AGENCY: Food and Drug Administration, HHS.
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: Vaccines and Related Biological Products
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 November 13, 2013,
between approximately 12:30 p.m. and 3:45 p.m.
Location: Rockwall II, Conference Room 1033, 5515 Security Lane,
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 for More Information: Donald W. Jehn or Denise
Royster, Food and Drug Administration, 1401 Rockville Pike (HFM-71),
Rockville, MD 20852, 301-827-0314, 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 November 13, 2013, the committee will meet in open
session to hear an overview of the research programs in the Laboratory
of Retroviruses and Laboratory of Immunoregulation, Division of Viral
Products, Office of Vaccines Research and Review, Center for Biologics
Evaluation and Review, 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 November 13, 2013, from 12:30 p.m. to approximately
3:10 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 November 6, 2013. Oral presentations from
the public will be scheduled between approximately 2:10 p.m. and
approximately 3:10 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 October 29, 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 October
Closed Committee Deliberations: On November 13, 2013, between
approximately 3:10 p.m. and approximately 3:45 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 the report of the 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 Donald W. Jehn or
Denise Royster 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).