[Federal Register: November 2, 2006 (Volume 71, Number 212)]
[Page 64541]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Cellular, Tissue and Gene Therapies Advisory Committee; Notice of 

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 
    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 
    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]