[Federal Register Volume 89, Number 154 (Friday, August 9, 2024)]
[Notices]
[Pages 65368-65369]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-17778]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Animal Food Ingredient Consultation; Draft Guidance for Industry; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of draft guidance for industry #294 entitled ``Animal 
Food Ingredient Consultation (AFIC).'' This draft guidance describes 
FDA's interim AFIC process and explains one way FDA intends to work 
with firms that are developing animal food ingredients after the 
Memorandum of Understanding (MOU) with the Association of American Feed 
Control Officials (AAFCO) expires on October 1, 2024, and while FDA 
evaluates the animal Food Additive Petition and generally recognized as 
safe (GRAS) Notification programs. The new AFIC process will provide 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 will also allow for public 
awareness of and input on such ingredients. In addition, this draft 
guidance describes FDA's enforcement policy for certain ingredients 
assessed using the AFIC process.

DATES: Submit either electronic or written comments on the draft 
guidance by September 9, 2024 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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 for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Charlotte Conway, Center for 
Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-402-6768, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of draft guidance for industry 
#294 entitled ``Animal Food Ingredient Consultation (AFIC).'' This 
draft guidance describes FDA's interim AFIC process and explains one 
way FDA intends to work with firms that are developing animal

[[Page 65369]]

food ingredients after the MOU with AAFCO expires on October 1, 2024, 
and while FDA evaluates the animal Food Additive Petition and GRAS 
Notification programs. In addition, this draft guidance describes FDA's 
enforcement policy for certain ingredients reviewed using the AFIC 
process.
    The Food, Drug, and Cosmetic Act (FD&C Act) gives FDA the authority 
to regulate substances used in animal food, including substances that 
are food additives and substances that are GRAS for their intended uses 
in food.\1\
---------------------------------------------------------------------------

    \1\ See 21 CFR part 570, subpart E.
---------------------------------------------------------------------------

    Since 1920, AAFCO has maintained the AAFCO Official Publication 
(OP), which contains, among other things, a comprehensive list of 
animal food ingredients, including FDA-approved food additives, 
substances that are GRAS for one or more intended uses, and animal food 
ingredient definitions established through the AAFCO Ingredient 
Definition Request Process. In 2007, FDA entered into an MOU, 225-07-
7001, with AAFCO that outlines how FDA would provide its scientific and 
technical expertise to AAFCO in reviewing requested ingredient 
definitions requested by industry or AAFCO. This MOU has been renewed 
and revised several times. The current MOU 225-07-7001 expires in 
October 2024 and will not be renewed. See https://www.fda.gov/animal-veterinary/animal-food-feeds/fda-letter-stakeholders-acknowledgment-expiring-fda-aafco-mou.
    Following the expiration of the MOU, FDA plans to evaluate its 
animal Food Additive Petition and GRAS Notification programs to 
determine if changes are needed to promote the efficient development 
and review of new animal food ingredients.
    We are issuing this draft guidance to announce the creation of the 
AFIC process to provide an additional way for engagement with FDA 
regarding animal food ingredients following the expiration of the MOU 
with AAFCO and during this interim evaluation period. AFIC will provide 
a process that will help FDA be aware of new ingredients that are 
marketed in interstate commerce and any potential safety concerns 
associated with such ingredients. AFIC will serve to provide a baseline 
of safety information available about such an ingredient, making it 
easier to compare developments that might occur during marketing. AFIC 
also will give FDA an opportunity to discuss any potential safety 
concerns with the developer, ideally before the ingredient is marketed.
    AFIC also will allow for public awareness of and input on 
ingredients for which FDA is providing consultation. Our goal is to 
support innovation in animal food technologies while maintaining as our 
priority the production of safe animal food.
    FDA generally does not intend to initiate enforcement action with 
respect to the food additive approval requirements of the FD&C Act for 
an ingredient, or animal food containing such ingredient, if such an 
ingredient has been reviewed and is the subject of a ``consultation 
complete'' letter under the AFIC process, and is used in accordance 
with the ``consultation complete'' letter, as long as there continues 
to be no questions or concerns about the safety of the ingredient.
    Elsewhere in this issue of the Federal Register, we are publishing 
a notice of availability for a draft guidance #293, ``FDA Enforcement 
Policy for AAFCO-Defined Animal Feed Ingredients.'' This draft guidance 
communicates FDA's enforcement policy regarding certain ingredients 
listed in chapter 6 of the 2024 AAFCO OP (or recommended by FDA for 
inclusion in the AAFCO OP) after the expiration of the Agency's MOU 
with AAFCO.
    Elsewhere in this issue of the Federal Register, we also are 
publishing a notice seeking stakeholder input regarding our current 
Food Additive Petition and GRAS Notification review processes for 
animal food ingredients. Additionally, we intend to hold listening 
sessions and will later provide scheduling information for those 
listening sessions.
    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 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

    FDA tentatively concludes that this draft guidance contains no 
collection of information subject to review and approval by the Office 
of Management and Budget (OMB) under the Paperwork Reduction Act of 
1995 (44 U.S.C. 3501-3521), as at this time we believe that fewer than 
10 persons will avail themselves of this process in any given year. The 
draft guidance does refer to previously approved FDA collections of 
information. The collections of information in 21 CFR 570 have been 
approved under 0910-0342; the collections of information in 21 CFR 571 
have been approved under 0910-0546.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: August 6, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-17778 Filed 8-8-24; 8:45 am]
BILLING CODE 4164-01-P