SAVE Act of 2021

IIB 117TH CONGRESS 1ST SESSION H. R. 3146 IN THE SENATE OF THE UNITED STATES MAY 19, 2021 Received; read twice and referred to the Committee on Banking, Housing, and Urban Affairs AN ACT To amend the Defense Production Act of 1950 to ensure the supply of certain medical materials essential to na- tional defense, 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 03:15 May 20, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H3146.RFS H3146 kjohnson on DSK79L0C42PROD with BILLS 2 HR 3146 RFS SECTION 1. SHORT TITLE. 1 This Act may be cited as the ‘‘Securing America’s 2 Vaccines for Emergencies Act of 2021’’ or the ‘‘SAVE Act 3 of 2021’’. 4 SEC. 2. SECURING ESSENTIAL MEDICAL MATERIALS. 5 (a) STATEMENT OF POLICY.—Section 2(b) of the De- 6 fense Production Act of 1950 (50 U.S.C. 4502) is amend- 7 ed— 8 (1) by redesignating paragraphs (3) through 9 (8) as paragraphs (4) through (9), respectively; and 10 (2) by inserting after paragraph (2) the fol- 11 lowing: 12 ‘‘(3) authorities under this Act should be used 13 when appropriate to ensure the availability of med- 14 ical materials essential to national defense, including 15 through measures designed to secure the drug sup- 16 ply chain, and taking into consideration the impor- 17 tance of United States competitiveness, scientific 18 leadership and cooperation, and innovative capac- 19 ity;’’. 20 (b) STRENGTHENING DOMESTIC CAPABILITY.—Sec- 21 tion 107 of the Defense Production Act of 1950 (50 22 U.S.C. 4517) is amended— 23 (1) in subsection (a), by inserting ‘‘(including 24 medical materials)’’ after ‘‘materials’’; and 25 VerDate Sep 11 2014 03:15 May 20, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H3146.RFS H3146 kjohnson on DSK79L0C42PROD with BILLS 3 HR 3146 RFS (2) in subsection (b)(1), by inserting ‘‘(includ- 1 ing medical materials such as drugs, devices, and bi- 2 ological products to diagnose, cure, mitigate, treat, 3 or prevent disease that are essential to national de- 4 fense)’’ after ‘‘essential materials’’. 5 (c) STRATEGY ON SECURING SUPPLY CHAINS FOR 6 MEDICAL MATERIALS.—Title I of the Defense Production 7 Act of 1950 (50 U.S.C. 4511 et seq.) is amended by add- 8 ing at the end the following: 9 ‘‘SEC. 109. STRATEGY ON SECURING SUPPLY CHAINS FOR 10 MEDICAL MATERIALS. 11 ‘‘(a) IN GENERAL.—Not later than 180 days after 12 the date of the enactment of this section, the President, 13 in consultation with the Secretary of Health and Human 14 Services, the Secretary of Commerce, the Secretary of 15 Homeland Security, and the Secretary of Defense, shall 16 transmit a strategy to the appropriate Members of Con- 17 gress that includes the following: 18 ‘‘(1) A detailed plan to use the authorities 19 under this title and title III, or any other provision 20 of law, to ensure the supply of medical materials (in- 21 cluding drugs, devices, and biological products (as 22 that term is defined in section 351 of the Public 23 Health Service Act (42 U.S.C. 262)) to diagnose, 24 cure, mitigate, treat, or prevent disease) essential to 25 VerDate Sep 11 2014 03:15 May 20, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H3146.RFS H3146 kjohnson on DSK79L0C42PROD with BILLS 4 HR 3146 RFS national defense, to the extent necessary for the pur- 1 poses of this Act. 2 ‘‘(2) An analysis of vulnerabilities to existing 3 supply chains for such medical materials, and rec- 4 ommendations to address the vulnerabilities. 5 ‘‘(3) Measures to be undertaken by the Presi- 6 dent to diversify such supply chains, as appropriate 7 and as required for national defense. 8 ‘‘(4) A discussion of— 9 ‘‘(A) any significant effects resulting from 10 the plan and measures described in this sub- 11 section on the production, cost, or distribution 12 of biological products (as that term is defined 13 in section 351 of the Public Health Service Act 14 (42 U.S.C. 262)) or any other devices or drugs 15 (as defined under the Federal Food, Drug, and 16 Cosmetic Act (21 U.S.C. 301 et seq.)); 17 ‘‘(B) a timeline to ensure that essential 18 components of the supply chain for medical ma- 19 terials are not under the exclusive control of a 20 foreign government in a manner that the Presi- 21 dent determines could threaten the national de- 22 fense of the United States; and 23 ‘‘(C) efforts to mitigate any risks resulting 24 from the plan and measures described in this 25 VerDate Sep 11 2014 03:15 May 20, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H3146.RFS H3146 kjohnson on DSK79L0C42PROD with BILLS 5 HR 3146 RFS subsection to United States competitiveness, 1 scientific leadership, and innovative capacity, 2 including efforts to cooperate and proactively 3 engage with United States allies. 4 ‘‘(b) PROGRESS REPORT.—Following submission of 5 the strategy under subsection (a), the President shall sub- 6 mit to the appropriate Members of Congress an annual 7 progress report until September 30, 2025, evaluating the 8 implementation of the strategy, and may include updates 9 to the strategy as appropriate. The strategy and progress 10 reports shall be submitted in unclassified form but may 11 contain a classified annex. 12 ‘‘(c) APPROPRIATE MEMBERS OF CONGRESS.—The 13 term ‘appropriate Members of Congress’ means the 14 Speaker, majority leader, and minority leader of the 15 House of Representatives, the majority leader and minor- 16 ity leader of the Senate, the Chairman and Ranking Mem- 17 ber of the Committee on Financial Services of the House 18 of Representatives, and the Chairman and Ranking Mem- 19 ber of the Committee on Banking, Housing, and Urban 20 Affairs of the Senate.’’. 21 SEC. 3. INVESTMENT IN SUPPLY CHAIN SECURITY. 22 (a) IN GENERAL.—Section 303 of the Defense Pro- 23 duction Act of 1950 (50 U.S.C. 4533) is amended by add- 24 ing at the end the following: 25 VerDate Sep 11 2014 03:15 May 20, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H3146.RFS H3146 kjohnson on DSK79L0C42PROD with BILLS 6 HR 3146 RFS ‘‘(h) INVESTMENT IN SUPPLY CHAIN SECURITY.— 1 ‘‘(1) IN GENERAL.—In addition to other au- 2 thorities in this title, the President may make avail- 3 able to an eligible entity described in paragraph (2) 4 payments to increase the security of supply chains 5 and supply chain activities, if the President certifies 6 to Congress not less than 30 days before making 7 such a payment that the payment is critical to meet 8 national defense requirements of the United States. 9 ‘‘(2) ELIGIBLE ENTITY.—An eligible entity de- 10 scribed in this paragraph is an entity that— 11 ‘‘(A) is organized under the laws of the 12 United States or any jurisdiction within the 13 United States; and 14 ‘‘(B) produces— 15 ‘‘(i) one or more critical components; 16 ‘‘(ii) critical technology; or 17 ‘‘(iii) one or more products or raw 18 materials for the security of supply chains 19 or supply chain activities. 20 ‘‘(3) DEFINITIONS.—In this subsection, the 21 terms ‘supply chain’ and ‘supply chain activities’ 22 have the meanings given those terms by the Presi- 23 dent by regulation.’’. 24 (b) REGULATIONS.— 25 VerDate Sep 11 2014 03:15 May 20, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H3146.RFS H3146 kjohnson on DSK79L0C42PROD with BILLS 7 HR 3146 RFS (1) IN GENERAL.—Not later than 90 days after 1 the date of the enactment of this Act, the President 2 shall prescribe regulations setting forth definitions 3 for the terms ‘‘supply chain’’ and ‘‘supply chain ac- 4 tivities’’ for the purposes of section 303(h) of the 5 Defense Production Act of 1950 (50 U.S.C. 6 4533(h)), as added by subsection (a). 7 (2) SCOPE OF DEFINITIONS.—The definitions 8 required by paragraph (1)— 9 (A) shall encompass— 10 (i) the organization, people, activities, 11 information, and resources involved in the 12 delivery and operation of a product or serv- 13 ice used by the Government; or 14 (ii) critical infrastructure as defined 15 in Presidential Policy Directive 21 (Feb- 16 ruary 12, 2013; relating to critical infra- 17 structure security and resilience); and 18 VerDate Sep 11 2014 03:15 May 20, 2021 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H3146.RFS H3146 kjohnson on DSK79L0C42PROD with BILLS 8 HR 3146 RFS (B) may include variations as determined 1 necessary and appropriate by the President for 2 purposes of national defense. 3 Passed the House of Representatives May 18, 2021. Attest: CHERYL L. JOHNSON, Clerk. VerDate Sep 11 2014 03:15 May 20, 2021 Jkt 019200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H3146.RFS H3146 kjohnson on DSK79L0C42PROD with BILLS