[Federal Register Volume 78, Number 141 (Tuesday, July 23, 2013)]
[Page 44133]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-17600]

[[Page 44133]]



Food and Drug Administration

[Docket No. FDA-2013-N-0001]

Cellular, Tissue and Gene Therapies Advisory Committee; Notice of 

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


    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: [email protected] or [email protected] 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 protected]) 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: July 17, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-17600 Filed 7-22-13; 8:45 am]