[Federal Register: December 28, 2007 (Volume 72, Number 248)]
[Page 73850-73851]
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 
February 5, 2008, from 12 noon to approximately 3:15 p.m. Eastern Time.
    Location: National Institutes of Health, Building 29B, Conference 
Room C, 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, on site. 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.
 Because of 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

[[Page 73851]]

line/phone line to learn about possible modifications before coming to 
the meeting.
    Agenda: On February 5, 2008, the committee will meet in open 
session to hear updates of research programs in the Division of 
Therapeutic Proteins and the Division of Monoclonal Antibodies, Office 
of Biotechnology Products, Center for Drug Evaluation and Research, 
    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 will be 
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 2008 and scroll down to the appropriate advisory committee 
    Procedure: On February 5, 2008, from 12 noon to approximately 2:30 
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 January 29, 2008. Oral presentations from the 
public will be scheduled between approximately 1:30 p.m. and 2:30 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 January 21, 2008. 
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 
person regarding their request to speak by January 22, 2008.
    Closed Committee Deliberations: On February 5, 2008, from 
approximately 2:30 p.m. to 3:15p.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 
issues related to personnel progress and promotion.
    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.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/oc/advisory/default.htm
 for procedures on public conduct during advisory committee 

    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: December 18, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7-25124 Filed 12-27-07; 8:45 am]