#aad? ,,congress #b;d ,session ,s4 #ahgh ,,an ,,act ,to ext5d ! p$iatric priority review v\*] program4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,advanc+ ,hope ,act ( #bjaf4 #b4 ,reau?orization ( program = priority review to enc\rage treatm5ts = r>e p$iatric diseases 7a7 ,9 ,g5]al ,section #ebi ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;ff7 is am5d$-- 7#a7 9 subsection 7a7-- 7,a7 9 p>agraph 7#c71 by am5d+ subp>agraph 7,a7 to read z foll[s3 7,a7 ,! disease is a s]i\s or life-?reat5+ disease 9 :i* ! s]i\s or life-?reat5+ manife/ations prim>ily affect individuals ag$ f bir? to #ah ye>s1 includ+ age gr\ps (t5 call$ neonates1 infants1 *ildr51 & adolesc5ts4 2 & 7,b7 9 p>agraph 7#d77;,f71 by /rik+ ,prescription ,drug ,us] ,fee ,am5dm5ts ( #bjab & ins]t+ ,advanc+ ,hope ,act ( #bjaf2 7#b7 9 subsection 7b7-- 7,a7 by /rik+ p>agraph 7#d7 & ins]t+ ! foll[+3 7#d7 ,notification 7,a7 ,sponsor ( a r>e p$iatric disease product 7i7 ,9 ,g5]al ,beg9n+ on ! date t is #ij days aft] ! date ( enactm5t ( ! ,advanc+ ,hope ,act ( #bjaf1 ! sponsor ( a r>e p$iatric disease product application t int5ds to reque/ a priority review v\*] "u ?is section %all notify ! ,secret>y ( su* int5t ^u submission ( ! r>e p$iatric disease product application t is ! basis ( ! reque/ = a priority review v\*]4 7ii7 ,applications submitt$ b n yet approv$ ,! sponsor ( a r>e p$iatric disease product application t 0 submitt$ & t has n be5 approv$ z ( ! date ( enactm5t ( ! ,advanc+ ,hope ,act ( #bjaf %all be consid]$ eligible = a priority review v\*]1 if-- 7,i7 su* sponsor has submitt$ su* r>e p$iatric disease product application-- 7aa7 on or aft] ! date t is #ij days aft] ! date ( enactm5t ( ! ,prescription ,drug ,us] ,fee ,am5dm5ts ( #bjab2 & 7bb7 on or be=e ! date ( enactm5t ( ! ,advanc+ ,hope ,act ( #bjaf2 & 7,,ii7 su* application o!rwise meets ! crit]ia = a priority review v\*] "u ?is section4 7,b7 ,sponsor ( a drug application us+ a priority review v\*] 7i7 ,9 ,g5]al ,! sponsor ( a human drug application %all notify ! ,secret>y n lat] ?an #ij days prior to submission ( ! human drug application t is ! subject ( a priority review v\*] ( an int5t to submit ! human drug application1 includ+ ! date on :i* ! sponsor int5ds to submit ! application4 ,su* notification %all be a legally b9d+ commitm5t to pay ! us] fee to be assess$ 9 accordance ) ?is section4 7ii7 ,transf] aft] notice ,! sponsor ( a human drug application t provides notification ( ! int5t ( su* sponsor to use ! v\*] = ! human drug application "u clause 7i7 may transf] ! v\*] aft] su* notification is provid$1 if su* sponsor has n yet submitt$ ! human drug application describ$ 9 ! notification4 2 & 7,b7 by /rik+ p>agraph 7#e7 & ins]t+ ! foll[+3 7#e7 ,t]m9ation ( au?ority ,! ,secret>y may n aw>d any priority review v\*]s "u p>agraph 7#a7 aft] ,decemb] #ca1 #bjaf4 2 & 7#c7 9 subsection 7g71 by ins]t+ be=e ! p]iod 1 except t no sponsor ( a r>e p$iatric disease product application may receive m ?an "o priority review v\*] issu$ "u any section ( ?is ,act ) respect to ! drug = :i* ! application is made4 7b7 ,rule ( con/ruction ,no?+ 9 ?is ,act1 or ! am5dm5ts made by ?is ,act1 %all be con/ru$ to affect ! validity ( a priority review v\*] t 0 issu$ "u section #ebi ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;ff7 be=e ! date ( enactm5t ( ?is ,act4 #c4 ,,gao report 7a7 ,/udy ,! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a /udy on ! effectiv5ess ( aw>d+ priority review v\*]s "u section #ebi ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;ff7 9 provid+ inc5tives = ! developm5t ( drugs t treat or prev5t r>e p$iatric diseases 7z def9$ 9 subsection 7a77#c7 ( su* section7 t w\ld n o!rwise h be5 develop$4 ,9 conduct+ su* /udy1 ! ,comptroll] ,g5]al %all exam9e ! foll[+3 7#a7 ,! indications = :i* ea* drug = :i* a priority review v\*] 0 aw>d$ "u su* section #ebi 0 approv$ "u section #eje7;b77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77#a77 or section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7;a774 7#b7 ,:e!r ! priority review v\*] impact$ sponsors' decisions to inve/ 9 develop+ a drug to treat or prev5t a r>e p$iatric disease4 7#c7 ,an analysis ( ! drugs = :i* su* priority review v\*]s 7 us$1 :i* %all include-- 7,a7 ! indications = :i* su* drugs 7 approv$ "u section #eje7;b77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77#a77 or section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7;a772 7,b7 :e!r unmet m$ical ne$s 7 address$ ?r\gh ! approval ( su* drugs1 includ+1 = ea* su* drug-- 7i7 if an alt]native !rapy 0 previ\sly available to treat ! indication2 & 7ii7 if ! drug provid$ a b5efit or advantage ov] ano!r available !rapy2 7,c7 ! numb] ( pati5ts pot5tially treat$ by su* drugs2 7,d7 ! value ( ! priority review v\*] if transf]r$2 & 7,e7 ! l5g? ( "t betwe5 ! date on :i* a priority review v\*] 0 aw>d$ & ! date on :i* x 0 us$4 7#d7 ,) respect to ! priority review v\*] program "u section #ebi ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;ff7-- 7,a7 ! res\rces us$ by ! ,food & ,drug ,adm9i/ration 9 implem5t+ su* program1 includ+ ! effect ( su* program on ! ,food & ,drug ,adm9i/ration's review ( drugs = :i* a priority review v\*] 0 n aw>d$ or us$2 7,b7 ! impact ( ! program on ! public heal? z a result ( ! review & approval ( drugs t receiv$ a priority review v\*] & products t 7 ! subject ( a r$eem$ priority review v\*]2 & 7,c7 alt]native approa*es to improv+ su* program s t ! program is appropriately t>get$ t[>d provid+ inc5tives = ! developm5t ( cl9ically important drugs t-- 7i7 prev5t or treat r>e p$iatric diseases2 & 7ii7 w\ld likely n o!rwise h be5 develop$ to prev5t or treat su* diseases4 7b7 ,report ,n lat] ?an ,janu>y #ca1 #bjbb1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ( ! ,s5ate & ! ,committee on ,en]gy & ,comm]ce ( ! ,h\se ( ,repres5tatives a report conta9+ ! results ( ! /udy ( conduct$ "u subsection 7a74 ,pass$ ! ,s5ate ,septemb] #bb1 #bjaf4,secret>y