[Federal Register Volume 76, Number 155 (Thursday, August 11, 2011)]
[Pages 49774-49775]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-20399]



Food and Drug Administration

[Docket No. FDA-2011-N-0002]

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 
    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 September 22 and 23, 
2011, from 8 a.m. to 5 p.m.
    Location: Hilton Hotel, Washington, DC North/Gaithersburg, 620 
Perry Pkwy., Gaithersburg, MD 20977, 301-977-8900. For those unable to 
attend in person, the meeting will also be available by Web cast. On 
September 22, 2011, the link for the Web cast is available at http://fda.yorkcast.com/webcast/Viewer/?peid=637f14248dca4236a5f9a3b622e6501e1d. On September 23, 2011, the 
link for the Web cast is available at http://fda.yorkcast.com/webcast/Viewer/?peid=2e8b3eb7638d42ca9652c328a854efb51d.
    Contact Person: Gail Dapolito or Sheryl Clark (HFM-71), Center for 
Biologics Evaluation and Research, Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20853, 301-827-0314, or FDA Advisory 
Committee Information Line, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), and follow the prompts to the desired center or 
product area. 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

[[Page 49775]]

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 September 22, 2011, the committee will discuss BLA 
125397, Umbilical Cord Blood, New York Blood Center, indicated for 
hematologic malignancies, bone marrow failure, primary immunodeficiency 
diseases, beta thalassemia, Hurler syndrome, Krabbe disease, and X-
linked adrenoleukodystrophy. On September 23, 2011, the Committee will 
discuss HDE BH110018, CliniMACS CD34 Selection System, Miltenyi Biotec, 
for processing allogeneic HLA-matched hematopoietic progenitor cells-
apheresis (HPC-C) from a related donor to obtain a CD34\+\ Cell 
population intended for hematopoietic reconstitution following a 
Myeloablative preparative regimen without the need for additional 
graft-vs-host disease (GVHD) prophylaxis in patients with acute 
myelogenous leukemia in first or second morphologic complete remission.
    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://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
    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 
September 15, 2011. Oral presentations from the public will be 
scheduled on September 22, 2011, between approximately 11 a.m. and 12 
noon and on September 23, 2011, between approximately 11:30 a.m. and 
12:30 p.m. Those individuals interested in making 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 September 7, 2011. 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 September 
8, 2011.
    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://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures 
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: August 8, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-20399 Filed 8-10-11; 8:45 am]