S.Amdt. 2530

SA 2530. Mr. ALEXANDER submitted an amendment intended to be proposed
to amendment SA 2499 proposed by Mr. McConnell to the bill S. 178, to
condemn gross human rights violations of ethnic Turkic Muslims in
Xinjiang, and calling for an end to arbitrary detention, torture, and
harassment of these communities inside and outside China; which was
ordered to lie on the table; as follows:

At the appropriate place, insert the following:

TITLE __PANDEMIC PREPARATION

SEC. _01. SHORT TITLE.

This title may be cited as the ``Preparing for the Next
Pandemic Act''.

SEC. _02. SUSTAINED ON-SHORE MANUFACTURING CAPACITY FOR
PUBLIC HEALTH EMERGENCIES.

(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 domestic manufacturing surge
capacity of products or platform technologies, including
manufacturing capacity and capabilities to utilize platform
technologies to provide for flexible manufacturing
initiatives;''; and
(C) in clause (vi) (as so redesginated), by inserting
``manufacture,'' after ``improvement,'';
(2) in subsection (b)--
(A) in the first sentence of paragraph (1), by inserting
``support for domestic manufacturing surge capacity,'' 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 manufacturing surge capacities
and capabilities to increase the availability of existing
medical countermeasures and utilize existing novel platforms
to manufacture new medical countermeasures to meet
manufacturing demands to address threats that pose a
significant level of risk to national security; and'';
(3) in subsection (c)--
(A) in paragraph (2)--
(i) in subparagraph (C), by striking ``and'' at the end;
(ii) in subparagraph (D), by striking the period and
inserting ``; and''; and
(iii) by adding at the end the following:
``(E) promoting domestic manufacturing surge capacity and
capabilities for countermeasure advanced research and
development, including facilitating contracts to support
flexible or surge manufacturing.'';
(B) in paragraph (4)--
(i) 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) support and maintain domestic manufacturing surge
capacity and capabilities, including through contracts to
support flexible or surge manufacturing, to ensure that
additional production of countermeasures is available in the
event that the Secretary determines there is such a need for
additional production.'';
(ii) in subparagraph (D)--

(I) in clause (ii), by striking ``and'' at the end;
(II) by redesignating clause (iii) as clause (iv); and
(III) by inserting after clause (ii) the following:

``(iii) research to advance manufacturing capacities and
capabilities for medical countermeasures and platform
technologies that may be utilized for medical
countermeasures; and''; and
(iii) in subparagraph (E), by striking clause (ix); and
(C) in paragraph (7)(C)(i), by striking ``up to 100 highly
qualified individuals, or up to 50 percent of the total
number of employees, whichever is less,'' and inserting ``75
percent of the total number of employees'';
(4) in subsection (d), by adding at the end the following:
``(3) Additional funding.--For necessary expenses to
improve and expand manufacturing surge capacity and
capabilities pursuant to subsection (c)(4)(B)(v), there is
authorized to be appropriated $5,000,000,000 for fiscal year
2021, to remain available until September 30, 2030.
``(4) Advance appropriation.--
``(A) In general.--There is appropriated, out of amounts in
the Treasury not otherwise appropriated for the fiscal year
ending September 30, 2021, for necessary expenses to improve
and expand manufacturing surge capacity and capabilities
pursuant to subsection (c)(4)(B)(v), $5,000,000,000, to
remain available until September 30, 2030.
``(B) Emergency designation.--
``(i) In general.--The amounts provided by this paragraph
are designated as an emergency requirement pursuant to
section 4(g) of the Statutory Pay-As-You-Go Act of 2010 (2
U.S.C. 933(g)).
``(ii) Designation in senate.--In the Senate, this
paragraph is designated as an emergency requirement pursuant
to section 4112(a) of H. Con. Res. 71 (115th Congress), the
concurrent resolution on the budget for fiscal year 2018.
``(C) Application of provisions.--Amounts appropriated
pursuant to this paragraph for fiscal year 2021 shall be
subject to the requirements contained in Public Law 116-94
for funds for programs authorized under section 319L of this
Act.'';

[[Page S4805]]

(5) in subsection (e)(1)--
(A) by redesignating subparagraphs (B) through (D) as
subparagraphs (C) through (E), respectively; and
(B) by inserting after subparagraph (A), the following:
``(B) Temporary flexibility.--During a public health
emergency under section 319, the Secretary shall be provided
with an additional 60 business days to comply with
information requests for the disclosure of information under
section 552 of title 5, United States Code, related to the
activities under this section (unless such activities are
otherwise exempt under subparagraph (A)).''; and
(6) 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 Preparing for the Next Pandemic Act''; and
(B) in paragraph (2), by striking ``Not later than 1 year
after the date of enactment of this subsection'' and
inserting ``Not later than 1 year after the date of enactment
of the Preparing for the Next Pandemic Act''.
(b) Medical Countermeasure Innovation Partner.--The
restrictions under section 202 of division A of the Further
Consolidated Appropriations Act, 2020 (Public Law 116-94), or
any other provision of law imposing a restriction on salaries
of individuals related to a previous appropriation to the
Department of Health and Human Services, shall not apply with
respect to salaries paid pursuant to an agreement under the
medical countermeasure innovation partner program under
section 319L(c)(4)(E) of the Public Health Service Act (42
U.S.C. 247d-7e(c)(4)(E)).

SEC. _03. IMPROVING AND SUSTAINING STATE MEDICAL STOCKPILES.

Section 319F-2 of the Public Health Service Act (42 U.S.C.
247d-6b) is amended by adding at the end the following:
``(i) Improving and Maintaining State Medical Stockpiles.--
``(1) In general.--The Secretary, acting through the
Assistant Secretary for Preparedness and Response, shall
award grants, contracts, or cooperative agreements to
eligible entities to maintain a stockpile of appropriate
drugs, vaccines and other biological products, medical
devices, and other medical supplies (including personal
protective equipment, ancillary medical supplies, and other
applicable supplies required for the administration of drugs,
vaccines and other biological products, medical devices, and
diagnostic tests) to be used during a public health emergency
declared by the Governor of a State or by the Secretary under
section 319, or a major disaster or emergency declared by the
President under section 401 or 501, respectively, of the
Robert T. Stafford Disaster Relief and Emergency Assistance
Act, in order to support the preparedness goals described in
paragraphs (2), (3), and (8) of section 2802(b).
``(2) Eligible entities.--
``(A) In general.--To be eligible to receive an award under
paragraph (1), an entity shall--
``(i) be a State or consortium of States that is a
recipient of an award under section 319C-1(b); and
``(ii) prepare, in consultation with appropriate health
care providers and health officials within the State or
consortium of States, and submit to the Secretary an
application that contains such information as the Secretary
may require, including a plan for the State stockpile and a
description of the activities such entity will carry out
under the agreement, consistent with the requirements of
paragraph (3).
``(B) Limitation.--The Secretary may make an award under
this subsection to not more than one eligible entity in each
State.
``(C) Supplement not supplant.--Awards, contracts, or
grants awarded under this subsection shall supplement, not
supplant, the reserve amounts of medical supplies procured by
and for the Strategic National Stockpile under subsection
(a).
``(D) Administrative expenses.--Not more than 5 percent of
amounts received by an entity pursuant to an award under this
subsection may be used for administrative expenses.
``(E) Clarification.--An eligible entity receiving an award
under this subsection may assign a lead entity to manage the
State stockpile, which may be a recipient of an award under
section 319C-2(b).
``(F) Requirement of matching funds.--
``(i) In general.--Subject to clause (ii), the Secretary
may not make an award under this subsection unless the
applicant agrees, with respect to the costs to be incurred by
the applicant in carrying out the purpose described in this
subsection, to make available non-Federal contributions
toward such costs in an amount equal to--

``(I) for each of fiscal years 2023 and 2024, not less than
$1 for each $10 of Federal funds provided in the award;
``(II) for each of fiscal years 2025 and 2026, not less
than $1 for each $5 of Federal funds provided in the award;
and
``(III) for fiscal year 2027 and each fiscal year
thereafter, not less than $1 for each $3 of Federal funds
provided in the award.

``(ii) Waiver.--

``(I) In general.--The Secretary may, upon the request of a
State, waive the requirement under clause (i) in whole or in
part if the Secretary determines that extraordinary economic
conditions in the State in the fiscal year involved or in the
previous fiscal year justify the waiver.
``(II) Applicability of waiver.--A waiver provided by the
Secretary under this subparagraph shall apply only to the
fiscal year involved.

``(3) Stockpiling activities and requirements.--A recipient
of a grant, contract, or cooperative agreement under this
subsection shall use such funds to carry out the following:
``(A) Maintaining a stockpile of appropriate drugs,
vaccines and other biological products, medical devices, and
other supplies (including personal protective equipment,
ancillary medical supplies, and other applicable supplies
required for the administration of drugs, vaccines and other
biological products, medical devices, and diagnostic tests)
to be used during a public health emergency in such numbers,
types, and amounts as the State determines necessary,
consistent with such State's stockpile plan. Such a recipient
may not use funds to support the stockpiling of
countermeasures as defined under subsection (c), unless the
eligible entity provides justification for maintaining such
products and the Secretary determines such appropriate and
applicable.
``(B) Deploying the stockpile as required by the State to
respond to an actual or potential public health emergency.
``(C) Replenishing and making necessary additions or
modifications to the contents of such stockpile or
stockpiles, including to address potential depletion.
``(D) In consultation with Federal, State, and local
officials, take into consideration the availability,
deployment, dispensing, and administration requirements of
medical products within the stockpile.
``(E) Ensuring that procedures are followed for inventory
management and accounting, and for the physical security of
the stockpile, as appropriate.
``(F) Reviewing and revising, as appropriate, the contents
of the stockpile on a regular basis to ensure that to the
extent practicable, advanced technologies and medical
products are considered.
``(G) Carrying out exercises, drills, and other training
for purposes of stockpile deployment, dispensing, and
administration of medical products, and for purposes of
assessing the capability of such stockpile to address the
medical supply needs of public health emergencies of varying
types and scales, which may be conducted in accordance with
requirements related to exercises, drills, and other training
for recipients of awards under section 319C-1 or 319C-2, as
applicable.
``(H) Carrying out other activities as the State determines
appropriate, to support State efforts to prepare for, and
respond to, public health threats.
``(4) State plan coordination.--The eligible entity under
this subsection shall ensure appropriate coordination of the
State stockpile plan developed pursuant to paragraph
(2)(A)(ii) and the plans required pursuant to section 319C-1.
``(5) Guidance for states.--Not later than 180 days after
the date of enactment of this subsection, the Secretary,
acting through the Assistant Secretary for Preparedness and
Response, shall issue guidance for States related to
maintaining and replenishing a stockpile of medical products.
The Secretary shall update such guidance as appropriate.
``(6) Assistance to states.--The Secretary shall provide
assistance to States, including technical assistance, as
appropriate, to maintain and improve State and local public
health preparedness capabilities to distribute and dispense
medical products from a State stockpile.
``(7) Coordination with the strategic national stockpile.--
Each recipient of an award under this subsection shall ensure
that the State stockpile plan developed pursuant to paragraph
(2)(A)(ii) contains such information as the Secretary may
require related to current inventory of supplies maintained
pursuant to paragraph (3), and any plans to replenish such
supplies, or procure new or alternative supplies. The
Secretary shall use information obtained from State stockpile
plans to inform the maintenance and management of the
Strategic National Stockpile pursuant to subsection (a).
``(8) Performance and accountability.--
``(A) In general.--The Secretary, acting through the
Assistant Secretary for Preparedness and Response, shall
develop and implement a process to review and audit entities
in receipt of an award under this subsection, including by
establishing metrics to ensure that each entity receiving
such an award is carrying out activities in accordance with
the applicable State stockpile plan. The Secretary may
require entities to--
``(i) measure progress toward achieving the outcome goals;
and
``(ii) at least annually, test, exercise, and rigorously
evaluate the stockpile capacity and response capabilities of
the entity, and report to the Secretary on the results of
such test, exercise, and evaluation, and on progress toward
achieving outcome goals, based on criteria established by the
Secretary.
``(B) Notification of failure.--The Secretary shall develop
and implement a process to notify entities that are
determined by the Secretary to have failed to meet the
requirements of the terms of an award under this subsection.
Such process shall provide such entities with the opportunity
to correct such noncompliance. An entity that fails to
correct such noncompliance shall be subject to subparagraph
(C).

[[Page S4806]]

``(C) Withholding of certain amounts from entities that
fail to achieve benchmarks or submit state stockpile plan.--
Beginning with fiscal year 2022, and in each succeeding
fiscal year, the Secretary shall withhold from each entity
that has failed substantially to meet the terms of an award
under this subsection for at least 1 of the 2 immediately
preceding fiscal years (beginning with fiscal year 2022), the
amount allowed for administrative expenses described in
described in paragraph (2)(D).
``(9) Authorization of appropriations.--For the purpose of
carrying out this subsection, there are authorized to be
appropriated $1,000,000,000 for each of fiscal years 2021
through 2030, to remain available until expended.
``(10) Advance appropriation.--
``(A) In general.--There is appropriated, out of amounts in
the Treasury not otherwise appropriated, for fiscal year
2021, for necessary expenses to establish and maintain State
medical stockpiles pursuant to this subsection,
$10,000,000,000, to remain available until September 30,
2030.
``(B) Emergency designation.--
``(i) In general.--The amounts provided by this paragraph
are designated as an emergency requirement pursuant to
section 4(g) of the Statutory Pay-As-You-Go Act of 2010 (2
U.S.C. 933(g)).
``(ii) Designation in senate.--In the Senate, this
paragraph is designated as an emergency requirement pursuant
to section 4112(a) of H. Con. Res. 71 (115th Congress), the
concurrent resolution on the budget for fiscal year 2018.
``(C) Application of provisions.--Amounts appropriated
pursuant to this paragraph for fiscal year 2021 shall be
subject to the requirements contained in Public Law 116-94
for funds for programs authorized under section 319F-2 of
this Act.''.

SEC. _04. STRENGTHENING THE STRATEGIC NATIONAL STOCKPILE.

Section 319F-2 of the Public Health Service Act (42 U.S.C.
247d-6b) is amended--
(1) in subsection (a)--
(A) in paragraph (2)(A), by adding ``and the contracts
issued under paragraph (5)'' after ``paragraph (1)'';
(B) in paragraph (3)(F), by striking ``Secretary of
Homeland Security'' and inserting ``Secretary of Health and
Human Services, in coordination with or at the request of,
the Secretary of Homeland Security,'';
(C) by redesignating paragraph (5) as paragraph (6);
(D) by inserting after paragraph (4) the following:
``(5) Surge capacity.--The Secretary, in maintaining the
stockpile under paragraph (1) and carrying out procedures
under paragraph (3), may--
``(A) enter into contracts or cooperative agreements with
vendors for procurement, maintenance, and storage of reserve
amounts of drugs, vaccines and other biological products,
medical devices, and other medical supplies (including
personal protective equipment, ancillary medical supplies,
and other applicable supplies required for the administration
of drugs, vaccines and other biological products, medical
devices, and diagnostic tests in the stockpile), under such
terms and conditions (including quantity, production
schedule, maintenance costs, and price of product) as the
Secretary may specify, including for purposes of--
``(i) maintenance and storage of reserve amounts of
products intended to be delivered to the ownership of the
Federal Government under the contract, which may consider
costs of shipping, or otherwise transporting, handling,
storage, and related costs for such product or products; and
``(ii) maintaining domestic manufacturing capacity of such
products to ensure additional reserved production capacity of
such products is available, and that such products are
provided in a timely manner, to be delivered to the ownership
of the Federal Government under the contract and deployed in
the event that the Secretary determines that there is a need
to quickly purchase additional quantities of such product;
and
``(B) promulgate such regulations as the Secretary
determines necessary to implement this paragraph.''; and
(E) in subparagraph (A) of paragraph (6), as so
redesignated--
(i) in clause (viii), by striking ``; and'' and inserting a
semicolon;
(ii) in clause (ix), by striking the period and inserting
``; and''; and
(iii) by adding at the end the following:
``(x) an assessment of the contracts or cooperative
agreements entered into pursuant to paragraph (5).''; and
(2) in subsection (c)(2)(C), by striking ``on an annual
basis'' and inserting ``not later than March 15 of each
year''.
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