II 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Medical Counter5 measures Surge Capacity Act of 2022’’. 

6 SEC. 2. WARM BASE MANUFACTURING CAPACITY FOR MED7 ICAL COUNTERMEASURES. 

8 (a) IN GENERAL.—Section 319L of the Public 

9 Health Service Act (42 U.S.C. 247d–7e) is amended— 


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1 (1) in subsection (a)(6)(B)— 

2 (A) by redesignating clauses (iv) and (v) as 

3 clauses (v) and (vi), respectively; 

4 (B) by inserting after clause (iii), the fol5 lowing: 

6 ‘‘(iv) activities to support, maintain, 

7 and improve domestic manufacturing surge 

8 capacity and capabilities, as appropriate, 

9 including through the utilization of ad10 vanced manufacturing and platform tech11 nologies, to increase the availability of 

12 products that are or may become qualified 

13 countermeasures or qualified pandemic or 

14 epidemic products;’’; and 

15 (C) in clause (vi) (as so redesignated), by 

16 inserting ‘‘manufacturing,’’ after ‘‘improve17 ment,’’; 

18 (2) in subsection (b)— 

19 (A) in the first sentence of paragraph (1), 

20 by inserting ‘‘support for domestic manufac21 turing surge capacity and capabilities,’’ after 

22 ‘‘initiatives for innovation,’’; and 

23 (B) in paragraph (2)— 

24 (i) in subparagraph (B), by striking 

25 ‘‘and’’ at the end; 


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1 (ii) by redesignating subparagraph 

2 (C) as subparagraph (D); and 

3 (iii) by inserting after subparagraph 

4 (B), the following: 

5 ‘‘(C) activities to support, maintain, and 

6 improve domestic manufacturing surge capacity 

7 and capabilities, as appropriate, including 

8 through the utilization of advanced manufac9 turing and platform technologies, to increase 

10 the availability of products that are or may be11 come qualified countermeasures or qualified 

12 pandemic or epidemic products; and’’; 

13 (3) in subsection (c)— 

14 (A) in paragraph (2)(B), by inserting be15 fore the semicolon ‘‘, including through the es16 tablishment and maintenance of domestic man17 ufacturing surge capacity and capabilities, con18 sistent with subsection (a)(6)(B)(iv)’’; 

19 (B) in paragraph (4)— 

20 (i) in subparagraph (A)— 

21 (I) in clause (i)— 

22 (aa) in subclause (I), by 

23 striking ‘‘and’’ at the end; and 

24 (bb) by adding at the end 

25 the following: 


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1 ‘‘(III) facilitating such commu2 nication, as appropriate, regarding 

3 manufacturing surge capacity and ca4 pabilities with respect to qualified 

5 countermeasures and qualified pan6 demic or epidemic products to prepare 

7 for, or respond to, a public health 

8 emergency or potential public health 

9 emergency; and 

10 ‘‘(IV) facilitating such commu11 nication, as appropriate and in a man12 ner that does not compromise national 

13 security, with respect to potential eli14 gibility for the material threat medical 

15 countermeasure priority review vouch16 er program under section 565A of the 

17 Federal Food, Drug, and Cosmetic 

18 Act;’’; 

19 (II) in clause (ii)(III), by striking 

20 ‘‘and’’ at the end; 

21 (III) by redesignating clause (iii) 

22 as clause (iv); and 

23 (IV) by inserting after clause (ii), 

24 the following: 


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1 ‘‘(iii) communicate regularly with enti2 ties in receipt of an award pursuant to 

3 subparagraph (B)(v), and facilitate com4 munication between such entities and other 

5 entities in receipt of an award pursuant to 

6 subparagraph (B)(iv), as appropriate, for 

7 purposes of planning regarding the avail8 ability of countermeasures and the mainte9 nance of domestic manufacturing surge ca10 pacity and capabilities, including any 

11 planned uses of such capacity and capabili12 ties in the near- and mid-term, and identi13 fication of any significant challenges re14 lated to the long-term maintenance of such 

15 capacity and capabilities; and’’; 

16 (ii) in subparagraph (B)— 

17 (I) in clause (iii), by striking 

18 ‘‘and’’ at the end; 

19 (II) in clause (iv), by striking the 

20 period and inserting ‘‘; and’’; and 

21 (III) by adding at the end the 

22 following: 

23 ‘‘(v) award contracts, grants, and co24 operative agreements and enter into other 

25 transactions to support, maintain, and imVerDate Sep 11 2014 22:46 Feb 14, 2022 Jkt 029200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S3588.IS S3588

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1 prove domestic manufacturing surge capac2 ity and capabilities, including through sup3 porting flexible or advanced manufac4 turing, to ensure that additional capacity 

5 is available to rapidly manufacture prod6 ucts that are or may become qualified 

7 countermeasures or qualified pandemic or 

8 epidemic products in the event of a public 

9 health emergency declaration or significant 

10 potential for a public health emergency.’’; 

11 (iii) in subparagraph (C)— 

12 (I) in clause (i), by striking 

13 ‘‘and’’ at the end; 

14 (II) in clause (ii), by striking the 

15 period at the end and inserting ‘‘; 

16 and’’; and 

17 (III) by adding at the end the 

18 following: 

19 ‘‘(iii) consult with the Commissioner 

20 of Food and Drugs, pursuant to section 

21 565(b)(2) of the Federal Food, Drug, and 

22 Cosmetic Act, to ensure that facilities per23 forming manufacturing, pursuant to an 

24 award under subparagraph (B)(v), are in 

25 compliance with applicable requirements 


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1 under such Act and this Act, as appro2 priate, including current good manufac3 turing practice pursuant to section 

4 501(a)(2)(B) of the Food, Drug, and Cos5 metic Act; and’’; 

6 (iv) in subparagraph (D)(i), by insert7 ing ‘‘, including to improve manufacturing 

8 capacities and capabilities for medical 

9 countermeasures’’ before the semicolon; 

10 (v) in subparagraph (E)(ix), by strik11 ing ‘‘2023’’ and inserting ‘‘2028’’; and 

12 (vi) by adding at the end the fol13 lowing: 

14 ‘‘(G) ANNUAL REPORTS BY AWARD RECIPI15 ENTS.—As a condition of receiving an award 

16 under subparagraph (B)(v), a recipient shall de17 velop and submit to the Secretary annual re18 ports related to the maintenance of such capac19 ity and capabilities, including ensuring that 

20 such capacity and capabilities are able to sup21 port the rapid manufacture of countermeasures 

22 as required by the Secretary.’’; and 

23 (C) in paragraph (5), by adding at the end 

24 the following: 


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1 ‘‘(H) SUPPORTING WARM-BASE AND SURGE

2 CAPACITY AND CAPABILITIES.—Pursuant to an 

3 award under subparagraph (B)(v), the Sec4 retary may make payments for activities nec5 essary to maintain domestic manufacturing 

6 surge capacity and capabilities supported under 

7 such award to ensure that such capacity and 

8 capabilities are able to support the rapid manu9 facture of countermeasures as required by the 

10 Secretary to prepare for, or respond to, an ex11 isting or potential public health emergency or 

12 otherwise address threats that pose a signifi13 cant level of risk to national security. The Sec14 retary may support the utilization of such ca15 pacity and capabilities under awards for coun16 termeasure and product advanced research and 

17 development, as appropriate, to provide for the 

18 maintenance of such capacity and capabilities.’’; 

19 and 

20 (4) in subsection (f)— 

21 (A) in paragraph (1), by striking ‘‘Not 

22 later than 180 days after the date of enactment 

23 of this subsection’’ and inserting ‘‘Not later 

24 than 180 days after the date of enactment of 


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1 the Medical Countermeasures Surge Capacity 

2 Act of 2022’’; 

3 (B) in paragraph (2)— 

4 (i) in the matter preceding subpara5 graph (A), by striking ‘‘this subsection’’ 

6 and inserting ‘‘the Medical Counter7 measures Surge Capacity Act of 2022’’; 

8 (ii) in subparagraph (B), by striking 

9 ‘‘and’’ at the end; and 

10 (iii) in subparagraph (C), by striking 

11 the period and inserting ‘‘; and’’; and 

12 (C) by adding at the end the following: 

13 ‘‘(D) plans for the near-, mid-, and long14 term sustainment of manufacturing activities 

15 carried out under this section, including such 

16 activities pursuant to subsection (c)(5)(H), spe17 cific actions to regularly assess the ability of re18 cipients of an award under subsection 

19 (c)(4)(B)(v) to rapidly manufacture counter20 measures as required by the Secretary, and rec21 ommendations to address challenges, if any, re22 lated to such activities.’’. 

Æ 


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