[Federal Register Volume 63, Number 124 (Monday, June 29, 1998)]
[Notices]
[Page 35238]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-17146]


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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 July 30, 1998, 8 a.m. to 
6 p.m.
    Location: Bethesda Holiday Inn, Versailles Ballrooms I and II, 8120 
Wisconsin Ave., Bethesda, MD.
    Contact Person: Gail M. Dapolito or Rosanna L. Harvey, Center for 
Biologics Evaluation and Research (HFM-211), 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: The committee will discuss: (1) Biologics license 
application 97-0509, Amgen Inc.'s Stemgen<Register> (ancestim); (2) the 
report from the December 17, 1997, meeting of the Xenotransplantation 
Subcommittee; and (3) the research programs in the Laboratory of 
Immunology and the Laboratory of Molecular Immunology, Office of 
Therapeutics Research and Review, Center for Biologics Evaluation and 
Research. An indication is sought, in combination with 
Neupogen<Register> (filgrastim), for use in mobilization of peripheral 
blood progenitor cells.
    Procedure: On July 30, 1998, from 8 a.m. to 5 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 July 20, 1998. 
Oral presentations from the public will be scheduled between 
approximately 8 a.m. and 9 a.m. Time allotted for each presentation may 
be limited. Those desiring to make formal oral presentations should 
notify the contact person before July 20, 1998, 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 July 30, 1998, from 5 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 confidential information 
relevant to the scientific site visit report of the Laboratory of 
Immunology and the Laboratory of Molecular Immunology, Office of 
Therapeutics Research and Review, Center for Biologics Evaluation and 
Research.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).
    Dated: June 18, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-17146 Filed 6-26-98; 8:45 am]
BILLING CODE 4160-01-F