Extramural Research
FDA funds medical countermeasure regulatory science to develop tools, standards, and approaches to assess MCM safety, efficacy, quality, and performance
BAA funding | Areas of interest | Current projects | Completed projects | Alignment with U.S. MCM priorities
To help develop solutions to complex regulatory science challenges, FDA funds medical countermeasure (MCM)-related regulatory science through intramural and extramural research grants.
Our goal is to help develop the tools, standards, and approaches to assess MCM safety, efficacy, quality, and performance and to help translate cutting-edge science and technology into innovative, safe, and effective MCMs.
BAA funding
FDA has established a robust extramural research portfolio under the Medical Countermeasures Initiative (MCMi) regulatory science program. Extramural MCM regulatory science is primarily funded through a Broad Agency Announcement (BAA) for research and development to support regulatory science and innovation. See: Regulatory Science Extramural Research and Development Projects: FDA Broad Agency Announcement (BAA)
The FDA Office of Acquisitions and Grants Services (OAGS) will be hosting the FY24 BAA Day on October 25, 2023. A tentative agenda is available and will include a presentation on the MCMi Extramural Research Program. For those unable to connect to the event, slides and recordings will be made available later in the fiscal year. Also see: FDA BAA Questions & Answers
Areas of interest
MCM-related research areas of interest include modernizing development and evaluation of FDA-regulated products (e.g., advanced manufacturing approaches, alternative methods, and biomarkers), and invigorating public health preparedness and response.
For more information, please view the full BAA PDF (833 - KB link updated). Potential offerors are strongly encouraged to review the BAA timelines (59 - KB); for consideration in FY2024, Stage 1 submissions are due by 5:00 p.m. EST, February 19, 2024.
Current projects
| Project | Awarded To | Dates | Funding Mechanism |
|---|---|---|---|
| Characterizing immunity to Ebola and Marburg to support medical countermeasure development | University of California, Los Angeles (UCLA) School of Public Health | September 2019 - September 2023 | BAA |
| FDA and global partners to analyze coronavirus samples Study expanded to add characterization of SARS-CoV-2 (including variants of concern) pathogenesis and disease severity in humans and animal models (August 2021) |
University of Liverpool | September 2020 - September 2025 | BAA |
| Cellular signaling and immune correlates for SARS-CoV-2 infection Study expanded to research diversity of immune responses across clinical populations (September 2021) |
Stanford University School of Medicine | October 2020 - September 2024 | BAA |
| Expanding next-generation sequencing tools to support pandemic preparedness and response |
Embleema and George Washington University | September 2021 - September 2025 | BAA |
| Strengthening coronavirus models with systems biology and machine learning | Commonwealth Scientific and Industrial Research Organisation (CSIRO), Australia | September 2021 – September 2026 | BAA |
| Using real-world evidence to advance COVID-19 medical countermeasures | Aetion | September 2021 - September 2023 | BAA |
| Pediatric disease modeling for long COVID | Children’s Hospital Los Angeles | June 2022 - June 2024 | BAA |
Completed projects
| Project | Awarded To | Dates | Funding Mechanism | |
|---|---|---|---|---|
| Adverse Events Monitoring and Analysis Pilot Program | MITRE Corporation | September 2013 - March 2015 | FFRDC | |
| Cross-Species Immune System Reference | Stanford University | October 2012 - June 2016 | BAA | |
| Ensuring Appropriate Public Use of Medical Countermeasures through Effective Emergency Communication | University of Pittsburgh Medical Center - UPMC Center for Health Security | June 2014 - June 2016 | BAA | |
| Investigating Decontamination and Reuse of Respirators in Public Health Emergencies | Battelle Memorial Institute | August 2014 - July 2016 | BAA | |
| Companion Studies to Define the Distribution and Duration of Zika Virus in Non-Human Primates | University of California, Davis | October 2016 - April 2017 | FDA Contract: HHSF223201610542P | |
| Supporting Field Laboratory Testing of Ebola Antibodies in Sierra Leone | National Institute for Infectious Diseases “Lazzaro Spallanzani” (INMI) | September 2015 - September 2018 | BAA | |
| Organs-On-Chips for Radiation Countermeasures Study expanded to analyze differences in sex-specific responses to radiation in September 2018 |
Wyss Institute for Biologically Inspired Engineering at Harvard University | September 2013 - April 2019 | BAA (2013) and FDA Contract: HHSF223201820398A/0001 (2018) | |
| Streamlining Countermeasure Data Collection During Public Health Emergencies (Discovery, the Critical Care Research Network) | University of Southern California | September 2014 - September 2019 | BAA | |
| Optimizing Respirator Decontamination to Ensure Supplies for Emergency Preparedness | Applied Research Associates, Inc. (ARA) | September 2014 - September 2019 | BAA | |
| Melioidosis Modeling: Research to Support Countermeasures for a Tricky Pathogen | Defence Science and Technology Laboratory (Dstl) | September 2015 - September 2019 | BAA | |
| Developing a Toolkit to Assess Efficacy of Ebola Vaccines and Therapeutics Study expanded to apply technology used for the Ebola project to gather important information about COVID-19 infection (March 2020) |
Public Health England (PHE) | September 2015 - March 2021 | BAA | |
| Assessing the Role of Additive Manufacturing in Support of the U.S. COVID-19 Response | National Center for Defense Manufacturing and Machining (America Makes) | September 2020 - February 2021 | FDA Contract: 75F40120P00531 | |
| U.S. Department of Defense and FDA collaborate to help speed potential countermeasures for Ebola and other viruses | U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) | September 2018 - September 2021 | Interagency Agreement (IAA) | |
| A new approach for understanding Ebola virus pathogenesis Study expanded to apply technology used for the Ebola project to gather important information about COVID-19 infection (March 2021) |
Broad Institute of MIT and Harvard | November 2018 - September 2021 | BAA | |
| Survivor Studies: Better Understanding Ebola's After-Effects to Help Find New Treatments Study expanded to include investigation of Zika virus disease (September 2017), apply new technologies (September 2019), and development and evaluation of potential medical countermeasures for COVID-19 (March 2020) |
Stanford University School of Medicine | May 2016 - June 2022 | BAA | |
| Comparison of Host Responses to Ebola Virus Disease (EVD) Study expanded to apply technology used for the Ebola project to gather important information about COVID-19 infection (March 2020) |
UK Health Security Agency (formerly Public Health England) | October 2017 - October 2022 | BAA | |
| Human organ chips for radiation countermeasure development Study expanded to add development of new organs-on-chips to aid development and evaluation of countermeasures for COVID-19 (September 2021) |
Wyss Institute for Biologically Inspired Engineering at Harvard University | September 2019 - March 2024 | BAA |
View FDA BAA awards in other research areas
Alignment with U.S. MCM priorities
To ensure that funded research aligns with Public Health Emergency Medical Countermeasures Enterprise priorities, FDA established a Steering Committee for Advancing MCMi Regulatory Science.
Representatives evaluate MCMi Regulatory Science Program research proposals for scientific/technical merit and feasibility and alignment with U.S. MCM priorities. In addition to FDA, members include:
- National Institutes of Health (NIH)
- Centers for Disease Control and Prevention (CDC)
- Biomedical Advanced Research and Development Authority (BARDA)
- U.S. Department of Defense (DoD)
FDA Focus Areas of Regulatory Science
The Focus Areas of Regulatory Science (FARS) report outlines topics FDA has identified as needing continued targeted investment in regulatory science research to facilitate development of innovative products, provide data and methods to inform regulatory decision-making, and improve guidance to sponsors. Public health preparedness and response is a focus area, including medical countermeasures and preparedness for emerging infectious diseases. Please contact FARS@fda.hhs.gov with questions about this initiative.