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Federal solicitation · 75A50126C00005 · back to recent

BARDA DRIVe EZ-BAA (EZBAA - 22-100-SOL-00003)

HEALTH AND HUMAN SERVICES, DEPARTMENT OF · NAICS 541714 · $7.5M est.

View on SAM.gov →

Likely incumbent

AVITA MEDICAL AMERICAS, LLC on contract 75A50126C00003

Heuristic partial prefix match. Total value $25.5M. Awarded 2026-04-06. Agency: Department of Health and Human Services.

Prefix-match heuristic; treat as a strong lead, not a confirmed fact.

Solicitation description

The purpose of the proposed Contract is for Nebulization Therapy to Prevent and Treat Pulmonary Foam Caused by Inhaled Chemical Agents. The primary goal of the R&D effort described in this statement of work (SOW) is to generate the necessary data and information to support an initial FDA meeting to align on the regulatory strategy. The contract scope includes early-stage formulation and analytical development of the drug product; nebulizer characterization including flow rates and particle size distribution; bioanalytical development to support non-GLP studies using the proposed test article including PK, dose range finding, and chlorine exposure proof-of-concept (POC); and development of an overall regulatory strategy. This scope of work is expected to support a productive FDA engagement and advance the technical readiness level (TRL) through TRL 5 to meet minimum requirements to support various future contract vehicles. The generated data and completed non-GLP studies, along with FDA feedback, will inform work required in later development phases.

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Data this profile does NOT cover

  • No FPDSAward rows for NAICS 541714 in the trailing 12 months; vendor concentration unavailable.