Intent to Sole Source

The Food and Drug Administration has issued a sole source notice announcing its intent to award a firm-fixed price purchase order to NEUROSETTA, LLC for specialized scientific research services. This procurement falls under the Research and Development in Biotechnology NAICS code and involves evaluating an in vitro spinal rosette array platform to identify potential developmental neurotoxicity hazards in foods and food-related products. The contract is being awarded under simplified acquisition procedures using FAR Part 6 authority, specifically section 6.302-1 for "Only One Responsible Source," indicating that NEUROSETTA is considered the sole capable provider for this specific research requirement. The FDA emphasizes that this is not a competitive solicitation but rather a direct award notification to the identified contractor.

The primary objective of this contract is to conduct testing on 36 chemicals of interest and provide raw data for internal FDA evaluation as part of food safety research initiatives. Interested firms have until August 6, 2025, to respond to this notice if they believe they can meet the specialized requirements. Any company seeking consideration must submit a capability statement demonstrating their ability to perform the required research using the specific in vitro spinal rosette array platform technology. The government retains sole discretion in determining whether to make this procurement competitive based on any responses received. This research initiative supports the FDA's broader mission to assess potential neurotoxicity risks associated with food and food-related products, contributing to public health protection through advanced biotechnology research methods.