,i #aae? ,,congress #b;d ,session ,h4 ,r4 #eeii ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,april #bd1 #bjah ,mr4 ,hudson 7= himself1 ,mr4 ,s*rad]1 ,mr4 ,buc%on1 ,mr4 ,butt]field1 & ,mr4 ,mull97 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,a ,,bill ,to am5d ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act to exp& ! conditional approval pa?way = m animal drugs1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,animal ,heal? & ,innovation ,act ( #bjah4 #b4 ,conditional approval ( new animal drugs ,section #ega ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;ccc7 is am5d$-- 7#a7 9 ! section head+1 by /rik+ species & ins]t+ species & c]ta9 new animal drugs2 7#b7 9 subsection 7a7-- 7,a7 by am5d+ p>agraph 7#a7 to read z foll[s3 7#a7 7,a7 ,except z provid$ 9 p>agraph 7#c71 any p]son may file ) ! ,secret>y an application = conditional approval (-- 7i7 a new animal drug int5d$ = a m9or use or a m9or species2 or 7ii7 a new animal drug n int5d$ = a m9or use or m9or species-- 7,i7 t is int5d$ to treat a s]i\s or life-?reat5+ disease or condition or addresses an unmet animal or human heal? ne$2 & 7,,ii7 = :i* ! ,secret>y det]m9es t a demon/ration ( effectiv5ess w\ld require a complex or p>ticul>ly difficult /udy or /udies4 7,b7 ,! ,secret>y %all1 n lat] ?an ,septemb] #cj1 #bjai1 issue guidance or regulations fur!r cl>ify+ ! crit]ia specifi$ 9 subp>agraph 7,a77ii74 7,c7 ,an application "u ?is p>agraph %all comply 9 all respects ) ! provisions ( section #eab except = subsections 7a77#d71 7b77#b71 7c77#a71 7c77#b71 7c77#c71 7d77#a71 7e71 7h71 & 7n7 ( su* section unless o!rwise /at$ 9 ?is section1 & any additional provisions ( ?is section4 7,d7 ,new animal drugs conditionally approv$ "u ?is section are subject to application ( ! same safety /&>ds t w\ld be appli$ to new animal drugs approv$ "u section #eab7;d7 7includ+1 = antimicrobial new animal drugs1 ) respect to antimicrobial resi/ance74 2 & 7,b7 9 p>agraph 7#c7-- 7i7 9 subp>agraph 7,a71 by /rik+ ! p]iod at ! end & ins]t+ or a new animal drug t is an antibiotic drug22 & 7ii7 9 subp>agraph 7,b71 by /rik+ 2 or & ins]t+ 2 or2 & 7#c7 9 subsection 7f7-- 7,a7 9 p>agraph 7#a71 9 ! matt] prec$+ subp>agraph 7,a71 by ins]t+ = ! conditionally approv$ use aft] %all2 & 7,b7 9 p>agraph 7#b7-- 7i7 by /rik+ ,an int5d$ use & ins]t+ ,! ,secret>y %all1 ?r\gh regulation or guidance1 det]m9e "u :at conditions an int5d$ use2 & 7ii7 by /rik+ %all n & ins]t+ may4