Notice of Intent to Sole Source: Human Induced Pluripotent Stem Cell-derived Cells

This Special Notice announces the U.S. Food and Drug Administration's intent to award a sole-source commercial product purchase order. The FDA Office of Science and Engineering Laboratories Division of Biomedical Physics requires human induced pluripotent stem cell-derived cardiomyocytes, neurons, astrocytes and hepatocytes to support its active research program. FUJIFILM CELLULAR DYNAMICS, INC. is determined to be the only reasonably available source that can provide the proprietary iPSC line and differentiation processes needed due to its validation and verification by the FDA.

Any other interested parties have until March 28, 2024 at 10:00 a.m. ET to submit a written capability statement to the contracting officer demonstrating how they can meet the research requirements. The response date allows any contractor believing they can fulfill the requirement to establish eligibility for consideration within the sole-source award anticipated to be made to FUJIFILM CELLULAR DYNAMICS, INC. within fifteen days, unless another party is deemed capable. Interested parties must submit capability statements to Contracting Officer Benjamin Dorgan at the provided email address by the stated deadline to be considered for the sole-source award and research program opportunity.