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 (§§ 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 www.fda.gov/​cosmetics/​registration-listing-cosmetic-product-facilities-and-products.

We have also developed the guidance document, “Registration and Listing of Cosmetic Product Facilities and Products” (December 2024), available at www.fda.gov/​regulatory-information/​search-fda-guidance-documents/​guidance-industry-registration-and-listing-cosmetic-product-facilities-and-products. 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:

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 ( printed page 65221) 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.

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.

91 FR 65219