,i  #aac? ,,congress  #a/ ,session  ,h4 
,r4 #cjia  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,septemb] #ab1        
#bjac,mr4 ,lance 7= himself1 ,mr4       
,roskam1 ,mr4 ,gu?rie1 ,mr4 ,pauls51    
,mr4 ,rangel1 ,mr4 ,runyan1 ,ms4        
,s*w>tz1 ,mr4 ,k+ ( ,new ,york1 ,mr4    
,mc,caul1 ,mr4 ,wald51 ,mr4 ,tib]i1 ,mr4
 ,loebsack1 ,mr4 ,b5 ,ray ,lujn ( ,new  
,mexico1 ,mr4 ,ellison1 ,mr4 ,jones1 &  
,mr4 ,long7 introduc$ ! foll[+ bill2 :i*
 0 ref]r$ to ! ,committee on ,en]gy &   
,comm]ce1 & 9 addition to ! ,committees 
on ,ways & ,means & ! ,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      
promote ! developm5t ( mean+ful         
treatm5ts = pati5ts4  #a4 ,%ort title   
,?is ,act may be cit$ z ! ,mod]niz+ ,our
 ,drug  ,diagno/ics ,evaluation &       
,regulatory ,network ,cures ,act ( #bjac
 or ! ,,modd]n ,cures ,act ( #bjac4  #b4
 ,table ( cont5ts ,! table ( cont5ts =  

?is ,act is z foll[s3 ,sec4 #a4 ,%ort   
title4,sec4 #b4 ,table ( cont5ts4,sec4  
#c4 ,f9d+s4,sec4 #d4 ,def9itions4,title 
,i--,advanc+ diagno/ics = patients,sec4 
#aja4 ,develop+ a common lexicon to     
facilitate progress on diagno/ics4,sec4 
#ajb4 ,creat+ inc5tives = innovative    
diagno/ics4,sec4 #ajc4 ,promot+ !       
developm5t ( innovative                 
diagno/ics4,title ,,ii--,captur+ lo/    
opportunities = patients,sec4 #bja4     
,dormant !rapies4,sec4 #bjb4 ,/udy      
reg>d+ new indications = exi/+ !rapies4 
#c4 ,f9d+s ,! ,congress makes ! foll[+  
f9d+s3 7#a7 ,m ?an #acc million         
,am]icans1 or #de p]c5t ( ! population1 
h at lea/ "o *ronic condition4 ,a qu>t] 
( ,am]icans h multiple *ronic           
conditions4  7#b7 ,*ronic diseases h    
become ! lead+ cause ( dea? & disability
 9 ! ,unit$ ,/ates4 ,sev5 out ( e #aj   
dea?s are attributable to *ronic        
disease4 ,*ronic diseases also          
compromise ! quality ( life ( millions (
 ,am]icans4  7#c7 ,despite #hj billion  

sp5t annually on rese>* & developm5t1 _m
 diseases & conditions lack effective   
treatm5ts4  7#d7 ,_m commonly us$ drugs 
are effective 9 only #ej to #ge p]c5t ( 
! pati5t population1 :i* c lead to      
deva/at+ long-t]m side effects1 result+ 
9 ! pot5tial risks outweigh+ ! b5efits =
 "s pati5ts4  7#e7 ,advanc$ & innovative
 diagno/ic te/s h ! pot5tial to         
dramatically increase ! efficacy &      
safety ( drugs by bett] pr$ict+ h[      
pati5ts w respond to a giv5 !rapy4  7#f7
 ,despite _! promise1 _m drugs &        
diagno/ics may g undevelop$ due to      
unc]ta9 regulatory & reimbursem5t       
processes1 among o!r reasons4  7#g7 ,9  
addition1 !re is reason to believe t    
pot5tial treatm5ts ) trem5d\s value to  
pati5ts are nev] develop$ or are        
discont9u$ dur+ rese>* & developm5t due 
to insuffici5cies 9 ! intellectual      
prop]ty sy/em4  7#h7 ,x is 9 ! public   
int]e/ to address ! hurdles t may be    
preclud+ new treatm5ts f rea*+ pati5ts &
 to remove ! dis9c5tives = ! developm5t 

( !rapies = ^! unmet ne$s4  #d4         
,def9itions ,9 ?is ,act3 7#a7 ,! t]m    
biological product has ! mean+ giv5 to t
 t]m 9 section #cea ( ! ,public ,heal?  
,s]vice ,act 7#db ,u4,s4,c4 #bfb74  7#b7
 ,! t]m drug has ! mean+ giv5 to t t]m 9
 section #bja ( ! ,f$]al ,food1 ,drug1 &
 ,cosmetic ,act 7#ba ,u4,s4,c4 #cba74   
7#c7 ,! t]m m$ic9e means a biological   
product or a drug4  7#d7 ,! t]m         
,secret>y means ! ,secret>y ( ,heal? &  
,human ,s]vices4  ,i ,advanc+ diagno/ics
 = pati5ts  #aja4 ,develop+ a common    
lexicon to facilitate progress on       
diagno/ics  7a7 ,9 g5]al ,n lat] ?an    
#ahj days aft] ! date ( enactm5t ( ?is  
,act1 ! ,secret>y %all e/abli% )9 !     
,dep>tm5t ( ,heal? & ,human ,s]vices !  
,advanc$ ,diagno/ics ,education ,c\ncil 
79 ?is section ref]r$ to z ! ,c\ncil74  
7b7 ,duties  7#a7 ,9 g5]al ,! ,c\ncil   
%all promote an improv$ und]/&+ ( key   
concepts relat$ to innovative diagno/ics
 by recomm5d+ /&>d t]ms & def9itions =  
use by pati5ts1 physicians1 heal? c>e   

provid]s1 pay]s1 & policymak]s4  7#b7   
,guide ,! ,secret>y %all publi% &       
dissem9ate a guide reg>d+ su* recomm5d$ 
t]ms & def9itions = pati5ts1 physicians1
 heal? c>e provid]s1 pay]s1 &           
policymak]s4  7#c7 ,report ,n lat] ?an  
#ab mon?s aft] ! e/abli%m5t ( ! ,c\ncil1
 ! ,secret>y %all prep>e & submit a     
report to ! ,congress & to ! public on !
 ,c\ncil's delib]ations1 activities1 &  
det]m9ations ) respect to meet+ its     
duties describ$ 9 p>agraphs 7#a7 & 7#b74
  7c7 ,*airp]son ,! ,secret>y1 or !     
,secret>y's designee1 %all s]ve z       
*airp]son ( ! ,c\ncil4  7d7 ,memb]s ,9  
addition to ! ,secret>y1 ! ,c\ncil %all 
consi/ ( ! foll[+3 7#a7 ,! head ( ea* ! 
foll[+ ag5cies 7or a designee !re(73    
7,a7 ,! ,national ,in/itutes ( ,heal?4  
7,b7 ,! ,c5t]s = ,disease ,control &    
,prev5tion4  7,c7 ,! ,food & ,drug      
,adm9i/ration4  7,d7 ,! ,ag5cy =        
,heal?c>e ,rese>* & ,quality4  7,e7 ,!  
,c5t]s = ,m$ic>e  ,m$icaid ,s]vices4    
7,f7 ,! ,dep>tm5t ( ,def5se4  7,g7 ,!   

,dep>tm5t ( ,vet]ans ,affairs4  7,h7 ,! 
,heal? ,res\rces & ,s]vices             
,adm9i/ration4  7,i7 ,! ,sub/ance ,abuse
 & ,m5tal ,heal? ,s]vices ,adm9i/ration4
  7,j7 ,! ,indian ,heal? ,s]vice4  7#b7 
,sev5 memb]s appo9t$ by ! ,secret>y f   
among individuals :o collectively-- 7,a7
 repres5t a broad range ( p]spectives2 &
  7,b7 h exp]tise 9-- 7i7 basic &       
translational rese>*1 includ+ ) respect 
to molecul> biology & g5etics2  7ii7    
bio9=matics2  7iii7 ! discov]y1         
developm5t1 & comm]cialization ( 9 vitro
 diagno/ics2 &  7iv7 law & e?ics4  7#c7 
,f\r memb]s appo9t$ by ! ,secret>y :o   
are ea* a *ief m$ical or sci5tific (fic]
 ( a pati5t advocacy organization4  7e7 
,public input ,9 c>ry+ out its duties1 !
 ,c\ncil %all solicit input f relevant  
/akehold]s & ! public4  7f7 ,t]m9ation  
,! ,c\ncil %all t]m9ate aft] publi%+ !  
guide requir$ by subsection 7b77#b7 &   
submitt+ ! report requir$ by subsection 
7b77#c71 or lat] at ! discretion ( !    
,secret>y4  #ajb4 ,creat+ inc5tives =   

innovative diagno/ics  7a7 ,improvem5ts 
to process = det]m9+ fee s*$ule am\nts =
 new te/s  7#a7 ,cl>ify+ factors =      
rate-sett+  7,a7 ,9 g5]al ,9 det]m9+ !  
paym5t am\nt "u gapfill+ proc$ures 7z   
describ$ 9 section #dad4ejh7;b7 ( title 
#db1 ,code ( ,f$]al ,regulations1 or any
 successor regulation to su* section7 = 
new cl9ical diagno/ic laboratory te/s "u
 section #ahcc7;h77#h7 ( ! ,social      
,security ,act 7#db ,u4,s4,c4           
#aciel7h77#h771 ! ,secret>y %all take   
into acc\nt1 z applicable & available1 !
 foll[+ factors ) respect to su* a new  
te/3 7i7 ,impact on pati5t c>e ,! impact
 ( ! new te/ on pati5t c>e1 pati5t      
managem5t1 or pati5t treatm5t4  7ii7    
,te*nical *>act]i/ics ,! te*nical       
*>act]i/ics ( ! new te/1 & ! res\rces   
requir$ to develop1 validate1 & p]=m !  
new te/4  7iii7 ,claims data ,data f    
claims = :i* paym5t is made "u "p ,b (  
title ,,xviii ( ! ,social ,security     
,act4  7iv7 ,laboratory *>ges ,am\nts   
*>g$ by laboratories to self-pay pati5ts

 = ! new te/4  7v7 ,private insurance   
rates ,am\nts paid to laboratories = su*
 new te/ "u private heal? insurance     
cov]age (f]$ 9 ! gr\p m>ket & !         
individual m>ket4  7vi7 ,advisory panel 
recomm5dations ,! f9d+s & recomm5dations
 ( ! indep5d5t advisory panel conv5$ "u 
p>agraph 7#b7 ) respect to t new te/ &  
any comm5ts receiv$ dur+ ! op5 meet+ ( !
 advisory panel4  7vii7 ,additional     
factors ,su* o!r factors z ! ,secret>y  
may specify4  7#b7 ,input f pati5ts1    
cl9icians1 & te*nical exp]ts  7,a7      
,requirem5t = indep5d5t advisory panel  
,! ,secret>y %all conv5e an indep5d5t   
advisory panel f :i* ! ,secret>y %all   
reque/ in=mation & recomm5dations reg>d+
 any new te/ 7z ref]r$ to "u subp>agraph
 7,a7 ( section #ahcc7;h77#h7 ( !       
,social ,security ,act 7#db ,u4,s4,c4   
#aciel7h77#h777 = :i* paym5t is made "u 
su* section1 includ+ te*nical1 cl9ical1 
& quality in=mation4  7,b7 ,composition 
( indep5d5t advisory panel ,! indep5d5t 
advisory panel %all be compris$ ( #ai   

memb]s1 includ+-- 7i7 #d individuals )  
exp]tise & exp]i5ce ) advanc$ cl9ical   
diagno/ic laboratory te/s1 includ+      
exp]tise 9 ! te*nical *>act]i/ics ( !   
new te/2  7ii7 #c repres5tatives (      
pati5ts1 includ+ a pati5t repres5tative 
= r>e disord]s2  7iii7 #c cl9icians :o  
use results ( ! new te/ 9 pati5t c>e2   
7iv7 #c individuals ) exp]tise 9 !      
requirem5ts to develop1 validate1 & p]=m
 ! new te/2  7v7 #b laboratorians2  7vi7
 #b exp]ts 9 ! area ( ph>macoeconomics  
or heal? te*nology assessm5t2 &  7vii7  
#b individuals ) exp]tise on ! impact ( 
new te/s on quality ( pati5t c>e1       
includ+ g5etic c\nselors4  7,c7 ,t]ms ,a
 memb] ( ! panel %all be appo9t$ to s]ve
 a t]m ( #f ye>s1 except ) respect to ! 
memb]s fir/ appo9t$1 ^: t]ms ( appo9tm5t
 %all be /agg]$ ev5ly ov] #b-ye>        
increm5ts4  7,d7 ,exp]t consultants ,!  
,secret>y may include to s]ve tempor>ily
 on ! panel individuals :o h exp]tise   
p]ta9+ to ! new te/ involv$4  7,e7 ,op5 
meet+s ,! ,secret>y %all receive or     

review ! f9d+s & recomm5dations ( !     
indep5d5t advisory panel ) respect to ! 
new te/s describ$ 9 subp>agraph 7,a7    
involv$ dur+ a meet+ op5 to ! public &  
provide opportunity = public comm5t4    
7,f7 ,cl>ification ( au?ority ( secret>y
 to consult c>ri]s ,no?+ 9 ?is section  
%all be con/ru$ z affect+ ! au?ority ( !
 ,secret>y to consult ) appropriate     
,m$ic>e adm9i/rative contractors4  7b7  
,process = assignm5t ( tempor>y codes = 
diagno/ic te/s ,! ,secret>y %all e/abli%
 a process = application = ! assignm5t (
 a tempor>y national ,,hcpcs code to    
uniquely id5tify a diagno/ic te/ until a
 p]man5t national ,,hcpcs code is       
available = assignm5t to t te/4         
,assignm5ts ( a tempor>y national       
,,hcpcs code %all occur on a qu>t]ly    
basis4 ,! ,secret>y %all provide public 
notice ?r\gh ! ,c5t]s = ,m$ic>e         
,m$icaid ,s]vices website ( applications
 made = su* tempor>y national ,,hcpcs   
codes4 ,^u assignm5t ( a tempor>y code  
"u ?is process1 ! ,secret>y %all treat  

su* te/ z a new te/ = purposes ( section
 #ahcc7;h77#h7 ( ! ,social ,security    
,act4  7c7 ,developm5t ( fur!r          
improvem5ts 9 rate-,sett+ processes ,!  
,secret>y %all analyze ! process us$ = !
 gapfill+ proc$ure us$ 9 det]m9+ paym5t 
am\nts = new cl9ical diagno/ic          
laboratory te/s "u section #ahcc7;h77#h7
 ( ! ,social ,security ,act4 ,tak+ into 
acc\nt ! *anges made by ?is section1 !  
,secret>y %all id5tify fur!r *anges to  
improve ! accuracy & appropriat5ess (   
result+ rates & ! op5ness1 transp>5cy1 &
 pr$ictability ( ! process4 ,! ,secret>y
 %all exam9e :at & h[ _m entities %\ld  
p]=m gapfill+1 "u contract or o!rwise1 &
 h[ to ensure t ! process is in=m$ by   
appropriate exp]tise & proce$s 9 a      
transp>5t & acc\ntable mann]4 ,!        
,secret>y %all implem5t improvem5ts 9 ! 
process1 ins(> z ^! are possible "u !   
law ?r\gh regulations1 aft] public      
notice & opportunity = comm5t4 ,= *anges
 ! ,secret>y det]m9es w\ld require a    
*ange 9 law1 ! ,secret>y %all transmit  

recomm5dations to ! ,speak] ( ! ,h\se ( 
,repres5tatives & ! ,presid5t ( ! ,s5ate
 n lat] ?an ,july #a1 #bjae4  7d7       
,def9itions ,= purposes ( ?is section3  
7#a7 ,new cl9ical diagno/ic laboratory  
te/s ,! t]m new cl9ical diagno/ic       
laboratory te/ means a cl9ical diagno/ic
 laboratory te/-- 7,a7 t is assign$ a   
new or sub/antially revis$ code on or   
aft] ,janu>y #a1 #bjae2 or  7,b7 = :i*  
an application = a tempor>y national    
,,hcpcs code is made "u subsection 7b7  
on or aft] ,janu>y #a1 #bjae4  7#b7     
,self-pay pati5t ,! t]m self-pay pati5t 
means1 ) respect to a heal? c>e item or 
s]vice1 an individual :o pays out (     
pocket = su* item or s]vice & :o does n 
h heal? insurance cov]age = su* item or 
s]vice4  7e7 ,effective date ,?is       
section %all take effect on ! date (    
enactm5t ( ?is ,act1 & %all apply )     
respect to new cl9ical diagno/ic        
laboratory te/s4  #ajc4 ,promot+ !      
developm5t ( innovative diagno/ics  7a7 
,det]m9ation  7#a7 ,reque/ ,!           

manufactur] or sponsor ( a m$ic9e may   
reque/ ! ,secret>y to det]m9e t-- 7,a7 a
 diagno/ic te/ has be5 develop$ by1 or )
 ! p>ticipation (1 ! manufactur] or     
sponsor ( ! m$ic9e2 &  7,b7 use ( !     
diagno/ic te/1 z demon/rat$ ?r\gh valid 
sci5tific in=mation su* z pe]-review$   
lit]ature-- 7i7 provides = or improves !
 id5tification ( a pati5t population =  
:i* ! m$ic9e w or w n be us$ 9          
accordance ) its approv$ indications2   
7ii7 provides = or improves !           
det]m9ation ( ! mo/ appropriate treatm5t
 option = a pati5t population ) ! m$ic9e
 9 accordance ) its approv$ indications2
 or  7iii7 provides = ! detection ( a   
qualify+ pa?og5 7z def9$ 9 section      
#eje;,e7f7 ( ! ,f$]al ,food1 ,drug1 &   
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;f774
  7#b7 ,response by ,secret>y ,n lat]   
?an #cj days aft] ! submission ( a      
reque/ "u p>agraph 7#a71 ! ,secret>y1   
%all-- 7,a7 make ! reque/$ det]m9ation &
 publi% a notice ( su* det]m9ation & any
 ext5sion "u ?is section result+ f su*  

det]m9ation2 or  7,b7 provide an        
explanation to ! manufactur] or sponsor 
submitt+ ! reque/ ( :y ! det]m9ation is 
n w>rant$4  7b7 ,applicable ext5sion    
p]iod ,= purposes ( subsections 7c7 &   
7d71 ! applicable ext5sion p]iod is--   
7#a7 ) respect to a diagno/ic te/       
develop$ 7z describ$ 9 subsection       
7a77#a77;,a77 contemporane\sly ) !      
developm5t ( ! m$ic9e involv$1 #ab      
mon?s2 &  7#b7 ) respect to a diagno/ic 
te/ develop$ o!rwise1 #f mon?s4  7c7    
,ext5sion = drugs ,if1 at ! reque/ ( !  
manufactur] or sponsor ( a drug1 !      
,secret>y makes ! det]m9ation describ$ 9
 subsection 7a77#a7 ) respect to su*    
drug & a diagno/ic te/1 !n-- 7#a7 ! f\r-
 & five-ye> p]iods describ$ 9           
subsections 7c77#c77;,e77ii7 &          
7j77#e77;,f77ii7 ( section #eje ( !     
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cee71 ! ?ree-ye> p]iods 
describ$ 9 clauses 7iii7 & 7iv7 (       
subsection 7c77#c77;,e7 & clauses 7iii7 
& 7iv7 ( subsection 7j77#e77;,f7 ( su*  

section #eje1 or ! sev5-ye> p]iod       
describ$ 9 section #ebg ( ! ,f$]al      
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cfj;cc71 z applicable1 %all  
be ext5d$ by ! applicable ext5sion      
p]iod2  7#b7 if ! drug is ! subject (-- 
7,a7 a li/$ pat5t = :i* a c]tification  
has be5 submitt$ "u subsection          
7b77#b77;,a77ii7 or                     
7j77#b77;,a77vii77,,ii7 ( su* section   
#eje2 or  7,b7 a li/$ pat5t = :i* a     
c]tification has be5 submitt$ "u        
subsection 7b77#b77;,a77iii7 or         
7j77#b77;,a77vii77,,iii7 ( su* section  
#eje1  !n ! p]iod dur+ :i* an           
application may n be approv$ "u         
subsection 7c77#c7 or 7j77#e77;,b7 ( su*
 section #eje %all be ext5d$ by !       
applicable ext5sion p]iod aft] ! date ! 
pat5t expires 7includ+ any pat5t        
ext5sions72 &  7#c7 if ! drug is !      
subject ( a li/$ pat5t = :i* a          
c]tification has be5 submitt$ "u        
subsection 7b77#b77;,a77iv7 or          
7j77#b77;,a77vii77,,iv7 ( su* section   

#eje1 & 9 ! pat5t infr+em5t litigation  
result+ f ! c]tification ! c\rt det]m9es
 t ! pat5t is valid & w\ld be infr+$1 ! 
p]iod dur+ :i* an application may n be  
approv$ "u subsection 7c77#c7 or        
7j77#e77;,b7 ( su* section #eje %all be 
ext5d$ by ! applicable ext5sion p]iod   
aft] ! date ! pat5t expires 7includ+ any
 pat5t ext5sion74  7d7 ,ext5sion =      
biological products ,if1 at ! reque/ ( !
 manufactur] or sponsor ( a biological  
product1 ! ,secret>y makes ! det]m9ation
 describ$ 9 subsection 7a77#a7 ) respect
 to su* biological product & a diagno/ic
 te/1 !n ! #ab-ye> p]iod describ$ 9     
subsection 7k77#g77;,a7 ( section #cea (
 ! ,public ,heal? ,s]vice ,act 7#db     
,u4,s4,c4 #bfb71 ! #d-ye> p]iod describ$
 9 subsection 7k77#g77;,b7 ( su* section
 #cea1 & ! #g-ye> p]iod describ$ 9      
section #ebg ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;cc71 
z applicable1 %all be ext5d$ by !       
applicable ext5sion p]iod4  7e7         
,relation to p$iatric exclusivity ,any  

ext5sion "u subsection 7c7 or 7d7 ( a   
p]iod %all be 9 addition to any ext5sion
 ( ! p]iod "u section #eje;,a ( ! ,f$]al
 ,food1 ,drug1 & ,cosmetic ,act 7#ba    
,u4,s4,c4 #cee;a7 ) respect to ! m$ic9e4
  7f7 ,limitations ,ext5sions "u ?is    
section may apply-- 7#a7 n m ?an twice )
 respect to ! same m$ic9e2 &  7#b7 n m  
?an once ) respect to ! same indication 
to be treat$ by ! same m$ic9e4  ,,ii    
,captur+ lo/ opportunities = pati5ts    
#bja4 ,dormant !rapies  7a7 ,designation
 z dormant !rapy ,! ,secret>y %all      
designate a m$ic9e z a dormant !rapy    
if-- 7#a7 ! sponsor ( ! m$ic9e submits a
 reque/ = su* designation meet+ !       
requirem5ts "u subsection 7b71 & !      
reque/ has n be5 )drawn "u subsection   
7d77#a72 &  7#b7 ! ,secret>y det]m9es   
t-- 7,a7 ! m$ic9e is be+ inve/igat$ or  
is int5d$ to be inve/igat$ = an         
indication to address "o or m unmet     
m$ical ne$s2  7,b7 a suitable cl9ical   
plan = su* inve/igations ( ! m$ic9e has 
be5 develop$ by ! sponsor2  7,c7 !      

sponsor int5ds to file an application   
pursuant to section #eje7;b7 ( ! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee7;b77 or section #cea7;a7 
( ! ,public ,heal? ,s]vice ,act 7#db    
,u4,s4,c4 #bfb7;a77 = approval or lic5s+
 ( ! m$ic9e = an indication describ$ 9  
subp>agraph 7,a72 &  7,d7 ! reque/ =    
designation 0 made on or be=e ! date (  
submission ( any application "u section 
#eje ( ! ,f$]al ,food1 ,drug1 &         
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or  
section #cea ( ! ,public ,heal? ,s]vice 
,act 7#db ,u4,s4,c4 #bfb7 = ! approval  
or lic5sure ( comm]cial m>ket+ or use ( 
a m$ic9e t 9 ! case ( a drug %>es an    
active moiety t is ! same z1 & 9 ! case 
( a biologic conta9s an active moiety t 
is highly simil> to1 an active moiety 9 
! m$ic9e = :i* designation is be+       
reque/$4  7b7 ,requirem5ts = reque/ =   
designation z dormant !rapy ,a reque/ "u
 subsection 7a77#a7 ) respect to a      
m$ic9e may only be made by ! sponsor ( !
 m$ic9e & %all conta9 ea* ( ! foll[+3   

7#a7 ,a li/+ ( all pat5ts & applications
 = pat5ts "u :i* ! sponsor has rights & 
t may be reasonably con/ru$ to provide  
protection = ! m$ic9e4  7#b7 ,a waiv] ( 
pat5t rights to ! ext5t requir$ "u      
subsection 7c7 to take effect1 if at    
all1 z provid$ "u subsection 7c77#c74   
7#c7 ,su* additional in=mation z !      
,secret>y may require by regulation 9   
ord] to det]m9e eligibility =           
designation "u subsection 7a74  7c7     
,waiv] ( pat5t rights expir+ aft] !     
protection p]iod ends  7#a7 ,pat5t waiv]
  7,a7 ,9 g5]al ,subject to subp>agraph 
7,b71 ! reque/ "u ?is subsection %all   
include a waiv] ( ! "r to en=ce or      
o!rwise ass]t any pat5t describ$ 9      
subsection 7b77#a7 7or any pat5t issu$  
on ! basis ( an application describ$ 9  
subsection 7b77#a771 :i* may expire aft]
 ! end ( ! protection p]iod = ! dormant 
!rapy1 aga9/ any applicable product     
describ$ 9 p>agraph 7#b74 ,! waiv] %all 
be made by ! own] ( ! pat5t or          
application = pat5t1 z ! case may be4   

7,b7 ,limitations on pat5t waiv] ,any   
pat5t waiv] provid$ pursuant to ?is     
section1 %\ld x become effective-- 7i7  
%all h no effect dur+ ! protection p]iod
 = ! m$ic9e to :i* ! waiv] relates2 &   
7ii7 %all h no effect ) respect to !    
subject matt] ( a claim$ inv5tion 9 a   
pat5t t does n provide any protection = 
su* m$ic9e ) respect to an applicable   
product describ$ 9 p>agraph 7#b74  7#b7 
,applicable products describ$ ,an       
applicable product is describ$ 9 ?is    
p>agraph only if-- 7,a7 x is approv$ or 
lic5s$ pursuant to an application t--   
7i7 is fil$ "u section #eje7;b77#b7 or  
#eje7;j7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act 7#ba ,u4,s4,c4           
#cee7;b77#b71 7j77 or section #cea7k7 ( 
! ,public ,heal? ,s]vice ,act 7#db      
,u4,s4,c4 #bfb7k772 &  7ii7 ref]5ces or 
o!rwise relies ^u ! approval or lic5sure
 ( ! dormant !rapy to :i* ! waiv]       
relates2 &  7,b7 ! approval ( ! product 
occurs aft] ! expiration ( ! protection 
p]iod applicable to ! m$ic9e to :i* !   

reque/ "u subsection 7a77#a7 relates4   
7#c7 ,effective date ( waiv] ,a waiv] "u
 subsection 7b77#b7 ) respect to a pat5t
 %all take effect1 if at all1 on ! date 
! ,director publi%es ! notice requir$ "u
 subsection 7e77#b77;,f7 relat+ to !    
pat5t4  7d7 ,)drawal ( reque/ =         
designation1 revocation by ! secret>y   
7#a7 ,9 g5]al ,! sponsor ( a m$ic9e may 
)draw a reque/ = designation "u         
subsection 7a77#a7 ) respect to a m$ic9e
 unless ! m$ic9e has be5 approv$ or     
lic5s$ "u section #eje ( ! ,f$]al ,food1
 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 
#cee7 or section #cea ( ! ,public ,heal?
 ,s]vice ,act 7#db ,u4,s4,c4 #bfb74 ,!  
,secret>y %all d5y a designation reque/ 
or revoke any designation grant$ if at  
any "t ! ,secret>y f9ds t ! sponsor is n
 9 compliance ) subsections 7c77#a7 &   
7g77#a74  7#b7 ,effects ( )drawal (     
reque/ or revocation ( designation ,if !
 sponsor ( a m$ic9e )draws a reque/ "u  
subsection 7b7 or ! ,secret>y d5ies a   
designation reque/ or revokes a         

designation ) respect to ! m$ic9e-- 7,a7
 any pat5t waiv] submitt$ "u ?is section
 ) respect to ! m$ic9e1 b n yet         
effective1 is cancel$ & deem$ a nullity2
  7,b7 any pat5t waiv] t has tak5 effect
 "u ?is section ) respect to ! m$ic9e   
%all rema9 9 effect2  7,c7 any pat5t t]m
 ext5sion grant$ by ! ,director "u      
subsection 7e77#b7 ) respect to ! m$ic9e
 %all be cancel$1 except t ! ,director  
%all ma9ta9 ! pat5t t]m ext5sion = "o   
pat5t1 to be select$ by ! sponsor ( !   
m$ic9e1 = ! p]iod ( ext5sion t w\ld h   
be5 applicable "u section #aef ( title  
#ce1 ,unit$ ,/ates ,code2 &  7,d7 !     
designation1 if made1 o!rwise %all be   
treat$ z nev] hav+ be5 reque/$ or made  
or hav+ effect4  7#c7 ,basis =          
revocation ,! ,secret>y may revoke a    
designation made "u subsection 7a71 b   
only bas$ ^u a f9d+ by ! ,secret>y "u   
p>agraph 7#a74  7e7 ,gu>ante$           
protections = dormant !rapies  7#a7     
,applications fil$ dur+ ! protection    
p]iod ,dur+ ! protection p]iod = a      

dormant !rapy1 not)/&+ any o!r provision
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   
,act 7#ba ,u4,s4,c4 #cja et seq47 or !  
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bja et seq47-- 7,a7 abs5t a  
"r ( ref]5ce f ! hold] ( su* approv$    
application = ! dormant !rapy1 !        
,secret>y %all n approve an application 
fil$ pursuant to section #eje7;b77#b7 or
 section #eje7;j7 ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7;b77#b71 7j77 or section #cea7k7 ( 
! ,public ,heal? ,s]vice ,act 7#db      
,u4,s4,c4 #bfb7k77 ref]5c+ or o!rwise   
rely+ on ! approval or lic5sure ( !     
dormant !rapy2  7,b7 ! ,secret>y %all n 
approve-- 7i7 an application fil$       
pursuant to su* section #eje7;b77#b7 or 
#eje7;j7 t ref]5ces or o!rwise relies on
 ! approval or lic5sure ( a m$ic9e t is 
n ! dormant !rapy1 0 approv$ subsequ5t  
to ! approval ( ! dormant !rapy1 &      
conta9s ! same active moiety z ! active 
moiety 9 ! dormant !rapy 7or if !       
dormant !rapy conta9s m ?an "o active   

moiety1 all ( ! active moieties are !   
same72 or  7ii7 an application fil$     
pursuant to su* section #cea7k7 t       
ref]5ces or o!rwise relies on ! approval
 or lic5sure ( a m$ic9e t is n ! dormant
 !rapy1 0 approv$ subsequ5t to !        
approval or lic5sure ( ! dormant !rapy1 
& conta9s an active moiety t is highly  
simil> to ! active moiety 9 ! dormant   
!rapy 7or if ! dormant !rapy conta9s m  
?an "o active moiety1 all ( ! active    
moieties are highly simil>72 &  7,c7 !  
,secret>y %all n approve an application 
fil$ pursuant to section #eje7;b77#a7 ( 
! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 
7#ba ,u4,s4,c4 #cee7;b77#a77 = a drug t 
conta9s ! same active moiety z ! active 
moiety 9 ! dormant !rapy 7or if !       
dormant !rapy conta9s m ?an "o active   
moiety1 all ( ! active moieties are !   
same71 or an application fil$ pursuant  
to section #cea7;a7 ( ! ,public ,heal?  
,s]vice ,act 7#db ,u4,s4,c4 #bfb7;a77 = 
a biological product t conta9s an active
 moiety t is highly simil> to ! active  

moiety 9 ! dormant !rapy 7or if !       
dormant !rapy conta9s m ?an "o active   
moiety1 all ( ! active moieties are     
highly simil>71 unless-- 7i7 ! in=mation
 provid$ to support approval ( su*      
application is comp>able 9 scope &      
ext5t1 includ+ ) respect to design &    
ext5t ( precl9ical & cl9ical te/+1 to ! 
in=mation provid$ to support approval ( 
! application = ! dormant !rapy "u      
section #eje7;b7 ( ! ,f$]al ,food1 ,drug
 & ,cosmetic ,act 7#ba ,u4,s4,c4        
#cee7;b77 or section #cea7;a7 ( !       
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bfb7;a772 &  7ii7 if su*     
cl9ical te/+ _h n comm5c$ be=e !        
approval ( ! application = ! dormant    
!rapy1 ! cl9ical te/+ e/abli%es cl9ical 
sup]iority 9 ! =m ( a significant       
!rapeutic advantage ov] & above t       
provid$ by ! dormant !rapy 9 "o or m ( !
 foll[+ ways3 7,i7 ,great] effectiv5ess 
on a cl9ically mean+ful endpo9t4  7,,ii7
 ,great] safety 9 a sub/antial portion (
 ! t>get populations4  7,,iii7 ,:]e     

nei!r great] safety nor great]          
effectiv5ess has be5 %[n1 a demon/ration
 t ! drug o!rwise makes a major         
contribution to pati5t c>e4  7#b7 ,pat5t
 t]m alignm5t ) data package protection 
p]iod  7,a7 ,9 g5]al ,not)/&+ any       
provision ( title #ce1 ,unit$ ,/ates    
,code1 a sponsor ( a m$ic9e designat$ z 
a dormant !rapy "u subsection 7a77#a71  
^u ! approval or lic5sure !re( "u       
section #eje ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or  
section #cea ( ! ,public ,heal? ,s]vice 
,act 7#db ,u4,s4,c4 #bfb71 & 9 lieu (   
fil+ a pat5t t]m ext5sion application "u
 section #aef7;d7 ( su* title #ce1 %all 
be entitl$ to pat5t t]m ext5sions 9     
accordance ) ?is p>agraph4  7,b7        
,submission ( f9al li/+ ( pat5ts &      
applications = pat5ts foll[+ approval   
7i7 ,submission ,! sponsor ( ! dormant  
!rapy1 )9 a p]iod to be set by !        
,director ( n less ?an #b mon?s beg9n+  
on ! date ! ,secret>y approves or       
lic5ses ! dormant !rapy1 %all submit to 

! ,director-- 7,i7 ! li/+ ( pat5ts &    
applications = pat5ts provid$ to !      
,secret>y "u subsection 7b77#a72  7,,ii7
 any revisions to su* li/+ z may be     
requir$ = compliance ) subsection       
7b77#a72 &  7,,iii7 any docum5tation !  
,director may require f ! pat5tee or    
pat5t applicant 7z ! case may be7 ( !   
waiv] ( pat5t rights requir$ "u         
subsection 7b77#b74  7ii7 ,failure to   
provide suffici5t docum5tation ( waiv]  
,if ! ,director det]m9es t ! sponsor has
 n compli$ ) ! waiv] requirem5ts "u     
subsection 7c71 aft] provid+ ! sponsor !
 opportunity to rem$y any insuffici5cy1 
! ,director %all s notify ! ,secret>y t 
! pat5t waiv] requirem5ts = designation 
h n be5 satisfi$4  7,c7 ,ext5sion (     
pat5ts  7i7 ,9 g5]al ,unless ! ,director
 has notifi$ ! ,secret>y ( a det]m9ation
 "u subp>agraph 7,b77ii71 = ea* pat5t   
id5tifi$ 9 a submission pursuant to     
subp>agraph 7,b77i71 & = ea* pat5t issu+
 bas$ ^u an application = pat5t s       
id5tifi$1 ! ,director %all1 )9 ! #c-mon?

 p]iod beg9n+ on ! date ( ! submission1 
ext5d ! pat5t to expire at ! end ( !    
protection p]iod = ! dormant !rapy1 if !
 pat5t w\ld o!rwise expire be=e ! end ( 
! protection p]iod4 ,if ! ,director has 
s notifi$ ! ,secret>y "u subp>agraph    
7,b77ii71 ! ,director %all ext5d "o su* 
pat5t1 select$ by ! sponsor1 = ! p]iod t
 w\ld h be5 applicable _h an application
 = ext5sion be5 fil$ "u section #aef (  
title #ce1 ,unit$ ,/ates ,code1 )       
respect to su* pat5t4  7ii7 ,application
 ( c]ta9 provisions ,dur+ ! p]iod ( an  
ext5sion "u clause 7i7-- 7,i7 ! rights  
"u ! pat5t %all be limit$ 9 ! mann]     
provid$ "u section #aef7;b7 ( title #ce1
 ,unit$ ,/ates ,code2 &  7,,ii7 ! t]ms  
product & approv$ product 9 su* section 
#aef7;b7 %all be deem$ to include =ms ( 
! active moiety ( ! dormant !rapy &     
highly simil> active moieties t might be
 approv$ by ! ,secret>y bas$ ^u an      
application fil$ "u section #eje7;b77#b7
 or #eje7;j7 ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4           

#cee7;b77#b71 7j77 or "u section #cea7k7
 ( ! ,public ,heal? ,s]vice ,act 7#db   
,u4,s4,c4 #bfb7k77 t ref]5ces or o!rwise
 relies ^u ! dormant !rapy4  7,d7       
,int]im pat5t ext5sions ,not)/&+ any    
provision ( title #ce1 ,unit$ ,/ates    
,code1 ) respect to any pat5t li/$ 7or  
pat5t issu+ on an application li/$7 "u  
subsection 7b77#a7 t w\ld o!rwise expire
 be=e ! sponsor c\ld make a submission  
"u subp>agraph 7,b71 ! ,director1 ^u    
application ( ! pat5tee1 %all grant to !
 pat5tee an int]im ext5sion ( su* pat5t1
 subject to ! limitations 9 section     
#aef7;d77#e77;,f7 ( su* title #ce1 = su*
 p]iod z may be necess>y to p]mit !     
sponsor to submit ! li/+ "u subp>agraph 
7,b7 &1 if ! pat5t is !re9 li/$1 to     
ext5d ! pat5t z provid$ "u subp>agraph  
7,c74 ,! ,director may require1 = any   
pat5t ext5d$ "u ?is subp>agraph1 t !    
sponsor ( ! dormant !rapy to :i* ! pat5t
 relates provide p]iodic c]tifications t
 developm5t ( ! dormant !rapy is        
cont9u+4 ,! ,director may t]m9ate any   

int]im ext5sion = :i* a requir$         
c]tification has n be5 made4  7,e7      
,notice ( ext5sion ,= ea* pat5t t is    
ext5d$ "u ?is p>agraph1 ! ,director %all
 publi% a notice ( su* ext5sion & issue 
a c]tificate ( ext5sion describ$ 9      
section #aef7;e77#a7 ( title #ce1 ,unit$
 ,/ates ,code4  7,f7 ,notice ( waiv] ,= 
ea* pat5t id5tifi$ 9 a submission "u    
subp>agraph 7,b77i71 & ea* pat5t issu+  
bas$ ^u an application = pat5t s        
id5tifi$1 t expires aft] ! end ( !      
protection p]iod = ! dormant !rapy1 !   
,director %all publi% a notice t ! pat5t
 is subject to ! limit$ waiv] ( ! "r to 
en=ce describ$ 9 subsection 7c77#a74    
7f7 ,c]ta9 ,,fda protections            
inapplicable ,if a m$ic9e has be5       
designat$ z a dormant !rapy "u          
subsection 7a71 ! protections o!rwise   
applicable ) respect to su* m$ic9e "u   
sections #eje;,a1 #eje;,e1 & #ebg ( !   
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cee;a1 #cee;f1 #cfj;cc7 
%all n apply4 ,! prec$+ s5t5ce %all n be

 con/ru$ to affect any protections      
applicable ) respect to a drug1 includ+ 
a drug designat$ "u section #ebf ( su*  
,act 7#ba ,u4,s4,c4 #cfj;bb7 = a r>e    
disease or condition1 "u provisions o!r 
?an su* sections #eje;,a1 #eje;,e1 &    
#ebg4  7g7 ,developm5t c]tifications    
7#a7 ,9 g5]al ,! ,secret>y %all require 
t ! sponsor ( a dormant !rapy provide   
p]iodic c]tifications t developm5t ( !  
dormant !rapy to address "o or m unmet  
m$ical ne$s is cont9u+4  7#b7           
,det]m9ation ( noncompliance ,if !      
,secret>y concludes t ! sponsor has n   
compli$ ) p>agraph 7#a71 aft] provid+ ! 
sponsor ! opportunity to rem$y any      
insuffici5cy1 ! ,secret>y %all1 =       
purposes ( subsection 7d77#a71 det]m9e t
 ! sponsor is n 9 compliance ) !        
c]tification requirem5t "u p>agraph     
7#a74  7h7 ,collaboration ,no?+ 9 ?is   
section %all be con/ru$ z prev5t+ a     
sponsor f collaborat+ ) o!r entities 9  
develop+ a dormant !rapy or apply+ = a  
dormant !rapy designation4  7i7         

,def9itions ,= purposes ( ?is section3  
7#a7 ,! t]m address "o or m unmet m$ical
 ne$s ref]s to-- 7,a7 address+ a ne$ =  
m$ic9es = ! treatm5t ( "o or m          
life-?reat5+ or o!r s]i\s diseases or   
conditions = :i* no !rapy exi/s2 or     
7,b7 if "o or m !rapies are available = 
! treatm5t ( su* a disease or condition1
 demon/rat+ ?r\gh cl9ical               
inve/igations-- 7i7 "o or m improv$     
effects on s]i\s outcomes ( ! disease or
 condition t are affect$ by alt]native  
!rapies1 su* z sup]iority ( ! m$ic9e us$
 alone or 9 comb9ation ) o!r !rapies 9  
an active controll$ trial assess+ an    
endpo9t reflect+ s]i\s morbidity2  7ii7 
"o or m effects on s]i\s outcomes ( !   
disease or condition n kn[n to be       
affect$ by alt]native !rapies1 su* z    
progressive disability 9 multiple       
scl]osis :5 alt]native !rapies h %[n an 
effect on exac]bations b h n %[n an     
effect on progressive disability2  7iii7
 an ability-- 7,i7 to provide "o or m   
b5efits 9 pati5ts :o are unable to      

tol]ate or are unresponsive to          
alt]native !rapies1 su* z an            
antipsy*otic ag5t t is effective 9 p    
fail+ /&>d !rapy2 or  7,,ii7 to be us$  
effectively 9 comb9ation ) o!r critical 
ag5ts t _c be comb9$ ) alt]native       
!rapies2  7iv7 an ability to provide "o 
or m b5efits simil> to ^? ( alt]native  
!rapies :ile-- 7,i7 avoid+ s]i\s        
toxicity t is pres5t 9 alt]native       
!rapies2 or  7,,ii7 avoid+ less s]i\s   
toxicity t is common 9 alt]native       
!rapies & causes discont9uation (       
treatm5t ( a life-?reat5+ or s]i\s      
disease2 or  7v7 an ability to provide  
"o or m b5efits simil> to ^? (          
alt]native !rapies b ) improvem5t 9 "s  
factor1 su* z compliance or conv5i5ce1 t
 is %[n to lead to improv$ effects on   
s]i\s outcomes4  7#b7 ,! t]m ,director  
means ! ,"u ,secret>y ( ,comm]ce =      
,intellectual ,prop]ty & ,director ( !  
,unit$ ,/ates ,pat5t & ,tradem>k ,(fice4
  7#c7 ,! t]m dormant !rapy means a     
m$ic9e designat$ z a dormant !rapy "u   

subsection 7a74  7#d7 ,! t]m protection 
p]iod = a dormant !rapy means ! p]iod   
t-- 7,a7 beg9s on ! date on :i* !       
,secret>y fir/ approves an application  
"u section #eje7;b7 ( ! ,f$]al ,food1   
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee7;b77 or section #cea7;a7 ( !       
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bfb7;a77 = ! dormant !rapy = 
any indication2 &  7,b7 ends on ! date t
 is #ae ye>s aft] ! date ( su* approval4
  7#e7 ,! t]m sponsor = a dormant !rapy 
is ! p]son :o takes responsibility = !  
designation & developm5t ( ! dormant    
!rapy4 ,! sponsor may be a s+le entity  
or an entity collaborat+ ) "o or m o!r  
entities4  #bjb4 ,/udy reg>d+ new       
indications = exi/+ !rapies ,n lat] ?an 
"o ye> aft] ! date ( ! enactm5t ( ?is   
,act1 ! ,secret>y %all ent] into an     
arrangem5t ) ! ,in/itute ( ,m$ic9e 7or1 
if ! ,in/itute decl9es1 ano!r           
appropriate entity7-- 7#a7 to conduct a 
/udy on intellectual prop]ty laws & _!  
impact on !rapy & diagno/ic developm5t 9

 ord] to =mulate recomm5dations on h[ to
 facilitate ! cl9ical evaluation &      
developm5t ( !rapies curr5tly available 
on ! m>ket = new pot5tial indications2 &
  7#b7 n lat] ?an #ah mon?s aft] su*    
date ( ! enactm5t1 to submit a report to
 ! ,secret>y & ! ,congress conta9+ !    
results ( su* /udy4