[Federal Register Volume 68, Number 65 (Friday, April 4, 2003)]
[Notices]
[Pages 16542-16543]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-8167]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1662]


``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 document entitled ``Guidance for Industry: Source 
Animal, Product, Preclinical, and Clinical Issues Concerning the Use of 
Xenotransplantation Products in Humans'' dated April 2003. The document 
provides guidance on the production, testing, and evaluation of 
products intended for use in xenotransplantation. The guidance 
announced in this notice finalizes the draft guidance document of the 
same title dated February 2001.

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written or electronic requests for single copies of 
this guidance 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 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 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. Submit electronic comments to 
http://www.fda.gov/dockets/ecomments.

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 document entitled 
``Guidance for Industry: Source Animal, Product, Preclinical, and 
Clinical Issues Concerning the Use of Xenotransplantation Products in 
Humans'' dated April 2003. The document provides guidance on the 
production, testing, and evaluation of products intended for use in 
xenotransplantation. The guidance document announced in this notice was 
revised based on public comments received on the draft guidance, and it 
finalizes the draft document of the same title dated February 2001 (66 
FR 9348, February 7, 2001).
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). This guidance document represents 
the agency's current thinking on this topic. 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 statutes and regulations.

II. Comments

    Interested persons may, at any time, submit written or electronic 
comments to the Dockets Management Branch (see ADDRESSES) regarding 
this guidance document. Two copies of any mailed comments are to be 
submitted, except individuals may submit one copy. Comments should be 
identified with the docket number found in the brackets in

[[Page 16543]]

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 
either http://www.fda.gov/cber/guidelines.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: March 27, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-8167 Filed 4-3-03; 8:45 am]
BILLING CODE 4160-01-S