Biomedical Advanced Research and Development Authority (BARDA) Broad Agency Announcement (BAA) - Federal Contract Opportunity

Analysis of Federal Contract Opportunity Solicitation #: BAA-23-100-SOL-00004 by G2X Lumen AI

Key Information

NAICS Code
Agency
HEALTH AND HUMAN SERVICES, DEPARTMENT OF
Response Deadline
September 25, 2028
Type
Solicitation
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Executive Summary

Executive Summary

This document analyzes Amendment 6 (May 29, 2025) to the Broad Agency Announcement (BAA) BARDA-BAA-23-100-SOL-00004, specifically focusing on changes and updates across various Areas of Interest (AOIs). The BAA, issued by the Biomedical Advanced Research and Development Authority (BARDA), seeks proposals for research and development in medical countermeasures. Key updates include revisions to multiple AOIs, with a particular focus on vaccines, therapeutics, diagnostics, and medical countermeasures for chemical, biological, radiological, and nuclear (CBRN) threats.

The updates span several areas, including changes to introductory language, specific AOI objectives, technical requirements, and evaluation criteria. Notably, several AOIs have been updated to reflect current priorities and emerging threats, while others have been suspended or had their scope adjusted. The document also highlights changes to proposal instructions, submission requirements, and evaluation factors, emphasizing the importance of staying current with the latest amendments for proposal preparation. The final proposal submission deadline for open areas of interest is September 25, 2028, at 4:30 PM Eastern Time.

Detailed Analysis

Detailed Analysis

Agency and Opportunity Overview

The opportunity is a Broad Agency Announcement (BAA) issued by the Biomedical Advanced Research and Development Authority (BARDA). The BAA number is BARDA-BAA-23-100-SOL-00004. This analysis focuses on Amendment 6, released on May 29, 2025, and its subsequent amendments. The BAA solicits proposals for research and development of medical countermeasures against CBRN threats and emerging infectious diseases.

Objectives and Requirements

The BAA aims to stimulate innovation in medical countermeasures. Amendment 6 includes updates to several Areas of Interest (AOIs). Key updates are summarized below:

  • Area of Interest #1: CBRN Vaccines: Updates to introductory language, AOI 1.2 (Sudan Virus and Marburg Virus), and AOI 1.3 (Flexible Vaccine Manufacturing Platform Technologies)
  • Area of Interest #2: CBRN Antivirals and Antitoxins: Updated AOI 2.2 (Botulism Antitoxins) and AOI 2.4 (Filovirus Antivirals)
  • Area of Interest #3: Antimicrobials: Updates to introductory language, AOI 3.1 (MDR Bacteria and Biothreat Pathogens), and AOI 3.2 (MDR Fungal Infections). Updated language under Qualities That Strengthen the Competitiveness of a Proposal.
  • Area of Interest #4: Radiological/Nuclear Threat Medical Countermeasures: Updates to introductory paragraphs, AOI 4.1 (Acute Radiation Syndrome), AOI 4.2 (Uncontrolled Hemorrhage), AOI 4.3 (Radiation Injury and Trauma Pathophysiologies), and AOI 4.4 (Enabling Technologies and Platforms). AOI 4.5 (Decorporation Agents) is suspended. Updated language under Qualities That Strengthen the Competitiveness of a Proposal.
  • Area of Interest #5: Chemical Medical Countermeasures: Updated language under Qualities That Strengthen the Competitiveness of a Proposal
  • Area of Interest #6: Burn and Blast Medical Countermeasures: Updates to introductory paragraphs, AOI 6.1 (Burn and Blast Traumatic Injuries Management), AOI 6.2 (Management of Head Injuries in Trauma), AOI 6.3 (Hemorrhage Control), AOI 6.5 (Management of Thoracoabdominal Trauma Injuries), and AOI 6.6 (Musculoskeletal Injuries). AOI 6.7 (Special Instruction for Health Economic Impact Assessment of Burn MCMs) is suspended. Updates to AOI 6.8 (Platform Agnostic Software for AI Augmentation of Ultrasound Imaging Data), including deleting AOI 6.8.1 (Final Product – Device-Agnostic Ultrasound Algorithm), AOI 6.8.2 (Proposal Requirements), and AOI 6.8.3 (Sustainability Planning). Updated language under Qualities That Strengthen the Competitiveness of a Proposal.
  • Area of Interest #7: Diagnostics: Updated language under introductory paragraphs.
  • Area of Interest #8: IEID Vaccines: Updated Technical POC.
  • 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.
  • 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.
  • Area of Interest #12: Flexible and Strategic Therapeutics (FASTx): Suspended.

Amendment 5 made the following changes.

  • Added Vol. II, Attachment 12: Supply Chain Risk Assessment
  • Added Vol. II, Attachment 13: Procurements Involving Synthetic Nucleic Acid and Screening

Amendment 6 rescinded:

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

Submission Guidelines and Timeline

The final proposal submission deadline is September 25, 2028, at 4:30 PM Eastern Time for open areas of interest. All contracting-related inquiries should be sent to [email protected].

Evaluation and Acquisition Strategy

The document includes updates to Part VII: Proposal Evaluation. Updated language under Program Relevance; Added additional Other Evaluation Factors and Considerations. BARDA utilizes a multi-stage evaluation process, as described in the BAA.

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