,,ii  #aaf? ,,congress  #b;d ,session   
,s4 #cgha  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,may #bj1 #bjbj,mr4    
,pet]s introduc$ ! foll[+ bill2 :i* 0   
read twice & ref]r$ to ! ,committee on  
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to increase report+ (1 help 
mitigate pot5tial %ortages relat$ to1 & 
promote1 acc\ntability & transp>5cy =   
ph>maceuticals & m$ical devices4  #a4   
,%ort title ,?is ,act may be cit$ z !   
,ph>maceutical ,acc\ntability1          
,responsibility1 & ,transp>5cy ,act or !
 ,,"p ,act4  #b4 ,,fda increas$ dem&    
report+ ) respect to drugs ,section     
#ejf;,c ( ! ,f$]al ,food1 ,drug1 &      
,cosmetic ,act 7#ba ,u4,s4,c4 #cef;c71 z
 am5d$ by ! ,,c>es ,act 7,public ,law   
#aaf-acf71 is fur!r am5d$-- 7#a7 9      
subsections 7c71 7e71 7f71 7g71 & 7j71  
by ins]t+ or 7k7 aft] subsection 7a7 ea*
 place su* t]m appe>s2 &  7#b7 by add+  
at ! end ! foll[+3  7k7 ,increas$ dem&  
report+  7#a7 ,9 g5]al ,! manufactur] ( 
a drug describ$ 9 subsection 7a7 or a   

biological product subject to subsection
 7i77#c7 %all notify ! ,secret>y1 9     
accordance ) p>agraph 7#b71 ( any-- 7,a7
 increase 9 dem& = ! drug t !           
manufactur] likely w be unable to meet2 
or  7,b7 export re/rictions or o!r      
limitations impos$1 on or aft] ! date ( 
enactm5t ( ! ,,"p ,act1 on manufactur+  
or %ipm5t ( ! drug or any ( its active  
ph>maceutical +r$i5ts by ! c\ntry 9 :i* 
su* drug or any su* +r$i5t is           
manufactur$4  7#b7 ,tim+ ,a notice      
requir$ "u p>agraph 7#a7 %all be        
submitt$ to ! ,secret>y z soon z        
practicable b n lat] ?an #e cal5d> days 
aft] ! manufactur] becomes aw>e ( !     
issue requir+ notification "u su*       
p>agraph4  7#c7 ,notification (         
resolution ( issue ,a manufactur] ( a   
drug :o submits a notification to !     
,secret>y "u p>agraph 7#a7 %all notify !
 ,secret>y aft] ! issue giv+ rise to su*
 notification has be5 resolv$ or :5 !   
manufactur] is able to meet dem&4  4    
#c4 ,,fda increas$ dem& report+ )       

respect to devices ,section #ejf;,j ( ! 
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cef;c7 is am5d$-- 7#a7 9
 subsections 7c71 7e71 & 7f71 by ins]t+ 
or 7j7 aft] subsection 7a7 ea* place su*
 t]m appe>s2 &  7#b7 by add+ at ! end ! 
foll[+3  7j7 ,increas$ dem& report+     
7#a7 ,9 g5]al ,! manufactur] ( a device 
describ$ 9 subsection 7a7 %all notify ! 
,secret>y1 9 accordance ) p>agraph 7#b71
 ( any-- 7,a7 increase 9 dem& = ! device
 t ! manufactur] likely w be unable to  
meet2 or  7,b7 export re/rictions or o!r
 limitations impos$1 on or aft] ! date (
 enactm5t ( ! ,,"p ,act1 on manufactur+ 
or export ( ! device by ! c\ntry 9 :i*  
su* device or any compon5t ( ! device is
 manufactur$4  7#b7 ,tim+ ,a notice     
requir$ "u p>agraph 7#a7 %all be        
submitt$ to ! ,secret>y z soon z        
practicable b n lat] ?an #e cal5d> days 
aft] ! manufactur] becomes aw>e ( !     
issue requir+ notification "u su*       
p>agraph4  7#c7 ,notification (         
resolution ( issue ,a manufactur] ( a   

device :o submits a notification to !   
,secret>y "u p>agraph 7#a7 %all notify !
 ,secret>y aft] ! issue giv+ rise to su*
 notification has be5 resolv$ or :5 !   
manufactur] is able to meet dem&4  4    
#d4 ,qu>t]ly manufactur] report+ )      
respect to drugs & devices  7a7         
,regi/ration ( c]ta9 =eign e/abli%m5ts  
,section #eaj7;i7 ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cfj7;i77 is am5d$ by ins]t+ at ! end ! 
foll[+ new p>agraph3  7#e7 ,!           
requirem5ts ( p>agraphs 7#a7 & 7#b7 %all
 apply to e/abli%m5ts )9 a =eign c\ntry 
engag$ 9 ! manufacture1 prep>ation1     
propagation1 comp\nd+1 or process+ ( any
 drug1 includ+ ! active ph>maceutical   
+r$i5t1 or device t is requir$ to be    
li/$ pursuant to subsection 7j74 ,su*   
requirem5ts %all apply reg>dless ( :e!r 
! drug1 active ph>maceutical +r$i5t1 or 
device und]goes fur!r manufacture1      
prep>ation1 propagation1 comp\nd+1 or   
process+ at a sep>ate e/abli%m5t or     
e/abli%m5ts outside ! ,unit$ ,/ates     

prior to be+ import$ or (f]$ = import   
into ! ,unit$ ,/ates4  4  7b7 ,li/+ (   
drugs ,section #eaj7;j77#a7 ( ! ,f$]al  
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cfj7;j77#a77 is am5d$-- 7#a7 
9 subp>agraph 7,d71 by /rik+ & at ! end2
  7#b7 9 subp>agraph 7,e71 by /rik+ !   
p]iod at ! end & ins]t+ 2 &2 &  7#c7 by 
add+ at ! end ! foll[+ new subp>agraph3 
7,f7 9 ! case ( a drug conta9$ 9 !      
applicable li/1 a c]tification t !      
regi/rant has-- 7i7 id5tifi$ e o!r      
e/abli%m5t :]e manufactur+ is p]=m$ = ! 
drug2 &  7ii7 notifi$ ea* kn[n =eign    
e/abli%m5t engag$ 9 ! manufacture1      
prep>ation1 propagation1 comp\nd+1 or   
process+ ( ! drug1 includ+ ! active     
ph>maceutical +r$i5t1 ( ! inclusion ( ! 
drug 9 ! li/ & ! obligation to regi/] "u
 subsection 7i77#e74  4  7c7 ,qu>t]ly   
report+ ,p>agraph 7#c7 ( section        
#eaj7;j7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7;j771
 z am5d$ by ! ,,c>es ,act 7,public ,law 
#aaf-acf71 is am5d$ to read z foll[s3   

7#c7 7,a7 ,subject to subp>agraph 7,c7  
ea* p]son :o regi/]s ) ! ,secret>y "u   
?is section %all submit to ! ,secret>y  
qu>t]ly reports1 9 su* electronic data  
=mat z ! ,secret>y requires1 conta9+ !  
foll[+ in=mation1 z applicable1 )       
respect to all drugs1 drug sub/ances1 & 
devices manufactur$1 prep>$1 propagat$1 
comp\nd$1 or process$ at ! e/abli%m5t1  
:e!r = import into ! ,unit$ ,/ates or   
di/ribution 9 ano!r c\ntry3 7i7 ,)      
respect to a f9i%$ drug product-- 7,i7 !
 numb] ( dosage units manufactur$ at ea*
 e/abli%m5t s9ce ! la/ report1 brok5 d[n
 by-- 7aa7 ! numb] ( dosage units       
manufactur$ at ea* e/abli%m5t at :i*    
f9al manufactur+ occurr$1 & ! unique    
facility id5tifi] ( ea* su* e/abli%m5t2 
7bb7 ! numb] ( dosage units f ea* su*   
e/abli%m5t t 7 di/ribut$ 7or are int5d$ 
to be di/ribut$7 = use 9 ! ,unit$ ,/ates
 & ! numb] ( dosage units t 7 di/ribut$ 
7or are int5d$ to be di/ribut$7 = use   
outside ( ! ,unit$ ,/ates2 &  7,,ii7 !  
s\rces ( drug sub/ances us$ 9 !         

manufactur+ ( ! f9i%$ drug product1 &1 =
 ea* su* s\rce-- 7aa7 ! unique facility 
id5tifi] ( ea* s\rce ( drug sub/ance2 & 
7bb7 ! numb] ( dosage units ( ! f9i%$   
drug product manufactur$ us+ t drug     
sub/ance f ea* s\rce ( drug sub/ance2 & 
7,,iii7 ! ,national ,drug ,code numb]4  
7ii7 ,) respect to a drug sub/ance--    
7,i7 ! am\nt ( drug sub/ance manufactur$
 at ea* e/abli%m5t s9ce ! la/ report & !
 unique facility id5tifi] ( ea* su*     
e/abli%m5t2  7,,ii7 ! am\nt ( ! drug    
sub/ance manufactur$ at ea* su*         
e/abli%m5t t 0 di/ribut$ 7or are int5d$ 
to be di/ribut$7 = use 9 ! ,unit$ ,/ates
 & ! am\nt t 0 di/ribut$ 7or are int5d$ 
to be di/ribut$7 = use outside ( !      
,unit$ ,/ates2 &  7,,iii7 ! ,national   
,drug ,code numb]4  7iii7 ,) respect to 
a device1 ! numb] ( units manufactur$ at
 ea* e/abli%m5t s9ce ! la/ report1 brok5
 d[n by-- 7,i7 ! numb] ( units          
manufactur$ at ea* e/abli%m5t at :i*    
f9al manufactur+ occurr$1 & ! e/abli%m5t
 id5tification numb] ( ea* su*          

e/abli%m5t2 &  7,,ii7 ! numb] ( units f 
ea* su* e/abli%m5t t 7 di/ribut$ 7or are
 int5d$ to be di/ribut$7 = use 9 !      
,unit$ ,/ates & ! numb] ( units t 7     
di/ribut$ 7or are int5d$ to be          
di/ribut$7 = use outside ( ! ,unit$     
,/ates4  7,b7 ,by ord] ( ! ,secret>y1   
c]ta9 biological products or categories 
( biological products may be exempt f "s
 or all ( ! report+ requirem5ts "u      
subp>agraph 7,a71 if ! ,secret>y        
det]m9es1 at ! ,secret>y's sole         
discretion1 t apply+ su* report+        
requirem5ts to su* biological products  
or categories is n necess>y to protect !
 public heal?4  7,c7 ,! det]m9ation ( ! 
appropriate /ructur$ electronic data    
=mat by ! ,secret>y "u subp>agraph 7,a71
 :e!r to exempt c]ta9 biological        
products or categories ( biological     
products "u subp>agraph 7,b71 & ! date  
on :i* report+ beg9s "u ?is section %all
 be exempt f ! requirem5ts ( section    
#eec ( title #e1 ,unit$ ,/ates ,code4  4
  7d7 ,effective date ,! am5dm5ts made  

by ?is section %all take effect on      
,septemb] #bc1 #bjbj4  7e7              
,confid5tiality ,no?+ 9 ! am5dm5ts made 
by ?is section %all be con/ru$ z        
au?oriz+ ! ,secret>y to disclose any    
in=mation t is a trade secret or        
confid5tial in=mation subject to section
 #eeb7;b77#d7 ( title #e1 ,unit$ ,/ates 
,code1 or section #aije ( title #ah1    
,unit$ ,/ates ,code4  #e4 ,requir+ ,,fda
 to %>e manufactur+ in=mation ) ,,aspr &
 ! ,assi/ant ,secret>y ( ,def5se =      
,heal? ,affairs  7a7 ,9 g5]al ,beg9n+ z 
soon z practicable1 b n lat] ?an #a ye> 
aft] ! date ( enactm5t ( ?is ,act1 !    
,secret>y ( ,heal? & ,human ,s]vices1   
act+ ?r\gh ! ,commission] ( ,food &     
,drugs1 %all provide to ! ,assi/ant     
,secret>y = ,prep>$ness & ,response & ! 
,assi/ant ,secret>y ( ,def5se = ,heal?  
,affairs all drug & device manufactur+  
data describ$ 9 subsection 7b71 z       
appropriate & applicable1 = any ( !     
foll[+ purposes3 7#a7 ,ma9ta9+ !        
/rategic national /ockpile "u section   

#cai;,f-#b ( ! ,public ,heal? ,s]vice   
,act 7#db ,u4,s4,c4 #bdg;d-#f;b74  7#b7 
,evaluat+ heal? infra/ructure "u !      
,division ( ,critical ,infra/ructure    
,protection ( ! ,(fice ( ! ,assi/ant    
,secret>y = ,prep>$ness & ,response4    
7#c7 ,prep>+ = & respond+ to public     
heal? em]g5cies & national security     
conc]ns4  7#d7 ,mitigat+ pot5tial drug  
%ortages4  7b7 ,report+ provisions ,!   
drug & device manufactur+ data requir$  
to be provid$ z describ$ 9 subsection   
7a7 includes-- 7#a7 in=mation report$ by
 any manufactur] "u subsection 7a7 or   
7k7 ( section #ejf;,c7a7 ( ! ,f$]al     
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cef;c7 or subsection 7a7 or  
7j7 ( section #ejf;,j ( su* ,act 7#ba   
,u4,s4,c4 #cef;j72  7#b7 any risk       
managem5t plan "u section #ejf;,c7j7 (  
su* ,act 7#ba ,u4,s4,c4 #cef;c7j77 t is 
made available to ! ,secret>y pursuant  
to su* section2  7#c7 records or o!r    
in=mation provid$ "u section            
#gjd7;a77#d7 ( su* ,act 7#ba ,u4,s4,c4  

#cgd7;a77#d772 &  7#d7 to ! ext5t n     
already provid$1 ! locations :]e ea*    
drug t is a subject ( a report or plan  
"u p>agraph 7#a71 7#b71 or 7#c7 is      
manufactur$4  7c7 ,memor&a ( und]/&+ ,! 
,commission] ( ,food & ,drugs & !       
,assi/ant ,secret>y = ,prep>$ness &     
,response1 & ! ,commission] ( ,food &   
,drugs & ! ,assi/ant ,secret>y ( ,def5se
 = ,heal? ,affairs1 %all ent] into      
memor&a ( und]/&+ to set =? ! mann] 9   
:i* data w be %>$ "u ?is section & !    
proc$ures = protect+ any nonpublic data 
f fur!r disclosure4