Federal Register #FDA-2026-N-7131

FDA Seeks Public Comment on Infant Formula Information Collection Requirements

The Food and Drug Administration (FDA), under the Department of Health and Human Services, is seeking public comment on proposed information collection requirements for infant formula regulations. - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - Targeted Respondents: - Manufacturers of infant formula (no specific OEMs or vendors named) - Requested Information: - Compliance with labeling requirements for infant formula - Quality control procedures and recordkeeping - Notification requirements for new infant formula submissions - Use of electronic Form FDA 3978 for standardized reporting - Reporting of product samples testing positive for Cronobacter spp. or Salmonella - Adherence to 21 CFR parts 106 and 107 regulatory framework - Special provisions for exempt formulas for infants with unique medical or dietary needs - Notable Requirements: - Emphasis on safety and nutritional adequacy of infant formulas - Reference to guidance documents for industry compliance - No specific products, part numbers, or quantities requested - This is a request for public comment, not a procurement or award opportunity

Description

The Food and Drug Administration (FDA) is seeking public comment on the proposed collection of information related to infant formula regulations. This includes requirements for infant formula labeling, quality control procedures, notification requirements, and recordkeeping. The notice also requests comments on electronic Form FDA 3978, which allows manufacturers to submit reports and notifications in a standardized format. The regulations aim to ensure the safety and nutritional adequacy of infant formulas and include provisions for exempt infant formulas used by infants with special medical or dietary needs.

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