What it changes

1 change to S. 1260

Adds a section
  1. Adds SEC. __. EXPANDING THE DOMESTIC PRODUCTION OF MEDICAL SUPPLIES wherever appropriate

    Adds a section

    Inserted: SEC. __. EXPANDING THE DOMESTIC PRODUCTION OF MEDICAL SUPPLIES.

    Inserted: Title III of the Public Health Service Act is amended by inserting after section 319F-4 (42 U.S.C. 247d-6e) the following:

    Inserted: "SEC. 319F-5. EXPANDING THE DOMESTIC PRODUCTION OF MEDICAL SUPPLIES.

    Inserted: "(a) In General.--The Secretary, in consultation with the Secretary of Defense, shall award grants to drug, biological product (including vaccines), device (including respiratory protective devices), and other medical supply manufacturers for the purpose of incentivizing such manufacturers to manufacture such products domestically using advanced manufacturing, and to ensure that the Nation is able to retain or acquire necessary supplies to address critical public health needs, including countermeasures required during a pandemic or other public health emergency.

    Inserted: "(b) Eligible Products.--The Secretary, in consultation with the Secretary of Defense, shall compile and update a list of drugs, biological products (including vaccines), devices (including respiratory protective devices), and other medical supplies that are, or may become, critical supplies in the event of a pandemic or public health emergency.

    Inserted: "(c) Eligibility.--To be eligible for a grant under this section, a manufacturer shall submit an application to the Secretary at such time, in such manner, and containing such information as the Secretary may require, including the applicant's plan for the advanced manufacturing, domestically, of a product on the list under subsection (b).

    Inserted: "(d) Grant Awards.--A grant awarded under this section--

    Inserted: "(1) shall be used for the capital costs associated with the installation of countermeasure manufacturing equipment (including both final finished products and the related critical components required for these products), including the building and assembly of manufacturing equipment, modifications to existing facilities to accommodate such equipment, or expansion of existing facilities to accommodate such equipment, in accordance with the advanced manufacturing plan set forth in the application under subsection (c); and

    Inserted: "(2) shall be in amount not to exceed the amount sufficient to cover up to 50 percent of the costs described in paragraph (1).

    Inserted: "(e) Waiver of Certain Requirements.--The requirements of section 75.323 of title 45, Code of Federal Regulations (or any successor regulations) shall not apply with respect to a grant awarded under this section.

    Inserted: "(f) Ongoing Monitoring.--The Secretary, in coordination with the Secretary of Defense, shall establish and implement procedures for the ongoing monitoring of the program under this section to ensure that such program works toward the goal of expanding domestic production of drugs, biological products (including vaccines), devices (including respiratory protective devices), and other medical supplies.

    Inserted: "(g) Reporting.--Not later than 180 days after the date of the enactment of this section and annually thereafter, the Secretary, in coordination with the Secretary of Defense, shall submit to Congress a report on the program under this section. Each such report shall include certification that all funds appropriated for the purpose of carrying out this section are used solely for such purpose.

    Show 1 more inserted paragraph

    Inserted: "(h) Authorization of Appropriations.--To carry out this section, there are authorized to be appropriated $250,000,000 for each of fiscal years 2022 through 2026.".

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    Original wording

    At the appropriate place, insert the following:

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As printed

SA 1515. Ms. ERNST submitted an amendment intended to be proposed by her to the bill S. 1260, to establish a new Directorate for Technology and Innovation in the National Science Foundation, to establish a regional technology hub program, to require a strategy and report on economic security, science, research, innovation, manufacturing, and job creation, to establish a critical supply chain resiliency program, and for other purposes; which was ordered to lie on the table; as follows:

At the appropriate place, insert the following:

SEC. __. EXPANDING THE DOMESTIC PRODUCTION OF MEDICAL SUPPLIES.

Title III of the Public Health Service Act is amended by inserting after section 319F-4 (42 U.S.C. 247d-6e) the following:

“SEC. 319F-5. EXPANDING THE DOMESTIC PRODUCTION OF MEDICAL SUPPLIES.

“(a) In General.--The Secretary, in consultation with the Secretary of Defense, shall award grants to drug, biological product (including vaccines), device (including respiratory protective devices), and other medical supply manufacturers for the purpose of incentivizing such manufacturers to manufacture such products domestically using advanced manufacturing, and to ensure that the Nation is able to retain or acquire necessary supplies to address critical public health needs, including countermeasures required during a pandemic or other public health emergency.

“(b) Eligible Products.--The Secretary, in consultation with the Secretary of Defense, shall compile and update a list of drugs, biological products (including vaccines), devices (including respiratory protective devices), and other medical supplies that are, or may become, critical supplies in the event of a pandemic or public health emergency.

“(c) Eligibility.--To be eligible for a grant under this section, a manufacturer shall submit an application to the Secretary at such time, in such manner, and containing such information as the Secretary may require, including the applicant's plan for the advanced manufacturing, domestically, of a product on the list under subsection (b).

“(d) Grant Awards.--A grant awarded under this section--

“(1) shall be used for the capital costs associated with the installation of countermeasure manufacturing equipment (including both final finished products and the related critical components required for these products), including the building and assembly of manufacturing equipment, modifications to existing facilities to accommodate such equipment, or expansion of existing facilities to accommodate such equipment, in accordance with the advanced manufacturing plan set forth in the application under subsection (c); and

“(2) shall be in amount not to exceed the amount sufficient to cover up to 50 percent of the costs described in paragraph (1).

“(e) Waiver of Certain Requirements.--The requirements of section 75.323 of title 45, Code of Federal Regulations (or any successor regulations) shall not apply with respect to a grant awarded under this section.

“(f) Ongoing Monitoring.--The Secretary, in coordination with the Secretary of Defense, shall establish and implement procedures for the ongoing monitoring of the program under this section to ensure that such program works toward the goal of expanding domestic production of drugs, biological products (including vaccines), devices (including respiratory protective devices), and other medical supplies.

“(g) Reporting.--Not later than 180 days after the date of the enactment of this section and annually thereafter, the Secretary, in coordination with the Secretary of Defense, shall submit to Congress a report on the program under this section. Each such report shall include certification that all funds appropriated for the purpose of carrying out this section are used solely for such purpose.

“(h) Authorization of Appropriations.--To carry out this section, there are authorized to be appropriated $250,000,000 for each of fiscal years 2022 through 2026.”.

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Senate amendment submitted

May 18, 2021