PROJECT BIOSHIELD

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.

CREATION OF PROJECT BIOSHIELD

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.

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Funding of Needed Countermeasures

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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.

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Facilitating Research and Development

Facilitating Research and Development

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.

Facilitating Use of Medical Countermeasures in Emergencies

Facilitating Use of Medical Countermeasures in Emergencies

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).

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CBRN 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.

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 United States Government’s biodefense strategy. 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 Assistant Secretary for Preparedness and Response (ASPR), executes acquisition programs leveraging unique authorities under project Bioshield to develop and stockpile medical countermeasures. BARDA also works to promote open communication of U.S. Government needs to industry, by engaging with our partners through the TechWatch meeting forum, annual BARDA Industry Day and scientific conferences. The Project Bioshield authority and subsequent funding demonstrates USG substantial and long-term funding commitment to supporting medical countermeasures development and stockpiling. Project Bioshield has proven successful, demonstrated by the substantial number of FDA Approvals since inception, and has been a critical incentive to mobilize industry partners to development new medical countermeasures to save lives.
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Celebrating 61 FDA Approvals, Licensures, and Clearances for Medical Countermeasures. Supported by BARDA under Novel Public Private Partnerships.
Saving Lives, Protecting Americans.

Historical Project BioShield Annual Reports

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