COVID–19 Testing Inventory Act

I 116TH CONGRESS 2D SESSION H. R. 6901 To require the Secretary of Health and Human Services to provide updated information about COVID–19 testing to the public, and for other purposes. IN THE HOUSE OF REPRESENTATIVES MAY 15, 2020 Ms. ESHOO introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To require the Secretary of Health and Human Services to provide updated information about COVID–19 testing to the public, 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. 3 This Act may be cited as the ‘‘COVID–19 Testing 4 Inventory Act’’. 5 SEC. 2. PUBLIC INFORMATION ABOUT COVID–19 DIAG- 6 NOSTIC TESTS. 7 The Secretary of Health and Human Services, in con- 8 sultation with the Administrator of the Federal Emer- 9 gency Management Agency, the Commissioner of Food 10 VerDate Sep 11 2014 16:31 Jun 05, 2020 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H6901.IH H6901 pamtmann on DSKBC07HB2PROD with BILLS 2 •HR 6901 IH and Drugs, the Director of the Indian Health Service, and 1 other Federal agencies, as appropriate, shall develop a 2 public-facing inventory, which shall be made available on 3 a single internet website, that provides real-time data and 4 information on in vitro diagnostic tests (as defined in sec- 5 tion 809.3 of title 21, Code of Federal Regulations (or 6 successor regulations)), for the detection of SARS–CoV– 7 2 or the diagnosis of the virus that causes COVID–19, 8 or for the detection of antibodies from COVID–19 (re- 9 ferred to in this section as ‘‘COVID–19 diagnostic tests’’), 10 including— 11 (1) the number and type of COVID–19 diag- 12 nostic tests that are available for use in each State, 13 territory, or Indian Tribe, by— 14 (A) county; 15 (B) sites of care where the tests are avail- 16 able for use; 17 (C) type of tests, including molecular, anti- 18 gen, and serological tests; and 19 (D) percentage of tests that deliver rapid 20 results at the point-of-care; 21 (2) for each laboratory, hospital, or other health 22 care facility that receives COVID–19 diagnostic 23 tests, the number and type of COVID–19 diagnostic 24 tests received; 25 VerDate Sep 11 2014 16:31 Jun 05, 2020 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H6901.IH H6901 pamtmann on DSKBC07HB2PROD with BILLS 3 •HR 6901 IH (3) each hospital or other health care facility 1 that has the capability, capacity, and testing-related 2 supplies to process COVID–19 diagnostic tests, in- 3 cluding test type and location by State, territory, or 4 Indian Tribe; 5 (4) each laboratory that has the capability, ca- 6 pacity, and testing-related supplies to process 7 COVID–19 diagnostic tests, including test type and 8 location by State, territory, or Indian Tribe; 9 (5) for each COVID–19 diagnostic test listed 10 pursuant to paragraph (1), the time required to re- 11 ceive test results, including any time for processing 12 and shipping, measured in the smallest unit of meas- 13 urement reasonable for the particular test, whether 14 minutes, hours, or days; 15 (6) for each COVID–19 diagnostic test listed 16 pursuant to paragraph (1), the approximate time 17 per employee required to run the test; 18 (7) for each COVID–19 diagnostic test listed 19 pursuant to paragraph (1), each test that the Sec- 20 retary has authorized, cleared, or approved under 21 the Federal Food, Drug, and Cosmetic Act (21 22 U.S.C. 301 et seq.), or is marketed in accordance 23 with applicable guidance issued by the Secretary; 24 VerDate Sep 11 2014 16:31 Jun 05, 2020 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H6901.IH H6901 pamtmann on DSKBC07HB2PROD with BILLS 4 •HR 6901 IH (8) a list of each laboratory, hospital, and other 1 health care facility that has reported a shortage of 2 testing-related supplies, and which such supplies are 3 reported to be in shortage; 4 (9) for each COVID–19 test manufacturer— 5 (A) the number and type of COVID–19 di- 6 agnostic tests for which such manufacturer 7 has— 8 (i) current inventory and projected 9 production capacity for the next 180 days 10 for at least the 180-day period following 11 the date on which such information is sub- 12 mitted; and 13 (ii) received orders, including orders 14 such manufacturer does not have capacity 15 to deliver; and 16 (B) a description of materials that are in 17 shortage that are hindering production of 18 COVID–19 diagnostic tests by amount and type 19 of test; and 20 (10) for each laboratory, hospital, and other 21 health care facility that receives COVID–19 diag- 22 nostic tests, the number of samples collected per day 23 and the number of results transmitted to patients 24 VerDate Sep 11 2014 16:31 Jun 05, 2020 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H6901.IH H6901 pamtmann on DSKBC07HB2PROD with BILLS 5 •HR 6901 IH (including results transmitted to health care pro- 1 viders for patients) per day. 2 Æ VerDate Sep 11 2014 16:31 Jun 05, 2020 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6301 E:\BILLS\H6901.IH H6901 pamtmann on DSKBC07HB2PROD with BILLS