Operation Warp Speed Act of 2021

II 117TH CONGRESS 1ST SESSION S. 1604 To codify the successes of rapid development of safe vaccines through Oper- ation Warp Speed, for the next administration to use as a guide in the event of another pandemic. IN THE SENATE OF THE UNITED STATES MAY 13, 2021 Mr. COTTON introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To codify the successes of rapid development of safe vaccines through Operation Warp Speed, for the next administra- tion to use as a guide in the event of another pandemic. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Operation Warp Speed 4 Act of 2021’’. 5 SEC. 2. FINDINGS. 6 Congress finds as follows: 7 VerDate Sep 11 2014 00:43 May 27, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S1604.IS S1604 kjohnson on DSK79L0C42PROD with BILLS 2 •S 1604 IS (1) COVID–19 has infected more than 1 32,000,000 people in the United States and taken 2 the lives of more than 550,000. 3 (2) The Trump Administration’s creation of 4 Operation Warp Speed, on May 15, 2020, and the 5 development of 3 COVID–19 vaccines, in less than 6 a year, was the greatest success in getting the 7 COVID–19 pandemic under control, and one of the 8 greatest public health programs in history. 9 (3) As a result of the Trump Administration’s 10 partnership with the private sector, more than 11 150,000,000 doses of authorized vaccines have been 12 administered in the United States. 13 (4) The unprecedented rapid deployment of 14 COVID–19 vaccines and therapeutics, thanks to the 15 public-private partnership of Operation Warp Speed, 16 has helped the United States combat the spread of 17 COVID–19, protect at-risk populations, save millions 18 of lives, and return to normal life. 19 SEC. 3. CODIFYING SUCCESSES. 20 (a) ADDRESSING THE STRATEGIC NATIONAL STOCK- 21 PILE.— 22 (1) ANNUAL THREAT-BASED REVIEW.—In con- 23 ducting the annual threat-based review with respect 24 to the Strategic National Stockpile under section 25 VerDate Sep 11 2014 00:43 May 27, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1604.IS S1604 kjohnson on DSK79L0C42PROD with BILLS 3 •S 1604 IS 319F–2(a)(2)(A) of the Public Health Service Act 1 (42 U.S.C. 247d–6b(a)(2)(A)), the Secretary of 2 Health and Human Services (referred to in this sec- 3 tion as the ‘‘Secretary’’) shall ensure that such re- 4 view considers, and the report to Congress includes, 5 information about the supply levels in such stockpile 6 and any materials that may be missing. The review 7 described in the previous sentence shall include a 8 supply chain assessment of materials in the Stra- 9 tegic National Stockpile that considers whether the 10 United States could procure such materials in the 11 event of a pandemic that limits trade and access to 12 international supply chains. 13 (2) PROCURING SUPPLIES FOR THE SNS.—In 14 procuring supplies for the Strategic National Stock- 15 pile under section 319F–2(a) of the Public Health 16 Service Act (42 U.S.C. 247d–6b(a)), the Secretary 17 shall— 18 (A) give priority to manufacturers of such 19 supplies, including vaccines, that are manufac- 20 tured by companies located in the United 21 States; 22 (B) in the case that no domestic manufac- 23 turer is available for certain supplies, including 24 vaccines, assess ways to ramp up domestic 25 VerDate Sep 11 2014 00:43 May 27, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S1604.IS S1604 kjohnson on DSK79L0C42PROD with BILLS 4 •S 1604 IS manufacturing of such supplies, including vac- 1 cines; and 2 (C) in the case that no domestic manufac- 3 turer is available for certain supplies, including 4 vaccines, and it is determined that domestic 5 manufacturing cannot be ramped up in an ap- 6 propriate amount of time, give priority to com- 7 panies that are located in countries other than 8 the People’s Republic of China. 9 (b) INCREASING SPEED FOR SAFE EUA.—Section 10 564 of the Federal Food, Drug, and Cosmetic Act (21 11 U.S.C. 360bbb–3) is amended— 12 (1) in subsection (c)— 13 (A) in the matter preceding paragraph 14 (1)— 15 (i) by inserting ‘‘the Commissioner of 16 Food and Drugs,’’ before ‘‘the Assistant 17 Secretary for’’; and 18 (ii) by striking ‘‘the Secretary con- 19 cludes’’ and inserting ‘‘not fewer than 3 of 20 such Commissioner, such Assistant Sec- 21 retary, and such Directors, vote in favor of 22 such authorization after concluding’’; 23 (B) in paragraph (4), by striking ‘‘; and’’ 24 and inserting a semicolon; 25 VerDate Sep 11 2014 00:43 May 27, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S1604.IS S1604 kjohnson on DSK79L0C42PROD with BILLS 5 •S 1604 IS (C) by redesignating paragraph (5) as 1 paragraph (6); and 2 (D) by inserting after paragraph (4) the 3 following: 4 ‘‘(5) that the product complies with standards 5 for clinical trials established by the Secretary, in 6 consultation with such Commissioner, such Assistant 7 Secretary, and such Directors; and’’; and 8 (2) by adding at the end the following: 9 ‘‘(n) CONSIDERATION OF DATA.—The Secretary, and 10 the heads of agencies described in subsection (c), shall 11 consider the data submitted with respect to a product for 12 which authorization is being sought under this section, on 13 a rolling basis, as such data becomes available to such Sec- 14 retary and heads of agencies.’’. 15 (c) GAPS IN CLINICAL TRIALS.—The Director of the 16 National Institutes of Health shall assess any geographical 17 gaps in clinical trial sites for drugs or biological products 18 and shall develop a plan for increasing the number of such 19 sites across broad geographic areas. 20 (d) REQUIRING ASPR TO IMPROVE MANUFAC- 21 TURING CAPABILITIES UNDER CONDITIONS OF PRES- 22 SURE.— 23 (1) VACCINE PRODUCTION.—The Secretary is 24 authorized to use amounts made available to the De- 25 VerDate Sep 11 2014 22:31 Jun 04, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S1604.IS S1604 kjohnson on DSK79L0C42PROD with BILLS 6 •S 1604 IS partment of Health and Human Services for pur- 1 poses of producing vaccines in response to a public 2 health emergency prior to emergency use authoriza- 3 tion of such vaccine under section 564 of the Fed- 4 eral Food, Drug, and Cosmetic Act (21 U.S.C. 5 360bbb–3) or licensure of such vaccine under section 6 351 of the Public Health Service Act (42 U.S.C. 7 262). 8 (2) OPERATION WARP SPEED DIRECTOR.—Sec- 9 tion 2811 of the Public Health Service Act (42 10 U.S.C. 300hh–10) is amended by adding at the end 11 the following: 12 ‘‘(g) OPERATION WARP SPEED DIRECTOR.—There is 13 established within the Office of the Assistant Secretary for 14 Preparedness and Response an Office of Operation Warp 15 Speed, for purposes of responding to public health emer- 16 gencies by ensuring timely and sufficient development of 17 vaccines and other medical countermeasures (including 18 vaccines, therapeutics, and diagnostics), as well as domes- 19 tic manufacturing, through preparation in advance of any 20 such public health emergency. Such Office shall be headed 21 by a Director who has substantial relevant private sector 22 experience and is appointed by the President, by and with 23 the advice and consent of the Senate.’’. 24 Æ VerDate Sep 11 2014 00:43 May 27, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6301 E:\BILLS\S1604.IS S1604 kjohnson on DSK79L0C42PROD with BILLS