FDA-SS NOI-126983.pdf

FDA-Sole Source- 126983

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Document Type: Notice of Intent to Sole Source Solicitation Number: FDA - Sole Source - 126983 Posted Date: April 09, 2025 Questions Due Date: 10AM EST on April 21, 2025 Response Date: 10AM EST May 02, 2025 NAICS Code: 541714-Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

The Food and Drug Administration intends to make a sole source award for purchase of human induced pluripotent stem cell-derived cells.

INTENDED SOURCE:

Fujifilm Cellular Dynamics 525 Science Dr Madison, WI 53711

In accordance with FAR 6.302-1 (a)(2)(ii), FAR 13.106(b) and FAR 5.203, this solicitation contains circumstances permitting other than full and open competition for developmental and/or research capabilities.

The Food and Drug Administration (FDA) is conducting a research program to evaluate the usefulness of microphysiological systems (MPS). MPS or organs-on-a-chip have been identified as a potential alternative to traditional in-vitro models. MPS are designed to maintain cells in a 3D microenvironment and have been shown to better recapitulate the in-vivo physiological environment compared to traditional cell culture methods. Given their enhanced physiological relevance, MPS could have a potential role in pre-clinical pharmacokinetic and toxicology studies.

MPS utilizes large quantities of human induced pluripotent stem cell-derived cells (e.g., cardiomyocytes, neurons, astrocytes, and hepatocytes). The cells are used across multiple program areas. The experiments conducted support regulatory science research projects to support drug safety and efficacy assessment.

The objective of this procurement is to obtain Human Induced Pluripotent Stem Cell-Derived Cells. These cells will provide the FDA with the required material to support MPS studies. The cells will be used to support FDA scientist throughout FDA organizations. The cells will enable scientific capabilities consistent with the mission of the Center for Drug Evaluation and Research (CDER).

The Contractor shall provide the following deliverable(s):

• Differentiated human induced pluripotent stem cell derived cells (e.g., cardiomyocytes, neurons, astrocytes, and hepatocytes. Shall be shipped cryopreserved.

FDA-Sole Source- 126983

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The proposed Contractor has already completed the work for the past 5 years and switching to a different vendor would be a substantial expense to the government, additional time to validate the new vendor, on behalf of the FDA which will result in significant delays to project timelines.

In accordance with FAR 6.302-1, a sole source award shall be made to Fuji Film Cellular Dynamics. It is in the best interest of the government to plan an award to Fuji Film Cellular Dynamics.

This notice of intent is not a request for competitive quotes. However, all responsible sources may submit a capability statement within fifteen (15) days after the publication of this synopsis which shall be considered by the agency. Responses received after 15 days or without the required information may not be considered.

For information concerning this acquisition contact:

Telisha Wilson Contract Specialist Telisha.Wilson@fda.hhs.gov

A determination by the Government not to compete because of information received is solely within the discretion of the Government. Information received will normally be considered solely for determining whether to conduct a competitive procurement.

No phone calls or faxes will be accepted.