Document ID: FDA-2011-N-0002-0152
Agency: fda
Document Type: Notice
Title: Meetings: Cellular, Tissue, and Gene Therapies Advisory Committee
Posted Date: 2011-12-28T05:00Z

[Federal Register Volume 76, Number 249 (Wednesday, December 28, 2011)]
[Notices]
[Pages 81513-81514]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-33220]

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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.

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    This notice announces a forthcoming teleconference meeting of a 
public advisory committee of the Food and Drug Administration (FDA). At 
least one

[[Page 81514]]

portion of the meeting will be closed 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 teleconference meeting will be held on February 
10, 2012, from 2 p.m. to 5 p.m. EST
    Location: National Institutes of Health (NIH), 9000 Rockville Pike, 
Bldg. 29B, Conference Room A-B, Bethesda, MD 20892. The public is 
welcome to attend the meeting at the specified location where a 
speakerphone will be provided. Public participation in the meeting is 
limited to the use of the speakerphone in the conference room. 
Important information about transportation and directions to the NIH 
campus, parking and security procedures is available on the Internet at 
http://www.nih.gov/about/visitor/index.htm. (FDA has verified the Web 
site address, but FDA is not responsible for any subsequent changes to 
the Web site after this document publishes in the Federal Register.) 
Visitors must show two forms of identification, one of which must be a 
government-issued photo identification such as a Federal employee 
badge, driver's license, passport, green card, etc. Detailed 
information about security procedures is located at http://www.nih.gov/about/visitorsecurity.htm. Due to the limited available parking, 
visitors are encouraged to use public transportation.
    Contact Person: Gail Dapolito or Sheryl Clark, 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 February 10, 2012, the committee will meet in open 
session to hear updates of the research programs in the Cellular and 
Tissue Branch, Office of Cellular, Tissue and Gene Therapies, Center 
for Biologics Evaluation and Research, FDA.
    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: On February 10, 2012, from 2 p.m. to 4:15 p.m. (EST) 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 February 3, 2012. Oral presentations from the public will be 
scheduled between approximately 3:15 p.m. and 4:15 p.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 January 26, 2012. 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 January 27, 2012.
    Closed Committee Deliberations: On February 10, 2012, from 4:15 
p.m. to 5 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 and make recommendations regarding 
personnel staffing decisions.
    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: December 21, 2011.
Leslie Kux,
    Acting Assistant Commissioner for Policy.
[FR Doc. 2011-33220 Filed 12-27-11; 8:45 am]
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