MCM-Related Cooperative Arrangements

FDA and the Medical Countermeasures Initiative use a variety of cooperative arrangements to further development and availability of medical countermeasures (MCMs). These include Memoranda of Understanding and Confidentiality Commitments. Current arrangements are listed below by category, then by effective date, with the newest first in each list.

Memoranda of Understanding (MOUs)

• FDA and the Veterans Health Administration (VHA) [MOU 225-23-008]
  May 10, 2023: To provide a framework for collaboration to facilitate the development of requirements for trusted networks needed to help enable the use of distributed manufacturing and digital stockpiles to protect public health by promoting supply chain resilience during emergencies, shortages, and pandemics.
• FDA, the CDC National Institute for Occupational Safety and Health (NIOSH), and the Occupational and Safety Health Administration (OSHA) [MOU 225-22-026]
  April 12, 2023: To provide a framework for continued collaboration, including the sharing of certain information to facilitate coordination, decision-making, law enforcement activities, and guidance or regulation development through the agencies’ respective authorities and overlapping missions.  
• FDA and the National Center for Advancing Translational Sciences (NCATS) at NIH [MOU 225-23-003]
  January 12, 2023: To provide a framework between NCATS and FDA for coordination and collaborative efforts towards widespread use of microphysiological systems (MPS) in advancing novel therapies that are safe and effective, and in biomedical research for understanding pathophysiology and modeling of human diseases/conditions.  
• FDA, the Centers for Disease Control and Prevention (CDC), and several stakeholders [MOU 225-22-020] 
  May 6, 2022: To collaborate on enhancing laboratory testing surge capacity outside of CDC and public health laboratories before and during public health emergencies. Partnerships and engagement between the public and private sector are crucial to supporting a significant increase in demand for diagnostic testing during a public health emergency and to respond to emerging public health threats before reaching the level of a pandemic.
• FDA, the National Institutes of Health (NIH), and the Animal and Plant Health Inspection Service (APHIS), U.S. Department of Agriculture (USDA) [MOU 225-16-010]
  June 24, 2021: MOU renewal, to set forth a framework for reciprocal cooperation which will assist each agency in meeting its responsibilities in promoting proper laboratory animal care and welfare. The original MOU was signed in 2016. 
• FDA and the National Institute of Standards and Technology (NIST) [MOU 225-21-006]
  January 15, 2021: To collaborate to increase U.S. medical supply chain resilience and advance domestic manufacturing of pharmaceuticals, biopharmaceuticals, and medical devices through adoption of 21st century manufacturing technologies including smart technologies, emerging manufacturing processes, and artificial intelligence and machine learning.
• FDA, US Army Medical Research and Materiel Command [MOU 225-20-010]
  April 17, 2020: To establish a training program in the form of an inter-agency detail to support their shared interests in the training of scientific and medical personnel in medical product development and FDA’s regulatory processes.
• FDA, National Institutes of Health (NIH) , and Veterans Health Administration (VA) [MOU 225-20-008]
  March 27, 2020: To share data, and coordinate on open-source medical products for the COVID-19 response with other stakeholders such as America Makes.
• FDA and the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) [MOU 225-19-013]
  April 10, 2019: MOU renewal, to provide a framework for coordination and collaborative efforts related to the development and availability of MCMs in public health medical emergencies. The original MOU was signed in 2012.
• FDA and the Department of Defense (DoD) [MOU 225-19-001]
  November 2, 2018: To establish the framework under which DoD and FDA will implement the 2017 law for enhanced engagements to facilitate the development and availability of safe and effective medical products that serve the military’s needs.
• FDA and the National Aeronautics And Space Administration (NASA) [MOU 225-18-027]
  September 26, 2018: To provide mutual support to biomedical research on drugs, biologics, and medical devices and for medical countermeasure development.
• FDA and the CDC National Institute for Occupational Safety and Health (NIOSH) [MOU 225-18-006]
  November 29, 2017: Provides a framework for coordination and collaboration between the agencies relating to regulation of surgical N95 respirators and N95 filtering facepiece respirators (FFRs) used in healthcare settings.
• FDA and the Bill and Melinda Gates Foundation [MOU 225-17-019]
  June 27, 2017: Establishes a framework to facilitate collaboration to carry out common goals to improve public health by stimulating and fostering medical product innovation and enabling medical product development, including medical countermeasures.
• FDA and the Defense Advanced Research Projects Agency (DARPA) [MOU 225-17-015]
  June 1, 2017: Promotes collaboration between FDA and DARPA, and provides a mechanism for the sharing of certain nonpublic information. (Replaces MOU 225-12-0037 [2012])
• FDA and the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the Office of the Secretary for Preparedness and Response (ASPR)/Biomedical Advanced Research and Development Authority (BARDA), HHS [MOU 225-16-018]
  May 19, 2016: For development of innovative technologies to identify antimicrobial-resistant bacteria.
• FDA and the Centers for Disease Control and Prevention (CDC) [MOU 225-16-008]
  February 19, 2016: Establishes a framework for the agencies’ coordination in support of CDC’s use of its delegated authority to develop and issue emergency use instructions (EUI) for eligible medical countermeasures.
• FDA and the HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) [MOU 225-13-028]
  March 11, 2014: Establishes a framework to promote efficiency and collaboration between FDA and PHEMCE partners to meet needs for issues related to safety, efficacy and use of drugs, biologics and medical devices for use in emergencies.

International Confidentiality Commitments - Current and Potential Public Health Emergencies

• FDA and the European Medicines Agency and DG SANTE (from FDA)
  August 23, 2017: New commitment allows FDA and European Commission/EMA to share full inspection reports as part of cooperative law enforcement or cooperative regulatory activities.
• FDA and the European Medicines Agency and DG SANTE (from EMA and DG SANTE)
  August 23, 2017: New commitment allows FDA and European Commission/EMA to share full inspection reports as part of cooperative law enforcement or cooperative regulatory activities.
• FDA and the World Health Organization Department of Essential Medicines and Health Products (WHO EMP)
  August 25, 2014: To help facilitate communications regarding an actual or potential public health (PH) crisis or PH emergency of international concern; allows sharing of information that is non-public but important to address public health emergencies.

International Confidentiality Commitments - 2014-2015 Ebola Epidemic in West Africa

• FDA and the Ministry of Public Health and Hygiene of Guinea
  September 1, 2015: To help facilitate communications between the two agencies on medical products used, or proposed to be used, for Ebola-related purposes as part of cooperative regulatory activities.
• FDA and the Pharmacy Board of Sierra Leone (PBSL)
  March 18, 2015: To help facilitate communications between FDA and the PBSL on medical products used, or proposed to be used, for Ebola-related purposes as part of cooperative regulatory activities.
• FDA and the Liberian Medicines and Health Products Regulatory Authority (LMHRA)
  February 3, 2015: To help facilitate communications between FDA and the LMHRA on medical products used, or proposed to be used, for Ebola-related purposes as part of cooperative regulatory activities.

Other International Arrangements - 2014-2015 Ebola Epidemic in West Africa

• International Coalition of Medicines Regulatory Authorities (ICMRA) - Statement [ARCHIVED]
  September 4, 2014: Medicines regulators to work together internationally to find innovative solutions to facilitate evaluation of and access to potential new medicines to counter Ebola outbreaks.

International Confidentiality Commitments - Middle East Respiratory Syndrome Coronavirus

• FDA and the Saudi Food and Drug Authority (SFDA)
  October 20, 2015: To help facilitate communications between the two agencies on medical products used, or proposed to be used, for Middle East Respiratory Syndrome Coronavirus (MERS-CoV) as part of cooperative regulatory activities.

Joint Statement of Continued Cooperation Between FDA and ANVISA, Zika Virus Disease

• FDA and the Brazilian Health Regulatory Agency (ANVISA) [ARCHIVED]
  April 11, 2016: Statement of Continued Cooperation Between FDA and ANVISA - Zika Virus Disease

Related Links

• MCMi Collaborations
• More FDA Memoranda of Understanding (MOUs)
• More FDA Confidentiality Commitments
• About FDA's International Arrangements