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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: bpritche@cvm.fda.gov.
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published a notice of availability for a draft guidance entitled ``Use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