[Federal Register Volume 62, Number 115 (Monday, June 16, 1997)]
[Notices]
[Page 32619]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-15634]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
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). The meeting will
be open 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 regulatory issues.
Date and Time: The meeting will be held on July 24 and 25, 1997, 8
a.m. to 5:30 p.m.
Location: Holiday Inn, Versailles Ballrooms I, II, and III, 8120
Wisconsin Ave., Bethesda, MD.
Contact Person: William Freas, Gail M. Dapolito, or Rosanna L.
Harvey, Center for Biologics Evaluation and Research (HFM-21), 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 12388. Please call the
Information Line for up-to-date information on this meeting.
Agenda: On July 24, 1997, during the morning session, the committee
will discuss Neumega (oprelvekin, recombinant human
interleukin eleven, rhIL-11), Genetics Institute. An indication is
sought for Neumega for the prevention of chemotherapy-induced
thrombocytopenia and reduction in the need for platelet transfusions in
patients with nonmyeloid malignancies. During the afternoon session,
the committee will discuss a premarket approval application for a
device to concentrate CD34 positive cells in autologous peripheral
blood stem cell products used for hematopoietic rescue. General data
requirements for cell selection devices for hematopoietic rescue will
also be discussed. On July 25, 1997, the committee will discuss
Rituximab (C2B8 monoclonal antibody), IDEC. The company is seeking an
indication for Rituximab as a treatment for patients with relapsed or
refractory low grade or follicular B-cell non-Hodgkin's Lymphoma. The
committee will also discuss Neupogen, (Filgrastim,
granulocyte colony-stimulating factor), Amgen. An indication is sought
for use of Neupogen to reduce the duration of neutropenia,
fever, hospitalization, and antibiotic use in patients with acute
myeloid leukemia.
Procedure: 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 July 17, 1997.
Oral presentations from the public will be scheduled between
approximately 8 a.m. and 8:30 a.m., both days. Time allotted for each
presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before July 17, 1997,
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.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: June 9, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-15634 Filed 6-13-97; 8:45 am]
BILLING CODE 4160-01-F
