Expanding COVID–19 Testing Capacity Act of 2020

II 116TH CONGRESS 2D SESSION S. 5082 To provide Federal support for COVID–19 testing, and for other purposes. IN THE SENATE OF THE UNITED STATES DECEMBER 21, 2020 Ms. WARREN introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To provide Federal support for COVID–19 testing, 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 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 3 (a) SHORT TITLE.—This Act may be cited as the 4 ‘‘Expanding COVID–19 Testing Capacity Act of 2020’’. 5 (b) TABLE OF CONTENTS.—The table of contents for 6 the Act is as follows: 7 Sec. 1. Short title; table of contents. Sec. 2. Definitions. Sec. 3. Federal manufacturing of COVID–19 diagnostic tests. Sec. 4. COVID–19 testing for covered Federal employees. Sec. 5. Federal distribution of COVID–19 tests to qualified entities. Sec. 6. Supplemental grants for COVID–19 testing. Sec. 7. Reports and guidance on COVID–19 diagnostic testing. Sec. 8. Demographic and geographic data collection. VerDate Sep 11 2014 23:32 Jan 20, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6211 E:\BILLS\S5082.IS S5082 pbinns on DSKJLVW7X2PROD with BILLS 2 •S 5082 IS SEC. 2. DEFINITIONS. 1 In this Act: 2 (1) ASSOCIATED MEDICAL SUPPLIES.—The 3 term ‘‘associated medical supplies’’ means any prod- 4 uct necessary for the development and administra- 5 tion of COVID–19 diagnostic tests, including chem- 6 ical reagents, test swabs, and personal protective 7 equipment (including surgical masks, surgical 8 gowns, face shields, gloves, and N95 masks). 9 (2) COVID–19 DIAGNOSTIC TEST.—The term 10 ‘‘COVID–19 diagnostic test’’ means a test— 11 (A) that is an in vitro diagnostic product 12 (as defined in section 809.3 of title 21, Code of 13 Federal Regulations, or any successor thereto) 14 for the detection of SARS–CoV–2 or the diag- 15 nosis of COVID–19; and 16 (B) the administration of which— 17 (i) is approved, cleared, or authorized 18 under section 510(k), 513, 515, or 564 of 19 the Federal Food, Drug, and Cosmetic Act 20 (21 U.S.C. 360(k), 360c, 360e, 360bbb–3); 21 or 22 (ii) the developer has received an 23 emergency use authorization under section 24 564 of the Federal Food, Drug, and Cos- 25 metic Act (21 U.S.C. 360bbb–3), unless 26 VerDate Sep 11 2014 23:32 Jan 20, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S5082.IS S5082 pbinns on DSKJLVW7X2PROD with BILLS 3 •S 5082 IS and until the emergency use authorization 1 request under such section 564. 2 (3) COVID–19 PANDEMIC.—The term 3 ‘‘COVID–19 pandemic’’ means the period beginning 4 on the date that the public health emergency with 5 respect to COVID–19 took effect, and ending on the 6 date that is 6 months after the date on which the 7 public health emergency declaration with respect to 8 COVID–19 terminates. 9 (4) INDIAN TRIBE.—Except as otherwise pro- 10 vided, the term ‘‘Indian Tribe’’ has the meaning 11 given the term ‘‘Indian tribe’’ in section 4 of the In- 12 dian Self-Determination and Education Assistance 13 Act (25 U.S.C. 5304). 14 (5) PUBLIC HEALTH EMERGENCY WITH RE- 15 SPECT TO COVID–19.—The term ‘‘public health 16 emergency with respect to COVID–19’’ means the 17 public health emergency declared by the Secretary 18 under section 319 of the Public Health Service Act 19 (21 U.S.C. 247d) on January 31, 2020, with respect 20 to COVID–19. 21 (6) SECRETARY.—The term ‘‘Secretary’’ means 22 the Secretary of Health and Human Services. 23 (7) TRIBAL ORGANIZATION.—Except as other- 24 wise provided, the term ‘‘Tribal organization’’ has 25 VerDate Sep 11 2014 23:32 Jan 20, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S5082.IS S5082 pbinns on DSKJLVW7X2PROD with BILLS 4 •S 5082 IS the meaning given the term ‘‘tribal organization’’ in 1 section 4 of the Indian Self-Determination and Edu- 2 cation Assistance Act (25 U.S.C. 5304). 3 (8) URBAN INDIAN ORGANIZATION.—The term 4 ‘‘urban Indian organization’’ has the meaning given 5 the term in section 4 of the Indian Health Care Im- 6 provement Act (25 U.S.C. 1603). 7 SEC. 3. FEDERAL MANUFACTURING OF COVID–19 DIAG- 8 NOSTIC TESTS. 9 (a) IN GENERAL.—As soon as practicable after the 10 date of enactment of this Act, but no later than 15 days 11 after such date of enactment, the Secretary shall begin 12 the process of manufacturing, or contracting with entities 13 for the manufacture of, COVID–19 diagnostic tests and 14 associated medical supplies, with a particular focus on ex- 15 traction-free highly sensitive molecular tests, pooled highly 16 sensitive molecular tests, low-cost rapid antigen test, low- 17 cost highly sensitive molecular tests, assays that can use 18 a variety of reagents, and other products as determined 19 by the Secretary. The Secretary shall continue such proc- 20 ess until the end of the COVID–19 pandemic. 21 (b) SUBMISSION OF APPLICATIONS.—For each 22 COVID–19 diagnostic test and associated drug or device 23 that the Secretary intends to market, or contract with an- 24 other entity for the marketing of, the Secretary shall— 25 VerDate Sep 11 2014 23:32 Jan 20, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S5082.IS S5082 pbinns on DSKJLVW7X2PROD with BILLS 5 •S 5082 IS (1) submit an application under subsection (b) 1 or (j) of section 505 or section 515 of the Federal 2 Food, Drug, and Cosmetic Act (21 U.S.C. 355, 3 360e) or subsection (a) or (j) of section 351 of the 4 Public Health Service Act (42 U.S.C. 262), submit 5 a notification under section 510(k) of the Federal 6 Food, Drug, and Cosmetic Act (21 U.S.C. 360(k)), 7 or submit a request for classification under section 8 513(f)(2) of the Federal Food, Drug, and Cosmetic 9 Act (21 U.S.C. 360c(f)(2)) (or enter into a contract 10 with another entity to submit such an application, 11 notification, or request); 12 (2) request an emergency use authorization of 13 the product under section 564 of the Federal Food, 14 Drug, and Cosmetic Act (21 U.S.C. 360bbb–3) (or 15 enter into a contract with another entity to submit 16 an application for such use); or 17 (3) obtain from the holder of an application ap- 18 proved under subsection (c) or (j) of section 505 or 19 section 515 of the Federal Food, Drug, and Cos- 20 metic Act or subsection (a) or (k) of section 351 of 21 the Public Health Service Act, or cleared under sec- 22 tion 510(k) of the Federal Food, Drug, and Cos- 23 metic Act, rights to manufacture such product. 24 VerDate Sep 11 2014 23:32 Jan 20, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S5082.IS S5082 pbinns on DSKJLVW7X2PROD with BILLS 6 •S 5082 IS (c) PROVISION OF PRODUCTS.—With respect to 1 COVID–19 diagnostic tests and associated drugs and de- 2 vices manufactured pursuant to subsection (a), the Sec- 3 retary shall— 4 (1) provide such COVID–19 diagnostic tests 5 and associated medical supplies at no cost to Fed- 6 eral, State, local, territorial, and Native health pro- 7 grams, and other domestic health care providers, in- 8 cluding domestic commercial health care providers, 9 as determined by the Secretary; and 10 (2) sell additional tests and associated drugs 11 and devices, at-cost, to other commercial entities and 12 international entities not described in paragraph (1). 13 (d) OBTAINING RIGHTS TO MANUFACTURE AND 14 MARKET.— 15 (1) IN GENERAL.—When necessary to fulfill the 16 Secretary’s duties under this section, the Secretary 17 shall acquire the rights to manufacture and market 18 COVID–19 diagnostic tests and associated drugs 19 and devices as authorized under this section. 20 (2) LICENSING AUTHORITY.— 21 (A) IN GENERAL.—Notwithstanding any 22 other provision of law, the Secretary may issue 23 licenses, as useful for fulfilling the duties under 24 this Act, allowing the Department of Health 25 VerDate Sep 11 2014 23:32 Jan 20, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S5082.IS S5082 pbinns on DSKJLVW7X2PROD with BILLS 7 •S 5082 IS and Human Services to practice or have prac- 1 ticed (which may include licensure of retroactive 2 practice) any invention in the United States or 3 territories of the United States, including mak- 4 ing, using, offering to sell or selling, importing, 5 or exporting such invention, to reference or rely 6 upon clinical trial data submitted to a regu- 7 latory authority or the grant of marketing ap- 8 proval, and to access and use otherwise con- 9 fidential information, including know-how, re- 10 lated to the manufacture of COVID–19 diag- 11 nostic tests and associated medical supplies. 12 (B) NON-VOLUNTARY LICENSING.—For 13 any license that involves a non-voluntary au- 14 thorization to use patented inventions, regu- 15 latory test data, data, know-how or other intel- 16 lectual property rights, the license shall provide 17 for reasonable remuneration to rights holders 18 such as a reasonable royalty on the sales of 19 product, a 1-time payment, or some combina- 20 tion, provided that the combined royalty pay- 21 ments to all rights holders shall not exceed the 22 percentage of sales that is the average percent 23 of all royalty payments reported to the Internal 24 Revenue Service by companies in the pharma- 25 VerDate Sep 11 2014 23:32 Jan 20, 2021 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S5082.IS S5082 pbinns on DSKJLVW7X2PROD with BILLS 8 •S 5082 IS ceutical and medicines sector, North American 1 Industry Classification System code 325410, 2 provided that when products are distributed for 3 free, the royalty shall be based upon the cost of 4 goods. When there are multiple rights holders, 5 the allocation of the total royalty payments 6 shall be determined by— 7 (i) agreement among the rights hold- 8 ers; 9 (ii) allocation by arbitration among 10 the rights holders; or 11 (iii) if neither clause (i) nor (ii) ap- 12 plies, by the Secretary. 13 (3) TRANSPARENCY.—Subject to paragraph (4), 14 the Secretary shall post any contract agreement 15 under subsection (a) or license issued under para- 16 graph (2)(A) on the public internet website of the 17 Department of Health and Human Services, on the 18 date on which such agreement or license takes ef- 19 fect. 20 (4) PROTECTED INFORMATION.—In carrying 21 out this section, the Secretary shall enforce applica- 22 ble law concerning the protection of confidential 23 commercial information and trade secrets. 24 (e) PRICING DETERMINATIONS.— 25 VerDate Sep 11 2014 23:32 Jan 20, 2021 Jkt 019200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S5082.IS S5082 pbinns on DSKJLVW7X2PROD with BILLS 9 •S 5082 IS (1) AT-COST PRICE.—In determining an at-cost 1 price for COVID–19 diagnostic tests and associated 2 medical supplies for purposes of subsection (c)(2), 3 the Secretary shall consider— 4 (A) the cost to the Federal Government of 5 manufacturing the applicable COVID–19 diag- 6 nostic test or associated drug or device; and 7 (B) the cost to acquire or manufacture 8 under subparagraph (A) the applicable COVID– 9 19 diagnostic test or associated drug or device. 10 (2) TRANSPARENCY.—All prices charged for 11 COVID–19 diagnostic tests and associated medical 12 supplies shall be made publicly available by the Sec- 13 retary. 14 (f) AWARDING CONTRACTS.— 15 (1) PRIORITY.—In awarding contracts under 16 this section, the Secretary shall prioritize entities 17 manufacturing COVID–19 diagnostic tests or associ- 18 ated medical supplies using components originating 19 from, and manufactured in, the United States. 20 (2) CONTRACT REQUIREMENTS.—All contracts 21 issued under this section shall include a requirement 22 that the contract recipients reasonably price prod- 23 ucts produced under the contract. 24 VerDate Sep 11 2014 23:32 Jan 20, 2021 Jkt 019200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S5082.IS S5082 pbinns on DSKJLVW7X2PROD with BILLS 10 •S 5082 IS (g) REPORT TO THE PRESIDENT AND CONGRESS.— 1 The Secretary shall prepare and submit to the President, 2 the Committee on Health, Education, Labor, and Pen- 3 sions of the Senate, and the Committee on Energy and 4 Commerce of the House of Representatives, a monthly re- 5 port during the COVID–19 pandemic, and a final report 6 3 months after such pandemic has concluded, that in- 7 cludes— 8 (1) an assessment of the major supply chain 9 challenges facing health care facilities, medical pro- 10 viders, the Federal Government, State, local, terri- 11 torial, and Tribal governments, and the private sec- 12 tor in COVID–19 diagnostic tests and associated 13 medical supplies; and 14 (2) a description of the authorization or ap- 15 proval status and available supply of all COVID–19 16 diagnostic tests and associated medical supplies for 17 which manufacturing has been authorized under this 18 section, including products for which the Secretary 19 has submitted an application for approval, a notifi- 20 cation for clearance, or a request for classification to 21 the Food and Drug Administration but has not yet 22 received approval, clearance, or classification, and 23 products for which the Secretary has received ap- 24 proval, clearance, or classification, from the Food 25 VerDate Sep 11 2014 23:32 Jan 20, 2021 Jkt 019200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S5082.IS S5082 pbinns on DSKJLVW7X2PROD with BILLS 11 •S 5082 IS and Drug Administration but are not being manu- 1 factured. 2 (h) PROCEEDS FROM SALES.—There are authorized 3 to be appropriated to the Secretary for each fiscal year, 4 for purposes of carrying out this section, an amount equal 5 to the proceeds from the sale of COVID–19 diagnostic 6 tests and associated medical supplies described in sub- 7 section (c)(2) in the previous fiscal year. 8 SEC. 4. COVID–19 TESTING FOR COVERED FEDERAL EM- 9 PLOYEES. 10 (a) DEFINITIONS.—In this section: 11 (1) AGENCY.—The term ‘‘agency’’— 12 (A) means— 13 (i) each agency, office, or other estab- 14 lishment in the executive, legislative, or ju- 15 dicial branch of the Federal Government, 16 including— 17 (I) an Executive agency, as that 18 term is defined in section 105 of title 19 5, United States Code; 20 (II) a military department, as 21 that term is defined in section 102 of 22 title 5, United States Code; 23 (III) the Federal Aviation Ad- 24 ministration; 25 VerDate Sep 11 2014 23:32 Jan 20, 2021 Jkt 019200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\S5082.IS S5082 pbinns on DSKJLVW7X2PROD with BILLS 12 •S 5082 IS (IV) the Transportation Security 1 Administration; 2 (V) the Department of Veterans 3 Affairs; 4 (VI) the Government Account- 5 ability Office; 6 (VII) the Library of Congress; 7 (VIII) the Postal Service; 8 (IX) the House of Representa- 9 tives; 10 (X) [Text truncated for display. Full text available on Congress.gov.]