AGENCY: Food and Drug Administration, HHS.
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 October 22, 2013, from 8
a.m. to 5:30 p.m. and October 23, 2013, from 8 a.m. to 5 p.m.
Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building
31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD
20993. Information regarding special accommodations due to a
disability, visitor parking, and transportation may be accessed at:
http://www.fda.gov/AdvisoryCommittees/default.htm; under the heading
"Resources for You,'' click on "Public Meetings at the FDA White Oak
Campus.'' Please note that visitors to the White Oak Campus must enter
through Building 1.
Contact Person: Gail Dapolito or Rosanna Harvey, Food and Drug
Administration, Center for Biologics Evaluation and Research, 1401
Rockville Pike, HFM-71, Rockville, MD 20852, 301-827-1289 or 301-827-
1297, email: Gail.Dapolito@fda.hhs.gov or Rosanna.Harvey@fda.hhs.gov 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 October 22, 2013, from 8 a.m. to 5:30 p.m., and on
October 23, 2013, from 8 a.m. to approximately 11:15 a.m., the
Committee will discuss oocyte modification in assisted reproduction for
the prevention of transmission of mitochondrial disease or treatment of
infertility. On October 23, 2013, from approximately 11:15 a.m. to
11:30 a.m., the Committee will hear updates on guidance documents
issued from the Office of Cellular, Tissue and Gene Therapies, Center
for Biologics Evaluation and Research (CBER), FDA. On October 23, 2013,
from 12:30 p.m. to approximately 5 p.m. the Committee will discuss
considerations for the design of early-phase clinical trials of
cellular and gene therapy products. CBER is planning to publish
guidance on this topic during calendar year 2013.
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: 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
October 15, 2013. Oral presentations from the public will be scheduled
between approximately 2:15 p.m. and 3:15 p.m. on October 22, 2013, and
between approximately 1:15 p.m. and 1:45 p.m. on October 23, 2013.
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
October 7, 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 October 8, 2013.
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
(email@example.com) 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).