Opportunity Overview
The U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Division of Applied Regulatory Science, is seeking Human Hindbrain Organoid Functional Assay Services, RFQ_CDR-2026-135968 to support in vitro research evaluating drug-induced effects on respiratory-relevant neural circuits.
Deadline
Quotes and supporting capability information are due September 17, 2026 at 10:30 AM Eastern Time. The questions deadline has passed.
Scope
The requirement includes human induced pluripotent stem cell-derived hindbrain organoids, associated cells, reagents and consumables, and functional characterization using three-dimensional multi-electrode array technology. The contractor will test FDA-identified drug and reversal-agent combinations, assess electrophysiological responses and batch-to-batch reproducibility, collect exposed drug solutions for FDA verification, analyze data, and provide raw and analyzed data, analysis files, and study reports.
The requirement includes twelve scheduled deliveries to the FDA White Oak Campus. The first delivery is 96 organoids, followed by eleven deliveries of 48 organoids each. Functional characterization is performed at the contractor’s laboratory. The anticipated period of performance is eighteen months from award.
Competition and Classification
The FDA intends a sole-source firm-fixed-price purchase order to OrganoTherapeutics SARL. The acquisition is not set aside for small business, but any responsible source that believes it can satisfy the complete requirement may submit a quotation and supporting capability information for consideration. NAICS is 541714, Research and Development in Biotechnology, and PSC is B504, Special Studies/Analysis – Chemical/Biological.
Funding / Contract Value
No fixed maximum contract value is stated in the public notice.
Qualification Guidance
Potential alternate sources must be able to substantiate the complete organoid-production and functional-assay requirement, including the specified delivery schedule, 3D MEA characterization, drug-response testing, reproducibility assessment, sample return, data analysis, reporting, and all submission requirements in the live solicitation.