[Federal Register Volume 64, Number 124 (Tuesday, June 29, 1999)]
[Notices]
[Page 34816]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-16442]
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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 15, 1999, 8 a.m. to
5:45 p.m.
Location: 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-71), 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: On July 15, 1999, the committee will discuss the following
issues: (1) An update of FDA's regulatory policy concerning the
implications on biological product development of fast track and the
recent pediatric rule, (2) a scientific discussion concerning immune
reactions to therapeutic and diagnostic biological products, (3) the
report of the June 3 through 4, 1999, meeting of the
xenotransplantation subcommittee, and (4) an update of research
programs in the Laboratory of Cytokine Research, Office of Therapeutics
Research and Review, Center for Biologics Evaluation and Research.
Procedure: On July 15, 1999, from 8 a.m. to approximately 1 p.m.,
and from 1:30 p.m. to approximately 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 8, 1999. Oral
presentations from the public will be scheduled between approximately
8:10 a.m. to 9:10 a.m. Time allotted for each presentation may be
limited. Those desiring to make formal oral presentations should notify
the contact person before July 8, 1999, 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 15, 1999, from 1 p.m. to
1:30 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)).
The meeting will be closed to discuss issues relating to pending or
proposed investigational new drug applications. The meeting will also
be closed from 5 p.m. to 5:45 p.m., to permit discussion 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.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: June 21, 1999.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 99-16442 Filed 6-28-99; 8:45 am]
BILLING CODE 4160-01-F
