Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Submission of Petitions: Food Additive, Color Additive (Including Labeling), Submission of Information to a Master File in Support of Petitions; and Electronic Submission Using Food and Drug Administration Form 3503

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Published

September 29, 2026

Issuing agencies

Health and Human Services DepartmentFood and Drug Administration

Abstract

The Food and Drug Administration (FDA) 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 91 Issue 187 (Tuesday, September 29, 2026)</title>
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[Federal Register Volume 91, Number 187 (Tuesday, September 29, 2026)]
[Notices]
[Pages 61408-61410]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-19850]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2026-N-2743]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Submission of
Petitions: Food Additive, Color Additive (Including Labeling),
Submission of Information to a Master File in Support of Petitions; and
Electronic Submission Using Food and Drug Administration Form 3503

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the

[[Page 61409]]

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 October 29, 2026.

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 0910-0016. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Michael Ellison, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 240-402-2093,
<a href="/cdn-cgi/l/email-protection#752527342601141313351311145b1d1d065b121a03"><span class="__cf_email__" data-cfemail="c797958694b3a6a1a187a1a3a6e9afafb4e9a0a8b1">[email&#160;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.

Submission of Petitions

Food Additive, Color Additive (Including Labeling), Submission of
Information to a Master File in Support of Petitions; and Electronic
Submission Using Form FDA 3503--21 CFR 21 CFR 70.25, 71.1, and 171.1
and 21 CFR parts 172, 173, 179, and 180

OMB Control Number 0910-0016--Extension

Section 409(a) of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 348(a)) provides that a food additive shall be deemed
to be unsafe, unless: (1) the additive and its use, or intended use,
are in conformity with a regulation issued under section 409 that
describes the condition(s) under which the additive may be safely used;
(2) the additive and its use, or intended use, conform to the terms of
an exemption for investigational use; or (3) a food contact
notification submitted under section 409(h) is effective. Food additive
petitions (FAPs) are submitted by individuals or companies to obtain
approval of a new food additive or to amend the conditions of use
permitted under an existing food additive regulation. Section 171.1 of
FDA's regulations (21 CFR 171.1) specifies the information that a
petitioner must submit in order to establish that the proposed use of a
food additive is safe and to secure the publication of a food additive
regulation describing the conditions under which the additive may be
safely used. Parts 172, 173, 179, and 180 (21 CFR parts 172, 173, 179,
and 180) contain labeling requirements for certain food additives to
ensure their safe use.
Section 721(a) of the FD&C Act (21 U.S.C. 379e(a)) provides that a
color additive shall be deemed to be unsafe unless the additive and its
use are in conformity with a regulation that describes the condition(s)
under which the additive may safely be used, or the additive and its
use conform to the terms of an exemption for investigational use issued
under section 721(f). Color additive petitions (CAPs) are submitted by
individuals or companies to obtain approval of a new color additive or
a change in the conditions of use permitted for a color additive that
is already approved. Section 71.1 of the Agency's regulations (21 CFR
71.1) specifies the information that a petitioner must submit to
establish the safety of a color additive and to secure the issuance of
a regulation permitting its use. FDA's color additive labeling
requirements in Sec. 70.25 (21 CFR 70.25) require that color additives
that are to be used in food, drugs, cosmetics, or medical devices be
labeled with sufficient information to ensure their safe use.
FDA scientific personnel review FAPs to ensure the safety of the
intended use of the additive in or on food, or that may be present in
food as a result of its use in articles that contact food. Likewise,
FDA personnel review CAPs to ensure the safety of the color additive
prior to its use in food, drugs, cosmetics, or medical devices.
Respondents may transmit FAP or CAP regulatory submissions in
electronic format or paper format to the Human Foods Program (HFP)
using Form FDA 3503. Form FDA 3503 helps the respondent organize their
submission to focus on the information needed for FDA's safety review.
Form FDA 3503 can also be used to organize information within a master
file submitted in support of petitions according to the items listed on
the form. Master files can be used as repositories for information that
can be referenced in multiple submissions to the Agency, thus
minimizing paperwork burden for food and color additive approvals.
We improved the information collection by using the HFP Centralized
Online Submission Module (COSM). COSM provides a real-time user
interface process that assists respondents in preparing and making
submissions to HFP. COSM, available 24 hours a day and 7 days a week,
is a web-based tool that supports electronic submissions, thereby
eliminating the need for printing and mailing of paper submissions.
Further information about COSM, including user instruction, is
available on the internet at: <a href="https://www.fda.gov/food/registration-food-facilities-and-other-submissions/centralized-online-submission-module-cosm">https://www.fda.gov/food/registration-food-facilities-and-other-submissions/centralized-online-submission-module-cosm</a>.
Description of Respondents: Respondents are businesses engaged in
the manufacture or sale of food, food ingredients, color additives, or
substances used in materials that come into contact with food.
In the Federal Register of April 10, 2026 (91 FR 18466), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received but was not PRA-
related and will not be addressed here.
We estimate the burden of this collection of information as
follows:

Table 1--Estimated Annual Reporting Burden \1\
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Total
Numbers of Number of Total annual Average burden operating and
Activity/21 CFR section; or Form No. respondents responses per responses per response Total hours maintenance
respondent costs
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Submission of Petitions: Color Additive Including 4 1 4 1,337 5,348 $11,200
Labeling--70.25, 71.1..................................
Submission of Petitions: Food Additive Including 3 1 3 7,093 21,279 0
Labeling--171.1........................................
Form FDA 3503\2\........................................ 5 1 5 1 5 0
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[[Page 61410]]

Total............................................... .............. .............. .............. .............. 26,632 $11,200
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\1\There are no capital costs associated with this collection of information.
\2\Form FDA 3503 is used for both CAPs and FAPs.

Based on a review of the information collection since our last
request for OMB approval, we have adjusted our burden estimate for CAPs
since the average number submitted has increased over the last 10
years. Due to the increase of submissions, we estimate that 4 CAPs will
be submitted annually. Thus, the estimated burden for the information
collection reflects an overall increase of 2,674 hours. Our estimate of
burden attributable to FAPs or CAPs is based on our experience with the
information collection, which FAPs has not changed since our last
review and reflects the average number of petitions we have received
annually over a period of 10 years. The attendant burden we estimate
also reflects an industry average, although burden associated with
individual petitions may vary depending on the complexity of the
petition, and the amount and type of data needed for scientific
analysis.
CAPs are subject to fees. The listing fee for a CAP ranges from
$1,600 to $3,000, depending on the intended use of the color additive
and the scope of the requested amendment. A complete schedule of fees
is set forth in 21 CFR 70.19. An average of two Category A and two
Category B CAPs are expected per year. The maximum CAP fee for a
Category A petition is $2,600, and the maximum CAP fee for a Category B
petition is $3,000. Because an average of four CAPs are expected per
calendar year, the estimated total annual operating and maintenance
cost burden to petitioners for this startup cost would be less than or
equal to $11,200 ((2 x $2,600) + (2 x $3,000) listing fees). There are
no capital costs associated with CAPs.
The labeling requirements for food and color additives were
designed to specify the minimum information needed for labeling so 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 under Sec. 70.25 for a particular color additive involve
information required as part of the CAP safety review process, the
estimate for number of respondents is the same for Sec. Sec. 70.25 and
71.1, and the burden hours for labeling are included in the estimate
for Sec. 71.1. Also, because labeling requirements under parts 172,
173, 179, and 180 for particular food additives involve information
required as part of the FAP safety review process under Sec. 171.1,
the burden hours for labeling are included in the estimate for Sec.
171.1.

Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-19850 Filed 9-28-26; 8:45 am]
BILLING CODE 4164-01-P

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