Notice of Intent to Sole Source.pdf

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Tiny-TIM smartificial gut simulation system
Solicitation number
75F40123Q00476
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This notice of intent to sole source concerns a planned sole source award by the U.S. Food and Drug Administration to TIM B.V. for the Tiny-TIM smartificial gut simulation system. The scope of work involves providing a gastrointestinal module containing gastrointestinal compartments and a control unit to enable a plug flow transport of gastric content into the small intestinal compartment. It also requires a dispensing module with syringe pumps for accurate distribution of digestive fluids to each fluid reservoir. The system must use syringe pumps with a maximum 100mL volume and acceptable dispensing accuracy. The related federal contract opportunity on usaspending.gov is for the Tiny-TIM smartificial gut simulation system under solicitation number 75F40123Q00476 being issued by the Department of Health and Human Services Food and Drug Administration Office of Acquisition and Grant Services as a special notice.

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Notice of Intent to Sole Source

Date: September 12, 2023

Subject: Tiny-TIM smartificial gut simulation system.

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:

a) 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).

b) 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.

c) 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.

File details come from the government source that posted it. Updated .