,,ii  #aag? ,,congress  #a/ ,session    
,s4 #bjhb  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,june #af1 #bjba,mr4   
,scott ( ,s\? ,c>ol9a 7= himself & ,ms4 
,ros57 introduc$ ! foll[+ bill2 :i* 0   
read twice & ref]r$ to ! ,committee on  
,f9ance  ,a ,,bill  ,to mitigate drug   
%ortages & provide inc5tives = ma9ta9+1 
exp&+1 & relocat+ ! manufactur+ ( active
 ph>maceutical +r$i5ts1 excipi5ts1      
m$ical diagno/ic devices1               
ph>maceuticals1 & p]sonal protective    
equipm5t 9 ! ,unit$ ,/ates1 & = o!r     
purposes4  #a4 ,%ort title ,?is ,act may
 be cit$ z ! ,manufactur+ ,,api1 ,drugs1
 & ,excipi5ts 9 ,am]ica ,act or ! ,,made
 9 ,am]ica ,act4  #b4 ,table ( cont5ts  
,! table ( cont5ts ( ?is ,act is z      
foll[s3 ,sec4 #a4 ,%ort title4,sec4 #b4 
,table ( cont5ts4,,title ,i--,heal?     
provisions,sec4 #aja4 ,report to        
,congress on b>ri]s to dome/ic          
manufactur+ ( m$ical products4,sec4     
#ajb4 ,enhance intra-ag5cy coord9ation &
 public heal? assessm5t ) reg>d to      

compliance activities4,sec4 #ajc4       
,report+ ( mutual recognition agreem5ts 
= inspections & review activities4,sec4 
#ajd4 ,enhanc+ transp>5cy ( drug        
facility inspection timel9es4,sec4 #aje4
 ,advanc$ manufactur+ te*nologies       
program4,,title ,,ii--,tax inc5tives to 
increase dome/ic ph>maceutical & m$ical 
device production,sec4 #bja4 ,cr$it =   
ph>maceutical & m$ical device production
 activities 9 di/ress$ zones4  ,i ,heal?
 provisions  #aja4 ,report to ,congress 
on b>ri]s to dome/ic manufactur+ (      
m$ical products  7a7 ,report ,n lat] ?an
 #f mon?s aft] ! date ( enactm5t ( ?is  
,act1 ! ,secret>y ( ,heal? & ,human     
,s]vices1 ! ,secret>y ( ! ,treasury1 !  
,secret>y ( ,comm]ce1 & ! ,unit$ ,/ates 
,trade ,repres5tative 7collectively     
ref]r$ to 9 ?is section z ! ,secret>ies7
 %all submit to ! ,committee on ,heal?1 
,education1 ,labor1 & ,p5sions ( !      
,s5ate & ! ,committee on ,en]gy &       
,comm]ce ( ! ,h\se ( ,repres5tatives a  
report on b>ri]s to dome/ic manufactur+ 

( active ph>maceutical +r$i5ts1 f9i%$   
drug products1 & devices t are import$ f
 outside ( ! ,unit$ ,/ates4  7b7        
,cont5ts ,su* report %all-- 7#a7 id5tify
 factors t limit or o!rwise disc\rage ! 
dome/ic manufactur+ ( active            
ph>maceutical +r$i5ts1 drugs1 & devices 
t are curr5tly import$ f outside ( !    
,unit$ ,/ates1 includ+ any ,f$]al1      
,/ate1 local1 or ,tribal laws t h9d]    
dome/ic manufactur+ opportunities2 &    
7#b7 recomm5d specific /rategies to     
ov]come ! *all5ges id5tifi$ "u p>agraph 
7#a71 includ+ /rategies-- 7,a7 to       
develop effective inc5tives = dome/ic   
manufactur+2 &  7,b7 to make *anges to  
laws or regulations t h9d] dome/ic      
manufactur+ opportunities4  7c7         
,consultation ,9 prep>+ ! report "u     
subsection 7a71 ! ,secret>ies %all      
consult )-- 7#a7 ! ,food & ,drug        
,adm9i/ration1 ! ,c5t]s = ,m$ic>e       
,m$icaid ,s]vices1 ! ,dep>tm5t (        
,def5se1 ! ,dep>tm5t ( ,/ate1 !         
,dep>tm5t ( ,vet]ans ,affairs1 !        

,dep>tm5t ( ,ju/ice1 & any o!r ,f$]al   
ag5cies z appropriate2 &  7#b7 relevant 
/akehold]s1 includ+ drug1 device1 &     
active ph>maceutical +r$i5t             
manufactur]s1 & o!r entities1 z         
appropriate4  7d7 ,def9ition ,9 ?is     
section1 ! t]m active ph>maceutical     
+r$i5t has ! mean+ giv5 to su* t]m 9    
section #bjg4a ( title #ba1 ,code (     
,f$]al ,regulations 7or any successor   
regulations74  7e7 ,publication ,!      
,secret>y %all make ! report "u         
subsection 7a7 available on ! public    
website ( ! ,dep>tm5t ( ,heal? & ,human 
,s]vices4  #ajb4 ,enhance intra-ag5cy   
coord9ation & public heal? assessm5t )  
reg>d to compliance activities  7a7     
,coord9ation ,section #ejf;,d ( ! ,f$]al
 ,food1 ,drug1 & ,cosmetic ,act 7#ba    
,u4,s4,c4 #cef;d7 is am5d$ by add+ at ! 
end ! foll[+3  7g7 ,coord9ation ,!      
,secret>y %all ensure timely & effective
 int]nal coord9ation & alignm5t among ! 
field inve/igators ( ! ,food & ,drug    
,adm9i/ration & ! /aff ( ! ,c5t] = ,drug

 ,evaluation & ,rese>*'s ,(fice (       
,compliance & ,drug ,%ortage ,program   
reg>d+ ! reviews ( reports %>$ pursuant 
to section #gjd7;b77#b71 & any fe$back  
or corrective or prev5tive actions 9    
response to su* reports4  4  7b7        
,report+ ,section #ejf;,c-#a7;a77#b7 ( !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act  
7#ba ,u4,s4,c4 #cef;c-#a7;a77#b77 is    
am5d$ to read z foll[s3  7#b7 7,a7      
describes ! communication betwe5 ! field
 inve/igators ( ! ,food & ,drug         
,adm9i/ration & ! /aff ( ! ,c5t] = ,drug
 ,evaluation & ,rese>*'s ,(fice (       
,compliance & ,drug ,%ortage ,program1  
includ+ ! ,food & ,drug ,adm9i/ration's 
proc$ures = enabl+ & ensur+ su*         
communication2  7,b7 provides ! numb] ( 
reports describ$ 9 section #gjd7;b77#b7 
t 7 requir$ to be s5t to ! appropriate  
(fices ( ! ,food & ,drug ,adm9i/ration )
 exp]tise reg>d+ drug %ortage & ! numb] 
( su* reports t 7 s5t2 &  7,c7 describes
 ! adoption & utilization ( ! approa*   
describ$ 9 section #ejf;,d7g72  4  7c7  

,applicability  7#a7 ,subsection 7a7 ,! 
am5dm5t made by subsection 7a7 %all     
apply beg9n+ on ! date ( enactm5t ( ?is 
,act4  7#b7 ,subsection 7b7 ,! am5dm5t  
made by subsection 7b7 %all apply beg9n+
 on ! date t is #a ye> aft] ! date (    
enactm5t ( ?is ,act4  #ajc4 ,report+ (  
mutual recognition agreem5ts =          
inspections & review activities  7a7 ,9 
g5]al ,n lat] ?an ! end ( cal5d> ye>    
#bjbj1 & annually !reaft]1 ! ,secret>y (
 ,heal? & ,human ,s]vices 7ref]r$ to 9  
?is section z ! ,secret>y7 %all publi% a
 report on ! public website ( ! ,food & 
,drug ,adm9i/ration on ! utilization (  
agreem5ts ent]$ into pursuant to section
 #hji ( ! ,f$]al ,food1 ,drug1 &        
,cosmetic ,act 7#ba ,u4,s4,c4 #chd;e7 or
 o!rwise ent]$ into by ! ,secret>y to   
recognize inspections betwe5 drug       
regulatory au?orities across c\ntries & 
int]national regions ) analog\s review  
crit]ia to ! ,food & ,drug              
,adm9i/ration1 su* z ! ,ph>maceutical   
,inspection ,co-,op]ation ,s*eme1 !     

,mutual ,recognition ,agreem5t ) !      
,european ,union1 & !                   
,au/ralia-,canada-,s+apore-,switz]l&    
,consortium1 9 ! previ\s fiscal ye>4    
7b7 ,cont5t ,! report "u subsection 7a7 
%all include ea* ( ! foll[+3 7#a7 ,!    
total numb] ( e/abli%m5ts t are regi/]$ 
"u section #eaj7;i7 ( ! ,f$]al ,food1   
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cfj7;i771 & ( su* e/abli%m5ts1 ! numb] 
9 ea* region ( int]e/4  7#b7 ,! total   
numb] ( inspections conduct$ z describ$ 
9 subp>agraphs 7,a7 & 7,b7 ( p>agraph   
7#e7 at e/abli%m5ts describ$ 9 p>agraph 
7#a74  7#c7 ,( ! inspections describ$ 9 
p>agraph 7#b71 ! total numb] (          
inspections 9 ea* ( region ( int]e/4    
7#d7 ,( ! inspections 9 ea* region (    
int]e/ report$ pursuant to p>agraph     
7#c71 ! numb] ( inspections 9 ea* ,,fda 
inspection category4  7#e7 ,( ! numb] ( 
inspections report$ "u ea* ( p>agraphs  
7#c7 & 7#d7-- 7,a7 ! numb] ( inspections
 :i* h be5 conduct$ pursuant to an      
agreem5t or o!r recognition describ$ 9  

subsection 7a72 &  7,b7 ! numb] (       
inspections :i* h be5 conduct$ by       
employees or contractors ( ! ,food &    
,drug ,adm9i/ration4  7c7 ,def9itions ,9
 ?is subsection3 7#a7 ,,fda inspection  
category ,! t]m ,,fda inspection        
category means ! foll[+ inspection      
categories3 7,a7 ,inspections to support
 approvals ( *anges to ! manufactur+    
process ( drugs approv$ "u section #eje 
( ! ,f$]al ,food1 ,drug1 & ,cosmetic    
,act 7#ba ,u4,s4,c4 #cee7 or section    
#cea ( ! ,public ,heal? ,s]vice ,act    
7#db ,u4,s4,c4 #bfb74  7,b7 ,good       
manufactur+ practice surveillance       
inspections4  7,c7 ,=-cause inspections4
  7#b7 ,region ( int]e/ ,! t]m region ( 
int]e/ means ,*9a1 ,india1 ! ,european  
,union1 & any o!r geographic region z ! 
,secret>y det]m9es appropriate4  #ajd4  
,enhanc+ transp>5cy ( drug facility     
inspection timel9es ,section #ijb ( !   
,,fda ,reau?orization ,act ( #bjag 7#ba 
,u4,s4,c4 #cee note7 is am5d$ to read z 
foll[s3  #ijb4 ,annual report on        

inspections ,n lat] ?an ,m>* #a ( ea*   
ye>1 ! ,secret>y ( ,heal? & ,human      
,s]vices %all po/ on ! public website ( 
! ,food & ,drug ,adm9i/ration in=mation 
relat$ to inspections ( facilities1     
includ+ inspections t are necess>y =    
approval ( a drug "u subsection 7c7 or  
7j7 ( section #eje ( ! ,f$]al ,food1    
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee71 approval ( a device "u section   
#eae ( su* ,act 7#ba ,u4,s4,c4 #cfj;e71 
or cle>ance ( a device "u section       
#eaj7k7 ( su* ,act 7#ba ,u4,s4,c4       
#cfj7k77 t 7 conduct$ dur+ ! previ\s    
cal5d> ye>4 ,su* in=mation %all include 
! foll[+3 7#a7 ,! m$ian "t foll[+ a     
reque/ f /aff ( ! ,food & ,drug         
,adm9i/ration review+ an application or 
report to ! beg9n+ ( ! inspection1      
includ+-- 7,a7 ! m$ian "t = drugs       
describ$ 9 section #eje7;j77#aa77;,a77i7
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   
,act 7#ba ,u4,s4,c4                     
#cee7;j77#aa77;,a77i772  7,b7 ! m$ian "t
 = drugs describ$ 9 section #ejf;,c7a7 (

 su* ,act 7#ba ,u4,s4,c4 #cef;c7a77     
only2 &  7,c7 ! m$ian "t = drugs on !   
drug %ortage li/ 9 effect "u section    
#ejf;,e ( su* ,act 7#ba ,u4,s4,c4       
#cef;f74  7#b7 ,! m$ian "t f ! issuance 
( a report pursuant to section #gjd7;b7 
( su* ,act 7#ba ,u4,s4,c4 #cgd7;b77 to !
 s5d+ ( a w>n+ lett]1 issuance ( an     
import al]t1 or hold+ ( a regulatory    
meet+ = inspections = :i* ! ,secret>y   
conclud$ t regulatory or en=cem5t action
 0 indicat$1 includ+ ! m$ian "t = ea*   
category ( drugs li/$ 9 subp>agraphs    
7,a7 ?r\gh 7,c7 ( p>agraph 7#a74  7#c7  
,! m$ian "t f ! s5d+ ( a w>n+ lett]1    
issuance ( an import al]t1 or hold+ ( a 
regulatory meet+ to resolution ( !      
actions indicat$ to address ! conditions
 or practices obs]v$ dur+ an inspection4
  7#d7 ,! numb] ( facilities t 7 unable 
to implem5t reque/$ corrective or       
prev5tive actions foll[+ a report       
pursuant to su* section #gjd7;b71       
result+ 9 a )hold recomm5dation1 includ+
 ! numb] ( su* times = ea* category (   

drugs li/$ 9 subp>agraphs 7,a7 ?r\gh    
7,c7 ( p>agraph 7#a74  4  #aje4 ,advanc$
 manufactur+ te*nologies program        
,sub*apt] ,a ( *apt] ,v ( ! ,f$]al      
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cea et seq47 is am5d$ by add+
 at ! end ! foll[+3  #ebd;,b4 ,advanc$  
manufactur+ te*nologies program  7a7 ,9 
g5]al ,n lat] ?an #a ye> aft] ! date (  
enactm5t ( ! ,manufactur+ ,,api1 ,drugs1
 & ,excipi5ts 9 ,am]ica ,act1 !         
,secret>y %all cont9ue 9 effect !       
programs to facilitate ! developm5t &   
review ( an application "u subsection   
7b7 or 7j7 ( section #eje ( ?is ,act or 
subsection 7a7 or 7k7 ( section #cea ( !
 ,public ,heal? ,s]vice ,act = a drug or
 biological product t is manufactur$ us+
 "o ( m advanc$ manufactur+ te*nologies 
t h be5 designat$ 9 accordance )        
subsection 7b74  7b7 ,designation ,!    
,secret>y %all designate a me?od (      
manufactur+ or developm5t ( a drug or   
biological product z an advanc$         
manufactur+ te*nology "u ?is section if 

x incorporates a novel te*nology or uses
 an e/abli%$ te*nique or te*nology 9 a  
novel way t-- 7#a7 enhances drug        
quality2 or  7#b7 improves !            
flexibility1 robu/ness1 or effici5cy ( !
 manufactur+ process to-- 7,a7 prev5t or
 resolve a drug %ortage2  7,b7 r$uce    
prem>ket developm5t "t2 or  7,c7        
increase ! supply ( drugs describ$ 9    
p>agraph 7#a7 or 7#b7 ( section         
#ejf;,c7a7 = national em]g5cies4  7c7   
,consultation ,if ! ,secret>y designates
 a me?od ( manufactur+ z an advanc$     
manufactur+ te*nology "u ?is section1 ! 
,secret>y %all take actions to exp$ite !
 developm5t & implem5tation ( su* me?od 
( manufacture = purposes ( approval ( an
 application "u subsection 7c7 or 7j7 ( 
section #eje ( ?is ,act or subsection   
7a7 or 7k7 ( section #cea ( ! ,public   
,heal? ,s]vice ,act1 :i* may include1 z 
appropriate1 hold+ meet+s betwe5 !      
sponsor ( ! application & appropriate   
,food & ,drug ,adm9i/ration /aff ?r\gh\t
 ! developm5t ( ! drug ( biological     

product us+ su* advanc$ manufactur+     
te*nology4  7d7 ,evaluation ( an advanc$
 manufactur+ te*nology  7#a7 ,package ,a
 p]son :o seeks designation ( an advanc$
 manufactur+ te*nology "u ?is section   
%all submit to ! ,secret>y a package (  
sci5tific evid5ce support+ !            
implem5tation ( ! advanc$ manufactur+   
te*nology 9 a p>ticul> context-(-use4 ,!
 ,secret>y %all assi/ ) ! developm5t (  
su* package by-- 7,a7 provid+ timely    
advice to1 & int]active communication )1
 ! sponsor reg>d+ ! developm5t ( !      
te*nology2 &  7,b7 involv+ s5ior manag]s
 & exp]i5c$ /aff ( ! ,food & ,drug      
,adm9i/ration1 z appropriate1 9 a       
collaborative1 cross-discipl9>y review (
 ! me?od ( manufactur+4  7#b7           
,evaluation ,)9 #ij days ( receiv+ a    
package "u p>agraph 7#a71 ! ,secret>y   
%all det]m9e :e!r a designat$ advanc$   
manufactur+ te*nology is validat$ = !   
propos$ context ( use bas$ on !         
sci5tific m]it ! support+ evid5ce       
provid$ by ! sponsor4  7#c7 ,effect (   

designation ,^u designation ( an advanc$
 manufactur+ te*nology1 ! hold] ( !     
advanc$ manufactur+ te*nology           
designation1 or a p]son ! advanc$       
manufactur+ te*nology designation hold] 
au?orizes1 may rely ^u ! advanc$        
manufactur+ te*nology = use across      
multiple manufactur+ or product l9es )9 
! same context-(-use )\t hav+ to        
re-submit data to ! ,secret>y validat+ !
 und]ly+ te*nology4  7e7 ,implem5tation 
& report+  7#a7 ,public meet+ ,!        
,secret>y %all publi% 9 ! ,f$]al ,regi/]
 a notice ( a public meet+1 to be held n
 lat] ?an #a ye> aft] ! date ( enactm5t 
( ! ,manufactur+ ,,api1 ,drugs1 &       
,excipi5ts 9 ,am]ica ,act1 to discuss & 
obta9 input & recomm5dations f          
/akehold]s reg>d+ ! goals & scope (1 & a
 suitable framework & proc$ures &       
requirem5ts =1 ! program "u ?is section4
  7#b7 ,program guidance ,! ,secret>y   
%all-- 7,a7 n lat] ?an #a ye> aft] !    
date ( enactm5t ( ! ,manufactur+ ,,api1 
,drugs1 & ,excipi5ts 9 ,am]ica ,act1    

issue draft guidance reg>d+ ! goals &   
implem5tation ( ! program "u ?is        
section2 &  7,b7 n lat] ?an #b ye>s aft]
 ! date ( enactm5t ( ! ,manufactur+     
,,api1 ,drugs1 & ,excipi5ts 9 ,am]ica   
,act1 issue f9al guidance ) respect to !
 implem5tation ( su* program4  7#c7     
,report ,! ,secret>y %all make available
 on ! public website ( ! ,food & ,drug  
,adm9i/ration an annual report on !     
progress ( ! programs "u ?is section4  4
  ,,ii ,tax inc5tives to increase       
dome/ic ph>maceutical & m$ical device   
production  #bja4 ,cr$it = ph>maceutical
 & m$ical device production activities 9
 di/ress$ zones  7a7 ,9 g5]al ,subp>t ,d
 ( "p ,,iv ( sub*apt] ,a ( *apt] #a ( ! 
,int]nal ,rev5ue ,code ( #aihf is am5d$ 
by add+ at ! end ! foll[+ new section3  
#de,u4 ,di/ress$ zone ph>maceutical &   
m$ical device production cr$it  7a7 ,9  
g5]al ,= purposes ( section #ch1 !      
di/ress$ zone ph>maceutical & m$ical    
device production cr$it = ! taxable ye> 
%all be an am\nt equal to ! applicable  

p]c5tage ( ! qualifi$ production        
activity exp5ditures ( ! taxpay] = !    
taxable ye>4  7b7 ,applicable p]c5tage  
,= purposes ( ?is section-- 7#a7 ,9     
g5]al ,except z provid$ 9 p>agraph 7#b71
 ! t]m applicable p]c5tage means #be    
p]c5t4  7#b7 ,increas$ am\nt :]e        
employees reside 9 di/ress$ zone ,9 !   
case ( any qualifi$ ph>maceutical or    
m$ical device production bus9ess a      
sub/antial portion ( ! employees ( :i*  
reside 9 a di/ress$ zone1 ! applicable  
p]c5tage %all be #cj p]c5t4  7c7        
,qualifi$ production activity           
exp5ditures ,= purposes ( ?is section-- 
7#a7 ,9 g5]al ,! t]m qualifi$ production
 activity exp5ditures means-- 7,a7 wages
 paid or incurr$ to an employee ( !     
taxpay] = s]vices p]=m$ by su* employee 
9 ! conduct ( a qualifi$ ph>maceutical  
or diagno/ic m$ical device production   
bus9ess 9 a di/ress$ zone 7b only if !  
employee's pr9cipal place ( employm5t is
 9 a di/ress$ zone71 &  7,b7 qualifi$   
ph>maceutical or m$ical device          

production exp5ditures4  7#b7 ,qualifi$ 
ph>maceutical or m$ical device          
production bus9ess  7,a7 ,9 g5]al ,! t]m
 qualifi$ ph>maceutical or m$ical device
 production bus9ess means ! trade or    
bus9ess ( produc+ qualifi$              
ph>maceuticals 9 comm]cial quantities4  
7,b7 ,qualifi$ ph>maceuticals  7i7 ,9   
g5]al ,! t]m qualifi$ ph>maceuticals    
means ph>maceuticals1 active            
ph>maceutical +r$i5ts1 excipi5ts1 m$ical
 diagno/ic devices1 or p]sonal          
protective equipm5t4  7ii7              
,ph>maceutical ,! t]m ph>maceuticals--  
7,i7 means any drug 7z def9$ 9 section  
#bja ( ! ,f$]al ,food1 ,drug1 &         
,cosmetic ,act72 &  7,,ii7 includes a   
biological product 7z def9$ 9 section   
#cea ( ! ,public ,heal? ,s]vice ,act74  
7iii7 ,active ph>maceutical +r$i5t ,!   
t]m active ph>maceutical +r$i5ts has !  
mean+ giv5 to su* t]m 9 section #bjg4a (
 title #ba1 ,code ( ,f$]al ,regulations 
7or any successor regulations74  7iv7   
,excipi5t ,! t]m excipi5t-- 7,i7 means  

any inactive +r$i5t t is int5tionally   
add$ to a ph>maceutical t is n int5d$ to
 ex]t !rapeutic effects at ! int5d$     
dosage1 o!r ?an by act+ to improve      
product deliv]y2 &  7,,ii7 includes any 
su* fill]1 ext5d]s1 dilu5t1 wett+ ag5t1 
solv5t1 emulsifi]1 pres]vative1 flavor1 
absorption enhanc]1 su/a9$ release      
matrix1 & color+ ag5t4  7v7 ,m$ical     
diagno/ic device ,! t]m m$ical diagno/ic
 device means any device 7z def9$ 9     
section #bja7;h7 ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act7 int5d$ = use 9 
! diagnosis ( disease or o!r conditions4
  7vi7 ,p]sonal protective equipm5t ,!  
t]m p]sonal protective equipm5t means-- 
7,i7 any device 7z def9$ 9 section      
#bja7;h7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act7 t is a face mask1 filt]+
 facepiece respirator1 face %ield1      
surgical mask1 g[n1 o!r app>el1 or glove
 t is int5d$ = a m$ical purpose2 &      
7,,ii7 any p>ticulate filt]+ air purify+
 respiratory protective device t is     
approv$ by ! ,national ,in/itute =      

,occupational ,safety & ,heal? "u "p #hd
 ( title #db1 ,code ( ,f$]al            
,regulations 7or successor regulations74
  7#c7 ,c]ta9 heal? plan exp5ses treat$ 
z wages  7,a7 ,9 g5]al ,! t]m wages %all
 include s mu* ( ! eligible employ]'s   
qualifi$ heal? plan exp5ses z are       
prop]ly allocable to su* wages4  7,b7   
,qualifi$ heal? plan exp5ses ,= purposes
 ( ?is p>agraph1 ! t]m qualifi$ heal?   
plan exp5ses means am\nts paid or       
incurr$ by ! eligible employ] to provide
 & ma9ta9 a gr\p heal? plan 7z def9$ 9  
section #ejjj7;b77#a771 b only to !     
ext5t t su* am\nts are exclud$ f ! gross
 income ( employees by reason ( section 
#ajf7;a7 ( su* ,code4  7,c7 ,allocation 
rules ,= purposes ( ?is p>agraph1       
qualifi$ heal? plan exp5ses %all be     
allocat$ to qualifi$ wages 9 su* mann] z
 ! ,secret>y may prescribe4 ,except z   
o!rwise provid$ by ! ,secret>y1 su*     
allocation %all be treat$ z prop]ly made
 if made on ! basis ( be+ pro rata among
 employees & pro rata on ! basis (      

p]iods ( cov]age 7relative to ! p]iods  
to :i* su* wages relate74  7#d7         
,qualifi$ ph>maceutical or m$ical device
 production exp5ditures  7,a7 ,def9ition
 ,! t]m qualifi$ ph>maceutical or m$ical
 device production exp5ditures means    
am\nt paid or incurr$ 7:e!r or n        
*>geable to capital acc\nt7 = qualifi$  
prop]ty us$ 9 ! conduct ( a qualifi$    
ph>maceutical or m$ical device          
production bus9ess 9 a di/ress$ zone 7b 
only if ! prim>y use ( su* prop]ty is 9 
a di/ress$ zone74  7,b7 ,qualifi$       
prop]ty  7i7 ,9 g5]al ,! t]m qualifi$   
prop]ty means any tangible p]sonal      
prop]ty 7o!r ?an a build+ or its        
/ructural compon5ts7 us$ 9 ! conduct ( a
 qualifi$ ph>maceutical or m$ical device
 production bus9ess 9 a di/ress$ zone 7b
 only if ! prim>y use ( su* prop]ty is 9
 a di/ress$ zone74  7ii7 ,exception ,su*
 t]m %all n include any prop]ty describ$
 9 section #ej7;b7 7det]m9$ z if !      
,unit$ ,/ates includ$ ,pu]to ,rico74    
7d7 ,di/ress$ zone ,= purposes ( ?is    

section1 ! t]m di/ress$ zone means a    
population c5sus tract-- 7#a7 :i* has   
be5 designat$ z a qualifi$ opportunity  
zone "u section #adjj,z-#a1 &  7#b7 :i* 
has a pov]ty rate 9 excess ( #cj p]c5t =
 ! cal5d> ye> prior to ! cal5d> ye> t   
includes ! date ( enactm5t ( ?is        
section4  7e7 ,special rules  7#a7      
,application to ,unit$ ,/ates %>ehold]s 
( controll$ =eign corporations  7,a7 ,9 
g5]al ,9 ! case ( a dome/ic corporation 
t is a ,unit$ ,/ates %>ehold] ( a       
qualifi$ controll$ =eign corporation1 ! 
cr$it "u subsection 7a7 7det]m9$ )\t    
reg>d to ?is p>agraph7 %all be increas$ 
by an am\nt equal to #cj p]c5t ( !      
corporation's pro rata %>e 7det]m9$ "u  
rules simil> to ! rules ( section       
#iea7;a77#b77 ( qualifi$ production     
activity exp5ditures ( su* controll$    
=eign corporation = ! taxable ye> ( !   
qualifi$ controll$ =eign corporation    
end+ ) or )9 ! taxable ye> ( ! dome/ic  
corporation4  7,b7 ,qualifi$ corporation
 ,= purposes ( subp>agraph 7,a71 ! t]m  

qualifi$ controll$ =eign corporation    
means1 = any taxable ye>1 a controll$   
=eign corporation :i* does n h gross    
income t is effectively connect$ ) !    
conduct ( a trade or bus9ess )9 ! ,unit$
 ,/ates = su* taxable ye> 4  7#b7       
,r$uction 9 basis ,if a cr$it is det]m9$
 "u ?is section ) respect to any prop]ty
 by reason ( any qualifi$ production    
activity exp5ditures describ$ 9         
subsection 7b77#a77;,b71 ! basis ( su*  
prop]ty %all be r$uc$ by ! am\nt ( !    
cr$it s det]m9$4  7#c7 ,coord9ation )   
o!r cr$its ,any qualifi$ production     
activity exp5ditures tak5 into acc\nt 9 
det]m9+ ! am\nt ( ! cr$it "u subsection 
7a7 %all n be tak5 into acc\nt 9 det]m9+
 a cr$it "u any o!r provision ( ?is     
*apt]4  7f7 ,recapture  7#a7 ,9 g5]al   
,if1 dur+ any taxable ye>1 prop]ty take 
into acc\nt "u subsection 7c77#a77;,b7  
is dispos$ (1 or o!rwise ceases to be   
us$ by ! taxpay] 9 ! active trade or    
bus9ess ( produc+ qualifi$              
ph>maceuticals 9 comm]cial quantities1  

be=e ! close ( ! recapture p]iod1 !n !  
tax "u ?is *apt] = su* taxable ye> %all 
be increas$ by ! recapture p]c5tage ( ! 
aggregate decrease 9 ! cr$its all[$ "u  
section #ch = all prior taxable ye>s :i*
 w\ld h result$ solely f r$uc+ to z]o   
any cr$it det]m9$ "u ?is section )      
respect to su* prop]ty4  7#b7 ,recapture
 p]c5tage ,= purposes ( subp>agraph     
7,a71 ! recapture p]c5tage %all be      
det]m9$ 9 ! same mann] z "u section     
#ej7;a77#a77;,b74  7#c7 ,application to 
,unit$ ,/ates %>ehold]s ,9 ! case ( any 
taxpay] to :om a cr$it is all[$ by      
reason ( subsection 7e77#a71 p>agraph   
7#a7 %all be appli$ by sub/itut+ !      
controll$ =eign corporation ) respect to
 :i* ! taxpay] is a ,unit$ ,/ates       
%>ehold] = ! taxpay]4  7#d7 ,application
 ( o!r rules ,= purposes ( ?is p>agraph1
 rules simil> to ! rules ( p>agraphs    
7#c71 7#d71 & 7#e7 7o!r ?an subp>agraph 
7,a7 !re(7 ( section #ej7;a77#a7 %all   
apply4  4  7b7 ,cr$it all[$ aga9/       
alt]native m9imum tax ,section          

#ch7;c77#d77;,b7 ( su* ,code is am5d$ by
 r$esignat+ clauses 7x71 7xi71 & 7xii7 z
 clauses 7xi71 7xii71 & 7xiii71         
respectively1 & by ins]t+ aft] clause   
7ix7 ! foll[+ new clause3  7x7 ! cr$it  
det]m9$ "u section #de,u1  4  7c7 ,cr$it
 all[$ aga9/ base erosion anti-,abuse   
tax ,section #ei;,a7b77#a77;,b77ii7 (   
su* ,code is am5d$ by /rik+ plus at !   
end ( subclause 7,i71 by r$esignat+     
subclause 7,,ii7 z subclause 7,,iii71 & 
by ins]t+ aft] subclause 7,i7 7z s      
am5d$7 ! foll[+ new subclause3  7,,ii7 !
 cr$it all[$ "u section #ch = ! taxable 
ye> :i* is prop]ly allocable to !       
di/ress$ zone ph>maceutical & m$ical    
device production cr$it det]m9$ "u      
section #de,u7a71 plus  4  7d7 ,d5ial ( 
d$uction ,section #bhj;,c ( su* ,code is
 am5d$ by add+ at ! end ! foll[+ new    
subsection3  7i7 ,di/ress$ zone         
ph>maceutical & m$ical device production
 cr$it ,no d$uction %all be all[$ = t   
portion ( ! qualifi$ production activity
 exp5ditures 7z def9$ 9 section         

#de,u7b77 o!rwise all[able z a d$uction 
= ! taxable ye> :i* is equal to ! am\nt 
( ! di/ress$ zone ph>maceutical & m$ical
 device production cr$it det]m9$ = su*  
taxable ye> "u section #de,u7a74  4  7e7
 ,"p ( g5]al bus9ess cr$it ,section     
#ch7;b7 ( su* ,code is am5d$ by /rik+   
plus at ! end ( p>agraph 7#cb71 by /rik+
 ! p]iod at ! end ( p>agraph 7#cc7 &    
ins]t+ 1 plus1 & by add+ at ! end !     
foll[+ new p>agraph3  7#cd7 ! di/ress$  
zone ph>maceutical & m$ical device      
production cr$it det]m9$ "u section     
#de,u7a74  4  7f7 ,cl]ical am5dm5t ,!   
table ( sections = subp>t ,d ( "p ,,iv (
 sub*apt] ,a ( *apt] #a is am5d$ by add+
 at ! end ! foll[+ new item3  ,sec4     
#de,u4 ,di/ress$ zone ph>maceutical &   
m$ical device production cr$it4  4  7g7 
,effective date ,! am5dm5ts made by ?is 
section %all apply to am\nts paid or    
incurr$ aft] ! date ( ! enactm5t ( ?is  
,act4