Notice of Intent to Award a Sole Source Commercial Simplified Acquisition Procedures (SAP) Purchase Order for Metabolism-Qualified Cryopreserved Human Hepatocytes CDER-2026-132690

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 received from interested vendors. This acquisition is being conducted using simplified acquisition procedures in accordance with FAR RFO Part 12 for the acquisition of commercial products and commercial services. The North American Industry Classification System (NAICS) code for the proposed acquisition is 325414; Biological Product (except Diagnostic) Manufacturing, with a small business standard size of 1,250 employees. Deliverables The contractor shall provide up to 4 distinct female donor lots totaling 24 vials of cryopreserved human hepatocytes. Delivery must occur within 7 days of award. Cryopreserved Human Hepatocytes Donor Lot 1: Single-donor female metabolism-qualified cryoplatable human hepatocytes (Age 20 35 years), minimum viable cells/vials with >85% post-thaw viability 6 Vials Cryopreserved Human Hepatocytes Donor Lot 2: Single-donor female metabolism-qualified cryoplatable human hepatocytes (Age 54 70 years), minimum 5 million viable cells/vials with >85% post-thaw viability 6 Vials Cryopreserved Human Hepatocytes Donor Lot 3: Single-donor female metabolism-qualified cryoplatable human hepatocytes (Age 54 70 years), minimum 5 million viable cells/vials with >85% post-thaw viability 6 Vials Cryopreserved Human Hepatocytes Donor Lot 4: Single-donor female metabolism-qualified cryoplatable human hepatocytes (Age 54 70 years), minimum 5 million viable cells/vials with >85% post-thaw viability 6 Vials Cell Culture Media INVITROGRO HI Medium: 250 mL bottles 2 Bottles Cell Culture Media INVITROGRO CP Medium: 250 mL bottles 2 Bottles Antibiotic Reagent TORPEDO Antibiotic Mix 22 mL 1 Bottle Shipping Requirement: Domestic cryogenic shipping container/cryoshipper for temperature-controlled delivery 1 Each Technical Documentation Certificate of Analysis (COA): Donor characterization information for each donor lot 4 COAs Technical Documentation Protocols: Thawing, plating, culturing, and media preparation protocols in PDF format 1 Complete Protocol Package Responses Responses to this notice should be sent to Shavone Jeter at shavone.jeter@fda.hhs.gov no later than 5:00 pm (ET) on May 29, 2026. 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.