#aaf? ,,congress  #a/ ,session  ,h4 ,r4 
#ihg  ,,an ,,act  ,to am5d ! ,pati5t    
,protection & ,af=dable ,c>e ,act to    
provide = ,f$]al ,ex*ange outrea* &     
educational activities4  #a4 ,%ort title
 ,?is ,act may be cit$ z ! ,/r5g!n+     
,heal? ,c>e & ,l[]+ ,prescription ,drug 
,co/s ,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        
,subtitle ,d--,/udy on role ( ,f$]al    
assi/ance 9 drug developm5t ,sec4 #aca4 
,/udy on role ( ,f$]al assi/ance 9 drug 
developm5t4 ,subtitle ,e--,ph>macy      
,s*ool ,outrea* ,sec4 #ada4 ,ph>macy    
s*ool outrea*4 ,subtitle ,f--,reports   
,sec4 #aea4 ,effects ( increases 9      
prescription drug price4 ,title         
,,ii--,heal? ,insurance ,m>ket          
,/abilization ,sec4 #bja4 ,pres]v+ ,/ate
 option to implem5t heal? c>e           
m>ketplaces4 ,sec4 #bjb4 ,provid+ =     
additional requirem5ts ) respect to !   
navigator program4 ,sec4 #bjc4 ,f$]al   
,ex*ange outrea* & educational          
activities & annual enrollm5t t>gets4   
,sec4 #bjd4 ,%ort-t]m limit$ duration   
insurance rule prohibition4 ,sec4 #bje4 
,protection ( heal? insurance cov]age 9 
c]ta9 ,ex*anges4 ,sec4 #bjf4 ,s5se (    

,congress relat+ to ! practice ( silv]  
load+4 ,sec4 #bjg4 ,consum] outrea*1    
education1 & assi/ance4 ,sec4 #bjh4     
,,gao report4 ,sec4 #bji4 ,report on !  
effects ( website ma9t5ance dur+ op5    
enrollm5t4 ,title ,,iii--,budget>y      
,effects ,sec4 #cja4 ,det]m9ation (     
budget>y effects4  ,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$ #g4e million 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
 ?ree 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 ?ree  
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 ( !        
,/r5g!n+ ,heal? ,c>e & ,l[]+            
,prescription ,drug ,co/s ,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 ( !   
,/r5g!n+ ,heal? ,c>e & ,l[]+            
,prescription ,drug ,co/s ,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 ( !       
,/r5g!n+ ,heal? ,c>e & ,l[]+            
,prescription ,drug ,co/s ,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  ,d ,/udy on role (   
,f$]al assi/ance 9 drug developm5t      
#aca4 ,/udy on role ( ,f$]al assi/ance 9
 drug developm5t  7a7 ,9 g5]al ,n lat]  
?an #b ye>s aft] ! date ( ! enactm5t (  
?is ,act1 ! ,secret>y ( ! ,heal? &      
,human ,s]vices %all ent] into a        
contract ) ! ,national ,academy (       
,m$ic9e to conduct a /udy on1 & submit  
to ,congress a report on1 ! foll[+3     
7#a7 ,! p]c5tage ( drugs develop$ 9 !   
,unit$ ,/ates us+ at lea/ "s am\nt (    
,f$]al fund+ f any ,f$]al s\rce4  7#b7  
,! av]age co/ incurr$ by a drug develop]
 to develop a drug4  7#c7 ,! av]age     
am\nt ( rev5ue & pr(its made by drug    

develop]s f ! sales ( drugs4  7#d7 ,!   
p]c5tage ( su* rev5ue & pr(its t are    
re9ve/$ into rese>* & developm5t ( new  
drugs4  7#e7 ,! appropriate p]c5tage1 if
 any1 ( su* rev5ue & pr(its ! ,secret>y1
 9 consultation ) ! ,national ,academy (
 ,m$ic9e1 recomm5ds %\ld be return$ to  
,f$]al entities = ,f$]al fund+ us$ 9 !  
developm5t ( ! drugs involv$4  7b7      
,en=cem5t ,a drug develop] %all1 z a    
condition ( receipt ( any ,f$]al fund+ =
 ! developm5t ( drugs1 comply ) any     
reque/ = ! data necess>y to p]=m ! /udy 
"u subsection 7a74  7c7 ,confid5tiality 
,?is section does n au?orize !          
disclosure ( any trade secret1          
confid5tial comm]cial or f9ancial       
in=mation1 or o!r matt] li/$ 9 section  
#eeb7;b7 ( title #e1 ,unit$ ,/ates      
,code4  7d7 ,def9itions ,9 ?is section3 
7#a7 ,! t]m drug has ! mean+ giv5 su*   
t]m 9 section #bja ( ! ,f$]al ,food1    
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cba74  7#b7 ,! t]m drug develop] means 
an entity t submitt$1 & receiv$ approval

 (1 an application "u section #eje ( !  
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cee7 or section #cea ( !
 ,public ,heal? ,s]vice ,act 7#db       
,u4,s4,c4 #bfb74  ,e ,ph>macy ,s*ool    
,outrea*  #ada4 ,ph>macy s*ool outrea*  
,! ,secret>y ( ,heal? & ,human ,s]vices 
& ! ,secret>y ( ,education %all make e  
ef=t necess>y to ensure appropriate     
outrea* to in/itutions ( high] education
 to ensure t /ud5ts & faculty at s*ools 
( ph>macy are provid$ ) mat]ials reg>d+ 
g5]ic drugs & biosimil> biological      
products1 includ+ mat]ials on-- 7#a7 h[ 
g5]ic drugs & biosimil> biological      
products are equival5t or simil> to     
br&-"n drugs2  7#b7 ! approval process  
at ! ,food & ,drug ,adm9i/ration = g5]ic
 drugs & biosimil> biological products2 
7#c7 h[ to make consum]s aw>e ( !       
availability ( g5]ic drugs & biosimil>  
biological products2  7#d7 requirem5ts =
 sub/itut+ g5]ic drugs & biosimli>      
biological products 9 place (           
correspond+ drugs products2 &  7#e7 !   

impacts ( g5]ic drugs & biosimil>       
biological products on consum] co/s4  ,f
 ,reports  #aea4 ,effects ( increases 9 
prescription drug price ,n lat] ?an #a  
ye> aft] ! date ( enactm5t ( ?is ,act1 !
 ,secret>y ( ,heal? & ,human ,s]vices   
%all submit a report to ! ,congress on !
 ext5t to :i* increases 9 prescription  
drug prices may h caus$ ,m$ic>e         
b5efici>ies to =ego recomm5d$ treatm5t1 
includ+ fail+ to fill prescriptions4    
,,ii ,heal? ,insurance ,m>ket           
,/abilization  #bja4 ,pres]v+ ,/ate     
option to implem5t heal? c>e m>ketplaces
  7a7 ,9 g5]al ,section #acaa ( !       
,pati5t ,protection & ,af=dable ,c>e    
,act 7#db ,u4,s4,c4 #ahjca7 is am5d$--  
7#a7 9 subsection 7a7-- 7,a7 9 p>agraph 
7#d77;,b71 by /rik+ "u ?is subsection & 
ins]t+ "u ?is p>agraph or p>agraph 7#a72
 &  7,b7 by add+ at ! end ! foll[+ new  
p>agraph3  7#f7 ,additional plann+ &    
e/abli%m5t grants  7,a7 ,9 g5]al ,!re   
%all be appropriat$ to ! ,secret>y1 out 
( any moneys 9 ! ,treasury n o!rwise    

appropriat$1 #bjj million to aw>d grants
 to eligible ,/ates = ! uses describ$ 9 
p>agraph 7#c74  7,b7 ,duration &        
r5ewability ,a grant aw>d$ "u           
subp>agraph 7,a7 %all be = a p]iod ( #b 
ye>s & may n be r5ew$4  7,c7 ,limitation
 ,a grant may n be aw>d$ "u subp>agraph 
7,a7 aft] ,decemb] #ca1 #bjbc4  7,d7    
,eligible ,/ate def9$ ,= purposes ( ?is 
p>agraph1 ! t]m eligible ,/ate means a  
,/ate t1 z ( ! date ( ! enactm5t ( ?is  
p>agraph1 is n op]at+ an ,ex*ange 7o!r  
?an an ,ex*ange describ$ 9 section      
#aee4bjj7;f7 ( title #de1 ,code ( ,f$]al
 ,regulations74  2 &  7#b7 9 subsection 
7d77#e77;,a7--  7,a7 by /rik+           
op]ations4--,9 e/abli%+ an ,ex*ange "u  
?is section & ins]t+ op]ations4--  7i7  
,9 g5]al ,9 e/abli%+ an ,ex*ange "u ?is 
section 7o!r ?an 9 e/abli%+ an ,ex*ange 
pursuant to a grant aw>d$ "u subsection 
7a77#f77  2 &  7,b7 by add+ at ! end !  
foll[+3  7ii7 ,additional plann+ &      
e/abli%m5t grants ,9 e/abli%+ an        
,ex*ange pursuant to a grant aw>d$ "u   

subsection 7a77#f71 ! ,/ate %all ensure 
t su* ,ex*ange is self-su/a9+ beg9n+ on 
,janu>y #a1 #bjbe1 includ+ all[+ !      
,ex*ange to *>ge assessm5ts or us] fees 
to p>ticipat+ heal? insurance issu]s1 or
 to o!rwise g5]ate fund+1 to support its
 op]ations4  4  7b7 ,cl>ification reg>d+
 failure to e/abli% ,ex*ange or implem5t
 requirem5ts ,section #acba7;c7 ( !     
,pati5t ,protection & ,af=dable ,c>e    
,act 7#db ,u4,s4,c4 #ahjda7;c77 is      
am5d$--  7#a7 9 p>agraph 7#a71 by /rik+ 
,if & ins]t+ ,subject to p>agraph 7#c71 
if2 &  7#b7 by add+ at ! end ! foll[+   
new p>agraph3  7#c7 ,cl>ification ,?is  
subsection %all n apply 9 ! case ( a    
,/ate t elects to apply ! requirem5ts   
describ$ 9 subsection 7a7 & satisfies ! 
requirem5t describ$ 9 subsection 7b7 on 
or aft] ,janu>y #a1 #bjad4  4  #bjb4    
,provid+ = additional requirem5ts )     
respect to ! navigator program  7a7 ,9  
g5]al ,section #acaa7;i7 ( ! ,pati5t    
,protection & ,af=dable ,c>e ,act 7#db  
,u4,s4,c4 #ahjca7;i77 is am5d$--  7#a7 9

 p>agraph 7#b71 by add+ at ! end !      
foll[+ new subp>agraph3  7,c7 ,selection
 ( recipi5ts ,9 ! case ( an ,ex*ange    
e/abli%$ & op]at$ by ! ,secret>y )9 a   
,/ate pursuant to section #acba7;c71 9  
aw>d+ grants "u p>agraph 7#a71 !        
,ex*ange %all--  7i7 select entities to 
receive su* grants bas$ on an entity's  
demon/rat$ capacity to c>ry out ea* ( ! 
duties specifi$ 9 p>agraph 7#c72  7ii7 n
 take into acc\nt :e!r or n ! entity has
 demon/rat$ h[ ! entity w provide       
in=mation to individuals relat+ to gr\p 
heal? plans (f]$ by a gr\p or           
association ( employ]s describ$ 9       
section #beaj4c-e7;b7 ( title #bi1 ,code
 ( ,f$]al ,regulations 7or any successor
 regulation71 or %ort-t]m limit$        
duration insurance 7z def9$ by !        
,secret>y = purposes ( section          
#bgia7;b77#e7 ( ! ,public ,heal? ,s]vice
 ,act72 &  7iii7 ensure t1 ea* ye>1 !   
,ex*ange aw>ds su* a grant to-- 7,i7 at 
lea/ "o entity describ$ 9 ?is p>agraph t
 is a community & consum]-focus$        

nonpr(it gr\p2 &  7,,ii7 at lea/ "o     
entity describ$ 9 subp>agraph 7,b71 :i* 
may include ano!r community &           
consum]-focus$ nonpr(it gr\p 9 addition 
to any su* gr\p aw>d$ a grant pursuant  
to subclause 7,i74  ,9 aw>d+ su* grants1
 an ,ex*ange may consid] an entity's    
record ) respect to wa/e1 fraud1 & abuse
 = purposes ( ma9ta9+ ! integrity ( su* 
,ex*ange4 4  7#b7 9 p>agraph 7#c7--     
7,a7 by am5d+ subp>agraph 7,c7 to read z
 foll[s3  7,c7 facilitate enrollm5t1    
includ+ ) respect to individuals )      
limit$ ,engli% pr(ici5cy & individuals )
 *ronic illnesses1 9 qualifi$ heal?     
plans1 ,/ate m$icaid plans "u title     
,,xix ( ! ,social ,security ,act1 &     
,/ate *ild heal? plans "u title ,,xxi ( 
su* ,act2  2  7,b7 9 subp>agraph 7,d71  
by /rik+ & at ! end2  7,c7 9 subp>agraph
 7,e71 by /rik+ ! p]iod at ! end &      
ins]t+ a semicolon2  7,d7 by ins]t+ aft]
 subp>agraph 7,e7 ! foll[+3  7,f7       
conduct public education activities 9   
pla9 language to raise aw>5ess ( !      

requirem5ts ( & ! protections provid$   
"u--  7i7 ! ess5tial heal? b5efits      
package 7z def9$ 9 section #acjb7;a772 &
  7ii7 section #bgbf ( ! ,public ,heal? 
,s]vice ,act 7relat+ to p>ity 9 m5tal   
heal? & sub/ance use disord] b5efits72 &
  2  7,e7 by ins]t+ aft] subp>agraph    
7,f7 7z add$ by subp>agraph 7,d77 !     
foll[+ new subp>agraph3  7,g7 provide   
ref]rals to community-bas$ organizations
 t address social ne$s relat$ to heal?  
outcomes4  2 &  7,f7 by add+ at ! end ! 
foll[+ flu% left s5t5ce3 ,! duties      
specifi$ 9 ! prec$+ s5t5ces may be c>ri$
 out by su* a navigator at any "t dur+ a
 ye>4 2  7#c7 9 p>agraph 7#d77;,a7--    
7,a7 9 ! matt] prec$+ clause 7i71 by    
/rik+ n2  7,b7 9 clause 7i7--  7i7 by   
ins]t+ n be=e be2 &  7ii7 by /rik+ 2 or 
& ins]t+ a semicolon2  7,c7 9 clause    
7ii7-- 7i7 by ins]t+ n be=e receive2 &  
7ii7 by /rik+ ! p]iod & ins]t+ a        
semicolon2 &  7,d7 by add+ at ! end !   
foll[+ new clauses3  7iii7 ma9ta9       
physical pres5ce 9 ! ,/ate ( ! ,ex*ange 

s z to all[ 9-p]son assi/ance to        
consum]s2  7iv7 receive tra9+ on h[ to  
assi/ individuals ) enroll+ = m$ical    
assi/ance "u ,/ate plans "u ! ,m$icaid  
program "u title ,,xix ( ! ,social      
,security ,act or = *ild heal? assi/ance
 "u ,/ate *ild heal? plans "u title     
,,xxi ( su* ,act2 &  7v7 receive opioid 
specific education & tra9+ t ensures !  
navigator c be/ educate individuals on  
qualifi$ heal? plans (f]$ ?r\gh an      
,ex*ange1 specifically cov]age "u su*   
plans = opioid heal? c>e treatm5t4  2 & 
7#d7 9 p>agraph 7#f7--  7,a7 by /rik+   
,fund+4--,grants "u & ins]t+ ,fund+4--  
7,a7 ,/ate ,ex*anges ,subject to        
subp>agraph 7,c71 grants "u  2 &  7,b7  
by add+ at ! end ! foll[+ new           
subp>agraphs3  7,b7 ,f$]al ,ex*anges ,= 
purposes ( c>ry+ out ?is subsection1 )  
respect to an ,ex*ange e/abli%$ & op]at$
 by ! ,secret>y )9 a ,/ate pursuant to  
section #acba7;c71 ! ,secret>y %all     
obligate #ajj million out ( am\nts      
collect$ ?r\gh ! us] fees on p>ticipat+ 

heal? insurance issu]s pursuant to      
section #aef4ej ( title #de1 ,code (    
,f$]al ,regulations 7or any successor   
regulations7 = fiscal ye> #bjbj & ea*   
subsequ5t fiscal ye>4 ,su* am\nt = a    
fiscal ye> %all rema9 available until   
exp5d$4  7,c7 ,/ate ,ex*anges ,= !      
purposes ( c>ry+ out ?is subsection1 )  
respect to an ,ex*ange op]at$ by a ,/ate
 pursuant to ?is section1 !re is        
au?oriz$ to be appropriat$ #be million =
 fiscal ye> #bjbj & ea* subsequ5t fiscal
 ye>4 ,ea* ,/ate receiv+ a grant        
pursuant to ?is subp>agraph %all receive
 a grant 9 an am\nt t is n less ?an #a  
million4  4  7b7 ,/udy on effects (     
fund+ cuts ,n lat] ?an #a ye> aft] !    
date ( ! enactm5t ( ?is ,act1 !         
,comptroll] ,g5]al ( ! ,unit$ ,/ates    
%all /udy ! effects ( fund+ cuts made = 
plan ye> #bjai ) respect to ! navigator 
program 7z describ$ 9 section #acaa7;i7 
( ! ,pati5t ,protection & ,af=dable ,c>e
 ,act 7#db ,u4,s4,c4 #ahjca7;i777 & o!r 
education & outrea* activities c>ri$ out

 ) respect to ,ex*anges e/abli%$ by !   
,secret>y ( ,heal? & ,human ,s]vices    
pursuant to section #acba7;c7 ( su*     
,act4 ,su* /udy %all describe ! foll[+3 
7#a7 ,h[ su* fund+ cuts negatively      
impact$ ! ability ( entities "u su*     
program to conduct outrea* activities & 
fulfill duties requir$ "u su* section   
#acaa7;i74  7#b7 ,! ov]all effect on--  
7,a7 ! numb] ( individuals enroll$ 9    
heal? insurance cov]age (f]$ 9 !        
individual m>ket = plan ye> #bjai2 &    
7,b7 ! co/s ( heal? insurance cov]age   
(f]$ 9 ! individual m>ket4  7c7 ,promote
 transp>5cy & acc\ntability 9 !         
adm9i/ration's exp5ditures ( ex*ange us]
 fees ,= plan ye> #bjbj & ea* subsequ5t 
plan ye>1 n lat] ?an ! date t is #c     
mon?s aft] ! end ( su* plan ye>1 !      
,secret>y ( ,heal? & ,human ,s]vices    
%all submit to ! appropriate committees 
( ,congress & make available to ! public
 an annual report on ! exp5ditures by ! 
,dep>tm5t ( ,heal? & ,human ,s]vices (  
us] fees collect$ pursuant to section   

#aef4ej ( title #de1 ,code ( ,f$]al     
,regulations 7or any successor          
regulations74 ,ea* su* report = a plan  
ye> %all include a detail$ acc\nt+ ( !  
am\nt ( su* us] fees collect$ dur+ su*  
plan ye> & ( ! am\nt ( su* exp5ditures  
us$ dur+ su* plan ye> = ! f$]ally       
facilitat$ ,ex*ange op]at$ pursuant to  
section #acba7;c7 ( ! ,pati5t           
,protection & ,af=dable ,c>e ,act 7#db  
,u4,s4,c4 #ahjda7;c77 on outrea* &      
enrollm5t activities1 navigators1       
ma9t5ance ( ,heal?c>e4gov1 & op]ation ( 
call c5t]s4  7d7 ,effective date ,!     
am5dm5ts made by ?is section %all apply 
) respect to plan ye>s beg9n+ on or aft]
 ,janu>y #a1 #bjbj4  #bjc4 ,f$]al       
,ex*ange outrea* & educational          
activities & annual enrollm5t t>gets    
7a7 ,9 g5]al ,section #acba7;c7 ( !     
,pati5t ,protection & ,af=dable ,c>e    
,act 7#db ,u4,s4,c4 #ahjda7;c771 z am5d$
 by section #bja7;b77#b71 is fur!r am5d$
 by add+ at ! end ! foll[+ new          
p>agraphs3  7#d7 ,outrea* & educational 

activities  7,a7 ,9 g5]al ,9 ! case ( an
 ,ex*ange e/abli%$ or op]at$ by !       
,secret>y )9 a ,/ate pursuant to ?is    
subsection1 ! ,secret>y %all c>ry out   
outrea* & educational activities =      
purposes ( in=m+ individuals ab\t       
qualifi$ heal? plans (f]$ ?r\gh !       
,ex*ange1 includ+ by in=m+ su*          
individuals ( ! availability ( cov]age  
"u su* plans & f9ancial assi/ance =     
cov]age "u su* plans4 ,su* outrea* &    
educational activities %all be provid$ 9
 a mann] t is culturally & l+ui/ically  
appropriate to ! ne$s ( ! populations   
be+ s]v$ by ! ,ex*ange 7includ+         
h>d-to-rea* populations1 su* z racial & 
sexual m9orities1 limit$ ,engli%        
pr(ici5t populations1 individuals resid+
 9 areas :]e ! unemploym5t rates exce$s 
! national av]age unemploym5t rate1     
individuals 9 rural areas1 vet]ans1 & "y
 adults7 & %all be provid$ to           
populations resid+ 9 high heal? disp>ity
 areas 7z def9$ 9 subp>agraph 7,e77 s]v$
 by ! ,ex*ange1 9 addition to o!r       

populations s]v$ by ! ,ex*ange4  7,b7   
,limitation on use ( funds ,no funds    
appropriat$ "u ?is p>agraph %all be us$ 
= exp5ditures = promot+ non-,,aca       
compliant heal? insurance cov]age4  7,c7
 ,non-aca compliant heal? insurance     
cov]age ,= purposes ( subp>agraph 7,b73 
7i7 ,! t]m non-,,aca compliant heal?    
insurance cov]age means heal? insurance 
cov]age1 or a gr\p heal? plan1 t is n a 
qualifi$ heal? plan4  7ii7 ,su* t]m     
includes ! foll[+3 7,i7 ,an association 
heal? plan4  7,,ii7 ,%ort-t]m limit$    
duration insurance4  7,d7 ,fund+ ,out ( 
any funds 9 ! ,treasury n o!rwise       
appropriat$1 !re are h]eby appropriat$ =
 fiscal ye> #bjbj & ea* subsequ5t fiscal
 ye>1 #ajj million to c>ry out ?is      
p>agraph4 ,funds appropriat$ "u ?is     
subp>agraph %all rema9 available until  
exp5d$4  7,e7 ,high heal? disp>ity area 
def9$ ,= purposes ( subp>agraph 7,a71 ! 
t]m high heal? disp>ity area means a    
contigu\s geographic area t-- 7i7 is    
locat$ 9 "o c5sus tract or ,,zip code2  

7ii7 has measurable & docum5t$ racial1  
e?nic1 or geographic heal? disp>ities2  
7iii7 has a l[-income population1 z     
demon/rat$ by--  7,i7 av]age income bel[
 #ach p]c5t ( ! ,f$]al pov]ty l9e2 or   
7,,ii7 a rate ( p>ticipation 9 ! special
 supplem5tal nutrition program "u       
section #ag ( ! ,*ild ,nutrition ,act ( 
#aiff 7#db ,u4,s4,c4 #aghf7 t is high]  
?an ! national av]age rate (            
p>ticipation 9 su* program2  7iv7 has   
poor heal? outcomes1 z demon/rat$ by--  
7,i7 l[] life expectancy ?an ! national 
av]age2 or  7,,ii7 a high] p]c5tage (   
in/ances ( l[ bir? weight ?an ! national
 av]age2 &  7v7 is "p ( a ,metropolitan 
,/ati/ical ,area id5tifi$ by ! ,(fice ( 
,managem5t & ,budget4  7#e7 ,annual     
enrollm5t t>gets ,= plan ye> #bjbj & ea*
 subsequ5t plan ye>1 9 ! case ( an      
,ex*ange e/abli%$ or op]at$ by !        
,secret>y )9 a ,/ate pursuant to ?is    
subsection1 ! ,secret>y %all e/abli%    
annual enrollm5t t>gets = su* ,ex*ange =
 su* ye>4  4  7b7 ,/udy & report ,n lat]

 ?an #cj days aft] ! date ( ! enactm5t (
 ?is ,act1 ! ,secret>y ( ,heal? & ,human
 ,s]vices %all release to ,congress all 
aggregat$ docum5ts relat+ to /udies &   
data sets t 7 creat$ on or aft] ,janu>y 
#a1 #bjad1 & relat$ to m>ket+ & outrea* 
) respect to qualifi$ heal? plans (f]$  
?r\gh ,ex*anges "u title ,i ( ! ,pati5t 
,protection & ,af=dable ,c>e ,act4      
#bjd4 ,%ort-t]m limit$ duration         
insurance rule prohibition  7a7 ,f9d+s  
,congress f9ds ! foll[+3 7#a7 ,on ,augu/
 #c1 #bjah1 ! ,adm9i/ration issu$ a f9al
 rule entitl$ ,%ort-,t]m1               
,limit$-,duration ,insurance 7#hc ,f$4  
,reg4 #chbab74  7#b7 ,! f9al rule       
dramatically exp&s ! sale & m>ket+ (    
insurance t-- 7,a7 may discrim9ate aga9/
 individuals liv+ ) preexi/+ heal?      
conditions1 includ+ *ildr5 ) complex    
m$ical ne$s & disabilities & _!         
families2  7,b7 lacks important f9ancial
 protections provid$ by ! ,pati5t       
,protection & ,af=dable ,c>e ,act       
7,public ,law #aaa-adh71 includ+ !      

prohibition ( annual & lifetime cov]age 
limits & annual out-(-pocket limits1 t  
may increase ! co/ ( treatm5t & cause   
f9ancial h>d%ip to ^? requir+ m$ical    
c>e1 includ+ *ildr5 ) complex m$ical    
ne$s & disabilities & _! families2 &    
7,c7 excludes cov]age ( ess5tial heal?  
b5efits includ+ hospitalization1        
prescription drugs1 & o!r lifesav+ c>e4 
7#c7 ,! implem5tation & en=cem5t ( !    
f9al rule weak5s critical protections = 
up to #acj million ,am]icans liv+ )     
preexi/+ heal? conditions & may place a 
l>ge f9ancial burd5 on ^? :o enroll 9   
%ort-t]m limit$-duration insurance1 :i* 
jeop>dizes ,am]icans' access to quality1
 af=dable heal? insurance4  7b7         
,prohibition ,! ,secret>y ( ,heal? &    
,human ,s]vices1 ! ,secret>y ( !        
,treasury1 & ! ,secret>y ( ,labor may n 
take any action to implem5t1 en=ce1 or  
o!rwise give effect to ! rule entitl$   
,%ort-,t]m1 ,limit$ ,duration ,insurance
 7#hc ,f$4 ,reg4 #chbab 7,augu/ #c1     
#bjah771 & ! ,secret>ies may n          

promulgate any sub/antially simil> rule4
  #bje4 ,protection ( heal? insurance   
cov]age 9 c]ta9 ,ex*anges ,9 ! case ( an
 ,ex*ange t ! ,secret>y ( ,heal? &      
,human ,s]vices op]ates pursuant to     
section #acba7;c77#a7 ( ! ,pati5t       
,protection & ,af=dable ,c>e ,act 7#db  
,u4,s4,c4 #ahjda7;c77#a771 ! ,secret>y  
may n implem5t any process t w\ld       
t]m9ate ! heal? insurance cov]age ( an  
enrollee solely because su* enrollee did
 n actively enroll dur+ ! mo/ rec5t op5 
enrollm5t p]iod4  #bjf4 ,s5se (         
,congress relat+ to ! practice ( silv]  
load+ ,x is ! s5se ( ,congress t !      
,secret>y ( ,heal? & ,human ,s]vices    
%\ld n take any action to prohibit or   
o!rwise re/rict ! practice commonly kn[n
 z silv] load+ 7z describ$ 9 ! rule     
entitl$ ,pati5t ,protection & ,af=dable 
,c>e ,act2 ,,hhs ,notice ( ,b5efit &    
,paym5t ,p>amet]s = #bjbj publi%$ on    
,april #be1 #bjai 7#hd ,f$4 ,reg4       
#agecc774  #bjg4 ,consum] outrea*1      
education1 & assi/ance  7a7 ,op5        

enrollm5t reports ,= plan ye> #bjbj &   
ea* subsequ5t ye>1 ! ,secret>y ( ,heal? 
& ,human ,s]vices 7ref]r$ to 9 ?is      
section z ! ,secret>y71 9 coord9ation ) 
! ,secret>y ( ! ,treasury & ! ,secret>y 
( ,labor1 %all issue biweekly public    
reports dur+ ! annual op5 enrollm5t     
p]iod on ! p]=mance ( ! ,f$]al ,ex*ange4
 ,ea* su* report %all include a summ>y1 
includ+ in=mation on a ,/ate-by-,/ate   
basis :]e available1 (-- 7#a7 ! numb] ( 
unique website visits2  7#b7 ! numb] (  
individuals :o create an acc\nt2  7#c7 !
 numb] ( calls to ! call c5t]2  7#d7 !  
av]age wait "t = call]s contact+ ! call 
c5t]2  7#e7 ! numb] ( individuals :o    
enroll 9 a qualifi$ heal? plan2 &  7#f7 
! p]c5tage ( individuals :o enroll 9 a  
qualifi$ heal? plan ?r\gh ea* (-- 7,a7 !
 website2  7,b7 ! call c5t]2  7,c7      
navigators2  7,d7 ag5ts & brok]s2  7,e7 
! enrollm5t assi/ant program2  7,f7     
directly f issu]s or web brok]s2 &  7,g7
 o!r means4  7b7 ,op5 ,enrollm5t ,aft]  
,action ,report ,= plan ye> #bjbj & ea* 

subsequ5t ye>1 ! ,secret>y1 9           
coord9ation ) ! ,secret>y ( ! ,treasury 
& ! ,secret>y ( ,labor1 %all publi% an  
aft] action report n lat] ?an #c mon?s  
aft] ! completion ( ! annual op5        
enrollm5t p]iod reg>d+ ! p]=mance ( !   
,f$]al ,ex*ange = ! applicable plan ye>4
 ,ea* su* report %all include a summ>y1 
includ+ in=mation on a ,/ate-by-,/ate   
basis :]e available1 (-- 7#a7 ! op5     
enrollm5t data report$ "u subsection 7a7
 = ! entirety ( ! enrollm5t p]iod2 &    
7#b7 activities relat$ to pati5t        
navigators describ$ 9 section #acaa7;i7 
( ! ,pati5t ,protection & ,af=dable ,c>e
 ,act 7#db ,u4,s4,c4 #ahjca7;i771       
includ+-- 7,a7 ! p]=mance objectives    
e/abli%$ by ! ,secret>y = su* pati5t    
navigators2  7,b7 ! numb] ( consum]s    
enroll$ by su* a pati5t navigator2  7,c7
 an assessm5t ( h[ su* pati5t navigators
 h met e/abli%$ p]=mance metrics1       
includ+ a detail$ li/ ( all pati5t      
navigators1 fund+ receiv$ by pati5t     
navigators1 & :e!r e/abli%$ p]=mance    

objectives ( pati5t navigators 7 met2 & 
7,d7 ) respect to ! p]=mance objectives 
describ$ 9 subp>agraph 7,a7-- 7i7 :e!r  
su* objectives assess ! full scope (    
pati5t navigator responsibilities1      
includ+ g5]al education1 plan selection1
 & det]m9ation ( eligibility = tax      
cr$its1 co/-%>+ r$uctions1 or o!r       
cov]age2  7ii7 h[ ! ,secret>y work$ )   
pati5t navigators to e/abli% su*        
objectives2 &  7iii7 h[ ! ,secret>y     
adju/$ su* objectives = case complexity 
& o!r contextual factors4  7c7 ,report  
on adv]tis+ & consum] outrea* ,n lat]   
?an #c mon?s aft] ! completion ( !      
annual op5 enrollm5t p]iod = ! #bjbj    
plan ye>1 ! ,secret>y %all issue a      
report on adv]tis+ & outrea* to consum]s
 = ! op5 enrollm5t p]iod = ! #bjbj plan 
ye>4 ,su* report %all include a         
description (-- 7#a7 ! division ( sp5d+ 
on individual adv]tis+ plat=ms1 includ+ 
television & radio adv]tisem5ts &       
digital m$ia1 to raise consum] aw>5ess (
 op5 enrollm5t2  7#b7 ! division ( sp5d+

 on individual outrea* plat=ms1 includ+ 
email & text messages1 to raise consum] 
aw>5ess ( op5 enrollm5t2 &  7#c7 :e!r ! 
,secret>y conduct$ t>get$ outrea* to    
specific demographic gr\ps & geographic 
areas4  #bjh4 ,,gao report ,n lat] ?an  
#a ye> aft] ! date ( ! enactm5t ( ?is   
,act1 ! ,comptroll] ,g5]al ( ! ,unit$   
,/ates %all submit to ,congress a /udy t
 analyzes ! co/s & b5efits ( !          
e/abli%m5t ( ,/ate-adm9i/]$ heal?       
insurance plans to be (f]$ 9 ! insurance
 m>ket ( su* ,/ates t *oose to adm9i/] &
 (f] su* a plan4  #bji4 ,report on !    
effects ( website ma9t5ance dur+ op5    
enrollm5t ,n lat] ?an #a ye> aft] ! date
 ( ! enactm5t ( ?is ,act1 ! ,comptroll] 
,g5]al ( ! ,unit$ ,/ates %all submit to 
,congress a report exam9+ :e!r !        
,dep>tm5t ( ,heal? & ,human ,s]vices has
 be5 conduct+ ma9t5ance on ! website    
commonly ref]r$ to z ,heal?c>e4gov dur+ 
annual op5 enrollm5t p]iods 7z describ$ 
9 section #acaa7;c77#f77;,b7 ( ! ,pati5t
 ,protection & ,af=dable ,c>e ,act 7#db 

,u4,s4,c4 #ahjca7;c77#f77;,b77 9 su* a  
mann] s z to m9imize any disruption to !
 use ( su* website result+ f su*        
ma9t5ance4  ,,iii ,budget>y ,effects    
#cja4 ,det]m9ation ( budget>y effects ,!
 budget>y effects ( ?is ,act1 = !       
purpose ( comply+ ) ! ,/atutory         
,pay-,z-,y-,g ,act ( #bjaj1 %all be     
det]m9$ by ref]5ce to ! late/ /atem5t   
titl$ ,budget>y ,effects ( ,,paygo      
,legislation = ?is ,act1 submitt$ =     
pr9t+ 9 ! ,congressional ,record by !   
,*airman ( ! ,h\se ,budget ,committee1  
provid$ t su* /atem5t has be5 submitt$  
prior to ! vote on passage4  ,pass$ !   
,h\se ( ,repres5tatives ,may #af1       
#bjai4;,cl]k4