The U.S. Department of Health and Human Services (HHS), through the National Institutes of Health (NIH) and the National Institute of Allergy and Infectious Diseases (NIAID), has released the Broad Agency Announcement (BAA) HHS-NIH-NIAID-BAA2025-1. This announcement presents an exciting opportunity for researchers, organizations, and industry leaders to contribute to critical biomedical and biodefense initiatives.
Overview of Solicitation
HHS-NIH-NIAID-BAA2025-1 seeks innovative proposals to develop medical countermeasures for biodefense and emerging infectious disease. Proposals can be written to address one of two Research Areas (RAs):
- RA 001: Offerors may submit a proposal in response to Topics A, B, and/or C.
- Topic A: Develop therapeutics for antimicrobial resistant (AMR) bacterial or fungal pathogens, with special interest in therapeutics against AMR Pseudomonas aeruginosa, Acinetobacter baumannii, Candida auris, Cryptococcus spp., Aspergillus fumigatus, and/or This Topic will support lead optimization, pre-clinical Investigational New Drug (IND) enabling studies, and clinical Phase I trials of lead candidates with demonstrated therapeutic activities.
- Topic B: Advance vaccine candidates for AMR bacterial pathogens Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, and Enterobacter species. The scope of this vaccine Topic covers advancement of a promising lead candidate from pre-clinical testing through IND submission to the FDA and a Phase I clinical trial.
- Topic C: Develop in vitro diagnostics to identify fungal pathogens and determine possible AMR status. Offerors may propose multiplexed fungal species identification platforms, a comprehensive antifungal susceptibility testing platform, or a combination of both. Pathogens that must be detected by the proposed solution include at least one (preferably several) of the following: Candida and associated resistance markers; Aspergillus fumigatus and associated resistance markers; Coccidioides spp.; and Mucorales.
- RA 002: Development of direct acting antivirals (DAA) for viral families of pandemic potential. Proposals for this RA must focus on antivirals that meet all of the following criteria:
- Directly modify viral target function (not act through modulation of the host response; therefore, this RA does not call for vaccine development against viruses of pandemic potential)
- Act to reduce viral burden in early stages of disease
- Act against viruses of pandemic potential, such as Filoviridae, Coronaviridae, Bunyaviridae, Flaviviridae, Orthopoxviridae, Paramyxoviridae, Picornaviridae, and Note that proposed products are not required to be narrow-spectrum and may include other pathogens in their spectrum of activity, in addition to at least one of the pathogens listed above.
- Are new chemical entities limited to small molecules and nanobody conjugates/fusion products that are directly acting on viral targets/functions (not through host response modulation)
- Have safety profiles and suitable administration routes for broad outpatient use
RA002 will support lead optimization, pre-clinical (IND enabling) studies, and/or Phase I clinical trials, depending on the stage of the proposed product.
Submission Process
The proposal must contain both a technical proposal and a business proposal. A separate proposal should be submitted for each RA and/or Topic as appropriate. Each RA has its own proposal submission deadline:
- Research Area 001 Proposal Deadline: February 21, 2025 at 3pm EST
- Research Area 002 Proposal Deadline: January 21, 2025 at 3pm EST
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