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[Federal Register Volume 90, Number 4 (Tuesday, January 7, 2025)]
[Notices]
[Pages 1138-1139]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31525]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-D-2978]

Food and Drug Administration Animal Food Ingredient Consultation; 
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 #294 entitled 
``Animal Food Ingredient Consultation (AFIC).'' This guidance describes 
FDA's interim AFIC process and explains one way FDA will work with 
firms that are developing animal food ingredients now that the 
Memorandum of Understanding (MOU) with the Association of American Feed 
Control Officials (AAFCO) expired on October 1, 2024, and while FDA 
evaluates the animal Food Additive Petition and Generally Recognized as 
Safe (GRAS) Notification programs. The AFIC process provides an 
additional way for engagement with FDA regarding ingredients for which 
firms may otherwise have used the AAFCO ingredient definition process. 
AFIC will help FDA identify any potential safety concerns associated 
with such ingredients. The AFIC process also allows for public 
awareness of and input on such ingredients. In addition, this guidance 
describes FDA's enforcement policy for certain ingredients assessed 
using the AFIC process.

DATES: The announcement of the guidance is published in the Federal 
Register on January 7, 2025.

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:
     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.
     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:
     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.
     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-2978 for ``Animal Food Ingredient Consultation (AFIC).'' 
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.
     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., Rockville, MD 20855. Send one 
self-addressed adhesive label to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section

[[Page 1139]]

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, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of August 9, 2024 (89 FR 65368), FDA 
published the notice of availability for a draft guidance #294 entitled 
``Animal Food Ingredient Consultation (AFIC),'' 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 and drug industries, AAFCO, a veterinary 
association, a State food and agriculture department, and private 
citizens, and those comments were considered as the guidance was 
finalized. In response to comments, the guidance was revised. First, we 
clarified the scope of the AFIC process as including any animal food 
ingredient for which firms may have otherwise utilized the AAFCO 
ingredient definition process. We also clarified that a proposed 
ingredient name and definition should be included in the consultation 
for FDA's consideration. We removed the recommendation to submit a 
statement of environmental risk. In addition, we clarified that firms 
participating in the AFIC process should not resubmit information they 
have already provided to FDA and added clarification regarding what 
information interested parties should include when providing comments 
on pending AFICs through the docket. Lastly, editorial changes were 
made to improve clarity. The guidance announced in this notice 
finalizes the draft guidance dated August 9, 2024.
    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 ``Animal Food Ingredient Consultation 
(AFIC).'' 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

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3521), Federal Agencies must obtain approval from the Office of 
Management and Budget (OMB) for each collection of information they 
conduct or sponsor. FDA is issuing this guidance, as final, that 
includes information collection recommendations regarding animal food 
ingredient consultations with FDA, which are subject to review and 
approval by OMB under the PRA. FDA will implement the information 
collection recommendations upon OMB approval and will announce OMB 
approval in the Federal Register. Information collection pertaining to 
animal food ingredient safety is currently provided for in FDA 
regulations in 21 CFR parts 570 and 571, currently approved in OMB 
control numbers 0910-0342 and 0910-0546, respectively. Disclosures 
under 21 CFR 501.22 requiring animal food manufacturers to declare the 
presence of certified and noncertified color additives in animal food 
product labeling are also currently approved in OMB control number 
0910-0546. However, upon our review of the latter information 
collection, we note that while we account for general reporting 
activities applicable to animal food ingredient regulations, we do not 
discuss activities that may be specifically attributable to animal food 
ingredient consultations with FDA. We also acknowledge that 
discontinuation of the MOU with AAFCO may result in an adjustment for 
some respondents with regard to how they engage in consultation with 
FDA. On December 19, 2024, FDA published a notice (89 FR 103838) under 
the PRA of its intent to revise the information collection to 
explicitly discuss animal food ingredient consultations that we believe 
are implicitly contemplated by the existing regulations in 21 CFR parts 
570 and 571 specifically to invite comment on the associated burden.

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: December 27, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-31525 Filed 1-6-25; 8:45 am]
BILLING CODE 4164-01-P
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