[Congressional Record Volume 167, Number 87 (Wednesday, May 19, 2021)]
[Senate]
[Pages S3099-S3100]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

  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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