Sec. 302. Biomedical advanced research and development authority

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Section 319L(c)(4) of the Public Health Service Act (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 grants supporting innovative candidate products in preclinical and clinical development, to 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 disease, 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(c)(5)(A) of the Public Health Service Act (42 U.S.C. 247d–7e(c)(5)(A)) is amended— by amending clause

(i)to read as follows: The Secretary shall have the authority to engage in transactions other than a contract, grant, or cooperative agreement with respect to projects under this section. ; and in clause (ii)— by amending subclause

(I)to read as follows: To the maximum extent practicable, competitive procedures shall be used when entering into agreements to carry out projects under this section. ; and in subclause (II), by striking $20,000,000 and inserting $100,000,000 . Section 319L of the Public Health Service Act ( 42 U.S.C. 247d–7e ) is amended— by redesignating subsections

(d)through

(f)as subsections

(f)through (h), 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 research and development activities for qualified pandemic or epidemic products (as defined in section 319F–3(i)), including by developing innovative technologies to enhance rapid response to threats relating to pandemic influenza; ensures readiness to respond to pandemic influenza threats by supporting the development and manufacturing of influenza virus seeds, clinical trial lots, and stockpiles of novel influenza strains; and sustains and replenishes pandemic stockpiles of bulk antigen and adjuvant material, including annually testing the potency and shelf-life potential of all existing pandemic stockpiles held by the Department of Health and Human Services. The Secretary, acting through the Director of BARDA, shall establish and implement a program that supports research and development, and manufacturing infrastructure, activities with respect to an emerging infectious disease. . Subsection

(f)of section 319L of the Public Health Service Act ( 42 U.S.C. 247d–7e ), as redesignated by subsection (b)(1), is amended— in paragraph (2)— by inserting (other than subsections

(d)and (e)) after purposes of this section ; and by striking $415,000,000 for each of fiscal years 2014 through 2018 and inserting $536,700,000 for each of fiscal years 2019 through 2023 ; and by adding at the end the following new paragraphs: To carry out the purposes of subsection (d), 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 the purposes of subsection (d). To carry out the purposes of subsection (e), 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 the purposes of subsection (e). .

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42 USC 247d–7e(c)(5)(A)
42 USC 247d–7e

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Sec. 302

Biomedical advanced research and development authority

Cite42 USC 247d–7e(c)(5)(A)

Cite42 USC 247d–7e

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