I 

117TH CONGRESS 

1ST SESSION H. R. 349 

To direct the Secretary of Health and Human Services to award contracts, 

grants, and cooperative agreements to expand and enhance capacity 

for manufacturing covered products to prevent and control the spread 

of SARS–CoV–2 and COVID–19. 

IN THE HOUSE OF REPRESENTATIVES 

JANUARY 19, 2021 

Ms. KUSTER (for herself and Mr. JEFFRIES) introduced the following bill; 

which was referred to the Committee on Energy and Commerce 

A BILL 

To direct the Secretary of Health and Human Services to 

award contracts, grants, and cooperative agreements to 

expand and enhance capacity for manufacturing covered 

products to prevent and control the spread of SARS– 

CoV–2 and COVID–19. 

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 ‘‘Coronavirus Vaccine 

5 and Therapeutic Development Act of 2021’’. 


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•HR 349 IH

1 SEC. 2. COVERED PRODUCT DEVELOPMENT AND PROCURE2 MENT. 

3 (a) ENHANCING DEVELOPMENT, PROCUREMENT, 

4 AND MANUFACTURING CAPACITY.— 

5 (1) IN GENERAL.—The Secretary of Health and 

6 Human Services shall, as appropriate, award con7 tracts, grants, and cooperative agreements, and 

8 enter into other transactions— 

9 (A) expanding and enhancing covered 

10 product research and development; 

11 (B) procuring covered products; and 

12 (C) expanding and enhancing capacity for 

13 manufacturing covered products. 

14 (2) AUTHORIZATION OF APPROPRIATIONS.—To 

15 carry out this subsection, there is authorized to be 

16 appropriated $20,000,000,000 for fiscal years 2021 

17 through 2025, to remain available until expended. 

18 (b) REPORT ON VACCINE AND THERAPEUTIC MANU19 FACTURING AND ADMINISTRATION CAPACITY.—Not later 

20 than December 31, 2021, the Secretary shall submit to 

21 the Committee on Energy and Commerce of the House 

22 of Representatives and the Committee on Health, Edu23 cation, Labor and Pensions of the Senate a report detail24 ing— 

25 (1) an assessment of the estimated supply of 

26 covered products necessary to prevent and control 


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•HR 349 IH

1 the spread of SARS–CoV–2 and COVID–19, domes2 tically and internationally; 

3 (2) an assessment of current and future domes4 tic manufacturing capacity for covered products, in5 cluding identification of any gaps in manufacturing 

6 capacity, including— 

7 (A) identification of any gaps in capacity 

8 for manufacturing; and 

9 (B) an analysis of the effects of shifting 

10 manufacturing resources to address COVID–19; 

11 (3) activities conducted to expand and enhance 

12 manufacturing capacity for covered products to lev13 els sufficient to prevent and control the spread of 

14 SARS–CoV–2 and COVID–19, domestically and 

15 internationally, including a list and explanation of 

16 all contracts, grants, and cooperative agreements 

17 awarded, and other transactions entered into, for 

18 purposes of such expansion and enhancement and 

19 how such activities will help to meet future domestic 

20 manufacturing capacity needs; 

21 (4) a plan for the ongoing support of enhanced 

22 manufacturing capacity for covered products, domes23 tically and internationally; and 

24 (5) a plan— 


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1 (A) to ensure that manufacturing capacity 

2 meets the distribution targets and goals of cov3 ered products, domestically and internationally; 

4 and 

5 (B) to support the administration of cov6 ered products approved or authorized by the 

7 Food and Drug Administration to prevent and 

8 control the spread of SARS–CoV–2 and 

9 COVID–19, domestically and internationally, 

10 including Federal workforce enhancements nec11 essary to administer such products. 

12 (c) DEFINITIONS.—In this section: 

13 (1) The term ‘‘ancillary medical supply’’ in14 cludes— 

15 (A) vials; 

16 (B) bandages; 

17 (C) alcohol swabs; 

18 (D) syringes; 

19 (E) needles; 

20 (F) gloves and other personal protective 

21 equipment; and 

22 (G) other medical products the Secretary 

23 determines necessary for the administration of 

24 covered products. 


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1 (2) The term ‘‘covered product’’ means a vac2 cine, therapeutic, or ancillary medical supply to pre3 vent and control the spread of SARS–CoV–2 and 

4 COVID–19. 

5 (3) The term ‘‘Secretary’’ means the Secretary 

6 of Health and Human Services. 

Æ 


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