[Federal Register: March 5, 2007 (Volume 72, Number 42)]
[Page 9766]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2007N-0061]

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 on March 29, 2007, from 8 
a.m. to approximately 6:30 p.m. and on March 30, 2007 from 8 a.m. to 
approximately 3 p.m.
    Address: 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 Docket No. 2007N-0061, 

``Sipuleucel-T Dendreon,'' 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 22, 2007. 
All comments received will be posted without change, including any 
personal information provided. Comments received on or before March 22, 
2007, will be provided to the committee before or at the meeting.
    Location: Hilton Washington DC North/Gaithersburg, 620 Perry Pkwy., 
Gaithersburg, MD, Grand Ballroom.
    Contact Person: Gail Dapolito or Rosanna L. Harvey, Center for 
Biologics Evaluation and Research (HFM-71), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-1289, 
FAX: 301-827-0294, 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 
    Agenda: On March 29, 2007, in open session, the committee will 
discuss Sipuleucel-T, Dendreon (BLA-STN 125197) indicated for the 
treatment of men with asymptomatic metastatic hormone refractory 
prostate cancer. The committee will also hear overviews of research 
programs in the Division of Cellular and Gene Therapies, Center for 
Biologics Evaluation and Research. On March 30, 2007, in open session, 
the committee will discuss the draft document entitled ``Guidance for 
Industry: Minimally Manipulated, Unrelated, Allogeneic Placental/
Umbilical Cord Blood Intended for Hematopoietic Reconstitution in 
Patients with Hematological Malignancies.'' For a copy of the draft 
guidance visit http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/gdlns/cordbld.pdf. The committee 

will also discuss scientific issues regarding minimally manipulated, 
unrelated allogeneic peripheral blood stem cells.
    FDA intends to make background material available to the public no 
later than 1 business day 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 March 29, 2007, from 8 a.m. to approximately 5:30 
p.m., and on March 30, 2007, from 8 a.m. to approximately 3 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 March 15, 2007. Oral presentations from the public will be 
scheduled between approximately 11:30 a.m. and 12:30 p.m. on March 29, 
2007, and between 10 a.m. and 11 a.m. on March 30, 2007. 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 7, 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 March 8, 2007.
    Closed Committee Deliberations: On March 29, 2007, at approximately 
5:30 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 a report of 
intramural research programs in the Division of Cellular and Gene 
    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: February 26, 2007.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E7-3712 Filed 3-2-07; 8:45 am]