,,ii #aag? ,,congress #b;d ,session ,s4 #cdgh ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,janu>y #aa 7legislative day1 ,janu>y #aj71 #bjbb,mr4 ,casey 7= himself1 ,mr4 ,cassidy1 & ,mr4 ,murphy7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,a ,,bill ,to provide = ! designation ( biological products z qualifi$ infecti\s disease products4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,g5]at+ ,antibiotic ,inc5tives ,n[ ,?r\gh ,op5+ ,opportunities to ,lev]age ,sci5ce ,act ( #bjbb or ! ,,ga9 ,,tools ,act ( #bjbb4 #b4 ,exp&+ qualifi$ infecti\s disease products to include biological products 7a7 ,9 g5]al ,section #eje;,e ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee;f7 is am5d$-- 7#a7 9 subsection 7c7-- 7,a7 9 p>agraph 7#b71 by /rik+ 2 or & ins]t+ 22 7,b7 9 p>agraph 7#c71 by /rik+ ! p]iod & ins]t+ 2 or2 & 7,c7 by add+ at ! end ! foll[+3 7#d7 an application pursuant to section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act4 2 7#b7 9 subsection 7d77#a71 by ins]t+ ( ?is ,act or section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act aft] section #eje7;b72 & 7#c7 by am5d+ subsection 7g7 to read z foll[s3 7g7 ,qualifi$ infecti\s disease product ,! t]m qualifi$ infecti\s disease product means a drug or biological product = human use t-- 7#a7 is-- 7,a7 an antibact]ial or antifungal drug2 or 7,b7 a biological product t acts directly on bact]ia or fungi or on sub/ances produc$ by su* bact]ia or fungi2 & 7#b7 is int5d$ to treat a s]i\s or life-?reat5+ infection1 includ+ su* an infection caus$ by-- 7,a7 an antibact]ial or antifungal resi/ant pa?og51 includ+ novel or em]g+ infecti\s pa?og5s2 or 7,b7 qualify+ pa?og5s li/$ by ! ,secret>y "u subsection 7f74 4 7b7 ,priority review ,section #ebd;,a7a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfjn-#a7;a77 is am5d$ by ins]t+ ( ?is ,act1 or section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act1 t requires cl9ical data 7o!r ?an bioavailability /udies7 to demon/rate safety or effectiv5ess be=e ! p]iod4