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FDA plays a pivotal role in protecting our nation from chemical, biological, radiological, and nuclear threats, and from emerging infectious diseases. FDA’s responsibility is to ensure that medical countermeasures (MCMs)—such as drugs, vaccines, and diagnostic tests—to counter these threats are safe, effective, and secure.

MCM research areas of interest under the BAA include:

• Develop, character, and qualify tools to support MCM development under the Animal Rule or Accelerated Approval
• Modernize tools to evaluate MCM product safety, efficacy, and quality, and secure the MCM supply chain
• Advance the development of tools to enable the rapid development and availability of investigational MCMs
• Enable development and evaluation of novel and improved materials and manufacturing methods (see Priority Area 3)

Extramural Research Funded through the BAA

1. Cross-Species Immune System Reference
2. Organs-on-Chips for Radiation Countermeasures
3. Ensuring Appropriate Public Use of Medical Countermeasures through Effective Emergency Communication
4. Investigating Decontamination and Reuse of Respirators in Public Health Emergencies
5. Optimizing Respirator Decontamination to Ensure Supplies for Emergency Preparedness
6. Streamlining Countermeasure Data Collection During Public Health Emergencies
7. Hybrid Genome Sequencing and Assembly of Bacterial Pathogens Using Emerging Innovative Technologies
8. Flu therapeutic area data standards development
9. Melioidosis Modeling: Research to Support Countermeasures for a Tricky Pathogen
10. Developing a Toolkit to Assess Efficacy of Ebola Vaccines and Therapeutics
11. Supporting Field Laboratory Testing of Ebola Antibodies in Sierra Leone
12. Survivor Studies: Better Understanding Ebola's After-Effects to Help Find New Treatments
13. Comparison of Host Responses to Ebola Virus Disease (EVD)
14. A new approach for understanding Ebola virus pathogenesis
15. Characterizing immunity to Ebola and Marburg to support medical countermeasure development
16. Human organ chips for radiation countermeasure development
17. FDA and global partners to analyze coronavirus samples
18. Cellular signaling and immune correlates for SARS-CoV-2 infection
19. Expanding next-generation sequencing tools to support pandemic preparedness and response
20. Strengthening coronavirus models with systems biology and machine learning
21. Using real-world evidence to advance COVID-19 medical countermeasures