Note of Intent to Award Sole Source

The Defense Health Agency Contracting Agency (DHACA) is issuing a Notice of Intent to Modify an Existing Contract within Scope to increase the cost ceiling of the current contract. The contract modification is for the authorization of an Emergency Use Authorization (EUA) and the execution of all activities commensurate with serving as the Investigational New Drug (IND) application holder and regulatory sponsor. The anticipated additional activities and costs may include consultant costs, professional travel, and regulatory costs. The market research conducted by PEO OPMED found that there are no other FDA licensed companies in the U.S. that can manufacture the required product and complete FDA licensure. * The contract modification is for the authorization of an EUA and the execution of all activities commensurate with serving as the IND application holder and regulatory sponsor. * The anticipated additional activities and costs may include consultant costs, professional travel, and regulatory costs. * The market research conducted by PEO OPMED found that there are no other FDA licensed companies in the U.S. that can manufacture the required product and complete FDA licensure. * The contract modification will be issued on a sole source basis.