This Government Contract opportunity from Department Of Health And Human Services was posted on May 20, 2026. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

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

Closed

CDER-2026-132690Federal

Submission Closed05/29/2026, 09:00:00 PM UTC

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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NAICS: 325414

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AI Contract Overview

The Food and Drug Administration (FDA) plans to award a sole source, firm-fixed-price commercial purchase order to BioIVT, LLC for metabolism-qualified cryopreserved human hepatocytes under authority permitting non-competitive procurement due to the absence of alternative sources capable of meeting specific technical requirements. BioIVT is identified as the only vendor able to supply hepatocytes with precise donor characteristics including age ranges, post-thaw viability exceeding 85%, and validated metabolic activity essential for ongoing FDA research. This acquisition employs simplified procedures for commercial items and is classified under NAICS code 325414, with no small business set-aside. The contract includes four distinct female donor lots totaling 24 vials—six vials from a young donor (20–35 years) and 18 vials from three older donors (54–70 years)—along with specialized cell culture media, an antibiotic reagent, a cryogenic shipping container, four certificates of analysis detailing donor data, and a complete protocol package for handling and culturing the cells. All deliverables must be shipped within seven days of contract award. The notice serves as an opportunity for other potential vendors to submit capability statements by May 29, 2026, but the government retains full discretion to proceed solely with BioIVT based on the unique nature of the requirement.

General Info

FDA awards sole source contract to BioIVT for cryopreserved human hepatocytes, 24 vials, seven-day delivery.

Agency

Department Of Health And Human Services → FDA Office Of Acq Grant SvcsView Agency

NAICS

325414 - Biological Product (except Diagnostic) ManufacturingView NAICS

Place of Performance

MD, USA

Set-Aside

NONE

Documents

(0)

No documents available

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Timeline

PhaseClosed

PostedMay 20

special-notice

Response DeadlineMay 29

Deadline has passed

Submission Closed

05/29/2026, 09:00:00 PM UTC

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Organization & Contact Information

AgencyDepartment Of Health And Human Services → FDA Office Of Acq Grant Svcs

Contacts1 person available

OfficeRockville, MD, 20852, USA

Organization / Agency

Department Of Health And Human Services → FDA Office Of Acq Grant Svcs

View Agency Profile

Office AddressRockville, MD, 20852, USA

Contacts

Craig Wright

contact@example.gov

Full Description

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.