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

Statement of Work (SOW) / Performance Work Statement (PWS)

This Statement of Work (SOW) outlines the requirements for Fentanyl/Norfentanyl Immunoassay Reagent Kits for the Department of War (DoW) Drug Demand Reduction Program (DDRP). These kits are intended for use with the currently installed Beckman Coulter AU5800 series systems to detect fentanyl and norfentanyl in human urine samples.

• The reagents must be capable of detecting fentanyl/norfentanyl in human urine at concentrations equal to or greater than 1 ng/mL.

• The immunoassay is limited to a two (2) reagent assay procedure and must be compatible with the Beckman Coulter AU5800 Series Clinical Chemistry Analyzers.

• The reagent must not require separate pre-treatment of specimens and should not interfere with other immunoassay procedures on the analyzer.

• The reagent must not impose additional maintenance, servicing, or calibration requirements on the analyzer.

• Kits must have clearance from the FDA.

• The reagent shall demonstrate calibration stability and require calibration no more than once per 8-hour testing period.

• The document specifies initial screen and confirmation cutoffs for various drugs, including fentanyl.

• Reagents must be capable of identifying specimens positive for fentanyl at concentrations >= 1 ng/mL and negative below 1 ng/mL, as determined by GC-MS or LC-MS/MS.

• Reagent performance must be stable over an eight-hour testing period without re-calibration.

• Precision and accuracy must be demonstrated within and between batches for concentrations ranging between 50-200% of the calibrator/cutoff.

• Reagents must produce non-overlapping quality control (QC) sample ranges.

• Minimal cross-reactivity with analytes other than fentanyl and its analogues is required.

• The requirement is for an ordering period of five (5) years.

• The estimated number of tests required is up to 500,000 tests per month.

• The reagents will be used at various Department of War (DoW) Forensic Toxicology Drug Testing Laboratories (FTDTLs), including those at Navy Drug Screening Laboratories, Air Force Drug Testing Laboratory, and Army Forensic Toxicology Drug Testing Laboratory.

• Offerors must be an Original Equipment Manufacturer (OEM) of reagents, or an authorized dealer, distributor, or reseller, ensuring OEM parameters, quality controls, and services are provided and maintained by the OEM.

• Reagents shall not be repackaged or relabeled by the Offeror unless authorized.

• Reagents must comply with FDA and ISO or Quality Assurance documentation.

• Minimum shelf life of unopened reagents is 180 days from the date of delivery; opened components have a shelf life of at least 14 days.

• Packaging must provide thermal protection for biologic reagents.

• The manufacturer must possess current ISO-9000 or ISO 13485 certification or equivalent documentation for their Quality Assurance Program.

• Lot numbers must be used for tracking all immunoassay components.

Solicitation / RFP / RFQ

This is a combined synopsis/solicitation for commercial items, prepared in accordance with Federal Acquisition Regulation (FAR) Part 12, Simplified Acquisition Procedures. The U.S. Navy is soliciting interested sources for the Drug Demand Reduction Program - Fentanyl Reagent Kits. The acquisition is for products that the Government intends to solicit and negotiate on a Firm-Fixed-Price Indefinite Delivery, Indefinite Quantity (IDIQ) contract basis, under which delivery orders will be issued. The NAICS code is 325413 - In-Vitro Diagnostic Substance Manufacturing, with a small business standard of $1,250.00.

• Product: FDA and Quality Management Documented Fentanyl/Norfentanyl Immunoassay Reagent Kits for use with the currently installed Beckman Coulter AU5800 series systems.

• Capability: Reagents must be capable of detecting fentanyl/norfentanyl in human urine samples.

• Minimum Shelf Life: Un-opened reagent kits must have a 180-day minimum shelf life from the date of product delivery; opened reagent kits must be stable for at least 14 days.

• Contract Type: Firm-Fixed-Price IDIQ.

• Period of Performance: 01 August 2026 to 31 July 2031.

• Estimated Quantity: 30,000,000 Each.

• Minimum Order Per Order: 1,000 Each.

• Maximum Order Per Order: 6,000,000 Each.

• Government Minimum Order: 5,000 Each.

• Government Maximum Order: 30,000,000 Each.

• Questions Due: 29 May 2026, 12:00 PM Eastern Time.

• Two-Step Process:

  • Step One (Technical Approach): Due 03 June 2026, 12:00 PM Eastern Time. Submit Volume I (Technical Approach) via email. This includes FDA Authorization/ISO Certification, SOW Compliance Attestation/OEM Requirements, and Reagent Preparation/Calibration Information. Evaluated on a Pass/Fail basis.
  • Step Two (Non-Price and Price Proposals): For viable competitors from Step One. Includes Volume II (Non-Price Proposal) and Volume III (Price Proposal). Due 26 June 2026, 12:00 PM Eastern Time.

• Evaluation: Best value tradeoff process. Non-price factors are more important than price. Non-price factors include: Performance Test - Minimum Requirements (Pass/Fail), Performance Test - Enhancing Factors, Past Performance, and Small Business Participation Plan.

• This acquisition is UNRESTRICTED.

• Small business subcontracting goals are outlined, including 30% for Small Business (SB), 5% for Small Disadvantaged Business (SDB), 5% for Women-Owned Small Business (WOSB), 3% for HUBZone Small Business, and 3% for Service-Disabled Veteran-Owned Small Business (SDVOSB).

• Paper copies of this solicitation will not be available.

• Applicable clauses and provisions can be accessed at https://www.acquisition.gov/far-overhaul.

• Offerors must submit proposals in two volumes: Volume II (Non-Price) and Volume III (Price).

• The contract will be a Firm-Fixed-Price (FFP) type.