[Federal Register Volume 76, Number 65 (Tuesday, April 5, 2011)]
[Notices]
[Page 18768]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-7968]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
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). At least one
portion of the meeting will be closed 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 May 31, 2011, from 2:30
p.m. to 6:15 p.m.
Location: National Institutes of Health (NIH) Campus, 29 Lincoln
Dr., Bldg. 29B, Conference Rooms A and B, Bethesda, MD 20892.
The public is welcome to attend the meeting at NIH, Building 29B,
Conference Rooms A and B, where a speakerphone will be provided. Public
participation in the meeting is limited to the use of the speakerphone
in the conference room. Important information about transportation and
directions to the NIH campus, parking, and security procedures is
available on the Internet at http://www.nih.gov/about/visitor/index.htm. (FDA has verified the Web site address, but FDA is not
responsible for any subsequent changes to the Web site after this
document publishes in the Federal Register.) Visitors must show two
forms of identification, one of which must be a government-issued photo
identification such as a Federal employee badge, driver's license,
passport, green card, etc. Detailed information about security
procedures is located at http://www.nih.gov/about/visitorsecurity.htm.
Due to the limited available parking, visitors are encouraged to use
public transportation.
Contact Person: Gail Dapolito or Sheryl Clark (HFM-71), Center for
Biologics Evaluation and Research, Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852, 301-827-0314, or FDA Advisory
Committee Information Line, 1-800-741-8138 (301-443-0572 in the
Washington, DC area), and follow the prompts to the desired center or
product area. Please call the Information Line for up-to-date
information on this meeting. 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
and call the appropriate advisory committee hot line/phone line to
learn about possible modifications before coming to the meeting.
Agenda: On May 31, 2011, the committee will meet in open session to
hear brief overviews of research programs in the Laboratory of
Biochemistry, Division of Therapeutic Proteins, Center for Drug
Evaluation and Research; and the Laboratory of Cell Biology, the
Laboratory of Molecular and Developmental Immunology, the Laboratory of
Molecular Oncology, Division of Monoclonal Antibodies, Center for Drug
Evaluation and Research.
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 link.
Procedure: On May 31, 2011, from 2:30 p.m. to approximately 5:15
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 May 24, 2011. Oral presentations from the public
will be scheduled between approximately 4:15 p.m. and 5:15 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 May
16, 2011. 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 May 17, 2011.
Closed Committee Deliberations: On May 31, 2011, from 5:15 p.m. to
6:15 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 a report 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
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: March 30, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-7968 Filed 4-4-11; 8:45 am]
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