Justification and Approval for Other Than Full and Open Competition

This is a Justification and Approval (J&A) document from the Department of Veterans Affairs for a sole source acquisition to award a fixed-price indefinite delivery contract to PETNET Solutions, Inc. for F18 Florbetapir (Amyvid) injection. The Orlando VA Medical Center is requesting a 12-month base period plus four 12-month option periods, with an estimated award date of October 23, 2026, and an effective date of October 30, 2026. The current contract (36C24821D0041) expires October 8, 2026. The contract will supply F18 Florbetapir, a radiotracer used for PET/CT imaging to evaluate beta-amyloid neuritic plaque density in adult patients with cognitive impairment being evaluated for Alzheimer's Disease. The estimated amount per period is redacted in the document.

The J&A justifies the sole source award under 41 USC §3304(a)(1) citing that only one responsible source and no other supplies or services will satisfy the agency's requirements. Technical justification emphasizes that F18 Florbetapir is the only radiotracer currently on the PBM Formulary Management Specialty Distribution Meds list for this specific application and is the only one offering the combination of moderate white matter attachment providing defined contrast, minimal regional uptake variation, a 30-minute circulation period reducing patient facility time, FDA approval as the first beta-amyloid plaque tracer, established databases, and physician training compatibility. PETNET Solutions, Inc. has proprietary rights to F18 Florbetapir through an agreement with Eli Lilly & Company. The document notes that an Intent to Sole Source was issued on September 23, 2026, with only PETNET Solutions, Inc. responding. The Contracting Officer certifies anticipated costs are fair and reasonable based on FSS contract pricing previously determined fair and reasonable, with no additional fees beyond manufacturers' FSS prices and delivery fees.