This Combined Synopsis/Solicitation opportunity from Department Of Health And Human Services was posted on September 11, 2026. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

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Human Hindbrain Organoid Functional Assay Services.

Closed

RFQ_CDR-2026-135968Federal

Submission Closed09/17/2026, 02:30:00 PM UTC

Contract Overview

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

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NAICS: 541714

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in 7 days

AI Contract Overview

The U.S. Food and Drug Administration's Center for Drug Evaluation and Research is seeking a firm-fixed-price purchase order for human induced pluripotent stem cell-derived hindbrain organoid functional assay services. The contract involves the provision of human hindbrain organoids and associated culture materials, with twelve scheduled deliveries to the FDA White Oak Campus in Silver Spring, Maryland. The first delivery will consist of 96 organoids, followed by eleven subsequent deliveries of 48 organoids each. The contractor will perform functional characterization at its own laboratory using three-dimensional multi-electrode array technology to evaluate electrophysiological responses to FDA-identified drug and reversal-agent combinations. Key deliverables include the raw and analyzed data, analysis files, and comprehensive study reports. The anticipated period of performance is 18 months from the date of award. This is a commercial service acquisition under FAR Part 12, intended as a sole-source award to OrganoTherapeutics SARL based on market research identifying them as the only source capable of meeting the full requirement. Award will be based on best value, with technical capability and past performance weighted more heavily than price. All invoicing must be processed electronically through the U.S. Department of Treasury's Invoice Processing Platform.

General Info

FDA sole-source contract with OrganoTherapeutics for hindbrain organoid functional assay services over 18 months.

Agency

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

NAICS

541714 - Research and Development in Biotechnology (except Nanobiotechnology)

Place of Performance

Set-Aside

NONE

Documents

CDER-2026-135969 Purchase of Human Hindbrain Organoids

sow

High

RFQ_CDER-2026-135968 - Human Hindbrain Organoid Functional Assay Services

rfq

High

CDER-2026-135969 Sole Source Justification - Hindbrain Organoid Functional Assay Services

justification-and-authorization

Low

AI Contract Breakdown

Uniform Contract Format

Timeline

PhaseClosed

PostedSep 11

Combined Synopsis

Response DeadlineSep 17

Deadline has passed

Submission Closed

09/17/2026, 02:30:00 PM UTC

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Organization & Contact Information

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

Contacts2 people available

OfficeRockville, MD, 20852, USA

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

Office AddressRockville, MD, 20852, USA

Contacts

Iris Johnson

L. Maria Finan

Full Description

The U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Division of Applied Regulatory Science (DARS), intends to award a sole-source, Firm-Fixed-Price purchase order to OrganoTherapeutics SARL for Human iPSC-Derived Hindbrain Organoid Functional Assay Services.

The requirement includes the provision of human induced pluripotent stem cell (iPSC)-derived hindbrain organoids and associated materials necessary to support in vitro research evaluating drug-induced effects on respiratory-relevant neural circuits. The contractor will also perform functional characterization of the organoids using three-dimensional multi-electrode array (3D MEA) technology to assess electrophysiological responses to drugs known to affect respiratory function.

The functional characterization includes testing FDA-identified drug and reversal-agent combinations, MEA measurements, evaluation of batch-to-batch reproducibility, collection of exposed drug solutions for FDA verification, data analysis, and delivery of raw data, analyzed data, analysis files, and study reports.

The requirement also includes twelve scheduled deliveries of human hindbrain organoids to the FDA White Oak Campus. The first delivery will consist of 96 organoids, with subsequent deliveries consisting of 48 organoids each. Functional characterization will be performed at the contractor's laboratory.

The anticipated period of performance is eighteen (18) months from the date of award.

This acquisition is being conducted as a commercial service acquisition under RFO FAR Part 12. The Government's decision to restrict competition is documented pursuant to RFO FAR 12.102(a). Market research identified OrganoTherapeutics SARL as the only source capable of satisfying the Government's complete requirement for both the required human hindbrain organoids and associated functional assay services.

This notice is not intended to restrict consideration of any responsible source capable of meeting the Government's complete requirement. All responsible sources may submit a quotation and supporting capability information by the response date identified in this notice. Any timely response demonstrating the capability to satisfy the Government's complete requirement will be considered by the Contracting Officer prior to award.

NAICS: 541714
PSC: B504 – Special Studies/Analysis – Chemical/Biological
Place of Delivery: FDA White Oak Campus, Silver Spring, Maryland
Place of Service Performance: Contractor's laboratory