Notice of Intent to Award a Sole Source Commercial Simplified Acquisition Procedures (SAP) Contract for Development of a Human Neural Network Formation New Approach Method for the Evaluation of Potential Developmental Neurotoxicity

The Food and Drug Administration (FDA) intends to award a Sole Source firm-fixed price contract to Cyprotex US, LLC, 200 Staples Drive, Framingham, MA 01702, USA, incorporated for the purchase of Development of a Human Neural Network Formation New Approach Method for the Evaluation of Potential Developmental Neurotoxicity, in accordance with the authority under FAR Part 6.302-1. Only one responsible source and no other supplies or services will satisfy agency requirements.

Cyprotex US, LLC is qualified for DT/OCT/OLOAS/HFP unique requirement because they are the only vendor that offers a neural network formation NAM which utilizes microelectrode array (MEA) technology that can be appropriately adapted for the agency specific needs. This acquisition is being conducted using simplified acquisition procedures in accordance with FAR RFO Part 12 for the acquisition of commercial products and commercial services.

The North American Industry Classification System (NAICS) code for the proposed acquisition is 541690 - Other Scientific and Technical Consulting Services. Deliverables Raw experimental data, noting any deviations from standard procedure - Electronic file (.csv or .RData preferred) - Estimated Delivery Date - 01/31/27 Responses Responses to this notice should be sent to Haroon Gulzar at haroon.gulzar@fda.hhs.gov no later than 5:00 pm (ET) on July 10, 2026. This notice is not a request for competitive quotes.

Any other firms desiring consideration must fully identify their interest and capability of meeting the requirements by submitting a capability statement. Any response shall undergo review to determine if it can meet the requirements. A determination by the Government not to compete this proposed requirement based upon a response to this notice is solely within the discretion of the Government.