[Federal Register Volume 77, Number 201 (Wednesday, October 17, 2012)]
[Pages 63840-63841]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-25482]



Food and Drug Administration

[Docket No. FDA-2012-N-0001]

Cellular, Tissue and Gene Therapies Advisory Committee; Notice of 

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


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

[[Page 63841]]

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.

DATES: Date and Time: The teleconference meeting will be held on 
November 29, 2012 from 1 p.m. to 5 p.m., Eastern Time.
    Location: National Institutes of Health (NIH), Building 29A, 
Conference Room 1A09, 9000 Rockville Pike, 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). 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 
at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to 
the appropriate advisory committee meeting link, or call the advisory 
committee information line to learn about possible modifications before 
coming to the meeting.
    Agenda: On November 29, 2012 the committee will meet in open 
session to hear updates of research programs in the Gene Transfer and 
Immunogenicity Branch, Office of Cellular, Tissue and Gene Therapies, 
Center for Biologics Evaluation and Research, and the Laboratory of 
Immunology, Office of Biotechnology Products, Center for Drug 
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 November 29, 2012, from 1 p.m. to 4 p.m. (Eastern 
Time) 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 November 21, 2012. Oral presentations from the 
public will be scheduled between approximately 3 p.m. and 4 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 
November 14, 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 November 15, 
    Closed Committee Deliberations: On November 29, 2012, from 4 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 reports 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 
    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: October 9, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-25482 Filed 10-16-12; 8:45 am]