Coronavirus Vaccine and Therapeutic Development Act of 2021

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. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Coronavirus Vaccine 4 and Therapeutic Development Act of 2021’’. 5 VerDate Sep 11 2014 23:02 Feb 07, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H349.IH H349 pbinns on DSKJLVW7X2PROD with BILLS 2 •HR 349 IH SEC. 2. COVERED PRODUCT DEVELOPMENT AND PROCURE- 1 MENT. 2 (a) ENHANCING DEVELOPMENT, PROCUREMENT, 3 AND MANUFACTURING CAPACITY.— 4 (1) IN GENERAL.—The Secretary of Health and 5 Human Services shall, as appropriate, award con- 6 tracts, grants, and cooperative agreements, and 7 enter into other transactions— 8 (A) expanding and enhancing covered 9 product research and development; 10 (B) procuring covered products; and 11 (C) expanding and enhancing capacity for 12 manufacturing covered products. 13 (2) AUTHORIZATION OF APPROPRIATIONS.—To 14 carry out this subsection, there is authorized to be 15 appropriated $20,000,000,000 for fiscal years 2021 16 through 2025, to remain available until expended. 17 (b) REPORT ON VACCINE AND THERAPEUTIC MANU- 18 FACTURING AND ADMINISTRATION CAPACITY.—Not later 19 than December 31, 2021, the Secretary shall submit to 20 the Committee on Energy and Commerce of the House 21 of Representatives and the Committee on Health, Edu- 22 cation, Labor and Pensions of the Senate a report detail- 23 ing— 24 (1) an assessment of the estimated supply of 25 covered products necessary to prevent and control 26 VerDate Sep 11 2014 23:02 Feb 07, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H349.IH H349 pbinns on DSKJLVW7X2PROD with BILLS 3 •HR 349 IH the spread of SARS–CoV–2 and COVID–19, domes- 1 tically and internationally; 2 (2) an assessment of current and future domes- 3 tic manufacturing capacity for covered products, in- 4 cluding identification of any gaps in manufacturing 5 capacity, including— 6 (A) identification of any gaps in capacity 7 for manufacturing; and 8 (B) an analysis of the effects of shifting 9 manufacturing resources to address COVID–19; 10 (3) activities conducted to expand and enhance 11 manufacturing capacity for covered products to lev- 12 els sufficient to prevent and control the spread of 13 SARS–CoV–2 and COVID–19, domestically and 14 internationally, including a list and explanation of 15 all contracts, grants, and cooperative agreements 16 awarded, and other transactions entered into, for 17 purposes of such expansion and enhancement and 18 how such activities will help to meet future domestic 19 manufacturing capacity needs; 20 (4) a plan for the ongoing support of enhanced 21 manufacturing capacity for covered products, domes- 22 tically and internationally; and 23 (5) a plan— 24 VerDate Sep 11 2014 23:02 Feb 07, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H349.IH H349 pbinns on DSKJLVW7X2PROD with BILLS 4 •HR 349 IH (A) to ensure that manufacturing capacity 1 meets the distribution targets and goals of cov- 2 ered products, domestically and internationally; 3 and 4 (B) to support the administration of cov- 5 ered products approved or authorized by the 6 Food and Drug Administration to prevent and 7 control the spread of SARS–CoV–2 and 8 COVID–19, domestically and internationally, 9 including Federal workforce enhancements nec- 10 essary to administer such products. 11 (c) DEFINITIONS.—In this section: 12 (1) The term ‘‘ancillary medical supply’’ in- 13 cludes— 14 (A) vials; 15 (B) bandages; 16 (C) alcohol swabs; 17 (D) syringes; 18 (E) needles; 19 (F) gloves and other personal protective 20 equipment; and 21 (G) other medical products the Secretary 22 determines necessary for the administration of 23 covered products. 24 VerDate Sep 11 2014 23:02 Feb 07, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H349.IH H349 pbinns on DSKJLVW7X2PROD with BILLS 5 •HR 349 IH (2) The term ‘‘covered product’’ means a vac- 1 cine, therapeutic, or ancillary medical supply to pre- 2 vent and control the spread of SARS–CoV–2 and 3 COVID–19. 4 (3) The term ‘‘Secretary’’ means the Secretary 5 of Health and Human Services. 6 Æ VerDate Sep 11 2014 23:02 Feb 07, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6301 E:\BILLS\H349.IH H349 pbinns on DSKJLVW7X2PROD with BILLS