Amendment_2_Changes_Table.pdf

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Biomedical Advanced Research and Development Authority (BARDA) Broad Agency Announcement (BAA)
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BAA-23-100-SOL-00004
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This document is a change history table for Amendment 2 to the Biomedical Advanced Research and Development Authority (BARDA) Broad Agency Announcement (BAA) solicitation number BAA-23-100-SOL-00004. Amendment 2 suspends Area of Interest 9.4 regarding COVID-19 monoclonal antibody therapeutics for treatment. Earlier Amendment 1 updated various parts of the BAA including the overview information, background, development and technical objectives, pre-submission and proposal instructions, evaluation criteria, and specific areas of interest related to burn and blast medical countermeasures, diagnostics for biothreat agents and influenza, and infectious disease therapeutics.

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Change History Table: Original – Amendments (2) 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)

Amendment 1 (Nov 9, 2023)

• 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

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