Sec. 404. PREPARING FOR PANDEMIC INFLUENZA, ANTIMICROBIAL RESISTANCE, AND OTHER SIGNIFICANT THREATS
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## 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: > > ##### “(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 significant 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 initiatives 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 countermeasures 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, manufacturing, and appropriate stockpiling of qualified pandemic or epidemic products, and products, technologies, or processes to support the advanced research and development of such countermeasures (including multiuse platform technologies for diagnostics, vaccines, and therapeutics; virus seeds; clinical trial lots; novel virus strains; and antigen and adjuvant material); and > > > ###### “(iii) > > threats that may result primarily or secondarily 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.” > . ###
(b)Protection of National Security From Threats Section 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 implement strategic initiatives or activities to address threats, including pandemic influenza and which may include a chemical, 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 security based on the characteristics of such threat. Such initiatives shall include activities to— > > > ##### “(A) > > accelerate and support the advanced research, development, manufacturing capacity, procurement, and stockpiling of countermeasures, including initiatives under section 319L(c)(4)(F); > > > ##### “(B) > > support the development and manufacturing of virus seeds, clinical trial lots, and stockpiles of novel virus strains; and > > > ##### “(C) > > maintain or improve preparedness activities, including for pandemic influenza. > > > #### “(2) Authorization of appropriations > > > ##### “(A) In general > > To carry out this subsection, there is authorized to be appropriated $250,000,000 for each of fiscal years 2019 through 2023. > > > ##### “(B) Supplement, not supplant > > Amounts appropriated under this paragraph shall be used to supplement and not supplant funds provided under sections 319L(d) and 319F-2(g). > > > ##### “(C) Documentation required > > The Assistant Secretary for Preparedness and Response, in accordance with subsection (b)(7), shall document amounts expended for purposes of carrying out this subsection, including amounts appropriated under the heading ‘Public Health and Social Services Emergency Fund’ under the heading ‘Office of the Secretary’ under title II of division H of the Consolidated Appropriations Act, 2018 (Public Law 115-141) and allocated to carrying out section 319L(c)(4)(F).” > .
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Sec. 404
PREPARING FOR PANDEMIC INFLUENZA, ANTIMICROBIAL RESISTANCE, AND OTHER SIGNIFICANT THREATS
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