Amendment_6_Changes_Table.pdf

Change History Table: Original – Amendments (6)

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

• Updated language under Background

• Updated Table 2

4. Updates to Part I: Development and Technical Objectives

• Updated language to Development and Manufacturing Approach

5. Updates to Part VI: Proposal Instructions (Stage 3) – Volume II – Cost Proposal Attachments

• Rescinded Vol. II, Attachment 13: Procurements Involving Synthetic Nucleic Acid and Screening

6. Updates to Part VII: Proposal Evaluation

• Updated language under Program Relevance

• Added additional Other Evaluation Factors and Considerations for:

i. Gain of Function Research

ii. Domestic Based Manufacturing

7. Updates to Part VII: Research and Development Areas of Interest

• Added definitions

8. Updates to Area of Interest #1: CBRN Vaccines

• Updated language under introductory paragraph to AOI

• Updated AOI 1.2. Sudan Virus and Marburg Virus

• Updated AOI 1.3. Flexible Vaccine Manufacturing Platform Technologies

• Updated AOI 2.2. Botulism Antitoxins

• Updated AOI 2.4. Filovirus Antivirals

9. Updates to Area of Interest #3: Antimicrobials

• Updated language under introductory paragraph to AOI

• Updated AOI 3.1. MDR Bacteria and Biothreat Pathogens

• Updated AOI 3.2. MDR Fungal Infections

• Updated language under Qualities That Strengthen the Competitiveness of a Proposal

10. Updates to Area of Interest #4: Radiological/Nuclear Threat Medical Countermeasures

• Updated language under introductory paragraphs to AOI

• Updated AOI 4.1. Acute Radiation Syndrome (ARS)

• Updated AOI 4.2. Uncontrolled Hemorrhage

• Updated AOI 4.3. Radiation Injury and Trauma Pathophysiologies

• Updated AOI 4.4. Enabling Technologies and Platforms

• Suspend AOI 4.5. Decorporation Agents

• Updated language under Qualities That Strengthen the Competitiveness of a Proposal

11. Updates to Area of Interest #5: Chemical Medical Countermeasures

• Updated language under Qualities That Strengthen the Competitiveness of a Proposal

12. 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, including:

i. Updated language under Enabling technology products

• Updated AOI 6.2. Management of Head Injuries in Trauma

• Updated AOI 6.3. Hemorrhage Control

• Updated AOI 6.5. Management of Thoracoabdominal 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:

i. Deleted AOI 6.8.1 Final Product – Device-Agnostic Ultrasound Algorithm

ii. Deleted AOI 6.8.2 Proposal Requirements

iii. Deleted AOI 6.8.3 Sustainability Planning

• Updated language under Qualities That Strengthen the Competitiveness of a Proposal

13. Updates to Area of Interest #7: Diagnostics

• Updated language under introductory paragraphs to AOI, including:

i. Updated language under Definitions for the purpose of this AOI

ii. Technology Readiness Level (TRL) Requirement

iii. Development of Instrumentation

iv. Qualities that Strengthen the Competitiveness of a Proposal to AOI #7 (Diagnostics)

• Updated AOI 7.1. Biothreat Agent Diagnostics

• Updated AOI 7.2. Antibiotic Resistance Diagnostics for Priority Bacterial Pathogens

• Updated AOI 7.3. Influenza Diagnostics

• Updated AOI 7.4. Threat Agnostic Diagnostics

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

• Updated AOI 8.2. Innovative Vaccine Product and Production Enhancements, including:

i. Updated language under AOI 8.2.1 Platform technologies

• Updated language under Qualities That Strengthen the Competitiveness of a Proposal

• Updated Technical POC

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

• Updated language under introductory paragraph to AOI

• Updated AOI 9.1. Broad Spectrum Antiviral Therapeutics for Influenza

• Updated AOI 9.2. Immune Modulators or Therapeutics Promoting Lung Repair

• Updated language under Additional Assessment Factors for the Specific Topic AOIs

16. Updates to Area of Interest #10: ImmuneChip+

• Updated language under introductory paragraphs to AOI

• Updated language under Overview

• Updated language under Submission Requirements and Desired Attributes

• Updated language under Out-of-Scope Project Attributes

• Deleted language under Chem MCM Program Interest Areas

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:

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

Amendment 5 (December 18, 2024)

• Updated language under Qualities That Strengthen the Competitiveness of a Proposal

9. Updates to Area of Interest #7: Diagnostics

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

18. Updated AOI 7.2.1. Bacterial Antimicrobial Resistance (AMR) Testing Direct from Specimen

19. Updated AOI 7.3. Influenza Diagnostics

20. Updated AOI 7.3.1. Influenza Testing in an OTC and CLIA waived environment

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

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

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

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

vi. 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

24. Updated TRL Requirement

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

26. Updated AOI 7.2.1. Bacterial Antimicrobial Resistance (AMR) Testing Direct from Specimen

27. Updated AOI 7.3. Influenza Diagnostics

28. 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

• 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 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