,i  #aac? ,,congress  #b;d ,session  ,h4
 ,r4 #ddid  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,april #bh1 #bjad ,ms4
 ,de,gette 7= h]self & ,mr4 ,pauls57    
introduc$ ! foll[+ bill2 :i* 0 ref]r$ to
 ! ,committee on ,en]gy & ,comm]ce  ,a  
,,bill  ,to laun* a national /rategy to 
support reg5]ative m$ic9e ?r\gh fund+ = 
rese>* & comm]cial developm5t (         
reg5]ative m$ic9e products & developm5t 
( a regulatory environm5t t enables     
rapid approval ( safe & effective       
products1 & = o!r purposes4  #a4 ,%ort  
title2 table ( cont5ts  7a7 ,%ort title 
,?is ,act may be cit$ z ! ,reg5]ative   
,m$ic9e ,promotion ,act ( #bjad4  7b7   
,table ( cont5ts ,! table ( cont5ts (   
?is ,act is z foll[s3  ,sec4 #a4 ,%ort  
title2 table ( cont5ts4 ,sec4 #b4       
,f9d+s4 ,sec4 #c4 ,report on ongo+      
,f$]al programs & activities reg>d+     
reg5]ative m$ic9e4 ,sec4 #d4 ,e/abli%m5t
 ( ,reg5]ative ,m$ic9e ,coord9at+       
,c\ncil4 ,sec4 #e4 ,grants = basic or   
precl9ical rese>* into reg5]ative       

m$ic9e4 ,sec4 #f4 ,grants = developm5t (
 drugs1 biological products1 m$ical     
devices1 & biomat]ials = use 9          
reg5]ative m$ic9e4 ,sec4 #g4 ,support+  
innovation 9 reg5]ative m$ic9e ?r\gh    
cures accel]ation network4 ,sec4 #h4    
,fund+ = ,food & ,drug ,adm9i/ration    
rese>*4  #b4 ,f9d+s ,congress f9ds !    
foll[+3  7#a7 ,reg5]ative m$ic9e has !  
pot5tial to treat _m *ronic diseases1   
promote economic gr[?1 & r$uce heal? c>e
 sp5d+ 9 ! ,unit$ ,/ates4  7#b7         
,reg5]ative m$ic9e products h already   
successfully treat$ num]\s heal?        
conditions1 & h ! pot5tial to provide   
cures1 treatm5ts1 & diagno/ics = a range
 ( diseases & disabilities includ+      
diabetes1 sp9al cord injury1 he>t       
disease1 /roke1 & v>i\s =ms ( canc]4    
7#c7 ,a ,unit$ ,/ates national /rategy  
on reg5]ative m$ic9e is critical to     
ensure t ?is te*nology fulfills its     
pot5tial to cure & treat diseases &     
disabilities1 r$uce ov]all heal? sp5d+1 
& promote economic gr[?4  7#d7 ,!       

,dep>tm5t ( ,def5se has /at$ t          
reg5]ative m$ic9e has ! pot5tial to     
treat _m battlefield injuries su* z     
burns1 t x has ! pot5tial to heal w\nds 
)\t sc>r+1 & t x has ! pot5tial to be   
us$ = traumatic bra9 injury & o!r =ms ( 
trauma1 crani(acial recon/ruction1 limb 
recon/ruction1 reg5]ation1 &            
transplantation4  7#e7 ,! ,dep>tm5t (   
,heal? & ,human ,s]vices & !            
,multi-,ag5cy ,tissue ,eng9e]+ ,sci5ce  
,int]ag5cy ,work+ ,gr\p h endors$ a     
national initiative to support rese>* & 
product developm5t 9 reg5]ative m$ic9e4 
7#f7 ,! ,dep>tm5t ( ,heal? & ,human     
,s]vices has said ! pot5tial b5efits (  
reg5]ative m$ic9e 9 improv$ heal? c>e & 
economic sav+s are enorm\s4 ,/ates t h  
inve/$ 9 reg5]ative m$ic9e h exp]i5c$   
economic gr[? & see future gr[?         
pot5tial1 includ+ an increase 9 biote*  
employm5t1 payroll increases1 &         
proportional impacts on tax receipts4   
#c4 ,report on ongo+ ,f$]al programs &  
activities reg>d+ reg5]ative m$ic9e ,n  

lat] ?an #ahj days aft] ! date ( !      
enactm5t ( ?is ,act1 ! ,comptroll]      
,g5]al ( ! ,unit$ ,/ates %all provide = 
! completion1 & submission to !         
,congress1 ( a report id5tify+ all ongo+
 ,f$]al programs & activities reg>d+    
reg5]ative m$ic9e4  #d4 ,e/abli%m5t (   
,reg5]ative ,m$ic9e ,coord9at+ ,c\ncil  
7a7 ,e/abli%m5t ,! ,secret>y ( ,heal? & 
,human ,s]vices %all e/abli%1 )9 six    
mon?s ( ! enactm5t ( ?is ,act1 9 !      
,(fice ( ! ,secret>y1 a ,reg5]ative     
,m$ic9e ,coord9at+ ,c\ncil 79 ?is       
section ref]r$ to z ! ,c\ncil74  7b7    
,composition ,! ,c\ncil %all be compos$ 
( ! foll[+3  7#a7 ,! ,secret>y (        
,comm]ce4  7#b7 ,! ,secret>y ( ,def5se4 
7#c7 ,! ,secret>y ( ,heal? & ,human     
,s]vices4  7#d7 ,! ,secret>y ( !        
,treasury4  7#e7 ,! ,secret>y ( ,vet]ans
 ,affairs4  7#f7 ,! ,adm9i/rator ( !    
,ag5cy = ,heal?c>e ,rese>* & ,quality4  
7#g7 ,! ,adm9i/rator ( ! ,c5t]s =       
,m$ic>e  ,m$icaid ,s]vices4  7#h7 ,!    
,commission] ( ,food & ,drugs4  7#i7 ,! 

,director ( ! ,national ,in/itutes (    
,heal?4  7#aj7 ,! ,director ( !         
,national ,in/itutes ( ,/&>ds &         
,te*nology4  7#aa7 ,! memb]s appo9t$ by 
! ,secret>y "u subsection 7d74  7c7     
,*air ,! ,secret>y ( ,heal? & ,human    
,s]vices %all be ! ,*air ( ! ,c\ncil4   
7d7 ,memb]s appo9t$ by secret>y ,!      
,secret>y %all appo9t at lea/ #e p]sons 
to s]ve z memb]s ( ! ,c\ncil "u         
subsection 7b77#aa74 ,! memb]s ( !      
,c\ncil appo9t$ "u ! prec$+ s5t5ce %all 
include p]sons ) exp]tise 9 ?ird-p>ty   
paym5t1 reg5]ative m$ic9e rese>*]s f    
academic in/itutions1 pati5t advocates1 
p]sons ) exp]tise 9 drug discov]y1      
p]sons ) exp]tise 9 drug developm5t1    
p]sons ) exp]tise 9 basic rese>*1 p]sons
 ) exp]tise 9 translational rese>*1     
p]sons ) exp]tise 9 m$ical device       
developm5t1 p]sons ) exp]tise 9         
biomat]ials1 cl9icians1 & p]sons )      
exp]tise 9 cl9ical rese>*4  7e7         
,functions ,! ,c\ncil %all--  7#a7      
consult )1 & provide in=mation to1 !    

,secret>y ( ,heal? & ,human ,s]vices =  
purposes ( implem5t+ any recomm5dations 
9 ! report requir$ by section #c2  7#b7 
prep>e1 & keep up-to-date1 a national   
/rategy to support rese>* into          
reg5]ative m$ic9e & ! developm5t (      
drugs1 biological products1 m$ical      
devices1 & biomat]ials = use 9          
reg5]ative m$ic9e2  7#c7 prep>e a plan  
specify+ priorities = rese>* into       
reg5]ative m$ic9e2  7#d7 n lat] ?an #a  
ye> aft] ! date ( ! enactm5t ( ?is ,act1
 e/abli% priorities = ! aw>d ( grants "u
 sections #e & #f 7relat+ to grants =   
basic or precl9ical rese>* into         
reg5]ative m$ic9e & = developm5t (      
drugs1 biological products1 m$ical      
devices1 & biomat]ials = use 9          
reg5]ative m$ic9e1 respectively72  7#e7 
id5tify s\rces ( fund+ = rese>* into    
reg5]ative m$ic9e2  7#f7 id5tify areas  
:]e su* fund+ is inadequate2  7#g7 make 
recomm5dations reg>d+ ,f$]al regulatory1
 reimbursem5t1 tax1 & o!r policies t w  
support developm5t & m>ket+ ( reg5]ative

 m$ic9e products2  7#h7 facilitate      
developm5t ( cons5sus /&>ds reg>d+      
sci5tific issues critical to regulatory 
approval ( reg5]ative m$ic9e products2 &
  7#i7 det]m9e ! ne$ = e/abli%+ c5t]s ( 
excell5ce or consortia to fur!r advance 
reg5]ative m$ic9e4  7f7 ,transp>5cy2    
report+ requirem5ts  7#a7 ,transp>5cy ,!
 ,c\ncil %all adopt proc$ures to ensure 
! receipt ( public input1 su* z hold+   
public /akehold] meet+s or creat+       
advisory bo>ds4  7#b7 ,annual reports ,!
 ,c\ncil %all submit an annual report on
 its activities to ! ,congress1 !       
,director ( ! ,national ,in/itutes (    
,heal?1 & ! ,commission] ( ,food &      
,drugs4 ,ea* su* report %all--  7,a7    
provide details on progress 9 meet+     
goals id5tifi$ by ! ,c\ncil = reg5]ative
 m$ic9e2  7,b7 make recomm5dations      
reg>d+ fund+1 regulatory1 or o!r        
policies to a*ieve reg5]ative m$ic9e    
goals id5tifi$ by ! ,c\ncil2  7,c7      
id5tify all reg5]ative m$ic9e products  
curr5tly on ! m>ket & ^? 9 developm5t2  

7,d7 id5tify reg5]ative m$ic9e rese>* & 
te*nological advances & discov]ies t    
occurr$ 9 ! previ\s ye>2 &  7,e7 assess 
! impact ( reg5]ative m$ic9e on !       
,nation's economy1 includ+ ) respect    
to--  7i7 ! numb] ( p employ$ 9         
companies or rese>* in/itutions work+ 9 
reg5]ative m$ic9e2  7ii7 ! numb] (      
companies pursu+ reg5]ative m$ic9e      
products2  7iii7 increases 9 tax        
rev5ues2 &  7iv7 ! impact on national   
heal? sp5d+4  #e4 ,grants = basic or    
precl9ical rese>* into reg5]ative m$ic9e
  7a7 ,grants = basic or precl9ical     
rese>* ,! ,secret>y may make grants to  
eligible entities = ! purpose ( fund+   
basic or precl9ical rese>* into         
reg5]ative m$ic9e4  7b7 ,conditions ,!  
,secret>y may make a grant "u ?is       
section = rese>* only if--  7#a7 !      
rese>* is c>ri$ out directly by ! grant 
recipi5t2  7#b7 ! rese>* is p>tly fund$ 
by "o or m private entities2 &  7#c7 !  
am\nt ( ! grant does n exce$ ! total    
am\nt provid$ = ! rese>* by private     

entities 7o!r ?an ! grant recipi5t      
itself74  7c7 ,t]ms & conditions ,a     
grant "u ?is section may be made on su* 
t]ms & conditions z ! ,secret>y det]m9es
 appropriate4  7d7 ,priority ,9 aw>d+   
grants "u ?is section1 ! ,secret>y %all 
take into consid]ation ! priorities     
e/abli%$ by ! ,reg5]ative ,m$ic9e       
,coord9at+ ,c\ncil "u section #d7;e74   
7e7 ,def9itions ,9 ?is section3  7#a7 ,!
 t]m eligible entity means a nonpr(it   
entity or an in/itution ( high]         
education4  7#b7 ,! t]m in/itution (    
high] education has ! mean+ giv5 t t]m 9
 section #aja ( ! ,high] ,education ,act
 ( #aife 7#bj ,u4,s4,c4 #ajja74  7#c7 ,!
 t]m nonpr(it entity means an entity t--
  7,a7 is describ$ 9 section            
#eja7;c77#c7 ( ! ,int]nal ,rev5ue ,code 
( #aihf 7#bf ,u4,s4,c4 #eja7;c77#c772 & 
7,b7 is exempt f tax "u section #eja7;a7
 ( ! ,int]nal ,rev5ue ,code ( #aihf 7#bf
 ,u4,s4,c4 #eja7;a774  7#d7 ,! t]m      
,secret>y means ! ,secret>y ( ,heal? &  
,human ,s]vices1 act+ ?r\gh ! ,director 

( ! ,national ,in/itutes ( ,heal?4  #f4 
,grants = developm5t ( drugs1 biological
 products1 m$ical devices1 & biomat]ials
 = use 9 reg5]ative m$ic9e  7a7 ,grants 
= drug developm5t ,! ,secret>y may make 
grants to eligible entities = ! purpose 
( fund+ projects t h z _! aim--  7#a7 ! 
rese>* & developm5t ( drugs1 biological 
products1 m$ical devices1 & biomat]ials 
= use 9 reg5]ative m$ic9e2 &  7#b7 !    
mak+ ( an inve/igational new drug       
application ) respect to su* drugs or   
biological products1 or ! mak+ ( an     
inve/igational device exemption         
application ) respect to su* devices1 by
 n lat] ?an ! end ( ! #d-ye> p]iod      
beg9n+ on ! date on :i* su* grant is    
made4  7b7 ,t]ms & conditions ,a grant  
"u ?is section may be made on su* t]ms &
 conditions z ! ,secret>y det]m9es      
appropriate4  7c7 ,priority ,9 aw>d+    
grants "u ?is section1 ! ,secret>y %all 
take into consid]ation ! priorities     
e/abli%$ by ! ,reg5]ative ,m$ic9e       
,coord9at+ ,c\ncil "u section #d7;e74   

7d7 ,def9itions ,9 ?is section3  7#a7 ,!
 t]m biological product has ! mean+ giv5
 ! t]m 9 section #cea7;i7 ( ! ,public   
,heal? ,s]vice ,act 7#db ,u4,s4,c4      
#bfb7;i774  7#b7 ,! t]ms drug & m$ical  
device h ! mean+s giv5 to ! t]ms drug & 
device1 respectively1 9 section #bja ( !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act  
7#ba ,u4,s4,c4 #cba74  7#c7 ,! t]m      
eligible entity means a collaborative   
p>tn]%ip includ+--  7,a7 a qualifi$     
nonpr(it entity or an in/itution ( high]
 education2 &  7,b7 a =-pr(it entity4   
7#d7 ,! t]m in/itution ( high] education
 has ! mean+ giv5 t t]m 9 section #aja (
 ! ,high] ,education ,act ( #aife 7#bj  
,u4,s4,c4 #ajja74  7#e7 ,! t]m          
inve/igational new drug application     
means an inve/igational new drug        
application t is made to ! ,food & ,drug
 ,adm9i/ration "u section #eje7;i7 ( !  
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #eje7;i774  7#f7 ,! t]m  
inve/igational device exemption         
application means an application = an   

inve/igational device exemption t is    
made to ! ,food & ,drug ,adm9i/ration "u
 section #ebj7;g7 ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cfj;j7g774  7#g7 ,! t]m qualifi$       
nonpr(it entity means an entity t--     
7,a7 is describ$ 9 section #eja7;c77#c7 
( ! ,int]nal ,rev5ue ,code ( #aihf 7#bf 
,u4,s4,c4 #eja7;c77#c772 &  7,b7 is     
exempt f tax "u section #eja7;a7 ( !    
,int]nal ,rev5ue ,code ( #aihf 7#bf     
,u4,s4,c4 #eja7;a774  7#h7 ,! t]m       
,secret>y means ! ,secret>y ( ,heal? &  
,human ,s]vices1 act+ ?r\gh ! ,director 
( ! ,national ,in/itutes ( ,heal?4  #g4 
,support+ innovation 9 reg5]ative m$ic9e
 ?r\gh cures accel]ation network        
,section #dhj ( ! ,public ,heal? ,s]vice
 ,act 7#db ,u4,s4,c4 #bhg;a7 is am5d$-- 
7#a7 9 subsection 7d71 by add+ at ! end 
! foll[+3  7#g7 ,collaboration ,)       
respect to activities ( ! ,bo>d relat+  
to m$ical products & behavioral !rapies 
= use 9 reg5]ative m$ic9e1 ! ,bo>d %all 
collaborate ) ! ,reg5]ative ,m$ic9e     

,coord9at+ ,c\ncil4  2 &  7#b7 9        
subsection 7e77#c71 by add+ at ! end !  
foll[+3  7,d7 ,! cures accel]ation aw>ds
 ) respect to products & !rapies = use 9
 reg5]ative m$ic9e ,! ,director ( ,,nih 
may1 )\t reg>d to subp>agraphs 7,a71    
7,b71 & 7,c71 provide assi/ance "u      
p>agraph 7#a7 ) respect to m$ical       
products & behavioral !rapies = use 9   
reg5]ative m$ic9e1 includ+ assi/ance--  
7i7 to p]=m cl9ical trials "u a protocol
 approv$ by ! ,commission] ( ,food &    
,drugs or /udies :i* use good           
manufactur+ practice or good laboratory 
practice proc$ures & ! data f :i* are   
int5d$ = inclusion 9 an inve/igational  
new drug application or an              
inve/igational device exemption         
application2 or  7ii7 to p]=m basic     
rese>* or precl9ical /udies 9 reg5]ative
 m$ic9e ! data f :i* are n int5d$ =     
inclusion 9 an inve/igational new drug  
application or an inve/igational device 
exemption application4  4  #h4 ,fund+ = 
,food & ,drug ,adm9i/ration rese>*  7a7 

,grants ,! ,secret>y may--  7#a7        
conduct1 support1 or collaborate 9      
regulatory rese>* = ! purpose ( assi/+ !
 ,food & ,drug ,adm9i/ration to p]=m its
 functions ) respect to reg5]ative      
m$ic9e2 or  7#b7 make grants to fund    
regulatory rese>* = su* purpose4  7b7   
,def9itions ,9 ?is section3  7#a7 ,! t]m
 regulatory rese>* means rese>* reg>d+  
developm5t1 evaluation1 & availability (
 new or improv$ tools1 me?ods1 /&>ds1 & 
appli$ sci5ce t support a bett] und]/&+ 
& improv$ evaluation ( product safety1  
quality1 effectiv5ess1 & manufactur+    
?r\gh\t ! product life cycle4  7#b7 ,!  
t]m ,secret>y means ! ,secret>y ( ,heal?
 & ,human ,s]vices1 act+ ?r\gh !        
,commission] ( ,food & ,drugs4