,i  #aaf? ,,congress  #a/ ,session  ,h4 
,r4 #bgjj  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,may #ad1 #bjai,mr4   
,burgess 7= himself1 ,mr4 ,wald51 ,mr4  
,upton1 ,mr4 ,mc,kinley1 ,mr4 ,c>t] (   
,georgia1 ,mr4 ,buc%on1 ,mr4 ,bilirakis1
 ,mr4 ,mull91 ,mrs4 ,rodg]s ( ,wa%+ton1 
,mr4 ,long1 ,mr4 ,flores1 ,mr4 ,hudson1 
,mr4 ,%imkus1 ,mr4 ,walb]g1 ,mr4 ,k9z+]1
 ,mr4 ,olson1 ,mr4 ,johnson ( ,ohio1    
,mr4 ,gu?rie1 ,mr4 ,griffi?1 ,mr4       
,duncan1 ,mrs4 ,brooks ( ,indiana1 ,mr4 
,gian=te1 ,mr4 ,latta1 ,mr4 ,scalise1   
,mr4 ,s5s5br5n]1 ,mr4 ,coll9s (         
,georgia1 ,mr4 ,/iv]s1 ,mr4 ,hill (     
,arkansas1 ,mr4 ,mit*ell1 & ,mr4 ,hurd (
 ,texas7 introduc$ ! foll[+ bill2 :i* 0 
ref]r$ to ! ,committee on ,en]gy &      
,comm]ce1 & 9 addition to ! ,committee  
on ! ,judici>y1 = 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 inc5tivize      
l[-co/ drug options & g5]ic competition1

 & to provide ext5sions = community     
heal? c5t]s & ! ,national ,heal? ,s]vice
 ,corps1 & = o!r purposes4  #a4 ,%ort   
title ,?is ,act may be cit$ z ! ,l[]+   
,prescription ,drug ,co/s & ,ext5d+     
,community ,heal? ,c5t]s & ,o!r ,public 
,heal? ,priorities ,act4  #b4 ,table (  
cont5ts ,! table ( cont5ts ( ?is ,act is
 z foll[s3 ,sec4 #a4 ,%ort title4 ,sec4 
#b4 ,table ( cont5ts4 ,title ,i--,l[]+  
,prescription ,drug ,co/s ,subtitle     
,a--,br++ ,l[-,co/ ,options &           
,competition ,:ile ,keep+ ,inc5tives =  
,new ,g5]ics ,sec4 #aja4 ,*ange         
conditions ( fir/ g5]ic exclusivity to  
spur access & competition4 ,subtitle    
,b--,protect+ ,consum] ,access to ,g5]ic
 ,drugs ,sec4 #aaa4 ,unlawful agreem5ts4
 ,sec4 #aab4 ,notice & c]tification (   
agreem5ts4 ,sec4 #aac4 ,=feiture (      
#ahj-;day exclusivity p]iod4 ,sec4 #aad4
 ,commission litigation au?ority4 ,sec4 
#aae4 ,/atute ( limitations4 ,subtitle  
,c--,creat+ & ,re/or+ ,equal ,access to 
,equival5t ,samples ,sec4 #aba4 ,actions

 = delays ( g5]ic drugs & biosimil>     
biological products4 ,sec4 #abb4 ,,rems 
approval process = subsequ5t fil]s4     
,sec4 #abc4 ,rule ( con/ruction4 ,title 
,,ii--,ext5sion ( ,public ,heal?        
,programs ,sec4 #bja4 ,ext5sion =       
community heal? c5t]s1 ! ,national      
,heal? ,s]vice ,corps1 & tea*+ heal?    
c5t]s t op]ate ,,gme programs4 ,sec4    
#bjb4 ,ext5sion = special diabetes      
programs4 ,sec4 #bjc4 ,ext5sion =       
family-to-family heal? in=mation c5t]s4 
,sec4 #bjd4 ,ext5sion = sexual risk     
avoidance education & p]sonal           
responsibility education4  ,i ,l[]+     
,prescription ,drug ,co/s  ,a ,br++     
,l[-,co/ ,options & ,competition ,:ile  
,keep+ ,inc5tives = ,new ,g5]ics  #aja4 
,*ange conditions ( fir/ g5]ic          
exclusivity to spur access & competition
 ,section #eje7;j77#e77;,b77iv7 ( !     
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cee7;j77#e77;,b77iv77 is
 am5d$--  7#a7 9 subclause 7,i71 by     
/rik+ #ahj days aft] & all t foll[s     

?r\gh ! p]iod at ! end & ins]t+ !       
foll[+3 #ahj days aft] ! e>li] (-- 7aa7 
! date ( ! fir/ comm]cial m>ket+ ( !    
drug 7includ+ ! comm]cial m>ket+ ( !    
li/$ drug7 by any fir/ applicant2 or    
7bb7 ! applicable date specifi$ 9       
subclause 7,,iii74  2 &  7#b7 by add+ at
 ! end ! foll[+ new subclause3  7,,iii7 
,applicable date ,! applicable date     
specifi$ 9 ?is subclause1 ) respect to  
an application = a drug describ$ 9      
subclause 7,i71 is ! date on :i* ea* ( !
 foll[+ conditions is fir/ met3  7aa7 ,!
 approval ( su* an application c\ld be  
made effective1 b = ! eligibility ( a   
fir/ applicant = #ahj-;day exclusivity  
"u ?is clause4  7bb7 ,at lea/ #cj mon?s 
h pass$ s9ce ! date ( submission ( an   
application = ! drug by at lea/ "o fir/ 
applicant4  7cc7 ,approval ( an         
application = ! drug submitt$ by at lea/
 "o fir/ applicant is n preclud$ "u     
clause 7iii74  7dd7 ,no application = ! 
drug submitt$ by any fir/ applicant is  
approv$ at ! "t ! conditions "u items   

7aa71 7bb71 & 7cc7 are all met1         
reg>dless ( :e!r su* an application is  
subsequ5tly approv$4  4  ,b ,protect+   
,consum] ,access to ,g5]ic ,drugs  #aaa4
 ,unlawful agreem5ts  7a7 ,agreem5ts    
prohibit$ ,subject to subsections 7b7 & 
7c71 x %all be unlawful = an ,,nda or   
,,bla hold] & a subsequ5t fil] 7or = two
 subsequ5t fil]s7 to ent] into1 or c>ry 
out1 an agreem5t resolv+ or settl+ a    
cov]$ pat5t infr+em5t claim on a f9al or
 int]im basis if "u su* agreem5t--  7#a7
 a subsequ5t fil] directly or indirectly
 receives f su* hold] 7or 9 ! case ( su*
 an agreem5t betwe5 two subsequ5t fil]s1
 ! o!r subsequ5t fil]7 any?+ ( value1   
includ+ a lic5se2 &  7#b7 ! subsequ5t   
fil] agrees to limit or =ego rese>* on1 
or developm5t1 manufactur+1 m>ket+1 or  
sales1 = any p]iod ( "t1 ( ! cov]$      
product t is ! subject ( ! application  
describ$ 9 subp>agraph 7,a7 or 7,b7 (   
subsection 7g77#h74  7b7 ,exclusion ,x  
%all n be unlawful "u subsection 7a7 if 
a p>ty to an agreem5t describ$ 9 su*    

subsection demon/rates by cle> & conv9c+
 evid5ce t ! value describ$ 9 subsection
 7a77#a7 is comp5sation solely = o!r    
goods or s]vices t ! subsequ5t fil] has 
promis$ to provide4  7c7 ,limitation    
,no?+ 9 ?is section %all prohibit an    
agreem5t resolv+ or settl+ a cov]$ pat5t
 infr+em5t claim 9 :i* ! consid]ation   
grant$ by ! ,,nda or ,,bla hold] to !   
subsequ5t fil] 7or f "o subsequ5t fil]  
to ano!r7 z "p ( ! resolution or        
settlem5t includes only "o or m ( !     
foll[+3  7#a7 ,! "r to m>ket ! cov]$    
product t is ! subject ( ! application  
describ$ 9 subp>agraph 7,a7 or 7,b7 (   
subsection 7g77#h7 9 ! ,unit$ ,/ates    
be=e ! expiration (--  7,a7 any pat5t t 
is ! basis ( ! cov]$ pat5t infr+em5t    
claim2 or  7,b7 any pat5t "r or o!r     
/atutory exclusivity t w\ld prev5t !    
m>ket+ ( su* cov]$ product4  7#b7 ,a    
paym5t = reasonable litigation exp5ses n
 to exce$ #g1ejj1jjj 9 ! aggregate4     
7#c7 ,a cov5ant n to sue on any claim t 
su* cov]$ product infr+es a pat5t4  7d7 

,en=cem5t by ,f$]al ,trade ,commission  
7#a7 ,g5]al application ,! requirem5ts (
 ?is section apply1 accord+ to _! t]ms1 
to an ,,nda or ,,bla hold] or subsequ5t 
fil] t is--  7,a7 a p]son1 p>tn]%ip1 or 
corporation ov] :i* ! ,commission has   
au?ority pursuant to section #e7;a77#b7 
( ! ,f$]al ,trade ,commission ,act 7#ae 
,u4,s4,c4 #de7;a77#b772 or  7,b7 a      
p]son1 p>tn]%ip1 or corporation ov] :i* 
! ,commission w\ld h au?ority pursuant  
to su* section b = ! fact t su* p]son1  
p>tn]%ip1 or corporation is n organiz$  
to c>ry on bus9ess = its own pr(it or t 
( its memb]s4  7#b7 ,unfair or deceptive
 acts or practices en=cem5t au?ority    
7,a7 ,9 g5]al ,a violation ( ?is section
 %all be treat$ z an unfair or deceptive
 act or practice 9 violation ( section  
#e7;a77#a7 ( ! ,f$]al ,trade ,commission
 ,act 7#ae ,u4,s4,c4 #de7;a77#a774  7,b7
 ,p[]s ( ,commission ,except z provid$ 9
 subp>agraph 7,c7 & p>agraphs 7#a77;,b7 
& 7#c7-- 7i7 ! ,commission %all en=ce   
?is section 9 ! same mann]1 by ! same   

means1 & ) ! same jurisdiction1 p[]s1 & 
duties z ?\gh all applicable t]ms &     
provisions ( ! ,f$]al ,trade ,commission
 ,act 7#ae ,u4,s4,c4 #da et seq47 7     
incorporat$ into & made a "p ( ?is      
section2 &  7ii7 any ,,nda or ,,bla     
hold] or subsequ5t fil] t violates ?is  
section %all be subject to ! p5alties & 
entitl$ to ! privileges & immunities    
provid$ 9 ! ,f$]al ,trade ,commission   
,act4  7,c7 ,judicial review ,9 ! case (
 a cease & desi/ ord] issu$ by !        
,commission "u section #e ( ! ,f$]al    
,trade ,commission ,act 7#ae ,u4,s4,c4  
#de7 = violation ( ?is section1 a p>ty  
to su* ord] may obta9 judicial review ( 
su* ord] z provid$ 9 su* section #e1    
except t--  7i7 su* review may only be  
obta9$ 9-- 7,i7 ! ,unit$ ,/ates ,c\rt ( 
,appeals = ! ,di/rict ( ,columbia       
,circuit2  7,,ii7 ! ,unit$ ,/ates ,c\rt 
( ,appeals = ! circuit 9 :i* ! ultimate 
p>5t entity1 z def9$ 9 section          
#hja4a7;a77#c7 ( title #af1 ,code (     
,f$]al ,regulations1 or any successor   

!reto1 ( ! ,,nda or ,,bla hold] 7if any 
su* hold] is a p>ty to su* ord]7 is     
incorporat$ z ( ! date t ! application  
describ$ 9 subp>agraph 7,a7 or 7,b7 (   
subsection 7g77#h7 or an approv$        
application t is deem$ to be a lic5se = 
a biological product "u section #cea7k7 
( ! ,public ,heal? ,s]vice ,act 7#db    
,u4,s4,c4 #bfb7k77 pursuant to section  
#gjjb7;e77#d7 ( ! ,biologics ,price     
,competition & ,innovation ,act ( #bjji 
7,public ,law #aaa-adh2 #abd ,/at4 #hag7
 is submitt$ to ! ,commission] ( ,food &
 ,drugs2 or  7,,iii7 ! ,unit$ ,/ates    
,c\rt ( ,appeals = ! circuit 9 :i* !    
ultimate p>5t entity1 z s def9$1 ( any  
subsequ5t fil] t is a p>ty to su* ord]  
is incorporat$ z ( ! date t !           
application describ$ 9 subp>agraph 7,a7 
or 7,b7 ( subsection 7g77#h7 is submitt$
 to ! ,commission] ( ,food & ,drugs2 &  
7ii7 ! petition = review %all be fil$ 9 
! c\rt n lat] ?an #cj days aft] su* ord]
 is s]v$ on ! p>ty seek+ review4  7#c7  
,additional en=cem5t au?ority  7,a7     

,civil p5alty ,! ,commission may comm5ce
 a civil action to recov] a civil p5alty
 9 a di/rict c\rt ( ! ,unit$ ,/ates     
aga9/ any ,,nda or ,,bla hold] or       
subsequ5t fil] t violates ?is section4  
7,b7 ,special rule = recov]y ( p5alty if
 cease & desi/ ord] issu$  7i7 ,9 g5]al 
,if ! ,commission has issu$ a cease &   
desi/ ord] 9 a proce$+ "u section #e ( !
 ,f$]al ,trade ,commission ,act 7#ae    
,u4,s4,c4 #de7 = violation ( ?is        
section--  7,i7 ! ,commission may       
comm5ce a civil action "u subp>agraph   
7,a7 to recov] a civil p5alty aga9/ any 
p>ty to su* ord] at any "t be=e !       
expiration ( ! #a-ye> p]iod beg9n+ on ! 
date on :i* su* ord] becomes f9al "u    
section #e7;g7 ( su* ,act 7#ae ,u4,s4,c4
 #de7;g772 &  7,,ii7 9 su* civil action1
 ! f9d+s ( ! ,commission z to ! mat]ial 
facts 9 su* proce$+ %all be conclusive1 
unless--  7aa7 ! t]ms ( su* ord]        
expressly provide t ! ,commission's     
f9d+s %all n be conclusive2 or  7bb7 su*
 ord] became f9al by reason ( section   

#e7;g77#a7 ( su* ,act 7#ae ,u4,s4,c4    
#de7;g77#a771 9 :i* case su* f9d+s %all 
be conclusive if support$ by evid5ce4   
7ii7 ,relation%ip to p5alty = violation 
( an ord] ,! p5alty provid$ 9 clause 7i7
 = violation ( ?is section is sep>ate f 
& 9 addition to any p5alty t may be     
incurr$ = violation ( an ord] ( !       
,commission "u section #e7l7 ( ! ,f$]al 
,trade ,commission ,act 7#ae ,u4,s4,c4  
#de7l774  7,c7 ,am\nt ( p5alty  7i7 ,9  
g5]al ,! am\nt ( a civil p5alty impos$ 9
 a civil action "u subp>agraph 7,a7 on a
 p>ty to an agreem5t describ$ 9         
subsection 7a7 %all be suffici5t to det]
 violations ( ?is section1 b 9 no ev5t  
great] ?an--  7,i7 if su* p>ty is !     
,,nda or ,,bla hold] 7or1 9 ! case ( an 
agreem5t betwe5 two subsequ5t fil]s1 !  
subsequ5t fil] :o gave ! value describ$ 
9 subsection 7a77#a771 ! great] (--     
7aa7 #c times ! value receiv$ by su*    
,,nda or ,,bla hold] 7or by su*         
subsequ5t fil]7 t is reasonably         
attributable to ! violation ( ?is       

section2 or  7bb7 #c times ! value giv5 
to ! subsequ5t fil] 7or to ! o!r        
subsequ5t fil]7 reasonably attributable 
to ! violation ( ?is section2 &  7,,ii7 
if su* p>ty is ! subsequ5t fil] 7or1 9 !
 case ( an agreem5t betwe5 two subsequ5t
 fil]s1 ! subsequ5t fil] :o receiv$ !   
value describ$ 9 subsection 7a77#a771 #c
 times ! value receiv$ by su* subsequ5t 
fil] t is reasonably attributable to !  
violation ( ?is section4  7ii7 ,factors 
= consid]ation ,9 det]m9+ su* am\nt1 !  
c\rt %all take into acc\nt-- 7,i7 !     
nature1 circum/ances1 ext5t1 & gravity (
 ! violation2  7,,ii7 ) respect to !    
violator1 ! degree ( culpability1 any   
hi/ory ( violations1 ! ability to pay1  
any effect on ! ability to cont9ue do+  
bus9ess1 pr(its e>n$ by ! ,,nda or ,,bla
 hold] 7or1 9 ! case ( an agreem5t      
betwe5 two subsequ5t fil]s1 ! subsequ5t 
fil] :o gave ! value describ$ 9         
subsection 7a77#a771 comp5sation receiv$
 by ! subsequ5t fil] 7or1 9 ! case ( an 
agreem5t betwe5 two subsequ5t fil]s1 !  

subsequ5t fil] :o receiv$ ! value       
describ$ 9 subsection 7a77#a771 & !     
am\nt ( comm]ce affect$2 &  7,,iii7 o!r 
matt]s t ju/ice requires4  7,d7         
,injunctions & o!r equitable relief ,9 a
 civil action "u subp>agraph 7,a71 !    
,unit$ ,/ates di/rict c\rts are emp[]$  
to grant m&atory injunctions & su* o!r &
 fur!r equitable relief z !y deem       
appropriate4  7#d7 ,rem$ies 9 addition  
,rem$ies provid$ 9 ?is subsection are 9 
addition to1 & n 9 lieu (1 any o!r rem$y
 provid$ by ,f$]al law4  7#e7           
,pres]vation ( au?ority ( ,commission   
,no?+ 9 ?is section %all be con/ru$ to  
affect any au?ority ( ! ,commission "u  
any o!r provision ( law4  7e7 ,f$]al    
,trade ,commission rulemak+ ,!          
,commission may1 9 its discretion1 by   
rule promulgat$ "u section #eec ( title 
#e1 ,unit$ ,/ates ,code1 exempt f ?is   
section c]ta9 agreem5ts describ$ 9      
subsection 7a7 if ! ,commission f9ds su*
 agreem5ts to be 9 fur!rance ( m>ket    
competition & = ! b5efit ( consum]s4    

7f7 ,antitru/ laws ,no?+ 9 ?is section  
%all modify1 impair1 limit1 or sup]s$e !
 applicability ( ! antitru/ laws z def9$
 9 subsection 7a7 ( ! fir/ section ( !  
,clayton ,act 7#ae ,u4,s4,c4 #ab7;a771 &
 ( section #e ( ! ,f$]al ,trade         
,commission ,act 7#ae ,u4,s4,c4 #de7 to 
! ext5t t su* section #e applies to     
unfair me?ods ( competition4 ,no?+ 9 ?is
 section %all modify1 impair1 limit1 or 
sup]s$e ! "r ( a subsequ5t fil] to ass]t
 claims or c\nt]claims aga9/ any p]son1 
"u ! antitru/ laws or o!r laws relat+ to
 unfair competition4  7g7 ,def9itions ,9
 ?is section3 7#a7 ,agreem5t resolv+ or 
settl+ a cov]$ pat5t infr+em5t claim ,! 
t]m agreem5t resolv+ or settl+ a cov]$  
pat5t infr+em5t claim means any agreem5t
 t--  7,a7 resolves or settles a cov]$  
pat5t infr+em5t claim2 or  7,b7 is      
cont+5t ^u1 provides = a cont+5t        
condition =1 or is o!rwise relat$ to !  
resolution or settlem5t ( a cov]$ pat5t 
infr+em5t claim4  7#b7 ,commission ,!   
t]m ,commission means ! ,f$]al ,trade   

,commission4  7#c7 ,cov]$ pat5t         
infr+em5t claim ,! t]m cov]$ pat5t      
infr+em5t claim means an allegation made
 by ! ,,nda or ,,bla hold] to a         
subsequ5t fil] 7or1 9 ! case ( an       
agreem5t betwe5 two subsequ5t fil]s1 by 
"o subsequ5t fil] to ano!r71 :e!r or n  
includ$ 9 a compla9t fil$ ) a c\rt (    
law1 t--  7,a7 ! submission ( !         
application describ$ 9 subp>agraph 7,a7 
or 7,b7 ( p>agraph 7#i71 or !           
manufacture1 use1 (f]+ = sale1 sale1 or 
importation into ! ,unit$ ,/ates ( a    
cov]$ product t is ! subject ( su* an   
application--  7i7 9 ! case ( an        
agreem5t betwe5 an ,,nda or ,,bla hold] 
& a subsequ5t fil]1 infr+es any pat5t   
own$ by1 or exclusively lic5s$ to1 !    
,,nda or ,,bla hold] ( ! cov]$ product2 
or  7ii7 9 ! case ( an agreem5t betwe5  
two subsequ5t fil]s1 infr+es any pat5t  
own$ by ! subsequ5t fil]2 or  7,b7 9 !  
case ( an agreem5t betwe5 an ,,nda or   
,,bla hold] & a subsequ5t fil]1 ! cov]$ 
product to be manufactur$ "u su*        

application uses a cov]$ product z      
claim$ 9 a publi%$ pat5t application4   
7#d7 ,cov]$ product ,! t]m cov]$ product
 means a drug 7z def9$ 9 section        
#bja7;g7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act 7#ba ,u4,s4,c4           
#cba7;g7771 includ+ a biological product
 7z def9$ 9 section #cea7;i7 ( ! ,public
 ,heal? ,s]vice ,act 7#db ,u4,s4,c4     
#bfb7;i774  7#e7 ,,nda or ,,bla hold] ,!
 t]m ,,nda or ,,bla hold] means-- 7,a7 !
 hold] (--  7i7 an approv$ new drug     
application fil$ "u section #eje7;b77#a7
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   
,act 7#ba ,u4,s4,c4 #cee7;b77#a77 = a   
cov]$ product2 or  7ii7 a biologics     
lic5se application fil$ "u section      
#cea7;a7 ( ! ,public ,heal? ,s]vice ,act
 7#db ,u4,s4,c4 #bfb7;a77 ) respect to a
 biological product2  7,b7 a p]son own+ 
or controll+ en=cem5t ( ! pat5t on-- 7i7
 ! li/ publi%$ "u section #eje7;j77#g7 (
 ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act
 7#ba ,u4,s4,c4 #cee7;j77#g77 9         
connection ) ! application describ$ 9   

subp>agraph 7,a77i72 or  7ii7 any li/   
publi%$ "u section #cea ( ! ,public     
,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7
 compris$ ( pat5ts associat$ ) biologics
 lic5se applications fil$ "u section    
#cea7;a7 ( su* ,act 7#db ,u4,s4,c4      
#bfb7;a772 or  7,c7 ! pr$ecessors1      
subsidi>ies1 divisions1 gr\ps1 &        
affiliates controll$ by1 controll+1 or  
"u common control ) any entity describ$ 
9 subp>agraph 7,a7 or 7,b7 7su* control 
to be presum$ by direct or indirect %>e 
own]%ip ( #ej p]c5t or great]71 z well z
 ! lic5sees1 lic5sors1 successors1 &    
assigns ( ea* ( ! entities4  7#f7 ,pat5t
 ,! t]m pat5t means a pat5t issu$ by !  
,unit$ ,/ates ,pat5t & ,tradem>k ,(fice4
  7#g7 ,/atutory exclusivity ,! t]m     
/atutory exclusivity means ^?           
prohibitions on ! submission or approval
 ( drug applications "u clauses 7ii7    
?r\gh 7iv7 ( section #eje7;c77#c77;,e7  
7#e- & #c-ye> exclusivity71 clauses 7ii7
 ?r\gh 7iv7 ( section #eje7;j77#e77;,f7 
7#e-ye> & #c-ye> exclusivity71 section  

#eje7;j77#e77;,b77iv7 7#ahj-;day        
exclusivity71 section #ebg 7orphan drug 
exclusivity71 section #eje;,a 7p$iatric 
exclusivity71 or section #eje;,e        
7qualifi$ infecti\s disease product     
exclusivity7 ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4           
#cee7;c77#c77;,e71                      
#cee7;j77#e77;,b77iv71                  
#cee7;j77#e77;,f71 #cfj;cc1 #cee;a1     
#cee;f71 or prohibitions on ! submission
 or lic5s+ ( biologics lic5se           
applications "u section #cea7k77#f7     
7int]*angeable biological product       
exclusivity7 or section #cea7k77#g7     
7biological product ref]5ce product     
exclusivity7 ( ! ,public ,heal? ,s]vice 
,act 7#db ,u4,s4,c4 #bfb7k77#f71 7#g774 
7#h7 ,subsequ5t fil] ,! t]m subsequ5t   
fil] means-- 7,a7 9 ! case ( a drug1 a  
p>ty t owns or controls an abbreviat$   
new drug application submitt$ pursuant  
to section #eje7;j7 ( ! ,f$]al ,food1   
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7;j77 or a new drug application     

submitt$ pursuant to section            
#eje7;b77#b7 ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba,u4,s4,c4            
#cee7;b77#b77 & fil$ "u section         
#eje7;b77#a7 ( su* ,act 7#ba ,u4,s4,c4  
#cee7;b77#a77 or has ! exclusive rights 
to di/ribute ! cov]$ product t is !     
subject ( su* application2 or  7,b7 9 ! 
case ( a biological product1 a p>ty t   
owns or controls an application fil$ ) !
 ,food & ,drug ,adm9i/ration "u section 
#cea7k7 ( ! ,public ,heal? ,s]vice ,act 
7#db ,u4,s4,c4 #bfb7k77 or has !        
exclusive rights to di/ribute !         
biological product t is ! subject ( su* 
application4  7h7 ,effective date ,?is  
section applies ) respect to agreem5ts  
describ$ 9 subsection 7a7 ent]$ into on 
or aft] ! date ( ! enactm5t ( ?is ,act4 
#aab4 ,notice & c]tification ( agreem5ts
  7a7 ,notice ( all agreem5ts ,section  
#aaaa7g7 ( ! ,m$ic>e ,prescription      
,drug1 ,improvem5t1 & ,mod]nization ,act
 ( #bjjc 7#ba ,u4,s4,c4 #cee note7 is   
am5d$ by ins]t+ or ! own] ( a pat5t =   

:i* a claim ( infr+em5t c\ld reasonably 
be ass]t$ aga9/ any p]son = mak+1 us+1  
(f]+ to sell1 sell+1 or import+ into !  
,unit$ ,/ates a biological product t is 
! subject ( a biosimil> biological      
product application be=e ! p]iod at !   
end4  7b7 ,c]tification ( agreem5ts     
,section #aaab ( su* ,act 7#ba ,u4,s4,c4
 #cee note7 is am5d$ by add+ at ! end ! 
foll[+3  7d7 ,c]tification ,! ,*ief     
,executive ,(fic] or ! company (ficial  
responsible = negotiat+ any agreem5t "u 
subsection 7a7 or 7b7 t is requir$ to be
 fil$ "u subsection 7c7 %all1 )9 #cj    
days ( su* fil+1 execute & file ) !     
,assi/ant ,attorney ,g5]al & !          
,commission a c]tification z foll[s3  ,i
 decl>e t ! foll[+ is true1 correct1 &  
complete to ! be/ ( my k3 ,! mat]ials   
fil$ ) ! ,f$]al ,trade ,commission & !  
,dep>tm5t ( ,ju/ice "u section #aaab ( !
 ,m$ic>e ,prescription ,drug1           
,improvem5t1 & ,mod]nization ,act (     
#bjjc1 ) respect to ! agreem5t ref]5c$ 9
 ?is c]tification-- 7#a7 repres5t !     

complete1 f9al1 & exclusive agreem5t    
betwe5 ! p>ties2  7#b7 include any      
ancill>y agreem5ts t are cont+5t ^u1    
provide a cont+5t condition =1 7 ent]$  
into )9 #cj days (1 or are o!rwise      
relat$ to1 ! ref]5c$ agreem5t2 &  7#c7  
include writt5 descriptions ( any oral  
agreem5ts1 repres5tations1 commitm5ts1  
or promises betwe5 ! p>ties t are       
responsive to subsection 7a7 or 7b7 (   
su* section #aaab & h n be5 r$uc$ to    
writ+4  4  4  #aac4 ,=feiture (         
#ahj-;day exclusivity p]iod ,section    
#eje7;j77#e77;,d77i77,v7 ( ! ,f$]al     
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee7;j77#e77;,d77i77,v77 is  
am5d$ by ins]t+ section #aaa ( ! ,l[]+  
,prescription ,drug ,co/s & ,ext5d+     
,community ,heal? ,c5t]s & ,o!r ,public 
,heal? ,priorities ,act or aft] t !     
agreem5t has violat$4  #aad4 ,commission
 litigation au?ority ,section           
#af7;a77#b7 ( ! ,f$]al ,trade           
,commission ,act 7#ae ,u4,s4,c4         
#ef7;a77#b77 is am5d$-- 7#a7 9          

subp>agraph 7,d71 by /rik+ or aft] !    
semicolon2  7#b7 9 subp>agraph 7,e71 by 
ins]t+ or aft] ! semicolon2 &  7#c7 by  
ins]t+ aft] subp>agraph 7,e7 ! foll[+3  
7,f7 "u section #aaa7;d77#c77;,a7 ( !   
,l[]+ ,prescription ,drug ,co/s &       
,ext5d+ ,community ,heal? ,c5t]s & ,o!r 
,public ,heal? ,priorities ,act2  4     
#aae4 ,/atute ( limitations  7a7 ,9     
g5]al ,except z provid$ 9 subsection    
7b71 ! ,commission %all comm5ce any     
adm9i/rative proce$+ or civil action to 
en=ce section #aaa ( ?is ,act n lat] ?an
 #f ye>s aft] ! date on :i* ! p>ties to 
! agreem5t file ! ,notice ( ,agreem5t z 
provid$ by section #aaab7;c77#b7 & 7d7 (
 ! ,m$ic>e ,prescription ,drug1         
,improvem5t1 & ,mod]nization ,act (     
#bjjc 7#ba ,u4,s4,c4 #cee note74  7b7   
,civil action aft] issuance ( cease &   
desi/ ord] ,if ! ,commission has issu$ a
 cease & desi/ ord] "u section #e ( !   
,f$]al ,trade ,commission ,act 7#ae     
,u4,s4,c4 #de7 = violation ( section    
#aaa ( ?is ,act & ! proce$+ = ! issuance

 ( su* ord] 0 comm5c$ )9 ! p]iod requir$
 by subsection 7a7 ( ?is section1 su*   
subsection does n prohibit ! comm5cem5t1
 aft] su* p]iod1 ( a civil action "u    
section #aaa7;d77#c77;,a7 aga9/ a p>ty  
to su* ord] or a civil action "u        
subsection 7l7 ( su* section #e =       
violation ( su* ord]4  ,c ,creat+ &     
,re/or+ ,equal ,access to ,equival5t    
,samples  #aba4 ,actions = delays (     
g5]ic drugs & biosimil> biological      
products  7a7 ,def9itions ,9 ?is        
section-- 7#a7 ! t]m comm]cially        
reasonable1 m>ket-bas$ t]ms means--     
7,a7 a nondiscrim9atory price = ! sale (
 ! cov]$ product at or bel[1 b n great] 
?an1 ! mo/ rec5t :olesale acquisition   
co/ = ! drug1 z def9$ 9 section         
#ahdg;,a7c77#f77;,b7 ( ! ,social        
,security ,act 7#db ,u4,s4,c4           
#aciew-#c;a7c77#f77;,b772  7,b7 a s*$ule
 = deliv]y t results 9 ! transf] ( !    
cov]$ product to ! eligible product     
develop] consi/5t ) ! tim+ "u subsection
 7b77#b77;,a77iv72 &  7,c7 no additional

 conditions are impos$ on ! sale ( !    
cov]$ product2  7#b7 ! t]m cov]$        
product--  7,a7 means-- 7i7 any drug    
approv$ "u subsection 7c7 or 7j7 (      
section #eje ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or  
biological product lic5s$ "u subsection 
7a7 or 7k7 ( section #cea ( ! ,public   
,heal? ,s]vice ,act 7#db ,u4,s4,c4      
#bfb72  7ii7 any comb9ation ( a drug or 
biological product describ$ 9 clause    
7i72 or  7iii7 :5 reasonably necess>y to
 support approval ( an application "u   
section #eje ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 or 
section #cea ( ! ,public ,heal? ,s]vice 
,act 7#db ,u4,s4,c4 #bfb71 z applicable1
 or o!rwise meet ! requirem5ts =        
approval "u ei!r su* section1 any       
product1 includ+ any device1 t is m>ket$
 or int5d$ = use ) su* a drug or        
biological product2 &  7,b7 does n      
include any drug or biological product t
 appe>s on ! drug %ortage li/ 9 effect  
"u section #ejf;,e ( ! ,f$]al ,food1    

,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cef;e71 unless--  7i7 ! drug or        
biological product has be5 on ! drug    
%ortage li/ 9 effect "u su* section     
#ejf;,e cont9u\sly = m ?an #f mon?s2 or 
7ii7 ! ,secret>y det]m9es t inclusion ( 
! drug or biological product z a cov]$  
product is likely to contribute to      
alleviat+ or prev5t+ a %ortage4  7#c7 ! 
t]m device has ! mean+ giv5 ! t]m 9     
section #bja ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4 #cba72    
7#d7 ! t]m eligible product develop]    
means a p]son t seeks to develop a      
product = approval pursuant to an       
application = approval "u subsection    
7b77#b7 or 7j7 ( section #eje ( ! ,f$]al
 ,food1 ,drug1 & ,cosmetic ,act 7#ba    
,u4,s4,c4 #cee7 or = lic5s+ pursuant to 
an application "u section #cea7k7 ( !   
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bfb7k772  7#e7 ! t]m lic5se  
hold] means ! hold] ( an application    
approv$ "u subsection 7c7 or 7j7 (      
section #eje ( ! ,f$]al ,food1 ,drug1 & 

,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or !
 hold] ( a lic5se "u subsection 7a7 or  
7k7 ( section #cea ( ! ,public ,heal?   
,s]vice ,act 7#db ,u4,s4,c4 #bfb7 = a   
cov]$ product2  7#f7 ! t]m ,,rems means 
a risk evaluation & mitigation /rategy  
"u section #eje-a ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee-a72  7#g7 ! t]m ,,rems ) ,,etasu   
means a ,,rems t conta9s elem5ts to     
assure safe use "u section #eje-a7;f7 ( 
! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 
7#ba ,u4,s4,c4 #cee-a7;f772  7#h7 ! t]m 
,secret>y means ! ,secret>y ( ,heal? &  
,human ,s]vices2  7#i7 ! t]m s+le1 %>$  
sy/em ( elem5ts to assure safe use means
 a s+le1 %>$ sy/em ( elem5ts to assure  
safe use "u section #eje-a7;f7 ( !      
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cee-a7;f772 &  7#aj7 !  
t]m suffici5t quantities means an am\nt 
( a cov]$ product t ! eligible product  
develop] det]m9es all[s x to-- 7,a7     
conduct te/+ to support an application  
"u--  7i7 subsection 7b77#b7 or 7j7 (   

section #eje ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4 #cee72 or 
7ii7 section #cea7k7 ( ! ,public ,heal? 
,s]vice ,act 7#db ,u4,s4,c4 #bfb7k772 & 
7,b7 fulfill any regulatory requirem5ts 
relat+ to approval ( su* an application4
  7b7 ,civil action = failure ,to       
provide suffici5t quantities ( a cov]$  
product  7#a7 ,9 g5]al ,an eligible     
product develop] may br+ a civil action 
aga9/ ! lic5se hold] = a cov]$ product  
seek+ relief "u ?is subsection 9 an     
appropriate di/rict c\rt ( ! ,unit$     
,/ates alleg+ t ! lic5se hold] has      
decl9$ to provide suffici5t quantities (
 ! cov]$ product to ! eligible product  
develop] on comm]cially reasonable1     
m>ket-bas$ t]ms4  7#b7 ,elem5ts  7,a7 ,9
 g5]al ,to prevail 9 a civil action     
br\ght "u p>agraph 7#a71 an eligible    
product develop] %all prove1 by a       
prepond]ance ( ! evid5ce--  7i7 t-- 7,i7
 ! cov]$ product is n subject to a      
,,rems ) ,,etasu2 or  7,,ii7 if ! cov]$ 
product is subject to a ,,rems )        

,,etasu-- 7aa7 ! eligible product       
develop] has obta9$ a cov]$ product     
au?orization f ! ,secret>y 9 accordance 
) subp>agraph 7,b72 &  7bb7 ! eligible  
product develop] has provid$ a copy ( ! 
cov]$ product au?orization to ! lic5se  
hold]2  7ii7 t1 z ( ! date on :i* !     
civil action is fil$1 ! product develop]
 has n obta9$ suffici5t quantities ( !  
cov]$ product on comm]cially reasonable1
 m>ket-bas$ t]ms2  7iii7 t ! eligible   
product develop] has submitt$ a writt5  
reque/ to pur*ase suffici5t quantities (
 ! cov]$ product to ! lic5se hold] & su*
 reque/--  7,i7 0 s5t to a nam$         
corporate (fic] ( ! lic5se hold]2       
7,,ii7 0 made by c]tifi$ or regi/]$ mail
 ) return receipt reque/$2  7,,iii7     
specifi$ an individual z ! po9t (       
contact = ! lic5se hold] to direct      
communications relat$ to ! sale ( !     
cov]$ product to ! eligible product     
develop] & a means = electronic & writt5
 communications ) t individual2 &       
7,,iv7 specifi$ an address to :i* !     

cov]$ product 0 to be %ipp$ ^u rea*+ an 
agreem5t to transf] ! cov]$ product2 &  
7iv7 t ! lic5se hold] has n deliv]$ to !
 eligible product develop] suffici5t    
quantities ( ! cov]$ product on         
comm]cially reasonable1 m>ket-bas$      
t]ms--  7,i7 = a cov]$ product t is n   
subject to a ,,rems ) ,,etasu1 by ! date
 t is #ca days aft] ! date on :i* !     
lic5se hold] receiv$ ! reque/ = ! cov]$ 
product2 &  7,,ii7 = a cov]$ product t  
is subject to a ,,rems ) ,,etasu1 by #ca
 days aft] ! lat] (-- 7aa7 ! date on :i*
 ! lic5se hold] receiv$ ! reque/ = !    
cov]$ product2 or  7bb7 ! date on :i* ! 
lic5se hold] receiv$ a copy ( ! cov]$   
product au?orization issu$ by !         
,secret>y 9 accordance ) subp>agraph    
7,b74  7,b7 ,au?orization = cov]$       
product subject to a ,,rems ) ,,etasu   
7i7 ,reque/ ,an eligible product        
develop] may submit to ! ,secret>y a    
writt5 reque/ = ! eligible product      
develop] to be au?oriz$ to obta9        
suffici5t quantities ( an individual    

cov]$ product subject to a ,,rems )     
,,etasu4  7ii7 ,au?orization ,n lat] ?an
 #abj days aft] ! date on :i* a reque/  
"u clause 7i7 is receiv$1 ! ,secret>y   
%all1 by writt5 notice1 au?orize !      
eligible product develop] to obta9      
suffici5t quantities ( an individual    
cov]$ product subject to a ,,rems )     
,,etasu = purposes (--  7,i7 developm5t 
& te/+ t does n involve human cl9ical   
trials1 if ! eligible product develop]  
has agre$ to comply ) any conditions !  
,secret>y det]m9es necess>y2 or  7,,ii7 
developm5t & te/+ t involves human      
cl9ical trials1 if ! eligible product   
develop] has-- 7aa7 7,,aa7 submitt$     
protocols1 in=m$ cons5t docum5ts1 &     
in=mational mat]ials = te/+ t include   
protections t provide safety protections
 comp>able to ^? provid$ by ! ,,rems = !
 cov]$ product2 or 7,,bb7 o!rwise       
satisfi$ ! ,secret>y t su* protections w
 be provid$2 &  7bb7 met any o!r        
requirem5ts ! ,secret>y may e/abli%4    
7iii7 ,notice ,a cov]$ product          

au?orization issu$ "u ?is subp>agraph   
%all /ate t ! provision ( ! cov]$       
product by ! lic5se hold] "u ! t]ms ( ! 
au?orization w n be a violation ( !     
,,rems = ! cov]$ product4  7#c7         
,affirmative def5se ,9 a civil action   
br\ght "u p>agraph 7#a71 x %all be an   
affirmative def5se1 on :i* ! def5dant   
has ! burd5 ( p]suasion by a            
prepond]ance ( ! evid5ce--  7,a7 t1 on !
 date on :i* ! eligible product develop]
 reque/$ to pur*ase suffici5t quantities
 ( ! cov]$ product f ! lic5se hold]--   
7i7 nei!r ! lic5se hold] nor any ( its  
ag5ts1 :olesal]s1 or di/ributors 0      
engag$ 9 ! manufactur+ or comm]cial     
m>ket+ ( ! cov]$ product2 &  7ii7 nei!r 
! lic5se hold] nor any ( its ag5ts1     
:olesal]s1 or di/ributors o!rwise _h    
access to inv5tory ( ! cov]$ product to 
supply to ! eligible product develop] on
 comm]cially reasonable1 m>ket-bas$     
t]ms2  7,b7 t-- 7i7 ! lic5se hold] sells
 ! cov]$ product ?r\gh ag5ts1           
di/ributors1 or :olesal]s2  7ii7 !      

lic5se hold] has plac$ no re/rictions1  
explicit or implicit1 on its ag5ts1     
di/ributors1 or :olesal]s to sell cov]$ 
products to eligible product develop]s2 
&  7iii7 ! cov]$ product c be pur*as$ by
 ! eligible product develop] 9 suffici5t
 quantities on comm]cially reasonable1  
m>ket-bas$ t]ms f ! ag5ts1 di/ributors1 
or :olesal]s ( ! lic5se hold]2 or  7,c7 
t ! lic5se hold] made an (f] to !       
individual specifi$ pursuant to p>agraph
 7#b77;,a77iii77,,iii71 by a means (    
communication 7electronic1 writt51 or   
bo?7 specifi$ pursuant to su* p>agraph1 
to sell suffici5t quantities ( ! cov]$  
product to ! eligible product develop]  
at comm]cially reasonable m>ket-bas$    
t]ms--  7i7 = a cov]$ product t is n    
subject to a ,,rems ) ,,etasu1 by ! date
 t is #ad days aft] ! date on :i* !     
lic5se hold] receiv$ ! reque/ = ! cov]$ 
product1 & ! eligible product develop]  
did n accept su* (f] by ! date t is #g  
days aft] ! date on :i* ! eligible      
product develop] receiv$ su* (f] f !    

lic5se hold]2 or  7ii7 = a cov]$ product
 t is subject to a ,,rems ) ,,etasu1 by 
! date t is #bj days aft] ! date on :i* 
! lic5se hold] receiv$ ! reque/ = !     
cov]$ product1 & ! eligible product     
develop] did n accept su* (f] by ! date 
t is #aj days aft] ! date on :i* !      
eligible product develop] receiv$ su*   
(f] f ! lic5se hold]4  7#d7 ,rem$ies    
7,a7 ,9 g5]al ,if an eligible product   
develop] prevails 9 a civil action      
br\ght "u p>agraph 7#a71 ! c\rt %all--  
7i7 ord] ! lic5se hold] to provide to ! 
eligible product develop] )\t delay     
suffici5t quantities ( ! cov]$ product  
on comm]cially reasonable1 m>ket-bas$   
t]ms2  7ii7 aw>d to ! eligible product  
develop] reasonable attorney's fees &   
co/s ( ! civil action2 &  7iii7 aw>d to 
! eligible product develop] a monet>y   
am\nt suffici5t to det] ! lic5se hold] f
 fail+ to provide eligible product      
develop]s ) suffici5t quantities ( a    
cov]$ product on comm]cially reasonable1
 m>ket-bas$ t]ms1 if ! c\rt f9ds1 by a  

prepond]ance ( ! evid5ce--  7,i7 t !    
lic5se hold] delay$ provid+ suffici5t   
quantities ( ! cov]$ product to !       
eligible product develop] )\t a         
legitimate bus9ess ju/ification2 or     
7,,ii7 t ! lic5se hold] fail$ to comply 
) an ord] issu$ "u clause 7i74  7,b7    
,maximum monet>y am\nt ,a monet>y am\nt 
aw>d$ "u subp>agraph 7,a77iii7 %all n be
 great] ?an ! rev5ue t ! lic5se hold]   
e>n$ on ! cov]$ product dur+ ! p]iod--  
7i7 beg9n+ on-- 7,i7 = a cov]$ product t
 is n subject to a ,,rems ) ,,etasu1 !  
date t is #ca days aft] ! date on :i* ! 
lic5se hold] receiv$ ! reque/2 or       
7,,ii7 = a cov]$ product t is subject to
 a ,,rems ) ,,etasu1 ! date t is #ca    
days aft] ! lat] (--  7aa7 ! date on :i*
 ! lic5se hold] receiv$ ! reque/2 or    
7bb7 ! date on :i* ! lic5se hold]       
receiv$ a copy ( ! cov]$ product        
au?orization issu$ by ! ,secret>y 9     
accordance ) p>agraph 7#b77;,b72 &  7ii7
 end+ on ! date on :i* ! eligible       
product develop] receiv$ suffici5t      

quantities ( ! cov]$ product4  7,c7     
,avoidance ( delay ,! c\rt may issue an 
ord] "u subp>agraph 7,a77i7 be=e        
conduct+ fur!r proce$+s t may be        
necess>y to det]m9e :e!r ! eligible     
product develop] is entitl$ to an aw>d  
"u clause 7ii7 or 7iii7 ( subp>agraph   
7,a71 or ! am\nt ( any su* aw>d4  7c7   
,limitation ( liability ,a lic5se hold] 
= a cov]$ product %all n be liable = any
 claim "u ,f$]al1 ,/ate1 or local law   
aris+ out ( ! failure ( an eligible     
product develop] to foll[ adequate      
safegu>ds to assure safe use ( ! cov]$  
product dur+ developm5t or te/+         
activities describ$ 9 ?is section1      
includ+ transportation1 h&l+1 use1 or   
disposal ( ! cov]$ product by ! eligible
 product develop]4  7d7 ,no violation ( 
,,rems ,section #eje-a ( ! ,f$]al ,food1
 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 
#cee-a7 is am5d$ by add+ at ! end !     
foll[+ new subsection3  7l7 ,provision (
 samples n a violation ( /rategy ,!     
provision ( samples ( a cov]$ product to

 an eligible product develop] 7z ^? t]ms
 are def9$ 9 section #aba7;a7 ( ! ,l[]+ 
,prescription ,drug ,co/s & ,ext5d+     
,community ,heal? ,c5t]s & ,o!r ,public 
,heal? ,priorities ,act7 %all n be      
consid]$ a violation ( ! requirem5ts (  
any risk evaluation & mitigation /rategy
 t may be 9 place "u ?is section = su*  
drug4  4  7e7 ,rule ( con/ruction  7#a7 
,def9ition ,9 ?is subsection1 ! t]m     
antitru/ laws-- 7,a7 has ! mean+ giv5 ! 
t]m 9 subsection 7a7 ( ! fir/ section ( 
! ,clayton ,act 7#ae ,u4,s4,c4 #ab72 &  
7,b7 includes section #e ( ! ,f$]al     
,trade ,commission ,act 7#ae ,u4,s4,c4  
#de7 to ! ext5t t su* section applies to
 unfair me?ods ( competition4  7#b7     
,antitru/ laws ,no?+ 9 ?is section %all 
be con/ru$ to limit ! op]ation ( any    
provision ( ! antitru/ laws4  #abb4     
,,rems approval process = subsequ5t     
fil]s ,section #eje-a ( ! ,f$]al ,food1 
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee-a71 z am5d$ by section #aba1 is    
fur!r am5d$--  7#a7 9 subsection        

7g77#d77;,b7-- 7,a7 9 clause 7i7 by     
/rik+ or aft] ! semicolon2  7,b7 9      
clause 7ii7 by /rik+ ! p]iod at ! end & 
ins]t+ 2 or2 &  7,c7 by add+ at ! end ! 
foll[+3  7iii7 accommodate diff]5t1     
comp>able aspects ( ! elem5ts to assure 
safe use = a drug t is ! subject ( an   
application "u section #eje7;j71 & !    
applicable li/$ drug4  2  7#b7 9        
subsection 7i77#a71 by /rik+ subp>agraph
 7,c7 & ins]t+ ! foll[+3  7,c7 7i7      
,elem5ts to assure safe use1 if requir$ 
"u subsection 7f7 = ! li/$ drug1 :i*1   
subject to clause 7ii71 = a drug t is ! 
subject ( an application "u section     
#eje7;j7 may use--  7,i7 a s+le1 %>$    
sy/em ) ! li/$ drug "u subsection 7f72  
or  7,,ii7 a diff]5t1 comp>able aspect (
 ! elem5ts to assure safe use "u        
subsection 7f74  7ii7 ,! ,secret>y may  
require a drug t is ! subject ( an      
application "u section #eje7;j7 & ! li/$
 drug to use a s+le1 %>$ sy/em "u       
subsection 7f71 if ! ,secret>y det]m9es 
t no diff]5t1 comp>able aspect ( !      

elem5ts to assure safe use c\ld satisfy 
! requirem5ts ( subsection 7f74  2  7#c7
 9 subsection 7i71 by add+ at ! end !   
foll[+3  7#c7 ,%>$ ,,rems ,if !         
,secret>y approves1 9 accordance )      
p>agraph 7#a77;,c77i77,,ii71 a diff]5t1 
comp>able aspect ( ! elem5ts to assure  
safe use "u subsection 7f7 = a drug t is
 ! subject ( an abbreviat$ new drug     
application "u section #eje7;j71 !      
,secret>y may require t su* diff]5t     
comp>able aspect ( ! elem5ts to assure  
safe use c be us$ ) respect to any o!r  
drug t is ! subject ( an application "u 
section #eje7;j7 or #eje7;b7 t ref]5ces 
! same li/$ drug4  2 &  7#d7 by add+ at 
! end ! foll[+3  7m7 ,sep>ate ,,rems ,:5
 us$ 9 ?is section1 ! t]ms diff]5t1     
comp>able aspect ( ! elem5ts to assure  
safe use or diff]5t1 comp>able approv$  
risk evaluation & mitigation /rategies  
means a risk evaluation & mitigation    
/rategy = a drug t is ! subject ( an    
application "u section #eje7;j7 t uses  
diff]5t me?ods or op]ational means ?an !

 /rategy requir$ "u subsection 7a7 = !  
applicable li/$ drug1 or o!r application
 "u section #eje7;j7 ) ! same su* li/$  
drug1 b a*ieves ! same level ( safety z 
su* /rategy4  4  #abc4 ,rule (          
con/ruction  7a7 ,9 g5]al ,no?+ 9 ?is   
subtitle1 ! am5dm5ts made by ?is        
subtitle1 or 9 section #eje-a ( ! ,f$]al
 ,food1 ,drug1 & ,cosmetic ,act 7#ba    
,u4,s4,c4 #cee-a71 %all be con/ru$ z--  
7#a7 prohibit+ a lic5se hold] f provid+ 
an eligible product develop] access to a
 cov]$ product 9 ! abs5ce ( an          
au?orization "u ?is subtitle2 or  7#b7 9
 any way negat+ ! applicability ( a     
,,rems ) ,,etasu1 z o!rwise requir$ "u  
su* section #eje-a1 ) respect to su*    
cov]$ product4  7b7 ,def9itions ,9 ?is  
section1 ! t]ms cov]$ product1 eligible 
product develop]1 lic5se hold]1 & ,,rems
 ) ,,etasu h ! mean+s giv5 su* t]ms 9   
section #aba7;a74  ,,ii ,ext5sion (     
,public ,heal? ,programs  #bja4         
,ext5sion = community heal? c5t]s1 !    
,national ,heal? ,s]vice ,corps1 & tea*+

 heal? c5t]s t op]ate ,,gme programs    
7a7 ,community ,heal? ,c5t]s ,fund+     
,section #ajejc7;b77#a77;,f7 ( ! ,pati5t
 ,protection & ,af=dable ,c>e ,act 7#db 
,u4,s4,c4 #bed;b-#b7;b77#a77;,f77 is    
am5d$ by /rik+ fiscal ye> #bjai & ins]t+
 ea* ( fiscal ye>s #bjai & #bjbj4  7b7  
,national ,heal? ,s]vice ,corps         
,section #ajejc7;b77#b77;,f7 ( ! ,pati5t
 ,protection & ,af=dable ,c>e ,act 7#db 
,u4,s4,c4 #bed;b-#b7;b77#b77;,f77 is    
am5d$ by /rik+ #bjah & #bjai & ins]t+   
#bjah1 #bjai1 & #bjbj4  7c7  ,tea*+     
heal? c5t]s t op]ate graduate m$ical    
education programs  ,section            
#cdj;,h7g77#a7 ( ! ,public ,heal?       
,s]vice ,act 7#db ,u4,s4,c4             
#bef;h7g77#a77 is am5d$ by /rik+ #bjah &
 #bjai & ins]t+ #bjah1 #bjai1 & #bjbj4  
7d7 ,application ,am\nts appropriat$    
pursuant to ?is section = fiscal ye>    
#bjbj are subject to ! requirem5ts      
conta9$ 9 ,public ,law #aae-bde = funds 
= programs au?oriz$ "u sections #ccj    
?r\gh #cdj ( ! ,public ,heal? ,s]vice   

,act 7#db ,u4,s4,c4 #bed;b-#bef74  7e7  
,con=m+ am5dm5t  ,section #cjad7;h77#d7 
( title #ah1 ,unit$ ,/ates ,code1 is    
am5d$ by /rik+ & section #ejija7;e7 ( ! 
,advanc+ ,*ronic ,c>e1 ,ext5d]s1 &      
,social ,s]vices ,act & ins]t+ 1 section
 #ejija7;e7 ( ! ,advanc+ ,*ronic ,c>e1  
,ext5d]s1 & ,social ,s]vices ,act1 &    
section #bja7;d7 ( ! ,l[]+ ,prescription
 ,drug ,co/s & ,ext5d+ ,community ,heal?
 ,c5t]s & ,o!r ,public ,heal?           
,priorities ,act4  #bjb4  ,ext5sion =   
special diabetes programs  7a7  ,special
 ,diabetes ,program = ,type ,i ,diabetes
  ,section #ccj;,b7b77#b77;,d7 ( !      
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bed;c-#b7;b77#b77;,d77 is    
am5d$ by /rik+ #bjah & #bjai & ins]t+   
#bjah1 #bjai1 & #bjbj4  7b7  ,special   
,diabetes ,program = ,indians  ,section 
#ccj;,c7c77#b77;,d7 ( ! ,public ,heal?  
,s]vice ,act 7#db ,u4,s4,c4             
#bed;c-#c7;c77#b77;,d77 is am5d$ by     
/rik+ #bjah & #bjai & ins]t+ #bjah1     
#bjai1 & #bjbj4  #bjc4  ,ext5sion =     

family-to-family heal? in=mation c5t]s  
7a7 ,9 g5]al ,section #eja7;c7 ( !      
,social ,security ,act 7#db ,u4,s4,c4   
#gja7;c77#a77;,a77vii77 is am5d$ by     
/rik+ #bjah & #bjai & ins]t+ #bjah1     
#bjai1 & #bjbj4  7b7 ,con=m+ *ange      
,section #eja7;c77#c77;,c7 ( ! ,social  
,security ,act 7#db ,u4,s4,c4           
#gja7;c77#c77;,c77 is am5d$ by /rik+    
#bjah & #bjai & ins]t+ #bjah1 #bjai1 &  
#bjbj4  #bjd4  ,ext5sion = sexual risk  
avoidance education & p]sonal           
responsibility education  7a7 ,sexual   
risk avoidance education ,subsections   
7a7 & 7f7 ( section #eaj ( ! ,social    
,security ,act 7#db ,u4,s4,c4 #gaj7 are 
am5d$ by /rik+ #bjah & #bjai ea* place x
 appe>s & ins]t+ #bjah1 #bjai1 & #bjbj4 
7b7 ,p]sonal responsibility education   
,section #eac ( ! ,social ,security ,act
 7#db ,u4,s4,c4 #gac7 is am5d$-- 7#a7 9 
subsection 7a77#a77;,a71 by /rik+ #bjai 
& ins]t+ #bjbj2 &  7#b7 9 subsection    
7a77#d71 by /rik+ #bjai ea* place x     
appe>s & ins]t+ #bjbj2 &  7#c7 9        

subsection 7f71 by /rik+ #bjai & ins]t+ 
#bjbj4