[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 Beth@a1.cber.fda.gov.
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 cbridges@lcgnet.com''
or cwaddell@lcgnet.com'', or pmilan@lcgnet.com''. 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
