Loren Data's SAM Daily™

SAMDAILY.US - ISSUE OF MAY 12, 2023 SAM #7836
SOLICITATION NOTICE

66 -- Notice of Intent to Sole Source-Procurement of Five (5) each Liver Human Emulation System 24 pk Quad Liver Chip Kits

Notice Date

5/10/2023 3:33:37 PM
 

Notice Type

Presolicitation
 

NAICS

334516 — Analytical Laboratory Instrument Manufacturing
 

Contracting Office

FDA OFFICE OF ACQ GRANT SVCS Beltsville MD 20705 USA
 

ZIP Code

20705
 

Solicitation Number

FDA-NOI-SS-117887
 

Response Due

5/23/2023 7:00:00 AM
 

Archive Date

05/24/2023
 

Point of Contact

Sarah Hussain
 

E-Mail Address

Sarah.Hussain@fda.hhs.gov
(Sarah.Hussain@fda.hhs.gov)
 

Small Business Set-Aside

SBA Total Small Business Set-Aside (FAR 19.5)
 

Description

The U.S. Food & Drug Administration (FDA) intends to issue a Sole Source award to Emulate, Inc. for procurement of Five (5) each Liver Human Emulation System 24 pk Quad Liver Chip Kits. 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 equipment. The FDA�s CFSAN Division of Toxicology currently has the Emulate Human Liver Organ-on-chips system which consist of the Zoe Culture Module and Orb Hub Module. FDA has conducted several plans and programs utilizing the Emulate system to support the Advancing Regulatory Science Plan. This plan recognized that the agency needed more predictive models to assess the safety of the products that it regulates. The microphysiological system (MPS) technology, which uses human cells, could provide the FDA important data that could fill some pressing regulatory gaps across the Agency.� To continue assessment and evaluation of the Emulate system, FDA CFSAN would like to purchase five (5) additional 24pk Quad Liver Chip kits. This will continue to develop performance guidelines that can be utilized by other laboratories, both nationally and internationally, to conduct research which accesses the hepatotoxic potential of chemicals of concern found in foods. Emulate, Inc. is the sole source provider of the Human Emulation System�, which is a platform comprised of (i) Organ-Chips (ii) automated instruments (Pod Portable Module, Zoe Culture Module, and Orb Hub Module) and (iii) software applications, designed to work with various Organ-Chips for integration and analysis. The Quad Liver Chip kits is only compatible with the Human Emulation System�. This will be a firm fixed price award.� The NAICS Code is: 334516 Analytical Laboratory Instrument Manufacturing Emulate, Inc. 27 Drydock Avenue, 5th Floor Boston, MA 02210 This notice of intent is not a request for competitive quotes. However, all responsible sources may submit a capability statement to Sarah Hussain, sarah.hussain@fda.hhs.gov in writing and must be within 14 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.
 

Web Link

SAM.gov Permalink
(https://sam.gov/opp/867b27448587441e87edfc21721a3ef3/view)
 

Place of Performance

Address: Laurel, MD 20708, USA

Zip Code: 20708

Country: USA
 

Record

SN06678570-F 20230512/230510230116 (samdaily.us)
 

Source

SAM.gov Link to This Notice
(may not be valid after Archive Date)

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