Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                MCM Regulatory Science

MCM Regulatory Science

                        Animal Rule Information
          Extramural Research
          Intramural Research
          MCMi Regulatory Science Presentations
          Regulatory Science Research Tools Home
          Emergency Preparedness and Response
          Counterterrorism and Emerging Threats
          Medical Countermeasures Initiative (MCMi)
          MCM Regulatory Science
          Extramural ResearchMCM Regulatory Science Extramural Research
  
  					FDA funds medical countermeasure regulatory science to develop tools, standards, and approaches to assess MCM safety, efficacy, quality, and performance
	
    Subscribe to Email Updates
    Share
    Post
    Linkedin

    Email
    PrintImage
              Photo montage of clipart that includes a microscope, viles, and test tubesBAA 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: FY23 FDA BAA for Advanced Research and Development of Regulatory Science*

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 MechanismCharacterizing immunity to Ebola and Marburg to support medical countermeasure development
			University of California, Los Angeles (UCLA) School of Public Health
			September 2019 -  September 2023
			BAAHuman 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 - September 2023
			BAAFDA 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
			BAACellular 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
			BAAExpanding next-generation sequencing tools to support pandemic preparedness and response
			Embleema and George Washington University
			September 2021 - September 2025
			BAAStrengthening coronavirus models with systems biology and machine learning
			Commonwealth Scientific and Industrial Research Organisation (CSIRO), Australia
			September 2021 – September 2026
			BAAUsing real-world evidence to advance COVID-19 medical countermeasures
			Aetion
			September 2021 - September 2023
			BAAPediatric disease modeling for long COVID
			Children’s Hospital Los Angeles
			June 2022 - June 2024
			BAA

Completed projects

Project
			Awarded To
			Dates
			Funding MechanismAdverse Events Monitoring and Analysis Pilot Program
			MITRE Corporation
			September 2013 - March 2015
			FFRDCCross-Species Immune System Reference
			Stanford University
			October 2012 - June 2016
			BAAEnsuring Appropriate Public Use of Medical Countermeasures through Effective Emergency Communication
			University of Pittsburgh Medical Center - UPMC Center for Health Security
			June 2014 - June 2016
			BAAInvestigating Decontamination and Reuse of Respirators in Public Health Emergencies
			Battelle Memorial Institute
			August 2014 - July 2016
			BAACompanion Studies to Define the Distribution and Duration of Zika Virus in Non-Human Primates
			University of California, Davis
			October 2016 - April 2017
			FDA Contract: HHSF223201610542PSupporting Field Laboratory Testing of Ebola Antibodies in Sierra Leone
			National Institute for Infectious Diseases “Lazzaro Spallanzani” (INMI)
			September 2015 - September 2018
			BAAOrgans-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
			BAAOptimizing Respirator Decontamination to Ensure Supplies for Emergency Preparedness
			Applied Research Associates, Inc. (ARA)
			September 2014 - September 2019
			BAAMelioidosis Modeling: Research to Support Countermeasures for a Tricky Pathogen
			Defence Science and Technology Laboratory (Dstl)
			September 2015 - September 2019
			BAADeveloping 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
			BAAAssessing 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: 75F40120P00531U.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
			BAASurvivor 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
			BAAComparison 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*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.

                                                                                  Content current as of:
      10/17/2023
              
              
Topic(s)
			  ResearchMCM Regulatory Science

          
                        Animal Rule Information
          Extramural Research
          Intramural Research
          MCMi Regulatory Science Presentations
          Regulatory Science Research Tools
 Subscribe
                        Sign up to receive email alerts on emergency preparedness and response topics from FDA, including regulatory science related to medical countermeasures and emerging infectious diseases.
    Enter your email address to subscribe:
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop