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<dc:title>117 HR 1473 IH: Vaccine Transparency Act of 2021</dc:title>
<dc:publisher>U.S. House of Representatives</dc:publisher>
<dc:date>2021-03-01</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">I</distribution-code><congress display="yes">117th CONGRESS</congress><session display="yes">1st Session</session><legis-num display="yes">H. R. 1473</legis-num><current-chamber>IN THE HOUSE OF REPRESENTATIVES</current-chamber><action display="yes"><action-date date="20210301">March 1, 2021</action-date><action-desc><sponsor name-id="S001214">Mr. Steube</sponsor> introduced the following bill; which was referred to the <committee-name committee-id="HIF00">Committee on Energy and Commerce</committee-name></action-desc></action><legis-type>A BILL</legis-type><official-title display="yes">To require the Commissioner of Food and Drugs and the Director of the Centers for Disease Control and Prevention to report to Congress all serious adverse events that are reported to such agencies in connection with administration of a COVID–19 vaccine, and for other purposes.</official-title></form><legis-body id="H0C86C4758281465397BECC7FB90ED0EF" style="OLC"><section id="H31BC41474F0C40C7BE03C2CCDEB71A3A" section-type="section-one"><enum>1.</enum><header>Short title</header><text display-inline="no-display-inline">This Act may be cited as the <quote><short-title>Vaccine Transparency Act of 2021</short-title></quote>.</text></section><section id="H6F96CC37785145898EF1F0EE00A856A1"><enum>2.</enum><header>Reports to Congress on serious adverse events in connection with COVID–19 vaccines</header><subsection id="HA8D7E01228404924B8F08252432B68DB"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">Not later than 60 days after the date of enactment of this Act, and every 60 days thereafter, the Commissioner of Food and Drugs and the Director of the Centers for Disease Control and Prevention, acting jointly, shall submit a report to the Congress on all serious adverse events that are reported—</text><paragraph id="HDC6A869782094399812C5BEA8A7FF228"><enum>(1)</enum><text>to either agency pursuant to the Vaccine Adverse Event Reporting System or otherwise during the period covered by the report; and</text></paragraph><paragraph id="HF560F355B8E9449099E1218026865512"><enum>(2)</enum><text>in connection with a COVID–19 vaccine.</text></paragraph></subsection><subsection id="HE147286BB1BC4F6E89B489F9430CC757"><enum>(b)</enum><header>Initial report</header><text display-inline="yes-display-inline">The reporting period of the initial report under subsection (a) shall begin on the date when the Commissioner of Food and Drugs first authorized emergency use of a COVID–19 vaccine under section 564 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360bbb-3">21 U.S.C. 360bbb–3</external-xref>). </text></subsection></section></legis-body></bill> 

