Project BioShield Overview

"We refuse to remain idle when modern technology might be turned against us. We will rally the great promise of American science and innovation to confront the greatest danger of our time."
President George W. Bush at the signing of the Project BioShield Act of 2004

Critical Mission for Biodefense

On July 21, 2004, President George W. Bush signed the Project BioShield Act of 2004 (Project BioShield) into law as part of a broader strategy to defend America against the threat of weapons of mass destruction. The purpose of Project BioShield is to accelerate the research, development, purchase, and availability of effective medical countermeasures against biological, chemical, radiological, and nuclear (CBRN) agents. HHS provides Congress with an annual report on its progress in the implementation of Project BioShield.

Project BioShield:

Three Approaches to Biodefense

  • Funding of Needed Countermeasures: Project BioShield institutes a secure funding source for the purchase of critical medical countermeasures, such as vaccines, therapeutics, and diagnostics. Project BioShield authorizes $5.6 billion in funding over 10 years for the advanced development and purchase of priority medical countermeasures. This "Special Reserve Fund" was provided in the FY2004 Department of Homeland Security Appropriations Act and becomes available to the Secretary of Health and Human Services (HHS) for procurements following interagency and White House approval. Within HHS, the Office of the Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response (ASPR) has the procurement authority for Project BioShield acquisitions utilizing the Special Reserve Fund.
  • Facilitating Research and Development: Project BioShield grants the National Institutes of Health/National Institute of Allergy and Infectious Diseases authorities to expedite and simplify the solicitation, review, and award of grants and contracts for the development of critical medical countermeasures.
  • Facilitating the Use of Medical Countermeasures in an Emergency: Project BioShield establishes the Emergency Use Authorization (EUA ) to provide access to the best available medical countermeasures following a Declaration of Emergency by the Secretary of Health and Human Services. The Declaration could be based on either the Secretary's determination of a public health emergency with the significant potential to affect national security, or on a heightened risk of a CBRN attack on the public or U.S. military forces (as determined by the Secretary of Homeland Security or the Secretary of Defense, respectively).

Project BioShield:

Critical Part of the U.S. Biodefense Strategy

Congress seeks to improve our Nation's emergency preparedness with Project BioShield, which provides the government with the ability to develop, acquire, stockpile, and make available the medical countermeasures needed to protect the U.S. population against weapons of mass destruction. The development and availability of medical countermeasures are key components of the President's biodefense strategy, as outlined in Biodefense for the 21st Century.

The three aspects of Project BioShield aim to seamlessly integrate medical countermeasure acquisitions with overall U.S. Government preparedness and emergency response plans. Under Project BioShield, the U.S. Government seeks to make balanced acquisitions of the most urgently needed medical countermeasures, within the constraints of the budget.

In support of this goal, the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Governance Board, which is chaired by the ASPR, is responsible for coordinating the research, development, regulation, procurement, stockpiling, and deployment of medical countermeasures needed to protect the public in the event of a public health emergency. Mission areas include:

  • Defining and prioritizing requirements for public health emergency medical countermeasures
  • Focusing research, development, and procurement activities on the identified requirements, and
  • Establishing deployment and use strategies for medical countermeasures in the Strategic National Stockpile (SNS).

HHS works in close collaboration with key partners, including the Department of Homeland Security and the Department of Defense. HHS, through BARDA and the Office of the Assistant Secretary for Preparedness and Response, executes acquisition programs, utilizing the Special Reserve Fund commensurate with these priorities. HHS also works to promote open communication of U.S. Government needs to industry, an essential partner in Project BioShield. The availability of a substantial, long-term funding source was designed to provide the incentive for industry to respond to U.S. Government requirements and develop critical medical countermeasures for the American public.