Federal Register #2026-20980

FDA information-collection requirements for infant formula manufacturers

The FDA is seeking public comments on information-collection requirements affecting infant formula manufacturers; this notice is not a procurement opportunity. - Government buyer: U.S. Department of Health and Human Services, Food and Drug Administration (FDA); no specific sub-agency or office is identified. - OEMs and vendors: None named. - Products or services requested: None. No products, services, part numbers, or quantities are listed. - Requirements covered: Manufacturer reporting, recordkeeping, quality control, labeling, recalls, notifications about supply disruptions affecting critical foods, and redundancy risk management plans. - Estimated annual burden: 14,938 reporting hours, 126,482 recordkeeping hours, and 645 third-party disclosure hours.

Description

The FDA submitted a proposed information collection concerning infant formula requirements to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995. It covers reporting, recordkeeping, labeling, quality-control, recall, and related requirements for infant formula manufacturers, including notifications and risk management plans for critical-food supply disruptions. The notice requests written comments on the information collection by November 13, 2026. The source reports estimated annual burdens of 14,938 reporting hours, 126,482 recordkeeping hours, and 645 third-party disclosure hours.

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