[Federal Register Volume 75, Number 147 (Monday, August 2, 2010)]
[Notices]
[Page 45130]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-18873]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0378]


Draft Compliance Policy Guide Sec. 690.800 Salmonella 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availability of a draft guidance for FDA staff entitled ``Compliance 
Policy Guide Sec. 690.800 Salmonella in Animal Feed'' (the draft CPG). 
The draft CPG, when finalized, is intended to provide guidance for FDA 
staff on regulatory policy relating to animal feed or feed ingredients 
that come in direct contact with humans, such as pet food and pet 
treats, contaminated with Salmonella and also on regulatory policy 
relating to animal feed or feed ingredients contaminated with a 
Salmonella serotype that is pathogenic to the target animal for the 
animal feed.

DATES:  Although you can comment on any CPG at any time (see 21 CFR 
10.115(g)(5)), to ensure that the agency considers your comment on the 
draft CPG before it begins work on the final version of the CPG, submit 
either electronic or written comments on the draft CPG by November 1, 
2010.

ADDRESSES:  Submit written requests for single copies of the CPG to the 
Division of Compliance Policy (HFC-230), Office of Enforcement, Food 
and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send 
two self-addressed adhesive labels to assist that office in processing 
your request. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft CPG.
    Submit electronic comments on the draft CPG to http://www.regulations.gov. Submit written comments on the draft CPG to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:  Kim Young, Center for Veterinary 
Medicine (HFV-230), Food and Drug Administration, 5100 Paint Branch 
Pkwy., College Park, MD 20740, 240-276-9200.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for FDA 
staff entitled ``Compliance Policy Guide Sec. 690.800 Salmonella in 
Animal Feed.'' The draft CPG provides guidance for FDA staff regarding 
the contamination of animal feed and feed ingredients with Salmonella. 
The draft CPG proposes criteria that should be considered in 
recommending enforcement action against animal feed or feed ingredients 
that are adulterated due to the presence of Salmonella. In particular, 
the draft CPG proposes regulatory action guidance relating to animal 
feed or feed ingredients that are contaminated with Salmonella and (1) 
come in direct contact with humans, such as pet food and pet treats, or 
(2) are contaminated with a Salmonella serotype that is pathogenic to 
the target animal for which the animal feed is intended. The draft CPG 
also contains information that may be useful to regulated industry and 
the public.
    FDA is issuing the draft CPG as Level 1 draft guidance consistent 
with FDA's good guidance practices regulation (21 CFR 10.115). The 
draft CPG, when finalized, will represent the agency's current thinking 
on enforcement recommendations for certain circumstances where animal 
feed or feed ingredients are contaminated with Salmonella. 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 approach may be used if such 
approach satisfies the requirements of the applicable statutes and 
regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding the 
draft CPG. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the draft CPG at 
either http://www.fda.gov/ora/compliance_ref/cpg/default.htm or http://www.regulations.gov.

    Dated: July 23, 2010.
Michael A. Chappell,
Acting Associate Commissioner for Regulatory Affairs.
[FR Doc. 2010-18873 Filed 7-30-10; 8:45 am]
BILLING CODE 4160-01-S