,i #aag? ,,congress #a/ ,session ,h4 ,r4 #befe ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,april #ae1 #bjba,mr4 ,bu*anan 7= himself1 ,mrs4 ,luria1 ,ms4 ,mace1 ,ms4 ,%]rill1 & ,mr4 ,br5dan ,f4 ,boyle ( ,p5nsylvania7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,a ,,bill ,to am5d ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act to all[ manufactur]s & sponsors ( a drug to use alt]native te/+ me?ods to animal te/+ to inve/igate ! safety & effectiv5ess ( a drug1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,,fda ,mod]nization ,act ( #bjba4 #b4 ,animal te/+ alt]natives ,section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 is am5d$-- 7#a7 9 subsection 7b77#e77;,b77i77,,ii71 by /rik+ animal & ins]t+ noncl9ical te/s or /udies2 7#b7 9 subsection 7i7-- 7,a7 9 p>agraph 7#a77;,a71 by /rik+ 7includ+ te/s on animals72 & 7,b7 9 p>agraph 7#b77;,b71 by /rik+ animal or human /udies & ins]t+ noncl9ical te/s or /udies2 & 7#c7 aft] subsection 7y71 by ins]t+ ! foll[+3 7z7 ,noncl9ical te/ or /udy def9$ ,= purposes ( ?is section1 ! t]m noncl9ical te/ or /udy means a te/ or /udy t is mo/ likely to pr$ict human response bas$ on sci5tific evid5ce & occurs be=e or dur+ ! cl9ical trial phase ( ! inve/igation ( ! safety & effectiv5ess ( a drug4 ,su* te/ or /udy may include ! foll[+3 7#a7 ,cell-bas$ assays4 7#b7 ,organ *ips & microphysiological sy/ems4 7#c7 ,sophi/icat$ comput] model+4 7#d7 ,o!r human biology-bas$ te/ me?ods4 7#e7 ,animal te/s4 4