[Federal Register: November 2, 2006 (Volume 71, Number 212)]
[Notices]
[Page 64541]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02no06-48]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Cellular, Tissue and Gene Therapies 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.
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 by teleconference on
November 20, 2006, from 2:15 p.m. to approximately 5 p.m.
Location: National Institutes of Health (NIH), Bldg. 29, rm. 121,
9000 Rockville Pike, 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 the specified location for public
participation in the meeting. Important information about
transportation, directions to the NIH campus, parking, and security
procedures is available on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.nih.gov/about/visitor/index.htm.
Visitors must show two forms of identification, one
of which must be a Government-issued photo identification such as a
Federal employee badge, driver's license, passport, green card, etc. If
you are planning to drive to and park on the NIH campus, you must enter
at the South Dr. entrance of the campus which is located on Wisconsin
Ave. (the Medical Center Metro entrance), and allow extra time for
vehicle inspection. Detailed information about security procedures is
located at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.nih.gov/about/visitorsecurity.htm. Due to the
limited available parking, visitors are encouraged to use public
transportation. (FDA has verified the Web site addresses, but FDA is
not responsible for any subsequent changes to the Web sites after this
document publishes in the Federal Register.)
Contact Person: Gail Dapolito or Rosanna 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 November 20, 2006, the committee will meet in open
session to hear updates of research programs in the Laboratory of
Immunobiology and the Laboratory of Immunology, Office of Biotechnology
Products, Center for Drug Evaluation and Research.
Procedure: On November 20, 2006, from 2:15 p.m. to approximately
4:30 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 on or before November 13, 2006. Oral presentations from
the public will be scheduled between approximately 3:30 p.m. and 4:30
p.m. Time allotted for each presentation may be limited. Those desiring
to make formal oral presentations should notify the contact person 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 or before November 13, 2006.
Closed Committee Deliberations: On November 20, 2006, from
approximately 4:30 p.m. to 5 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 report of intramural 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: October 27, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and Planning
[FR Doc. E6-18472 Filed 11-1-06; 8:45 am]
BILLING CODE 4160-01-S