[Federal Register: October 26, 2005 (Volume 70, Number 206)]
[Notices]
[Page 61828-61829]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26oc05-106]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
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). At least one
portion of the meeting will be closed 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 November 16, 2005, from
8:30 a.m. to 5:15 p.m. and on November 17, 2005, from 8:30 a.m. to 5:30
p.m.
Location: Holiday Inn Select, 8120 Wisconsin Ave., Bethesda, MD.
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.
Agenda: On November 16, 2005, the committee will hear presentations
and discuss the use of Madin-Darby Canine Kidney Cells for manufacture
of Inactivated Influenza Vaccines. On November 17, 2005, the committee
will discuss developing new Pneumococcal Vaccines for U.S. licensure
for adults.
Procedure: On November 16, 2005, from 8:30 a.m. to 5:15 p.m. and on
November 17, 2005, from 10 a.m. to 5:30 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 by November 9, 2005. Oral
presentations from the public will be scheduled on November 16, 2005,
between approximately 1:45 p.m. and 2:15 p.m. and on November 17, 2005,
between approximately 1 p.m. and 1:30 p.m. Time allotted for each
presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before November 9, 2005,
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.
Closed Committee Deliberations: On November 17, 2005, from 8:30
a.m. to 9:55 a.m., the meeting will be closed to permit discussion and
review of trade secret and/or confidential information (5 U.S.C.
552b(c)(4)).
Persons attending FDA's advisory committee meetings are advised
that the
[[Page 61829]]
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.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: October 18, 2005.
Jason Brodsky,
Acting Associate Commissioner for External Relations.
[FR Doc. 05-21350 Filed 10-25-05; 8:45 am]
BILLING CODE 4160-01-S