[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 3588 Introduced in Senate (IS)]
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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.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Medical Countermeasures Surge
Capacity Act of 2022''.
SEC. 2. WARM BASE MANUFACTURING CAPACITY FOR MEDICAL COUNTERMEASURES.
(a) In General.--Section 319L of the Public Health Service Act (42
U.S.C. 247d-7e) is amended--
(1) in subsection (a)(6)(B)--
(A) by redesignating clauses (iv) and (v) as
clauses (v) and (vi), respectively;
(B) by inserting after clause (iii), the following:
``(iv) activities to support, maintain, and
improve domestic manufacturing surge capacity
and capabilities, as appropriate, including
through the utilization of advanced
manufacturing and platform technologies, to
increase the availability of products that are
or may become qualified countermeasures or
qualified pandemic or epidemic products;''; and
(C) in clause (vi) (as so redesignated), by
inserting ``manufacturing,'' after ``improvement,'';
(2) in subsection (b)--
(A) in the first sentence of paragraph (1), by
inserting ``support for domestic manufacturing surge
capacity and capabilities,'' after ``initiatives for
innovation,''; and
(B) in paragraph (2)--
(i) in subparagraph (B), by striking
``and'' at the end;
(ii) by redesignating subparagraph (C) as
subparagraph (D); and
(iii) by inserting after subparagraph (B),
the following:
``(C) activities to support, maintain, and improve
domestic manufacturing surge capacity and capabilities,
as appropriate, including through the utilization of
advanced manufacturing and platform technologies, to
increase the availability of products that are or may
become qualified countermeasures or qualified pandemic
or epidemic products; and'';
(3) in subsection (c)--
(A) in paragraph (2)(B), by inserting before the
semicolon ``, including through the establishment and
maintenance of domestic manufacturing surge capacity
and capabilities, consistent with subsection
(a)(6)(B)(iv)'';
(B) in paragraph (4)--
(i) in subparagraph (A)--
(I) in clause (i)--
(aa) in subclause (I), by
striking ``and'' at the end;
and
(bb) by adding at the end
the following:
``(III) facilitating such
communication, as appropriate,
regarding manufacturing surge capacity
and capabilities with respect to
qualified countermeasures and qualified
pandemic or epidemic products to
prepare for, or respond to, a public
health emergency or potential public
health emergency; and
``(IV) facilitating such
communication, as appropriate and in a
manner that does not compromise
national security, with respect to
potential eligibility for the material
threat medical countermeasure priority
review voucher program under section
565A of the Federal Food, Drug, and
Cosmetic Act;'';
(II) in clause (ii)(III), by
striking ``and'' at the end;
(III) by redesignating clause (iii)
as clause (iv); and
(IV) by inserting after clause
(ii), the following:
``(iii) communicate regularly with entities
in receipt of an award pursuant to subparagraph
(B)(v), and facilitate communication between
such entities and other entities in receipt of
an award pursuant to subparagraph (B)(iv), as
appropriate, for purposes of planning regarding
the availability of countermeasures and the
maintenance of domestic manufacturing surge
capacity and capabilities, including any
planned uses of such capacity and capabilities
in the near- and mid-term, and identification
of any significant challenges related to the
long-term maintenance of such capacity and
capabilities; and'';
(ii) in subparagraph (B)--
(I) in clause (iii), by striking
``and'' at the end;
(II) in clause (iv), by striking
the period and inserting ``; and''; and
(III) by adding at the end the
following:
``(v) award contracts, grants, and
cooperative agreements and enter into other
transactions to support, maintain, and improve
domestic manufacturing surge capacity and
capabilities, including through supporting
flexible or advanced manufacturing, to ensure
that additional capacity is available to
rapidly manufacture products that are or may
become qualified countermeasures or qualified
pandemic or epidemic products in the event of a
public health emergency declaration or
significant potential for a public health
emergency.'';
(iii) in subparagraph (C)--
(I) in clause (i), by striking
``and'' at the end;
(II) in clause (ii), by striking
the period at the end and inserting ``;
and''; and
(III) by adding at the end the
following:
``(iii) consult with the Commissioner of
Food and Drugs, pursuant to section 565(b)(2)
of the Federal Food, Drug, and Cosmetic Act, to
ensure that facilities performing
manufacturing, pursuant to an award under
subparagraph (B)(v), are in compliance with
applicable requirements under such Act and this
Act, as appropriate, including current good
manufacturing practice pursuant to section
501(a)(2)(B) of the Food, Drug, and Cosmetic
Act; and'';
(iv) in subparagraph (D)(i), by inserting
``, including to improve manufacturing
capacities and capabilities for medical
countermeasures'' before the semicolon;
(v) in subparagraph (E)(ix), by striking
``2023'' and inserting ``2028''; and
(vi) by adding at the end the following:
``(G) Annual reports by award recipients.--As a
condition of receiving an award under subparagraph
(B)(v), a recipient shall develop and submit to the
Secretary annual reports related to the maintenance of
such capacity and capabilities, including ensuring that
such capacity and capabilities are able to support the
rapid manufacture of countermeasures as required by the
Secretary.''; and
(C) in paragraph (5), by adding at the end the
following:
``(H) Supporting warm-base and surge capacity and
capabilities.--Pursuant to an award under subparagraph
(B)(v), the Secretary may make payments for activities
necessary to maintain domestic manufacturing surge
capacity and capabilities supported under such award to
ensure that such capacity and capabilities are able to
support the rapid manufacture of countermeasures as
required by the Secretary to prepare for, or respond
to, an existing or potential public health emergency or
otherwise address threats that pose a significant level
of risk to national security. The Secretary may support
the utilization of such capacity and capabilities under
awards for countermeasure and product advanced research
and development, as appropriate, to provide for the
maintenance of such capacity and capabilities.''; and
(4) in subsection (f)--
(A) in paragraph (1), by striking ``Not later than
180 days after the date of enactment of this
subsection'' and inserting ``Not later than 180 days
after the date of enactment of the Medical
Countermeasures Surge Capacity Act of 2022'';
(B) in paragraph (2)--
(i) in the matter preceding subparagraph
(A), by striking ``this subsection'' and
inserting ``the Medical Countermeasures Surge
Capacity Act of 2022'';
(ii) in subparagraph (B), by striking
``and'' at the end; and
(iii) in subparagraph (C), by striking the
period and inserting ``; and''; and
(C) by adding at the end the following:
``(D) plans for the near-, mid-, and long-term
sustainment of manufacturing activities carried out
under this section, including such activities pursuant
to subsection (c)(5)(H), specific actions to regularly
assess the ability of recipients of an award under
subsection (c)(4)(B)(v) to rapidly manufacture
countermeasures as required by the Secretary, and
recommendations to address challenges, if any, related
to such activities.''.
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