Federal Register #2026-21913

FDA Color Additive Certification Information Collection Review

The FDA notice concerns review of an information collection, not a purchase of products or services. - Government offices - The Food and Drug Administration (FDA), within the Department of Health and Human Services (HHS), submitted the collection to the Office of Management and Budget (OMB) for review. - What the collection covers - Manufacturers request certification for certain color-additive batches by submitting batch information and a representative sample for FDA analysis. - Manufacturers must keep records of distribution and certification; FDA certification fees are based on batch weight. - Estimated annual burden - 67 respondents and 7,504 certification requests. - 1,651 reporting hours and 1,876 recordkeeping hours. - No OEMs, vendors, products, part numbers, or purchase quantities are identified.

Description

The FDA submitted a proposed information collection, “Color Additive Certification,” to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act. The collection supports FDA certification of certain color additive batches used in foods, drugs, cosmetics, and medical devices. Manufacturers submit certification requests with representative batch samples; FDA analyzes the samples and issues certificates for batches that meet applicable requirements. The notice also describes associated recordkeeping requirements and estimates the annual reporting and recordkeeping burden.

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