Preclinical Validation of Behavioral Economic Methods for Abuse Potential Assessment

Background
The Food and Drug Administration (FDA) intends to award a Sole Source firm-fixed price contract to Institutes for Behavior Resources, Inc. This procurement is being conducted under simplified acquisition procedures. The primary objective of this requirement is to assist with the Preclinical Validation of Behavioral Economic Methods for Abuse Potential Assessment.

Work Details
The contractor is expected to validate behavioral economic demand curve analysis for abuse potential assessment as described in Banks et al. 2026 (PMID: 41637884). The Contractor shall establish a quantitative framework for comparing the relative abuse potential of novel compounds against known drugs of abuse.

The Contractor shall conduct a multi-site validation to confirm the robustness and reproducibility of the methodology, alongside a simultaneous sensitivity evaluation to detect differences in essential value with drugs of varying mu-opioid receptor efficacy. The Contractor shall collect two types of data: FR dose-effect curve for ≥4 unit doses and vehicle, and demand curves for ≥2 unit doses for a positive control and for a test drug.

The Contractor shall utilize the same animal cohorts for standard Dose-Effect curves and Behavioral Economic (BE) Demand Curves to preserve catheter patency, save time, and ensure robust statistical power.

Period of Performance
The specific period of performance is not detailed in the solicitation.

Place of Performance
The geographic location(s) where the contract will be performed are not explicitly provided.

Bidder Requirements
This opportunity is set aside as '8(A) Sole Source (8AN)'. Bidders must demonstrate capability in conducting behavioral economic assessments and have relevant experience in preclinical validation methodologies.