,,ii #aai? ,,congress #b;d ,session ,s4 #dcbg ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,april #af 7legislative day1 ,april #ad71 #bjbf,mr4 ,cotton introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,a ,,bill ,to require regulatory review ( ph>maceutical products f ,*9ese entities1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,secur+ ,am]ica's ,drug ,supply f ,communi/ ,*9a ,act4 #b4 ,regulatory review ( ph>maceutical products f ,*9ese entities 7a7 ,def9itions ,9 ?is section3 7#a7 ,*9ese entity ,! t]m ,*9ese entity means an entity organiz$ "u ! laws ( ! ,p's ,republic ( ,*9a or o!rwise subject to ! jurisdiction ( ! ,gov]nm5t ( ! ,p's ,republic ( ,*9a4 7#b7 ,drug application ,! t]m drug application means an application submitt$ "u subsection 7b7 or 7j7 ( section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or subsection 7a7 or 7k7 ( section #cea ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb74 7#c7 ,,prc-1 ,,ccp-1 or ,,pla-affiliat$ entity 7,a7 ,9 g5]al ,! t]m ,,prc-1 ,,ccp-1 or ,,pla-affiliat$ entity means any entity t receives support directly or indirectly f ! ,gov]nm5t ( ! ,p's ,republic ( ,*9a1 ! ,*9ese ,communi/ ,p>ty1 or ! ,p's ,lib]ation ,army1 includ+-- 7i7 an entity own$ or controll$ by ! ,gov]nm5t ( ! ,p's ,republic ( ,*9a or an entity own$ or controll$ by su* an entity2 & 7ii7 an entity t has on its bo>d ( directors "o or m individuals describ$ 9 subp>agraph 7,b7 :o collectively hold an own]%ip int]e/ 9 ! entity4 7,b7 ,individuals describ$ ,an individual describ$ 9 ?is subp>agraph is-- 7i7 an (ficial ( ! ,gov]nm5t ( ! ,p's ,republic ( ,*9a1 ! ,*9ese ,communi/ ,p>ty1 or ! ,p's ,lib]ation ,army2 or 7ii7 an executive (fic] ( an entity own$ or controll$ by ! ,gov]nm5t ( ! ,p's ,republic ( ,*9a1 includ+ ! presid5t or vice presid5t (1 or any o!r executive (fic] :o p]=ms a policy-mak+ function =1 ! entity4 7#d7 ,secret>y ,! t]m ,secret>y means ! ,secret>y ( ,heal? & ,human ,s]vices1 act+ ?r\gh ! ,commission] ( ,food & ,drugs4 7b7 ,review ( c]ta9 new drug applications submitt$ on or aft] enactm5t 7#a7 ,9 g5]al ,! ,secret>y1 9 coord9ation ) ! ,(fice ( ,national ,security ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 %all review ea* drug application submitt$ on or aft] ! date ( enactm5t ( ?is ,act by a sponsor t is a ,*9ese entity1 or an entity lic5s+ a product own$ by a ,*9ese entity1 to det]m9e :e!r su* sponsor is a ,,prc-1 ,,ccp-1 or ,,pla-affiliat$ entity4 ,9 c>ry+ out ?is p>agraph1 ! ,secret>y may review any ,drug ,ma/] ,file ref]5c$ by su* an application4 7#b7 ,d5i$ approval ( c]ta9 applications ,! ,secret>y %all n approve any drug application submitt$ on or aft] ! date ( enactm5t ( ?is ,act if ! ,secret>y has det]m9$ "u p>agraph 7#a7 t ! sponsor ( su* application is a ,,prc-1 ,,ccp-1 or ,,pla-affiliat$ entity4 7c7 ,review ( c]ta9 new drug applications submitt$ prior to enactm5t 7#a7 ,9 g5]al ,! ,secret>y1 9 coord9ation ) ! ,(fice ( ,national ,security ( ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 %all review ea* drug application submitt$ dur+ ! p]iod describ$ 9 p>agraph 7#b7 to det]m9e :e!r ! sponsor ( ! application &1 if applicable1 ! hold] ( ! approv$ application1 is a ,,prc-1 ,,ccp-1 or ,,pla-affiliat$ entity4 ,9 c>ry+ out ?is p>agraph1 ! ,secret>y may review any ,drug ,ma/] ,file ref]5c$ by su* an application4 7#b7 ,p]iod describ$ ,! p]iod describ$ 9 ?is p>agraph is ! p]iod beg9n+ on ,janu>y #a1 #bjaf1 & end+ on ! day be=e ! date ( enactm5t ( ?is ,act4 7d7 ,refusal ( c]ta9 drugs (f]$ = import 7#a7 ,9 g5]al ,section #hja ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cha7 is am5d$ by add+ at ! end ! foll[+2 7v7 ,import ( drugs sponsor$ by ,,prc-1 ,,ccp-1 & ,,pla-,affiliat$ entities 7#a7 ,9 g5]al ,! ,secret>y %all furni% to ! ,commission] ( ,u4,s4 ,cu/oms & ,bord] ,protection a li/ ( drugs = :i* ! sponsor or hold] ( an approv$ application is det]m9$ "u section #b7;c7 ( ! ,secur+ ,am]ica's ,drug ,supply f ,communi/ ,*9a ,act to be a ,,prc-1 ,,ccp-1 or ,,pla-affiliat$ entity4 7#b7 ,refusal ,if x appe>s t a drug import$ or (f]$ = import into ! ,unit$ ,/ates is a drug = :i* ! sponsor or hold] ( an approv$ application is det]m9$ "u section #b7;c7 ( ! ,secur+ ,am]ica's ,drug ,supply f ,communi/ ,*9a ,act to be a ,,prc-1 ,,ccp-1 or ,,pla-affiliat$ entity1 !n su* drug %all be refus$1 except z provid$ 9 p>agraphs 7#c7 & 7#d71 & ! ,commission] ( ,u4,s4 ,cu/oms & ,bord] ,protection %all de/roy1 )\t ! opportunity = export1 su* drug4 7#c7 ,compliance 7,a7 ,9 g5]al ,! ,secret>y %all e/abli% a process "u :i* ! sponsor ( a drug describ$ 9 p>agraph 7#b7 or ! hold] ( an approv$ application = su* a drug1 z applicable1 may-- 7i7 demon/rate to ! ,secret>y t x is no long] a ,,prc-1 ,,ccp-1 or ,,pla-affiliat$ entity2 or 7ii7 )9 #ahj days1 sell ! approv$ application = su* drug to an entity t is n a ,,prc-1 ,,ccp-1 or ,,pla-affiliat$ entity4 7,b7 ,requirem5t ,! process e/abli%$ "u subp>agraph 7,a7 %all include ! opportunity to appe> be=e ! ,secret>y & introduce te/imony4 7,c7 ,notification ,if ! ,secret>y is satisfi$ ) ! action tak5 "u clause 7i7 or 7ii7 ( subp>agraph 7,a71 ! ,secret>y %all notify ! ,commission] ( ,u4,s4 ,cu/oms & ,bord] ,protection4 7#d7 ,waiv] ,! ,commission] ( ,u4,s4 ,cu/oms & ,bord] ,protection may waive ! requirem5ts ( p>agraph 7#b7 & au?orize ! import ( a drug describ$ 9 su* p>agraph if ! ,secret>y has det]m9$ t ! refusal ( ! import w\ld create or exac]bate a drug %ortage 9 ! ,unit$ ,/ates4 7#e7 ,def9ition ( ,,prc-1 ,,ccp-1 or ,,pla-affiliat$ entity ,9 ?is subsection1 ! t]m ,,prc-1 ,,ccp-1 or ,,pla-affiliat$ entity has ! mean+ giv5 su* t]m 9 section #b7;a7 ( ! ,secur+ ,am]ica's ,drug ,supply f ,communi/ ,*9a ,act4 4 7e7 ,au?orization ( ,appropriations ,!re is au?oriz$ to be appropriat$ to c>ry out ?is section & ! am5dm5ts made by ?is section #e1jjj1jjj1 to rema9 available until exp5d$4