II 117th CONGRESS 2d Session S. 3588 IN THE SENATE OF THE UNITED STATES February 7 (legislative day, February 3), 2022 Mr. Romney (for himself and Ms. Hassan ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To amend the Public Health Service Act to improve domestic manufacturing surge capacity and capabilities for biodefense and pandemic preparedness.

1. Short title This Act may be cited as the Medical Countermeasures Surge Capacity Act of 2022 . 2. Warm base manufacturing capacity for medical countermeasures (a) In general Section 319L of the Public Health Service Act ( 42 U.S.C. 247d–7e ) is amended— (1) in subsection (a)(6)(B)— (A) by redesignating clauses (iv) and (v) as clauses (v) and (vi), respectively; (B) by inserting after clause (iii), the following: (iv) activities to support, maintain, and improve domestic manufacturing surge capacity and capabilities, as appropriate, including through the utilization of advanced manufacturing and platform technologies, to increase the availability of products that are or may become qualified countermeasures or qualified pandemic or epidemic products; ; and (C) in clause (vi) (as so redesignated), by inserting manufacturing, after improvement, ; (2) in subsection (b)— (A) in the first sentence of paragraph (1), by inserting support for domestic manufacturing surge capacity and capabilities, after initiatives for innovation, ; and (B) in paragraph (2)— (i) in subparagraph (B), by striking and at the end; (ii) by redesignating subparagraph (C) as subparagraph (D); and (iii) by inserting after subparagraph (B), the following: (C) activities to support, maintain, and improve domestic manufacturing surge capacity and capabilities, as appropriate, including through the utilization of advanced manufacturing and platform technologies, to increase the availability of products that are or may become qualified countermeasures or qualified pandemic or epidemic products; and ; (3) in subsection (c)— (A) in paragraph (2)(B), by inserting before the semicolon , including through the establishment and maintenance of domestic manufacturing surge capacity and capabilities, consistent with subsection (a)(6)(B)(iv) ; (B) in paragraph (4)— (i) in subparagraph (A)— (I) in clause (i)— (aa) in subclause (I), by striking and at the end; and (bb) by adding at the end the following: (III) facilitating such communication, as appropriate, regarding manufacturing surge capacity and capabilities with respect to qualified countermeasures and qualified pandemic or epidemic products to prepare for, or respond to, a public health emergency or potential public health emergency; and (IV) facilitating such communication, as appropriate and in a manner that does not compromise national security, with respect to potential eligibility for the material threat medical countermeasure priority review voucher program under section 565A of the Federal Food, Drug, and Cosmetic Act; ; (II) in clause (ii)(III), by striking and at the end; (III) by redesignating clause (iii) as clause (iv); and (IV) by inserting after clause (ii), the following: (iii) communicate regularly with entities in receipt of an award pursuant to subparagraph (B)(v), and facilitate communication between such entities and other entities in receipt of an award pursuant to subparagraph (B)(iv), as appropriate, for purposes of planning regarding the availability of countermeasures and the maintenance of domestic manufacturing surge capacity and capabilities, including any planned uses of such capacity and capabilities in the near- and mid-term, and identification of any significant challenges related to the long-term maintenance of such capacity and capabilities; and ; (ii) in subparagraph (B)— (I) in clause (iii), by striking and at the end; (II) in clause (iv), by striking the period and inserting ; and ; and (III) by adding at the end the following: (v) award contracts, grants, and cooperative agreements and enter into other transactions to support, maintain, and improve domestic manufacturing surge capacity and capabilities, including through supporting flexible or advanced manufacturing, to ensure that additional capacity is available to rapidly manufacture products that are or may become qualified countermeasures or qualified pandemic or epidemic products in the event of a public health emergency declaration or significant potential for a public health emergency. ; (iii) in subparagraph (C)— (I) in clause (i), by striking and at the end; (II) in clause (ii), by striking the period at the end and inserting ; and ; and (III) by adding at the end the following: (iii) consult with the Commissioner of Food and Drugs, pursuant to section 565(b)(2) of the Federal Food, Drug, and Cosmetic Act, to ensure that facilities performing manufacturing, pursuant to an award under subparagraph (B)(v), are in compliance with applicable requirements under such Act and this Act, as appropriate, including current good manufacturing practice pursuant to section 501(a)(2)(B) of the Food, Drug, and Cosmetic Act; and ; (iv) in subparagraph (D)(i), by inserting , including to improve manufacturing capacities and capabilities for medical countermeasures before the semicolon; (v) in subparagraph (E)(ix), by striking 2023 and inserting 2028 ; and (vi) by adding at the end the following: (G) Annual reports by award recipients As a condition of receiving an award under subparagraph (B)(v), a recipient shall develop and submit to the Secretary annual reports related to the maintenance of such capacity and capabilities, including ensuring that such capacity and capabilities are able to support the rapid manufacture of countermeasures as required by the Secretary. ; and (C) in paragraph (5), by adding at the end the following: (H) Supporting warm-base and surge capacity and capabilities Pursuant to an award under subparagraph (B)(v), the Secretary may make payments for activities necessary to maintain domestic manufacturing surge capacity and capabilities supported under such award to ensure that such capacity and capabilities are able to support the rapid manufacture of countermeasures as required by the Secretary to prepare for, or respond to, an existing or potential public health emergency or otherwise address threats that pose a significant level of risk to national security. The Secretary may support the utilization of such capacity and capabilities under awards for countermeasure and product advanced research and development, as appropriate, to provide for the maintenance of such capacity and capabilities. ; and (4) in subsection (f)— (A) in paragraph (1), by striking Not later than 180 days after the date of enactment of this subsection and inserting Not later than 180 days after the date of enactment of the Medical Countermeasures Surge Capacity Act of 2022 ; (B) in paragraph (2)— (i) in the matter preceding subparagraph (A), by striking this subsection and inserting the Medical Countermeasures Surge Capacity Act of 2022 ; (ii) in subparagraph (B), by striking and at the end; and (iii) in subparagraph (C), by striking the period and inserting ; and ; and (C) by adding at the end the following: (D) plans for the near-, mid-, and long-term sustainment of manufacturing activities carried out under this section, including such activities pursuant to subsection (c)(5)(H), specific actions to regularly assess the ability of recipients of an award under subsection (c)(4)(B)(v) to rapidly manufacture countermeasures as required by the Secretary, and recommendations to address challenges, if any, related to such activities. .