Biomedical Advanced Research and Development Authority (BARDA) Broad Agency Announcement (BAA)

Amendment / Modification

This document, Amendment 5 (December 18, 2024), details numerous changes to the BARDA BAA-23-100-SOL-00004 solicitation. Key updates include:

• Background and Technical Objectives: Language updates related to the Detection, Diagnostics, and Devices Infrastructure (DDDI) Division and Manufacturing Development Activities.
• Proposal Instructions: Addition of Vol. II, Attachment 12 (Supply Chain Risk Assessment) and Vol. II, Attachment 13 (Procurements Involving Synthetic Nucleic Acid and Screening).
• Proposal Evaluation: Addition of information regarding Prospective Contractor Responsibility and Eligibility Standards: Supply Chain Risk Assessment.
• Areas of Interest (AOI) Updates: Significant modifications across multiple AOIs, including:
  • AOI 1.1 (CBRN Vaccines): Suspended needle-free technologies.
  • AOI 5 (Chemical Medical Countermeasures): Updates to pulmonary agents and pharmaceutical-based agents.
  • AOI 6 (Burn and Blast Medical Countermeasures): Updates to management of burn, blast, head, blunt trauma, and musculoskeletal injuries; suspension of AOI 6.4 regarding non-autologous topical products; addition of AI software for ultrasound imaging data.
  • AOI 7 (Diagnostics): Updates to biothreat agent diagnostics, AMR testing, influenza diagnostics (including home-use and point-of-care), and NGS-based diagnostics.
  • AOI 8 (IEID Vaccines): Updated Technical POC.
  • AOI 12 (FASTx): Suspended.
• New Appendix: Added Appendix 3: HHSAR Referenced Clause.

Previous amendments (1, 2, 3, and 4) also introduced changes, such as suspending specific AOIs (e.g., COVID-19 therapeutics, SARS-CoV-2 guidance), updating TRL requirements, and modifying proposal submission instructions and evaluation criteria.

• Background
• Part I: Development and Technical Objectives
• Part IV: Pre-Submission Call and Quad Chart/Market Research Abstract Instructions
• Part VI: Proposal Instructions (Stage 3)
• Part VII: Proposal Evaluation
• Various Areas of Interest (AOIs) across multiple categories (CBRN Vaccines, Chemical Medical Countermeasures, Burn and Blast Medical Countermeasures, Diagnostics, IEID Therapeutics, FASTx)
• Attachments and Appendices

These changes may impact proposal preparation, particularly concerning the scope of work for various AOIs, required attachments, and evaluation factors. Bidders should carefully review all updated sections and suspended AOIs to ensure their proposals align with the latest requirements.

Amendment / Modification

This document is Amendment 5 to the BARDA Broad Agency Announcement (BAA) BAA-23-100-SOL-00004. It updates the solicitation with new information and clarifications.

This amendment likely affects various sections of the original solicitation, including but not limited to:

• Areas of Interest (AOIs) with specific updates or clarifications.
• Submission deadlines and response times.
• Proposal preparation and evaluation criteria.
• Specific instructions or requirements for different stages of the application process.

Offerors should carefully review this amendment to understand any changes to proposal requirements, submission deadlines, or evaluation factors. It is crucial to ensure that proposals submitted in response to this BAA conform to the most current version of the solicitation, including all amendments.

Amendment / Modification

This document is Amendment 4 to the BARDA Broad Agency Announcement (BAA) BAA-23-100-SOL-00004, dated May 31, 2024. It serves to modernize the BAA to accelerate partnering, improve responsiveness, and decrease the time to award for developing Medical Countermeasures (MCMs).

This amendment updates the BAA to reflect changes based on experience and growth of the acquisition vehicle, aiming to enable BARDA to pivot and respond more quickly during public health emergencies.

No specific impact on proposal deadlines or submission requirements is detailed in this amendment, but it signifies a modernization of the BAA process.

Amendment / Modification

This document details changes made through four amendments to the BARDA BAA-23-100-SOL-00004.

Amendment 4 (May 31, 2024):

• Updates to Area of Interest #7 (Diagnostics), including TRL requirements and specific diagnostic AOIs for Filovirus, Bacterial Antimicrobial Resistance, and Influenza.
• Updates to Area of Interest #12 (Flexible and Strategic Therapeutics - FASTx), providing guidance for proposals related to PEP/PrEP indications and mAb platforms, and deleting guidance for SARS-CoV-2 proposals.

Amendment 3 (Mar 29, 2024):

• Updates to Area of Interest #3 (Antimicrobials), specifically MDR Bacteria and Fungal Infections.
• Updates to Area of Interest #5 (Chemical Medical Countermeasures), including AOI for Opioids and Respiratory Depressants, and TRL requirements.
• Updates to Area of Interest #6 (Burn and Blast Medical Countermeasures), adding AOIs for General Burn/Blast Injuries, Head Injuries, Hemorrhage Control, Blunt Trauma Injuries, and Advanced Imaging Technologies. AOI 6.4 (Non-Autologous Topical Products) was suspended. New AOIs for health economic impact assessment and AI for ultrasound imaging were added.
• Updates to Area of Interest #7 (Diagnostics), including TRL requirements and specific AOIs for Filovirus, Bacterial Antimicrobial Resistance, and suspending AOI 7.2.2 (Bacterial vs. Viral Infections).

Amendment 2 (Dec 22, 2023):

• Suspended AOI 9.4 related to COVID-19 Monoclonal Antibody Therapeutics for Treatment.

Amendment 1 (Nov 9, 2023):

• General updates to Overview Information, Background, Part I (Development and Technical Objectives), Part IV (Pre-Submission Call and Quad Chart/Market Research Abstract Instructions), and Part VI (Proposal Instructions).
• Updates to Area of Interest #6 (Burn and Blast Medical Countermeasures), including TRL requirements.
• Updates to Area of Interest #7 (Diagnostics), including TRL requirements and specific AOIs for Filovirus, Influenza Home-Use Testing, and Multiplex Assay for Influenza Virus.
• Updates to Area of Interest #9 (IEID Therapeutics), adding AOI 9.4 for COVID-19 Monoclonal Antibody Therapeutics and updating assessment factors. AOI #11 (COVID-19 Immune Assay) was suspended.

Numerous Areas of Interest (AOIs) across multiple sections of the solicitation have been updated, added, or suspended. Specific sections related to Overview Information, Background, Technical Objectives, Proposal Instructions, and Evaluation have also been modified.

Bidders should review all amendments carefully as they modify specific Areas of Interest, requirements, and guidance. The amendments introduce new Areas of Interest, suspend others, and update technical requirements and TRL expectations. It is crucial to consult the latest versions of the solicitation and its attachments as detailed in these amendments.

Amendment / Modification

This document details changes made to the BARDA BAA-23-100-SOL-00004 solicitation through three amendments:

Amendment 3 (March 29, 2024):

• Updates to Area of Interest #3 (Antimicrobials), specifically regarding MDR Bacteria and Biothreat Pathogens, and MDR Fungal Infections.
• Updates to Area of Interest #5 (Chemical Medical Countermeasures), including changes to Opioids and Other Respiratory Depressants, and TRL Requirement.
• Updates to Area of Interest #6 (Burn and Blast Medical Countermeasures), involving enabling technologies for burn/blast injuries, management of head injuries, hemorrhage control, suspension of AOI 6.4 (Non-Autologous Topical Products), addition of AOI 6.5 (Blunt Trauma Injuries), AOI 6.6 (Advanced Imaging Technologies), AOI 6.7 (Health Economic Impact Assessment for Burn MCMs), and AOI 6.8 (Platform Agnostic Software for AI Ultrasound Imaging).
• Updates to Area of Interest #7 (Diagnostics), including changes to Biothreat Agent Diagnostics, Bacterial Antimicrobial Resistance testing, suspension of AOI 7.2.2 (Bacterial vs. Viral Infections), and TRL Requirement.

Amendment 2 (December 22, 2023):

• Suspended AOI 9.4 (COVID-19 Monoclonal Antibody Therapeutics for Treatment).

Amendment 1 (November 9, 2023):

• Updates to Overview Information (R&D Description, Market Research, Application Process, Contract Information, Submission Instructions).
• Updates to Background.
• Updates to Part I (Development and Technical Objectives).
• Updates to Part IV (Pre-Submission Call and Quad Chart/Market Research Abstract Instructions), including the Process Flow Chart and Stage 1 POC.
• Updates to Part VI (Proposal Instructions - Stage 3), specifically regarding Past Performance Information and Reason for Proposed Award Type.
• Updates to Part VII (Proposal Evaluation).
• Updates to Area of Interest #6 (Burn and Blast Medical Countermeasures) regarding TRL Requirement.
• Updates to Area of Interest #7 (Diagnostics), including AOI 7.1.3, AOI 7.3.1, and AOI 7.3.3.
• Updates to Area of Interest #9 (IEID Therapeutics), adding AOI 9.4 and updating assessment factors.
• Suspended AOI #11 (COVID-19 Immune Assay(s) Development and Implementation).

Numerous Areas of Interest (AOIs) across multiple sections of the solicitation have been updated, added, or suspended. Specific parts related to Overview, Background, Technical Objectives, Pre-Submission Instructions, Proposal Instructions, and Proposal Evaluation have also been modified.

Bidders should review all amendments carefully as they modify the scope, requirements, and specific Areas of Interest within the solicitation. The amendments introduce new Areas of Interest, suspend others, and update technical requirements and instructions. It is crucial for bidders to consult the latest versions of all affected sections and attachments to ensure their proposals align with the most current requirements.

Amendment / Modification

This document is Amendment 3 to the BARDA Broad Agency Announcement (BAA) BAA-23-100-SOL-00004, dated March 29, 2024.

This amendment does not appear to introduce specific changes to sections, but rather serves as an update to the original solicitation.

This amendment does not appear to modify proposal deadlines or submission requirements. Offerors should refer to the original solicitation for these details.

Amendment / Modification

This document is Amendment 2 to the Broad Agency Announcement (BAA) BAA-23-100-SOL-00004. It was posted on December 22, 2023.

This amendment does not appear to modify specific sections of the original BAA but rather serves as an update to the announcement.

No specific impact on proposal deadlines or requirements is detailed in this amendment document itself. Offerors should refer to the original BAA and any other amendments for submission details.

Amendment / Modification

This document details changes made to the BARDA BAA-23-100-SOL-00004 solicitation through two amendments:

Amendment 2 (December 22, 2023):

• Suspended Area of Interest (AOI) 9.4, which pertains to COVID-19 Monoclonal Antibody Therapeutics for Treatment.

Amendment 1 (November 9, 2023):

• Overview Information: Updated description, market research, application process, contract/submission information, and electronic portal submission instructions.
• Background: Updated.
• Part I: Development and Technical Objectives: Updated.
• Part IV: Pre-Submission Call and Quad Chart/Market Research Abstract Instructions (Stages 1 & 2): Updated Figure 1 (Process Flow Chart) and Stage 1 instructions.
• Part VI: Proposal Instructions (Stage 3): Updated proposal preparation instructions, including Section M (Past Performance Information), Attachment 10 (Past Performance), and Attachment 11 (Reason for Proposed Award Type).
• Part VII: Proposal Evaluation: Updated.
• Area of Interest #6 (Burn and Blast Medical Countermeasures): Updated Technology Readiness Level (TRL) Requirement.
• Area of Interest #7 (Diagnostics): Updated AOI 7.1.3 (Biothreat Agent Diagnostics) and AOI 7.3.1 (Influenza Home-Use Testing).
• Area of Interest #9 (IEID Therapeutics): Added new AOI 9.4 (COVID-19 Monoclonal Antibody Therapeutics for Treatment) and updated assessment factors.
• AOI 7.3.3 (Point-of-Care Multiplex Assay for Detection of Influenza Virus): Updated.
• Suspended AOI #11 (COVID-19 Immune Assay(s) Development and Implementation).

Multiple sections of the original solicitation have been updated, including Overview Information, Background, Parts I, IV, VI, VII, and various Areas of Interest.

Potential bidders should review all changes, particularly those affecting proposal instructions, evaluation criteria, and specific Areas of Interest, as these may impact submission requirements and strategy.

Amendment / Modification

This document is Amendment 1 to the Broad Agency Announcement (BAA) BAA-23-100-SOL-00004. It was posted on November 9, 2023.

This amendment does not appear to modify specific sections of the original solicitation but rather serves as an update to the announcement.

No specific impact on submission deadlines or requirements is detailed in this amendment, but interested parties are encouraged to check the listed websites periodically for updates and amendments.

Amendment / Modification

This document details changes made in Amendment 1, dated November 9, 2023, to the BARDA BAA-23-100-SOL-00004.

Key changes include:

• Updates to the Overview Information, including the Research and Development Opportunity Description, General Market Research, Application Process, Contract and Submission Information, and Electronic Portal Submission Instructions.

• Updates to Background information.

• Updates to Part I: Development and Technical Objectives.

• Updates to Part IV: Pre-Submission Call and Quad Chart/Market Research Abstract Instructions (Stages 1 & 2), including an updated process flow chart and Stage 1 call details.

• Updates to Part VI: Proposal Instructions (Stage 3), specifically regarding Stage 3 Proposal Precreation, Section M (Past Performance Information), and attachments related to Past Performance and Reason for Proposed Award Type.

• Updates to Part VII: Proposal Evaluation.

• Updates to Area of Interest #6: Burn and Blast Medical Countermeasures, including an updated TRL Requirement.

• Updates to Area of Interest #7: Diagnostics, with specific updates to AOI 7.1.3, 7.3.1, and 7.3.3.

• Updates to Area of Interest #9: IEID Therapeutics, including a new Area of Interest 9.4 for COVID-19 Monoclonal Antibody Therapeutics and updated assessment factors.

• Suspension of AOI #11: COVID-19 Immune Assay(s) Development and Implementation.

• Overview Information

• Background

• Part I: Development and Technical Objectives

• Part IV: Pre-Submission Call and Quad Chart/Market Research Abstract Instructions

• Part VI: Proposal Instructions

• Part VII: Proposal Evaluation

• Area of Interest #6: Burn and Blast Medical Countermeasures

• Area of Interest #7: Diagnostics

• Area of Interest #9: IEID Therapeutics

• AOI #11: COVID-19 Immune Assay(s)

This amendment modifies various sections of the solicitation, including proposal instructions and evaluation criteria. Bidders should review all updated sections carefully to ensure their proposals comply with the revised requirements. Specific impacts on proposal deadlines or submission rules are not explicitly detailed in this summary of changes, but the updated instructions and evaluation criteria may affect proposal preparation.

Solicitation

This Broad Agency Announcement (BAA) from the Office of Biomedical Advanced Research and Development Authority (BARDA) seeks proposals for advanced research and development (R&D) of Medical Countermeasures (MCMs). The goal is to address threats such as chemical, biological, radiological, and nuclear (CBRN) incidents, pandemic influenza, and emerging infectious diseases. This BAA aims to accelerate partnering, improve responsiveness, and decrease the time to award for developing MCMs.

• Proposals should focus on R&D in the solicited Areas of Interest (AOIs), covering aspects from nonclinical R&D to clinical evaluation and manufacturing.

• Offerors must identify the Technology Readiness Level (TRL) of their product, which should meet or exceed the requirements of the given Development AOI.

• Submissions involve a three-stage process: Stage 1 (Pre-submission Call), Stage 2 (Quad Chart and Market Research Abstract), and Stage 3 (Proposal).

• Multiple awards of various values are anticipated.

• Contract types may include Cost-Reimbursement (Cost, Cost Sharing, CPIF, CPFF) and Firm-Fixed-Price (FFP).

• Government may also award grants and cooperative agreements.

• Stage 2 submissions (Quad Chart and Market Research Abstract) are due by September 25, 2028, 4:30 PM ET.

• Stage 3 Proposals are due as specified in the Invitation Letter, with a deadline of September 25, 2028, 4:30 PM ET.

• Proposals will be evaluated based on Program Relevance, Overall Scientific and Technical Merits, and Offeror's Capabilities and Related Experience.

• Cost/Price, Past Performance, and Subcontracting Program Evaluation are also considered.

• Open to all responsible sources, including private sector organizations, Government laboratories, and academic institutions.

• Historically Black Colleges and Universities (HBCUs), Minority Institutions, Small Business concerns, Small Disadvantaged Business concerns, Women-Owned Small Business concerns, Veteran-Owned Small Business concerns, Service-Disabled Veteran-Owned Small Business concerns, and HUBZone Small Business concerns are encouraged.

• This BAA is available on SAM.gov, MedicalCountermeasures.gov, and Grants.gov.

• Amendments will be posted on these websites.

• Offerors are encouraged to participate in the TechWatch program for pre-submission engagement.