[Federal Register Volume 63, Number 46 (Tuesday, March 10, 1998)]
[Notices]
[Page 11685]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-6210]


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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 regulatory issues.
    Date and Time: The meeting will be held on March 24, 1998, 8:30 
a.m. to 5 p.m.
    Location: DoubleTree Hotel, 1750 Rockville Pike, Rockville, 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 12389. Please call the 
Information Line for up-to-date information on this meeting.
    Agenda: The committee will discuss CellPro Inc.'s Ceprate 
SC System for use in processing autologous peripheral blood stem cells. 
The committee will also hear short briefings on research programs in 
the Laboratory of Cellular Immunology and the Laboratory of 
Developmental Biology.
    Procedure: On March 24, 1998, from 8:30 a.m. to 1:30 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 
March 17, 1998. Oral presentations from the public will be scheduled 
between approximately 8:30 a.m. and 9:30 a.m. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before March 17, 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 March 24, 1998, from 1:30 p.m. 
to 3:45 p.m., the meeting will be closed to permit discussion and 
review of trade secret and/or confidential information (5 U.S.C. 
552b(c)(4)). This portion of the meeting will be closed to discuss 
current investigational new drug application submissions under FDA 
review. On March 24, 1998, from 3:45 p.m. to 5 p.m., the meeting will 
be closed to review data of a personal nature where disclosure would 
constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 
552b(c)(6)). This portion of the meeting will be closed to permit 
discussion of this information.
    FDA regrets that it was unable to publish this notice 15 days prior 
to the March 24, 1998, Biological Response Modifiers Advisory Committee 
meeting. Because the agency believes there is some urgency to bring 
these issues to public discussion and qualified members of the 
Biological Response Modifiers Advisory Committee were available at this 
time, the Commissioner concluded that it was in the public interest to 
hold this meeting even if there was not sufficient time for the 
customary 15-day public notice.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

Dated: March 5, 1998.
Michael A. Friedman,
Deputy Commision for Operations.

[FR Doc. 98-6210 Filed 3-6-98; 12:21 pam]
BILLING CODE 4160-01-F