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 February 25, 2014, from
8 a.m. to approximately 5:30 p.m. and February 26, 2014, from 8 a.m. to
approximately 5 p.m.
Location: Hilton Washington, DC North/Gaithersburg, 620 Perry
Pkwy., Grand Ballroom, Gaithersburg, MD 20877. The hotel's phone number
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, 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 February 25, 2014, from 8 a.m. to 5:30 p.m. and on
February 26, 2014, 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 February 26, 2014, 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 February 26,
2014, from 1 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 published guidance on this
topic in July 2013 (http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/default.htm).
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: 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 18, 2014. Oral presentations from the public will be scheduled
between approximately 2:15 p.m. and 3:15 p.m. on February 25, 2014 and
between approximately 1:45 p.m. and 2:15 p.m. on February 26, 2014.
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
February 10, 2014. 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 February 11,
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.