Regulatory Science Tool for Transcranial Ultrasound Modeling

The Food and Drug Administration seeks development of a Regulatory Science Tool for Transcranial Ultrasound Modeling, a 12-month firm fixed-price research and development contract with a ceiling of $350,000, with proposals due August 31, 2026. This is an unrestricted procurement with no set-aside.

Place of performance is Silver Spring, Maryland. Custom software development and outsourced operations must be located in the continental United States to the maximum extent practicable; if work is performed outside the continental U.S., vendors must disclose locations and submit a detailed Information System Security Plan. All cloud data must be stored within the continental United States.

The procurement requires the principal investigator to have completed at least two TUS simulation research projects within the past five years, published at least three peer-reviewed journal articles on ultrasound propagation through heterogeneous biological media within the past 15 years (with at least one addressing transcranial ultrasound), and demonstrate immediate proficiency with TUS simulation platforms and computational infrastructure. Qualification requirements may be satisfied collectively by prime contractors, subcontractors, key personnel, and collaborating organizations, with each entity demonstrably capable of supporting one or more project components.

The tool must achieve focal location prediction error less than 2 millimeters, focal volume prediction error less than 10 cubic millimeters, peak pressure prediction error less than 25 percent, temperature prediction error less than 1 degree Celsius, and computation time less than 16 hours for full patient-specific simulations. Deliverables include quarterly milestones through Q4 culminating in RST package v1.0 with source code, User Guide, Technical Reference Manual, Validation Report, and scientific publication draft. All work products must be released as public domain. Offerors assume responsibility for obtaining all required validation datasets and computational resources, though the FDA may provide these collaboratively if available. The NAICS code is 541715. Subcontractors need not have separate SAM.gov registrations at proposal stage.