CNS Organoid Neuropharmacological Analysis

The FDA Office of Acquisition and Grant Services is seeking a contractor to perform CNS organoid neuropharmacological analysis under a Commercial Item-Firm Fixed Price contract, solicitation number 75F40126Q134171, with a response deadline of July 6, 2026, at 5:00 p.m. Eastern Time. The work involves characterizing the acute and chronic neuromodulatory effects of a marketed small molecule drug on human CNS-3D brain organoids derived from induced pluripotent stem cells, including analysis of spontaneous and induced calcium burst patterns, receptor role evaluation using the 5-HT5A inhibitor SB-699551, and transcriptomic changes following two weeks of drug exposure at concentrations of 25 µM and 100 µM, with serotonin and DMSO as controls. All data—including study design, experimental conditions, raw and analyzed results, statistical analyses, and final reports—must be delivered electronically via email or a secure internet site. The contract will be performed at the contractor’s facility, with performance estimated from August 1, 2026, to April 30, 2027. The contractor is responsible for providing all necessary materials except the test drug, which will be supplied by the government, and all shipping and handling costs must be included in the proposed price. The evaluation will be based on technical capability/risk, past performance, and price, with technical capability and past performance collectively significantly more important than price in determining best value. The government intends to select the most advantageous offeror considering all factors, or if technically acceptable, the lowest priced responsible offeror. The contractor must comply with multiple Federal Acquisition Regulation clauses and HHSAR provisions, including electronic invoicing through the U.S. Treasury’s IPP system under Net 30 payment terms with no advance payments, Section 508 accessibility compliance for all electronic deliverables, and adherence to NIST SP 800-88 and FDA IS2P Appendix T for sanitization of government information at contract closeout. Offerors must maintain an active SAM registration and provide their Unique Entity ID, submit proposals via email to Nick Sartain at nick.sartain@fda.hhs.gov, and include detailed pricing with full cost breakdowns. Electronic submissions must not include macros or executable files like .exe or .mso, as non-compliance renders the submission non-responsive. The contractor must affirm compliance