[Federal Register Volume 69, Number 98 (Thursday, May 20, 2004)]
[Notices]
[Page 29140]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-11366]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2002D-0468]


Guidance for Industry on the Manufacture and Labeling of Raw Meat 
Foods for Companion and Captive Noncompanion Carnivores and Omnivores; 
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 the guidance for industry ([numsign]122) entitled 
``Manufacture and Labeling of Raw Meat Foods for Companion and Captive 
Noncompanion Carnivores and Omnivores.'' The purpose of this document 
is to provide guidance on the manufacture and labeling of foods that 
contain raw meat, or other raw animal tissues, for consumption by dogs, 
cats, other companion or pet animals, and captive noncompanion animal 
carnivores and omnivores.

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

ADDRESSES: Submit written requests for single copies of the guidance 
document 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 document 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:///www.fda.gov/dockets/ecomments. Comments should be identified 
with the full title of the guidance document and the docket number 
found in brackets in the heading of this document. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the guidance 
document.

FOR FURTHER INFORMATION CONTACT: William Burkholder, Center for 
Veterinary Medicine (HFV-228), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0179, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of December 18, 2002 (67 FR 77500), FDA 
published a notice of availability for a draft guidance entitled 
``Draft Guidance for Industry on Manufacture and Labeling of Raw Meat 
Foods for Companion and Captive Noncompanion Carnivores and 
Omnivores.'' FDA gave interested persons until March 3, 2003, to 
comment. FDA considered all comments received and, where appropriate, 
incorporated them into the guidance.

II. Paperwork Reduction Act of 1995

    According to the Paperwork Reduction Act of 1995, a collection of 
information should display a valid OMB control number. This guidance 
contains no collections of information.

III. Significance of Guidance

    This level 1 guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The guidance represents 
the agency's current thinking about the manufacture and labeling of raw 
meat foods for companion and captive noncompanion carnivores and 
omnivores. It does not create or confer any rights for or on any person 
and will not operate to bind FDA or the public. An alternative approach 
may be used if such approach satisfies the requirements of the 
applicable statutes and regulations.

IV. Comments

    As with all of FDA's guidance, the public is encouraged to submit 
written or electronic comments on this guidance. FDA periodically will 
review the comments in the docket and, where appropriate, will amend 
the guidance.
    Interested persons may, at any time, submit written or electronic 
comments to the Division of Dockets Management (see Addresses) 
regarding this guidance. 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. A copy of the 
guidance and received comments are available for public examination in 
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

V. Electronic Access

    Electronic comments may be submitted on the Internet at http://www.fda.gov/dockets/ecomments. Once on this site, select [2002D-0468] 
``Manufacture and Labeling of Raw Meat Foods for Companion and Captive 
Noncompanion Carnivores and Omnivores'' and follow the directions. 
Copies of this guidance may be obtained on the Internet at http://www.fda.gov/cvm/guidance/published.htm.

    Dated: May 12, 2004.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 04-11366 Filed 5-19-04; 8:45 am]
BILLING CODE 4160-01-S