[Federal Register Volume 76, Number 155 (Thursday, August 11, 2011)]
[Notices]
[Pages 49774-49775]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-20399]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
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). The meeting will
be open to the public.
Name of Committee: Cellular, Tissue and Gene Therapies Advisory
Committee.
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
outlets.
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]
BILLING CODE 4160-01-P