Review of Infant Formula Nutrient Requirements

The FDA is seeking a contractor to conduct a comprehensive review of infant formula nutrient requirements. The review will incorporate the latest scientific findings regarding human milk composition, infant nutritional needs, and developmental requirements to ensure infant formula products support healthy growth and development. The contractor will be responsible for obtaining a comprehensive review of fourteen different nutrients for infant formula, including protein, fat, linoleic acid, carbohydrates, iron, copper, zinc, calcium, phosphorus, magnesium, vitamin K, DHA, ARA, alpha-linolenic acid, and L-carnitine. The key tasks include conducting a systematic scoping review, managing an expert panel, and developing proposed regulatory actions. Some key points to consider: • The contractor must have experience with FDA's infant formula regulatory framework and scientific synthesis. • The contractor must be able to begin work immediately and provide regular status updates. • The contractor must adhere to FDA-provided templates and guidance. • The contractor must ensure consistency with FDA internal methodologies. • The contractor must apply standardized assumptions and propose deviations for Government review and approval.