N0018926RB011 - Drug Demand Reduction Program, Fentanyl/Norfentanyl Immunoassay Reagent Kits

The Department of Defense, through the Naval Supply Systems Command Fleet Logistics Center Norfolk, is seeking a firm-fixed-price, indefinite-delivery/indefinite-quantity contract for FDA-authorized and quality-certified fentanyl/norfentanyl immunoassay reagent kits compatible with Beckman Coulter AU5800 series systems. The reagents must detect fentanyl and norfentanyl in human urine samples with a minimum of 95% accuracy at a cutoff concentration of 1 ng/mL, and they must have a shelf life of at least 180 days unopened and 14 days once opened. The contract will support an estimated monthly testing volume of up to 500,000 tests over a five-year ordering period from August 1, 2026, through July 31, 2031, with a total estimated quantity of 30,000,000 tests. All reagents must be manufactured under a quality assurance program certified to ISO-9000 or ISO 13485 standards, and the contractor must hold current FDA authorization for the product. Packaging must meet ASTM D 3951 standards, include mandatory labeling with expiration date, storage conditions, and MIL-STD-129 shelf life designation, and utilize insulated thermal shipping containers to protect against temperature-related degradation. The contractor is required to use the Wide Area WorkFlow system for invoicing and receiving reports, and all shipments must be clearly marked with the contract number and government delivery order number. The solicitation, classified under NAICS code 325413 and issued using simplified acquisition procedures under FAR Part 12, is set aside for HUBZone and Service-Disabled Veteran-Owned Small Businesses, with non-small business offerors required to submit a subcontracting plan with specific target goals across socio-economic categories. Proposals must be submitted via email as two separate volumes—non-price (Word or PDF, maximum 10 pages) and price (Excel only)—and must not exceed 10 MB per email. Offerors must attest to full compliance with the Statement of Work, provide current representations in SAM.gov, and avoid including classified information. Evaluation will be based on a tradeoff between non-price and price factors, with non-price elements weighted more heavily. The Performance Test—Minimum Requirements is a mandatory pass/fail gate; failure results in automatic disqualification. Past Performance and Performance Test—Enhancing Factors are the most important non-price