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<bill bill-type="olc" bill-stage="Introduced-in-Senate" dms-id="A1" public-private="public" slc-id="S1-TAM21377-C2C-RN-0FX"><metadata xmlns:dc="http://purl.org/dc/elements/1.1/">
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<dc:title>117 S482 IS: Taxpayer Research and Coronavirus Knowledge Act of 2021</dc:title>
<dc:publisher>U.S. Senate</dc:publisher>
<dc:date>2021-02-25</dc:date>
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<dc:language>EN</dc:language>
<dc:rights>Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.</dc:rights>
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<distribution-code display="yes">II</distribution-code><congress>117th CONGRESS</congress><session>1st Session</session><legis-num>S. 482</legis-num><current-chamber>IN THE SENATE OF THE UNITED STATES</current-chamber><action><action-date date="20210225">February 25, 2021</action-date><action-desc><sponsor name-id="S322">Mr. Merkley</sponsor> (for himself and <cosponsor name-id="S397">Mr. Braun</cosponsor>) introduced the following bill; which was read twice and referred to the <committee-name committee-id="SSHR00">Committee on Health, Education, Labor, and Pensions</committee-name></action-desc></action><legis-type>A BILL</legis-type><official-title>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.</official-title></form><legis-body style="OLC" display-enacting-clause="yes-display-enacting-clause" id="HBFBC46AD94C5410BA42299A2F7AAF732"><section section-type="section-one" id="HE39A1389C11F42E6B20BAB8D5FDF241A"><enum>1.</enum><header>Short title</header><text display-inline="no-display-inline">This Act may be cited as the <quote><short-title>Taxpayer Research and Coronavirus Knowledge Act of 2021</short-title></quote>.</text></section><section id="H7486907C2FAC45968E1D9F2C1415BB19"><enum>2.</enum><header>Database</header><subsection id="H2E08C59B76F741D1A64C0FD49C28944A"><enum>(a)</enum><header>In general</header><text>The Secretary of Health and Human Services, in coordination with the Director of the National Institutes of Health, the Assistant Secretary for Preparedness and Response, the Director of the Biomedical Advanced Research and Development Authority, the Secretary of Defense, the Secretary of Veterans Affairs, the Director of the National Institute of Allergy and Infectious Diseases, and such other Federal officials as the Secretary of Health and Human Services determines to be appropriate, shall—</text><paragraph id="HB715A85BB43846BE907376833BBCD2F0"><enum>(1)</enum><text>compile into a searchable database information relating to Federal support (before or after the date of enactment of this Act) for biomedical research and development related to COVID–19 (including biomedical research and development relating to a product or therapy that was later modified or repurposed to be used for COVID–19); and</text></paragraph><paragraph id="HD8517FC7B33247568B2E02FC80B7B0C9"><enum>(2)</enum><text>make such database available on the public website of the Department of Health and Human Services.</text></paragraph></subsection><subsection id="HE28545D4FF34479B965903ED4409C9DD"><enum>(b)</enum><header>Covered information</header><text>The information relating to Federal support described in subsection (a)(1) shall include all contracts, funding agreements, licensing arrangements, other transactions, and other arrangements entered into by, or on behalf of, the Federal Government and tax benefits provided with respect to research and development, and manufacturing, of a drug (including a biological product), cell or gene therapy, or medical device intended to be manufactured, used, designed, developed, modified, repurposed, licensed, or procured to diagnose, mitigate, prevent, treat, or cure COVID–19, including the following:</text><paragraph id="H7477D52E18C04E95B6BB1E4C0ECF5CD3"><enum>(1)</enum><text>Licensing agreements pursuant to section 207 or 209 of title 35, United States Code.</text></paragraph><paragraph id="H2F3F145E3BF5454D9D9ABAC199CF62D9"><enum>(2)</enum><text display-inline="yes-display-inline">Cooperative research and development agreements and licensing agreements pursuant to section 3710a of title 15, United States Code.</text></paragraph><paragraph id="HC725271057D24CC0A84FC8AC681D2556"><enum>(3)</enum><text display-inline="yes-display-inline">Funding agreements, as defined under section 201 of title 35, United States Code.</text></paragraph><paragraph id="H8B1E6AFD13DC4AE2878417A9EBB17F3A"><enum>(4)</enum><text>Transactions, contracts, grants, cooperative agreements, other agreements, and other arrangements entered into pursuant to the following statutes:</text><subparagraph id="H1D37DAD7100C480EA111F4A81E93201D"><enum>(A)</enum><text display-inline="yes-display-inline">The Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/201">42 U.S.C. 201</external-xref> et seq.), including sections 301, 319L, 421, and 480 of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/241">42 U.S.C. 241</external-xref>, 247d–7e, 285b–3, 287a).</text></subparagraph><subparagraph id="H0F21BB98AA564114BD9BBED8D147F6E9"><enum>(B)</enum><text display-inline="yes-display-inline">Section 105 of the National Institutes of Health Reform Act of 2006 (<external-xref legal-doc="usc" parsable-cite="usc/42/284n">42 U.S.C. 284n</external-xref>).</text></subparagraph><subparagraph id="HC3DE32FC4E854FF282C3F7E8502D2436"><enum>(C)</enum><text display-inline="yes-display-inline"><external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/10/139">Chapter 139</external-xref> of title 10, United States Code, including sections 2358, 2371, 2371a, 2371b, and 2373.</text></subparagraph></paragraph><paragraph id="H6EB77B45FC7D4F54898D23EA2BFB7B6E"><enum>(5)</enum><text display-inline="yes-display-inline">Grants, contracts, and other transactions pursuant to section 2371, 2371a, or 2371b of title 10, United States Code.</text></paragraph><paragraph id="H3FB51CB87CFA4A3891EE6F4BB36A8B9D"><enum>(6)</enum><text>Procurement contracts and other agreements pursuant to section 2373 of title 10, United States Code.</text></paragraph></subsection><subsection id="HD454AF5B60744D69BCA178B98DEAAF49"><enum>(c)</enum><header>Information required</header><text display-inline="yes-display-inline">Notwithstanding any other provision of law, the Federal officials described in subsection (a) shall include in the database under subsection (a), with regard to each contract, funding agreement, licensing agreement, other transaction, other arrangement, or tax benefit described in subsection (b), at least the following information:</text><paragraph id="HD6E061A17D874048BC73BA001C75F8A2"><enum>(1)</enum><text>The agency, program, institute, or other Federal Government entity providing the Federal grant, cooperative agreement, or other support.</text></paragraph><paragraph id="H83C36BC73BAB41B79D793C81323D7C5A"><enum>(2)</enum><text>The amount and period of Federal financial support with an itemized breakdown.</text></paragraph><paragraph id="HC9CB14221BDC4682910038E57D67418D"><enum>(3)</enum><text>Other Federal nonfinancial support, including the use of Federal personnel, Federal facilities, and Federal equipment.</text></paragraph><paragraph id="H4856B3AB696F478890AA3AF6E325DFED"><enum>(4)</enum><text>The grant number, if applicable.</text></paragraph><paragraph id="HF71F7277B2BC42E58648B2C47740FD17"><enum>(5)</enum><text>Associated clinical trial data, upon trial completion.</text></paragraph><paragraph id="H565F80E37F0B4C99BE07B1345965BBC4"><enum>(6)</enum><text>Associated patents and patent applications, specifying—</text><subparagraph id="HF8526AB2F7F54F03BDE6FB7FBF2B540E"><enum>(A)</enum><text>any Federal ownership in such patents and patent applications;</text></subparagraph><subparagraph id="H8AF22F1736454A36AB871D959C4FB16A"><enum>(B)</enum><text>the expiration date of such patents and filing dates of such patent applications; and</text></subparagraph><subparagraph id="H6B1D3B37FA6B4C00A57EFC70766C9949"><enum>(C)</enum><text>the numbers of such patents and patent applications.</text></subparagraph></paragraph><paragraph id="H092E3DC293A54CCFA5A691CE647BD6A3"><enum>(7)</enum><text>Associated periods of marketing exclusivity under Federal law and the durations of such periods.</text></paragraph><paragraph id="H928BB17363084F3E97601DBDF3360B92"><enum>(8)</enum><text>The corporation, nonprofit organization, academic institution, person, or other entity receiving the Federal support.</text></paragraph><paragraph id="HF1B14DA78D8240DB8DDFFD3DEAFF2FE6"><enum>(9)</enum><text>Any products (including repurposed products) approved, authorized, or cleared for marketing, or for which marketing approval, authorization, or clearance is being sought, the development of which was aided by Federal support, including—</text><subparagraph id="H3815D7330C7241EB97F12C9AEB7C49D0"><enum>(A)</enum><text>the names of such products;</text></subparagraph><subparagraph id="H1D3AEF779B7C4E26AFE6917781EC7FCE"><enum>(B)</enum><text>the prices of such products; and</text></subparagraph><subparagraph id="H906292574C1B43F5817C07807EC42E94"><enum>(C)</enum><text>the current and anticipated manufacturing capacity to produce such products.</text></subparagraph></paragraph><paragraph id="HB7EE3A1B813C4BB18D7A524680A12CCF"><enum>(10)</enum><text display-inline="yes-display-inline">The full terms of the contract, funding agreement, licensing agreement, other transaction, or other arrangement described in subsection (b).</text></paragraph></subsection><subsection id="HE02D3B38823F408A8FE29E396D4BDCEF"><enum>(d)</enum><header>Format of information</header><text>The database under subsection (a) shall be—</text><paragraph id="HB33B257EEB88449CA1D986CF8241DD82"><enum>(1)</enum><text>searchable and filterable according to the categories of information described in subsection (c); and</text></paragraph><paragraph id="H34966DB1C1C141B18FFB3ECA78894ED8"><enum>(2)</enum><text>presented in a user-friendly format.</text></paragraph></subsection><subsection id="HDB0C028FFAD34231935B4E139432CEB5"><enum>(e)</enum><header>Timing</header><text>The database under subsection (a) shall be—</text><paragraph id="H52B2FFB0C75A4F0996686E8E549B7B82"><enum>(1)</enum><text>made publicly available not later than 1 month of the date of enactment of this Act; and</text></paragraph><paragraph id="HBD5936BC471747EBA74971B406C39B0D"><enum>(2)</enum><text>updated not less than every 2 weeks.</text></paragraph></subsection><subsection id="HA05A4CC7C10548009654F4968A8D68D3"><enum>(f)</enum><header>Disclosure</header><paragraph id="HD5B09F0390EB4512B022E5FE92811CF6"><enum>(1)</enum><header>In general</header><text>Notwithstanding any other provision of law, to the extent necessary for an official described in subsection (a) to carry out this section, such official may require entities receiving Federal support described in subsection (a)(1) to disclose to the official any information relating to such Federal support and required to be included in the database under subsection (a).</text></paragraph><paragraph id="HC395EEA1E39746F295271A453E8C9C52"><enum>(2)</enum><header>Intermediary cooperation</header><text display-inline="yes-display-inline">Any arrangement entered into by the Federal Government with an entity providing for such entity to enter into contracts, licensing agreements, grants, other transactions, or other arrangements with third parties on behalf of the Federal Government shall require such entity to disclose in a timely manner any information necessary for the Federal Government to fulfill its duties under this Act. With respect to any such arrangement in place as of the date of enactment of this Act, an official described in subsection (a) may require the entity to disclose to the official any information required to be included in the database under subsection (a).</text></paragraph><paragraph id="H5A706817F9AD4138ABB993A78FAEE955"><enum>(3)</enum><header>Penalty for nondisclosure</header><text display-inline="yes-display-inline">If an entity that is required to disclose information pursuant to paragraph (1) or (2) fails to disclose such information by the date that is 2 weeks after the date on which the official requests such information, or by such reasonable deadline as the official may specify, whichever is sooner, then such entity shall be liable to the United States for a civil penalty in an amount not to exceed $10,000 for each day on which such failure continues.</text></paragraph></subsection></section></legis-body></bill> 

