[Federal Register: December 19, 2007 (Volume 72, Number 243)]
[Page 71922-71923]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2007N-0471]

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). The meeting will 
be open to the public.
    Name of Committee: Cellular, Tissue and Gene Therapies Advisory 

[[Page 71923]]

    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 April 10, 2008, from 9 
a.m. to approximately 6 p.m. and on April 11, 2008, from 8 a.m. to 
approximately 12 noon.
    Addresses: Electronic comments should be submitted to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
 Select ``2007N-0471--Scientific 

Considerations for Safety Testing for Cellular Therapy Products Derived 
From Human Embryonic Stem Cell'' and follow prompts to submit your 
statement. Written comments should be submitted to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852, by close of business on 
March 26, 2008. All comments received will be posted without change, 
including any personal information provided. Comments received on or 
before March 26, 2008, will be provided to the committee before or at 
the meeting.
    Location: Hilton DC North/Gaithersburg, Grand Ballroom, 620 Perry 
Pkwy., Gaithersburg, MD.
    Contact Person: Gail Dapolito or Danielle Cubbage, 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. 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 meeting.
    Agenda: On April 10, 2008, the committee will meet to discuss 
scientific considerations for safety testing for cellular therapy 
products derived from human embryonic stem cells. On April 11, 2008, 
the committee will meet to discuss updates on the following topics: (1) 
Research management related to the September 29, 2005, review of 
research programs of the Office of Cellular, Tissue and Gene Therapies, 
Center for Biologics Evaluation and Research; (2) FDA's Somatic Cell 
Therapy Letter; and (3) recently released FDA guidance documents.
    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 2008 and scroll down to the appropriate advisory committee 
    Procedure: 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 
April 3, 2008. Oral presentations from the public will be scheduled on 
April 10, 2008, between approximately 1:45 p.m. and 2:15 p.m. and on 
April 11, 2008, between approximately 10:15 a.m. and 10:45 a.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 March 26, 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 
persons regarding their request to speak by March 27, 2008.
    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 12, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7-24629 Filed 12-18-07; 8:45 am]