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

SOL #: NOI-CC-26-003326Special NoticeSole Source

Overview

Buyer

Health And Human Services
National Institutes Of Health
Bethesda, MD, 20892, United States

Place of Performance

Bethesda, MD

NAICS

Other Scientific and Technical Consulting Services (541690)

PSC

Laboratory Equipment And Supplies (6640)

Set Aside

No set aside specified

Timeline

1
Posted
Mar 16, 2026
2
Action Date
Mar 26, 2026, 4:00 PM

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.

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Special Notice
Posted: Mar 16, 2026
Intent to Sole Source - F-DOPA Synthesis: Sets Disposible Cassette | GovScope