[Federal Register Volume 66, Number 26 (Wednesday, February 7, 2001)]
[Notices]
[Page 9348]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-3202]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1662]


Draft ``Guidance for Industry: Source Animal, Product, 
Preclinical, and Clinical Issues Concerning the Use of 
Xenotransplantation Products 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availability of a draft guidance document entitled ``Guidance for 
Industry: Source Animal, Product, Preclinical, and Clinical Issues 
Concerning the Use of Xenotransplantation Products in Humans'' dated 
February 2001. The draft guidance document is intended to provide 
guidance on the production, testing, and evaluation of products 
intended for use in xenotransplantation.

DATES: Submit written comments on the draft guidance to ensure their 
adequate consideration in preparation of the final document by May 8, 
2001.

ADDRESSES: Submit written requests for single copies of the draft 
guidance entitled ``Guidance for Industry: Source Animal, Product, 
Preclinical, and Clinical Issues Concerning the Use of 
Xenotransplantation Products in Humans'' dated February 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to the draft guidance document.
    Submit written comments on the draft guidance document to the 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: Stephen 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

    FDA is announcing the availability of a draft guidance document 
entitled ``Guidance for Industry: Source Animal, Product, Preclinical, 
and Clinical Issues Concerning the Use of Xenotransplantation Products 
in Humans'' dated February 2001. For the purpose of the draft guidance 
``xenotransplantation'' refers to any procedure that involves the 
transplantation, implantation, or infusion into a human recipient of 
either: (1) Live cells, tissues, or organs from a nonhuman animal 
source, or (2) human body fluids, cells, tissues, or organs that have 
had ex vivo contact with live nonhuman animal cells, tissues, or 
organs. This document is intended to provide guidance on the 
production, testing, and evaluation of products intended for use in 
xenotransplantation. The draft guidance includes scientific questions 
that should be addressed by sponsors during protocol development and 
during the preparation of submissions to FDA (e.g., investigational new 
drug application and biologics license application). The topics in the 
draft guidance include: Regulatory responsibility; source animal and 
xenotransplantation products characterization; microbiological testing 
of xenotransplantation products; manufacturing and process-related good 
manufacturing practice considerations for harvest and processing of 
xenotransplantation products; preclinical considerations for 
xenotransplantation products; and clinical issues in 
xenotransplantation.
    FDA has previously announced the availability of the guidance 
document entitled ``Guidance for Industry: Public Health Issues Posed 
by the Use of Nonhuman Primate Xenografts in Humans'' dated April 1999, 
in the Federal Register of April 6, 1999 (64 FR 16743). FDA also 
announced the availability of the draft guidance document ``Guidance 
for Industry: Precautionary Measures to Reduce the Possible Risk of 
Transmission of Zoonoses by Blood and Blood Products From 
Xenotransplantion Product Recipients and Their Contacts'' dated 
December 1999, in the Federal Register of December 30, 1999 (64 FR 
73562). In the future, FDA intends to finalize the guidance. 
Furthermore, FDA is considering developing draft guidance to address 
various issues pertaining to FDA's regulation of transgenic animals.
    This draft guidance is being issued consistent with FDA's good 
guidance practice regulation (21 CFR 10.115; 65 FR 56468, September 19, 
2000). This draft guidance document represents the agency's current 
thinking with regard to the production, testing, and evaluation of 
products intended for use in xenotransplantation. 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 requirements 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 draft guidance document is 
intended to provide information and does not set forth requirements.

II. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written comments regarding this draft guidance 
document. Submit written comments to ensure adequate consideration in 
preparation of the final document by May 8, 2001. 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 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 at 
http://www.fda.gov/cber/guidelines.htm.

    Dated: December 26, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-3202 Filed 2-6-01; 8:45 am]
BILLING CODE 4160-01-F