[Federal Register: June 22, 2005 (Volume 70, Number 119)]
[Notices]               
[Page 36189-36190]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22jn05-124]                         

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0219]

 
Guidance for Industry: General Principles for Evaluating the 
Safety of Compounds Used in Food-Producing Animals; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a revised guidance for industry entitled ``General 
Principles for Evaluating the Safety of Compounds Used in Food-
Producing Animals (GFI 3).'' This version of the guidance 
replaces the version that was made available in July 1994. This has 
been revised to remove outdated information on toxicological testing 
and to provide references to other available guidance on the topic. In 
addition, the document has been revised to address minor formatting 
issues.

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

ADDRESSES: Submit written requests for single copies of the guidance to 
the Communications Staff (HFV-12), Center for Veterinary Medicine, Food 
and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send 
one self-addressed adhesive label to assist that office in processing 
your requests.
    Submit written comments on the guidance to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
 See the SUPPLEMENTARY INFORMATION 

section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Mark M. Robinson, Center for 
Veterinary Medicine (HFV-150), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-5282, e-mail: 
mrobinson@cvm.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA published the guidance for industry entitled ``General 
Principles for Evaluating the Safety of Compounds Used in Food-
Producing Animals (GFI 3)'' in July 1994. Since that time, FDA 
has published a number of guidance documents in its participation with 
International Cooperation on Harmonization of Technical Requirements 
for Registration of Veterinary Medicinal Products (VICH) that provide 
recommendations on toxicological testing of compounds used in food-
producing animals. This version of guidance 3 replaces the 
version that was made available in July 1994. The guidance has been 
updated to remove outdated information on toxicological testing and 
refers the reader to the relevant Center for Veterinary Medicine/VICH 
guidance documents. In addition, the document was revised to address 
minor formatting issues including correcting an error in the numbering 
of the guidance sections.

II. Significance of Guidance

    This document is being revised as a level 2 guidance consistent 
with FDA's good guidance practices regulation (21 CFR 10.115.) The 
guidance represents the agency's current thinking on the subject 
matter. The document does not create or confer any rights for or on any 
person and will not operate to bind FDA or the public. Alternative 
methods may be used as long as they satisfy the requirements of the 
applicable statutes and regulations.

III. Comments

    As with all of FDA's guidances, the public is encouraged to submit 
written or electronic comments pertinent to this guidance. FDA will 
periodically review the comments in the docket and, where appropriate, 
will amend the guidance. The agency will notify the public of any such 
amendments through a notice in the Federal Register.
    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document.

[[Page 36190]]

Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

IV. Electronic Access

    Copies of the guidance document entitled ``General Principles for 
Evaluating the Safety of Compounds Used in Food-Producing Animals 
(3)'' may be obtained on the Internet from the CVM home page 
at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cvm.


    Dated: June 13, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-12323 Filed 6-21-05; 8:45 am]

BILLING CODE 4160-01-S