[Federal Register Volume 78, Number 176 (Wednesday, September 11, 2013)]
[Notices]
[Pages 55727-55728]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-22012]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0928]


Draft Guidance for Industry on Recommendations for Preparation 
and Submission of Animal Food Additive Petitions; 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availability of a draft guidance for industry (GFI 221) 
entitled ``Recommendations for Preparation and Submission of Animal 
Food Additive Petitions.''
    This draft guidance describes the types of information that FDA's 
Center for Veterinary Medicine (CVM) recommends for inclusion in food 
additive petitions (FAPs) submitted for food additives intended for use 
in food for animals. It is intended to help the petitioner submit such 
FAP information in a consistent and appropriate manner.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by November 12, 2013.

ADDRESSES: Submit written requests for single copies of the 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Sharon Benz, Center for Veterinary 
Medicine (HFV-220), Food and Drug Administration, 7519 Standish Place, 
Rockville, MD 20855, 240-453-6864, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
(GFI 221) entitled ``Recommendations for Preparation and 
Submission of Animal Food Additive Petitions.'' It is intended to help 
petitioners submit FAP information in a consistent and appropriate 
manner.
    The requirements for submitting an animal food additive petition to 
FDA are set forth in section 409 of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) (21 U.S.C. 348) and 21 CFR part 571. This draft 
guidance provides information for complying with these requirements.
    This draft guidance includes the following information:
     How to determine if an animal food ingredient is already 
the subject of an approved FAP.
     Who to contact for more information about approved food 
additives.
     Who to contact for more information on how to submit an 
FAP for approval.
     When and how to request a pre-petition consultation with 
CVM before submitting an FAP.
     When and how to submit study designs for CVM review.
     What data CVM considers adequate to support an FAP.
     Where to find other FDA guidances that may be helpful when 
preparing and submitting an FAP to CVM.
     General recommendations for the format of an FAP 
submission.
     Where and how to submit an FAP.

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

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under

[[Page 55728]]

the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in Sec. Sec.  571.1 and 571.6 have been 
approved under 0910-0546.

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: September 4, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-22012 Filed 9-10-13; 8:45 am]
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