[Federal Register Volume 77, Number 237 (Monday, December 10, 2012)]
[Notices]
[Pages 73472-73473]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-29706]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0001]
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 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.
DATES: Date and Time: The teleconference meeting will be held on
January 15, 2013 from 2 p.m. to 5:30 p.m., Eastern Time.
Location: National Institutes of Health (NIH), Building 29B,
Conference Room C, 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, Center for Biologics Evaluation and
Research (HFM-71), Food and Drug Administration, 1401 Rockville Pike,
Rockville MD 20852, 301-827-1289, or FDA Advisory Committee Information
Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), to find
out further information regarding FDA advisory committees. 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 January 15, 2013, the committee will meet in open
session to hear updates of research programs in the Laboratory of
Immunology, Division of Therapeutic Proteins, 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 meeting
link.
Procedure: On January 15, 2013, from 2 p.m. to 4:30 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 January 8, 2013. Oral presentations from the public
will be scheduled between approximately 3:30 p.m. and 4:30 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
December 31, 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 2, 2013.
Closed Committee Deliberations: On January 15, from 4:30 p.m. to
5:30 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
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).
[[Page 73473]]
Dated: December 5, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-29706 Filed 12-7-12; 8:45 am]
BILLING CODE 4160-01-P