,i  #aaf? ,,congress  #b;d ,session  ,h4
 ,r4 #fhhe  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,may #ae1 #bjbj,mr4   
,flores introduc$ ! foll[+ bill2 :i* 0  
ref]r$ to ! ,committee on ,en]gy &      
,comm]ce1 & 9 addition to ! ,committee  
on ,ways & ,means1 = a p]iod to be      
subsequ5tly det]m9$ by ! ,speak]1 9 ea* 
case = consid]ation ( su* provisions z  
fall )9 ! jurisdiction ( ! committee    
conc]n$  ,a ,,bill  ,to am5d ! ,f$]al   
,food1 ,drug1 & ,cosmetic ,act to       
prohibit ! importation ( a drug or      
device t 0 manufactur$ at a bann$ =eign 
facility1 to create inc5tives =         
ph>maceutical or device companies to    
increase manufactur+ capacity 9 ! ,unit$
 ,/ates1 & = o!r purposes4  #a4 ,%ort   
title ,?is ,act may be cit$ z ! ,safe & 
,secure ,m$ic9e ,supply = ,h>dwork+     
,am]icans ,act ( #bjbj4  #b4 ,table (   
cont5ts ,! table ( cont5ts ( ?is ,act is
 z foll[s3 ,sec4 #a4 ,%ort title4,sec4  
#b4 ,table ( cont5ts4,sec4 #c4 ,safe    
drug & device importation4,sec4 #d4     

,imposition ( additional duties on drugs
 f ,*9a1 ,india1 & o!r c\ntries4,sec4   
#e4 ,secure ,m$ic9es ,supply ,fund4,sec4
 #f4 ,regi/ry ( drugs manufactur$       
outside ! ,unit$ ,/ates4,sec4 #g4       
,c\ntry-(-orig9 label+4  #c4 ,safe drug 
& device importation  7a7 ,prohibit$ act
 ,section #cja ( ! ,f$]al ,food1 ,drug1 
& ,cosmetic ,act 7#ba ,u4,s4,c4 #cca7 is
 am5d$ by add+ at ! end ! foll[+3  7fff7
 ,! importation ( a drug or device t 0  
manufactur$ or process$ at a bann$ =eign
 facility = :i* an ord] is 9 effect "u  
section #haj4  4  7b7 ,issuance ( ord]  
,! ,f$]al ,food1 ,drug1 & ,cosmetic ,act
 is am5d$ by ins]t+ aft] section #hji ( 
su* ,act 7#ba ,u4,s4,c4 #chd;e7 ! foll[+
 new section3  #haj4 ,bann$ =eign       
facilities  7a7 ,det]m9ation ,!         
,secret>y %all issue an ord] det]m9+ a  
facility to be a bann$ =eign facility   
if-- 7#a7 ! facility manufactures or    
processes any drug or device t is       
import$ into ! ,unit$ ,/ates2 &  7#b7 a 
,class ,i or ,class ,,ii recall is issu$

 by ! ,food & ,drug ,adm9i/ration = any 
drug or device t is manufactur$ or      
process$ at su* facility4  7b7 ,duration
  7#a7 ,bann$ facilities ) ,class ,i    
recall ,= a bann$ facility = :i* a      
,class ,i recall is issu$ z describ$ 9  
subsection 7a77#b73 7,a7 ,! designation 
( ! bann$ facility pursuant to an ord]  
"u subsection 7a71 bas$ on an initial   
,class ,i recall ( a drug or device     
manufactur$ or process$ at ! facility1  
%all be 9 effect = ! #aj-ye> p]iod      
beg9n+ on ! date t is "o ye> aft] !     
issuance ( ! ord]4  7,b7 ,! designation 
( ! bann$ facility pursuant to an ord]  
"u subsection 7a71 bas$ on a subsequ5t  
,class ,i recall ( a drug or device     
manufactur$ or process$ at ! facility1  
%all be 9 effect p]man5tly beg9n+ on !  
date t is "o ye> aft] ! issuance ( su*  
ord]4  7#b7 ,bann$ facilities ) ,class  
,,ii recall ,= a bann$ facility = :i* a 
class ,,ii recall is issu$ z describ$ 9 
subsection 7a77#b73 7,a7 ,! designation 
( ! bann$ facility pursuant to an ord]  

"u subsection 7a71 bas$ on an initial   
,class ,,ii recall ( a drug or device   
manufactur$ or process$ at ! facility1  
%all be 9 effect = ! #e-ye> p]iod beg9n+
 on ! date t is "o ye> aft] ! issuance (
 ! ord]4  7,b7 ,! designation ( ! bann$ 
facility pursuant to an ord] "u         
subsection 7a71 bas$ on a fir/ subsequ5t
 ,class ,,ii recall ( a drug or device  
manufactur$ or process$ at ! facility1  
may be r5ew$ to be 9 effect = a p]iod ( 
#e ye>s beg9n+-- 7i7 if ! initial #e-ye>
 p]iod "u subp>agraph 7,a7 has conclud$1
 "o ye> f ! date ( ! fir/ subsequ5t     
recall2 or  7ii7 if ! initial #e-ye>    
p]iod "u subp>agraph 7,a7 has n         
conclud$1 at ! conclusion ( su* initial 
#e-ye> p]iod4  7,c7 ,! designation ( !  
bann$ facility pursuant to an ord] "u   
subsection 7a71 bas$ on a second        
subsequ5t ,class ,,ii recall ( a drug or
 device manufactur$ or process$ at !    
facility1 %all be 9 effect p]man5tly    
beg9n+-- 7i7 if ! fir/ subsequ5t #e-ye> 
p]iod "u subp>agraph 7,b7 has conclud$1 

"o ye> aft] ! issuance ( ! ord]2 or     
7ii7 if ! fir/ subsequ5t #e-ye> p]iod "u
 subp>agraph 7,b7 has n conclud$1       
imm$iately4  7c7 ,def9ition ,9 ?is      
section3 7#a7 ,! t]m bann$ facility     
means a bann$ =eign facility = :i* an   
ord] is 9 effect "u subsection 7a74     
7#b7 ,! t]ms ,class ,i & ,class ,,ii1 9 
connection ) a recall1 mean classifi$ z 
,class ,i or ,class ,,ii1 respectively1 
by ! ,food & ,drug ,adm9i/ration        
pursuant to section #g4da ( title #ba1  
,code ( ,f$]al ,regulations 7or any     
successor regulations74  4  7c7         
,applicability ,section #haj ( ! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act1 z add$  
by subsection 7b71 applies only )       
respect to recalls issu$ or reissu$ on  
or aft] ! date ( enactm5t ( ?is ,act4   
7d7 ,civil monet>y p5alties ,subsection 
7f7 ( section #cjc ( ! ,f$]al ,food1    
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#ccc7 is am5d$ by add+ at ! end ! foll[+
 new p>agraph3  7#aj7 ,any p]son :o     
violates section #cja7;fff7 %all be     

subject to a civil money p5alty n to    
exce$-- 7,a7 if ! violation involves a  
,class ,i recall1 z describ$ 9 section  
#haj7;a77#b7-- 7i7 #be1jjj1jjj if !     
violation is ! fir/ violation ( section 
#cja7;fff7 by su* p]son2 &  7ii7        
#ajj1jjj1jjj if ! violation is a        
subsequ5t violation ( section #cja7;fff7
 by su* p]son2 &  7,b7 if ! violation   
involves a ,class ,,ii recall1 z        
describ$ 9 section #haj7;a77#b7-- 7i7   
#aj1jjj1jjj if ! violation is ! fir/    
violation ( section #cja7;fff7 by su*   
p]son2 &  7ii7 #ej1jjj1jjj if !         
violation is a subsequ5t violation (    
section #cja7;fff7 by su* p]son4  4  #d4
 ,imposition ( additional duties on     
drugs f ,*9a1 ,india1 & o!r c\ntries    
7a7 ,drugs f ,*9a  7#a7 ,9 g5]al ,9     
addition to any o!r duty1 !re is impos$ 
a duty on drugs :i* are be+ import$ or  
(f]$ = import into ! ,unit$ ,/ates 7)9 !
 mean+ ( section #hja ( ! ,f$]al ,food1 
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cha7;a777 f ! ,p's ,republic ( ,*9a4   

7#b7 ,rate ( duty ,! rate ( duty impos$ 
by p>agraph 7#a7 %all be #be p]c5t ad   
valorem4  7b7 ,drugs f ,india  7#a7 ,9  
g5]al ,9 addition to any o!r duty1 !re  
is impos$ a duty on drugs :i* are be+   
import$ or (f]$ = import into ! ,unit$  
,/ates 7)9 ! mean+ ( section #hja ( !   
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cha7;a777 f ! ,republic 
( ,india4  7#b7 ,rate ( duty ,! rate (  
duty impos$ by p>agraph 7#a7 %all be #bj
 p]c5t ad valorem4  7c7 ,drugs f o!r    
c\ntries  7#a7 ,9 g5]al ,9 addition to  
any o!r duty1 !re is impos$ a duty on   
drugs :i* are be+ import$ or (f]$ =     
import into ! ,unit$ ,/ates 7)9 ! mean+ 
( section #hja ( ! ,f$]al ,food1 ,drug1 
& ,cosmetic ,act 7#ba ,u4,s4,c4         
#cha7;a777 f any =eign c\ntry o!r ?an ! 
,p's ,republic ( ,*9a or ! ,republic (  
,india4  7#b7 ,rate ( duty  7,a7 ,9     
g5]al ,except z provid$ 9 subp>agraph   
7,b71 ! rate ( duty impos$ by p>agraph  
7#a7 %all be #aj p]c5t ad valorem4  7,b7
 ,exception ,9 ! case ( a drug t        

includes "o or m active ph>maceutical   
+r$i5ts orig9at+ f ! ,p's ,republic (   
,*9a or ! ,republic ( ,india1 ! rate (  
duty impos$ by p>agraph 7#a7 %all be--  
7i7 #be p]c5t ad valorem = ^? conta9+ an
 active ph>maceutical +r$i5t f ,*9a2 &  
7ii7 #bj p]c5t ad valorem = ^? conta9+  
an active ph>maceutical +r$i5t f ,india4
  7d7 ,effective date ,! provisions (   
?is section %all apply to articles      
describ$ 9 subsections 7a71 7b71 & 7c7  
ent]$1 or )drawn f w>eh\se =            
consumption1 on or aft] ! date t is #ae 
days aft] ! date ( ! enactm5t ( ?is     
,act4  #e4 ,secure ,m$ic9es ,supply     
,fund  7a7 ,e/abli%m5t ,!re is e/abli%$ 
9 ! ,treasury ( ! ,unit$ ,/ates a fund1 
to be kn[n z ! ,secure ,m$ic9es ,supply 
,fund 79 ?is section ref]r$ to z !      
,fund71 consi/+ ( su* am\nts z may be   
deposit$ to ! ,fund pursuant to         
subsection 7b7 to be us$1 9 accordance )
 subsection 7c71 = ! purpose ( support+ 
& inc5tiviz+ ph>maceutical or device    
companies to inve/ 9 new ph>maceutical  

or device manufactur+ capacity 9 ! #ej  
,/ates1 ! ,di/rict ( ,columbia1 ,pu]to  
,rico1 ! ,virg9 ,isl&s1 ,guam1 ,am]ican 
,samoa1 & ! ,commonweal? ( ! ,nor!rn    
,m>iana ,isl&s4  7b7 ,requirem5ts ,to be
 eligible = inve/m5t "u subsection 7a71 
new ph>maceutical or device manufactur+ 
capacity %all meet ea* ( ! foll[+3 7#a7 
,! products support$ by ! new           
ph>maceutical or device manufactur+     
capacity d n use active ph>maceutical   
+r$i5ts or p>ts manufactur$ 9 ,*9a or   
,india4  7#b7 ,at lea/ #ej p]c5t ( !    
active ph>maceutical +r$i5ts or p>ts = !
 total product l9e ( ! respective       
company is manufactur$ 9 any ( ! #ej    
,/ates1 ! ,di/rict ( ,columbia1 ,pu]to  
,rico1 ! ,virg9 ,isl&s1 ,guam1 ,am]ican 
,samoa1 or ! ,commonweal? ( ! ,nor!rn   
,m>iana ,isl&s4  7c7 ,fund+  7#a7       
,duties ,am\nts collect$ f duties impos$
 pursuant to section #d %all be deposit$
 9 ! ,fund1 to rema9 available until    
exp5d$4  7#b7 ,f9es ,am\nts collect$ f  
civil monet>y p5alties impos$ pursuant  

to p>agraph 7#aj7 ( section #cjc7;f7 ( !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act  
7#ba ,u4,s4,c4 #ccc7;f771 z add$ by     
section #c7;d71 %all be deposit$ 9 !    
,fund1 to rema9 available until exp5d$4 
7d7 ,di/ribution ( funds  7#a7 ,grants  
,! ,secret>y ( ,heal? & ,human ,s]vices 
%all e/abli% a grant program to support 
& inc5tivize ph>maceutical or device    
companies to manufacture prescription   
drugs1 active ph>maceutical +r$i5ts1 or 
devices 9 any ( ! #ej ,/ates1 ! ,di/rict
 ( ,columbia1 ,pu]to ,rico1 ! ,virg9    
,isl&s1 ,guam1 ,am]ican ,samoa1 & !     
,commonweal? ( ! ,nor!rn ,m>iana ,isl&s4
  7#b7 ,limitations on use ( funds ,z a 
condition on receipt ( a grant "u ?is   
section1 ! recipi5t ( ! grant %all agree
 to use-- 7,a7 n m ?an #aj p]c5t ( !    
grant = new or exp&$ manufactur+        
capacity2  7,b7 n m ?an #ej p]c5t ( !   
grant = tra9+ manufactur+ work]s2 &     
7,c7 n m ?an #be p]c5t ( ! grant =      
develop+ "o or m new prescription drugs1
 new active ph>maceutical +r$i5ts1 or   

new antibiotics4  7#c7 ,s\rce ( fund+   
,all am\nts us$ to c>ry out ?is section 
%all be d]iv$ f ! ,fund4  7e7 ,report ,n
 lat] ?an "o ye> aft] ! date ( enactm5t 
( ?is ,act1 & annually !reaft]1 !       
,secret>y ( ,heal? & ,human ,s]vices    
%all submit to ! ,congress a report on !
 ,fund4 ,ea* su* report %all address !  
foll[+3 7#a7 ,! am\nts deposit$ into !  
,fund 9 ! mo/ rec5t ?ree fiscal ye>s4   
7#b7 ,! di/ribution ( su* am\nts        
pursuant to grants "u ?is section dur+ !
 la/ ?ree fiscal ye>s1 includ+ !        
allocation ( su* am\nts =-- 7,a7 new or 
exp&$ manufactur+ capacity2  7,b7 tra9+ 
work]s2 &  7,c7 develop+ new            
prescription drugs1 new active          
ph>maceutical +r$i5ts1 or new           
antibiotics4  7f7 ,device ,9 ?is        
section1 ! t]m device has ! mean+ giv5  
to su* t]m 9 section #bja ( ! ,f$]al    
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cba74  7g7 ,sunset ,?is      
section 7o!r ?an subsection 7e77 %all   
cease to h effect beg9n+ on ! date t is 

#aj ye>s aft] ! date ( ! enactm5t ( ?is 
,act4  7h7 ,unus$ funds return$ to !    
g5]al fund ( ! treasury ,if any am\nts  
rema9 9 ! ,fund aft] ! date describ$ 9  
subsection 7f71 ! ,secret>y ( !         
,treasury %all transf] su* am\nts to !  
g5]al fund ( ! ,treasury4  #f4 ,regi/ry 
( drugs manufactur$ outside ! ,unit$    
,/ates ,! ,f$]al ,food1 ,drug1 &        
,cosmetic ,act is am5d$ by ins]t+ aft]  
section #ebd;,a ( su* ,act 7#ba         
,u4,s4,c4 #cfjn-#a7 ! foll[+ new        
section3  #ebd;,b4 ,regi/ry ( drugs     
manufactur$ outside ! ,unit$ ,/ates  7a7
 ,9 g5]al ,! ,secret>y %all compile &   
ma9ta9 a regi/ry ( all drugs approv$ "u 
subsection 7c7 or 7j7 ( section #eje (  
?is ,act or lic5s$ "u sub-section 7a7 or
 7k7 ( section #cea ( ! ,public ,heal?  
,s]vice ,act1 & any active ph>maceutical
 +r$i5ts 9 su* drugs1 t are manufactur$ 
outside ( ! ,unit$ ,/ates4 ,! ,secret>y 
%all update su* regi/ry at lea/         
biannually4  7b7 ,additional li/  7#a7  
,9 g5]al ,9 conjunction ) ! regi/ry "u  

subsection 7a71 ! ,secret>y %all compile
 & ma9ta9 a li/ ( ^? drugs includ$ 9 !  
regi/ry = :i* #ej p]c5t or m ( _! active
 ph>maceutical +r$i5ts are manufactur$ 9
 locations )9 a s+le c\ntry outside !   
,unit$ ,/ates4  7#b7 ,cont5ts ,! li/ (  
drugs "u p>agraph 7#a7 %all-- 7,a7      
id5tify bo? ! drugs & ! associat$       
sole-s\rce c\ntry2  7,b7 be updat$ at   
lea/ bi-annually2 &  7,c7 be publicly   
available4  7c7 ,requirem5t ,! regi/ry  
"u subsection 7a7 %all1 ) respect to ea*
 drug includ$ on ! regi/ry1 provide     
in=mation ab\t ! drug's supply *a91     
includ+ ea* /ep 9 ! supply *a9 t occurs 
prior to ! drug's importation into !    
,unit$ ,/ates4  4  #g4 ,c\ntry-(-orig9  
label+ ,section #ejb ( ! ,f$]al ,food1  
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#ceb7 is am5d$ by add+ at ! end !       
foll[+3  7ee7 ,if x is a drug & its     
label+ does n specify ! c\ntry ( orig9 (
 ea* active ph>maceutical +r$i5t conta9$
 9 ! drug4  4