[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availability of a draft guidance for FDA staff entitled ``Compliance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FDA is announcing the availability of a draft guidance for FDA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