Currently, there are no approved diagnostics, vaccines, or treatments for COVID-19 infections, and the U.S. government, and governments around the world, are struggling to fight this hidden enemy. As part of a U.S. government-wide effort to mitigate the spread of COVID-19, the U.S. Department of Health and Human Services (“HHS”) recently updated a Broad Agency Announcement (“BAA”) to focus research on several categories of products to diagnose, prevent, and/or treat coronavirus infections.
Specifically, the Office of Biomedical Advanced Research and Development Authority (“BARDA”), under the HHS’s Office of the Assistant Secretary for Preparedness and Response (“ASPR”), issued Amendment 13 to its existing BAA, BAA-18-100-SOL-00003, to solicit research proposals for the development and licensure of diagnostics, vaccines, or medicines such as therapeutics or antivirals specifically targeting COVID-19 infections. BARDA will provide funding as well as expertise and core services to support development projects selected and is actively seeking market research packages in the following areas:
- AOI 7.7.1 Diagnostic assay for human coronavirus using existing FDA platforms;
- AOI 7.7.2 Point-of-care diagnostic assay for detection of SARS-CoV-2 virus;
- AOI 7.7.3 Diagnostic assay for detection of COVID-19 disease (SARS-CoV-2 infection);
- AOI 8.3 COVID-19 vaccine;
- AOI 9.2 COVID-19 therapeutics;
- AOI 9.3 Immunomodulators or therapeutics targeting lung repair;
- AOI 9.5 Pre-exposure and post-exposure prophylaxis;
- AOI 10 Respiratory protective devices;
- AOI 11 Ventilators; and
- AOI 17 Advanced manufacturing technologies.
The BAA is open to all responsible offerors, which include single entities or teams from private organizations, government laboratories, and academic institutions. Multiple awards of various values are anticipated, and BARDA may award any appropriate contract type through either the Federal Acquisition Regulations (FAR) or through its Other Transactions Authority. Offerors must complete a two-step submission process. Step one requires submitting a quad chart and a white paper. Step two requires submitting a full proposal.
Additional information about the submission process can be found on ASPR’s website, and the deadline for submissions is October 31, 2020. Should you need assistance addressing this or any U.S. government contracting concern, please contact one of Frost Brown Todd’s experienced government contract attorneys to assist you during this unprecedented time.