Intent to Sole Source - Endotoxin Detection System Cartridges
Contract Overview
Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.
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The National Institute of Health, Clinical Center intends to sole source the purchase of proprietary endotoxin detection system cartridges from Charles River Laboratories to support the production and release of PET IND products. These cartridges are essential for bacterial endotoxin testing, ensuring all radiopharmaceuticals are pyrogen-free prior to patient administration, and are compatible only with the institution’s existing portable testing system. Due to the proprietary nature of the cartridges, no alternative suppliers can meet the technical requirements, justifying a sole source acquisition under 41 U.S.C. 253(c)(1) and FAR 6.302-1. The contract requires delivery of cartridges estimated at $22,200 by February 1, 2025, to prevent disruption in patient-ready product release; failure to meet this deadline would compromise the ability to conduct mandatory testing. A separate shipment for additional cartridges is also required by August 24, 2026, to sustain ongoing operations. This is not a request for proposal, but a notice of intent allowing other possible sources to submit capability statements by 12:00 PM Eastern Standard Time on August 7, 2026, to Valerie Gregorio at valerie.gregorio@nih.gov. All submissions received by the deadline will be evaluated, and the government retains full discretion to proceed without competition based on the responses.
General Info
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NAICS
Place of Performance
Bethesda, MD, 20892, USASet-Aside
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Organization & Contact Information
Full 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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