[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