Biomedical Advanced Research and Development Authority

The Biomedical Advanced Research and Development Authority (BARDA) is a U.S. Department of Health and Human Services office responsible for procurement and development of countermeasures principally against bioterrorism, but also including chemical, nuclear and radiological threats. BARDA reports to the Office of the Assistant Secretary for Preparedness and Response and manages Project BioShield. BARDA also procures materials, such as vaccines, for the , and more broadly is an established interface between the U.S. Government and the biomedical industry. BARDA also manages the governmental inter-agency Public Health Emergency Medical Countermeasures Enterprise, providing coordination across the government in development and deployment of such countermeasures.

The office was established in 2006 through the Pandemic and All-Hazards Preparedness Act.

BARDA sets for requirements for medical countermeasures in order to reduce the threats of public health emergencies such as pandemic influenza, CBRN threats, and emerging diseases. The requirements tell private industry what is required in order to produce medical countermeasures acceptable for BARDA.

Stakeholders across the federal government and the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) create the requirements. After the requirements are established, they drive BARDA advanced research and development and acquisition. The requirements are created consistent with the planning and prioritization expressed in the HHS PHEMCE Implementation Plan for CBRN Threats.

Pandemic Influenza requirements are defined by strategic objectives established in the "National Strategy for Pandemic Influenza", and the "HHS Pandemic Influenza Plan".

From its inception, BARDA has been committed to creating a robust and dynamic pipeline of medical countermeasures through advanced development of new and improved medical countermeasures. The goal of medical countermeasure development is to provide multiple product candidates in each program to both account for attrition in medical countermeasure development and to establish multi-product/multi-manufacturer portfolios for sustainability and redundancy.

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