SAM #NOI-CC-OLAO-26-007979

NIH Notice of Intent to Sole Source Endotoxin Detection System Cartridges from Charles River Laboratories

This notice announces the NIH Clinical Center's intent to procure proprietary endotoxin detection system cartridges from Charles River Laboratories on a sole source basis. - Agency: National Institutes of Health, Clinical Center (NIH-CC) - Requirement: Endotoxin detection system cartridges for the Charles River Laboratories' FDA-licensed portable testing system (PTS) - Used to test PET IND products for pyrogens prior to release - At least one cartridge required per PET IND produced - Sole Source Justification: - Cartridges are proprietary and unique to the Charles River PTS system - Only Charles River Laboratories can supply these consumables - Estimated Value: $22,200 - Delivery Location: NIH Clinical Center, Bethesda, MD - No specific part numbers or quantities provided in the notice - No recurring or option periods mentioned

Description

This is a Notice of Intent, not a request for proposal.  The National Institute of Health, Clinical Center (NIH-CC) intends to negotiate on an other than full and open competition basis with the following vendor: Charles River Laboratories.

Acquisition Description:

The PET Radiopharmacy uses Charles River Laboratories’ FDA licensed endotoxin detection system, a portable testing system (PTS) to ensure all manufactured PET IND products are pyrogen-free prior to release.  The PTS utilizes disposable cartridges unique to the system.  At least one cartridge is needed for every PET IND produced. 

The endotoxin detection system cartridges are estimated to cost $22,200 and is required to be delivered by 08/24/2026.

The PTS and cartridges are used for bacterial endotoxin testing required for each PET IND produced.

Because of the proprietary of these cartridges to our PTS units, only one source is solicited. The cartridges must be delivered by 02/01/2025.  If the required delivery date is not met, there will not be enough cartridges available to perform testing required to release of PET IND products for patient use.

The statutory authority for this sole source requirement is 41 U.S.C. 253(c) (1) as implemented by FAR 6.302-1 only one responsible source and no other supply of service will satisfy agency requirements. THIS IS NOT A REQUEST FOR PROPOSAL.  All responsible sources that could provide the required may submit a capability statement that will be considered by email (subject line to reference NOI-CC-OLAO-26-007979) by 12:00 PM eastern standard time on 08/07/2026 to: valerie.gregorio@nih.gov.

All responses received by the closing date of this synopsis will be considered by the Government.  A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government.

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