[Federal Register Volume 62, Number 181 (Thursday, September 18, 1997)]
[Notices]
[Page 49015]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-24849]
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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 October 17, 1997, 8 a.m.
to 5:30 p.m.
Location: Holiday Inn, Ballroom, Two Montgomery Village Ave.,
Gaithersburg, MD.
Contact Person: 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: During the morning session, the committee will discuss
Zenapax, (dacliximab, a humanized monoclonal antibody
directed against the human interleukin 2 receptor), Hoffmann-La Roche.
An indication is sought for the prophylaxis of acute organ rejection as
part of an immunosuppressive regimen for patients receiving cadaveric
kidney transplants. During the afternoon session, the committee will
discuss Intron-A, (recombinant human interferon, interferon
alfa-2b), Schering-Plough Corp. An indication is sought for the
treatment of patients with high-tumor burden, follicular non-Hodgkin's
lymphoma, in conjunction with combination chemotherapy.
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 October 10,
1997. Oral presentations from the public will be scheduled between
approximately 8 a.m. to 8:30 a.m., and 1 p.m. to 1:30 p.m. Time
allotted for each presentation may be limited. Those desiring to make
formal oral presentations should notify the contact person before
October 10, 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: September 9, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-24849 Filed 9-17-97; 8:45 am]
BILLING CODE 4160-01-F
