[Federal Register Volume 74, Number 80 (Tuesday, April 28, 2009)]
[Pages 19226-19227]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-9592]



Food and Drug Administration

[Docket No. FDA-2009-N-0664]

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 May 14, 2009, from 8 
a.m. to approximately 6 p.m. and on May 15, 2009, from 8 a.m. to 
approximately 1 pm.
    Location: Hilton Hotel, Grand Ballroom, 620 Perry Pkwy., 
Gaithersburg, MD.
    Contact Person: Gail Dapolito or Danielle Cubbage, Food and Drug 
Administration, 1401 Rockville Pike (HFM-71), Rockville, MD, 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 May 14 in the morning, in open session, the Committee 
will discuss the potential for Chlamydia trachomatis and Neisseria 
gonorrhea transmission by human cells, tissues, and cellular and 

[[Page 19227]]

products (HCT/Ps) that are recovered from the reproductive system or 
gestational tissues (e.g., amnionic membrane and placenta, cells 
recovered from menstrual blood, foreskin, placental/umbilical cord 
blood derived cell products), or other sources. In the afternoon, in 
open session, the Committee will discuss animal models for porcine 
xenotransplantation products intended to treat Type 1 diabetes or 
acute liver failure. On May 15, in open session, the Committee will: 
(1) Receive an update on Guidance documents from the Office of 
Cellular, Tissue and Gene Therapies, Center for Biologics Evaluation 
and Research and the Center for Veterinary Medicine and (2) discuss 
clinical issues related to the FDA draft guidance ``Preparation of 
IDEs and INDs for Products Intended to Repair or Replace Knee 
    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/ohrms/dockets/ac/acmenu.htm, click on the year 2009 and 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 
May 7, 2009. Oral presentations from the public will be scheduled on 
May 14 between approximately 11 a.m. and 11:20 a.m. and between 
approximately 2 p.m. and 2:20 p.m. and on May 15 between 
approximately 10 a.m. and 10:20 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 May 6, 2009. 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 May 7, 2009.
    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/oc/advisory/default.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: April 17, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-9592 Filed 4-27-09; 8:45 am]