[Federal Register Volume 68, Number 22 (Monday, February 3, 2003)]
[Notices]
[Pages 5296-5297]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-2374]


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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