Intent to Sole Source - F-DOPA Synthesis: Sets Disposible Cassette
Overview
Buyer
Place of Performance
NAICS
PSC
Set Aside
Original Source
Timeline
Qualification Details
Fit reasons
- NAICS alignment with historical contract wins in similar service areas.
- Scope strongly matches core technical capabilities and delivery model.
Risks
- Past performance thresholds may require one additional teaming partner.
- Potential clarification needed on staffing minimums before bid/no-bid.
Next steps
Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.
Quick Summary
The National Institutes of Health (NIH) has issued a Notice of Intent (NOI) to award a sole source contract to iPharmaSupports for the procurement of F-18 FDOPA cassettes and chemical kits. These kits are essential for the production of the PET drug F-18 FDOPA, used in human PET imaging studies. This action is justified by regulatory requirements and the vendor's exclusive supply.
Scope of Work
The requirement is for the continued procurement of F-18 FDOPA cassettes and chemical kits. These kits are critical components for the manufacturing process of the PET drug F-18 FDOPA, which is utilized in human PET imaging studies.
Contract & Timeline
- Type: Special Notice (Intent to Sole Source)
- Duration: Base year plus two option years (total 3 years)
- Set-Aside: None (Sole Source)
- Response Due: March 26, 2026, by 12:00 PM Eastern Standard Time
- Published: March 16, 2026
- Agency: National Institutes of Health (NIH), Health And Human Services
- Product/Service Code: 6640 (Laboratory Equipment And Supplies)
- Place of Performance: Bethesda, MD
Justification
The statutory authority for this sole source requirement is 41 U.S.C. 253(c)(1), as implemented by FAR 6.302-1, citing "only one responsible source and no other supply of service will satisfy agency requirements." iPharmaSupports is the exclusive North American vendor for these kits. Furthermore, cGMP Regulations and FDA-approved IND #35513 mandate the use of approved, well-established vendors for key ingredients in the PET drug manufacturing process, necessitating continued procurement from iPharmaSupports.
Action Items
This is not a Request for Proposal. However, all responsible sources capable of providing the required F-18 FDOPA cassettes and chemical kits may submit a capability statement. Statements should reference NOI-CC-26-003326 in the subject line and be emailed to valerie.gregorio@nih.gov by the response due date. The Government retains discretion on whether to compete this requirement based on responses.