Amends the Public Health Service Act to require the Secretary of Health and Human Services to develop and make public a strategic plan to integrate biodefense and emerging infectious disease requirements with advanced research and development, strategic initiatives for innovation, and the procurement of qualified countermeasures and qualified pandemic or epidemic products.
Establishes the Biomedical Advanced Research and Development Authority (BARDA) within the Department of Health and Human Services (HHS). Requires the Secretary to coordinate the acceleration of countermeasure and product advanced research and development.
Requires the Secretary to:
(1) facilitate and increase expeditious and direct communication with respect to such research and development;
(2) conduct ongoing searches for, and support calls for, potential qualified countermeasures and qualified pandemic or epidemic products;
(3) direct and coordinate such research and development activities of HHS;
(4) establish strategic initiatives to accelerate such research and development and innovation in priority unmet need areas; and
(5) connect interested persons with authorized offices or employees to advise such persons regarding relevant regulatory requirements related to qualified countermeasures or qualified pandemic or epidemic products.
Allows the Secretary to award contracts, grants, and cooperative agreements or enter into other transactions to promote:
(1) innovation in technologies that may assist such research and development;
(2) research on and development of research tools and other devices and technologies; and
(3) research to promote strategic initiatives, such as rapid diagnostics, broad spectrum antimicrobials, and vaccine manufacturing technologies.
Authorizes the Secretary to enter into other transactions for countermeasure and product advanced research and development in the same manner as the Secretary of Defense. Limits such authority for certain prototype projects and by requiring a written determination for projects that exceed certain costs.
Requires the Secretary to establish guidelines regarding such authority.
Gives the Secretary expedited procurement authorities, the authority to expedite peer review, and the authority for personal services contracts.
Directs the Secretary to require that, as a condition of being awarded a contract, grant, cooperative agreement, or other transaction, a person make available to the Secretary all data related to or resulting from such research and development.
Authorizes the Secretary to waive advertising and advance payment requirements if such waiver is necessary to obtain countermeasures or products.
Allows the Secretary to:
(1) use milestone-based awards and payments;
(2) make awards to and enter into transactions with highly qualified foreign national persons outside the United States;
(3) establish one or more federally-funded research and development centers or university-affiliated research centers if it is not feasible or appropriate to establish an arrangement with an existing research center;
(4) give priority to the advanced research and development of qualified countermeasures and qualified pandemic or epidemic products that are likely to be safe and effective with respect to children, pregnant women, the elderly, and other at-risk individuals;
(5) appoint highly qualified individuals to scientific or professional positions in BARDA without regard to federal provisions governing appointments in the competitive service; and
(6) appoint special consultants.
Establishes the Biodefense Medical Countermeasure Development Fund to carry out this section.
Requires the Secretary to withhold from disclosure under the Freedom of Information Act specific technical data or scientific information that is created or obtained during the countermeasure and product advanced research and development carried out under this section that reveals significant and not otherwise known vulnerabilities of existing medical or public health defenses against biological, chemical, nuclear, or radiological threats.