,i  #aaf? ,,congress  #b;d ,session  ,h4
 ,r4 #ficj  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,may #ai1 #bjbj ,mr4  
,c>t] ( ,georgia 7= himself1 ,mr4       
,griffi?1 ,mr4 ,mc,kinley1 ,mr4 ,craw=d1
 & ,mr4 ,soto7 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 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 ( #bjbj or 
! ,,made 9 ,am]ica ,act ( #bjbj4  #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$ical products & 
supplies4 ,sec4 #ajb4 ,enhance          
intraag5cy coord9ation & public heal?   
assessm5t ) reg>d to compliance         
activities4 ,sec4 #ajc4 ,enc\rag+       
int]national h>monization4 ,sec4 #ajd4  
,mutual recognition agreem5ts =         
inspections & review activities4 ,sec4  
#aje4 ,enhanc+ transp>5cy ( drug        
facility inspection timel9es4 ,sec4     
#ajf4 ,advanc$ 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$ical products & supplies  7a7 ,report 
,n lat] ?an ,janu>y #a1 #bjba1 !        
,secret>y ( ,heal? & ,human ,s]vices    
7ref]r$ to 9 ?is section z ! ,secret>y7 

%all submit to ! ,committee on ,en]gy & 
,comm]ce ( ! ,h\se ( ,repres5tatives & !
 ,committee on ,heal?1 ,education1      
,labor1 & ,p5sions ( ! ,s5ate a report  
on b>ri]s to dome/ic manufactur+ (      
active ph>maceutical +r$i5ts1 drugs1 &  
devices t are s\rc$ or manufactur$      
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$i5ts1 drugs1 & devices 
t are curr5tly s\rc$ or manufactur$     
outside ( ! ,unit$ ,/ates1 includ+ any  
,f$]al1 ,/ate1 local1 or ,tribal laws & 
regulations t h9d] dome/ic manufactur+  
opportunities2 &  7#b7 recomm5d specific
 /rategies to ov]come ! *all5ges        
id5tifi$ "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 c>ry+ out !      
report "u subsection 7a71 ! ,secret>y   

%all consult )-- 7#a7 ! ,food & ,drug   
,adm9i/ration1 ! ,c5t]s = ,m$ic>e       
,m$icaid ,s]vices1 ! ,dep>tm5t (        
,def5se1 ! ,dep>tm5t ( ,comm]ce1 !      
,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 7& 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 intraag5cy    
coord9ation & public heal? assessm5t )  
reg>d to compliance activities  7a7     
,b5efit_/,risk framework  7#a7 ,9 g5]al 
,p>agraph 7#b7 ( section #gjd7;b7 ( !   

,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cgd7;b77 is am5d$ by    
add+ at ! end ! foll[+3 ,! ,secret>y    
%all ensure timely & effective          
coord9ation among su* (fices reg>d+ !   
reviews ( su* report & ! alignm5t ( any 
fe$back reg>d+ su* report1 & any        
corrective or prev5tive actions 9       
response to su* report1 aft]            
consid]ation ( ! b5efits & risks to !   
public heal?1 pati5t safety1 ! drug     
supply & drug supply *a91 & timely      
pati5t access to drugs44  7#b7 ,annual  
report+ ,subsection 7b7 ( section #gjd (
 ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act
 7#ba ,u4,s4,c4 #cgd7 is am5d$ by add+  
at ! end ! foll[+ new p>agraph3  7#c7   
,on an annual basis1 ! ,secret>y %all   
prep>e a report on ! utilization ( !    
framework describ$ 9 p>agraph 7#b7 & po/
 su* report on ! public website ( !     
,food & ,drug ,adm9i/ration4  4  7#c7   
,applicability ,! am5dm5ts made by      
p>agraphs 7#a7 & 7#b7 %all take effect  
on ! effective date describ$ 9 section  

#caab ( ! ,,c>es ,act 7,public ,law     
#aaf-acf71 aft] execut+ ! am5dm5ts made 
by su* section #caab1 & %all apply      
beg9n+ on ! date t is #a ye> aft] ! date
 ( enactm5t ( ?is ,act4  7b7 ,public    
meet+ ,! ,secret>y ( ,heal? & ,human    
,s]vices %all publi% 9 ! ,f$]al ,regi/] 
a notice ( a public meet+ to be held no 
lat] ?an six mon?s aft] ! date (        
enactm5t ( ?is ,act to discuss & obta9  
input & recomm5dations f public         
/akehold]s1 includ+ pati5t advocates1   
consum]s1 regulat$ indu/ry1 & heal? c>e 
provid]s1 reg>d+ ! cont5ts ( a          
b5efit_/risk framework describ$ 9       
section #gjd7;b77#b7 ( ! ,f$]al ,food1  
,drug1 & ,cosmetic ,act1 z am5d$ by     
subsection 7a71 t supports a safe1      
/able1 r$undant drug supply *a94  7c7   
,guidance ,! ,secret>y ( ,heal? & ,human
 ,s]vices %all-- 7#a7 n lat] ?an "o ye> 
aft] ! date ( enactm5t ( ?is ,act1 issue
 draft guidance reg>d+ ! goals &        
implem5tation ( a b5efit_/risk framework
 describ$ 9 subsection 7b72 &  7#b7 n   

lat] ?an two ye>s aft] su* date (       
enactm5t1 issue f9al guidance ) respect 
to ! implem5tation ( su* a framework4   
#ajc4 ,enc\rag+ int]national            
h>monization  7a7 ,,gao /udy ,n lat] ?an
 "o ye> aft] ! date ( enactm5t ( ?is    
,act1 ! ,comptroll] ,g5]al ( ! ,unit$   
,/ates %all issue a report evaluat+--   
7#a7 ! consi/5cy ) :i* ! ,int]national  
,conf]5ce on ,h>monisation 79 ?is       
section ref]r$ to z ,,i*7 guidel9es on  
good manufactur+ practices1 includ+ ,,i*
 ,guidel9es ,q#h-aa1 are be+ implem5t$  
by drug regulatory au?orities across    
c\ntries & int]national regions2  7#b7  
:e!r dome/ic active ph>maceutical +r$i5t
 manufactur]s 7includ+ any su* contract 
manufactur]s7 are provid$ suffici5t     
opportunity to p>ticipate ) regulatory  
au?orities 9 ! developm5t ( guidel9es   
prior to implem5tation2  7#c7 :e!r      
div]g5ce f ,,i* guidel9es or diff]+     
regulatory /&>ds or requirem5ts by drug 
regulatory au?orities across c\ntries & 
int]national regions creates-- 7,a7     

ineffici5cies 9 drug manufactur+2  7,b7 
incompatible requirem5ts t c contribute 
to or exac]bate drug %ortages2 &  7,c7 !
 mo/ common areas ( div]g5ce betwe5 ,,i*
 guidel9es & regulatory /&>ds &         
requirem5ts by drug regulatory          
au?orities across c\ntries &            
int]national regions t1 if rectifi$1 may
 r$uce ! ineffici5cies &                
incompatibilities id5tifi$ pursuant to  
subp>agraphs 7,a7 & 7,b74  7b7          
,int]national tra9+ program ,n lat] ?an 
two ye>s aft] ! date ( enactm5t ( ?is   
,act1 in=m$ by ! ne$s id5tifi$ 9 !      
report issu$ pursuant to subsection 7a71
 ! ,secret>y ( ,heal? & ,human ,s]vices1
 9 conjunction ) drug regulatory        
au?orities across c\ntries &            
int]national regions & ! ,,i*1 %all     
develop & implem5t a tra9+ program =    
drug regulatory au?orities across       
c\ntries & int]national regions to      
promote consi/5t application ( & r$uce  
div]g5ce f ,,i* guidel9es on good       
manufactur+ practices4  #ajd4 ,mutual   

recognition agreem5ts = inspections &   
review activities  7a7 ,mutual          
,recognition ( ,inspections ,pursuant to
 section #hji ( ! ,f$]al ,food1 ,drug & 
,cosmetics ,act 7#ba ,u4,s4,c4 #chd;e71 
! ,secret>y ( ,heal? & ,human ,s]vices  
79 ?is section ref]r$ to z ! ,secret>y7 
%all e/abli% or exp& initiatives =      
mutual %>+ ( review & inspection crit]ia
 betwe5 drug regulatory au?orities      
across c\ntries & int]national regions1 
su* z ?r\gh ! ,ph>maceutical ,coop]ation
 ,inspection ,s*eme1 ! ,mutual          
,recognition ,agreem5t ) ! ,european    
,union1 & !                             
,au/ralia-,canada-,s+apore-,switz]l&    
,consortium1 to--  7#a7 r$uce ! pot5tial
 = duplicative regulatory evaluation (  
m$ical products regulat$ by ! ,food &   
,drug ,adm9i/ration2 &  7#b7 m          
con/ructively allocate appropriations to
 ! ,food & ,drug ,adm9i/ration1 includ+ 
^? attributable to us] fees1 to h>moniz$
 regulatory processes4  7b7 ,additional 
c\ntries1 regions1 & evaluation ,9 c>ry+

 out subsection 7a71 ! ,secret>y may    
exp& ! initiatives to include-- 7#a7    
additional c\ntries & geographic regions
 ) e/abli%$ & compet5t regulatory       
frameworks2 &  7#b7 additional types (  
regulatory evaluation1 includ+ ) respect
 to-- 7,a7 good manufactur+ practice    
inspections2 &  7,b7 approval ( *anges  
to ! manufactur+ ( drugs = :i* an       
approval or lic5sure is 9 effect "u     
section #eje ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or  
section #cea ( ! ,public ,heal? ,s]vice 
,act 7#db ,u4,s4,c4 #bfb74  7c7         
,implem5tation framework  7#a7          
,publication ,n lat] ?an "o ye> aft] !  
date ( enactm5t ( ?is ,act1 ! ,secret>y 
%all publi% an implem5tation framework =
 ! agreem5ts to %>e review & inspection 
crit]ia "u subsection 7a7 on ! public   
website ( ! ,food & ,drug ,adm9i/ration4
  7#b7 ,cont5ts ,! implem5tation        
framework "u ?is subsection %all-- 7,a7 
include ! timel9e = e/abli%+ or exp&+   
initiatives describ$ 9 subsection 7a72  

7,b7 describe additional types (        
regulatory processes t w become subject 
to su* initiatives2  7,c7 specify !     
c\ntries & geographic regions :]e su*   
initiatives w be e/abli%$ or exp&$2 &   
7,d7 id5tify additional opportunities & 
*all5ges = exp&+ mutual recognition     
agreem5ts 9 drug & biologic regulation4 
7d7 ,annual report+  7#a7 ,9 g5]al ,n   
lat] ?an ! end ( cal5d> ye> #bjbj &     
annually !reaft]1 ! ,secret>y %all      
publi% a report on ! public website ( ! 
,food & ,drug ,adm9i/ration on !        
utilization ( agreem5ts describ$ 9      
subsection 7c77#a7 9 ! previ\s fiscal   
ye>4  7#b7 ,cont5ts ,! report "u        
p>agraph 7#a7 %all include ea* ( !      
foll[+3 7,a7 ,! total numb] (           
e/abli%m5ts t are regi/]$ "u section    
#eaj7;i7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7 &   
locat$ outside ( ! ,unit$ ,/ates1 & ( ^!
 e/abli%m5ts1 ! numb] 9 ea* region (    
int]e/4  7,b7 ,! total numb] (          
inspections conduct$ at e/abli%m5ts     

describ$ 9 subp>agraph 7,a74  7,c7 ,( ! 
inspections describ$ 9 subp>agraph 7,b71
 ! total numb] ( inspections 9 ea* (    
region ( int]e/4  7,d7 ,( ! inspections 
9 ea* region ( int]e/ report$ pursuant  
to subp>agraph 7,c71 ! numb] (          
inspections 9 ea* ,,fda inspection      
category4  7,e7 ,( ! numb] ( inspections
 report$ "u ea* ( subp>agraphs 7,b71    
7,c71 & 7,d7--  7i7 ! numb] (           
inspections :i* h be5 conduct$ pursuant 
to an agreem5t describ$ 9 subsection    
7c77#a72 &  7ii7 ! numb] ( inspections  
:i* h be5 conduct$ by employees or o!r  
ag5ts ( ! ,food & ,drug ,adm9i/ration4  
7#c7 ,def9itions ,9 ?is subsection3 7,a7
 ,! t]m region ( int]e/ ref]s to ,*9a1  
,india1 ! ,european ,union1 & any o!r   
geographic region z det]m9$ appropriate 
by ! ,secret>y4  7,b7 ,! t]m ,,fda      
inspection category means ref]s to !    
foll[+ inspection categories3 7i7       
,inspections to support an approval ( a 
drug "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     
7ii7 ,good manufactur+ practice         
inspections4  7iii7 ,=-cause            
inspections4  #aje4 ,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 ( facilities 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 & !  
m$ian "t f ! beg9n+ ( an inspection to !
 issuance ( a report pursuant to section
 #gjd7;b7 ( ! ,f$]al ,food1 ,drug1 &    
,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7;b771
 includ+-- 7,a7 ! m$ian "t = drugs      
describ$ 9 #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  
su* section #gjd7;b7 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$ian "t f ! s5d+ ( a   
w>n+ lett]1 issuance ( an import al]t1  
or hold+ ( a regulatory meet+ to        
resolution ( ! regulatory or en=cem5t   
action indicat$ = inspections = :i* !   
,secret>y conclud$ t su* action 0       
indicat$4  7#d7 ,! numb] ( times t a    
facility 0 issu$ a report pursuant to   
su* section #gjd7;b7 & approval ( an    
application 0 delay$ due to ! issuance (
 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  #ajf4 ,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 ,act ( #bjbj1 ! 
,secret>y %all cont9ue 9 effect !       
program to evaluate new drug manufactur+

 te*nologies t are includ$ 9 an         
application1 or supplem5t to an         
application1 = a drug "u subsection 7b7 
or 7j7 ( section #eje ( ?is ,act or = a 
biological product submitt$ "u          
subsection 7a7 or 7k7 ( section #cea ( !
 ,public ,heal? ,s]vice ,act4  7b7      
,designation ,! ,secret>y %all designate
 a me?od ( manufactur+ a drug z an      
advanc$ manufactur+ te*nology "u ?is    
section if ! drug manufactur]           
demon/rates t su* te*nology is likely   
to--  7#a7 prev5t or resolve a drug     
%ortage2  7#b7 ma9ta9 an adequate supply
 ( critical m$ications = national       
em]g5cies2 or  7#c7 promote ! adoption (
 innovative approa*es to drug product   
design & manufactur+4  7c7 ,consultation
 ,if ! ,secret>y designates a me?od (   
manufactur+ z an advanc$ manufactur+    
te*nology "u ?is section1 ! ,secret>y   
%all take actions to exp$ite !          
developm5t & implem5tation ( su* me?od (
 manufacture = purposes ( approval ( !  
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 
appropriate--  7#a7 hold+ meet+s betwe5 
! sponsor ( ! application & appropriate 
,food & ,drug ,adm9i/ration /aff ?r\gh\t
 ! developm5t ( ! te*nology2  7#b7      
provid+ timely advice to1 & int]active  
communication )1 ! sponsor reg>d+ !     
developm5t ( ! te*nology2 &  7#c7       
involv+ s5ior manag]s & exp]i5c$ /aff ( 
! ,food & ,drug ,adm9i/ration1 z        
appropriate1 9 a collaborative1         
cross-discipl9>y review ( ! me?od (     
manufactur+4  7d7 ,evaluation ( an      
,advanc$ ,manufactur+ ,te*nology  7#a7  
,package ,a sponsor :o receives         
designation ( an advanc$ manufactur+    
te*nology "u ?is section %all provide ! 
,secret>y ) a package ( sci5tific       
evid5ce support+ ! implem5tation ( !    
advanc$ manufactur+ te*nology 9 a       
p>ticul> context-(-use4  7#b7           
,evaluation ,)9 #ij days ( receiv+ !    
package1 ! ,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 ( ,approval ,^u approval1 ! same
 sponsor may rely ^u ! advanc$          
manufactur+ te*nology = use across      
multiple manufactur+ 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$]al ,regi/]
 a notice ( a public meet+ to be held no
 lat] ?an #a ye> aft] ! date ( enactm5t 
( ! ,manufactur+ ,,api1 ,drugs1 &       
,excipi5ts 9 ,am]ica ,act ( #bjbj to    
discuss & obta9 input & recomm5dations f
 /akehold]s reg>d+ ! goals & scope (1 & 
a suitable framework & proc$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 ,act (   

#bjbj1 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   
,act ( #bjbj1 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 ( ! program "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 #cj p]c5t ( ! qualifi$         
production activity exp5ditures ( !     
taxpay] = ! taxable ye>4  7b7 ,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 or  7,b7 am\nts    
paid or incurr$ = any tangible p]sonal  
prop]ty 7:e!r or n o!rwise prop]ly      
*>geable to capital acc\nt7 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$ 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+ ph>maceuticals1   
excipi5ts1 active ph>maceutical +r$i5ts1
 m$ical diagno/ic devices1 or p]sonal   
protective equipm5t4  7,b7 ,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$]al ,regulations 7& any     
successor regulations74  7,c7 ,excipi5t 
,! t]m excipi5t--  7i7 means any        
inactive +r$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 &  7ii7 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  7,d7 ,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
  7,e7 ,p]sonal protective equipm5t ,!  

t]m p]sonal protective equipm5t means-- 
7i7 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$ical purpose2 &  7ii7
 any p>ticulate filt]+ air purify+      
respiratory protective device t is      
approv$ by ! ,national ,in/itute =      
,occupational ,safety & ,heal? "u "p #hd
 ( title #db1 ,code ( ,f$]al            
,regulations 7or successor regulations74
  7,f7 ,ph>maceutical ,! t]m            
ph>maceutical-- 7i7 means any drug 7z   
def9$ 9 section #bja ( ! ,f$]al ,food1  
,drug1 & ,cosmetic ,act72 &  7ii7       
includes a biological product 7z def9$ 9
 section #cea ( ! ,public ,heal? ,s]vice
 ,act74  7#c7 ,c]ta9 heal? plan exp5ses 
treat$ z wages  7,a7 ,9 g5]al ,=        
purposes ( p>agraph 7#a71 ! 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         
,di/ress$ zone ,! 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  7c7 ,special rules  7#a7
 ,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$4  7#b7 ,coord9ation )  
o!r cr$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  7#c7 ,limitation on wages tak5  
into acc\nt ,! am\nt ( wages tak5 into  
acc\nt "u subsection 7a7 ) respect to   
any employee %all n exce$ an am\nt equal
 to ! contribution & b5efit base 9      
effect "u section #bcj ( ! ,social      
,security ,act = ! cal5d> ye> 9 :i* !   
taxable ye> beg9s4  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         
respectively & by ins]t+ aft] clause    
7ix7 ! foll[+ new clause3  7x7 ! cr$it  
det]m9$ "u section #de,u1  4  7c7       
,special rule = controll$ =eign         
corporations ,section #ifj7;d7 ( su*    
,code is am5d$ by add+ at ! end ! foll[+
 new p>agraph3  7#d7 ,special =         
controll$ =eign corporations ) di/ress$ 
zone ph>maceutical & m$ical device      
exp5ditures ,! am\nt ( =eign taxes deem$
 paid by a dome/ic corporation "u       
p>agraph 7#a7 7det]m9$ )\t reg>d to ?is 
p>agraph7 %all be increas$ by an am\nt  
equal to ! less] (--  7,a7 ! excess (-- 
7i7 ! am\nt calculat$ ) respect to su*  
corporation "u p>agraph 7#a7 7det]m9$   
)\t reg>d to ?is p>agraph & by sub/itut+
 #ajj p]c5t = #hj p]c5t71 ov]  7ii7 !   
am\nt calculat$ ) respect to su*        
corporation "u p>agraph 7#a7 7det]m9$   
)\t reg>d to ?is p>agraph71 or  7,b7 an 
am\nt equal to #ae p]c5t ( ! qualifi$   
production activity exp5ditures 7z def9$
 9 section #de,u7b77#a77 ( ! controll$  

=eign corporation = ! taxable ye> ( !   
=eign corporation end+ 9 or ) ! taxable 
ye> ( ! dome/ic corporation4  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