,,ii  #aag? ,,congress  #b;d ,session   
,s4 #dddf  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,june #bb1 #bjbb,ms4   
,coll9s 7= h]self & ,mr4 ,ka9e7         
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to mod]nize ! process (     
accel]at$ approval ( a drug = a s]i\s or
 life-?reat5+ disease or condition4  #a4
 ,%ort title ,?is ,act may be cit$ z !  
,mod]niz+ ! ,accel]at$ ,approval ,pa?way
 ,act ( #bjbb4  #b4 ,mod]niz+ accel]at$ 
approval  7a7 ,9 g5]al ,section #ejf7;c7
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   
,act 7#ba ,u4,s4,c4 #cef7;c77 is am5d$--
 7#a7 9 p>agraph 7#b7-- 7,a7 by         
r$esignat+ subp>agraphs 7,a7 & 7,b7 z   
clauses 7i7 & 7ii71 respectively1 &     
adju/+ ! m>g9s accord+ly2  7,b7 by /rik+
 ,approval ( a product & ins]t+ !       
foll[+3  7,a7 ,9 g5]al ,approval ( a    
product  2  7,c7 9 clause 7i7 ( su*     
subp>agraph 7,a71 z s r$esignat$1 by    
/rik+ appropriate po/approval /udies &  

ins]t+ an appropriate po/approval /udy  
or /udies 7:i* may be augm5t$ or        
support$ by real _w evid5ce72 &  7,d7 by
 add+ at ! end ! foll[+3  7,b7 ,/udies n
 requir$ ,if ! ,secret>y does n require 
t ! sponsor ( a product approv$ "u      
accel]at$ approval conduct a po/approval
 /udy "u ?is p>agraph1 ! ,secret>y %all 
publi% on ! website ( ! ,food & ,drug   
,adm9i/ration ! rationale = :y su* /udy 
is n appropriate or necess>y4  7,c7     
,po/approval /udy conditions ,n lat] ?an
 ! "t ( approval ( a product "u         
accel]at$ approval1 ! ,secret>y %all    
specify ! conditions = a po/approval    
/udy or /udies requir$ to be conduct$ "u
 ?is p>agraph ) respect to su* product1 
:i* may include enrollm5t t>gets1 ! /udy
 protocol1 & mile/ones1 includ+ ! t>get 
date ( /udy completion4  7,d7 ,/udies   
,begun ,be=e ,approval ,! ,secret>y may 
require su* /udy or /udies to be und]way
 prior to approval4  2 &  7#b7 9        
p>agraph 7#c7-- 7,a7 by r$esignat+      
subp>agraphs 7,a7 ?r\gh 7,d7 z clauses  

7i7 ?r\gh 7iv71 respectively1 & adju/+ !
 m>g9s accord+ly2  7,b7 by /rik+ ,!     
,secret>y may & ins]t+ ! foll[+3  7,a7  
,9 g5]al ,! ,secret>y may  2  7,c7 9    
clause 7i7 ( su* subp>agraph 7,a71 z s  
r$esignat$1 by /rik+ drug ) due dilig5ce
 & ins]t+ product ) due dilig5ce1       
includ+ ) respect to conditions specifi$
 by ! ,secret>y "u p>agraph 7#b77;,c72  
7,d7 9 clause 7iii7 ( su* subp>agraph   
7,a71 z s r$esignat$1 by ins]t+ %[n to  
be aft] product is n2 &  7,e7 by add+ at
 ! end ! foll[+3  7,b7 ,exp$it$         
proc$ures describ$ ,exp$it$ proc$ures   
describ$ 9 ?is subp>agraph %all consi/  
(1 prior to ! )drawal ( accel]at$       
approval-- 7i7 provid+ ! sponsor )--    
7,i7 due notice2  7,,ii7 an explanation 
= ! propos$ )drawal2  7,,iii7 an        
opportunity = a meet+ ) ! ,commission]  
or ! ,commission]'s designee2 &  7,,iv7 
an opportunity = writt5 appeal to-- 7aa7
 ! ,commission]2 or  7bb7 a designee ( !
 ,commission] :o has n p>ticipat$ 9 !   
proposal )drawal ( approval 7o!r ?an a  

meet+ pursuant to subclause 7,,iii77 &  
is n subord9ate ( an individual 7o!r ?an
 ! ,commission]7 :o p>ticipat$ 9 su*    
propos$ )drawal2  7ii7 provid+ an       
opportunity = public comm5t on ! propos+
 to )drawal approval2  7iii7 !          
publication ( a summ>y ( ! public       
comm5ts receiv$1 & ! ,secret>y's        
response to su* comm5ts1 on ! website ( 
! ,food & ,drug ,adm9i/ration2 &  7iv7  
conv5+ & consult+ an advisory committee 
on issues relat$ to ! propos$ )drawal1  
if reque/$ by ! sponsor & if no su*     
advisory committee has previ\sly advis$ 
! ,secret>y on su* issues ) respect to !
 )drawal ( ! product prior to !         
sponsor's reque/4  4  7b7 ,reports (    
po/m>ket+ /udies ,section #ejf;,b7a7 ( !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act  
7#ba ,u4,s4,c4 #cef;b7a77 is am5d$--    
7#a7 by r$esignat+ p>agraph 7#b7 z      
p>agraph 7#c72 &  7#b7 by ins]t+ aft]   
p>agraph 7#a7 ! foll[+3  7#b7 ,accel]at$
 approval ,not)/&+ p>agraph 7#a71 a     
sponsor ( a drug approv$ "u accel]at$   

approval %all submit to ! ,secret>y a   
report ( ! progress ( any /udy requir$  
"u section #ejf7;c71 includ+ progress   
t[>d enrollm5t t>gets1 mile/ones1 & o!r 
in=mation z requir$ by ! ,secret>y1 n   
lat] ?an #ahj days aft] ! approval ( su*
 drug & n less frequ5tly ?an e #ahj days
 !reaft]1 until ! /udy is complet$ or   
t]m9at$4 ,! ,secret>y %all promptly     
publi% on ! website ( ! ,food & ,drug   
,adm9i/ration ! in=mation s report$1 9  
an easily se>*able =mat4  4  7c7        
,en=cem5t ,section #cja ( ! ,f$]al      
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cca71 is am5d$ by add+ at !  
end ! foll[+3  7fff7 ,! failure ( a     
sponsor ( a product approv$ "u accel]at$
 approval pursuant to section #ejf7;c7--
 7#a7 to conduct ) due dilig5ce any     
po/approval /udy requir$ "u section     
#ejf7;c7 ) respect to su* product2 or   
7#b7 to submit timely reports ) respect 
to su* product 9 accordance ) section   
#ejf;,b7a77#b74  4  7d7 ,guidance  7#a7 
,9 g5]al ,! ,secret>y ( ,heal? & ,human 

,s]vices %all issue guidance describ+-- 
7,a7 h[ sponsor que/ions relat$ to !    
id5tification ( novel surrogate or      
int]m$iate cl9ical endpo9ts may be      
address$ 9 e>ly-/age developm5t meet+s )
 ! ,food & ,drug ,adm9i/ration2  7,b7 ! 
use ( novel cl9ical trial designs t may 
be us$ to conduct appropriate           
po/-approval /udies z may be requir$ "u 
section #ejf7;c77#b77;,a7 ( ! ,f$]al    
,food1 ,drug1 & ,cosmetic ,act1 z am5d$ 
by subsection 7a72  7,c7 ! exp$it$      
proc$ures describ$ 9 section            
#ejf7;c77#c77;,b7 ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act2 &  7,d7        
consid]ations relat$ to ! use (         
surrogate or int]m$iate cl9ical endpo9ts
 t may support ! accel]at$ approval ( an
 application "u #ejf7;c77#a77;,a71      
includ+ consid]ations 9 evaluat+ !      
evid5ce relat$ to any su* endpo9ts4     
7#b7 ,f9al guidance ,! ,secret>y %all   
issue-- 7,a7 draft guidance "u p>agraph 
7#a7 n lat] ?an #ah mon?s aft] ! date ( 
enactm5t ( ?is ,act2 &  7,b7 f9al       

guidance n lat] ?an #a ye> aft] ! close 
( ! public comm5t p]iod on su* draft    
guidance4  7e7 ,r>e disease endpo9t     
advancem5t pilot  7#a7 ,9 g5]al ,!      
,secret>y ( ,heal? & ,human ,s]vices    
%all e/abli% a pilot program "u :i* !   
,secret>y w e/abli% proc$ures to provide
 increas$ int]action ) sponsors ( r>e   
disease drug developm5t programs =      
purposes ( advanc+ ! developm5t (       
efficacy endpo9ts1 includ+ surrogate &  
int]m$iate endpo9ts1 = drugs int5d$ to  
treat r>e diseases1 includ+ ?r\gh-- 7,a7
 det]m9+ eligibility ( p>ticipants = su*
 program2 &  7,b7 develop+ & implem5t+ a
 process = apply+ to1 & p>ticipat+ 91   
su* a program4  7#b7 ,public work%ops ,!
 ,secret>y %all conduct up to #c public 
work%ops1 :i* %all be complet$ n lat]   
?an ,septemb] #cj1 #bjbf1 to discuss    
topics relevant to ! developm5t (       
endpo9ts = r>e diseases1 :i* may include
 discussions ab\t-- 7,a7 novel endpo9ts 
develop$ ?r\gh ! pilot program e/abli%$ 
"u ?is subsection2 &  7,b7 z            

appropriate1 ! use ( real _w evid5ce &  
real "w data to support ! validation (  
efficacy endpo9ts1 includ+ surrogate &  
int]m$iate endpo9ts1 = r>e diseases4    
7#c7 ,report ,n lat] ?an ,septemb] #cj1 
#bjbg1 ! ,secret>y %all submit to !     
,committee on ,en]gy & ,comm]ce ( !     
,h\se ( ,repres5tatives & ! ,committee  
on ,heal?1 ,education1 ,labor1 &        
,p5sions ( ! ,s5ate a report describ+ ! 
outcomes ( ! pilot program e/abli%$ "u  
?is subsection4  7#d7 ,guidance ,n lat] 
?an ,septemb] #cj1 #bjbg1 ! ,secret>y   
%all issue guidance describ+ be/        
practices & /rategies = developm5t (    
efficacy endpo9ts1 includ+ surrogate &  
int]m$iate endpo9ts1 = r>e diseases4    
7#e7 ,sunset ,! ,secret>y may n accept  
any new application or reque/ to        
p>ticipate 9 ! program e/abli%$ by ?is  
subsection on or aft] ,octob] #a1 #bjbg4
  7f7 ,accel]at$ approval c\ncil  7#a7  
,g5]al ,n lat] ?an #ahj days aft] ! date
 ( enactm5t ( ?is ,act1 ! ,secret>y (   
,heal? & ,human ,s]vices %all e/abli% an

 intra-ag5cy coord9at+ c\ncil )9 ! ,food
 & ,drug ,adm9i/ration to ensure !      
consi/5t & appropriate use ( accel]at$  
approval across ! ,food & ,drug         
,adm9i/ration1 pursuant to section      
#ejf7;c7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act 7#ba ,u4,s4,c4 #cef7;c774
  7#b7 ,memb]%ip ,! memb]s ( ! ,c\ncil  
%all consi/ ( ! foll[+ s5ior (ficials1  
or a designee ( su* (ficial1 f ! ,food &
 ,drug ,adm9i/ration & relevant ,c5t]s3 
7,a7 ,! ,director ( ! ,c5t] = ,drug     
,evaluation & ,rese>*4  7,b7 ,!         
,director ( ! ,c5t] = ,biologics        
,evaluation & ,rese>*4  7,c7 ,!         
,director ( ! ,oncology ,c5t] (         
,excell5ce4  7,d7 ,! ,director ( !      
,(fice ( ,new ,drugs4  7,e7 ,! ,director
 ( ! ,(fice ( ,orphan ,products         
,developm5t4  7,f7 ,! ,director ( !     
,(fice ( ,tissues & ,advanc$ ,!rapies4  
7,g7 ,! ,director ( ! ,(fice ( ,m$ical  
,policy4  7,h7 ,at lea/ #c directors (  
review division ov]see+ products approv$
 "u accel]at$ approval1 includ+ at lea/ 

"o director ( a review division )9 !    
,(fice ( ,neurosci5ce4  7#c7 ,duties ( !
 c\ncil  7,a7 ,meet+s ,! ,c\ncil %all   
conv5e n few] ?an #c times p] cal5d> ye>
 to discuss issues relat$ to accel]at$  
approval1 includ+ any relevant          
cross-discipl9>y approa*es relat$ to    
product review ) respect to accel]at$   
approval4  7,b7 ,policy developm5t ,!   
,c\ncil %all directly engage ) product  
review teams to support ! consi/5t &    
appropriate use ( accel]at$ approval    
across ! ,food & ,drug ,adm9i/ration4   
,su* activities may include-- 7i7       
develop+ guidance = ,food & ,drug       
,adm9i/ration /aff & be/ practices =1 & 
across1 product review teams1 includ+ ) 
respect to communication betwe5 sponsors
 & ! ,food & ,drug ,adm9i/ration & !    
review ( products "u accel]at$ approval2
  7ii7 provid+ tra9+ = product review   
teams2 &  7iii7 advis+ review divisions 
on product-specific developm5t1 review1 
& )drawal ( products "u accel]at$       
approval4  7#d7 ,publication ( a report 

,n lat] ?an #a ye> aft] ! date (        
enactm5t ( ?is ,act1 & annually !reaft]1
 ! c\ncil %all publi% on ! public       
website ( ! ,food & ,drug ,adm9i/ration 
a report on ! activities ( ! c\ncil4    
7g7 ,rule ( con/ruction ,no?+ 9 ?is     
section 7includ+ ! am5dm5ts made by ?is 
section7 %all be con/ru$ to affect      
products approv$ pursuant to #ejf7;c7 ( 
! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 
7#ba ,u4,s4,c4 #cef7;c77 prior to ! date
 ( enactm5t ( ?is ,act4