Federal Register #FDA-2026-N-6739

FDA public comment notice on cosmetic-product information-collection requirements

The FDA notice concerns regulatory information collection for cosmetic products, not a purchase of goods or services. - Government buyer: U.S. Department of Health and Human Services, Food and Drug Administration (FDA); the collection is submitted to the Office of Management and Budget (OMB) for review. - Purpose: Gather public comment on information-collection requirements for cosmetic-product adverse-event records, facility registration, product listing, safety substantiation, and labeling under the Modernization of Cosmetics Regulation Act and FDA regulations. - Submission methods mentioned: Cosmetics Direct, the Electronic Submission Gateway Next Generation, Structured Product Labeling software, and paper forms, including FDA Forms 5066 and 5067. - OEMs and vendors: None identified. - Procurement items: No products or services are being requested; there are no quantities, part numbers, or contract value stated.

Description

The FDA submitted a proposed information collection to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995. The collection supports statutory and regulatory requirements for cosmetic products, including adverse-event records, facility registration, product listing, safety substantiation, and labeling. It includes requirements established or amended by the Modernization of Cosmetics Regulation Act of 2022 and FDA regulations in 21 CFR part 701. Written comments were due by November 13, 2026.

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