Amendment_5_Changes_Table.pdf

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

• 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 Testing in an OTC and CLIA waived environment

• Suspend AOI 7.3.2. Pan-Influenza Diagnostics: Point-of-Care or Laboratory

• Suspend AOI 7.3.3. Point-of-Care Multiplex Assay for Detection of Influenza Virus

• Updated AOI 7.4.1. Next-Generation Sequencing (NGS)-Based Diagnostic for Viral Pathogens, including:

i. Updated information under Out-of-Scope Topics for AOI 7.4.1

ii. Updated information under Qualities that Strengthen the Competitiveness of a Proposal to AOI #7 (Diagnostics)

10. Updates to Area of Interest #8: IEID Vaccines

• Updated Technical POC

11. Suspend Area of Interest #12: Flexible and Strategic Therapeutics (FASTx)

12. Added Appendix 3: HHSAR Referenced Clause

Amendment 4 (June 4, 2024): BARDA BAA-23-100-SOL-00004 List of Changes:

Amendment 4 (June 4, 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

• Added new AOI 6.7. Special Instruction for health economic impact assessment of Burn MCMs

Amendment 3 (Mar 29, 2024)

• 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:

Amendment 1 (Nov 9, 2023)

1. Updates to Overview Information –

• Updated Research and Development Opportunity Description

• Updated General Market Research (TechWatch Program),

• Updated Application Process,

• Updated Contract and Submission Information,

• Updated Electronic Portal Submission Instructions

2. Updates to Background

3. Updates to Part I: Development and Technical Objectives

4. Updates to Part IV: Pre-Submission Call and Quad Chart/Market Research Abstract Instructions (Stages 1 & 2)

• Updated Figure 1. BARDA BAA Process Flow Chart

• Updated Stage 1: Pre-submission Call with Technical POC

5. Updates to Part VI: Proposal Instructions (Stage 3)

• Updates to Stage 3: Proposal Precreation

Amendment 1 (Nov 9, 2023) o Section M. Past Performance Information & o Vol. II, Attachment 10: Past Performance o Vol. II, Attachment 11: Reason for the Proposed Award Type

6. Updates to Part VII: Proposal Evaluation

7. Updates to Area of Interest #6: Burn and Blast Medical Countermeasures

• Updated TRL Requirement

8. Updates to Area of Interest #7: Diagnostics

• Updated AOI 7.1.3 Biothreat Agent Diagnostics: Filovirus Point-of-Care and Remote Settings

• Updated AOI 7.3.1 Influenza Home-Use Testing (for OTC or Prescription At-home)

• Updated AOI 7.3.3 Point-of-Care Multiplex Assay for Detection of Influenza Virus

9. Updates to Area of Interest #9: IEID Therapeutics

• Added new Area of Interest 9.4 COVID-19 Monoclonal Antibody Therapeutics for Treatment

• Updated Additional Assessment Factors for the Specific Topic AOIs

10. Suspend AOI #11: COVID-19 Immune Assay(s) Development and Implementation