Notice2026-20990
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Requirements for Cosmetic Products
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 14, 2026
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 91 Issue 197 (Wednesday, October 14, 2026)</title>
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[Federal Register Volume 91, Number 197 (Wednesday, October 14, 2026)]
[Notices]
[Pages 65219-65221]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-20990]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-6739]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Requirements for
Cosmetic Products
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 November 13, 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 0910-0599. 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
[[Page 65220]]
20852, 240-402-5733, <a href="/cdn-cgi/l/email-protection#a7f7f5e6f4d3c6c1c1e7c1c3c689cfcfd489c0c8d1"><span class="__cf_email__" data-cfemail="e9b9bba8ba9d888f8fa98f8d88c781819ac78e869f">[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.
Requirements for Cosmetic Products
OMB Control Number 0910-0599--Revision
This information collection supports the implementation of
statutory and regulatory requirements that govern cosmetic products,
including requirements most recently established under the
Modernization of Cosmetics Regulation Act of 2022 (MoCRA). MoCRA
amended the Federal Food, Drug, and Cosmetic Act by adding, in
pertinent part, sections 604, 605, 607, 608, and 609 (21 U.S.C. 364b,
364c, 364e, and 364g), which establish or amend definitions and
requirements related to adverse events, facility registration, cosmetic
product listing, safety substantiation, and labeling. Agency
regulations in 21 CFR part 701, subparts A, B, and C (Sec. Sec. 701.1-
701.30), establish cosmetic labeling requirements, including general
provisions, package form requirements, and labeling requirements for
specific ingredients. Respondents to the information collection consist
primarily of responsible persons as defined in section 604(4) of the
FD&C Act, meaning the manufacturer, packer, or distributor of a
cosmetic product whose name appears on the label of such cosmetic
product in accordance with section 609(a) of the FD&C Act or section
4(a) of the Fair Packaging and Labeling Act.
The respondent totals and burden figures are based on facility
registration, cosmetic product listing, and labeling data derived from
multiple submission pathways, including Cosmetics Direct, the
Electronic Submission Gateway (ESG) Next Generation (NextGen),
Structured Product Labeling (SPL) authoring software, and paper
submissions. Cosmetics Direct is an online submission tool that allows
users to enter required data, generate an SPL submission, and submit
facility registrations, product listing, and renewals for cosmetic
products directly to FDA. Alternatively, industry may use its own
software to create an SPL-formatted submission and transmit the
submission to FDA through the ESG.
To assist respondents with information collection and provide an
alternative to the ESG NextGen electronic submission process, we have
also developed Form FDA 5066, entitled ``Registration of Cosmetic
Product Facility,'' and Form FDA 5067, entitled ``Cosmetic Product
Listing,'' to be used for cosmetic product facility registrations and
product listings, respectively. These forms are available
electronically and in paper format at <a href="https://www.fda.gov/cosmetics/registration-listing-cosmetic-product-facilities-and-products">https://www.fda.gov/cosmetics/registration-listing-cosmetic-product-facilities-and-products</a>.
We have also developed the guidance document, ``Registration and
Listing of Cosmetic Product Facilities and Products'' (December 2024),
available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-registration-and-listing-cosmetic-product-facilities-and-products">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-registration-and-listing-cosmetic-product-facilities-and-products</a>. The guidance document is intended to
provide instruction in preparing and submitting registration and
product listing information as required by section 607 of the FD&C Act.
The guidance document discusses, among other things, who must register
and list, when, and what information must be submitted to FDA.
In the Federal Register of July 17, 2026 (91 FR 9287), we published
a 60-day notice requesting public comment on the proposed collections
of information. Although two comments were received, neither discussed
the information collection topics found in 5 CFR 1320.8(d)(1) for which
the Agency sought comment, nor did they suggest that we revise the
figures we attribute to the individual collection tasks.
We estimate the burden of the collections of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
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Number of
Information collection activity; FD&C act Number of responses per Total annual Average burden per response Total hours
section respondents respondent responses
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Sec. 605(e)(1): adverse event recordkeeping..... 1,165 1.2 1,398 0.6 (36 minutes)......................... 839
Sec. 607(a)(1): initial facility registrations.. 8,343 1 8,343 0.5 (30 minutes)......................... 4,172
Sec. 607(a)(2) and (5): biennial facility 2,107 1 2,107 0.17 (10 minutes)........................ 358
registration renewals and abbreviated facility
registration renewals.
Sec. 607(a)(4): facility registration updates... 3,141 1 3,141 0.25 (15 minutes)........................ 785
Sec. 607(f): post-hearing corrective action plan 5 1 5 10....................................... 50
Sec. 607(c)(1) & (2): initial cosmetic product 22,564 14.64 330,337 1........................................ 330,337
listing.
Sec. 607(c)(3): abbreviated cosmetic product 25,190 1 25,190 0.10 (6 minutes)......................... 2,519
listing renewals.
Sec. 607(c)(5): cosmetic product listing updates 3,020 8.15 24,613 0.25 (15 minutes)........................ 6,153
Sec. 608(a): safety substantiation recordkeeping 22,564 1 22,564 1........................................ 22,564
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Total....................................... .............. .............. 417,698 ......................................... 367,777
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\1\ There are no capital or operating and maintenance costs associated with the information collection.
Because 5 CFR 1320.3(m) defines a recordkeeping requirement to
include the reporting to the Federal government regarding such records,
we have denoted table 1 as recordkeeping burden, noting that applicable
requirements include the submission of information to FDA. We estimate
a total burden of 367,777 hours associated with annual reporting and
recordkeeping requirements cumulatively.
For facility registration activity, we assume approximately 8,343
annual respondents will engage in initial facility registration.
Respondents are required to register their facility only once and based
on internal trials and communication with industry, we estimate that
registration will take approximately 30 minutes to complete for a total
of 4,172 burden hours. Facility registration renewal occurs every two
years. Therefore, the initial facility registration figure does not
represent all currently active registrations and may appear low
compared to the number of cosmetic product listing activity
respondents. Differences in the timing of respondents completing
initial facility registrations account for differences in respondent
totals for initial facility registration, registration renewals, and
registration updates. Additionally, renewals and updates typically
involve less information input than the initial registration which
accounts for their smaller average burden per response and total burden
hours.
For cosmetic product listing activity, we assume a total of
approximately
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22,564 cosmetic product listing respondents and 25,190 cosmetic product
listing renewal respondents. However, these figures may overestimate
the total number of unique respondents because some respondents may
both list new products in compliance with section 607(c)(1) and (2) of
the FD&C Act and renew existing cosmetic product listings under section
or update cosmetic product listings 607(c)(5) of the FD&C Act.
Additionally, the total number of cosmetic product listing and listing
renewal respondents will differ due to variation in the timing of
respondents completing initial cosmetic product listings, as well as
the voluntary nature of product listing renewals. For cosmetic product
listing, we estimate an average of ~ 14.64 responses per respondent,
which amounts to 330,337 responses, at an average rate of 1 hour
response, for a total of 330,337 total burden hours. Like facility
registration, cosmetic product listing renewals and updates typically
involve less information input than the initial product listing which
accounts for their smaller average burden per response and total burden
hours.
Adverse event reporting is captured on FDA Form 3500A, and the
associated data are collected under OMB Control Number 0910-0291 (FDA's
Adverse Event and Product Experience Reporting Program: MedWatch and
the Safety Reporting Portal). Under section 605(e)(1) of the FD&C Act,
a responsible person must maintain a record for six years (three years
for qualifying small businesses) for each adverse event report that
they are required to submit. Accordingly, the adverse event
recordkeeping estimates presented in Table 1 are aligned with the data
collected under OMB Control Number 0910-0291. However, because that
information collection combines cosmetics-related adverse event reports
with food and infant formula adverse event reports, the actual number
of cosmetics adverse event reports may be lower than the figure
presented here. We will update the estimate if more precise data
becomes available.
We estimate that each of the 22,564 respondents will maintain, on
average, one safety substantiation record. Because section 608(a)
requires responsible persons to maintain records supporting the
``adequate substantiation of safety'' of cosmetic products, and because
responsible persons have discretion in determining which records
satisfy this requirement, we estimate that each respondent will create
and maintain at least one record for compliance purposes.
Table 2--Estimated Annual Third-Party Disclosure Burden \1\
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Number of Average
Regulatory authority: Number of disclosures Total annual burden per Total hours
information collection activity respondents per respondent disclosures disclosure
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21 CFR 701.3: declaration of 5,738 21 120,498 1 120,498
ingredients in order of
predominance..................
21 CFR 701.11: statement of 5,738 24 137,712 1 137,712
identity......................
21 CFR 701.12: name and place 5,738 24 137,712 1 137,712
of business...................
21 CFR 701.13: net quantity of 5,738 24 137,712 1 137,712
contents......................
FD&C sec. 609(a): contact 5,738 24 137,712 1 137,712
information to send adverse
event reports.................
FD&C sec. 609(c): professional 402 12 4,824 1 4,824
use only......................
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Total...................... .............. ............... 676,170 .............. 676,170
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
We estimate that 5,738 respondents will expend a total of 120,498-
137,712 burden hours annually (21 CFR 701.3, 701.11-13) including
required disclosures on an average of 21-24 product labels per
respondent. Similarly, we estimate 5,738 respondents will expend a
total of 137,712 hours per label annually to ensure that an average of
24 product labels display requisite adverse event reporting
information, and that 402 respondents will expend an average of 4,824
hours annually disclosing requisite ``professional use only'' labeling
on an average of 12 products.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-20990 Filed 10-13-26; 8:45 am]
BILLING CODE 4164-01-P
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