Sec. 404. Preparing for pandemic influenza, antimicrobial resistance, and other significant threats

421 words·~2 min read·/bill/115/hr/6378/eh/section-404

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Section 319L(c)(4) (247d–7e(c)(4)) is amended by adding at the end the following: 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— 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; threats that consistently exist or continually circulate and have 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 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. .

Section 319L of the Public Health Service Act ( 42 U.S.C. 247d–7e ) is amended— by redesignating subsections (d), (e), and

(f)as subsections (e), (f), and (g), respectively; and by inserting after subsection

(c)the following new subsections: The Secretary, acting through the Director of BARDA, shall establish and implement a program that supports— advanced research and development activities for qualified pandemic or epidemic products; and manufacturing infrastructure activities with respect to an emerging infectious disease. To carry out paragraph (1), there is authorized to be appropriated $250,000,000 for each of fiscal years 2019 through 2023, to remain available until expended. Any funds provided to the Secretary under this paragraph shall be used to supplement and not supplant any other Federal funds provided to carry out paragraph (1). .

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42 USC 247d–7e

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Sec. 404

Preparing for pandemic influenza, antimicrobial resistance, and other significant threats

Cite42 USC 247d–7e

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