[Federal Register Volume 68, Number 217 (Monday, November 10, 2003)]
[Notices]
[Pages 63805-63806]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-28192]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0498]


Compliance Program Guidance Manual 7371.009; Bovine Spongiform 
Encephalopathy/Ruminant Feed Ban Inspections; 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 compliance program guidance manual (CP) entitled 
``Bovine Spongiform Encepholopathy/Ruminant Feed Ban Inspections.'' 
This CP is intended to assist investigators in determining compliance 
with the FDA regulation prohibiting the use of specified animal 
proteins in ruminant feeds (21 CFR 589.2000). The purpose of this 
regulation is to prevent the establishment and/or amplification within 
the United States of bovine spongiform encephalopathy (BSE), a fatal 
degenerative nerve disease of cattle.

DATES: Submit written or electronic comments on the CP at any time.

ADDRESSES: Submit written requests for single copies of the CP 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.
    Copies of the CP also may be downloaded to a personal computer with 
access to the Internet. The CVM home page includes a link to the CP and 
may be accessed at http://www.fda.gov/cvm. Submit written comments on 
the CP to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
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.

FOR FURTHER INFORMATION CONTACT: For technical questions concerning 
this compliance program: Neal Bataller, Center for Veterinary Medicine, 
HFV-230, Food and Drug Administration, 7500 Standish Pl., Rm. E441, 
Rockville, MD 20855, 301-827-0163, e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On August 4, 1997, the ruminant feed ban regulation in Sec.  
589.2000 (21 CFR 589.2000) became effective. This regulation prohibits 
the use of certain proteins derived from mammalian tissues in the 
feeding of ruminant animals. The regulation is intended to prevent the 
establishment and/or amplification within the United States of BSE, a 
fatal degenerative nerve disease of cattle.
    BSE is the bovine form of a group of uniformly fatal neurological 
diseases known as transmissible spongiform encephalopathies (TSEs). BSE 
appears to be spread through the feeding to cattle of protein derived 
from TSE-infected animal tissues. Specifically, epidemiologic evidence 
gathered in the United Kingdom suggests an association between BSE and 
the feeding to cattle of protein derived from sheep infected with 
scrapie, another TSE. BSE represents a public health concern based on 
the possible connection between BSE and a form of human TSE, new 
variant Creutzfeldt-Jacob disease (nv-CJD), that is believed to have 
resulted from people eating ruminant tissues infected with the BSE 
agent. BSE has had a devastating economic effect on the livestock 
industry in countries where it has been identified or suspected. BSE 
has not been diagnosed in the United States.
    The regulation in Sec.  589.2000 affects renderers, protein 
blenders, commercial animal feed manufacturers, distributors (including 
retailers), transporters of animal feed and feed ingredients, on-farm 
animal feed mixers, and ruminant feeders. Based on the acute need to 
prevent the entry and spread of BSE, FDA has set a goal of full 
compliance with the regulation. This CP is intended to assist in the 
conduct of inspections to enforce Sec.  589.2000 and thereby minimize 
risk to human or animal health.

II. Significance of Guidance

    This CP is being issued as a level 1 guidance consistent with our 
good guidance practices (GGPs) regulation in Sec.  10.115 (21 CFR 
10.115). It is being implemented immediately without prior public 
comment, under Sec.  10.115(g)(2), because of the agency's urgent need 
to provide guidance and instructions to both agency and state 
investigators in conducting inspections under Sec.  589.2000 for 
preventing the introduction and amplication of BSE in the United 
States. Such guidance is presently not available. However, under GGPs, 
FDA requests comments on the guidance and will revise the document, if 
appropriate. Comments will be considered by the agency in the 
development of future policy.
    The CP represents the FDA's current thinking on the subject. It 
does not create or confer any rights for or on any person and will not 
operate to bind FDA or the public. Alternative methods may be used as 
long as they satisfy the requirements of the applicable statutes and 
regulations.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this guidance 
document. Two copies of any comments are to be submitted, except that 
individuals may submit one copy. Comments are to be identified with the 
docket number found in brackets in the heading of this document. A copy 
of the guidance and received comments are available for public 
examination in the Division of Dockets Management

[[Page 63806]]

between 9 a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

    Copies of the CP may also be downloaded to a personal computer with 
access to the Internet. The CVM home page includes a link to the CP and 
may be accessed at http://www.fda.gov/cvm.

    Dated: November 3, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-28192 Filed 11-7-03; 8:45 am]
BILLING CODE 4160-01-S