CNS Organoid Neuropharmacological Analysis

The Food and Drug Administration's National Center for Toxicological Research (NCTR) is seeking qualified contractors to provide CNS organoid neuropharmacological analysis services, specifically functional examination of neuromodulatory effects of a marketed small molecule drug using human Central Nervous System 3D brain organoids. Key contract requirements include characterizing acute and chronic neuromodulatory effects through calcium flux measurements, evaluating the role of the 5-HT5A receptor via co-treatment studies, and performing RNA sequencing to assess transcriptional changes following chronic drug exposure. Eligible contractors must demonstrate technical capabilities in organoid testing, calcium flux analysis using FLIPR Tetra equipment, viability assessments via LDH assays, and transcriptomic analysis. Responses will be evaluated based on business information, technical specifications, three years of past performance, applicable GSA Schedule or government contracts, accessibility standards compliance, subcontracting plans, warranty and payment terms, and place of performance details. Capability statements must be submitted by May 4, 2026 at 1:00 PM Central Time to nick.sartain@fda.hhs.gov, with this Pre-solicitation Notice having been posted on April 24, 2026.

This opportunity carries no set-aside designation and does not identify any current contractors or incumbents. The contract is anticipated to be firm fixed price, with performance conducted at the contractor's facility from August 1, 2026 through March 31, 2027, and the FDA will furnish the test drug at a cost not to exceed $1,000. Specific technical requirements include testing using 28Bio organoids at 10 weeks of differentiation across 10 treatment groups with 32 organoids per group, with deliverables including a final study design within one month after award, acute and chronic neuromodulatory effects data by January 31, 2027, and transcriptomic data by March 31, 2027. The applicable NAICS code is 541380 (Testing Laboratories and Services) with a small business size standard of $19 million. This Pre-solicitation Notice does not constitute a binding solicitation or obligation to award a contract; responses will inform whether a future solicitation will be set aside for small business, opened for full competition, or conducted through alternative procurement procedures.