Notice of Intent to SS _1250159.pdf
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- Attached to
- Liver Human Emulation System Federal contract opportunity
- Solicitation number
- FDA_SS_1250159
About this file
This notice announces the Food and Drug Administration's intent to issue a sole source purchase order to Emulate for a Liver Human Emulation System. The FDA requires a Liver-Chip, Quad-Culture Kits, Zoe Culture Modules, an Orb Hub Module, and associated equipment with a simple user interface and small footprint. Responses are due by December 23, 2021 demonstrating ability to meet the requirements. The FDA intends to award to Emulate within 10 days thereafter unless another party demonstrates capability to provide the necessary products and services.
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Text version
December 9, 2021
Notice of Intent to Sole Source
Liver Human Emulation System
FDA_SS_1250159
The Food and Drug Administration (FDA) intends to award a Sole Source firm-fixed price purchase order to Emulate, 27 Dry Dock Avenue, Boston, MA 02210. In accordance with FAR part 6.302-1, the contractor is the only responsible source who can provide the required services as no other source has been identified who can provide the instruments to satisfy the agencies requirements.
The purpose of this notice is to inform the public that the FDA anticipates issuing an award to procure a Liver Human Emulation System.
The associated North American Industrial Classification System (NAICS) Code is 334516:
Analytical Laboratory Instrument Manufacturing.
TECHNICAL REQUIREMENTS:
A. Shall provide a Emulate's organ-chip, the Chip-S1® that can be configured to recreate a wide range of different organ tissues and disease models.
B. Shall provide two (2) The Zoë™ Culture Module ,that is designed to sustain the life of cells within Emulate’s Organ-Chips.
C. Shall provide one (1) Orb™ Hub Module, that is a central hub that connects to up to four Zoë™ Culture Modules.
D. Shall provide five (5) Liver-Chip, Quad-Culture Kits - 24 packages.
E. Shall include a small footprint.
F. Shall include a simple user interface.
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 Emulate 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: December 23, 2021 by 9:00AM Eastern Standard Daylight Time. Please email responses to Nicole Craig at nicole.craig@fda.hhs.gov. No phone calls will be accepted.
mailto:nicole.craig@fda.hhs.gov
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