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U.S. Department of Health and Human Services

PHEMCE Mission Components

The PHEMCE mission is to advance national preparedness for natural, accidental, and intentional threats by coordinating medical countermeasure-related efforts within HHS and in cooperation with PHEMCE interagency partners.
 
This is a complex mission space and many Federal agencies have responsibilities that are critical to its success. The PHEMCE is led by the Assistant Secretary for Preparedness and Response (ASPR). Core HHS members are the Director for the Centers for Disease Control and Prevention (CDC), the Director of the National Institute of Allergy and Infectious Disease  (NIAID) within the National Institutes of Health (NIH), and the Commissioner of the Food and Drug Administration (FDA). Key PHEMCE interagency partners include senior leadership from the Department of Veterans Affairs (VA), the Department of Defense (DoD), the Department of Homeland Security (DHS), and the U.S. Department of Agriculture (USDA). In addition to these Federal agencies, the PHEMCE works closely with a variety of non-Federal partners including State, local, tribal and territorial governments, public health systems, academia, private industry, and ultimately the American people.
 
This figure describes the Department of Health and Human Services (HHS) Public Health Emergency Medical Countermeasure Enterprise (PHEMCE), its mission components, the HHS and non-HHS partner agencies that have leadership roles in those mission components.   The PHEMCE mission space is divided into eight mission components.   1. “Requirements setting”: the Assistant Secretary for Preparedness and Response (ASPR) is identified as the HHS lead and the Department of Homeland Security (DHS) is identified as the non-HHS lead.    2. “Early Stage Research”: the National Institutes of Health (NIH) is identified as the HHS lead and both USDA and DoD are identified as non-HHS.   3. “Advanced Development / Manufacturing”: the Biomedical Advanced Research and Development Authority within ASPR (ASPR/BARDA) is identified as the HHS lead and both the U.S. Department of Agriculture (USDA) and the Department of Defense (DoD) are identified as non-HHS leads.   4. “Regulatory Science Management”: the Food and Drug Administration (FDA) is identified as the HHS lead and there are no non-HHS leads identified.   5. “Procurement / Inventory Management / Stockpiling”: both the Centers for Disease Control and Prevention (CDC) and ASPR/BARDA are identified as HHS leads and there are no non-HHS leads identified.   6. “Response Planning, Policy, Guidance and Communication”: both CDC and ASPR are identified as HHS leads, and both DoD and the Department of Veterans Affairs (VA) are identified as non-HHS leads.   7. “Deployment / Distribution / Dispensing / Administration”: ASPR is identified as the HHS lead and VA is identified as the non-HHS lead.   8. “Monitoring / Evaluation / Assessment”, both FDA and CDC are identified as HHS leads and no non-HHS leads are identified.  In addition, surrounding these mission components and lead agencies there are a number of non-federal stakeholders including the American public, State, Local, Tribal and Territorial Entities (SLTT), Private Industry, Academia, and Professional Societies.
 
The mission components include:
 
  • Requirements Setting: The PHEMCE is responsible for establishing requirements for civilian medical countermeasures based on many factors, including threat and risk assessments. DHS is the lead in conducting the threat and risk assessments that are leveraged in PHEMCE requirements setting. ASPR leads the requirements-setting process with engagement from all PHEMCE partners and expert inputs, including medical consequence and public health response assessments. 
  • Early Stage Research: NIH conducts and supports basic research to better understand threats of civilian public health concern. This research provides the foundation for developing medical products and strategies to diagnose, treat, and prevent a wide range of threats. DoD and USDA also conduct early stage research that is pertinent to the PHEMCE mission. 
  • Advanced Development/Manufacturing: ASPR/BARDA is the lead PHEMCE partner supporting advanced development and scale up of manufacturing capacity for medical countermeasures, including promoting partnerships with developers and manufacturers. DoD and USDA also conduct advanced development that is coordinated and leveraged through the PHEMCE.
  • Regulatory Science Management: The PHEMCE conducts regulatory science  to facilitate medical countermeasure development, regulatory assessment, and use. The FDA is the lead agency charged with ensuring medical countermeasures are safe and effective. Activities conducted in support of this mission component intersect with many other mission components in product development and utilization. 
  • Procurement / Inventory Management / Stockpiling: The PHEMCE oversees the procurement of medical countermeasures and their associated inventory management, including stockpiling. Both the CDC and ASPR/BARDA have lead roles in procuring medical countermeasures for stockpiling. The CDC leads the procurement and maintenance of commercially available medical countermeasures for stockpiling in the Strategic National Stockpile (SNS). BARDA procures certain medical countermeasures for the SNS using the Special Reserve Fund (SRF) authorized under the Project BioShield Act of 2004. DoD and the Department of Veterans’ Affairs may also serve as needed in planning or executing stockpiling options.
  • Response Planning, Policy, Guidance and Communication: The CDC and ASPR coordinate the development of Federal response plans, policy, guidance, and communication, and develop clinical utilization and allocation strategies as appropriate for medical countermeasures and assets. DoD, DHS, and VA are key PHEMCE partners in this mission component.
  • Deployment / Distribution / Dispensing / Administration: The CDC and ASPR coordinate interactions with State, local, tribal, territorial (SLTT), and private entities to provide timely and effective deployment, distribution, dispensing, and administration of medical countermeasures in an emergency. The VA is a key PHEMCE partner in this mission component.
  • Monitoring / Evaluation / Assessment: The CDC and FDA lead efforts to monitor safety and performance of deployed medical countermeasures during and after an emergency response. Other PHEMCE partners such as NIH can provide additional capability for clinical trials management or other support roles in evaluation of safety and performance.

 

     

  • This page last reviewed: February 27, 2015