[Federal Register Volume 81, Number 13 (Thursday, January 21, 2016)]
[Pages 3431-3432]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-01165]



Food and Drug Administration

[Docket No. FDA-2016-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 on February 16, 2016 from 1 
p.m. to 5 p.m.
    Location: FDA White Oak Conference Center, rm 1503. Answers to 
commonly asked questions including information regarding special 
accommodations due to a disability, visitor parking, and transportation 
may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    Contact Person: Janie Kim or Rosanna Harvey, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Silver Spring, MD 20993-0002, 301-796-9016 or 
240-402-8072, [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 February 16, 2016, the committee will meet by 
teleconference. In open session, the committee will hear updates of 
research programs in the Tumor Vaccines and Biotechnology Branch and 
the Cellular and Tissue Therapy Branch of the Division of Cellular and 
Gene Therapies, Office of Cellular, Tissue and Gene Therapy, Center for 
Biologics 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 
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting 
    Procedure: On February 16, 2016, from 1:00 p.m. to 3:55 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 February 1, 2016. Oral presentations from the public will be 
scheduled between approximately 2:55 p.m. to 3:55 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 
January 22, 2016. 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 January 25, 
    Closed Committee Deliberations: On February 16, 2016, from 3:55 
p.m. to 5:00 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 decisions.
    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 
disabilities. If you require accommodations due to a disability, please 
contact Janie Kim 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/

[[Page 3432]]

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: January 15, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-01165 Filed 1-20-16; 8:45 am]