Solicitation - Notice of Intent to SS.pdf
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- Attached to
- Notice of Intent to Sole Source
- Solicitation number
- FDA-1284766
- Issued by
-
Department of Health and Human Services
About this file
This document is a Notice of Intent to Sole Source for the purchase of human induced pluripotent stem cells (hiPSC) issued by the Food and Drug Administration (FDA) on June 5, 2025. The FDA intends to award a Firm Fixed Price contract to Fujifilm Irvine Scientific, Inc., located in Santa Ana, California, under FAR Part 6.302-1(a)(2)(ii) which allows for a sole source procurement when only one responsible source can satisfy agency requirements.
The solicitation (FDA_CDER128011) invites potential vendors to submit written capability statements by June 16, 2025, at 3:00 PM EST if they believe they can meet the agency's requirements. While the FDA anticipates awarding the contract to Fujifilm Irvine Scientific within ten days, they will review any submitted capability statements to determine if alternative sources exist. Interested parties should email their responses to Rodney D. Aytch at rodney.aytch@fda.hhs.gov, with the specific details of the requirement referenced in an attached Statement of Work. The contract's objective is to obtain hiPSC cells to support Microphysiological Systems (MPS) studies for the Center for Drug Evaluation and Research (CDER).
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| File | Type | Posted |
|---|---|---|
| SOW_042825.doc | DOC document |
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Text version
June 5, 2025
Notice of Intent to Sole Source
Purchase of hiPSC Cells
FDA_CDER128011
The Food and Drug Administration (FDA) intends to award a Sole Source Firm Fixed Price contract order to Fujifilm
Irvine Scientific, Inc., at 1830 E Warner Ave., Santa Ana, California 92705-5505.
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 contract.
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 Fujifilm Irvine Scientific, Inc., 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 16, 2025, by 3.00PM EST. Please email responses to Rodney D. Aytch – rodney.aytch@fda.hhs.gov.
Rodney D. Aytch
Contract Specialist mailto:rodney.aytch@fda.hhs.gov.
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