Notice of Intent to Award a Sole Source Contract.pdf
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- Attached to
- Intent to Sole Source
- Solicitation number
- 7-25-2025
About this file
This document is a Sole Source Notice from the Food and Drug Administration (FDA) announcing its intent to award a firm-fixed price purchase order to NEUROSETTA, LLC for a specialized scientific research project. The contract, valued under the Research and Development in Biotechnology NAICS code (541714), involves evaluating an in vitro spinal rosette array platform to identify potential developmental neurotoxicity hazards in foods and food-related products. The project scope includes testing 36 chemicals of interest and providing raw data for internal FDA evaluation, with responses to the notice due by August 6, 2025.
The procurement is being conducted under simplified acquisition procedures using FAR Part 6 authority (6.302-1, Only One Responsible Source), indicating NEUROSETTA is considered the sole capable provider for this specific research. The notice emphasizes that this is not a competitive solicitation, and any firms seeking consideration must submit a capability statement demonstrating their ability to meet the requirements, with the government retaining sole discretion on whether to compete the requirement.
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Sole Source Notice
Agency: The Food and Drug Administration (FDA) Posted Date: July 25, 2025 Response Date: August 6, 2025 Procurement Type: Sole Source NAICS Code: 541714 - Research and Development in Biotechnology (except Nanobiotechnology).
Threshold under the NAICS code to be considered a small business is 1,000 employees.
Contracting Office Address: Office of Acquisitions and Grants Services (OAGS) Authority: FAR Part 6 (i.e. 6.302-1, Only One Responsible Source)
Subject: Notice of Intent to Award a Sole Source Contract – Evaluation of an in vitro spinal rosette array platform for identification of potential developmental neurotoxicity hazard of foods and food-related products.
Description: The Food and Drug Administration (FDA) intends to award a Sole Source firm-fixed price purchase order to NEUROSETTA, LLC, 4140A Wisconsin Institute of Discovery, for the evaluation of an in vitro spinal rosette array platform for identification of potential developmental neurotoxicity hazard of foods and food-related products, in accordance with the authority under FAR Part 6 (i.e. 6.302-1, Only One Responsible Source). This procurement is being conducted under simplified acquisition procedures in accordance with FAR Part 13. The NAICS Code for this action is 541714 - Research and Development in Biotechnology (except Nanobiotechnology).
The purpose of this requisition is to obtain in vitro safety data on chemicals of interest to HFP for potential developmental neurotoxicity hazard. These data will allow DT/OCT/OLOAS/HFP/FDA to predict potential chemical-induced developmental neurotoxicity, which is a vital area of concern for public health decision-making in HFP and the Agency.
The scope of this work encompasses the evaluation of 36 chemicals of HFP interest in an in vitro spinal rosette array platform and providing the raw data to DT for internal evaluation.
Responses:
Responses to this notice should be sent to Hilda Aryeh at hilda.aryeh@fda.hhs.gov by August 6, 2025.
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.
Contracting Office Point of Contact:
Hilda Aryeh.
Email: hilda.aryeh@fda.hhs.gov mailto:hilda.aryeh@fda.hhs.gov
Intended Awardee:
NEUROSETTA, LLC
4140A Wisconsin Institute of Discovery 330 N Orchard St.
Madison, Wisconsin 53715
File details come from the government source that posted it. Updated .