[Federal Register Volume 62, Number 227 (Tuesday, November 25, 1997)]
[Notices]
[Pages 62776-62777]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-30910]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Biological Response Modifiers Advisory Committee; Notice of
Subcommittee 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: Subcommittee meeting of the 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 December 17, 1997, 9
a.m. to 6 p.m.
Location: DoubleTree Hotel, Plaza Ballrooms I and II, 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 12388. Please call the
Information Line for up-to-date information on this meeting.
Agenda: On December 17, 1997, the Xenotransplantation Subcommittee
will discuss the following public health issues concerning cross-
species transplantation: (1) Development of appropriate assays for
detection and identification of infectious retroviruses, (2)
limitations of current screening and diagnostic tools, (3) diagnostic
testing and clinical care of patients post-transplant, (4) impact of
diagnostic screening results on clinical trial
[[Page 62777]]
development, and (5) delineation of the key features of informed
consent for patients who have received a porcine xenograft and who
undergo screening for porcine endogenous retrovirus.
Procedure: On December 17, 1997, from 9 a.m. to 11:30 a.m., and 12
m. to 6 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 December 10, 1997. Oral presentations from the public
will be scheduled between approximately 9 a.m. and 10 a.m. Time
allotted for each presentation may be limited. Those desiring to make
formal oral presentations should notify the contact person before
December 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.
Closed Committee Deliberations: On December 17, 1997, from 11:30
a.m. to 12 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 current
investigational new drug application submissions under FDA review.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: November 17, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-30910 Filed 11-24-97; 8:45 am]
BILLING CODE 4160-01-F
