Contract · No Set aside used

Review of Infant Formula Nutrient Requirements

Agency
HEALTH AND HUMAN SERVICES, DEPARTMENT OF / FOOD AND DRUG ADMINISTRATION
Location
College Park, MD
Amount
Amount not listed
Deadline
Closes in 9 days (Jul 27, 2026)
Posted
Jul 6, 2026
Set-aside
No Set aside used
NAICS code
311514

What this contract is for

The Office of Critical Foods (OCF) Infant Formula Premarket Review Staff (IFPRS) within the Food and Drug Administration’s (FDA) Human Foods Program (HFP) Nutrition Center of Excellence (NCE) is seeking information to assess the feasibility of fulfilling a highly specialized requirement related to the comprehensive review of infant formula nutrient requirements mandated by the Food and Drug Omnibus Reform Act (FDORA) and a component of Operation Stork Speed. In March 2025, in coordination with the Department of Health and Human Services (HHS), FDA launched Operation Stork Speed (OSS)— a multi-pronged initiative to expand options for safe, reliable, and nutritious infant formula for American families. These enhanced commitments are focused on making sure a strong supply of infant formula—which is often the sole source of nutrition for infants—remains available for one of our nation’s most vulnerable populations. FDORA, enacted as part of the Consolidated Appropriations Act of 2023, mandates that FDA review infant formula nutrient requirements every four years, as appropriate, with the first review commencing in 2026. Although FDA regularly reviews individual nutrient requirements for infant formulas, the last comprehensive review was in 1998. This comprehensive nutrient review for infant formulas intended for healthy, full-term infants 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 and help inform our regulatory decision-making. This process will ensure that infants benefit from the most up-to-date science and innovation as research continues to advance our understanding of infants’ dietary needs. The Contrac...

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