NOI to sole source.pdf
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- Solicitation number
- NOI-CC-25-002085
About this file
This is a Notice of Intent to Sole Source from the NIH Clinical Center for Charles River Laboratories' FDA licensed endotoxin detection system cartridges. The PET Radiopharmacy requires proprietary disposable cartridges for their portable testing system (PTS) to ensure manufactured PET IND products are pyrogen-free prior to release. At least one cartridge is needed for each PET IND product produced.
The cartridges must be delivered by February 1, 2025 to maintain sufficient testing capability for patient use. The notice is posted under NAICS code 325414 (Biological Product Manufacturing) and PSC code 6640 (Laboratory Equipment and Supplies). Interested parties may submit responses identifying their interest and capabilities to Contract Specialist Ryssa Nix at Ryssa.nix@nih.gov by December 18, 2024 at 12pm EST. The posting date was December 11, 2024, and the notice number is NOI-CC-25-002354.
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Text version
Notice Number: NOI-CC-25-002354
Title: Notice of Intent to Sole Source – Charles River Laboratories
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. 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.
This acquisition is being conducted using policies unique to the Federal Acquisition Regulation (FAR) Part 13 –Simplified Acquisition Procedures, Subpart 13.106-1(b)(1), For purchases not exceeding the simplified acquisition threshold (SAT), contracting officers may solicit from one source if the contracting officer determines that the circumstance of the contract action deem only one source reasonably available. Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6- CompetitionRequirements.
Interested parties may identify their interest and capabilities in response to this posting. The determination by the Government not to compete the proposed requirement based upon responses to this notice is solely within the discretion of the Government.
Comments to this announcement, referencing this posting number, may be submitted to the NIH, Clinical Center, Office of Purchasing and Contracts, prior to the closing date specified in this announcement, to the attention of Ryssa Nix, Contract Specialist via email to Ryssa.nix@nih.gov by the close date stated below at 12pmEST.
Notice Type: Notice of Intent
NAICS Code: 325414 - Biological Product (except Diagnostic) Manufacturing 1250
PSC Code: 6640 - LABORATORY EQUIPMENT AND SUPPLIES
Posted Date: 12/11/2024
Close Date: 12/18/2024
End User IC: Clinical Center
POC Name: Ryssa Nix
Email Address: Ryssa.nix@nih.gov
File details come from the government source that posted it. Updated .