Notice of Intent to Award a Sole Source Commercial Simplified Acquisition Procedures (SAP) Purchase Order for Metabolism-Qualified Cryopreserved Human Hepatocytes

The Food and Drug Administration (FDA) intends to award a Sole Source firm-fixed-price commercial Purchase Order (PO) to BioIVT, LLC (BioIVT), 1450 South Rolling Road, Baltimore, MD, 21227, for the Purchase of Metabolism-Qualified Cryopreserved Human Hepatocytes in accordance with the authority under FAR RFO Part 6.103-1 , Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. BioIVT is the only known source capable of providing metabolism-qualified cryopreserved human hepatocytes meeting the required donor characteristics, viability thresholds, and metabolic activity specifications necessary to support continuity of the FDA research study. A Sources Sought notice was previously posted on SAM.gov and no capability statements or responses were receiv