Development of Radiological/Nuclear Medical Countermeasures (MCMs) And Biodosimetry Devices

The National Institute of Allergy and Infectious Diseases (NIAID) is soliciting proposals for the development of medical countermeasures (MCMs) and biodosimetry devices to address radiation-induced injuries from radiological or nuclear incidents. Offerors must submit proposals addressing either MCM development—drugs, biologics, or cellular therapies administered 24 hours or later post-exposure to mitigate or treat radiation injuries—or biodosimetry biomarkers and devices to assess radiation exposure and predict organ damage, but not both in a single proposal. MCM candidates must demonstrate clinically relevant efficacy in animal models with a defined Target Product Profile and regulatory pathway toward FDA approval under the Animal Rule, while biodosimetry solutions must distinguish between exposed and unexposed populations, estimate radiation dose within 0.5 Gy, and include a defined Target Product Profile and regulatory pathway toward FDA clearance. Technical proposals are limited to 200 pages and must be submitted electronically via the eCPS website by May 4, 2026, at 3:00 PM Eastern Time, with awards anticipated around March 1, 2027. The solicitation incorporates standard compliance requirements for human subjects research protections, live vertebrate animal care, data management and sharing, financial conflicts of interest, and Section 508 accessibility standards.

This solicitation is not set-aside for small business; however, small business subcontracting goals of 32% are anticipated, along with additional goals for small disadvantaged businesses (5%), women-owned small businesses (5%), HUBZone small businesses (3%), and service-disabled veteran-owned small businesses (3%). NIAID anticipates making 1-2 awards with a total planned set-aside of $12 million over three years, representing an estimated average annual cost of $2 million per award, or $6 million total per successful offeror over the three-year performance period. The anticipated contract structure consists of a FAR-based, multiple-year cost-reimbursement completion contract with a one-year base period and two one-year option periods, for a total period of performance not exceeding three years. Work will be performed in Westlake, Maryland, with offerors required to register in the System for Award Management (SAM) prior to contract award. Foreign organizations are eligible as prime contractors and subcontractors subject to applicable FAR requirements, and proposals must comply with Bayh-Dole Act provisions and standard FAR patent and data clauses.