[Federal Register: May 1, 2006 (Volume 71, Number 83)]
[Notices]
[Page 25593]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01my06-58]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Research Review Subcommittee of the 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 the Subcommittee: Research Review Subcommittee of the
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 May 19, 2006, from 8
a.m. to 4:30 p.m.
Location: Hilton Hotel, Washington DC North/Gaithersburg, 620 Perry
Pkwy., Gaithersburg, MD 20877.
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 May 19, 2006, the subcommittee will listen to
presentations about the research program at the Office of Vaccines
Research and Review (OVRR), Center for Biologics Evaluation and
Research (CBER). The program is intended to provide dynamic,
responsive, cutting edge research to contribute to OVRR's regulatory
mission and facilitate development of safe and effective biological
products. The subcommittee will discuss the program and make
recommendations to the Vaccines and Related Biological Products
Advisory Committee at a future open meeting of the full committee.
Information regarding CBER's scientific program is outlined in its
Strategic Plan of 2004 and is available to the public on the Internet
at: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/inside/mission.htm. Information regarding
FDA's Critical Path to New Medical Products is available to the public
on the Internet at: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/oc/initiatives/ criticalpath/.
Procedure: On May 19, 2006, from 8 a.m. to 1 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 May 12, 2006.
Oral presentations from the public will be scheduled between
approximately 12 p.m. to 1 p.m. Time allotted for each presentation may
be limited. Those desiring to make formal oral presentations should
notify the contact person before May 12, 2006, 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 May 19, 2006, from 2 p.m. to
4:30 p.m., the meeting will be closed to the public. 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 subcommittee will discuss
internal research programs in the Office of Vaccines Research and
Review, CBER.
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.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: April 21, 2006.
Jason Brodsky,
Acting Associate Commissioner for External Relations.
[FR Doc. E6-6508 Filed 4-28-06; 8:45 am]
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