The objective of Project BioShield is to accelerate the research, development, procurement, and availability of effective medical countermeasures against biological, chemical, radiological, and nuclear (CBRN) agents.
On July 21, 2004, the President signed into law the Project BioShield Act of 2004 (Project BioShield) 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) threats. HHS provides Congress with an annual report on its progress in the implementation of Project BioShield.
EXPLORE BARDA’s PROGRESS
Project BioShield originally instituted a secure funding source for the purchase of critical medical countermeasures, such as vaccines, therapeutics, and diagnostics. Project BioShield authorized $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 became 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) had the procurement authority for Project BioShield acquisitions utilizing the Special Reserve Fund.
Today, funds to implement Project Bioshield activities are provided to BARDA on a yearly basis through annual appropriations.
Explore the CBRN Portfolio
Project Bioshield gave BARDA PHEMCE partners new authorities, including granting 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.
Project BioShield authorizes the Food and Drug Administration to grant Emergency Use Authorizations (EUA) to medical countermeasures following a public health emergency declaration 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).
Learn About BARDA’s Impact in COVID-19 Response
Project BioShield originally instituted a secure funding source for the purchase of critical medical countermeasures, such as vaccines, therapeutics, and diagnostics. Project BioShield authorized $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 became 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) had the procurement authority for Project BioShield acquisitions utilizing the Special Reserve Fund.
Today, funds to implement Project Bioshield activities are provided to BARDA on a yearly basis through annual appropriations.
Explore the CBRN Portfolio
Project Bioshield gave BARDA PHEMCE partners new authorities, including granting 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.
Project BioShield authorizes the Food and Drug Administration to grant Emergency Use Authorizations (EUA) to medical countermeasures following a public health emergency declaration 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).
Learn About BARDA’s Impact in COVID-19 ResponseCBRN has a proven track record of developing life-saving medical countermeasures. We will continue to work with partners old and new to treat or prevent the medical consequences that result from CBRN threats.
