Amendment 7: Changes Table

Change History Table: Original – Amendments (7)
Amendment 7 (March 19, 2026): BARDA BAA-23-100-SOL-00004 List of Changes: Amendment 7 (March 19, 2026)

1. Updates to Background

• Updated language under BARDA’s Influenza and Emerging Infectious Diseases (IEID) Division • Updated Table 2
2. Updates to Part II: Reporting Requirements and Deliverables • Updated language to Reporting Requirements and Deliverables 3. Updates to Part III: Special Considerations
• Added additional Special Consideration – ASPR Public Access Policy 4. Updates to Part VIII: Research and Development Areas of Interest • Updated language under introductory paragraph to Part VIII 5. Updates to Area of Interest #2: CBRN Antivirals and Antitoxins • Suspend AOI 2.1. Anthrax Antitoxins
• Updated AOI 2.4. Filovirus Antivirals
6. Updates to Area of Interest #3: Antimicrobials
• Updated AOI 3.1. MDR Bacteria and Biothreat Pathogens 7. Updates to Area of Interest #7: Diagnostics
• Updated language under introductory paragraphs to AOI, including: i.
Development of Instrumentation
• Updated AOI 7.1. Biothreat Agent Diagnostics
• Updated AOI 7.1.3. Biothreat Agent Diagnostics: Filovirus Point-of-Care and Remote Settings • Updated AOI 7.2. Antibiotic Resistance Diagnostics for Priority Bacterial Pathogens • Updated AOI 7.2.1. Bacterial Antimicrobial Resistance (AMR) Testing Direct from Specimen • Updated AOI 7.3.1 Influenza Testing in an OTC and CLIA waived environment • Updated AOI 7.4. Threat Agnostic Diagnostics
• Updated AOI 7.4.1. Metagenomic Next-Generation Sequencing (mNGS)-Based Diagnostic for Viral and Bacterial Pathogens

Amendment 7 (March 19, 2026)
8. Updates to Area of Interest #9: IEID Therapeutics
• Updated AOI 9.1. Broad Spectrum Antiviral Therapeutics for Influenza • Updated AOI 9.3. Pre-exposure Prophylaxis – Influenza • Updated language under Additional Assessment Factors for the Specific Topic AOIs, including i. AOI #9.1: Broad Spectrum Antiviral Therapeutics for Influenza ii. AOI #9.2: Immune Modulators or Therapeutics Promoting Lung Repair iii. AOI #9.3: Pre-exposure Prophylaxis – Influenza
9. REOPENED Area of Interest #12: Flexible and Strategic Therapeutics (FASTx)

Amendment 6 (May 29, 2025): BARDA BAA-23-100-SOL-00004 List of Changes: Amendment 6 (May 29, 2025)

1. Updates to Introduction

• Updated language under Introduction
• Added additional Disclaimer

2. Updates to Overview Information

• Updated language under Eligible Offerors

3. Updates to Background