Federal Register #2026-10284

FDA Solicits Services for Protein Efficiency Ratio (PER) Rat Bioassay Studies for Infant Formula

The Food and Drug Administration (FDA) is seeking scientific and technical consulting services to support regulatory compliance for infant formula protein quality assessment. - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - Scope of Work: - Services for designing, conducting, evaluating, and reporting Protein Efficiency Ratio (PER) Rat Bioassay studies - Focus on new infant formula protein quality assessment - Guidance includes modifications to AOAC Official Method 960.48 - Intended for manufacturers and contract laboratories performing PER studies - Products/Services Requested: - No specific products, part numbers, or OEMs are named - Primary requirement is scientific and technical consulting services for PER studies - Unique/Notable Requirements: - Compliance with FDA regulations for infant formula protein quality - Adherence to detailed protocols for PER study design and reporting - Locations: - FDA facilities in College Park, MD and North Bethesda, MD

Description

The Food and Drug Administration (FDA) announces the availability of guidance for industry on Protein Efficiency Ratio (PER) Rat Bioassay Studies. This guidance assists manufacturers and laboratories in designing, conducting, evaluating, and reporting PER studies to demonstrate that a new infant formula meets the quality factor of sufficient biological quality of protein. It explains appropriate modifications of AOAC Official Method 960.48 to support successful PER studies. The guidance finalizes the approach from a 2023 draft and aims to ensure infant formula products meet FDA regulatory requirements.

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