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U.S. Department of Health and Human Services

Working with BARDA

Submitting Advanced Research and Development Proposals Related to Anthrax

BARDA is soliciting proposals for the advanced research and development of medical countermeasures to combat anthrax infections and other threats to national health security under its BARDA Broad Agency Announcement (BAA-18-100-SOL-00003). 

BARDA is interested in supporting medical countermeasures that relate to the following Areas of Interest (AOIs) defined in the BAA:

  • Anthrax Vaccines: BARDA is not considering submissions for anthrax vaccines during the open period of the current BAA, unless specifically announced through special instructions. See BAA AOI 1.1.
  • Expansion of availability of licensed anthrax and smallpox vaccines to at risk populations: BARDA is interested in programs to expand availability of licensed anthrax vaccines for at risk populations, e.g. pediatric populations. See BAA AOI 1.3.
  • Antibacterial products for post-exposure prophylaxis:  BARDA is interested in programs to develop and test antibacterial products that are in development for post-exposure prophylaxis and treatment efficacy against one or more of the following biodefense threat agents: Bacillus anthracis, Yersinia pestis, Francisella tularensis, Burkholderia mallei, and Burkholderia pseudomallei. BARDA requires minimum inhibitory concentration data for multiple strains of one or more of these biothreat agents. Data from non-clinical studies evaluating the antibacterial candidate against any of these biothreat agents in relevant animal models of infection will strengthen a proposal. See BAA AOI 3.1.
  • Rapid point-of-care diagnostic systems:  BARDA is interested in supporting the advanced development, clinical evaluation, and FDA clearance or approval of rapid, accurate point of care diagnostic systems for anthraxinfections. BARDA will consider assays designed to quantitatively detect lethal factor protein and at least one other toxin marker (lethal toxin protein, edema factor protein, or protective antigen protein). These assays must detect targets at clinically relevant concentrations that are present during the early stages of disease. These systems should be designed for ease-of-use by non-expert personnel (i.e., CLIA waived/waivable). If an instrument is used, it should be small, lightweight, portable, and have at least one FDA-cleared assay for common infectious diseases or other routine healthcare analytes. BARDA is seeking programs that are at a Technology Readiness Level of 4 or higher. See BAA AOI 7.2.

  • This page last reviewed: March 29, 2019