[Federal Register Volume 62, Number 249 (Tuesday, December 30, 1997)]
[Notices]
[Pages 67877-67878]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-33927]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Developing U.S. Public Health Service Policy on 
Xenotransplantation; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    The Food and Drug Administration (FDA) is announcing the following 
public workshop: Developing U.S. Public Health Service Policy on 
Xenotransplantation. The topic to be discussed is the current and 
evolving U.S. Public Health Service (U.S. PHS) policy on 
xenotransplantation. Xenotransplantation refers to any procedure that 
involves the use of live cells, tissues, and organs from a nonhuman 
animal source, transplanted or implanted into a human or used for ex 
vivo perfusion. The meeting is being sponsored by U.S. PHS agencies 
including FDA, National Institutes of Health, Centers for Disease 
Control and Prevention, and the Health Resources and Services 
Administration.
    Date and Time: The public workshop will be held on January 21 and 
22, 1998, 8 a.m. to 5 p.m.
    Location:  The public workshop will be held at the Natcher 
Auditorium, National Institutes of Health, 9000 Rockville Pike, Bldg. 
45, Bethesda, MD.
    Contact: Timothy W. Beth, Center for Biologics Evaluation and 
Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, 
suite 200N, Rockville, MD 20852, 301-827-6333, FAX 301-443-3874, or e-
mail B[email protected].
Supplementary Information:  The goals of the meeting include the 
following: (1) Describing the scope of current clinical trials in 
xenotransplantation; (2) exploring the potential public health benefits 
and risks of xenotransplantation; (3) presenting frameworks for the 
evaluation of ethical issues presented by xenotransplantation; (4) 
describing current and evolving PHS policy on xenotransplantation and 
the development of specific public health mechanisms to implement 
policy; such mechanisms may include, but are not limited to: (a) a 
revised U.S. PHS guideline on infectious disease issues in 
xenotransplantation; (b) the evolving regulatory framework for 
oversight of xenotransplantation; (c) the pilot xenotransplantation 
registry database; (d) the strategies for archiving biologic specimens 
for public health investigations; (e) the methods for ensuring public 
awareness of current issues and discussion of new developments in 
xenotransplantation; and (5) presenting international perspectives on 
xenotransplantation policy development. The meeting is open to all 
interested persons.
    Registration: There is no fee to attend this meeting. To register 
for the meeting please contact Cody Bridges, Chris

[[Page 67878]]

Waddel, or Pamela Milan at 301-490-5500, e-mail ``[email protected]'' 
or ``[email protected]'', or ``[email protected]''. If you need 
special accomodations due to a disability, please contact Cody Bridges 
at least 7 days in advance.
    Transcripts:  Transcripts of the meeting may be requested in 
writing from the Freedom of Information Office (HFI-35), Food and Drug 
Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, 
approximately 15 working days after the meeting at a cost of 10 cents 
per page.

    Dated: December 23, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-33927 Filed 12-29-97; 8:45 am]
BILLING CODE 4160-01-F