Agency Information Collection Activities; Proposed Collection; Comment Request; Requirements for Cosmetic Products
The Food and Drug Administration (FDA, the Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under ...
The Food and Drug Administration (FDA, the Agency, or we) 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 information collection activity requirements for cosmetic products.
DATES:
Either electronic or written comments on the collection of information must be submitted by September 15, 2026.
ADDRESSES:
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The
https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of September 15, 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:
Federal eRulemaking Portal:https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to
https://www.regulations.gov
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
https://www.regulations.gov.
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”).
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. for “Agency Information Collection Activities; Proposed Collection; Comment Request; Cosmetic Labeling Requirements and Facility Registration and Cosmetic Product Listing Program.” 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
https://www.regulations.gov
or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
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
https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly 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:
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket:
For access to the docket to read background documents or the electronic and written/paper comments received, go to
https://www.regulations.gov
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:
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,
PRAStaff@fda.hhs.gov.
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
( printed page 44851)
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.
Requirements for Cosmetic Products
OMB Control Number 0910-0599—Revision
This information collection supports 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. For purposes of this information collection, the relevant provisions of the Agency's regulations in Title 21 of the CFR are set forth in 21 CFR part 701, subparts A, B, and C (§§ 701.1-701.30), which establish cosmetic labeling requirements, including general provisions, package form requirements, and labeling requirements for specific ingredients.
The respondents to this 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 associated 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
https://www.fda.gov/cosmetics/registration-listing-cosmetic-product-facilities-and-products.
We estimate the burden of this collection of information as follows:
Table 1—Estimated Annual Recordkeeping Burden 1
Information collection activity; FD&C Act section
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
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 registration renewals and abbreviated facility registration renewals
2,107
1
2,107
0.17 (10 minutes)
358
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 listing
22,564
14.64
330,337
1
330,337
Sec. 607(c)(3): abbreviated cosmetic product listing renewals
25,190
1
25,190
0.10 (6 minutes)
2,519
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
Total
417,698
367,777
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
( printed page 44852)
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 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.
FD&C sec. 609(a): contact information to send adverse event reports
5,738
24
137,712
1
137,712
FD&C sec. 609(c): professional use only
402
12
4,824
1
4,824
Total
676,170
676,170
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.