[Federal Register: May 16, 2003 (Volume 68, Number 95)]
[Notices]
[Page 26628-26629]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16my03-98]
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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Draft Guidance for Industry: Use of Material From Deer and Elk in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availability of a draft guidance for industry (158) entitled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 This draft
guidance document, when finalized, will describe FDA's current thinking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DATES: Submit written or electronic comments on the draft guidance at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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Communications Staff (HFV-12), Center for Veterinary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the draft guidance to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.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Comments should be identified with the full title of the draft guidance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access to the draft guidance document.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: bpritche@cvm.fda.gov.
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cvm) and from the Dockets Management Branch
Web site (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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