Notice of Intent to Sole Source

The Department of Health and Human Services, specifically the Food and Drug Administration (FDA), has issued a Special Notice of Intent to Sole Source a contract for Human Induced Pluripotent Stem Cell-Derived Cells. The notice, posted on June 5, 2025, indicates the FDA's intent to award a Firm Fixed Price contract to Fujifilm Irvine Scientific, Inc. located in Santa Ana, California. The procurement is being conducted under FAR Part 6.302-1(a)(2)(ii), which allows for sole source procurement when only one responsible source can satisfy agency requirements. The contract is associated with the Center for Drug Evaluation and Research (CDER) and is identified by the solicitation number FDA_CDER128011. The objective is to obtain specific cell types to support Microphysiological Systems (MPS) studies and scientific capabilities.

The purpose of this contract is to acquire human induced pluripotent stem cell-derived cells, including specific cell types such as cardiomyocytes, neurons, astrocytes, and hepatocytes. Potential contractors have until June 16, 2025, at 3:00 PM EST to submit written capability statements if they believe they can meet the agency's requirements. The contract (CDER-OTS-25-C-1637) has a one-year performance period with a single delivery scheduled for May 15, 2025, to the FDA White Oak Campus in Silver Spring, MD. Interested parties must email their responses to Rodney D. Aytch, with detailed cell specifications including cryopreservation, viability (5-10 million viable cells per vial), and cell type purity (over 90-95%). The vendor must provide a batch/lot certificate, user guide, and culture medium, with delivery to be coordinated with the Project Officer, Bhavya Bhardwaj. While the FDA anticipates awarding the contract to Fujifilm Irvine Scientific within ten days, they will review any submitted capability statements to determine if alternative sources exist.