[Federal Register Volume 66, Number 19 (Monday, January 29, 2001)]
[Notices]
[Pages 8120-8121]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-2419]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96M-0311]
``PHS Guideline on Infectious Disease Issues in
Xenotransplantation;'' Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: On behalf of the U.S. Public Health Service (PHS), the Food
and Drug Administration (FDA) is announcing the availability of a
guideline entitled ``PHS Guideline on Infectious Disease Issues in
Xenotransplantation'' dated January 19, 2001. This guideline was
developed by the PHS to identify general principles for the prevention
and control of infectious diseases associated with xenotransplantation
that may pose a hazard to public health. The guideline is intended to
provide general guidance to local review bodies evaluating proposed
xenotransplantation protocols and to sponsors in developing
xenotransplantation protocols, in preparing submissions to FDA and the
Secretary's Advisory Committee on Xenotransplantation, and in
conducting xenotransplantation clinical trials. The guideline announced
in this document finalizes the ``Draft Public Health Service (PHS)
Guideline on Infectious Disease Issues in Xenotransplantation''
announced in the Federal Register of September 23, 1996, as revised in
response to comments.
DATES: Submit written comments at any time.
ADDRESSES: Submit written requests for single copies of the ``PHS
Guideline on Infectious Disease Issues in Xenotransplantation'' dated
January 19, 2001, to the Office of Communication, Training, and
Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and
Research, Food and Drug Administration, 1401 Rockville Pike, Rockville,
MD 20852-1448. Send one self-addressed adhesive label to assist the
office in processing your requests. The document may also be obtained
by mail by calling the CBER Voice Information System at 1-800-835-4709
or 301-827-1800, or by fax by calling the Fax Information System at 1-
888-CBER-FAX or 301-827-3844. See the SUPPLEMENTARY INFORMATION section
for electronic access to the guideline.
Submit written comments on the guideline to the Dockets Management
Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Stephen M. Ripley, Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
6210.
SUPPLEMENTARY INFORMATION:
I. Background
On behalf of the PHS, FDA is announcing the availability of a
document entitled ``PHS Guideline on Infectious Disease Issues in
Xenotransplantation'' dated January 19, 2001. This guideline was
jointly developed by agencies within the PHS of the Department of
Health and Human Services (DHHS), including FDA, the Centers for
Disease Control and Prevention, the Health Resources and Services
Administration, the National Institutes of Health, as well as the DHHS
Office of the Assistant Secretary for Planning and Evaluation. This
guideline is intended to identify general principles for the prevention
and control of infectious diseases associated with xenotransplantation
that may pose a hazard to public health. It is intended to provide
general guidance to local review bodies evaluating proposed
xenotransplantation protocols and to sponsors in developing
xenotransplantation protocols, in preparing submissions to FDA and the
Secretary's Advisory Committee on Xenotransplantation, and in
conducting xenotransplantation clinical trials. Such clinical trials
conducted within the United States are subject to regulation by FDA
under the Public Health Service Act (42 U.S.C. 262, 264), and the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq.).
The finalized guideline announced in this document was revised
based on public comments received in response to the ``Draft Public
Health Service (PHS) Guideline on Infectious Disease Issues in
Xenotransplantation'' announced in the Federal Register of September
23, 1996 (61 FR49920), as well as on input from national and
international conferences and workshops. The preamble to the final
guideline provides a summary of the major revisions and clarifications
made to the draft guideline.
In the Federal Register of May 26, 2000 (65 FR 34196), FDA, on
behalf of PHS, published a notice of the proposed reporting and
recordkeeping requirements associated with the implementation of the
guideline and provided an opportunity for public comment on the
paperwork burden estimates for the guideline.
In the Federal Register of October 18, 2000 (65 FR 62359), FDA, on
behalf of PHS, announced the submission of the reporting and
recordkeeping burden estimates to the Office and Management and Budget
for review and clearance under the Paperwork Reduction Act of 1995. The
information collection provisions related to this guideline have been
approved under OMB control number 0910-0456. This approval expires
January 31, 2004. An agency may not conduct or sponsor, and a person is
not obligated to respond to, a collection of information unless it
displays a currently valid OMB control number.
This guideline represents PHS' current thinking on certain
infectious disease issues in xenotransplantation. It does not create or
confer any rights for or on any person and does not operate to bind the
PHS or the public. This guideline is not intended to set forth an
approach that addresses all of the potential health hazards related to
infectious disease issues in xenotransplantation nor to establish the
only way in which the public health hazards that are identified in this
document may be addressed. The PHS acknowledges that not all of the
recommendations set forth within this document may be fully relevant to
all xenotransplantation products or xenotransplantation procedures.
Sponsors of clinical xenotransplantation trials are advised to confer
with relevant authorities (FDA, other reviewing authorities, funding
sources, etc.) in assessing the relevance and appropriate adaptation of
the general guidance offered here to specific clinical applications.
II. Comments
Interested persons may submit to the Dockets Management Branch
(address above) written comments on the guideline. Two copies of any
comments are to be submitted, except that individuals may submit one
copy. Comments are to be identified with the docket number found in the
brackets in the heading of this document. A copy of the guideline
document and received comments are available for public examination in
the Dockets
[[Page 8121]]
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet may obtain the guideline at
http://www.fda.gov/cber/guidelines.htm.
Dated: December 26, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-2419 Filed 1-26-01; 8:45 am]
BILLING CODE 4160-01-F