,i  #aah? ,,congress  #b;d ,session  ,h4
 ,r4 #fifc  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,janu>y #aa1 #bjbd,ms4
 ,e%oo 7= h]self1 ,ms4 ,de,gette1 & ,ms4
 ,s*ri]7 introduc$ ! foll[+ bill2 :i* 0 
ref]r$ to ! ,committee on ,en]gy &      
,comm]ce  ,a ,,bill  ,to direct !       
,secret>y ( ,heal? & ,human ,s]vices to 
ent] into agreem5ts ) drug manufactur]s 
to e/abli% res]ve supplies ( cov]$      
p$iatric canc] drugs1 & = o!r purposes4 
#a4 ,%ort title ,?is ,act may be cit$ z 
! ,p$iatric ,canc] ,drug ,supply ,act ( 
#bjbd4  #b4 ,e/abli%m5t ( ess5tial      
p$iatric canc] drug m>ketplace /ability 
pilot program  7a7 ,9 g5]al ,! ,secret>y
 %all c>ry out a pilot program "u :i* ! 
,secret>y ent]s into agreem5ts )        
manufactur]s to pur*ase & ma9ta9 n less 
?an a #f-mon? res]ve supply1 to be held 
by su* manufactur]s1 ( ea* cov]$        
p$iatric canc] drug4  7b7 ,pilot program
  7#a7 ,pref]5ce = multiple manufactur]s
 ,to ! greate/ ext5t practicable1 !     
,secret>y %all seek to ent] into        

agreem5ts describ$ 9 subsection 7a7 ) m 
?an #a manufactur] = ea* cov]$ p$iatric 
canc] drug4  7#b7 ,implem5tation goals  
,to ! greate/ ext5t practicable1 !      
,secret>y %all implem5t ! pilot program 
"u ?is section 9 a mann] t-- 7,a7       
m9imizes ! impact on ! m>ketplace =     
drugs includ$ on ! ess5tial p$iatric    
canc] drug li/ e/abli%$ "u section #c2  
7,b7 increases dome/ic manufactur+      
capacity2  7,c7 enc\rages competition 9 
! m>ketplace2  7,d7 assures t any cov]$ 
p$iatric canc] drugs t ! ,secret>y      
di/ributes or ord]s to be di/ribut$ "u  
section #d are us$ to treat p$iatric    
canc] pati5ts2 &  7,e7 rew>ds           
manufactur+ quality4  7#c7 ,requir$     
agreem5t t]ms ,ea* agreem5t "u ?is      
section betwe5 ! ,secret>y & a          
manufactur] ( a cov]$ p$iatric canc]    
drug %all include ! foll[+3 7,a7 ,!     
id5tity & quantity ( ea* cov]$ p$iatric 
canc] drug t ! manufactur] agrees to    
hold 9 res]ve supply4  7,b7 ,a          
requirem5t t su* quantities %all be 9   

addition to ! av]age levels ( inv5tory =
 ! relevant cov]$ p$iatric canc] drug   
held by ! manufactur] dur+ ! previ\s    
ye>4  7,c7 ,a provision to ensure t ea* 
drug held 9 res]ve supply has an        
expiration date at lea/ #a ye> beyond ! 
curr5t date4  7,d7 ,a provision to all[ 
! manufactur] to sell & replace1 ?r\gh  
normal comm]cial *annels1 any drug 9    
res]ve supply 9 ord] to rema9 9         
compliance ) ! provision describ$ 9     
subp>agraph 7,c74  7,e7 ,a requirem5t t 
! cov]$ p$iatric canc] drugs 9 res]ve   
supply may only be held at a location 9 
! ,unit$ ,/ates4  7,f7 ,9 ! case ( a    
cov]$ p$iatric canc] drug manufactur$ at
 an eligible s\rce facility t is n      
locat$ 9 ! ,unit$ ,/ates1 ! manufactur] 
( su* drug may comply ) subp>agraph     
7,e7-- 7i7 by /or+ ! drug at an         
e/abli%m5t locat$ 9 ! ,unit$ ,/ates t   
is-- 7,i7 regi/]$ "u section #eaj ( !   
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cfj72 &  7,,ii7 "u      
common own]%ip & control ) !            

manufactur]2 or  7ii7 by contract+ ) an 
au?oriz$ ?ird-p>ty logi/ics provid] 7z  
def9$ 9 section #eha ( ! ,f$]al ,food   
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cfj;eee77 locat$ 9 ! ,unit$ ,/ates to  
/ore ! drug 9 ! ,unit$ ,/ates4  7,g7 ,a 
requirem5t t any cov]$ p$iatric canc]   
drug held 9 res]ve supply be manufactur$
 & held 9 accordance )-- 7i7 good       
manufactur+ practice requirem5ts2  7ii7 
! approv$ application = su* drug "u     
section #eje ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or  
section #cea ( ! ,public ,heal? ,s]vice 
,act 7#db ,u4,s4,c4 #bfb72 &  7iii7     
applicable law4  7,h7 ,a provision t    
all[s ! ,secret>y1 or a ?ird p>ty       
designat$ by ! ,secret>y1 to audit !    
manufactur] & ! eligible s\rce facility 
= compliance ) ! t]ms ( ! agreem5t &    
applicable law-- 7i7 on an annual basis2
 or  7ii7 m frequ5tly1 if ! ,secret>y   
has a reasonable basis to believe t !   
manufactur] or eligible s\rce facility  
is n comply+ ) ! t]ms ( ! agreem5t or   

applicable law4  7,i7 ,a requirem5t t ! 
manufactur] c]tify to ! ,secret>y on an 
annual basis compliance ) ! t]ms ( !    
agreem5t4  7#d7 ,optional t]ms =        
acquisition1 con/ruction1 alt]ation1 or 
r5ovation ( e/abli%m5t ,an agreem5t "u  
?is section betwe5 ! ,secret>y & a      
manufactur] ( a cov]$ p$iatric canc]    
drug may include a provision to all[ !  
manufactur] to acquire1 con/ruct1 alt]1 
or r5ovate a non-f$]ally own$ e/abli%m5t
 = ! purpose ( manufactur+ cov]$        
p$iatric canc] drugs-- 7,a7 z !         
,secret>y det]m9es necess>y to ensure   
suffici5t am\nts ( su* drugs2 or  7,b7 z
 ! ,secret>y det]m9es necess>y to c>ry  
out or improve prep>$ness & response    
capability at ! ,/ate & local levels4   
7#e7 ,reasonable "t = manufacture ,!    
,secret>y %all all[ ea* manufactur] )   
:om ! ,secret>y has ent]$ into an       
agreem5t "u ?is section a reasonable    
am\nt ( "t aft] ent]+ into ! agreem5t to
 manufacture ! cov]$ p$iatric canc]     
drugs t w be held 9 res]ve supply       

pursuant to ! agreem5t4  7c7 ,paym5t    
t]ms  7#a7 ,paym5t am\nts  7,a7 ,9 g5]al
 ,! am\nt paid to ea* manufactur]       
pursuant to an agreem5t ) ! ,secret>y "u
 ?is section %all be bas$ on-- 7i7 !    
quantity ( ea* cov]$ p$iatric canc] drug
 ! manufactur] agrees to hold 9 res]ve  
supply2 &  7ii7 ! :olesale acquisition  
co/ ( ea* su* drug4  7,b7 ,adm9i/rative 
fee ,! ,secret>y may pay a manufactur]  
an adm9i/rative fee pursuant to an      
agreem5t "u ?is section1 provid$ t !    
paym5t ( ! adm9i/rative fee does n cause
 ! ,secret>y to exhau/ ! am\nts         
appropriat$ = ! pilot program "u ?is    
section prior to secur+ adequate res]ves
 = ea* cov]$ p$iatric canc] drug4  7#b7 
,paym5t condition$ on res]ve supply     
adequacy  7,a7 ,9 g5]al ,except z       
provid$ 9 subp>agraph 7,b71 ea* agreem5t
 ) a manufactur] "u ?is section %all    
provide t no paym5t "u ! agreem5t may be
 made until ! manufactur] demon/rates to
 ! ,secret>y t ! manufactur] has set    
aside a portion1 z det]m9$ by !         

,secret>y1 ( ! total quantity ( ! cov]$ 
p$iatric canc] drug to be held 9 res]ve 
supply "u ! agreem5t4  7,b7 ,exceptions 
= advance paym5t ,an agreem5t "u ?is    
section may provide t1 if ! ,secret>y   
det]m9es t an advance paym5t or p>tial  
paym5t = significant mile/ones is       
necess>y to ensure success ( ! t]ms ( ! 
agreem5t1 ! ,secret>y %all pay1 9       
advance1 an am\nt n to exce$ #aj p]c5t (
 ! total am\nt to be paid to !          
manufactur] by ! ,secret>y "u !         
agreem5t4  7d7 ,=feiture ,if a          
manufactur] is unable or fails to       
di/ribute a cov]$ p$iatric canc] drug 9 
accordance ) ! t]ms ( an agreem5t ent]$ 
into "u ?is section1 ! manufactur]      
%all-- 7#a7 =feit any paym5ts x has     
receiv$ "u ! agreem5t2 &  7#b7 n lat]   
?an #cj days aft] ! date ( su* inability
 or failure1 refund su* paym5ts4  #c4   
,ess5tial p$iatric canc] drug li/  7a7  
,9 g5]al ,! ,secret>y1 9 consultation ) 
! ,commission] ( ,food & ,drugs & !     
,director ( ! ,national ,canc]          

,in/itute1 %all-- 7#a7 n lat] ?an #aej  
days aft] ! date ( enactm5t ( ?is ,act1 
develop a li/ ( *emo!rapeutic drugs t   
are ess5tial = treat+ p$iatric canc]2 & 
7#b7 update su* li/ on a s*$ule det]m9$ 
by ! ,secret>y4  7b7 ,crit]ia ,"u       
subsection 7a71 a *emo!rapeutic drug    
%all be consid]$ ess5tial = treat+      
p$iatric canc] only if ! drug-- 7#a7 is 
approv$ "u section #eje ( ! ,f$]al      
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee7 or lic5s$ "u section    
#cea ( ! ,public ,heal? ,s]vice ,act    
7#db ,u4,s4,c4 #bfb7 = use 9 ! treatm5t 
( canc]2  7#b7 has ! pot5tial alone or 9
 comb9ation ) o!r drugs to treat a      
p$iatric canc]2  7#c7 is support$ by #a 
or m citations to treat a p$iatric canc]
 includ$ or approv$ = inclusion 9-- 7,a7
 ! ,national ,compreh5sive ,canc]       
,network ,comp5dia2  7,b7 ,am]ican      
,hospital ,=mul>y ,s]vice ,drug         
,in=mation2  7,c7 ! ,,drugdex ,in=mation
 ,sy/em2 or  7,d7 ! ,,pdq ,canc]        
,in=mation ,summ>ies = ,heal?           

,pr(essionals ( ! ,national ,canc]      
,in/itute2 &  7#d7 meets price1 quality1
 manufactur+ conc5tration1 manufactur+  
complexity1 & o!r appropriate metrics z 
det]m9$ by ! ,secret>y4  #d4            
,di/ributions f ess5tial p$iatric canc] 
drug res]ve supplies  7a7 ,9 g5]al ,if a
 cov]$ p$iatric canc] drug is 9 %ortage 
7z def9$ 9 section #ejf;,c7h7 ( ! ,f$]al
 ,food1 ,drug1 & ,cosmetic ,act 7#ba    
,u4,s4,c4 #cef;c7h7771 or ! ,secret>y   
has reason to believe t su* a drug may  
be at risk ( su* a %ortage1 ! ,secret>y 
may ord] a manufactur] ) :om ! ,secret>y
 has ent]$ into an agreem5t "u section  
#b to di/ribute su* drug f ! res]ve     
supply 9 accordance ) su* agreem5t 9 an 
ef=t to alleviate or prev5t ! %ortage4  
7b7 ,paym5ts = di/ribution  7#a7 ,9     
g5]al ,! ,secret>y %all require a       
recipi5t ( a cov]$ p$iatric canc] drug  
di/ribut$ "u subsection 7a7 to pay !    
,secret>y = su* drug4 ,! am\nt ( su*    
paym5t %all n exce$ ! price = :i* !     
,secret>y pur*as$ su* drug pursuant to  

an agreem5t "u section #b4  7#b7        
,limitation ,! ,secret>y may use paym5ts
 receiv$ pursuant to p>agraph 7#a7 only 
to repl5i% ! res]ve supply ( ! drugs    
di/ribut$ "u subsection 7a74  7c7       
,inability ,to di/ribute or manage      
res]ve supply  7#a7 ,inability to       
di/ribute ,if a manufactur] is n able or
 will+ to di/ribute drugs 9 accordance )
 an ord] ( ! ,secret>y "u subsection    
7a71 ! ,secret>y may take possession ( &
 di/ribute su* drugs4  7#b7 ,inability  
to manage res]ve supply ,if a           
manufactur] c no long] hold or manage a 
res]ve supply ( cov]$ p$iatric canc]    
drugs 9 accordance ) an agreem5t "u     
section #b1 ! ,secret>y may take        
possession ( ! res]ve supply4  #e4      
,reports to ,congress  7a7 ,9 g5]al ,=  
ea* ye> #a or m drugs are held by a     
manufactur] 9 res]ve supply pursuant to 
an agreem5t "u section #b1 ! ,secret>y  
%all submit to ,congress a report on !  
progress ( ! pilot program "u su*       
section4  7b7 ,cont5ts ,! reports ref]r$

 to 9 subsection 7a7 %all ea* include-- 
7#a7 ! ess5tial p$iatric canc] drug li/ 
9 effect dur+ ! ye> cov]$ by ! report   
7includ+ any *anges made to ! li/       
?r\gh\t ! ye>72  7#b7 ! total numb] (   
agreem5ts ent]$ into "u section #b dur+ 
su* ye>2  7#c7 ! total am\nt ( ea* cov]$
 p$iatric canc] drug pur*as$ by !       
,secret>y pursuant to su* agreem5ts dur+
 su* ye>2  7#d7 ! total am\nt ( ea*     
cov]$ p$iatric canc] drug di/ribut$ f ! 
res]ve supplies "u section #d dur+ su*  
ye>2 &  7#e7 any o!r in=mation t !      
,secret>y det]m9es relevant4  #f4       
,def9itions ,9 ?is ,act3 7#a7 ,cov]$    
p$iatric canc] drug ,! t]m cov]$        
p$iatric canc] drug means a drug-- 7,a7 
t is includ$ on ! ess5tial p$iatric     
canc] drug li/ e/abli%$ "u section #c2  
7,b7 t may be at risk ( a mean+ful      
disruption 7z def9$ 9 section #ejf;,j7j7
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   
,act 7#ba ,u4,s4,c4 #cef;j7j777 9 !     
supply ( ! drug2 &  7,c7 ^: f9al dosage 
=m is manufactur$ at an eligible s\rce  

facility4  7#b7 ,drug ,! t]m drug-- 7,a7
 means a drug 7z def9$ 9 section        
#bja7;g7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act 7#ba ,u4,s4,c4           
#cba7;g7772 &  7,b7 includes a          
biological product 7z def9$ 9 section   
#cea7;i7 ( ! ,public ,heal? ,s]vice ,act
 7#db ,u4,s4,c4 #bfb7;i7774  7#c7       
,eligible s\rce facility ,! t]m eligible
 s\rce facility means a facility-- 7,a7 
regi/]$ "u section #eaj ( ! ,f$]al      
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cfj72  7,b7 lawfully         
manufactur+ a cov]$ p$iatric canc] drug2
 &  7,c7 locat$ 9-- 7i7 ! ,unit$ ,/ates2
 or  7ii7 a c\ntry t is a memb] ( !     
,organisation = ,economic ,co-op]ation &
 ,developm5t4  7#d7 ,ess5tial p$iatric  
canc] drug li/ ,! t]m ess5tial p$iatric 
canc] drug li/ means ! li/ "u section   
#c7;a74  7#e7 ,secret>y ,! t]m ,secret>y
 means ! ,secret>y ( ,heal? & ,human    
,s]vices4  7#f7 ,unit$ ,/ates ,! t]m    
,unit$ ,/ates means ea* ( ! sev]al      
,/ates & ! t]ritories & possessions ( ! 

,unit$ ,/ates4  #g4 ,au?orization (     
appropriations ,to c>ry out ?is ,act1   
!re are au?oriz$ to be appropriat$      
#ejj1jjj1jjj = fiscal ye> #bjbd1 to     
rema9 available until exp5d$4