Notice2026-21913
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Color Additive Certification
Primary source
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
October 28, 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 207 (Wednesday, October 28, 2026)</title>
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[Federal Register Volume 91, Number 207 (Wednesday, October 28, 2026)]
[Notices]
[Pages 67842-67843]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-21913]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-2742]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Color Additive
Certification
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 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 November 27, 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 0910-0216. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Amber Barrett, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
<a href="/cdn-cgi/l/email-protection#67373526341306010127010306490f0f1449000811"><span class="__cf_email__" data-cfemail="d080829183a4b1b6b690b6b4b1feb8b8a3feb7bfa6">[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.
Color Additive Certification
OMB Control Number 0910-0216--Extension
This information collection supports FDA regulations governing
certification for color additives used in foods, drugs, cosmetics, and
medical devices. All color additives must have FDA-approval for their
intended use and be listed in the color additive regulations before
they are permitted for use in food, drugs, cosmetics, and many medical
devices. Some color additives have an additional requirement: they are
permitted only if they are from batches that FDA has certified under
section 721(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379e(a)). This means that FDA chemists have analyzed a sample from the
batch and have found that it meets the requirements for composition and
purity stated in the regulation, called a ``listing regulation,'' for
that color additive. We list color additives that have been shown to be
safe for their intended uses in Title 21 of the Code of Federal
Regulations (CFR). We require batch certification for all color
additives listed in 21 CFR part 74 and for all color additives
provisionally listed in 21 CFR part 82. Color additives listed in 21
CFR part 73 are exempted from certification.
The requirements for color additive certification are established
in 21 CFR part 80. Procedures for color additive certification are set
forth in part 80, subpart B (Sec. Sec. 80.21 through 80.39) and
communicate required data elements for requests for certification,
limitations of certificates, exemptions from certification for color
additive mixtures, treatment of batches pending and after
certification, and recordkeeping requirements for respondents to whom a
certificate is issued. During the batch certification procedure, a
manufacturer of color additives must submit a ``request for
certification'' that provides information about the batch, accompanied
by a representative sample of a new batch of color additive, to FDA's
Office of Cosmetics and Colors. FDA personnel perform chemical and
other analyses of the representative sample and, providing the sample
satisfies all certification requirements, issue a certificate that
contains a certification lot number for the batch. The batch can then
be used in FDA-regulated products marketed in the United States, in
compliance with the uses and restrictions in that color additive's
listing regulation. If the sample does not meet the requirements, the
batch will be rejected. We require manufacturers to keep complete
records showing disposal of all of the color additive covered by the
certification.
FDA's web-based color certification information system is available
for respondents to request color certification online, track their
submissions, and obtain account status information. Prior to submitting
a request for certification, the manufacturer must open a color
certification account by sending a letter, as an email attachment,
signed by responsible company representative, to FDA's Office of
Cosmetics and Colors at <a href="/cdn-cgi/l/email-protection#1f7c7073706d317c7a6d6b5f797b7e3177776c31787069"><span class="__cf_email__" data-cfemail="187b7774776a367b7d6a6c587e7c793670706b367f776e">[email protected]</span></a>. System certification
results are returned electronically, allowing submitters to sell their
certified color before receiving hard copy certificates.
We charge a fee for certification based on the batch weight and
require manufacturers to keep records of the batch pending and after
certification. The user fees support FDA's color certification program.
Additional information about color additive certification is available
at: <a href="https://www.fda.gov/industry/color-additives/color-certification">https://www.fda.gov/industry/color-additives/color-certification</a>.
The purpose for collecting this information is to help the Agency
assure that only safe color additives will be used in foods, drugs,
cosmetics, and medical devices sold in the United States.
[[Page 67843]]
Description of Respondents: The respondents include businesses
engaged in the manufacture of color additives used in FDA-regulated
foods, drugs, cosmetics, and medical devices. Respondents are from the
private sector (for-profit businesses).
In the Federal Register of March 10, 2026 (91 FR 18464), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
21 CFR section; activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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80.21 and 80.22; Request for 67 112 7,504 0.22 (13 1,651
certification accompanied by minutes).
sample.
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden\1\
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Number of Average burden
21 CFR section; activity Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
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80.39; Record of distribution. 67 112 7,504 0.25 (15 1,876
minutes).
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
We base our estimate on our review of the certification requests
received over the past 3 years. Using information from industry
personnel, we estimate that an average of 0.22 hour per response is
required for reporting (preparing certification requests and
accompanying samples) and an average of 0.25 hour per response is
required for recordkeeping.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-21913 Filed 10-27-26; 8:45 am]
BILLING CODE 4164-01-P
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