[Federal Register Volume 78, Number 48 (Tuesday, March 12, 2013)]
[Pages 15726-15727]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-05582]



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). 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 
the meeting.
    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

[[Page 15727]]

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).

    Dated: March 5, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-05582 Filed 3-11-13; 8:45 am]