
[Federal Register Volume 80, Number 54 (Friday, March 20, 2015)]
[Notices]
[Page 15014]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-06390]



[[Page 15014]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1180]


Draft Guidance for Industry on Ensuring Safety of Animal Feed 
Maintained and Fed On-Farm; 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availability of a draft guidance for industry #203 entitled ``Ensuring 
Safety of Animal Feed Maintained and Fed On-Farm.'' This draft guidance 
is intended to help animal producers (persons who feed animals) develop 
and implement on-farm practices to ensure the safety of animal feed 
maintained and fed to animals on the farm.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by June 3, 2015.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Communications Staff (HFV-12), Center for Veterinary 
Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, 
MD 20855. Send one self-addressed adhesive label to assist that office 
in processing your requests. See the SUPPLEMENTARY INFORMATION section 
for electronic access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Phares Okelo, Center for Veterinary 
Medicine (HFV-226), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-453-6862, email: phares.okelo@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
# 203 entitled ``Ensuring Safety of Animal Feed Maintained and Fed On-
Farm.'' This draft guidance is intended to help animal producers 
(persons who feed animals) develop and implement on-farm practices to 
ensure the safety of animal feed maintained and fed to animals on the 
farm. In this document, ``farm'' means animal production units such as 
integrated poultry grower operations, swine finishing units, and cattle 
feedlots. This document outlines basic measures that may be taken to 
maintain the safety of all types of feed held on the farm for use in 
animal production. This draft guidance recommends establishing measures 
to ensure the acquisition of safe feed and maintenance of its safety 
until the feed is offered to animals in the farm environment. This 
document does not address feed manufacture, which also may occur on 
farms.

II. Significance of Guidance

    This level 1 draft guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The draft guidance, 
when finalized, will represent the Agency's current thinking on this 
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 alternative approach may 
be used if such approach satisfies the requirements of the applicable 
statutes and regulations.

III. Paperwork Reduction Act of 1995

    FDA concludes that there are no collections of information under 
the Paperwork Reduction Act of 1995.

IV. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of 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 and will be posted to the docket at http://www.regulations.gov.

V. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov.

    Dated: March 16, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-06390 Filed 3-19-15; 8:45 am]
 BILLING CODE 4164-01-P


