[Federal Register Volume 78, Number 251 (Tuesday, December 31, 2013)]
[Unknown Section]
[Pages 79699-79700]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-31320]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-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 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 
Committee.
    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 
is 301-977-8700.
    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

[[Page 79700]]

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, 
2014.
    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).

    Dated: December 26, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-31320 Filed 12-30-13; 8:45 am]
BILLING CODE 4160-01-P