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<dc:title>116 HR 4553 IH: Adding Epidemic Diseases to the FDA Priority Review Voucher Program Act</dc:title>
<dc:publisher>U.S. House of Representatives</dc:publisher>
<dc:date>2019-09-27</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">116th CONGRESS</congress><session display="yes">1st Session</session><legis-num display="yes">H. R. 4553</legis-num><current-chamber>IN THE HOUSE OF REPRESENTATIVES</current-chamber><action display="yes"><action-date date="20190927">September 27, 2019</action-date><action-desc><sponsor name-id="B001296">Mr. Brendan F. Boyle of Pennsylvania</sponsor> (for himself, <cosponsor name-id="M001198">Mr. Marshall</cosponsor>, <cosponsor name-id="V000131">Mr. Veasey</cosponsor>, and <cosponsor name-id="F000449">Mr. Fortenberry</cosponsor>) 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 expand the tropical disease product priority review voucher program to encourage treatments for the Middle East respiratory syndrome, Nipah, and Rift Valley fever.</official-title></form><legis-body id="H0743A35927B74FAEBDB18FEFDE8C3DDA" style="OLC"> 
<section id="H8CDBF3A395E94923AE27B9E743FB20F5" 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>Adding Epidemic Diseases to the FDA Priority Review Voucher Program Act</short-title></quote>.</text></section> <section id="H8E00B33F5DD34951A0E1E743FB626038"><enum>2.</enum><header>Expanding tropical disease product priority review voucher program to encourage treatments for Middle East respiratory syndrome, Nipah, and Rift Valley fever</header><text display-inline="no-display-inline">Section 524(a)(3) of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360n">21 U.S.C. 360n(a)(3)</external-xref>) is amended—</text> 
<paragraph id="H1BD05569AE1C4FBE8319D8054DE1C913"><enum>(1)</enum><text>by redesignating subparagraph (S) as subparagraph (V); and</text></paragraph> <paragraph id="H8F51B17196B94F53AA374FDB7926ECFD"><enum>(2)</enum><text>by inserting after subparagraph (R) the following:</text> 
<quoted-block id="H57D7E1CC27B147D7B30FC34312B8D892" style="OLC"> 
<subparagraph id="H45CB73DC3FCB42018522AD43C854EDF4"><enum>(S)</enum><text display-inline="yes-display-inline">Middle East respiratory syndrome.</text></subparagraph> <subparagraph id="HD32F2A3400B9431EBAA30244E0B5FF78"><enum>(T)</enum><text>Nipah.</text></subparagraph> 
<subparagraph id="H2F63B5CE9A174449A3CE5D82362CAE71"><enum>(U)</enum><text>Rift Valley fever.</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></section> </legis-body></bill>

