Tiny-TIM smartificial gut simulation system

Closed Special Notice Posted

Solicitation number
75F40123Q00476
Agency
Responses due
Set-aside
No set-aside

Opportunity facts

Notice details come from SAM.gov. Updated .

About this opportunity

The U.S. Food and Drug Administration published a Special Notice on September 12, 2023 to announce its intent to award a sole source contract. The notice involves providing a Tiny-TIM smartificial gut simulation system to the FDA under solicitation number 75F40123Q00476 issued by the Department of Health and Human Services Food and Drug Administration Office of Acquisition and Grant Services.

The Special Notice seeks to procure a Tiny-TIM smartificial gut simulation system from TIM B.V. to include a gastrointestinal module with compartments and control unit enabling plug flow transport of gastric content. A dispensing module with syringe pumps must also be provided for accurate distribution of digestive fluids to each reservoir. The system must utilize syringe pumps with a maximum 100mL volume and acceptable dispensing accuracy. The FDA intends to make this sole source award to TIM B.V. by September 16, 2023 as only they can satisfy the agency's requirements for this specialized simulation system.

Notice text

The U.S. Food & Drug Administration (FDA) intends to issue a Sole Source award to TIM B.V. The Government intends to issue a sole source award in accordance with FAR 6.302-1, only one responsible source and no other will satisfy the agency requirements for the above stated service.

The scope of the work is to provide Tiny-TIM smartificial gut simulation system. The Tiny-TIM smartificial gut simulation system shall include but are not limited to:

  1. Gastrointestinal module containing the gastrointestinal compartments and control unit. This module encompasses a plug flow transport of gastric content into the small intestinal compartment, orchestrated by peristaltic valve pumps (PVP).
  2. Dispensing module with syringe pumps for accurate distribution of digestive fluids. The dispensing control system must use a syringe pump (100 mL max volume) for each fluid to dispense with acceptable accuracy (<2% variability). This syringe must be automatically cooled by the dispensing module.
  3. A Pyloric valve of a computer-controlled peristaltic valve pump (PVP) simulating the pyloric sphincter, transports gastric content to the small intestinal compartment by peristaltic movements.

This will be a firm fixed price award. 

The NAICS Code is: 334516-Analytical Laboratory Instrument Manufacturing.

TIM B.V.

Thijsseweg11

Delft

Netherlands

This notice of intent is not a request for competitive quotes. However, all responsible sources may submit a capability statement to Iris Johnson, Iris.Johnson1@fda.hhs.gov in writing and must be within seven (5) days after date of publication of this notice which may be considered by the agency.   A determination by the Government not to compete as a result of information received is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement.

No phone calls will be accepted.

Files

File Type Posted
Notice of Intent to Sole Source.pdf PDF

On GovTribe

Work this opportunity

  • Track it in your pipeline
  • Find teaming partners
  • Similar opportunities
  • Ask GovTribe AI about this opportunity