[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
