[Federal Register: August 29, 2005 (Volume 70, Number 166)]
[Notices]
[Page 51076]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29au05-64]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Research Review Subcommittee of the Cellular, Tissue and Gene
Therapies 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 Cellular,
Tissue and Gene Therapies 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 September 29, 2005, from
8 a.m. to 4 p.m.
Location: Holiday Inn Select, 8120 Wisconsin Ave., Bethesda, MD.
Contact Person: Gail Dapolito or Sheila Langford, 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 3014512389. Please call the
Information Line for up-to-date information on this meeting.
Agenda: On September 29, 2005, the subcommittee will listen to
presentations about the research program at the Office of Cellular,
Tissue and Gene Therapies (OCTGT), Center for Biologics Evaluation and
Research (CBER). The program is intended to provide dynamic,
responsive, cutting edge research to contribute to OCTGT's regulatory
mission and facilitate development of safe and effective biological
products. The subcommittee will discuss the program and make
recommendations to the Cellular Tissue and Gene Therapies 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 September 29, 2005, from 8 a.m. to approximately 1:20
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 September 22, 2005. Oral presentations from the public will
be scheduled between approximately 11:20 a.m. and 12:20 p.m. Time
allotted for each presentation may be limited. Those desiring to make
formal oral presentations should notify the contact person by September
22, 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 September 29, 2005, from
approximately 1:20 p.m. to 4 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 OCTGT, 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 Gail Dapolito 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: August 18, 2005.
Scott Gottlieb,
Deputy Commissioner for Policy.
[FR Doc. 05-17149 Filed 8-26-05; 8:45 am]
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