[Federal Register Volume 68, Number 179 (Tuesday, September 16, 2003)]
[Notices]
[Pages 54233-54234]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-23559]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0186]


Guidance for Industry on Use of Material From Deer and Elk in 
Animal Feed; 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 guidance ([numsign]158) entitled ``Use of Material 
From Deer and Elk in Animal Feed.'' This guidance document describes 
FDA's recommendations regarding the use in all animal feed of all 
material from deer and elk that are positive for chronic wasting 
disease (CWD) or are considered at high risk for CWD.

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

ADDRESSES: Submit written comments on this guidance document to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20855. 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 the heading of this document. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance document.
    Submit written requests for single copies of this 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.

FOR FURTHER INFORMATION CONTACT: Burt Pritchett, Center for Veterinary 
Medicine (HFV-222), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0177, e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of May 16, 2003 (68 FR 26628), FDA 
published a notice of availability for a draft guidance entitled ``Use 
of Material from Deer and Elk in Animal Feed'' giving interested 
persons until June 16, 2003, to submit comments. FDA considered all 
comments received.

II. Paperwork Reduction Act of 1995

    FDA concludes that this guidance contains no collections of 
information. Therefore, clearance by the Office of Management and 
Budget under the Paperwork Reduction Act of 1995 is not required.

III. Significance of Guidance

    This level 1 guidance document 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 the 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 method may be used as 
long as it satisfies the requirements of applicable statutes and 
regulations.

IV. Comments

    As with all of FDA's guidances, the public is encouraged to submit 
written or electronic comments with new data or other new information 
pertinent to this guidance. FDA periodically will review the comments 
in the docket and, where appropriate, will amend the guidance. The 
agency will notify the public 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 on the final guidance at 
any time. Comments should be identified with the docket number found in 
brackets in the heading of this document. A copy of the document 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

    Persons with access to the Internet may obtain a copy of the final 
guidance document entitled ``Use of Material From Deer and Elk in 
Animal Feed'' from the Center for Veterinary Medicine home page at 
http://www.fda.gov/cvm.


[[Page 54234]]


    Dated: August 29, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-23559 Filed 9-15-03; 8:45 am]
BILLING CODE 4160-01-S