[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announced in this notice finalizes the draft guidance document of the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