[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 3588 Introduced in Senate (IS)]

<DOC>






117th CONGRESS
  2d Session
                                S. 3588

      To amend the Public Health Service Act to improve domestic 
   manufacturing surge capacity and capabilities for biodefense and 
                         pandemic preparedness.


_______________________________________________________________________


                   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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Medical Countermeasures Surge 
Capacity Act of 2022''.

SEC. 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.''.
                                 <all>