AGENCY: Food and Drug Administration, HHS.
This notice announces a forthcoming 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
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 by teleconference on April
17, 2013, from 1:30 p.m. to 5 p.m.
Location: Rockwall II Building, 5515 Security Lane, Conference Room
1033, Rockville, MD 20852. 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.
Contact Person: Gail Dapolito (301-827-1289) or Rosanna Harvey
(301-827-1297), Food and Drug Administration, 1401 Rockville Pike (HFM-
71), Rockville, MD 20852, 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
Agenda: On April 17, 2013, the committee will meet by
teleconference. In open session, the committee will hear updates of
research programs in the Laboratory of Chemistry, 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
Procedure: On April 17, 2013, from 1:30 p.m. to from approximately
4 p.m., 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 April 10, 2013. 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
April 2, 2013. 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 April 3, 2013.
Closed Committee Deliberations: On April 17, 2013, 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
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).