Intent To Sole Source - F-Dopa Synthesis: Sets Disposible Cassette

special notice

Closed

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.

United States of America (USA)

Maryland

SAM.gov

Tender

Chemical (Industrial), Manufacturing (Industrial), Government