[Federal Register Volume 89, Number 206 (Thursday, October 24, 2024)]
[Rules and Regulations]
[Pages 84819-84820]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-24715]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Chapter I

[Docket No. FDA-2024-D-2977]


Food and Drug Administration Enforcement Policy for Association 
of American Feed Control Officials--Defined Animal Feed Ingredients; 
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance for industry #293 entitled ``FDA 
Enforcement Policy for AAFCO-Defined Animal Feed Ingredients.'' This 
communicates FDA's enforcement policy regarding ingredients listed in 
chapter six of the 2024 Association of American Feed Control Officials 
(AAFCO) Official Publication after the Agency's memorandum of 
understanding with AAFCO expired on October 1, 2024.

DATES: The announcement of the guidance is published in the Federal 
Register on October 24, 2024.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
    <bullet> If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
    <bullet> Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    <bullet> For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2024-D-2977 for ``FDA Enforcement Policy for AAFCO-Defined Animal 
Feed Ingredients.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at https://www.regulations.gov or at the Dockets Management 
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
    <bullet> Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the 
Policy and Regulations Staff, Center for Veterinary Medicine, Food and 
Drug Administration, 7500 Standish Pl.,

[[Page 84820]]

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.

FOR FURTHER INFORMATION CONTACT: Charlotte Conway, Center for 
Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-402-6768, <a href="/cdn-cgi/l/email-protection#17547f76657b786363723954787960766e57717376397f7f6439707861"><span class="__cf_email__" data-cfemail="95d6fdf4e7f9fae1e1f0bbd6fafbe2f4ecd5f3f1f4bbfdfde6bbf2fae3">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of August 9, 2024 (89 FR 65294), FDA 
published the notice of availability for a draft guidance #293 entitled 
``FDA Enforcement Policy for AAFCO-Defined Animal Feed Ingredients,'' 
giving interested persons until September 9, 2024, to comment on the 
draft guidance. FDA received numerous comments on the draft guidance, 
including comments from the animal food industry, AAFCO, a veterinary 
association, a State food and agriculture department, and private 
citizens, and those comments were considered as the guidance was 
finalized. The guidance was revised to provide clarification regarding 
where the referenced ingredient definitions are available to the 
public. In addition, editorial changes were made to improve clarity. 
The guidance announced in this document finalizes the draft guidance 
dated August 9, 2024.\1\
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    \1\ The Office of the Federal Register has published this 
document under the category ``Rules and Regulations'' pursuant to 1 
CFR 5.9(b). The Office of the Federal Register's categorization is 
solely for purposes of publication in the Federal Register and does 
not change the nature of the document and is not intended to affect 
its validity, content, or intent. See 1 CFR 5.1(c).
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    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 ``FDA Enforcement Policy for AAFCO-
Defined Animal Feed Ingredients.'' 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.

II. Paperwork Reduction Act of 1995

    This guidance contains no collection of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: October 18, 2024.
Eric Flamm,
Acting Associate Commissioner for Policy.
[FR Doc. 2024-24715 Filed 10-23-24; 8:45 am]
BILLING CODE 4164-01-P


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