Notice2024-17778
Animal Food Ingredient Consultation; Draft Guidance for Industry; Availability
Primary source
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Published
August 9, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of draft guidance for industry #294 entitled "Animal Food Ingredient Consultation (AFIC)." This draft guidance describes FDA's interim AFIC process and explains one way FDA intends to work with firms that are developing animal food ingredients after the Memorandum of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 In addition, this draft guidance describes FDA's enforcement policy for certain ingredients assessed using the AFIC process.
Full Text
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<title>Federal Register, Volume 89 Issue 154 (Friday, August 9, 2024)</title>
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[Federal Register Volume 89, Number 154 (Friday, August 9, 2024)]
[Notices]
[Pages 65368-65369]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-17778]
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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Animal Food Ingredient Consultation; Draft Guidance for Industry;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.
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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the availability of draft guidance for industry #294 entitled ``Animal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 This draft guidance describes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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<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-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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, <a href="/cdn-cgi/l/email-protection#e6a58e87948a89929283c8a5898891879fa6808287c88e8e95c8818990"><span class="__cf_email__" data-cfemail="b9fad1d8cbd5d6cdcddc97fad6d7ced8c0f9dfddd897d1d1ca97ded6cf">[email protected]</span></a>.
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\
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\1\ See 21 CFR part 570, subpart E.
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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 <a href="https://www.fda.gov/animal-veterinary/animal-food-feeds/fda-letter-stakeholders-acknowledgment-expiring-fda-aafco-mou">https://www.fda.gov/animal-veterinary/animal-food-feeds/fda-letter-stakeholders-acknowledgment-expiring-fda-aafco-mou</a>.
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 <a href="https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry">https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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
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