[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 4231 Introduced in Senate (IS)]
<DOC>
116th CONGRESS
2d Session
S. 4231
To strengthen and sustain on-shore manufacturing capacity and State
stockpiles, and to improve the Strategic National Stockpile.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
July 20, 2020
Mr. Alexander introduced the following bill; which was read twice and
referred to the Committee on Health, Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To strengthen and sustain on-shore manufacturing capacity and State
stockpiles, and to improve the Strategic National Stockpile.
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 ``Preparing for the Next Pandemic
Act''.
SEC. 2. 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, there is authorized to be appropriated to the
Fund $5,000,000,000, 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.'';
(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. 3. 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).
``(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. 4. 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''.
<all>