,,ii #aag? ,,congress #b;d ,session ,s4 #ceji ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,janu>y #ac 7legislative day1 ,janu>y #aj71 #bjbb,mr4 ,braun 7= himself & ,ms4 ,ern/7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,a ,,bill ,to /r5g!n ! au?ority ( ! ,food & ,drug ,adm9i/ration ) respect to =eign drug facility inspections4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,creat+ ,effici5cy 9 ,=eign ,facility ,inspections ,act4 #b4 ,/r5g!n+ =eign drug facility inspections ,section #gjd ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7 is am5d$ by add+ at ! end ! foll[+3 7i7 7#a7 ,:5 ! ,secret>y1 & (fic]s or employees duly designat$ by ! ,secret>y1 conduct inspections "u ?is section ( e/abli%m5ts engag$ 9 ! manufactur+1 process+1 pack+1 or hold+ ( drugs t are locat$ outside ( ! ,unit$ ,/ates1 ! ,secret>y %all n notify ! own] or op]ator ( su* e/abli%m5t ( ! plann$ inspection be=e ! inspection occurs unless-- 7,a7 notification to ! e/abli%m5t own] or op]ator 9 advance ( an inspection is m&at$ "u ! laws ( ! c\ntry :]e ! e/abli%m5t is locat$1 9 :i* case1 ! ,secret>y %all provide n m ?an ! m9imum advanc$ notice s m&at$2 or 7,b7 ! ,secret>y det]m9es t notification to ! e/abli%m5t own] or op]ator 9 advance ( an inspection is ne$$ to protect ! public heal?4 7#b7 7,a7 ,) respect to all inspections describ$ 9 p>agraph 7#a71 ! ,secret>y %all attempt to m9imize ! "t betwe5 advance notification to an e/abli%m5t own] or op]ator & ! conduct ( a surveillance inspection4 7,b7 ,if ! ,secret>y det]m9es t notification to an own] or op]ator ( a =eign e/abli%m5t ( an inspection 9 advance ( a surveillance inspection pursuant to p>agraph 7#a77;,b7 is ne$$1 ! ,secret>y %all provide su* notification only z f> 9 advance z is ne$$ to protect ! public heal?4 7#c7 ,if an e/abli%m5t is locat$ 9 a c\ntry t1 on or aft] ! date ( enactm5t ( ?is subsection1 enacts a law t prev5ts ! ,secret>y f c>ry+ out inspections z describ$ 9 ?is subsection1 ! manufactur] %all agree to waive any "r to en=ce any advanc$-notice requirem5t pursuant to su* a law1 to ! ext5t expressly p]mitt$ "u applicable local law4 ,if ! manufactur] does n agree to su* a waiv]1 ! manufactur] %all be deem$ to h refus$ to p]mit entry or inspection 9 violation ( section #cja7;f74 7#d7 ,! requirem5t ( p>agraph 7#a7 %all n apply to preapproval1 prelic5sure1 or =-cause inspections4 4