II 116th CONGRESS 2d Session S. 4368 IN THE SENATE OF THE UNITED STATES July 29, 2020 Mr. Brown introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To prepare the Strategic National Stockpile for a public health emergency and require the maintenance of a domestic supply chain for countermeasures in the stockpile, and for other purposes.

1. Short title This Act may be cited as the Protecting American Heroes Act of 2020 . 2. Strategic national stockpile (a) Additional provisions To prepare the Strategic National Stockpile for public health emergencies (1) In general Section 319F–2 of the Public Health Service Act ( 42 U.S.C. 247d–6b ) is amended— (A) by redesignating subsection (h) as subsection (i); and (B) by inserting after subsection (g) the following: (h) Additional provisions To prepare the Strategic National Stockpile for public health emergencies (1) Preparing for emergencies affecting all States (A) In general The Public Health Emergency Medical Countermeasures Enterprise established under section 2811–1 shall develop a model to enable the stockpile under subsection (a)(1) to be prepared to effectively respond to a public health emergency, including one that simultaneously affects all States. (B) Model The model under subparagraph (A) shall include— (i) (I) requirements with respect to the number, types, and amounts of countermeasures that are necessary to prepare the stockpile under subsection (a)(1) to respond to a public health emergency described in subparagraph (A); and (II) the cost necessary to meet such requirements; (ii) an assessment of the domestic supply chain for all countermeasures that are needed for the stockpile to be prepared for a public health emergency described in subparagraph (A), including— (I) an identification of any known domestic suppliers of such countermeasures; (II) an identification of any gaps in the domestic supply chain for such countermeasures; (III) steps needed to address the gaps in the domestic supply chain for such countermeasures; (IV) an identification of any countermeasure in the stockpile that only has one source, domestic or foreign, for procurement; and (V) steps needed to diversify sources for any countermeasure in the stockpile that has only one source, domestic or foreign, for procurement. (C) Submission to Congress Not later than 120 days after the date of enactment of the Protecting American Heroes Act of 2020 , the Public Health Emergency Medical Countermeasures Enterprise established under section 2811–1 shall submit the assessment required under subparagraph (B)(ii) to each Committee described in subsection (a)(2)(A). (2) Requirement to identify and maintain domestic supply chain (A) In general The Executive Deputy Assistant Secretary of the Strategic National Stockpile appointed under paragraph (3) (referred to in this paragraph as the Executive Deputy Assistant Secretary ) shall, in accordance with this paragraph, identify and maintain a domestic source (which may be multiple sources) for all countermeasures in the stockpile under subsection (a)(1). (B) Requirement for items in stockpile (i) In general Except as provided under clause (ii), the Executive Deputy Assistant Secretary shall require all countermeasures in the stockpile under subsection (a)(1), and any component part of such countermeasures, to be grown, reprocessed, reused, or produced in the United States. (ii) Waivers The Executive Deputy Assistant Secretary may, on a case-by-case basis, waive the requirement under clause (i) in the case of a contract for a countermeasure in the stockpile under subsection (a)(1)— (I) for which the Executive Deputy Assistant Secretary determines that a satisfactory quality and sufficient quantity of such countermeasure that is grown, reprocessed, reused, or produced in the United States cannot be procured as and when needed at United States market prices; or (II) that is, or includes, any material determined to be a nonavailable article under section 25.104 of the Federal Acquisition Regulation for purposes of subpart I of part 25 of the Federal Acquisition Regulation. (iii) Notification of waivers In the case of any contract for the procurement of a countermeasure in the stockpile under subsection (a)(1), if the Executive Deputy Assistant Secretary applies a waiver under clause (ii) with respect to that contract, the Executive Deputy Assistant Secretary shall, not later than 7 days after the award of the contract, submit to each Committee described in subsection (a)(2)(A) a notification that the waiver has been applied. (C) Notice of discontinuance or interruption in domestic supply chain (i) Timing The Executive Deputy Assistant Secretary shall require any manufacturer of a countermeasure in the stockpile under subsection (a)(1) (other than a countermeasure to which a waiver has been applied under subparagraph (B)(ii)) to provide notice to the Executive Deputy Assistant Secretary of any discontinuance or interruption in the manufacture of such countermeasure. Such notice shall be submitted to the Executive Deputy Assistant Secretary— (I) at least 6 months prior to the date of the discontinuance or interruption; or (II) if compliance with subclause (I) is not possible, as soon as practicable. (ii) Contents The notice required under clause (i) shall include disclosure of— (I) reasons for the discontinuation or interruption of the countermeasure; (II) if applicable, and without disclosing proprietary information, if an active pharmaceutical ingredient is a reason for, or risk factor in, such discontinuation or interruption, the source of the active pharmaceutical ingredient, and any alternative sources for the active pharmaceutical ingredient known by the manufacturer; (III) if applicable, whether any associated device used for preparation or administration included in the countermeasure is a reason for, or a risk factor in, such discontinuation or interruption; (IV) if applicable, the expected duration of the interruption; and (V) any such other information as the Executive Deputy Assistant Secretary may require. (3) Executive Deputy Assistant Secretary of the Strategic National Stockpile (A) In general The Assistant Secretary for Preparedness and Response shall appoint an Executive Deputy Assistant Secretary of the Strategic National Stockpile (referred to in this paragraph as the Executive Deputy Assistant Secretary ), who shall report directly to the Assistant Secretary for Preparedness and Response and serve in a career reserved position, as defined in section 3132(a) of title 5, United States Code. (B) Qualifications Any individual appointed as the Executive Deputy Assistant Secretary under subparagraph (A) shall be selected from individuals who, on the day before the date of enactment of the Protecting American Heroes Act of 2020 — (i) are career appointees, as defined in section 3132(a) of title 5, United States Code; or (ii) are former such career appointees and are eligible for reinstatement as such career appointees. (C) Functions The Executive Deputy Assistant Secretary appointed under subparagraph (A) shall— (i) notwithstanding the functions of the Assistant Secretary for Preparedness and Response under section 2811–1, have authority to make decisions with respect to the stockpile under subsection (a)(1); (ii) establish and maintain a domestic supply chain for countermeasures in such stockpile to the greatest extent possible; (iii) consult with States and relevant stakeholders, including public health organizations, about the procurement and distribution of countermeasures in the stockpile; and (iv) carry out all other duties of any individual serving as the Director of the Strategic National Stockpile prior to the date of enactment of the Protecting American Heroes Act of 2020 . (D) Quarterly report Not later than 180 days after the date of enactment of the Protecting American Heroes Act of 2020 , and each calendar quarter thereafter, the Executive Deputy Assistant Secretary shall submit to the Assistant Secretary for Preparedness and Response and each Committee described in subsection (a)(2)(A) a report that includes— (i) the number, types, and amounts of countermeasures in the stockpile under subsection (a)(1); (ii) whether such number, types, and amounts are sufficient to meet a public health emergency that simultaneously affects all States; (iii) whether any countermeasures in the stockpile have expired or failed to receive necessary maintenance in a timely fashion; (iv) the status of the domestic supply chain with respect to countermeasures in such stockpile, including— (I) whether there are gaps in the supply chain, including the domestic supply chain, for such countermeasures; and (II) any instance in which the Executive Deputy Assistant Secretary applies a waiver under paragraph (2)(B)(ii) to a countermeasure; (v) recommended steps necessary to address any gap described in clause (iv)(I); and (vi) (I) whether any countermeasures in such stockpile are obtained from a sole source; and (II) whether any steps should be taken to diversify sourcing of such countermeasures. (E) First appointment With respect to the first individual to serve as the Executive Deputy Assistant Secretary after the date of enactment of the Protecting American Heroes Act of 2020 , the Assistant Secretary for Preparedness and Response shall appoint such individual under subparagraph (A) not later than 90 days after such date of enactment. (4) Definition of countermeasure In this subsection, the term countermeasure includes a drug, vaccine or other biological product, medical device, or other supplies (including personal protective equipment, ancillary medical supplies, and other applicable supplies required for the administration of drugs, vaccines and other biological products, medical devices, and diagnostic tests in the stockpile) described in subsection (a)(1). . (2) Appropriations Section 319F–2(f) of the Public Health Service Act (42 U.S.C. 247d–6b(f)) is amended— (A) in the subsection heading, by striking Authorization of Appropriations and inserting Appropriations; authorization of appropriations ; and (B) by amending paragraph (1) to read as follows: (1) Strategic National Stockpile There are appropriated, out of any money in the Treasury not otherwise appropriated, such sums as necessary, to remain available until expended, to carry out subsections (a) and (h). Such amounts are in addition to any amounts in the special reserve fund under subsection (g). . (3) Conforming amendments (A) Section 319F–2 of the Public Health Service Act ( 42 U.S.C. 247d–6b ) is amended— (i) in subsection (c), by striking as defined in subsection (h) each place it appears; and (ii) in subsection (f), by striking as referred to in subsection (h) . (B) Section 2811(d)(2)(G) of the Public Health Service Act ( 42 U.S.C. 300hh–10(d)(2)(G) ) is amended by striking as defined in section 319F–2(h) and inserting as defined in section 319F–2(i) . (b) Domestic supply chain evaluations in threat assessment and GAO report; functions of Secretary Section 319F–2(a) of the Public Health Service Act (42 U.S.C. 247d–6b(a)) is amended— (1) in paragraph (2)— (A) in subparagraph (A), by inserting , including the domestic supply chain for such contents, after within the stockpile ; and (B) in subparagraph (B)(i)(II), by inserting , including domestic manufacturing capacity, after appropriate manufacturing capacity ; (2) in paragraph (3)— (A) by redesignating subparagraphs (E) through (J) as subparagraphs (F) through (K), respectively; (B) by inserting after subparagraph (D) the following: (E) acting through the Executive Deputy Assistant Secretary of the Strategic National Stockpile appointed under subsection (h)(3), in accordance with subsection (h)(2), establish, maintain, and (when necessary) expand a supply chain based in the United States for countermeasures (as defined in subsection (h)(4)) in the stockpile; ; and (C) in subparagraph (F), as so redesignated, by inserting to ensure a robust supply chain for the production in the United States of countermeasures (as defined in subsection (h)(4)), before in consultation with ; and (3) in paragraph (5)(A)— (A) by redesignating clauses (iii) through (ix) as clauses (iv) through (x), respectively; and (B) by inserting after clause (ii) the following: (iii) an assessment of the plans developed by the Executive Deputy Assistant Secretary of the Strategic National Stockpile appointed under subsection (h)(3) to, in accordance with subsection (h)(2), establish, maintain, and (when necessary) expand a supply chain based in the United States for countermeasures (as defined in subsection (h)(4)) procured for the stockpile; . (c) Enhancing threat-Based reviews Section 319F–2(a) of the Public Health Service Act (42 U.S.C. 247d–6b(a)) is amended— (1) in paragraph (1), by striking based on the review conducted under paragraph (2) and inserting based on any review conducted under paragraph (2) ; and (2) in paragraph (2), by adding at the end the following: (C) In-person or virtual briefings (i) In general Not later than 30 days after submitting each annual threat-based review under subparagraph (A) to the Committees described in such subparagraph, the Executive Deputy Assistant Secretary of the Strategic National Stockpile, appointed under subsection (h)(3), shall provide an in-person, or virtual, briefing on such review to the members of such Committees. (ii) Public health emergencies (I) Monthly reviews During the period of any public health emergency, the Executive Deputy Assistant Secretary of the Strategic National Stockpile, appointed under subsection (h)(3), shall, on a monthly basis, provide an in-person, or virtual, briefing to all members of Congress on— (aa) the countermeasures (as defined in subsection (h)4)) in the stockpile under paragraph (1); (bb) the status of the supply chain, including the domestic supply chain, for such countermeasures; (cc) how such countermeasures are being distributed; and (dd) communication with State and local governments on their needs with respect to acquiring such countermeasures in the stockpile and on the status of countermeasures that are available in the stockpile. (II) Baseline review Not later than 15 days after the date of enactment of the Protecting American Heroes Act of 2020 , the Secretary shall conduct a baseline review of the stockpile under paragraph (1) and provide an in-person, or virtual, briefing to all members of Congress on each issue described in items (aa) through (dd) of subclause (I). (D) Supplemental reviews In the event that the Executive Deputy Assistant Secretary of the Strategic National Stockpile, appointed under subsection (h)(3), determines there is a significant depletion of any countermeasure (as defined in subsection (h)(4)) in the stockpile under paragraph (1), the Executive Deputy Assistant Secretary of the Strategic National Stockpile shall, not later than 30 days after making such determination— (i) conduct a supplemental threat-based review on each issue described in items (aa) through (dd) of subparagraph (C)(I); and (ii) provide such review in writing to the Committees described in subparagraph (A). . 3. Enhancements to the Defense Production Act of 1950 Section 107 of the Defense Production Act of 1950 ( 50 U.S.C. 4517 ) is amended by adding at the end the following: (c) Health emergency authority With respect to a public health emergency declared under section 319 of the Public Health Service Act ( 42 U.S.C. 247d ), or preparations for such a public health emergency, the Secretary of Health and Human Services and the Administrator of the Federal Emergency Management Agency may carry out the authorities provided under this section to the same extent as the President. .