Notice2026-06935
Agency Information Collection Activities; Proposed Collection; 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
April 10, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of FDA's regulations for submission of petitions, including food and color additive petitions (including labeling), submission of information to a master file in support of petitions, and electronic submission using Form FDA 3503.
Full Text
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<title>Federal Register, Volume 91 Issue 69 (Friday, April 10, 2026)</title>
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[Federal Register Volume 91, Number 69 (Friday, April 10, 2026)]
[Notices]
[Pages 18466-18468]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-06935]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-2743]
Agency Information Collection Activities; Proposed Collection;
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 or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the information collection provisions of
FDA's regulations for submission of petitions, including food and color
additive petitions (including labeling), submission of information to a
master file in support of petitions, and electronic submission using
Form FDA 3503.
DATES: Either electronic or written comments on the collection of
information must be submitted by June 9, 2026.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 9, 2026. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received on or before that date.
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-2026-N-2743 for ``Agency Information Collection Activities;
Proposed Collection; 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.'' Received
comments, those filed in a timely manner (see ADDRESSES), 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
[[Page 18467]]
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.
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#bbebe9fae8cfdaddddfbdddfda95d3d3c895dcd4cd"><span class="__cf_email__" data-cfemail="520200130126333434123436337c3a3a217c353d24">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the 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.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
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.
We estimate the burden of this collection of information as
follows:
[[Page 18468]]
Table 1--Estimated Annual Reporting Burden \1\
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Total
Number of Number of Total annual Average burden operating and
Activity/21 CFR section; or form # 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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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 one Category A and one
Category B CAP is 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. 2026-06935 Filed 4-9-26; 8:45 am]
BILLING CODE 4164-01-P
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