Notice of Intent to Sole Source - FDA_2272025

The Food and Drug Administration (FDA) has issued a Special Notice of Intent to Sole Source a Firm Fixed Price contract to Emulate Bio, located in Boston, Massachusetts. The notice is published under Federal Acquisition Regulation (FAR) Part 6.302-1(a)(2)(ii), which allows for a sole source procurement when only one responsible source can satisfy agency requirements. Specifically, the FDA intends to purchase two Emulate Zoe CM1 and one Orb Hub Module-1 Organ-On-A-Chip culture modules for the Division of Applied Regulatory Science (DARS). These equipment pieces are currently on loan to FDA laboratories and are critical for supporting research on microphysiological systems for pre-clinical pharmacokinetic and toxicology studies. The procurement will support research activities at the FDA White Oak Campus in Silver Spring, Maryland.

The purpose of this Special Notice is to inform the public of the FDA's intent to award a contract to Emulate Bio while providing an opportunity for other potential contractors to demonstrate their capability to meet the agency's specific requirements. Contractors interested in competing for this opportunity must submit a written capability statement by March 7, 2025, at 3:00 PM EST to Contract Specialist Hilda Aryeh via email. While the notice is not a formal competitive solicitation, the government will review any submitted capability statements to determine if alternative sources can meet the technical specifications outlined in the Statement of Work. The technical requirements include precise specifications for pressure and media flow regulation in the Orb Hub and Zoe modules. The contract will have a 12-month performance period, and the government retains sole discretion to determine whether to compete the proposed contract based on submitted responses. Eligible contractors should carefully review the detailed technical requirements and be prepared to demonstrate complete alignment with the FDA's specific scientific and technical needs.