Amends the Public Health Service Act to establish the Biomedical Advanced Research and Development Agency (BARDA) within the Department of Health and Human Services (HHS) to coordinate and oversee activities that support and accelerate advanced research and development of qualified countermeasures to exposure to hazardous agents or infectious diseases or qualified pandemic or epidemic products.
Requires the Secretary of HHS, acting through the Director of BARDA, to:
(1) increase appropriate communication between the federal government and relevant industries, academia, and other persons;
(2) conduct continuous searches and support calls for potential countermeasures or products for drugs, biological products, devices, or research tools to diagnose, mitigate, prevent, or treat harm from existing, emerging or possible chemical, biological, radiological, and nuclear agents or potential pandemic infectious diseases that threaten public health and national security;
(3) direct the countermeasure and advanced research and development of HHS;
(4) award contracts, grants, cooperative agreements, and enter into other transactions to support the cost of such research and development and to ensure accelerated development of countermeasures and products;
(5) establish an office within BARDA to facilitate regular and ongoing communication between BARDA and the Food and Drug Administration (FDA) regarding the status of BARDA advanced research and development activities; and
(6) coordinate with the FDA to facilitate regulatory review and approval of promising classes of countermeasures or products through the development of research tools.
Allows the Secretary, acting through the Director, to award contracts, grants, cooperative agreements or enter into other transactions to promote innovation in technologies supporting the advanced research and development and production of qualified or security countermeasures or qualified pandemic or epidemic products.
Allows the Director to submit to the President and Congress an annual budget estimate for qualified countermeasure and pandemic or epidemic product advanced research and development and other BARDA activities.
Allows the Secretary, acting through the Director, to:
(1) support advanced research and development and innovation of potential countermeasures or products by highly qualified persons outside the United States; and
(2) establish one or more federally funded research and development centers or university affiliated research centers.
Allows the Director to:
(1) give priority to supporting and facilitating advanced research and development of countermeasures or products, and formulations of countermeasures or products, that are likely to be safe and effective for pediatric populations, pregnant women, and other vulnerable populations; and
(2) establish working groups to identify innovative technologies that have the potential to be developed as countermeasures or products and to advise the Director on functions.
Requires the Director to establish and convene a Vulnerable Populations Working Group composed of experts on pediatric populations, pregnant women, and other vulnerable populations to advise the Director regarding countermeasures effects on such populations.
Establishes the National Biodefense Advisory Board to provide expert advice and guidance to the Secretary on the threats, challenges, and opportunities presented by advances in biological and life sciences and the threat from natural infectious diseases and chemical, biological, radiological, and nuclear agents.
Establishes the Biodefense Medical Countermeasure Development Fund to be administered by the Director.