Determination. 

## SEC. 404. PREPARING FOR PANDEMIC INFLUENZA, ANTIMICROBIAL RESISTANCE, AND OTHER SIGNIFICANT THREATS. 

(a) STRATEGIC INITIATIVES.—Section 319L(c)(4) (247d–7e(c)(4)) is amended by adding at the end the following: 

(b) PROTECTION OF NATIONAL SECURITY FROM THREATS.—Sec- tion 2811 (42 U.S.C. 300hh–10) is amended by adding at the end the following: 

‘‘(f) PROTECTION OF NATIONAL SECURITY FROM THREATS.— 

‘‘(1) IN GENERAL.—In carrying out subsection (b)(3), the Assistant Secretary for Preparedness and Response shall imple- ment strategic initiatives or activities to address threats, including pandemic influenza and which may include a chem- ical, biological, radiological, or nuclear agent (including any such agent with a significant potential to become a pandemic), that pose a significant level of risk to public health and national 

‘‘(F) STRATEGIC INITIATIVES.—The Secretary, acting through the Director of BARDA, may implement strategic initiatives, including by building on existing programs and by awarding contracts, grants, and cooperative agreements, or entering into other transactions, to support innovative candidate products in preclinical and clinical development that address priority, naturally occurring and man-made threats that, as determined by the Secretary, pose a signifi- cant level of risk to national security based on the characteristics of a chemical, biological, radiological or nuclear threat, or existing capabilities to respond to such a threat (including medical response and treatment capabilities and manufacturing infrastructure). Such initia- tives shall accelerate and support the advanced research, development, and procurement of countermeasures and products, as applicable, to address areas including— 

‘‘(i) chemical, biological, radiological, or nuclear threats, including emerging infectious diseases, for which insufficient approved, licensed, or authorized countermeasures exist, or for which such threat, or the result of an exposure to such threat, may become resistant to countermeasures or existing counter- measures may be rendered ineffective; 

‘‘(ii) threats that consistently exist or continually circulate and have a significant potential to become a pandemic, such as pandemic influenza, which may include the advanced research and development, manu- facturing, and appropriate stockpiling of qualified pan- demic or epidemic products, and products, technologies, or processes to support the advanced research and development of such countermeasures (including multiuse platform technologies for diagnostics, vac- cines, and therapeutics; virus seeds; clinical trial lots; novel virus strains; and antigen and adjuvant mate- rial); and 

‘‘(iii) threats that may result primarily or second- arily from a chemical, biological, radiological, or nuclear agent, or emerging infectious diseases, and which may present increased treatment complications such as the occurrence of resistance to available countermeasures or potential countermeasures, including antimicrobial resistant pathogens.’’. 

