Document ID: FDA-2009-N-0664-0007
Agency: fda
Document Type: Notice
Title: Meetings: Vaccines and Related Biological Products Advisory Committee
Posted Date: 2009-02-10T05:00Z

[Federal Register: February 10, 2009 (Volume 74, Number 26)]
[Notices]
[Page 6644-6645]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10fe09-88]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]

Vaccines and Related Biological Products 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). The meeting will
be open to the public.
    Name of Committee: Vaccines and Related Biological Products
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 February 18, 2009, from
8:30 a.m. to approximately 5:30 p.m. and on February 19, 2009, from
8:30 a.m. to approximately 4 p.m.
    Location: Hilton Washington DC/Silver Spring, 8727 Colesville Rd.,
Silver Spring, MD 20910.
    Contact Person: Christine Walsh or Denise Royster, Center for
Biologics Evaluation and Research (HFM-71), 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), code 3014512391. 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 February 18, 2009, in the morning, the committee will
discuss and make recommendations on the selection of strains to be
included in the influenza virus vaccine for the 2009--2010 influenza
season and in the afternoon will discuss the utility of adding a second
B strain to current seasonal influenza vaccines. On February 19, 2009,
the committee will discuss the conducting of clinical studies of
pandemic influenza vaccine in the pediatric population in the absence
of an influenza pandemic.
    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/ohrms/dockets/ac/acmenu.htm, click on
the year 2009 and scroll down to the appropriate advisory committee
link.
    Procedure: 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 12, 2009. Oral presentations from the public will be scheduled
between approximately 1:15 p.m. and 1:45 p.m. on February 18, 2009, and
between approximately 1:30 p.m. and 2 p.m. on February 19, 2009. Those
desiring to make formal oral presentations should notify the contact
person and submit a brief statement of the general nature of the
evidence or

[[Page 6645]]

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 February 9, 2009. 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 February 10, 2009.
    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 Christine Walsh 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/oc/advisory/
default.htm for procedures on public conduct during advisory committee
meetings.
    FDA regrets that it was unable to publish this notice 15 days prior
to the February 18 and 19, 2009, Vaccines and Related Biological
Products Advisory Committee meeting. Because the agency believes there
is some urgency to bring these issues to public discussion and
qualified members of the Vaccines and Related Biological Products
Advisory Committee were available at this time, the Commissioner of
Food and Drugs concluded that it was in the public interest to hold
this meeting even if there was not sufficient time for the customary
15-day public notice.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: January 30, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-2726 Filed 2-5-09; 4:15 pm]

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