[Federal Register: January 27, 2005 (Volume 70, Number 17)]
[Notices]
[Page 3936]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27ja05-60]
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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 February 16, 2005, from
8:30 a.m. to approximately 5 p.m., and on February 17, 2005, from 8:30
a.m. to approximately 2:05 p.m.
Location: Holiday Inn Select Bethesda, 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 February 16, 2005, the committee will review and discuss
the selection of strains to be included in the influenza virus vaccine
for the 2005-2006 season. On February 17, 2005, the committee will hear
updates on FDA Critical Path Initiative and Research Programs in the
Center for Biologics Evaluation and Research.
Procedure: On February 16, 2005, from 8:30 a.m. to 5 p.m. and on
February 17, 2005, from 8:30 a.m. to 11:25 a.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 February 9, 2005. Oral
presentations from the public will be scheduled between approximately 1
p.m. and 1:30 p.m. on February 16, 2005, and approximately 8:45 a.m.
and 9:15 a.m. on February 17, 2005. Time allotted for each presentation
may be limited. Those desiring to make formal oral presentations should
notify the contact person before February 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 February 17, 2005, from
approximately 12 noon to 2:05 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)) and to
permit discussion and review of trade secret and/or confidential
information (5 U.S.C. 552b(c)(4)). The committee will discuss
individual Research Programs in the Center for Biologics Evaluation and
Research and receive an update on a product under review.
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 301-827-0314 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: January 18, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-1474 Filed 1-26-05; 8:45 am]
BILLING CODE 4160-01-S