,,ii #aad? ,,congress #a/ ,session ,s4 #bjda ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,septemb] #af1 #bjae ,mr4 ,casey 7= himself1 ,mr4 ,cassidy1 & ,mr4 ,m55dez7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,a ,,bill ,to promote ! developm5t ( safe drugs = neonates4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,promot+ ,life-,sav+ ,new ,!rapies = ,neonates ,act ( #bjae4 #b4 ,promot+ ! developm5t ( safe & effective !rapies = neonates ,sub*apt] ,b ( *apt] ,v ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;aa et seq47 is am5d$ by ins]t+ aft] section #ebi ! foll[+3 #ecj4 ,exclusivity to enc\rage developm5t ( safe & effective !rapies = neonates 7a7 ,def9itions ,9 ?is section3 7#a7 ,neonatal drug ,! t]m neonatal drug means a drug = ! prev5tion or treatm5t ( a disease or condition ( a pret]m or full-t]m neonate4 7#b7 ,neonatal drug application ,! t]m neonatal drug application means a human drug application1 z def9$ 9 section #gce7a71 t-- 7,a7 is = a drug or biological product-- 7i7 t is = ! prev5tion or treatm5t ( a disease or condition li/$ on ! ,priority ,li/ ( ,critical ,ne$s = ,neonates describ$ 9 subsection 7c72 & 7ii7 t conta9s no active +r$i5t 7includ+ any e/] or salt ( ! active +r$i5t7 t has be5 previ\sly approv$ 9 any o!r application "u section #eje7;b77#a71 #eje7;b77#b71 or #eje7;j7 ( ?is ,act or section #cea7;a7 or #cea7k7 ( ! ,public ,heal? ,s]vice ,act2 7,b7 is submitt$ "u section #eje7;b77#a7 ( ?is ,act or section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act2 7,c7 ! ,secret>y det]m9es to be eligible = a neonatal drug exclusivity v\*]1 9 accordance ) subsection 7b72 7,d7 relies on cl9ical data d]iv$ f /udies exam9+ a neonatal population & dosages ( ! drug int5d$ = t population2 & 7,e7 is approv$ aft] ! date ( ! enactm5t ( ! ,promot+ ,life-,sav+ ,new ,!rapies = ,neonates ,act ( #bjae4 7#c7 ,neonatal drug exclusivity v\*] ,! t]m neonatal drug exclusivity v\*] means a v\*] issu$ by ! ,secret>y to ! sponsor ( a neonatal drug application t entitles ! hold] ( su* v\*] to "o ye> ( transf]able ext5sion ( all exi/+ pat5ts & m>ket+ exclusivities1 includ+ any ext5sions1 = a s+le human drug ) respect to an application submitt$ "u section #eje7;b77#a7 or = a s+le human biologic product ) respect to an application submitt$ "u section #cea7;a7 ( ! ,public ,heal? ,s]vice ,act1 includ+ ! #f-mon? p]iod describ$ 9 section #eje;,a1 ! #d- & #e-ye> p]iods describ$ 9 subsections 7c77#c77;,e77ii7 & 7j77#e77;,f77ii7 ( section #eje1 ! #c-ye> p]iods describ$ 9 clauses 7iii7 & 7iv7 ( subsection 7c77#c77;,e7 & clauses 7iii7 & 7iv7 ( subsection 7j77#e77;,f7 ( section #eje1 ! #g-ye> p]iod describ$ 9 section #ebg1 ! #e-ye> p]iod describ$ 9 section #eje;,e1 & ! #ab-ye> p]iod describ$ 9 section #cea7k77#g74 7b7 ,neonatal drug exclusivity v\*] 7#a7 ,9 g5]al ,! ,secret>y %all aw>d a neonatal drug exclusivity v\*] to ! sponsor ( a neonatal drug application ^u approval by ! ,secret>y ( su* neonatal drug application4 7#b7 ,transf]ability 7,a7 ,9 g5]al ,! sponsor ( a neonatal drug application t receives a neonatal drug exclusivity v\*] "u ?is section may transf] 7includ+ by sale7 ! v\*] to a sponsor ( a human drug = :i* an application "u section #eje7;b77#a7 or section #cea ( ! ,public ,heal? ,s]vice ,act has be5 approv$1 w be submitt$1 or has be5 submitt$4 7,b7 ,nontransf]ability ,a neonatal exclusivity v\*] may n be transf]r$ to1 or us$ =1 a drug ) respect to :i* all pat5ts & exclusivities h expir$ z ( ! date ( ! transf]4 7,c7 ,notification ( transf] ,ea* p]son to :om a v\*] is transf]r$ %all notify ! ,secret>y ( su* *ange 9 own]%ip ( ! v\*] n lat] ?an #cj cal5d> days aft] su* transf]4 7,d7 ,prohibition on additional fees ,! ,secret>y %all n apply a fee = ! ex]cise ( a v\*] "u ?is section4 ,! prec$+ s5t5ce %all n affect ! au?ority ( ! ,secret>y to apply fees ) respect to a neonatal drug application t are o!rwise applicable "u law4 7,e7 ,revocation ( v\*] ,! ,secret>y may revoke any neonatal exclusivity v\*] if ! neonatal drug product = :i* su* v\*] 0 aw>d$ is n m>ket$ 9 ! ,unit$ ,/ates )9 ! #cfe-;day p]iod beg9n+ on ! date ( ! approval ( su* drug "u section #eje ( ?is ,act or section #cea ( ! ,public ,heal? ,s]vice ,act4 7#c7 ,limitations 7,a7 ,no aw>d = prior approv$ application ,a sponsor ( a neonatal drug may n receive a v\*] "u ?is section if ! neonatal drug application 0 submitt$ to ! ,secret>y prior to ! date ( enactm5t ( ?is section4 7,b7 ,requir$ ,p$iatric ,rese>* ,! ,secret>y %all limit grants ( exclusivity "u ?is section to drugs t are n requir$ to complete neonatal /udies "u section #eje;,b4 7,c7 ,no comb9+ v\*]s ,a sponsor may n use a neonatal exclusivity v\*] on a product = :i* ! sponsor also int5ds to use a v\*] obta9$ or pur*as$ pursuant to section #ebd or section #ebi4 7#d7 ,notification ( int5t to use v\*] 7,a7 ,notification by sponsor ,! sponsor ( a human drug application int5d+ to use a v\*] aw>d$ or transf]r$ "u ?is section %all notify ! ,secret>y n lat] ?an #ae mon?s prior to loss ( pat5t & exclusivities on ! drug = :i* ! v\*] w be r$eem$1 9 su* =m z ! ,secret>y may require4 7,b7 ,notification by ,secret>y ,)9 #cj cal5d> days ( su* notification to ! ,secret>y1 ! ,secret>y %all notify ! sponsor ( its eligibility to r$eem a v\*] = ! int5d$ drug4 7c7 ,priority li/ ( critical ne$s = neonates 7#a7 ,9 g5]al ,! ,secret>y1 9 consultation ) ! ,p$iatric ,advisory ,committee1 ! ,national ,in/itutes ( ,heal?1 ! ,int]national ,neonatal ,consortium sponsor$ by ,critical ,pa? ,in/itute1 & o!r /akehold]s1 %all1 )9 "o ye> ( ! date ( enactm5t ( ! ,promot+ ,life-,sav+ ,new ,!rapies = ,neonates ,act ( #bjae-- 7,a7 develop & publi% a li/ ( critical rese>* priorities relat$ to specific diseases or conditions common to ! neonatal population 7ref]r$ to z ! ,priority ,li/ ( ,critical ,ne$s = ,neonates72 7,b7 issue guidance specific to ! neonatal drug exclusivity v\*] program2 & 7,c7 p]=m o!r activities necess>y to support neonatal drug applications4 7#b7 ,public comm5t ,! ,secret>y %all provide a p]iod ( public notice & comm5t on ! propos$ li/ & %all hold public meet+s to elicit input f pati5t advocacy & o!r organizations prior to publi%+ ! f9al li/4 7#c7 ,subsequ5t update ,! ,secret>y may revise1 & publi% 9 accordance ) p>agraph 7#a77;,a71 ! ,priority ,li/ ( ,critical ,ne$s = ,neonates e #c ye>s1 or z frequ5tly z ! ,secret>y det]m9es necess>y4 7#d7 ,re/riction on removal f li/ ,no disease or condition on ! ,priority ,li/ ( ,critical ,ne$s = ,neonates may be remov$ until aft] completion ( ! /udy & report "u subsection 7d74 7d7 ,,gao /udy & report 7#a7 ,/udy 7,a7 ,9 g5]al ,beg9n+ #h ye>s aft] ! date ( enactm5t ( ! ,promot+ ,life-,sav+ ,new ,!rapies = ,neonates ,act ( #bjae or on ! date t ! ,secret>y aw>ds ! ?ird neonatal exclusivity v\*] "u ?is section1 :i*ev] is e>li]1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all conduct a /udy ( ! effectiv5ess ( ! program "u ?is section = ! developm5t ( human drugs to treat & prev5t diseases or conditions 9 ! neonatal population4 7,b7 ,cont5ts ( ! /udy ,9 conduct+ ! /udy "u subp>agraph 7,a71 ! ,comptroll] ,g5]al %all exam9e ! foll[+3 7i7 ,! numb] ( neonatal drug v\*]s aw>d$ "u ?is section4 7ii7 ,! indications = ea* drug = :i* a neonatal exclusivity v\*] 0 approv$ "u section #eje or section #cea ( ! ,public ,heal? ,s]vice ,act1 & :e!r any o!r drugs ) indications = populations o!r ?an neonates 7 approv$ ) an indication = neonates "u ^? sections4 7iii7 ,:e!r1 & to :at ext5t1 an unmet ne$ relat$ to ! treatm5t or prev5tion ( a disease or condition t affects ! neonatal population 0 met ?r\gh ! approval ( a neonatal drug4 7iv7 ,! value ( ! neonatal exclusivity v\*] if transf]r$4 7v7 ,id5tification ( ea* drug = :i* a neonatal exclusivity v\*] 0 us$4 7vi7 ,! l5g? ( ! p]iod ( "t betwe5 ! date on :i* a neonatal exclusivity v\*] 0 aw>d$ & ! date on :i* x 0 us$4 7#b7 ,report ,n lat] ?an #a ye> aft] ! date "u p>agraph 7#a77;,a71 ! ,comptroll] ,g5]al %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 "u p>agraph 7#a74 4