117 HR 349 IH: Coronavirus Vaccine and Therapeutic Development Act of 2021 U.S. House of Representatives 2021-01-19 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

I 117th CONGRESS1st Session H. R. 349 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.

Short title

This Act may be cited as the Coronavirus Vaccine and Therapeutic Development Act of 2021.

2.

Covered product development and procurement

(a)

Enhancing development, procurement, and manufacturing capacity

(1)

In general

The Secretary of Health and Human Services shall, as appropriate, award contracts, grants, and cooperative agreements, and enter into other transactions— (A)expanding and enhancing covered product research and development; (B)procuring covered products; and (C)expanding and enhancing capacity for manufacturing covered products. (2)

Authorization of appropriations

To carry out this subsection, there is authorized to be appropriated $20,000,000,000 for fiscal years 2021 through 2025, to remain available until expended. (b)

Report on vaccine and therapeutic manufacturing and administration capacity

Not later than December 31, 2021, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor and Pensions of the Senate a report detailing— (1)an assessment of the estimated supply of covered products necessary to prevent and control the spread of SARS–CoV–2 and COVID–19, domestically and internationally; (2)an assessment of current and future domestic manufacturing capacity for covered products, including identification of any gaps in manufacturing capacity, including— (A)identification of any gaps in capacity for manufacturing; and (B)an analysis of the effects of shifting manufacturing resources to address COVID–19; (3)activities conducted to expand and enhance manufacturing capacity for covered products to levels sufficient to prevent and control the spread of SARS–CoV–2 and COVID–19, domestically and internationally, including a list and explanation of all contracts, grants, and cooperative agreements awarded, and other transactions entered into, for purposes of such expansion and enhancement and how such activities will help to meet future domestic manufacturing capacity needs; (4)a plan for the ongoing support of enhanced manufacturing capacity for covered products, domestically and internationally; and (5)a plan— (A)to ensure that manufacturing capacity meets the distribution targets and goals of covered products, domestically and internationally; and (B)to support the administration of covered products approved or authorized by the Food and Drug Administration to prevent and control the spread of SARS–CoV–2 and COVID–19, domestically and internationally, including Federal workforce enhancements necessary to administer such products. (c)

Definitions

In this section: (1)The term ancillary medical supply includes— (A)vials; (B)bandages; (C)alcohol swabs; (D)syringes; (E)needles; (F)gloves and other personal protective equipment; and (G)other medical products the Secretary determines necessary for the administration of covered products. (2)The term covered product means a vaccine, therapeutic, or ancillary medical supply to prevent and control the spread of SARS–CoV–2 and COVID–19. (3)The term Secretary means the Secretary of Health and Human Services.