Guidance for Industry on Use of Material From Deer and Elk in Animal Feed; Availability

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.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a guidance (#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of May 16, 2003 (68 FR 26628), FDA published a notice of availability for a draft guidance entitled “Use of Material from Deer and Elk in Animal Feed” giving interested persons until June 16, 2003, to submit comments.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

.

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