I 117TH CONGRESS 1ST SESSION H. R. 1391 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 HOUSE OF REPRESENTATIVES FEBRUARY 26, 2021 Mr. DOGGETT (for himself, Ms. BARRAGA´N, Mrs. BEATTY, Mr. BEYER, Mr. BISHOP of Georgia, Mr. BLUMENAUER, Ms. CHU, Mr. CICILLINE, Mr. COHEN, Mr. COURTNEY, Mr. DEFAZIO, Ms. DEGETTE, Ms. DELAURO, Mr. DESAULNIER, Mrs. DINGELL, Mr. EVANS, Mr. GREEN of Texas, Mr. GRIJALVA, Mr. HASTINGS, Mrs. HAYES, Ms. JAYAPAL, Ms. JOHNSON of Texas, Ms. KAPTUR, Mr. KHANNA, Mr. KILDEE, Ms. LEE of California, Mr. LEVIN of Michigan, Mr. LOWENTHAL, Ms. MENG, Mr. NADLER, Mrs. NAPOLITANO, Ms. NORTON, Ms. PINGREE, Mr. POCAN, Ms. PORTER, Ms. SCANLON, Ms. SCHAKOWSKY, Ms. SPANBERGER, Mr. SUOZZI, Mr. TAKANO, Ms. TITUS, Mr. TRONE, Mr. VARGAS, Mr. WELCH, and Mr. TONKO) introduced the following bill; which was referred to the Com- mittee on Energy and Commerce, and in addition to the Committees on Armed Services, Veterans’ Affairs, Science, Space, and Technology, the Judiciary, and Ways and Means, for a period to be subsequently deter- mined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned 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. VerDate Sep 11 2014 15:45 Mar 24, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6652 E:\BILLS\H1391.IH H1391 pamtmann on DSKBC07HB2PROD with BILLS 2 •HR 1391 IH 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 SEC. 2. DATABASE. 6 (a) IN GENERAL.—The Secretary of Health and 7 Human Services, the Director of the National Institutes 8 of Health, the Assistant Secretary for Preparedness and 9 Response of the Department of Health and Human Serv- 10 ices, the Director of the Biomedical Advanced Research 11 and Development Authority, the Secretary of Defense, the 12 Secretary of Veterans Affairs, the Director of the National 13 Institute of Allergy and Infectious Diseases, and such 14 other Federal officials as the Secretary of Health and 15 Human Services determines to be relevant, acting in co- 16 ordination, shall— 17 (1) compile into a searchable database informa- 18 tion relating to Federal support (before or after the 19 date of enactment of this Act) for biomedical re- 20 search and development related to COVID–19 (in- 21 cluding biomedical research and development relat- 22 ing to a product or therapy that was later modified 23 or repurposed to be used for COVID–19); and 24 VerDate Sep 11 2014 15:45 Mar 24, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H1391.IH H1391 pamtmann on DSKBC07HB2PROD with BILLS 3 •HR 1391 IH (2) make such database available on the public 1 website of the Department of Health and Human 2 Services. 3 (b) COVERED INFORMATION.—The information relat- 4 ing to Federal support referred to in subsection (a)(1) in- 5 cludes all contracts, funding agreements, licensing ar- 6 rangements, other transactions, and other arrangements 7 entered into by or on behalf of the Federal Government 8 and tax benefits provided with respect to research and de- 9 velopment, and manufacturing, of a drug (including a bio- 10 logical product), cell or gene therapy, or medical device 11 intended to be manufactured, used, designed, developed, 12 modified, repurposed, licensed, or procured to diagnose, 13 mitigate, prevent, treat, or cure COVID–19, including the 14 following: 15 (1) Licensing agreements pursuant to section 16 207 or 209 of title 35, United States Code. 17 (2) Cooperative research and development 18 agreements and licensing agreements pursuant to 19 section 3710a of title 15, United States Code. 20 (3) Funding agreements, as defined under sec- 21 tion 201 of title 35, United States Code. 22 (4) Transactions, contracts, grants, cooperative 23 agreements, other agreements, and other arrange- 24 VerDate Sep 11 2014 15:45 Mar 24, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H1391.IH H1391 pamtmann on DSKBC07HB2PROD with BILLS 4 •HR 1391 IH ments entered into pursuant to the following stat- 1 utes: 2 (A) The Public Health Service Act (42 3 U.S.C. 201 et seq.), including sections 301, 4 319L, 421, and 480 of such Act (42 U.S.C. 5 241, 247d–7e, 285b–3, 287a). 6 (B) Section 105 of the National Institutes 7 of Health Reform Act of 2006 (42 U.S.C. 8 284n). 9 (C) Chapter 139 of title 10, United States 10 Code (10 U.S.C. 2351 et seq.), including sec- 11 tions 2358, 2371, 2371a, 2371b, and 2373. 12 (5) Grants, contracts, and other transactions 13 pursuant to section 2371, 2371a, or 2371b of title 14 10, United States Code. 15 (6) Procurement contracts and other agree- 16 ments pursuant to section 2373 of title 10, United 17 States Code. 18 (c) INFORMATION REQUIRED.—Notwithstanding any 19 other provision of law, the Federal officials referred to in 20 subsection (a) shall include in the database under sub- 21 section (a), with regard to each contract, funding agree- 22 ment, licensing agreement, other transaction, other ar- 23 rangement, or tax benefit described in subsection (b), at 24 least the following information: 25 VerDate Sep 11 2014 15:45 Mar 24, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H1391.IH H1391 pamtmann on DSKBC07HB2PROD with BILLS 5 •HR 1391 IH (1) The agency, program, institute, or other 1 Federal Government entity providing the Federal 2 grant, cooperative agreement, or other support. 3 (2) The amount and period of Federal financial 4 support with an itemized breakdown. 5 (3) Other Federal nonfinancial support, includ- 6 ing the use of Federal personnel, Federal facilities, 7 and Federal equipment. 8 (4) The grant number, if applicable. 9 (5) Associated clinical trial data, upon trial 10 completion. 11 (6) Associated patents and patent applications, 12 specifying— 13 (A) any Federal ownership in such patents 14 and patent applications; 15 (B) the expiration date of such patents 16 and filing dates of such patent applications; and 17 (C) the numbers of such patents and pat- 18 ent applications. 19 (7) Associated periods of marketing exclusivity 20 under Federal law and the durations of such peri- 21 ods. 22 (8) The corporation, nonprofit organization, 23 academic institution, person, or other entity receiv- 24 ing the Federal support. 25 VerDate Sep 11 2014 15:45 Mar 24, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H1391.IH H1391 pamtmann on DSKBC07HB2PROD with BILLS 6 •HR 1391 IH (9) Any products (including repurposed prod- 1 ucts) approved, authorized, or cleared for marketing, 2 or for which marketing approval, authorization, or 3 clearance is being sought, the development of which 4 was aided by Federal support, including— 5 (A) the names of such products; 6 (B) the prices of such products; and 7 (C) the current and anticipated manufac- 8 turing capacity to produce such products. 9 (10) The full terms of the contract, funding 10 agreement, licensing agreement, other transaction, 11 or other arrangement described in subsection (b). 12 (d) FORMAT OF INFORMATION.—The database under 13 subsection (a) shall be— 14 (1) searchable and filterable according to the 15 categories of information described in subsection (c); 16 and 17 (2) presented in a user-friendly format. 18 (e) TIMING.—The database under subsection (a) 19 shall be— 20 (1) made publicly available not later than 1 21 month of the date of enactment of this Act; and 22 (2) updated not less than every 2 weeks. 23 (f) DISCLOSURE.— 24 VerDate Sep 11 2014 15:45 Mar 24, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H1391.IH H1391 pamtmann on DSKBC07HB2PROD with BILLS 7 •HR 1391 IH (1) IN GENERAL.—Notwithstanding any other 1 provision of law, to the extent necessary for an offi- 2 cial referred to in subsection (a) to carry out this 3 section, such official may require entities receiving 4 Federal support referred to in subsection (a)(1) to 5 disclose to the official any information relating to 6 such Federal support and required to be included in 7 the database under subsection (a). 8 (2) INTERMEDIARY COOPERATION.—Any ar- 9 rangement entered into by the Federal Government 10 with an entity providing for such entity to enter into 11 contracts, licensing agreements, grants, other trans- 12 actions, or other arrangements with third parties on 13 behalf of the Federal Government shall require such 14 entity to disclose in a timely manner any informa- 15 tion necessary for the Federal Government to fulfill 16 its duties under this Act. With respect to any such 17 arrangement in place as of the date of enactment of 18 this Act, an official referred to in subsection (a) may 19 require the entity to disclose to the official any infor- 20 mation required to be included in the database 21 under subsection (a). 22 (3) PENALTY FOR NONDISCLOSURE.—If an en- 23 tity that is required to disclose information pursuant 24 to paragraph (1) or (2) fails to disclose such infor- 25 VerDate Sep 11 2014 15:45 Mar 24, 2021 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H1391.IH H1391 pamtmann on DSKBC07HB2PROD with BILLS 8 •HR 1391 IH mation by the date that is two weeks after the date 1 on which the official requests such information, or 2 by such reasonable deadline as the official may 3 specify, whichever is sooner, then such entity shall 4 be liable to the United States for a civil penalty in 5 an amount not to exceed $10,000 for each day on 6 which such failure continues. 7 Æ VerDate Sep 11 2014 15:45 Mar 24, 2021 Jkt 019200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6301 E:\BILLS\H1391.IH H1391 pamtmann on DSKBC07HB2PROD with BILLS