[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