S.Amdt. 1576

SA 1576. Mr. MANCHIN (for himself and Mrs. Capito) submitted an
amendment intended to be proposed to amendment SA 1502 proposed by Mr.
Schumer 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:

Strike subsections (e), (f), and (g) of section 4153 and
insert the following:
(e) Report.--
(1) In general.--Not later than 180 days after the date of
the enactment of this Act, the Director of the Office of
Management and Budget, in consultation with the covered
Secretaries, shall submit to the chairs and ranking members
of the appropriate congressional committees a report on the
procurement of personal protective equipment and solid oral
dose essential drugs (as defined in section 4154).

[[Page S3100]]

(2) Elements.--The report required under paragraph (1)
shall include the following elements:
(A) The United States long-term domestic procurement
strategy for PPE and solid oral dose essential drugs produced
in the United States, including strategies to incentivize
investment in and maintain United States supply chains for
all such PPE and drugs sufficient to meet the needs of the
United States during a public health emergency.
(B) An estimate of long-term demand quantities for all PPE
items and solid oral dose essential drugs procured by the
United States.
(C) Recommendations for congressional action required to
implement the United States Government's procurement
strategy.
(D) A determination whether all notifications, amendments,
and other necessary actions have been completed to bring the
United States existing international obligations into
conformity with the statutory requirements of this subtitle.
(f) Authorization of Transfer of Equipment.--
(1) In general.--A covered Secretary may transfer to the
Strategic National Stockpile established under section 319F-2
of the Public Health Service Act (42 U.S.C. 247d-6b) any
excess personal protective equipment or solid oral dose
essential drugs acquired under a contract executed pursuant
to subsection (b) or section 4154(b).
(2) Transfer of equipment during a public health
emergency.--
(A) Amendment.--Title V of the Homeland Security Act of
2002 (6 U.S.C. 311 et seq.) is amended by adding at the end
the following:

``SEC. 529. TRANSFER OF EQUIPMENT AND DRUGS DURING A PUBLIC
HEALTH EMERGENCY.

``(a) Authorization of Transfer of Equipment.--During a
public health emergency declared by the Secretary of Health
and Human Services under section 319(a) of the Public Health
Service Act (42 U.S.C. 247d(a)), the Secretary, at the
request of the Secretary of Health and Human Services, may
transfer to the Department of Health and Human Services, on a
reimbursable basis, excess personal protective equipment,
medically necessary equipment, or solid oral dose essential
drugs in the possession of the Department.
``(b) Determination by Secretaries.--
``(1) In general.--In carrying out this section--
``(A) before requesting a transfer under subsection (a),
the Secretary of Health and Human Services shall determine
whether the personal protective equipment, medically
necessary equipment, or solid oral dose essential drug is
otherwise available; and
``(B) before initiating a transfer under subsection (a),
the Secretary, in consultation with the heads of each
component within the Department, shall--
``(i) determine whether the personal protective equipment,
medically necessary equipment, or drug requested to be
transferred under subsection (a) is excess equipment or
drugs; and
``(ii) certify that the transfer of the personal protective
equipment, medically necessary equipment, or solid oral dose
essential drug will not adversely impact the health or safety
of officers, employees, or contractors of the Department.
``(2) Notification.--The Secretary of Health and Human
Services and the Secretary shall each submit to Congress a
notification explaining the determination made under
subparagraphs (A) and (B), respectively, of paragraph (1).
``(3) Required inventory.--
``(A) In general.--The Secretary shall--
``(i) acting through the Chief Medical Officer of the
Department, maintain an inventory of all personal protective
equipment, medically necessary equipment, and solid oral dose
essential drugs in the possession of the Department; and
``(ii) make the inventory required under clause (i)
available, on a continual basis, to--

``(I) the Secretary of Health and Human Services; and
``(II) the Committee on Appropriations and the Committee on
Homeland Security and Governmental Affairs of the Senate and
the Committee on Appropriations and the Committee on Homeland
Security of the House of Representatives.

``(B) Form.--Each inventory required to be made available
under subparagraph (A) shall be submitted in unclassified
form, but may include a classified annex.
``(c) Solid Oral Dose Essential Drugs.--In this section,
the term `solid oral dose essential drug' means a drug
included on the most recent list of essential medicines
issued by the Food and Drug Administration pursuant to
Executive Order 13944 (85 Fed. Reg. 49929) that is available
in a solid, oral dose form.''.
(B) Table of contents amendment.--The table of contents in
section 1(b) of the Homeland Security Act of 2002 (Public Law
107-296; 116 Stat. 2135) is amended by inserting after the
item relating to section 528 the following:

``Sec. 529. Transfer of equipment and drugs during a public health
emergency.''.
(3) Strategic national stockpile.--Section 319F-2(a) of the
Public Health Service Act (42 U.S.C. 247d-6b(a)) is amended
by adding at the end the following:
``(6) Transfers of items.--The Secretary, in coordination
with the Secretary of Homeland Security, may sell drugs,
vaccines and other biological products, medical devices, or
other supplies maintained in the stockpile under paragraph
(1) to a Federal agency or private, nonprofit, State, local,
tribal, or territorial entity for immediate use and
distribution, provided that any such items being sold are--
``(A) within 1 year of their expiration date; or
``(B) determined by the Secretary to no longer be needed in
the stockpile due to advances in medical or technical
capabilities.''.
(g) Compliance With International Agreements.--The
President or the President's designee shall take all
necessary steps, including invoking the rights of the United
States under Article III of the World Trade Organization's
Agreement on Government Procurement and the relevant
exceptions of other relevant agreements to which the United
States is a party, to ensure that the international
obligations of the United States are consistent with the
provisions of this subtitle.

SEC. 4154. REQUIREMENT OF LONG-TERM CONTRACTS FOR
DOMESTICALLY MANUFACTURED SOLID ORAL DOSE
ESSENTIAL DRUGS.

(a) Definitions.--In this section:
(1) Appropriate congressional committees.--The term
``appropriate congressional committees'' means--
(A) the Committee on Homeland Security and Governmental
Affairs, the Committee on Health, Education, Labor, and
Pensions, the Committee on Finance, and the Committee on
Veterans' Affairs of the Senate; and
(B) the Committee on Homeland Security, the Committee on
Oversight and Reform, the Committee on Energy and Commerce,
the Committee on Ways and Means, and the Committee on
Veterans' Affairs of the House of Representatives.
(2) Covered secretary.--The term ``covered Secretary''
means the Secretary of Homeland Security, the Secretary of
Health and Human Services, and the Secretary of Veterans
Affairs.
(3) Solid oral dose essential drug.--The term ``solid oral
dose essential drug'' means a drug included on the most
recent list of essential medicines issued by the Food and
Drug Administration pursuant to Executive Order 13944 (85
Fed. Reg. 49929) that is available in a solid, oral dose
form.
(4) United states.--The term ``United States'' means the 50
States, the District of Columbia, and the possessions of the
United States.
(b) Contract Requirements for Domestic Production.--
Beginning 90 days after the date of the enactment of this
Act, in order to ensure the sustainment and expansion of
solid oral dose essential drug manufacturing in the United
States and meet the needs of the current pandemic response,
any contract for the procurement of solid oral dose essential
drug entered into by a covered Secretary, or a covered
Secretary's designee, shall--
(1) be issued for a duration of at least 2 years, plus all
option periods necessary, to incentivize investment in the
production of a solid oral dose essential drug and the
ingredients thereof in the United States; and
(2) be for a solid oral dose essential drug, including the
ingredients thereof, that is manufactured, processed, or
packed in the United States.
(c) Alternatives to Domestic Production.--The requirement
under subsection (b) shall not apply to a solid oral dose
essential drug, or an ingredient thereof if, after maximizing
to the extent feasible sources consistent with subsection
(b), the covered Secretary--
(1) maximizes sources for the solid oral dose essential
drug that manufactured, processed, or packed outside the
United States containing only ingredients that are available
in the United States; and
(2) certifies every 120 days that it is necessary to
procure the solid oral dose essential drug under alternative
procedures to respond to the immediate needs of a public
health emergency.
(d) Availability Exception.--
(1) In general.--Subsections (b) and (c) shall not apply to
a solid oral dose essential drug, or ingredient thereof--
(A) that is, or that includes, a material listed in section
25.104 of the Federal Acquisition Regulation as one for which
a non-availability determination has been made; or
(B) as to which the covered Secretary determines that a
sufficient quantity of a satisfactory quality that is
manufactured, processed, or packed in the United States
cannot be procured as, and when, needed at United States
market prices.
(2) Certification requirement.--The covered Secretary shall
certify every 120 days that the exception under paragraph (1)
is necessary to meet the immediate needs of a public health
emergency.
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