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  1. MCM Regulatory Science
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BAA funding | Areas of interest | Current projects | Completed projects | Alignment with U.S. MCM priorities

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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, under area 7: Facilitate Development of Medical Countermeasures to Protect Against Threats to U.S. and Global Health and Security.

Proposers are encouraged to submit BAA white papers by 5:00 p.m. ET, January 21, 2022 for FY 2022 award consideration. 

Areas of interest

MCM-related research areas of interest include:

Area 3: Support New Approaches to Improve Product Manufacturing and Quality

Area 7: Facilitate Development and Availability of Medical Countermeasures (MCMs) to Protect Against Threats to U.S. and Global Health and Security

Offerors to Area 7 are encouraged to coordinate with FDA's Office of Counterterrorism and Emerging Threats, via the OAGS point of contact, for any questions or concept discussion prior to submission. 

MCMs include qualified countermeasures as defined in section 319F–1(a)(2)(A) of the Public Health Service Act (PHS Act) (42 USC. § 247d–6a(a))(2)(A); qualified pandemic or epidemic products as defined in section 319F–3(i)(7) of the PHS Act (42 USC. § 247d–6d(i)(7)); and security countermeasures as defined in section 319F-2(c)(1)(B) of the PHS Act (42 USC § 247d–6b(c)(1)(B)).

For more information, please view the full BAA PDF (414 KB).

Current projects

 Project  Awarded To  Dates  Funding Mechanism
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
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
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 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 - April 2023  BAA
Expanding next-generation sequencing tools to support pandemic preparedness and response
Embleema and George Washington University September 2021 - September 2022  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 - August 2022  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

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 2021: Advancing Regulatory Science at FDA: 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 [email protected] with questions about this initiative.


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