Strengthening America’s Strategic National Stockpile Act of 2021

IIB 117TH CONGRESS 1ST SESSION H. R. 3635 IN THE SENATE OF THE UNITED STATES OCTOBER 21, 2021 Received; read twice and referred to the Committee on Health, Education, Labor, and Pensions AN ACT To amend the Public Health Service Act with respect to the Strategic National Stockpile, and for other purposes. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 VerDate Sep 11 2014 01:39 Oct 22, 2021 Jkt 029200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H3635.RFS H3635 kjohnson on DSK79L0C42PROD with BILLS 2 HR 3635 RFS SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 1 (a) SHORT TITLE.—This Act may be cited as the 2 ‘‘Strengthening America’s Strategic National Stockpile 3 Act of 2021’’. 4 (b) TABLE OF CONTENTS.—The table of contents for 5 this Act is as follows: 6 Sec. 1. Short title; table of contents. Sec. 2. Reimbursable transfers. Sec. 3. Equipment maintenance. Sec. 4. Supply chain flexibility manufacturing pilot. Sec. 5. GAO study on the feasibility and benefits of a user fee agreement. Sec. 6. Grants for State strategic stockpiles. Sec. 7. Action reporting. Sec. 8. Improved, transparent processes. Sec. 9. Authorization of appropriations. SEC. 2. REIMBURSABLE TRANSFERS. 7 Section 319F–2(a) of the Public Health Service Act 8 (42 U.S.C. 247d–6b(a)) is amended by adding at the end 9 the following: 10 ‘‘(6) TRANSFERS AND REIMBURSEMENTS.— 11 ‘‘(A) IN GENERAL.—Without regard to 12 chapter 5 of title 40, United States Code, the 13 Secretary may transfer to any Federal depart- 14 ment or agency, on a reimbursable basis, any 15 drugs, vaccines and other biological products, 16 medical devices, and other supplies in the stock- 17 pile if— 18 ‘‘(i) the transferred supplies are less 19 than one year from expiry; 20 VerDate Sep 11 2014 01:39 Oct 22, 2021 Jkt 029200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H3635.RFS H3635 kjohnson on DSK79L0C42PROD with BILLS 3 HR 3635 RFS ‘‘(ii) the stockpile is able to replenish 1 the supplies, as appropriate; and 2 ‘‘(iii) the Secretary decides the trans- 3 fer is in the best interest of the United 4 States Government. 5 ‘‘(B) USE OF REIMBURSEMENT.—Reim- 6 bursement derived from the transfer of supplies 7 pursuant to subparagraph (A) may, to the ex- 8 tent and in the amounts made available in ad- 9 vance in appropriations Acts, be used by the 10 Secretary to carry out this section. Funds made 11 available pursuant to the preceding sentence are 12 in addition to any other funds that may be 13 made available for such purpose. 14 ‘‘(C) RULE OF CONSTRUCTION.—This 15 paragraph shall not be construed to preclude 16 transfers of products in the stockpile under 17 other authorities. 18 ‘‘(D) REPORT.—Not later than September 19 30, 2023, the Secretary shall submit to the 20 Committee on Energy and Commerce of the 21 House of Representatives and the Committee 22 on Health, Education, Labor, and Pensions of 23 the Senate a report on each transfer made 24 VerDate Sep 11 2014 01:39 Oct 22, 2021 Jkt 029200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H3635.RFS H3635 kjohnson on DSK79L0C42PROD with BILLS 4 HR 3635 RFS under this paragraph and the amount received 1 by the Secretary in exchange for that transfer. 2 ‘‘(E) SUNSET.—The authority to make 3 transfers under this paragraph shall cease to be 4 effective on September 30, 2024.’’. 5 SEC. 3. EQUIPMENT MAINTENANCE. 6 Section 319F–2 of the Public Health Service Act (42 7 U.S.C. 247d–6b) is amended— 8 (1) in subsection (a)(3)— 9 (A) in subparagraph (I), by striking ‘‘; 10 and’’ and inserting a semicolon; 11 (B) in subparagraph (J), by striking the 12 period at the end and inserting a semicolon; 13 and 14 (C) by inserting the following new subpara- 15 graph at the end: 16 ‘‘(K) ensure contents of the stockpile re- 17 main in good working order and, as appro- 18 priate, conduct maintenance services on con- 19 tents of the stockpile; and’’; and 20 (2) in subsection (c)(7)(B), by adding at the 21 end the following new clause: 22 ‘‘(ix) EQUIPMENT MAINTENANCE 23 SERVICE.—In carrying out this section, the 24 Secretary may enter into contracts for the 25 VerDate Sep 11 2014 01:39 Oct 22, 2021 Jkt 029200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H3635.RFS H3635 kjohnson on DSK79L0C42PROD with BILLS 5 HR 3635 RFS procurement of equipment maintenance 1 services.’’. 2 SEC. 4. SUPPLY CHAIN FLEXIBILITY MANUFACTURING 3 PILOT. 4 (a) IN GENERAL.—Section 319F–2(a)(3) of the Pub- 5 lic Health Service Act (42 U.S.C. 247d–6b(a)(3)), as 6 amended by section 3, is further amended by adding at 7 the end the following new subparagraph: 8 ‘‘(L) enhance medical supply chain elas- 9 ticity and establish and maintain domestic re- 10 serves of critical medical supplies (including 11 personal protective equipment, ancillary medical 12 supplies, and other applicable supplies required 13 for the administration of drugs, vaccines and 14 other biological products, and other medical de- 15 vices (including diagnostic tests)) by— 16 ‘‘(i) increasing emergency stock of 17 critical medical supplies; 18 ‘‘(ii) geographically diversifying do- 19 mestic production of such medical supplies, 20 as appropriate; 21 ‘‘(iii) entering into cooperative agree- 22 ments or partnerships with respect to man- 23 ufacturing lines, facilities, and equipment 24 VerDate Sep 11 2014 01:39 Oct 22, 2021 Jkt 029200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H3635.RFS H3635 kjohnson on DSK79L0C42PROD with BILLS 6 HR 3635 RFS for the domestic production of such med- 1 ical supplies; and 2 ‘‘(iv) managing, either directly or 3 through cooperative agreements with man- 4 ufacturers and distributors, domestic re- 5 serves established under this subparagraph 6 by refreshing and replenishing stock of 7 such medical supplies.’’. 8 (b) REPORTING; SUNSET.—Section 319F–2(a) of the 9 Public Health Service Act (42 U.S.C. 247d–6b(a)), as 10 amended by section 2, is further amended by adding at 11 the end the following: 12 ‘‘(7) REPORTING.—Not later than September 13 30, 2023, the Secretary shall submit to the Com- 14 mittee on Energy and Commerce of the House of 15 Representatives and the Committee on Health, Edu- 16 cation, Labor and Pensions of the Senate a report 17 on the details of each cooperative agreement or part- 18 nership entered into under paragraph (3)(L), includ- 19 ing the amount expended by the Secretary on each 20 such cooperative agreement or partnership. 21 ‘‘(8) SUNSET.—The authority to enter into co- 22 operative agreements or partnerships pursuant to 23 paragraph (3)(L) shall cease to be effective on Sep- 24 tember 30, 2024.’’. 25 VerDate Sep 11 2014 01:39 Oct 22, 2021 Jkt 029200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H3635.RFS H3635 kjohnson on DSK79L0C42PROD with BILLS 7 HR 3635 RFS (c) FUNDING.—Section 319F–2(f) of the Public 1 Health Service Act (42 U.S.C. 247d–6b(f)) is amended by 2 adding at the end the following: 3 ‘‘(3) SUPPLY CHAIN ELASTICITY.— 4 ‘‘(A) IN GENERAL.—For the purpose of 5 carrying out subsection (a)(3)(L), there is au- 6 thorized to be appropriated $500,000,000 for 7 each of fiscal years 2022 through 2024, to re- 8 main available until expended. 9 ‘‘(B) RELATION TO OTHER AMOUNTS.— 10 The amount authorized to be appropriated by 11 subparagraph (A) for the purpose of carrying 12 out subsection (a)(3)(L) is in addition to any 13 other amounts available for such purpose.’’. 14 SEC. 5. GAO STUDY ON THE FEASIBILITY AND BENEFITS OF 15 A USER FEE AGREEMENT. 16 (a) IN GENERAL.—The Comptroller General of the 17 United States shall conduct a study to investigate the fea- 18 sibility of establishing user fees to offset certain Federal 19 costs attributable to the procurement of single-source ma- 20 terials for the Strategic National Stockpile under section 21 319F–2 of the Public Health Service Act (42 U.S.C. 22 247d–6b) and distributions of such materials from the 23 Stockpile. In conducting this study, the Comptroller Gen- 24 eral shall consider, to the extent information is available— 25 VerDate Sep 11 2014 01:39 Oct 22, 2021 Jkt 029200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H3635.RFS H3635 kjohnson on DSK79L0C42PROD with BILLS 8 HR 3635 RFS (1) whether entities receiving such distributions 1 generate profits from those distributions; 2 (2) any Federal costs attributable to such dis- 3 tributions; 4 (3) whether such user fees would provide the 5 Secretary with funding to potentially offset procure- 6 ment costs of such materials for the Strategic Na- 7 tional Stockpile; and 8 (4) any other issues the Comptroller General 9 identifies as relevant. 10 (b) REPORT.—Not later than February 1, 2024, the 11 Comptroller General of the United States shall submit to 12 the Congress a report on the findings and conclusions of 13 the study under subsection (a). 14 SEC. 6. GRANTS FOR STATE STRATEGIC STOCKPILES. 15 Title III of the Public Health Service Act is amended 16 by inserting after section 319F–4 of such Act (42 U.S.C. 17 247d–6e) the following new section: 18 ‘‘SEC. 319F–5. GRANTS FOR STATE STRATEGIC STOCKPILES. 19 ‘‘(a) IN GENERAL.—The Secretary may establish a 20 pilot program consisting of awarding grants to States to 21 expand or maintain a strategic stockpile of commercially 22 available drugs, devices, personal protective equipment, 23 and other products deemed by the State to be essential 24 in the event of a public health emergency. 25 VerDate Sep 11 2014 01:39 Oct 22, 2021 Jkt 029200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H3635.RFS H3635 kjohnson on DSK79L0C42PROD with BILLS 9 HR 3635 RFS ‘‘(b) ALLOWABLE USE OF FUNDS.— 1 ‘‘(1) USES.—A State receiving a grant under 2 this section may use the grant funds to— 3 ‘‘(A) acquire commercially available prod- 4 ucts listed pursuant to paragraph (2) for inclu- 5 sion in the State’s strategic stockpile; 6 ‘‘(B) store, maintain, and distribute prod- 7 ucts in such stockpile; and 8 ‘‘(C) conduct planning in connection with 9 such activities. 10 ‘‘(2) LIST.—The Secretary shall develop and 11 publish a list of the products that are eligible, as de- 12 scribed in subsection (a), for inclusion in a State’s 13 strategic stockpile using funds received under this 14 section. 15 ‘‘(3) CONSULTATION.—In developing the list 16 under paragraph (2) and otherwise determining the 17 allowable uses of grant funds under this section, the 18 Secretary shall consult with States and relevant 19 stakeholders, including public health organizations. 20 ‘‘(c) FUNDING REQUIREMENT.—The Secretary may 21 not obligate or expend any funds to award grants or fund 22 any previously awarded grants under this section for a fis- 23 cal year unless the total amount made available to carry 24 out section 319F–2 for such fiscal year is equal to or 25 VerDate Sep 11 2014 01:39 Oct 22, 2021 Jkt 029200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H3635.RFS H3635 kjohnson on DSK79L0C42PROD with BILLS 10 HR 3635 RFS greater than the total amount of funds made available to 1 carry out section 319F–2 for fiscal year 2022. 2 ‘‘(d) MATCHING FUNDS.— 3 ‘‘(1) IN GENERAL.—With respect to the costs of 4 expanding and maintaining a strategic stockpile 5 through a grant under this section, as a condition on 6 receipt of the grant, a State shall make available (di- 7 rectly) non-Federal contributions in cash toward 8 such costs in an amount that is equal to not less 9 than the amount of Federal funds provided through 10 the grant. 11 ‘‘(2) WAIVER.—The Secretary may waive the 12 requirement of paragraph (1) with respect to a State 13 for the first two years of the State receiving a grant 14 under this section if the Secretary determines that 15 such waiver is needed for the State to establish a 16 strategic stockpile described in subsection (a). 17 ‘‘(e) TECHNICAL ASSISTANCE.—The Secretary shall 18 provide technical assistance to States in establishing, ex- 19 panding, and maintaining a stockpile described in sub- 20 section (a). 21 ‘‘(f) DEFINITION.—In this section, the term ‘drug’ 22 has the meaning given to that term in section 201 of the 23 Federal Food, Drug, and Cosmetic Act. 24 VerDate Sep 11 2014 01:39 Oct 22, 2021 Jkt 029200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H3635.RFS H3635 kjohnson on DSK79L0C42PROD with BILLS 11 HR 3635 RFS ‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—To 1 carry out this section, there is authorized to be appro- 2 priated $3,500,000,000 for each of fiscal years 2022 3 through 2024, to remain available until expended. 4 ‘‘(h) SUNSET.—The authority vested by this section 5 terminates at the end of fiscal year 2024.’’. 6 SEC. 7. ACTION REPORTING. 7 (a) IN GENERAL.—The Secretary of Health and 8 Human Services or the Assistant Secretary for Prepared- 9 ness and Response, in consultation with the Administrator 10 of the Federal Emergency Management Agency, shall— 11 (1) not later than 30 days after the date of en- 12 actment of this Act, issue a report to the Committee 13 on Energy and Commerce of the House of Rep- 14 resentatives and the Committee on Health, Edu- 15 cation, Labor, and Pensions of the Senate regarding 16 all State, local, Tribal, and territorial requests for 17 supplies from the Strategic National Stockpile re- 18 lated to COVID–19; and 19 (2) not less than every 30 days thereafter 20 through the end of the emergency period (as such 21 term is defined in section 1135(g)(1)(B) of the So- 22 cial Security Act (42 U.S.C. 1320b–5(g)(1)(B))), 23 submit to such committees an updated version of 24 such report. 25 VerDate Sep 11 2014 01:39 Oct 22, 2021 Jkt 029200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H3635.RFS H3635 kjohnson on DSK79L0C42PROD with BILLS 12 HR 3635 RFS (b) REPORTING PERIOD.— 1 (1) INITIAL REPORT.—The initial report under 2 subsection (a) shall address all requests described in 3 such subsection made during the period— 4 (A) beginning on January 31, 2022; and 5 (B) ending on the date that is 30 days be- 6 fore the date of submission of the report. 7 (2) UPDATES.—Each update to the report 8 under subsection (a) shall address all requests de- 9 scribed in such subsection made during the period— 10 (A) beginning at the end of the previous 11 reporting period under this section; and 12 (B) ending on the date that is 30 days be- 13 fore the date of submission of the updated re- 14 port. 15 (c) CONTENTS OF REPORT.—The report under sub- 16 section (a) (and updates thereto) shall include— 17 (1) the details of each request described in such 18 subsection, including— 19 (A) the specific medical countermeasures, 20 devices, personal protective equipment, and 21 other materials requested; and 22 (B) the amount of such materials re- 23 quested; and 24 VerDate Sep 11 2014 01:39 Oct 22, 2021 Jkt 029200 PO [Text truncated for display. 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