[Federal Register: June 19, 2007 (Volume 72, Number 117)]
[Page 33764]
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 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 
    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 July 
26, 2007 from 11 a.m. to approximately 3:15 p.m.
    Location: National Institutes of Health, Bldg. 29B, Conference rms. 
A/B, 9000 Rockville Pike, Bethesda, 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 and 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.
    Contact Person: Gail Dapolito or Danielle Cubbage, Center for 
Biologics Evaluation and Research, 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. A notice in the Federal 
Register about last minute modifications that impact a previously 
announced advisory committee meeting cannot always be published quickly 
enough to provide timely notice. Therefore, you should always check the 
agency's Web site and call the appropriate advisory committee hot line/
phone line to learn about possible modifications before coming to the 
    Agenda: On July 26, 2007, the committee will meet in open session 
to hear updates of research programs in: (1) The Division of 
Therapeutic Proteins and the Division of Monoclonal Antibodies, Office 
of Biotechnology Products, Center for Drug Evaluation and Research, FDA 
and (2) the Division of Cellular and Gene Therapies, Office of 
Cellular, Tissue, and Gene Therapies, Center for Biologics Evaluation 
and Research, FDA.
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its Web site prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's Web site after the meeting. Background material is 
available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on 

the year 2007 and scroll down to the appropriate advisory committee 
    Procedure: On July 26, 2007, from 11 a.m. to approximately 2 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 July 12, 2007. Oral presentations from the public will be 
scheduled between approximately 1 p.m. and 2 p.m. 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 July 18, 2007. Time allotted for 
each presentation may be limited. If the number of registrants 
requesting to speak is greater than can be reasonably accommodated 
during the scheduled open public hearing session, FDA may conduct a 
lottery to determine the speakers for the scheduled open public hearing 
session. The contact person will notify interested persons regarding 
their request to speak by July 19, 2007.
    Closed Committee Deliberations: On July 26, 2007, from 
approximately 2:15 p.m. to 3:30 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 reports of intramural research programs and make 
recommendations regarding personnel staffing decisions.
    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: June 11, 2007.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E7-11728 Filed 6-18-07; 8:45 am]