[Federal Register Volume 68, Number 95 (Friday, May 16, 2003)]
[Notices]
[Pages 26628-26629]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-12363]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 03D-0186]


Draft Guidance for Industry: Use of Material From Deer and Elk in 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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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[[Page 26629]]

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry (158) entitled 
``Use of Material From Deer and Elk in Animal Feed.'' This draft 
guidance document, when finalized, will describe FDA's current thinking 
regarding the use in animal feed of material from deer and elk that are 
positive for chronic wasting disease (CWD) or are at high risk for CWD.

DATES: Submit written or electronic comments on the draft guidance at 
any time, however, comments should be submitted by June 16, 2003, to 
ensure their adequate consideration in preparation of the final 
document. FDA is requesting comments within 30 days, rather than within 
a longer period, because of the need to finalize the guidance in late 
August, prior to the start of the next deer hunting season.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Communications Staff (HFV-12), Center for Veterinary 
Medicine (CVM), 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 electronic comments on 
the draft guidance to http://www.fda.gov/dockets/ecomments. Submit 
written comments to the Dockets Management Branch (HFA-305), Food and 
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Comments should be identified with the full title of the draft guidance 
and the docket number found in brackets in the heading of this 
document. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

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

SUPPLEMENTARY INFORMATION:

I. Background

    CWD is a neurological (brain) disease of farmed and wild deer and 
elk that belong in the cervidae animal family (cervids). CWD belongs to 
a family of animal and human diseases called transmissible spongiform 
encephalopathies (TSEs). These include (1) Bovine spongiform 
encephalopathy (BSE or ``mad cow'' disease) in cattle; (2) scrapie in 
sheep and goats; and (3) classical and variant Creutzfeldt-Jakob 
diseases (CJD and vCJD) in humans. There is no known treatment for 
these diseases and there is no vaccine to prevent them. In addition, 
although validated postmortem diagnostic tests are available, there are 
no validated diagnostic tests for CWD that can be used to test for the 
disease in live animals.
    Under FDA's BSE feed regulation (21 CFR 589.2000), most material 
from deer and elk is prohibited for use in feed for ruminant animals. 
This draft guidance document describes FDA's recommendations regarding 
the use in all animal feed of all material from deer and elk that are 
positive for CWD or are considered at high risk for CWD.
    The potential risks from CWD to humans or noncervid animals such as 
poultry or swine are not well understood. However, because of recent 
recognition that CWD is spreading rapidly in white-tailed deer and 
because CWD's route of transmission is poorly understood, FDA is making 
recommendations regarding the use in animal feed of rendered materials 
from deer and elk that are CWD positive or that are at high risk for 
CWD.

II. Significance of Guidance

    This draft level 1 guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). This draft 
guidance, when finalized, will represent 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 alternate 
method may be used as long as it satisfies the requirements of 
applicable statutes and regulations.

III. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this draft 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.

IV. Comments

    This draft guidance is being distributed for comment purposes only 
and is not intended for implementation at this time. Interested persons 
may submit to the Dockets Management Branch (see ADDRESSES) written or 
electronic comments regarding this draft guidance document. Two paper 
copies of any mailed comments are to be submitted, except that 
individuals may submit one paper copy. 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 Dockets Management Branch between 9 a.m. 
and 4 p.m., Monday through Friday.

V. Electronic Access

    Copies of the draft guidance document entitled ``Use of Material 
From Deer and Elk in Animal Feed'' may be obtained from the CVM home 
page (http://www.fda.gov/cvm) and from the Dockets Management Branch 
Web site (http://www.fda.gov/ohrms/dockets/default.htm).

    Dated: May 6, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-12363 Filed 5-15-03; 8:45 am]
BILLING CODE 4160-01-S