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Amendment 4: Changes Table

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A PDF document (133 KB) attached to Biomedical Advanced Research and Development Authority (BARDA) Broad Agency Announcement (BAA), from the Office of Assistant Secretary for Preparedness and Response. Due Sep 25, 2028, 4:30 PM (UTC-4).

File name: Amendment_4_Changes_Table.pdf

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Change History Table: Original – Amendments (4)
Amendment 4 (May 31, 2024): BARDA BAA-23-100-SOL-00004 List of Changes: Amendment 4 (May 31, 2024)

1. Updates to Area of Interest #7: Diagnostics
• Updated TRL Requirement
• Updated AOI 7.1.3. Biothreat Agent Diagnostics: Filovirus Point-of-Care and Remote Settings • Updated AOI 7.2.1. Bacterial Antimicrobial Resistance (AMR) Testing Direct from Specimen • Updated AOI 7.3. Influenza Diagnostics
• Updated AOI 7.3.1. Influenza Home-Use Testing (for OTC or Prescription At-home) 2. Updates to Area of Interest #12: Flexible and Strategic Therapeutics (FASTx) • Updated Guidance for proposals pursuing a PEP or PrEP indication • Updated Guidance for proposals pursuing a mAb platform • Deleted Important guidance for proposals for SARS-CoV-2

Amendment 3 (Mar 29, 2024): BARDA BAA-23-100-SOL-00004 List of Changes: Amendment 3 (Mar 29, 2024)
1. Updates to Area of Interest #3: Antimicrobials
• Updated AOI 3.1. MDR Bacteria and Biothreat Pathogens • Updated 3.2. MDR Fungal Infections
2. Updates to Area of Interest #5: Chemical Medical Countermeasures • Updated AOI 5.2. Opioids and Other Respiratory Depressants • Updated TRL Requirement
3. Updates to Area of Interest #6: Burn and Blast Medical Countermeasures • Updated AOI 6.1. Enabling Technologies to Address General Burn & Blast Traumatic Injuries • Updated AOI 6.2. Management of Head Injuries in Trauma • Updated AOI 6.3. Hemorrhage Control
• Suspend AOI 6.4. Non-Autologous Topical Products to Prevent or Reduce Burn Wound Conversion • Added new AOI 6.5. Management of Blunt Trauma Injuries • Added new AOI 6.6. Advanced Imaging Technologies in Management of Trauma

Amendment 3 (Mar 29, 2024)
• Added new AOI 6.7. Special Instruction for health economic impact assessment of Burn MCMs • Added new AOI 6.8 Special Instruction for Platform Agnostic Software for AI Augmentation of Ultrasound Imaging Data. 4. Updates to Area of Interest #7: Diagnostics
• Updated AOI 7.1.3. Biothreat Agent Diagnostics: Filovirus Point-of-Care and Remote Settings • Updated AOI 7.2.1. Bacterial Antimicrobial Resistance (AMR) Testing Direct from Specimen • Suspend AOI 7.2.2. Bacterial vs. Viral Infections: Point-of-Care • Updated TRL Requirement

Amendment 2 (Dec 22, 2023): BARDA BAA-23-100-SOL-00004 List of Changes: Amendment 2 (Dec 22, 2023)
1. Suspend AOI 9.4 COVID-19 Monoclonal Antibody Therapeutics for Treatment

Amendment 1 (Nov 9, 2023): BARDA BAA-23-100-SOL-00004 List of Changes:

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