Notice2025-07588
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Additives Intended for Use in Animal Food, Food Additive Petitions, Investigational Food Additive Files Exemptions, and Declaration on Animal Food Labels
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Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 1, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Full Text
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<title>Federal Register, Volume 90 Issue 83 (Thursday, May 1, 2025)</title>
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[Federal Register Volume 90, Number 83 (Thursday, May 1, 2025)]
[Notices]
[Pages 18660-18662]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-07588]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-5581]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Food Additives
Intended for Use in Animal Food, Food Additive Petitions,
Investigational Food Additive Files Exemptions, and Declaration on
Animal Food Labels
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing that a proposed collection of information has been submitted
to the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by June 2, 2025.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0546. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
<a href="/cdn-cgi/l/email-protection#752527342601141313351311145b1d1d065b121a03"><span class="__cf_email__" data-cfemail="c696948795b2a7a0a086a0a2a7e8aeaeb5e8a1a9b0">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Food Additives Intended for Use in Animal Food, Food Additive
Petitions, Investigational Food Additive Files Exemptions, and
Declarations on Animal Food Labels
OMB Control Number 0910-0546--Revision
This information collection helps support implementation of FDA's
authority over food additives intended for use in animal food.
Misbranded foods are prohibited under section 403 of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 343); food additives are
covered in section 409 of the FD&C Act (21 U.S.C. 348), which provides,
at section 409(a) of the FD&C Act, that a food additive shall be deemed
to be unsafe unless its use is permitted by a regulation that
prescribes the condition(s) under which it may safely be used, or
unless it is exempted by regulation for investigational use. Section
409(b) of the FD&C Act provides for petitions to establish safety of
food additives and specifies information that must be submitted to FDA
before a regulation permitting its use may be issued. Agency regulation
in 21 CFR part 570 sets forth general provisions applicable to food
additives intended for use in animal food, provides relevant
definitions, establishes principles for determining safety, and
explains prescribed elements to be included in a Generally Recognized
as Safe (GRAS) notice. The regulation also provides for certain
exemptions for investigational use and discusses related procedures.
Agency regulation in 21 CFR part 571 establishes procedural
requirements applicable to the submission of petitions filed under
section 409(b) of the FD&C Act, including content and format elements
to facilitate FDA processing of a food additive petition. Finally,
Agency regulation in 21 CFR part 501 establishes disclosure
requirements for animal food labeling, including the disclosure of the
presence of certified and noncertified color additives (21 CFR
501.22(k)). Additional disclosure requirements are found in 21 CFR
parts 573 (food additives permitted in feed and drinking water of
animals) and 579 (irradiation in the production, processing, and
handling of animal food), and are included in the scope of coverage for
the information collection.
We are revising the information collection to include related
authority established through enactment of the Animal Drug and Animal
Generic Drug User Fee Amendments of 2018 (2018 Amendments) (Pub. L.
115-234). Intending to help ensure the safety of pet food, section
306(c) of the 2018 Amendments provides for the issuance of guidance on
pre-petition consultations for animal food additives. We have issued
the following guidance documents to assist respondents in this regard:
Guidance for Industry (GFI) #262, ``Pre-Submission Consultation
Process for Animal Food Additive Petitions or Generally Recognized as
Safe (GRAS) Notices'' (December 2020), is available for download from
our website at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-262-pre-submission-consultation-process-animal-food-additive-petitions-or-generally">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-262-pre-submission-consultation-process-animal-food-additive-petitions-or-generally</a>. The guidance document
describes the types of information our Center for Veterinary Medicine
recommends be included in:
1. pre-petition consultations prior to submission of food additive
petitions (FAP) for food additives intended for use in animal food;
2. pre-submission consultations regarding an animal food substance
for which an entity plans to provide notice of its conclusion that the
intended use of the substance is GRAS under FDA's animal food GRAS
Notification program; or
3. a Food Use Authorization request to permit the use, in human or
animal foods, of animal products derived from animals that have been
administered an investigational substance intended for use in animal
food.
Additionally, GFI #294, ``Animal Food Ingredient Consultation
(AFIC)'' (January 2025), available for download at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-294-animal-food-ingredient-consultation-afic">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-294-animal-food-ingredient-consultation-afic</a>, describes the AFIC process,
which provides for a way, within the regulatory framework, for firms
that are developing animal food ingredients to consult with FDA, and
for FDA to review information from developers and the public regarding
the ingredients and any relevant safety concerns. The AFIC process
includes opportunities for public awareness of, and input on, the
ingredients for which FDA is providing consultation. The guidance
document also explains that FDA generally would not intend to take
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enforcement action against an ingredient for being an unapproved animal
food additive if FDA has sent an AFIC ``consultation complete'' letter,
provided the ingredient is used in accordance with the terms described
in the letter and there continues to be no questions or concerns about
the safety of the ingredient.
Description of Respondents: Respondents to this collection of
information are animal food manufacturers or animal food additive
manufactures. With regard to submission activities, we assume 2,508
respondents based on the number of registrants who identify as animal
food additive manufacturers. With regard to labeling activities under
21 CFR 501.22(k), we assume 3,120 respondents based on information
found in previous Agency rulemaking (RIN-0910AG02) regarding
declarations for animal food product labels.
In the Federal Register of December 19, 2024 (89 FR 103838), we
published a 60-day notice soliciting public comment on the proposed
collection of information. One comment was received offering general
support for the utility of the information collection.
Table 1--Estimated Annual Reporting Burden \1\
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Number of Total
Regulatory authority; Number of responses per annual Average burden per response Total
submission of information respondents respondent responses hours
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Food Additive Petitions
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21 CFR 571.1(c); Moderate 3 1 3 3,000...................... 9,000
Category.
21 CFR 571.1(c); Complex 3 1 3 10,000..................... 30,000
Category.
21 CFR 571.6; Amendment of 5 1 5 1,300...................... 6,500
Petition.
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Investigational Food Additive Files
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21 CFR 570.17; Moderate 8 1 8 1,500...................... 12,000
Category.
21 CFR 570.17; Complex 10 1 10 5,000...................... 50,000
Category.
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Animal Food Ingredient Consultation
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Consultation Category........ 12 1 12 3,000...................... 36,000
Amendment of Consultation.... 12 1 12 1,300...................... 15,600
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Color Additives
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21 CFR 501.22(k); labeling of 3,120 0.8292 2,587 0.25 (15 minutes).......... 647
color additive or lake of
color additive; labeling of
color additives not subject
to certification.
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Total Hours.............. ............ .............. .......... ........................... 159,747
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
We have determined that food additive petitions and investigational
food additive files that are submitted, fall into one of two categories
of complexity. Fluctuations in the number and types of food and color
additive petitions received in any given year are governed by market
forces.
Sec. 571.1(c) Moderate Category: For a food additive petition
without complex chemistry, manufacturing, efficacy and/or safety
issues, the estimated time requirement per petition is approximately
3,000 hours. We estimate that, annually, 3 respondents will submit 1
such petition, for a total of 9,000 hours.
Sec. 571.1(c) Complex Category: For a food additive petition with
complex chemistry, manufacturing, efficacy and/or safety issues, the
estimated time requirement per petition is approximately 10,000 hours.
We estimate that, annually, 3 respondents will each submit 1 such
petition, for a total of 30,000 hours.
Sec. 571.6 Amendment of Petition: For a food additive petition
amendment, the estimated time requirement per petition is approximately
1,300 hours. We estimate that, annually, 5 respondents will each submit
1 such amendment, for a total of 6,500 hours.
Sec. 570.17 Moderate Category: For an investigational food
additive file without complex chemistry, manufacturing, efficacy and/or
safety issues, the estimated time requirement per file is approximately
1,500 hours. We estimate that, annually, 8 respondents will each submit
1 such file, for a total of 12,000 hours.
Sec. 570.17 Complex Category: For an investigational food additive
file with complex chemistry, manufacturing, efficacy and/or safety
issues, the estimated time requirement per file is approximately 5,000
hours. We estimate that, annually, 10 respondents will each submit 1
such file, for a total of 50,000 hours.
Consultation Category: We estimate developers of animal food
ingredients will spend 3,000 hours consulting with FDA on an
ingredient. We estimate that, annually, 12 respondents will consult
with FDA, for a total of 36,000 hours.
The labeling requirements for food and color additives were
designed to specify the minimum information needed for labeling in
order that food and color manufacturers may comply with all applicable
provisions of the FD&C Act and other specific labeling acts
administered by FDA. Label information does not require any additional
information gathering beyond what is already required to assure
conformance with all specifications and limitations in any given food
or color additive regulation. Label information does not have any
specific recordkeeping requirements unique to preparing the label.
Therefore, because labeling requirements for a particular color
additive or food additive involve information required as part of the
safety review process, the burden hours for labeling are included in
the estimate for 21 CFR 501.22(k) and 571.1.
We base our estimate of the total annual responses on submissions
received over the last 3 years. We base
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our estimate of the hours per response on our experience with the
labeling, food additive petition, and filing processes.
Based on review of the information collection, there was a decrease
of food additive petition (FAP) responses and a corresponding decrease
in burden hours for FAPs. We attribute this adjustment to an increase
in the number of GRAS notices (21 CFR part 570, subpart E) received,
which tend to substitute for FAP submissions due to a similar quantity
and quality of data and information requirement. These numbers can
fluctuate year to year. We also note that investigational food additive
file responses have increased due to more respondents providing
information during the premarket process prior to providing a more
formal regulatory response (e.g., FAP or GRAS notice). We did not
adjust the number of responses received for the declaration of color
additives on animal food labels from the previous collection.
Our estimated burden for the information collection reflects an
overall increase of 40,600 total hours and 24 responses. We attribute
this to accounting for the consultation process for firms developing
animal food ingredients.
Dated: April 24, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-07588 Filed 4-30-25; 8:45 am]
BILLING CODE 4164-01-P
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