Sec. 621. All-Hazards Emergency Preparedness and Response

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Section 2811 of the Public Health Service Act ( 42 U.S.C. 300hh–10 ) is amended— in subsection (b)— in paragraph (3)— by striking Oversee advanced research, development, and procurement and inserting the following: Oversee advanced research, development, procurement, and replenishment ; and by adding at the end the following: Lead the development and approval, and, on a routine basis, the review and update, of requirements for such countermeasures and products, including related capabilities, to inform the advanced research, development, procurement, and replenishment decisions of the Secretary. ; in paragraph (4)— in subparagraph (F)— in the matter preceding clause (i), by striking and in consultation with the Secretary of Homeland Security, ; and in clause (i), by inserting enhance after capabilities and ; in subparagraph (G)— in the matter preceding clause (i), by inserting the Office of Pandemic Preparedness and Response Policy, after Veterans Affairs, ; in clause (i), by striking based on and inserting based on— ; in clause (ii), by striking ; and at the end and inserting a semicolon; in clause (iii), by striking the period and inserting ; and ; and by adding at the end the following: that include, as appropriate, participation by relevant industry, academia, professional societies, and other stakeholders. ; in subparagraph (H)— by inserting and the Director of the Office of Pandemic Preparedness and Response Policy after Security Affairs ; and by inserting and medical product and supply capacity planning pursuant to subparagraph (J), including discussion of any relevant identified supply chain vulnerabilities before the period at the end; in subparagraph (I), by inserting the Director of the Office of Pandemic Preparedness and Response Policy, after Security Affairs, ; and in subparagraph (J)(i), in the matter preceding subclause (I), by inserting (including ancillary medical supplies and components of medical products, such as active pharmaceutical ingredients, key starting materials, medical device components, testing kits, reagents, and other testing supplies) after supply needs ; and in paragraph (7)— in the matter preceding subparagraph (A), by inserting and the requirements developed pursuant to paragraph (3)(B) after subsection

(d); by redesignating subparagraphs

(E)and

(F)as subparagraphs

(F)and (G), respectively; and by inserting after subparagraph

(D)the following: include a professional judgment of anticipated budget needs for each future fiscal year accounted for in such plan to account for the full range of anticipated medical countermeasure needs and life-cycle costs to address such priorities and requirements; ; in subsection (d)— by amending paragraph

(1)to read as follows: Not later than March 15, 2020, and biennially thereafter, the Assistant Secretary for Preparedness and Response shall develop and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a coordinated strategy for medical countermeasures to address chemical, biological, radiological, and nuclear threats, informed by the requirements developed pursuant to subsection (b)(3)(B). Not later than 180 days after the submission of such strategy to such committees, the Assistant Secretary for Preparedness and Response shall submit an accompanying implementation plan to such committees. In developing such a strategy and plan, the Assistant Secretary for Preparedness and Response shall consult with the Public Health Emergency Medical Countermeasures Enterprise established under section 2811–1. Such strategy and plan shall be known as the Public Health Emergency Medical Countermeasures Enterprise Strategy and Implementation Plan. ; and in paragraph (2), in the matter preceding subparagraph (A), by inserting strategy and before plan ; and in subsection (f)— in paragraph (1), in the matter preceding subparagraph (A), by inserting , including such agents that are an emerging infectious disease after become a pandemic ; and in paragraph (2)(A), by striking $250,000,000 for each of fiscal years 2019 through 2023 and inserting $335,000,000 for each of fiscal years 2025 and 2026, to remain available through December 31, 2026 .

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42 USC 300hh–10

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Sec. 621

All-Hazards Emergency Preparedness and Response

Cite42 USC 300hh–10

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