BARDA BAA-23-100-SOL-00004
Below is a brief summary. Please check the full solicitation before applying (link in resources section).
Executive Summary:
The Office of Biomedical Advanced Research and Development Authority (BARDA) is seeking advanced research and development (R&D) proposals for Medical Countermeasures (MCMs) addressing CBRN threats, pandemic influenza, and emerging infectious diseases under BAA-23-100-SOL-00004 – Amendment 6 (May 29, 2025) .
This is an open, rolling Broad Agency Announcement (BAA) with a final submission deadline of September 25, 2028, at 4:30pm Eastern Time, unless otherwise indicated in an AOI .
BARDA is modernizing its acquisition approach to accelerate partnerships and reduce time to award. Multiple awards of various values are anticipated, subject to available funds and program priorities .
If your company is developing vaccines, therapeutics, diagnostics, antimicrobials, radiological/nuclear countermeasures, or platform technologies aligned to BARDA’s Areas of Interest (AOIs), this is a significant federal funding pathway.
How much funding would I receive?
The solicitation states:
Multiple awards of various values are anticipated
Funding depends on:
Program priorities
Scientific and technical merit
Alignment with BARDA AOIs
Available funds
Funding is subject to congressional appropriations
Specific award amounts, minimums, maximums, or total program funding are not specified in the solicitation, but generally range from $500k - $5m.
What could I use the funding for?
Funding supports advanced R&D of Medical Countermeasures (MCMs) for:
Chemical, Biological, Radiological, and Nuclear (CBRN) threats
Pandemic influenza
Emerging infectious diseases
Supported activities may include:
Nonclinical R&D
Clinical evaluation (Phase 1–3)
Process and platform development
Formulation
Manufacturing scale-up
Chemistry, Manufacturing, and Controls (CMC)
Regulatory strategy and FDA engagement
Diagnostics and device development
Antimicrobial and antifungal development
Radiological/nuclear injury countermeasures
Vaccine platform technologies
The BAA does not support the acquisition of products or construction of facilities .
Are there any additional benefits I would receive?
BARDA offers access to core support services that may benefit awardees, including:
Animal study networks
Flexible manufacturing facilities
Technical expertise in:
Development
Manufacturing
Regulatory affairs
Quality systems
Clinical studies
Award instruments may include:
FAR-based contracts (Cost-Reimbursement, Cost Sharing, CPIF, CPFF, FFP)
Grants
Cooperative agreements
Other Transaction agreements (OTAs)
What is the timeline to apply and when would I receive funding?
This is a three-stage process:
Stage 1 – Pre-Submission Call
May be initiated at any time during the open period
Acknowledged within 1 week
Stage 2 – Quad Chart & Market Research Abstract
May be submitted at any time prior to the deadline
Submission deadline: September 25, 2028, at 4:30pm Eastern Time, unless otherwise indicated in an AOI
Government response within 120 days of receipt
Stage 3 – Full Proposal
Proposal submission deadline: September 25, 2028, at 4:30pm Eastern Time, unless otherwise indicated in an AOI
Government response within 120 days of receipt
Awards proceed to negotiation following technical evaluation and availability of funds.
Where does this funding come from?
Funding comes from:
U.S. Department of Health and Human Services (HHS)
Administration for Strategic Preparedness and Response (ASPR)
Office of Biomedical Advanced Research and Development Authority (BARDA)
The BAA is issued under FAR 6.102(d)(2)(i) and authorized under federal preparedness statutes including PAHPA, PAHPRA, and PAHPAIA .
Who is eligible to apply?
The BAA is open to ALL responsible sources, including:
Private sector organizations
Academic institutions
Government laboratories
Teams and consortia
Offerors must be registered in SAM.gov prior to submission .
Special conditions apply to:
Federally Funded Research and Development Centers (FFRDCs)
Government entities
Small businesses, HBCUs, Minority Institutions, Women-Owned, Veteran-Owned, Service-Disabled Veteran-Owned, HUBZone, and Small Disadvantaged Businesses are encouraged to apply .
What companies and projects are likely to win?
Proposals are evaluated primarily on:
1. Program Relevance
Alignment with BARDA AOIs
Alignment with federal biodefense and pandemic strategies
Technological maturity (TRL justified with data)
Suitability for use during public health emergencies
Potential for sustainable commercial value
2. Scientific and Technical Merit
Innovation
Feasibility
Sound development plan
FDA regulatory pathway understanding
Freedom to operate (IP position)
Realistic schedule
3. Offeror Capabilities
Relevant experience
Qualified key personnel
Adequate facilities and infrastructure
BARDA does not support gain-of-function research .
Non-cost factors significantly outweigh cost considerations.
Are there any restrictions I should know about?
Key restrictions include:
Classified submissions are not accepted
All submissions must be UNCLASSIFIED
Salary rate limitation applies (Federal Executive Schedule Level II cap, as applicable)
Compliance required with:
GMP (21 CFR §§ 210, 211)
Biologics regulations (21 CFR §§ 600, 610)
Diagnostic regulations (21 CFR § 820)
GCP and GLP, as applicable
Export control laws must be followed
Supply chain risk assessment may be required
IP limitations must be disclosed
Electronic submission via BDR Portal is mandatory
Failure to comply with submission requirements may result in rejection.
How long will it take me to prepare an application?
Preparation effort depends on stage:
Stage 2 (Quad Chart + Market Research Abstract):
Up to 14 pages total
Includes ROM cost estimate
Requires TRL justification and high-level development plan
Stage 3 (Full Proposal):
Technical Volume: up to 120 pages
Detailed SOW, IMS, WBS, milestones
Full cost proposal with supporting documentation
Regulatory, IP, compliance documentation
This is a highly structured federal R&D submission and requires significant preparation.
How can BW&CO help?
BW&CO can:
Determine optimal AOI alignment
Conduct go/no-go eligibility review
Develop Stage 2 Quad Chart and Market Research Abstract
Build a compliant Stage 3 Technical Volume
Construct WBS, IMS, and Go/No-Go milestones
Develop ROM and full cost models aligned to FAR requirements
Position your product for strongest Program Relevance and Technical Merit scoring
Support negotiation preparation
We translate BARDA requirements into competitive, reviewer-aligned submissions.
How much would BW&CO Charge?
We have both fractional engagements ($250 an hour) and full engagements ($13,000 + 5%) available.