 Filed 4-26-05; 8:45 am]
BILLING CODE 4160-01-S