SAM #FDA_5212026

FDA Sole Source: Development of 3D Human Blood Brain Barrier Formation Assay by MIMETAS B.V.

This opportunity involves the FDA's intent to award a sole source contract to MIMETAS B.V. for the development of a 3D Human Blood Brain Barrier Formation Assay. - Agency: Food and Drug Administration (FDA), Human Foods Program, Division of Toxicology - Sole source award to MIMETAS B.V., 704 Quince Orchard RD, Suite 260, Gaithersburg, MD - Purpose: Develop an in vitro blood-brain barrier (BBB) formation and integrity new approach method (NAM) to assess developmental neurotoxicity hazards in foods and dietary supplements - Includes optimization of human-derived brain microvascular endothelial cells, neurons, and astrocytes in a multi-chip microfluidic plate format - Evaluation of assay control chemicals and four performance compounds - Delivery of raw experimental data and reporting of protocols and deviations - Only MIMETAS B.V. is considered capable of meeting requirements; however, capability statements from other vendors are invited - No specific products, part numbers, or quantities listed - Place of performance: Silver Spring, Maryland (FDA), with work performed at contractor's facilities - Contracting office: FDA Office of Acquisition and Grant Services, Rockville, MD - Period of performance: Delivery of raw data required within 60 days after experiment completion - No other OEMs or vendors mentioned; no competing products specified

Description

The Food and Drug Administration (FDA) intends to award a Sole Source Firm Fixed Price Purchase order to MIMETAS B.V.  704 Quince Orchard RD, Suite 260 Gaithersburg, Maryland 20878-1752.

In accordance with FAR Part 6.302-1 (a) (2)(ii) which states” Only one responsible source and no other supplies or services will satisfy agency requirement”.

The purpose of this notice is to inform the public that the Food and Drug Administration (FDA) anticipates issuing a Firm Fixed Price Purchase Order.

MINIMUM REQUIREMENTS:

See Attached Statement of Work

This notice is not a request for competitive proposals. However, any party that believes it can meet this requirement as stated herein may submit a written capability statement that clearly supports and demonstrates their ability to perform the requirement.

Capability statements must be received by the response date and time of this notice. Submissions will be reviewed to determine if they can meet the requirement. A determination by the Government to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government.

It is anticipated that an award will be issued to MIMETAS B.V. within approximately ten (10) days after the date of this notice unless the Government determines that any other organization has the capability to meet this requirement.

Response Date: June 12, 2026, by 3.00PM EST. Please email responses to Hilda Aryeh –hilda.aryeh@fda.hhs.gov.

Hilda Aryeh

Contract Specialist

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