Intent to Sole Source - F-DOPA Synthesis: Sets Disposible Cassette

This is a Notice of Intent, not a request for proposal. The National Institute of Health intends to negotiate on an other than full and open competition basis with the following vendor: iPharmaSupports.

Acquisition Description: CC/PET seeks to continue its procurement of F-18 FDOPA cassettes and chemical kits used for the production of the PET drug F-18 FDOPA for human PET imaging studies. The F-18 FDOPA cassettes/chemical kits are sold exclusively in North America by iPharmaSupports.

Such cassettes/kits have been procured previously under NIH contract HHSN269201800004B with iPharmaSupports that expired Aug 23, 2023. CC/PET seeks to continue procurement of F-18 FDOPA cassettes/chemicals kits exclusively with iPharmasupports for the next 3 years (Base plus 2 option years).

CC/PET is required to use the same vendor since this vendor is listed in the chemistry and manufacturing control document under FDA-approved IND # 35513. cGMP Regulations dictate that CC/PET uses approved, well-established vendors for key ingredients in the PET drug manufacturing process so CC/PET will continue to use iPharmaSupports for manufacture of F-18 FDOPA via the F-18 FDOPA cassettes/chemical kits. 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-26-003326) by 12:00 PM eastern standard time on 3/26/2026 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.