[Federal Register: June 30, 2005 (Volume 70, Number 125)]
[Notices]
[Page 37862-37863]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30jn05-105]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Research Review Subcommittee of the Blood 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 subcommittee 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 Subcommittee: Research Review Subcommittee of the Blood
Products Advisory Committee
[[Page 37863]]
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 July 22, 2005, from 8
a.m. to 5 p.m.
Location: Holiday Inn Gaithersburg, Two Montgomery Village Ave.,
Gaithersburg, MD 20879.
Contact Person: William Freas or Pearline K. Muckelvene, 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 3014519516. Please call the
Information Line for up-to-date information on this meeting.
Agenda: On July 22, 2005, the subcommittee will listen to
presentations to further a dynamic, responsive, and cutting edge
research program at the Office of Blood Research and Review, Center for
Biologics Evaluation and Research (CBER), that facilitates development
of safe and effective biological products. The subcommittee's
recommendations will be publicly discussed at a future meeting of the
Blood Products Advisory 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://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://www.fda.gov/oc/initiatives/criticalpath/
.
Procedure: On July 22, 2005, from 8 a.m. to 1:15 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 subcommittee. Written submissions may be made to the contact person
by July 14, 2005. Oral presentations from the public will be scheduled
between approximately 12:15 p.m. and 1:15 p.m. Time allotted for each
presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person by July 14, 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 Subcommittee Deliberations: On July 22, 2005, from 2:15 p.m.
to 5 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 the
internal research programs in the Office of Blood 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 William Freas or
Pearline K. Muckelvene 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: June 23, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-12962 Filed 6-29-05; 8:45 am]
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