Amendment 5: Changes Table

Change History Table: Original – Amendments (5)
Amendment 5 (December 18, 2024): BARDA BAA-23-100-SOL-00004 List of Changes: Amendment 5 (December 18, 2024)

1. Updates to Background

• Updated language under BARDA’s Detection, Diagnostics, and Devices Infrastructure (DDDI) Division 2. Updates to Part I: Development and Technical Objectives • Updated language under Development and Manufacturing Approach – Manufacturing Development Activities 3. Updates to Part VI: Proposal Instructions (Stage 3)
• Added Vol. II, Attachment 12: Supply Chain Risk Assessment • Added Vol. II, Attachment 13: Procurements Involving Synthetic Nucleic Acid and Screening 4. Updates to Part VII: Proposal Evaluation
• Added Additional Information – Prospective Contractor Responsibility and Eligibility Standards: Supply Chain Risk Assessment 5. Updates to Area of Interest #1: CBRN Vaccines
• Suspend AOI 1.1. Needle-Free Technologies to Administer Licensed Vaccines 6. Updates to Area of Interest #2: CBRN Antivirals and Antitoxins • Updated language under introductory paragraphs to AOI 7. Updates to Area of Interest #5: Chemical Medical Countermeasures • Updated AOI 5.1. Pulmonary Agents
• Updated AOI 5.2. Pharmaceutical-based Agents, including Opioids and Other Respiratory Depressants 8. Updates to Area of Interest #6: Burn and Blast Medical Countermeasures • Updated language under introductory paragraphs to AOI • Updated AOI 6.1. Burn and Blast Traumatic Injuries Management • 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 (Defined as a Worsening of a Burn Wound From its Original Depth)
• Updated AOI 6.5. Management of Blunt Trauma Injuries
• Updated AOI 6.6. Musculoskeletal Injuries
• Suspend AOI 6.7. Special Instruction for Health Economic Impact Assessment of Burn MCMs • Updated AOI 6.8. Platform Agnostic Software for AI Augmentation of Ultrasound Imaging Data, including:

Amendment 5 (December 18, 2024)
i. Updated AOI 6.8.1 Final Product – Device-Agnostic Ultrasound Algorithm ii. Updated AOI 6.8.2 Proposal Requirements – 6.8.2.1 through 6.8.2.8 iii. Updated AOI 6.8.3 Sustainability Planning
iv. Deleted AOI 6.8.4 Deadlines and USG Response Time
• Updated language under Qualities That Strengthen the Competitiveness of a Proposal 9. Updates to Area of Interest #7: Diagnostics
• Updated AOI 7.1.3. Biothreat Agent Diagnostics: Filovirus Point-of-Care and Remote Settings