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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

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 were encouraged to submit white papers by March 29, 2019 for fiscal year (FY) 2019 awards. This information will be updated soon for FY 2020.

Areas of interest

MCM-related research areas of interest include:

  • 7.1 Develop, characterize, and qualify tools to support MCM development under the Animal Rule or accelerated approval provisions
  • 7.2 Modernize tools to evaluate MCM product safety, efficacy, and quality; and improve/ensure MCM supply chain

For more detail on these areas, please view the full BAA PDF (648 KB). MCM research areas of interest descriptions begin on page 24.

Current projects

 Project  Awarded To  Dates  Funding Mechanism
Developing a Toolkit to Assess Efficacy of Ebola Vaccines and Therapeutics Public Health England (PHE) September 2015 - September 2020  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) and apply new technologies (September 2019) Stanford University School of Medicine May 2016 - May 2021  BAA
Comparison of Host Responses to Ebola Virus Disease (EVD) Public Health England (PHE) October 2017 - October 2020  BAA
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  Broad Institute of MIT and Harvard November 2018 - October 2020  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 2020  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
Hybrid Genome Sequencing and Assembly of Bacterial Pathogens Using Emerging Innovative Technologies [ARCHIVED] University of Maryland School of Medicine September 2013 - September 2017  BAA
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 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

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)

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