[Federal Register Volume 64, Number 65 (Tuesday, April 6, 1999)]
[Notices]
[Pages 16743-16744]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-8439]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99D-0557]


``Guidance for Industry: Public Health Issues Posed by the Use of 
Nonhuman Primate Xenografts in Humans;'' Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance document entitled ``Guidance for Industry: 
Public Health Issues Posed by the Use of Nonhuman Primate Xenografts in 
Humans.'' The guidance document is being issued in response to public 
comments and recent interest among clinical investigators in using 
nonhuman primate xenografts in the near future. The document is 
intended to provide guidance on nonhuman primate xenotransplantation in 
humans.

DATES: Written comments may be submitted at any time, however, comments 
should be submitted by July 6, 1999, to ensure adequate consideration 
in preparation of a revised document, if warranted. The agency is 
soliciting public comment but is implementing this guidance document 
immediately because of the public health concerns related to the use of 
live cells, tissues, and organs from nonhuman primate xenografts in 
humans.


[[Page 16744]]


ADDRESSES: Submit written requests for single copies of the guidance 
document entitled ``Guidance for Industry: Public Health Issues Posed 
by the Use of Nonhuman Primate Xenografts in Humans'' to the Office of 
Communication, Training, and Manufacturers Assistance (HFM-40), Center 
for Biologics Evaluation and Research (CBER), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. Send one 
self-addressed adhesive label to assist that office in processing your 
requests. The guidance 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 guidance document.
     Submit written comments on the guidance document to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Valerie A. Butler, 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

     FDA is announcing the availability of a guidance document entitled 
``Guidance for Industry: Public Health Issues Posed by the Use of 
Nonhuman Primate Xenografts in Humans.'' The document provides guidance 
to industry concerning: (1) The potential public health risks posed by 
nonhuman primate xenografts; (2) the need for further scientific 
research and evaluation of these risks, particularly infectious agents; 
and (3) the need for public discussion concerning these issues.
     Concerns have arisen in the last few years about the potential 
infectious disease and public health risks associated with 
xenotransplantation, particularly nonhuman primate xenotransplantation. 
For the purpose of this guidance document, xenotransplantation is 
defined as any procedure that involves the use of live cells, tissues, 
or organs from a nonhuman animal source transplanted or implanted into 
a human, or used for ex vivo contact with human body fluids, cells, 
tissues, or organs that are subsequently given to a human recipient. In 
addition, defined for the purpose of this document, xenografts include 
live cells, tissues, or organs from a nonhuman animal source used for 
xenotransplantation.
     In developing the guidance, FDA considered numerous sources of 
information, including concerns raised in public comments to the 
``Draft Public Health Service (PHS) Guideline on Infectious Disease 
Issues in Xenotransplantation'' (61 FR 49920, September 23, 1996) and 
concerns voiced by the scientific and lay community at the public 
workshops on xenotransplantation entitled ``Cross-Species Infectivity 
and Pathogenesis'' held on July 21 and 22, 1997, and ``Developing U.S. 
Public Health Service Policy in Xenotransplantation'' held on January 
21 and 22, 1998, sponsored by PHS.
     The approach outlined in the guidance document has been accepted 
by the other PHS agencies including the National Institutes of Health, 
the Centers for Disease Control and Prevention, and the Health 
Resources and Services Administration, as well as the Department of 
Health and Human Services Working Group on Xenotransplantation. The 
agency is aware that other species of animals have been used and are 
proposed as future sources of xenografts and may pose infectious 
disease risks. The public health issues raised by xenotransplantation, 
regardless of source animal species, will continue to receive 
scientific evaluation and discussion by appropriate Federal agencies 
and advisory committees.
     The guidance document represents the agency's current thinking on 
the potential public health risks posed by the use of nonhuman primate 
xenografts in humans, and the consequent need for further scientific 
evaluation and public discussion of this issue. It does not create or 
confer any rights for or on any person and does not operate to bind FDA 
or the public. An alternative approach may be used if such approach 
satisfies the requirement of the applicable statute, regulations, or 
both. As with other guidance documents, FDA does not intend this 
document to be all-inclusive and cautions that not all information may 
be applicable to all situations. The document is intended to provide 
information and does not set forth requirements.

 II. Comments

     The agency notes that measures taken during the production of some 
nonhuman primate xenografts products, such as extensive preclinical 
xenotransplant product testing for infectious agents, genetic 
engineering, enclosure of the product in a semipermeable barrier, and/
or the use of well-characterized cell lines which have been handled in 
a manner to avoid the introduction of new pathogens, could potentially 
provide greater control of infectious disease risks. The agency 
specifically solicits comments on the potential for such measures, 
alone or in combination, to substantially reduce the risks posed by 
nonhuman primate xenotransplantation. The agency is soliciting public 
comment but is implementing this guidance document immediately because 
of the public health concerns related to the use of live cells, tissues 
and organs from nonhuman primate xenografts in humans.
     Interested persons may submit to the Dockets Management Branch 
(address above) written comments regarding this guidance document. 
Written comments may be submitted at any time, however, comments should 
be submitted by July 6, 1999, to ensure adequate consideration in 
preparation of a revised document, if warranted. Two copies of any 
comments are to be submitted, except individuals may submit one copy. 
Comments should be identified with the docket number found in the 
brackets in the heading of this document. A copy of the guidance 
document and received comments are available for public examination in 
the Dockets 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 document using 
the World Wide Web (WWW). For WWW access, connect to CBER at ``http://
www.fda.gov/cber/guidelines.htm''.

    Dated: March 30, 1999.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 99-8439 Filed 4-5-99; 8:45 am]
BILLING CODE 4160-01-F