Strengthening National Preparedness: BARDA’s FY23 Modernized BAA
In response to today’s evolving public health landscape, the Biomedical Advanced Research and Development Authority (BARDA), a division of the U.S. Department of Health and Human Services (HHS) within the Administration for Strategic Preparedness and Response (ASPR), has released an update to its Broad Agency Announcement (BAA). BAA-23-100-SOL-00004, Amendment 6, published on May 29, 2025, includes updates to nine Areas of Interest (AOIs).
For over 15 years, BARDA’s open BAA mechanism has catalyzed innovation by funding high-impact public-private partnerships. This new iteration reflects a modernization strategy to reduce time-to-award, improve proposal responsiveness, and scale BARDA’s capacity to support a broader and more agile health security mission.
A Streamlined Path to Partnership
The FY23 Modernized BAA introduces a structured, three-stage process for engagement:
- Stage 1: Pre-submission Call (Optional) – Direct discussions with BARDA technical points of contact (POCs) to gauge alignment and reduce preparation burden.
- Stage 2: Quad Chart & Market Research Abstract – A concise, unclassified submission package that enables BARDA to evaluate technical merit and mission relevance.
- Stage 3: Full Proposal – By invitation only, based on favorable review of Stage 2 materials. Proposals are reviewed under Federal Acquisition Regulation (FAR) Part 35.
BARDA’s Areas of Interest: What They’re Funding
The BAA defines ten active AOIs, each aligned with BARDA’s preparedness mission. These include:
- AOI 1: CBRN Vaccines: Vaccines against threats like Ebola, Marburg, smallpox, and anthrax, including platform technologies for rapid scale-up and gene-to-IND timelines of under 6 months.
- AOI 2: CBRN Antivirals and Antitoxins (AVAT): Therapeutics for anthrax, botulism, smallpox, and filoviruses. Includes monoclonals, antivirals, and syndrome-based products.
- AOI 3: Antimicrobials: Targets biothreat pathogens and antimicrobial-resistant organisms including anthracis and Candida auris. TRL 6+ with a path to approval preferred.
- AOI 4: Radiological/Nuclear MCMs: MCMs for acute radiation syndrome, hemorrhage, vascular injury, and stem cell therapies post-radiation.
- AOI 5: Chemical MCMs: Treatments for chemical threats like nerve agents, opioids, and vesicants. Emphasizes field-use delivery and threat-agnostic solutions.
- AOI 6: Burn and Blast Trauma MCMs: Supports products for nuclear detonation-related trauma, including burns, crush injuries, and TBI diagnostics. Focus on early triage and AI-enhanced tools.
- AOI 7: Diagnostics: Rapid, point-of-care and lab-based diagnostics for biothreats, antibiotic resistance, influenza, and emerging viruses, including mNGS platforms.
- AOI 8: IEID Vaccines: Accelerated vaccine development for pandemic influenza and other EIDs, with emphasis on single-dose, needle-free, and stockpile-ready products.
- AOI 9: IEID Therapeutics: Broad-spectrum antivirals, ARDS therapeutics, and pre-exposure prophylactics for pandemic respiratory viruses. Long-acting and immune-modulating agents encouraged.
- AOI 10: ImmuneChip+: Advanced tissue-on-chip platforms with integrated immune components for drug screening and mechanistic modeling of host response.
- AOIs 11 and 12: [SUSPENDED] COVID-19 Immune Assays and FASTx: These topics are not accepting submissions at this time.
Main Updates in this BAA:
- AOI #1: CBRN Vaccines and AOI #2: CBRN Antivirals and Antitoxins have been updated to refine focus areas, such as clearer definitions of platform technologies, vaccine formulations, and priority pathogens.
- AOI #3: Antimicrobials has undergone textual changes including updates to priority targets and development stage expectations, possibly aligning with the latest National Action Plan for Combating Antibiotic-Resistant Bacteria (CARB).
- AOI #4: Radiological/Nuclear Threat Medical Countermeasures and AOI #5: Chemical Medical Countermeasures have been updated to include revised performance requirements, more precise technical objectives, and clarified endpoints for supported R&D.
- AOI #6: Burn and Blast Medical Countermeasures also reflects refined development goals, possibly integrating newer clinical endpoints or guidance from recent strategic planning documents.
Key Dates for Applicants
Offerors should be aware of the following deadlines and submission guidance:
- Pre-submission Call Requests: Open throughout the active period of the BAA
- Stage 2 (Quad Chart & Market Research Abstract):
- Due September 25th, 2028
- Stage 3: (Full Proposal):
- Due September 25th, 2028
All materials must be submitted electronically via BARDA’s BDR Portal in compliance with formatting and file size requirements.
Funding Structure and Award Expectations
BARDA anticipates making multiple awards under this announcement, with funding levels based on scientific merit, relevance to the agency’s mission, and availability of appropriations. Award instruments may include:
- Cost-Reimbursement and Cost-Sharing Contracts (CPFF, CPIF, etc.)
- Firm-Fixed-Price Contracts
- Grants and Cooperative Agreements
- Other Transaction Authority (OTA)
Projects may span discrete performance periods, with milestone-driven “go/no-go” options. Submissions from small businesses, HBCUs, and minority-serving institutions are strongly encouraged.
Advancing the Health Security Mission
The modernized BARDA BAA is more than a funding mechanism. It is a national preparedness initiative to identify, mature, and field the next generation of health security innovations. From non-invasive diagnostics to robust, shelf-stable vaccines and advanced cell therapies, the technologies supported by this BAA will shape the frontline of response for decades to come.
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