[Federal Register Volume 79, Number 146 (Wednesday, July 30, 2014)]
[Pages 44184-44185]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-17890]



Food and Drug Administration

[Docket No. FDA-2014-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 September 18, 2014, from 
1 p.m. to 4 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 
Conference Center, Rm. 1506-IR, Silver Spring, MD 20993-0002. 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. 
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, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 6124, Silver Spring, MD 20993-0002, 
240-402-8046, gail.dapolito@fda.hhs.gov; or Rosanna Harvey, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6136, 
Silver Spring, MD 20993-0002, 240-402-8072, rosanna.harvey@fda.hhs.gov; 
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 September 18, 2014, the committee will meet by 
teleconference. In open session, the committee will hear updates of 
research programs in the Laboratory of Biochemistry, Division of 
Therapeutic Proteins, the Laboratory of Molecular Oncology and the 
Laboratory of Molecular and Developmental Immunology, Division of 
Monoclonal Antibodies, Office of Biotechnology Products, Office of 
Pharmaceutical Sciences, 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 
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting 
    Procedure: On September 18, 2014, from 1 p.m. to 3:20 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 September 11, 2014. Oral presentations from the public will 
be scheduled between approximately 2:20 p.m. and 3:20 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 
September 3, 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 September 4, 
    Closed Committee Deliberations: On September 18, 2014, from 
approximately 3:20 p.m. to 4 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 
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

[[Page 44185]]

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 24, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-17890 Filed 7-29-14; 8:45 am]