Non-medical Use (NMU) Data Report Services

Background
The U.S. Food and Drug Administration (FDA) is seeking to obtain data reports on non-medical use (NMU) of prescription and over-the-counter drug products, illicit substances, and other drugs with emerging regulatory interest.

This requirement is aimed at supporting the FDA's mission to inform pharmaceutical regulatory efforts, identify emerging substances of concern, and enhance NMU prevention programs. The FDA's Office of Surveillance and Epidemiology (OSE) will utilize these reports to monitor trends in substance use and associated harms, particularly focusing on post-marketing epidemiologic data related to pharmaceuticals with central nervous system activity.

Work Details
The contractor will provide Non-medical Use Data Report Services, which include:
1. Bi-annual summary reports from post-marketing data on self-reported NMU of prescription and over-the-counter drugs, illicit substances, and other drugs of regulatory interest.
2. Ad-hoc reports and analytical datasets based on existing surveillance data as required or requested by the FDA.
3. The contractor must have access to population-based, de-identified data collected from individuals entering or being assessed for substance use disorder treatment within the U.S., ensuring geographic diversity across all four census regions.
4. The contractor shall demonstrate the ability to maintain data access throughout the contract performance period and provide technical documentation relevant to the data collection instruments used.

Period of Performance
The period of performance for this contract is from September 30, 2026, to September 29, 2031.

Place of Performance
The contract will be performed in the United States, specifically within the fifty states and the District of Columbia.