Intent to Sole Source - Endotoxin Detection System Cartridges
Closed Special Notice Posted
- Solicitation number
- NOI-CC-OLAO-26-007979
- Agency
-
National Institutes of Health
Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 325414 Biological Product (except Diagnostic) Manufacturing
- PSC
- 6640 Laboratory Equipment And Supplies
- Place of performance
- Bethesda, Maryland 20892, United States
Notice details come from SAM.gov. Updated .
About this opportunity
The National Institutes of Health, Clinical Center (NIH-CC) issued a Notice of Intent to sole-source endotoxin detection system cartridges from Charles River Laboratories, with a capability statement deadline of August 7, 2026 at 12:00 PM Eastern Time. The procurement is restricted to one source under 41 U.S.C. 253(c)(1) and FAR 6.302-1 because the cartridges are proprietary to the PET Radiopharmacy's existing portable testing system and no other supply will satisfy agency requirements. The NIH-CC estimates the cartridge purchase at $22,200 and requires delivery by August 24, 2026. The cartridges are consumables used for bacterial endotoxin testing on each PET IND product prior to release for patient use; at least one cartridge is needed per product manufactured. Responsible sources interested in providing the cartridges must submit a capability statement by the deadline via email to valerie.gregorio@nih.gov with subject line "NOI-CC-OLAO-26-007979." The Government reserves discretion to determine whether to proceed with this sole-source award or compete the requirement based on responses received.
Notice text
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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