II 117TH CONGRESS 1ST SESSION S. 482 To direct the Secretary of Health and Human Services and other Federal officials to compile into a searchable database information relating to Federal support for biomedical research and development related to COVID–19, and for other purposes. IN THE SENATE OF THE UNITED STATES FEBRUARY 25, 2021 Mr. MERKLEY (for himself and Mr. BRAUN) introduced the following bill; which was read twice and referred to the Committee on Health, Edu- cation, Labor, and Pensions A BILL To direct the Secretary of Health and Human Services and other Federal officials to compile into a searchable data- base information relating to Federal support for bio- medical research and development related to COVID– 19, 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 ‘‘Taxpayer Research 4 and Coronavirus Knowledge Act of 2021’’. 5 VerDate Sep 11 2014 23:56 Mar 19, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S482.IS S482 pbinns on DSKJLVW7X2PROD with BILLS 2 •S 482 IS SEC. 2. DATABASE. 1 (a) IN GENERAL.—The Secretary of Health and 2 Human Services, in coordination with the Director of the 3 National Institutes of Health, the Assistant Secretary for 4 Preparedness and Response, the Director of the Bio- 5 medical Advanced Research and Development Authority, 6 the Secretary of Defense, the Secretary of Veterans Af- 7 fairs, the Director of the National Institute of Allergy and 8 Infectious Diseases, and such other Federal officials as the 9 Secretary of Health and Human Services determines to 10 be appropriate, shall— 11 (1) compile into a searchable database informa- 12 tion relating to Federal support (before or after the 13 date of enactment of this Act) for biomedical re- 14 search and development related to COVID–19 (in- 15 cluding biomedical research and development relat- 16 ing to a product or therapy that was later modified 17 or repurposed to be used for COVID–19); and 18 (2) make such database available on the public 19 website of the Department of Health and Human 20 Services. 21 (b) COVERED INFORMATION.—The information relat- 22 ing to Federal support described in subsection (a)(1) shall 23 include all contracts, funding agreements, licensing ar- 24 rangements, other transactions, and other arrangements 25 entered into by, or on behalf of, the Federal Government 26 VerDate Sep 11 2014 23:56 Mar 19, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S482.IS S482 pbinns on DSKJLVW7X2PROD with BILLS 3 •S 482 IS and tax benefits provided with respect to research and de- 1 velopment, and manufacturing, of a drug (including a bio- 2 logical product), cell or gene therapy, or medical device 3 intended to be manufactured, used, designed, developed, 4 modified, repurposed, licensed, or procured to diagnose, 5 mitigate, prevent, treat, or cure COVID–19, including the 6 following: 7 (1) Licensing agreements pursuant to section 8 207 or 209 of title 35, United States Code. 9 (2) Cooperative research and development 10 agreements and licensing agreements pursuant to 11 section 3710a of title 15, United States Code. 12 (3) Funding agreements, as defined under sec- 13 tion 201 of title 35, United States Code. 14 (4) Transactions, contracts, grants, cooperative 15 agreements, other agreements, and other arrange- 16 ments entered into pursuant to the following stat- 17 utes: 18 (A) The Public Health Service Act (42 19 U.S.C. 201 et seq.), including sections 301, 20 319L, 421, and 480 of such Act (42 U.S.C. 21 241, 247d–7e, 285b–3, 287a). 22 (B) Section 105 of the National Institutes 23 of Health Reform Act of 2006 (42 U.S.C. 24 284n). 25 VerDate Sep 11 2014 23:56 Mar 19, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S482.IS S482 pbinns on DSKJLVW7X2PROD with BILLS 4 •S 482 IS (C) Chapter 139 of title 10, United States 1 Code, including sections 2358, 2371, 2371a, 2 2371b, and 2373. 3 (5) Grants, contracts, and other transactions 4 pursuant to section 2371, 2371a, or 2371b of title 5 10, United States Code. 6 (6) Procurement contracts and other agree- 7 ments pursuant to section 2373 of title 10, United 8 States Code. 9 (c) INFORMATION REQUIRED.—Notwithstanding any 10 other provision of law, the Federal officials described in 11 subsection (a) shall include in the database under sub- 12 section (a), with regard to each contract, funding agree- 13 ment, licensing agreement, other transaction, other ar- 14 rangement, or tax benefit described in subsection (b), at 15 least the following information: 16 (1) The agency, program, institute, or other 17 Federal Government entity providing the Federal 18 grant, cooperative agreement, or other support. 19 (2) The amount and period of Federal financial 20 support with an itemized breakdown. 21 (3) Other Federal nonfinancial support, includ- 22 ing the use of Federal personnel, Federal facilities, 23 and Federal equipment. 24 (4) The grant number, if applicable. 25 VerDate Sep 11 2014 23:56 Mar 19, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S482.IS S482 pbinns on DSKJLVW7X2PROD with BILLS 5 •S 482 IS (5) Associated clinical trial data, upon trial 1 completion. 2 (6) Associated patents and patent applications, 3 specifying— 4 (A) any Federal ownership in such patents 5 and patent applications; 6 (B) the expiration date of such patents 7 and filing dates of such patent applications; and 8 (C) the numbers of such patents and pat- 9 ent applications. 10 (7) Associated periods of marketing exclusivity 11 under Federal law and the durations of such peri- 12 ods. 13 (8) The corporation, nonprofit organization, 14 academic institution, person, or other entity receiv- 15 ing the Federal support. 16 (9) Any products (including repurposed prod- 17 ucts) approved, authorized, or cleared for marketing, 18 or for which marketing approval, authorization, or 19 clearance is being sought, the development of which 20 was aided by Federal support, including— 21 (A) the names of such products; 22 (B) the prices of such products; and 23 (C) the current and anticipated manufac- 24 turing capacity to produce such products. 25 VerDate Sep 11 2014 23:56 Mar 19, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S482.IS S482 pbinns on DSKJLVW7X2PROD with BILLS 6 •S 482 IS (10) The full terms of the contract, funding 1 agreement, licensing agreement, other transaction, 2 or other arrangement described in subsection (b). 3 (d) FORMAT OF INFORMATION.—The database under 4 subsection (a) shall be— 5 (1) searchable and filterable according to the 6 categories of information described in subsection (c); 7 and 8 (2) presented in a user-friendly format. 9 (e) TIMING.—The database under subsection (a) 10 shall be— 11 (1) made publicly available not later than 1 12 month of the date of enactment of this Act; and 13 (2) updated not less than every 2 weeks. 14 (f) DISCLOSURE.— 15 (1) IN GENERAL.—Notwithstanding any other 16 provision of law, to the extent necessary for an offi- 17 cial described in subsection (a) to carry out this sec- 18 tion, such official may require entities receiving Fed- 19 eral support described in subsection (a)(1) to dis- 20 close to the official any information relating to such 21 Federal support and required to be included in the 22 database under subsection (a). 23 (2) INTERMEDIARY COOPERATION.—Any ar- 24 rangement entered into by the Federal Government 25 VerDate Sep 11 2014 23:56 Mar 19, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S482.IS S482 pbinns on DSKJLVW7X2PROD with BILLS 7 •S 482 IS with an entity providing for such entity to enter into 1 contracts, licensing agreements, grants, other trans- 2 actions, or other arrangements with third parties on 3 behalf of the Federal Government shall require such 4 entity to disclose in a timely manner any informa- 5 tion necessary for the Federal Government to fulfill 6 its duties under this Act. With respect to any such 7 arrangement in place as of the date of enactment of 8 this Act, an official described in subsection (a) may 9 require the entity to disclose to the official any infor- 10 mation required to be included in the database 11 under subsection (a). 12 (3) PENALTY FOR NONDISCLOSURE.—If an en- 13 tity that is required to disclose information pursuant 14 to paragraph (1) or (2) fails to disclose such infor- 15 mation by the date that is 2 weeks after the date on 16 which the official requests such information, or by 17 such reasonable deadline as the official may specify, 18 whichever is sooner, then such entity shall be liable 19 to the United States for a civil penalty in an amount 20 not to exceed $10,000 for each day on which such 21 failure continues. 22 Æ VerDate Sep 11 2014 23:56 Mar 19, 2021 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6301 E:\BILLS\S482.IS S482 pbinns on DSKJLVW7X2PROD with BILLS