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  1. Office of the Chief Medical Officer

Office of Public Health Preparedness and Response Also referred to as: OPHPR

What We Do 

The Office of Public Health Preparedness and Response (OPHPR), in the Office of the Chief Medical Officer (OCMO), provides leadership, coordination, and oversight for FDA’s national and global public health preparedness and response portfolios including consumer safety reporting, health emergencies, and medical product and critical food shortages and applicable supply chain issues. 

Major Functions 

  • Develops and coordinates the implementation of FDA plans and strategies and serves as the FDA primary focal point for the above portfolios in support of, and collaboration with, FDA centers and offices, and with external U.S. Government and international partners. 

  • Oversees central governance structures, protocols, and coordination for consumer and public safety and concern reporting, including, as relevant, assuring that intake systems and triage systems operate efficiently and consistently; coordinating the business process alignment and development for any new consumer safety reporting management technology systems; and coordinating preparedness and response to consumer-related health safety signals that involve multiple centers or otherwise require an agency response. 

  • Serves as the primary focal point, on behalf of the Commissioner, for the Department of Health and Human Services’ Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) to protect the civilian population and the Department of Defense medical countermeasure (MCM) programs to support the warfighter. 

  • Coordinates policy and the FDA activities to prepare for and respond to public health emergencies. This includes internal collaborations with medical product centers, U.S. government partners such as the White House, HHS and DOD, well as with other entities, such as non-governmental and international entities. 

  • Develops and coordinates the implementation of crosscutting FDA policies and procedures to facilitate the availability and assessment of MCMs including efforts to enable access to available MCMs when necessary, through an appropriate mechanism, such as an Emergency Use Authorization, and assess MCM safety and effectiveness post-administration. 

  • Coordinates FDA-level policy engagement to prevent, detect and respond to medical product shortages. Coordinates activities within the FDA, working closely with center leads; serves as primary focal point for shortage coordination with Health and Human Services (HHS) and the White House. 

  • Promotes the goals and needs for the above portfolios in the FDA budgeting and priority-setting processes. 

  • Facilitates communication within the FDA and with external partners on matters related to the above portfolios on behalf of the Office of the Commissioner. 

Contact Us

Office of Public Health Preparedness and Response 
U.S. Food and Drug Administration 
10903 New Hampshire Ave, WO-32 
Silver Spring, MD 20993 

AskMCMi@fda.hhs.gov  



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