[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