,i  #aaf? ,,congress  #b;d ,session  ,h4
 ,r4 #hihg  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,decemb] #af1         
#bjbj,mr4 ,joyce ( ,p5nsylvania         
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 ! ,public ,heal?      
,s]vice ,act to inc5tivize ! manufacture
 ( c]ta9 m$ic9es 9 ! ,unit$ ,/ates & to 
enhance ! security ( ! ,unit$ ,/ates    
ph>maceutical supply *a91 & = o!r       
purposes4  #a4 ,%ort title ,?is ,act may
 be cit$ z ! ,enhanc+ ! ,security ( !   
,u4,s4 ,ph>maceutical ,supply ,*a9 ,act 
( #bjbj4  #b4 ,table ( cont5ts ,! table 
( cont5ts = ?is ,act is z foll[s3 ,sec4 
#a4 ,%ort title4,sec4 #b4 ,table (      
cont5ts4,sec4 #c4 ,id5tification1       
developm5t1 & procurem5t ( priority     
m$ic9es4,sec4 #d4 ,priority m$ic9e      

production cr$it4,sec4 #e4 ,improv+     
regulatory effici5cies = transf] (      
drugs4  #c4 ,id5tification1 developm5t1 
& procurem5t ( priority m$ic9es  7a7    
,priority m$ic9es ,title ,,xxviii ( !   
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #cjj;hh et seq47 is am5d$ by  
add+ at ! end ! foll[+3  #bhjd4         
,id5tification ( priority m$ic9es  7a7  
,priority m$ic9es ,! ,secret>y %all     
designate z a priority m$ic9e ea* cov]$ 
product t-- 7#a7 7,a7 is necess>y = use 
9 a public heal? em]g5cy decl>$ "u      
section #cai2 or  7,b7 is at high risk (
 becom+ 9 %ort supply2 &  7#b7 has a    
vuln]able global supply *a94  7b7       
,global supply *a9 vuln]ability ,9      
det]m9+ :e!r a cov]$ product has a      
vuln]able global supply *a9 "u          
subsection 7a77#b71 ! ,secret>y %all    
consid]-- 7#a7 ! f9d+s ( ! ,national    
,academies ( ,sci5ces1 ,eng9e]+1 &      
,m$ic9e 9 ! report publi%$ pursuant to  
section #daaa ( ! ,,c>es ,act 7,public  
,law #aaf-acf72  7#b7 ! numb] (         

manufactur]s ( ea* cov]$ product2  7#c7 
! manufactur+ locations1 & am\nt        
produc$1 ( ea* cov]$ product2  7#d7 !   
hi/ory ( ! importation ( ea* priority   
m$ic9e2 &  7#e7 ! probability ( !       
imposition ( duties on ! importation (  
ea* cov]$ product4  7c7 ,consultation ,9
 c>ry+ out subsection 7a71 ! ,secret>y  
%all consult ) ! ,public ,heal? ,em]g5cy
 ,m$ical ,c\nt]measures ,ent]prise      
e/abli%$ "u section #bhaa-a4  7d7       
,publication ( li/ ,! ,secret>y %all--  
7#a7 n lat] ?an #ahj days aft] ! date ( 
enactm5t ( ?is section1 publi% a        
prelim9>y li/ ( priority m$ic9es2  7#b7 
provide an opportunity = public comm5t  
on su* prelim9>y li/2  7#c7 n lat] ?an  
#a ye> aft] su* date ( enactm5t1 publi% 
a f9al li/ ( priority m$ic9es2 &  7#d7  
on an annual basis1 review &1 z         
appropriate1 update su* li/4  7e7       
,def9itions ,9 ?is section3 7#a7 ,active
 ph>maceutical +r$i5t ,! t]m active     
ph>maceutical +r$i5t-- 7,a7 means any   
compon5t t is int5d$ to furni%          

ph>macological activity or o!r direct   
effect 9 ! diagnosis1 cure1 mitigation1 
treatm5t1 or prev5tion ( a disease1 or  
to affect ! /ructure or any function ( !
 body ( a human or animal2 &  7,b7 does 
n include-- 7i7 int]m$iates us$ 9 !     
syn!sis ( a drug product2 or  7ii7      
compon5ts t may und]go *emical *ange 9 !
 manufacture ( a drug product & be      
pres5t 9 a drug product 9 a modifi$ =m t
 is int5d$ to furni% su* activity or    
effect4  7#b7 ,cov]$ product ,! t]m     
cov]$ product means a drug 7includ+ a   
biological product7 or an active        
ph>maceutical +r$i5t4  7#c7 ,priority   
m$ic9e ,! t]m priority m$ic9e means a   
priority m$ic9e = :i* a designation is 9
 effect "u subsection 7a74  4  7b7      
,national ,/rategic ,heal? ,/rategy     
,section #bhjb7;b7 ( ! ,public ,heal?   
,s]vice ,act 7#db ,u4,s4,c4             
#cjj;hh-#a7;b77 is am5d$ by add+ at !   
end ! foll[+3  7#aa7 ,priority m$ic9es  
,support+ ! id5tification1 production1 &
 procurem5t ( priority m$ic9es designat$

 "u section #bhjd4  4  7c7 ,public      
,heal? ,em]g5cy ,m$ical ,c\nt]measures  
,ent]prise recomm5dations ,section      
#bhaa-a7;c77#a7 ( ! ,public ,heal?      
,s]vice ,act 7#db ,u4,s4,c4             
#cjj;hh-#aj;a7c77 is am5d$ by add+ at ! 
end ! foll[+3  7,e7 ,provide            
recomm5dations to ! ,secret>y ) respect 
to ! priority m$ic9es designat$ "u      
section #bhjd4  4  7d7 ,/rategic plan = 
c\nt]measure rese>*1 developm5t1 &      
procurem5t ,section #cai,l7b7 ( !       
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bdg;d-#g;e7b77 is am5d$--    
7#a7 9 p>agraph 7#b7-- 7,a7 9           
subp>agraph 7,b71 by /rik+ & at ! end2  
7,b7 9 subp>agraph 7,c71 by /rik+ !     
p]iod at ! end & ins]t+ 2 &2 &  7,c7 by 
add+ at ! end ! foll[+3  7,d7 !         
developm5t & procurem5t ( priority      
m$ic9es designat$ "u section #bhjd4  2 &
  7#b7 by add+ at ! end ! foll[+3  7#c7 
,priority m$ic9es ,) respect to !       
developm5t & procurem5t ( priority      
m$ic9es1 ! ,secret>y %all promote a     

div]se & su/a9able supply *a91 includ+  
?r\gh grants & pur*ases4  4  7e7        
,critical drug consid]ation ,section    
#caja ( ! ,,c>es ,act 7,public ,law     
#aaf-acf7 is am5d$-- 7#a7 by r$esignat+ 
subsection 7d7 z subsection 7e72 &  7#b7
 aft] execut+ ! r$esignation 9 p>agraph 
7#a71 by ins]t+ aft] subsection 7c7 !   
foll[+3  7d7 ,consid]ation ,) respect to
 any analysis ( a critical drug "u      
subsection 7b77#a71 ! ,secret>y %all    
consid] ! vuln]ability ( su* drug )     
respect to ! global supply *a91 includ+ 
an analysis (-- 7#a7 ! numb] (          
manufactur]s ( su* drug2  7#b7 !        
manufactur+ locations1 & am\nts produc$1
 ( su* drug2  7#c7 ! hi/ory ( !         
importation ( su* drug2 &  7#d7 !       
probability ( ! imposition ( duties on !
 importation ( su* drug4  4  #d4        
,priority m$ic9e production cr$it  7a7  
,9 g5]al ,subp>t ,d ( "p ,,iv ( sub*apt]
 ,a ( *apt] #a ( ! ,int]nal ,rev5ue     
,code ( #aihf is am5d$ by add+ at ! end 
! foll[+ new section3  #de,u4 ,priority 

m$ic9e production cr$it  7a7 ,g5]al     
,rule ,= purposes ( section #ch1 !      
priority m$ic9e production cr$it det]m9$
 "u ?is section = ! taxable ye> is an   
am\nt equal to #ej p]c5t ( ! qualifi$   
priority m$ic9e exp5ses = ! taxable ye>4
  7b7 ,qualifi$ priority m$ic9e exp5ses 
7#a7 ,qualifi$ priority m$ic9e exp5ses  
,! t]m qualifi$ priority m$ic9e exp5ses 
means direct & indirect co/s paid or    
incurr$ by ! taxpay] dur+ ! taxable ye> 
= ! production ( priority m$ic9es4  7#b7
 ,priority m$ic9es ,= purposes ( ?is    
section1 a priority m$ic9e is a m$ic9e t
 0 includ$1 )9 ! #e cal5d> ye>s         
imm$iately prec$+ ! taxable ye>1 on !   
li/ develop$ & publi%$ by ! ,secret>y ( 
,heal? & ,human ,s]vices pursuant to    
section #bhjd7;d7 ( ! ,public ,heal?    
,s]vice ,act4  7#c7 ,coord9ation )      
section #bfc;,a  7,a7 ,coord9ation )    
section #bfc;,a ,9 apply+ section       
#bfc;,a1 indirect co/s %all be allocat$ 
betwe5 ! production ( priority m$ic9es &
 ! production ( o!r m$ic9es bas$ on !   

ratio 9 :i* ! numb] ( doses ( ! priority
 m$ic9es produc$ 9 ! taxable ye> be>s to
 ! total numb] ( doses ( all m$ic9es    
produc$ by ! taxpay] 9 t taxable ye> to 
:i* ! exp5se is attributable4  7,b7     
,regulations & guidance ,! ,secret>y    
%all by regulation or o!r guidance      
prescribe rules = ! prop] allocation (  
indirect co/s describ$ 9 subp>agraph    
7,a74  4  7b7 ,cr$it all[$ z bus9ess    
cr$it ,section #ch7;b7 ( ! ,int]nal     
,rev5ue ,code ( #aihf 7relat+ to curr5t 
ye> bus9ess cr$it7 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 & add+ at ! end ! foll[+ 
new p>agraph3  7#cd7 ! priority m$ic9e  
production cr$it det]m9$ "u section     
#de,u4  4  7c7 ,con=m+ am5dm5ts  7#a7   
,coord9ation ) section #ei  7,a7        
,section #ei;,a7b77#a77;,b77ii7 is      
am5d$-- 7i7 9 subclause 7,i71 by /rik+  
plus1 at ! end2  7ii7 9 subclause       
7,,ii71 by /rik+ ! p]iod at ! end1 &    
ins]t+ 1 plus2 &  7iii7 by add+ at ! end

 ! foll[+3  7,,iii7 ! cr$it all[$ "u    
section #ch = ! taxable ye> :i* is      
prop]ly allocable to ! priority m$ic9e  
production cr$it det]m9$ "u section     
#de,u4  4  7,b7 ,section                
#ei;,a7b77#b77;,b7 is am5d$ to read z   
foll[s3  7,b7 by r$uc+ 7b n bel[ z]o7 ! 
regul> tax liability 7z def9$ 9 section 
#bf7;b77 = purposes ( subp>agraph 7,b7  
!re( by ! excess 7if any7 ( ! aggregate 
am\nt ( ! cr$its all[$ "u ?is *apt]     
aga9/ su* regul> tax liability ov] !    
cr$it all[$ "u section #ch = ! taxable  
ye> :i* is prop]ly allocable to !       
priority m$ic9e production cr$it det]m9$
 "u section #de,u1 r ?an ! excess       
describ$ 9 su* p>agraph4  4  7#b7       
,coord9ation ) rese>* cr$it ,section    
#da7;c77#d77;,a7 is am5d$ by /rik+ #ad &
 ins]t+ #bj4  7d7 ,cl]ical am5dm5t ,!   
table ( sections = subp>t ,d ( "p ,,iv (
 sub*apt] ,a ( "p ,,iv ( sub*apt] ,a (  
*apt] #a ( ! ,int]nal ,rev5ue ,code (   
#aihf is am5d$ by ins]t+ aft] ! item    
relat+ to section #de,t ! foll[+ new    

item3 ,sec4 #de,u4 ,priority m$ic9e     
production cr$it4  7e7 ,effective date  
,! am5dm5ts made by ?is section %all    
apply to qualifi$ priority m$ic9e       
exp5ses paid or incurr$ aft] ,decemb]   
#ca1 #bjbj4  #e4 ,improv+ regulatory    
effici5cies = transf] ( drugs ,! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cja et seq47 is am5d$ by     
ins]t+ aft] section #eje-a ( su* ,act   
7#ba ,u4,s4,c4 #cee-a7 ! foll[+3        
#eje-b4 ,transf] ( drugs to dome/ic     
e/abli%m5ts  7a7 ,9 g5]al ,beg9n+ n lat]
 ?an #ij days aft] ! date ( ! enactm5t (
 ?is section1 ! ,secret>y %all exp$ite !
 review & approval ( a supplem5tal      
application to an abbreviat$ new drug   
application approv$ "u section #eje7;j7 
or a new drug application approv$ "u    
section #eje7;c7 t seeks to transf]     
manufactur+ ( "o or m f9i%$ dosage =ms (
 a drug or "o or m active ph>maceutical 
+r$i5ts !re9 f "o or m =eign e/abli%m5ts
 to "o or m new or exi/+ dome/ic        
e/abli%m5ts4  7b7 ,be=e supplem5tal     

application submission  7#a7 ,developm5t
 & pre-submission ,aft] an applicant    
submits a meet+ reque/ ) respect to     
exp$it$ review & approval ( a           
supplem5tal application pursuant to     
subsection 7a71 ! ,secret>y %all-- 7,a7 
n lat] ?an #cj days aft] receiv+ su*    
reque/1 conduct a meet+ ) ! applicant   
to-- 7i7 discuss ! in=mation necess>y to
 approve ! supplem5tal application2 &   
7ii7 if applicable1 s*$ule a            
pre-approval inspection2 &  7,b7 n lat] 
?an #fj days aft] receiv+ su* reque/1   
conduct a meet+ ) ! applicant to-- 7i7  
provide advice to ! applicant ) respect 
to ! supplem5tal application2 &  7ii7 if
 applicable1 select a fir/ drug to be   
id5tifi$ 9 accordance ) subsection 7c74 
7#b7 ,review & approval ,9 c>ry+ out    
subsection 7a71 ! ,secret>y %all-- 7,a7 
review & take action ) respect to a     
supplem5tal application n lat] ?an #f   
mon?s aft] ! date ( submission or       
resubmission ( su* application2 &  7,b7 
:]e ! ,secret>y recomm5ds a *ange to a  

dome/ic e/abli%m5t foll[+ an inspection 
( su* e/abli%m5t1 re9spect ! e/abli%m5t 
n lat] ?an #ij days aft] receiv+ a      
reque/ f ! applicant = re9spection4     
7#c7 ,relation to fee p]=mance goals ,! 
deadl9es specifi$ 9 p>agraph 7#a7       
sup]s$e any conflict+ p]=mance goals    
id5tifi$ 9 any /atute reau?oriz+ ! fee  
programs 9 p>ts #b & #g ( sub*apt] ,c ( 
title ,,vii ( ! ,f$]al ,food1 ,drug1 &  
,cosmetic ,act4  7c7 ,cont5ts ,) respect
 to a supplem5tal application "u        
subsection 7a7 = a transf] ( ! site (   
manufacture ( multiple drugs t %>e a    
simil> manufactur+ process1 ! ,secret>y 
%all-- 7#a7 reque/ a li/ ( ! drugs2     
7#b7 f ! li/ "u p>agraph 7#a71 id5tify a
 fir/ drug to be transf]r$2  7#c7       
det]m9e ! crit]ia necess>y to receive   
approval ( ! supplem5tal application2 & 
7#d7 require ! applicant to demon/rate1 
z "p ( su* crit]ia1 t ea* =eign         
e/abli%m5t f :i* ! drugs are to be      
transf]r$ has a satisfactory inspection 
hi/ory ) respect to ! drugs4  7d7       

,subsequ5t transf] ( drugs t %>e a      
simil> manufactur+ process ,aft] !      
approval ( a supplem5tal application "u 
subsection 7a7 = ! transf] ( !          
manufactur+ ( a fir/ drug id5tifi$ by ! 
,secret>y pursuant to subsection 7c77#b7
 f "o or m =eign e/abli%m5ts to "o or m 
new or exi/+ dome/ic e/abli%m5ts1 !     
,secret>y may all[ ! applicant to s     
transf] drugs t %>e a simil> manufactur+
 process ) su* fir/ drug pursuant to    
submission ( a report "u section        
#ejf;,a7d77#b7 r ?an by requir+         
submission ( a supplem5tal application4 
7e7 ,work+ gr\p  7#a7 ,e/abli%m5t ,n    
lat] ?an #ij days aft] ! date ( enactm5t
 ( ?is section1 ! ,secret>y %all e/abli%
 an intra-ag5cy work+ gr\p to be kn[n z 
! ,facility ,transf] ,work+ ,gr\p4  7#b7
 ,memb]%ip ,! ,secret>y %all appo9t     
memb]s ( ! ,facility ,transf] ,work+    
,gr\p f among (ficials & employees ( !  
,dep>tm5t ( ,heal? & ,human ,s]vices    
:o-- 7,a7 repres5t a cross-section ( !  
,dep>tm5t ( ,heal? & ,human ,s]vices2 & 

7,b7 h exp]tise on e/abli%m5ts us$ to   
manufacture drugs4  7#c7 ,duties ,!     
,facility ,transf] ,work+ ,gr\p %all--  
7,a7 assi/ ! ,secret>y 9 c>ry+ out ?is  
section2  7,b7 ^u reque/ by an          
applicant1 conduct an in=mational site  
visit dur+ ! developm5tal phase to      
discuss requirem5ts ) ! applicant )     
respect to facility design1 site /atus1 
& validation2  7,c7 n lat] ?an #cj days 
aft] conduct+ an in=mational site visit 
"u subp>agraph 7,b71 provide advice &   
fe$back to ! applicant ) respect to     
facility issues t may prev5t approval ( 
! supplem5tal application "u subsection 
7a71 includ+ any issues ) ! facility    
transf] plans2 &  7,d7 p>ticipate 9 any 
pre-approval inspection requir$ by !    
,secret>y = an e/abli%m5t or provide    
fe$back to ! ,secret>y ) respect to a   
supplem5tal application describ$ 9      
subsection 7a74  7f7 ,additional        
in=mational visits ,^u reque/ by !      
applicant1 ! ,secret>y may conduct      
in=mational site visits 9 addition to an

 in=mational site visit conduct$ by !   
,facility ,transf] ,work+ ,gr\p "u      
subsection 7e74  7g7 ,guidance  7#a7    
,issuance ,n lat] ?an #a ye> aft] ! date
 ( enactm5t ( ?is section1 ! ,secret>y  
%all issue guidance ) respect to ?is    
section4  7#b7 ,cont5t ,! guidance issu$
 "u ?is p>agraph %all include-- 7,a7 !  
process by :i* an applicant may seek    
exp$it$ review & approval ( a           
supplem5tal application "u subsection   
7a72 &  7,b7 a description ( ! actions !
 ,secret>y may take to exp$ite !        
submission & review ( su* supplem5tal   
application4  7h7 ,def9itions ,9 ?is    
section3 7#a7 ,satisfactory inspection  
hi/ory ,! t]m satisfactory inspection   
hi/ory means1 ) respect to a drug1 a    
hi/ory consi/+ ( "o or m inspections 9  
:i* ! mo/ rec5t manufactur+ inspection 0
 a satisfactory manufactur+ inspection  
dur+ :i*-- 7,a7 no objectionable        
conditions or practices 7 f\nd2 or  7,b7
 objectionable conditions 7 f\nd &      
volunt>y corrective action 0 left to !  

manufactur]4  7#b7 ,simil> manufactur+  
process ,! t]m simil> manufactur+       
process means processes us$ to          
manufacture drugs t %>e at lea/ "o unit 
op]ation hav+ ! same design pr9ciple4  4