SAM #HFP-2026-134390

FDA Sole Source Contract for Human Neural Network Formation Method (NAM) to Cyprotex US, LLC

This notice announces the FDA's intent to award a sole source contract to Cyprotex US, LLC for a specialized scientific method development. - Agency: Food and Drug Administration (FDA), Department of Health and Human Services - Sole source contract to Cyprotex US, LLC - Purpose: Development of a Human Neural Network Formation New Approach Method (NAM) for evaluating developmental neurotoxicity - Technology: Utilizes microelectrode array (MEA) technology, adapted to FDA requirements - Deliverable: Raw experimental data in electronic format (.csv or .RData), with documentation of any procedural deviations - Procurement method: Simplified acquisition for commercial products/services - NAICS code: 541690 (Other Scientific and Technical Consulting Services) - Only Cyprotex US, LLC identified as capable vendor; no other OEMs or competitors mentioned - Opportunity for other vendors to respond only if they can demonstrate equivalent capability - No specific period of performance dates provided; deliverable expected after contract award

Description

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.

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