[Federal Register: February 3, 2003 (Volume 68, Number 22)]
[Notices]
[Page 5296-5297]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03fe03-58]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Biological Response Modifiers 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: Biological Response Modifiers 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 27, 2003, from
8 a.m. to 6 p.m., and on February 28, 2003, from 8 a.m. to 4:30 p.m.
Location: Holiday Inn, 8777 Georgia Ave., Silver Spring, MD.
Contact Person: Gail Dapolito or Rosanna L. Harvey, 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 12389. Please call the Information
Line for up-to-date information on this meeting.
Agenda: On February 27, 2003, from 8 a.m. to approximately 3:45
p.m., the committee will discuss efficacy data for the use of minimally
manipulated hematopoietic stem cells from placental/umbilical cord
blood for hematopoietic reconstitution for particular age groups. From
approximately 3:45 p.m. to 5:30 p.m., the committee will receive
updates of
[[Page 5297]]
research programs in the Division of Monoclonal Antibodies, Center for
Biologics Evaluation and Research (CBER). On February 28, 2003, from 8
a.m. to approximately 4:30 p.m., the committee will discuss safety
issues related to the use of retrovirus vectors in gene therapy
clinical trials.
Procedure: On February 27, 2003, from 8 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
February 20, 2003. On February 27, oral presentations from the public
will be scheduled between approximately 11:30 a.m. and 12:30 p.m. On
February 28, oral presentations from the public will be scheduled
between approximately 11 a.m. and 12 noon. Time allotted for each
presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before February 20,
2003, 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 27, 2003, from
approximately 5:30 p.m. to 6 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)). The committee will
discuss reports of a review of individual research programs in 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 or
Rosanna L. Harvey 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 24, 2003.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 03-2374 Filed 1-31-03; 8:45 am]
BILLING CODE 4160-01-S