Document ID: FDA-2013-D-0928-0006
Agency: fda
Document Type: Notice
Title: Recommendations for Preparation and Submission of Animal Food 
Additive Petitions; Guidance for Industry; Availability
Posted Date: 2015-06-12T04:00Z

[Federal Register Volume 80, Number 113 (Friday, June 12, 2015)]
[Notices]
[Pages 33528-33529]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-14364]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

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

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Policy and Regulations Staff (HFV-6), 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 guidance document.
    Submit electronic comments on the 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: Center for Veterinary Medicine, 
Division of Animal Feeds (HFV-220), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-402-7077; AskCVM@fda.hhs.gov, in 
the subject line please include ATTN: Division of Animal Feeds.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of September 11, 2013 (78 FR 55727), FDA 
published the notice of availability for a draft guidance entitled 
``Recommendations for Preparation and Submission of Animal Food 
Additive Petitions'' giving interested persons until November 12, 2013, 
to comment on the draft guidance. In the Federal Register of December 
10, 2013 (78 FR 74154), FDA published a notice reopening the comment 
period for the draft guidance giving interested persons until January 
9, 2014, to comment on the draft guidance.
    FDA received four comments on the draft guidance and considered 
those comments as we finalized the guidance. The guidance announced in 
this notice finalizes the draft guidance dated September 2013.

II. Significance of Guidance

    This level 1 guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The guidance represents 
the current thinking of FDA on recommendations for preparation and 
submission of animal food additive petitions. It does not establish any 
rights for any person and is not binding on FDA or the public. You can 
use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.

III. Paperwork Reduction Act of 1995

    This 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 the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR 571.1 and 571.6 have been approved 
under OMB control number 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 guidance at 
either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov.

[[Page 33529]]

    Dated: June 8, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-14364 Filed 6-11-15; 8:45 am]
 BILLING CODE 4164-01-P