[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]
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