,,ii  #aai? ,,congress  #a/ ,session    
,s4 #hbb  ,,9 ,,! ,,s5ate ,,( ,,!       
,,unit$ ,,/ates  ,m>* #c1 #bjbe ,ms4    
,klobu*> 7= h]self & ,mr4 ,wick]7       
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to am5d ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act to e/abli% a    
process = sci5ce-focus$ drug developm5t 
meet+s l$ by ! ,reagan-,udall ,f\ndation
 = ! ,food & ,drug ,adm9i/ration )      
respect to drugs = r>e diseases &       
conditions1 & = o!r purposes4  #a4      
,%ort title  ,?is ,act may be cit$ z !  
,sci5tific ,ext]nal ,process = ,educat$ 
,review ( ,!rapeutics ,act ( #bjbe or ! 
,sci5tific ,,exp]t ,act ( #bjbe4  #b4   
,sci5ce-focus$ drug developm5t meet+s   
,! ,f$]al ,food1 ,drug1 & ,cosmetic ,act
 7#ba ,u4,s4,c4 #cja et seq47 is am5d$  
by ins]t+ aft] section #ggj 7#ba        
,u4,s4,c4 #cgi;dd7 ! foll[+3  #ggj;,a4  
,sci5ce-focus$ drug developm5t meet+s   
7a7  ,9 g5]al  ,! ,secret>y %all develop

 & implem5t a process = ,f\ndation l$1  
sci5ce-focus$ drug developm5t meet+s to 
provide an opportunity = academic       
rese>*]s & m$ical exp]ts1 drug sponsors1
 sci5tific organizations1 & pati5t      
organizations to--  7#a7 discuss        
sci5ce-relat$ *all5ges impact+ !        
developm5t ( drugs = r>e diseases &     
conditions2  7#b7 id5tify sci5tific     
approa*es & opportunities to facilitate 
! developm5t1 review1 & approval ( su*  
drugs2 &  7#c7 align on novel approa*es 
= ! developm5t ( drugs = p>ticul>       
diseases1 includ+ appropriate cl9ical   
trial designs & metrics1 manufactur+    
/&>ds1 pati5t populations1 cl9ical      
endpo9ts1 ! use ( biom>k]s z surrogate  
endpo9ts1 & natural hi/ory z a control1 
to advance treatm5t options to address  
unmet m$ical ne$s4  7b7  ,arrangem5t    
7#a7  ,qualifi$ ?ird p>ty conv5or  ,!   
,secret>y %all ent] into an arrangem5t )
 ! ,f\ndation "u :i* ! ,f\ndation agrees
 to conv5e ,,el-,,sfdd meet+s reg>d+    
drugs = r>e diseases or conditions 9    

accordance ) ?is section4  7#b7  ,m9imum
 numb] ( meet+s  ,! ,f\ndation %all     
conv5e no few] ?an #d ,,el-,,sfdd meet+s
 ea* ye>1 ) ea* su* meet+ focus$ on     
address+ a diff]5t r>e disease or       
condition or a diff]5t gr\p ( r>e       
diseases & conditions4  7#c7  ,/e]+     
committee  7,a7  ,9 g5]al  ,! ,f\ndation
 %all e/abli% & ma9ta9 a p]man5t /e]+   
committee1 to be kn[n z !               
,sci5ce-,focus$ ,drug ,developm5t       
,multi/akehold] ,/e]+ ,committee1 to    
advise ! ,f\ndation on implem5tation (  
?is section1 includ+ by--  7i7 e/abli%+ 
a process by :i* lic5s$ & bo>d-c]tifi$  
m$ical cl9icians & academics ) exp]tise 
9 a r>e disease or condition1 sponsors (
 drugs = a r>e disease or condition1    
sci5tific organizations1 r>e disease or 
condition pati5t organizations1 & o!r   
entities c provide sugge/$ meet+ topics 
to ! ,f\ndation2  7ii7 review+ su*      
sugge/$ meet+ topics = ,,el-,,sfdd      
meet+s2 &  7iii7 bas$ on ! crit]ia "u   
subp>agraph 7,b71 recomm5d+ to !        

,f\ndation topics = ,,el-,,sfdd meet+s4 
7,b7  ,crit]ia = meet+s  ,9 =mulat+     
recomm5dations "u subp>agraph 7,a71 !   
,f\ndation %all consid]--  7i7 unmet    
!rapeutic ne$s2  7ii7 ! size ( ! pati5t 
population ( ! r>e disease or condition2
  7iii7 :e!r !re 7 or are multiple      
products 9 developm5t to prev5t or treat
 ! r>e disease or condition involv$2    
7iv7 :e!r !re is a ne$ = increas$       
regulatory flexibility to facilitate !  
developm5t ( products2  7v7 :e!r ! r>e  
disease or condition involv$ w\ld b5efit
 f cl>ity & alignm5t on drug developm5t 
que/ions 7su* z cl9ical trial design1   
natural hi/ory z a control1 appropriate 
cl9ical endpo9ts1 biom>k]s t may s]ve z 
surrogate endpo9ts1 & o!r approa*es7 to 
exp$ite drug developm5t = su* disease or
 condition2 &  7vi7 :e!r ! discussions  
ab\t su* r>e disease or condition may h 
broad] impact on o!r r>e diseases &     
conditions4  7,c7  ,memb]%ip  ,! memb]s 
( ! ,/e]+ ,committee %all be subject to 
all relevant conflict ( int]e/ policies 

( ! ,f\ndation1 & %all include--  7i7   
repres5tatives ( ! ,c5t] = ,drug        
,evaluation & ,rese>*1 ! ,c5t] =        
,biologics ,evaluation & ,rese>*1 & !   
,c5t] = ,devices & ,radiological ,heal?2
  7ii7 academic & lic5s$ & bo>d-c]tifi$ 
m$ical cl9icians2  7iii7 pati5t         
repres5tatives2 &  7iv7 indu/ry         
repres5tatives engag$ 9 ! developm5t (  
drugs = r>e diseases & conditions4  7#d7
  ,plann+ process  ,9 plann+ an         
,,el-,,sfdd meet+ "u ?is section1 !     
,f\ndation1 9 consultation ) !          
/akehold]s li/$ 9 p>agraph 7#e71 %all   
develop--  7,a7 a li/ ( ! specific      
objectives ( ! meet+ relat$ to key drug 
developm5t issues = ! r>e disease or    
condition1 or gr\p ( r>e diseases &     
conditions1 ) a goal ( exp$it+ drug     
developm5t2  7,b7 a propos$ ag5da = !   
meet+2 &  7,c7 a li/ ( m$ical exp]ts1   
drug sponsors1 sci5tific organizations1 
pati5t organizations1 & o!r entities to 
be invit$ to p>ticipate 9 ! meet+4  7#e7
  ,ag5cy & /akehold] engagem5t  ,?r\gh\t

 ! process ( plann+ an ,,el-,,sfdd      
meet+1 ! ,f\ndation %all consult )--    
7,a7 appropriate /aff ( ! ,food & ,drug 
,adm9i/ration2  7,b7 ! ,/e]+ ,committee2
  7,c7 indu/ry repres5tatives engag$ 9 !
 developm5t ( products = r>e diseases & 
conditions to be discuss$ at su*        
,,el-,,sfdd meet+2  7,d7 pati5t         
repres5tatives ( r>e diseases &         
conditions "u discussion 9 su*          
,,el-,,sfdd meet+2  7,e7 academics or   
bo>d-c]tifi$ & lic5s$ m$ical cl9icians )
 exp]tise 9 treat+ a r>e disease or     
condition2 &  7,f7 o!r appropriate      
/akehold]s4  7#f7 ,po/-meet+ reports    
7,a7 ,9 g5]al ,n lat] ?an #ahj days aft]
 an ,,el-,,sfdd meet+1 ! ,f\ndation %all
 make publicly available on ! website ( 
! ,food & ,drug ,adm9i/ration--  7i7 a  
transcript & record+ ( ! meet+2 &  7ii7 
9 consultation ) ! /akehold]s li/$ 9    
p>agraph 7#e71 a summ>y analysis ( !    
input receiv$ dur+ ! meet+ t is relevant
 to approval or lic5s+ ( drugs = ! r>e  
disease or condition involv$4  7,b7     

,cont5ts  ,ea* publication "u           
subp>agraph 7,a7 %all include a cle>    
id5tification (--  7i7 areas ( cons5sus2
  7ii7 areas :]e additional cl>ification
 or in=mation is ne$$ to rea* cons5sus2 
&  7iii7 next /eps agre$ ^u ) ! ,food & 
,drug ,adm9i/ration4  7c7               
,repres5tatives ( ,,fda review divisions
 ,! ,secret>y %all require appropriate  
repres5tatives ( ! review divisions ( ! 
,food & ,drug ,adm9i/ration to          
p>ticipate 9 ea* ,,el-,,sfdd meet+ "u   
?is section4  7d7  ,rules ( con/ruction 
,no?+ 9 ?is section %all be con/ru$--   
7#a7 to prev5t o!r ?ird-p>ty            
organizations f organiz+ simil>ly       
/ructur$ ,,el-,,sfdd-l meet+s to discuss
 *all5ges 9 r>e disease drug developm5t2
  7#b7 to require ! ,food & ,drug       
,adm9i/ration to p>ticipate 9 additional
 meet+s describ$ 9 p>agraph 7#a72  7#c7 
to alt] ! protections (f]$ by laws1     
regulations1 or policies gov]n+         
disclosure ( confid5tial comm]cial or   
trade secret in=mation & any o!r        

in=mation exempt f disclosure pursuant  
to section #eeb7;b7 ( title #e1 ,unit$  
,/ates ,code2  7#d7 to limit ! ability (
 ! ,secret>y to consult ) individuals & 
organizations2  7#e7 to create a legal  
"r = consultation on any matt] or       
require ! ,secret>y to meet ) any       
p>ticul> exp]t or /akehold]2  7#f7 to   
alt] agre$-^u goals & proc$ures id5tifi$
 9 ! lett]s describ$ 9 section #ajja7;b7
 ( ! ,,fda ,us] ,fee ,reau?orization    
,act ( #bjbb2 or  7#g7 to increase !    
numb] ( review cycles = drugs4  7e7     
,def9itions ,9 ?is section3  7#a7 ,! t]m
 ,,el-,,sfdd meet+ means an ext]nally   
l$1 sci5ce-focus$ drug developm5t meet+4
  7#b7 ,! t]m r>e disease or condition  
has ! mean+ giv5 su* t]m 9 section #ebf4
  7#c7 ,! t]m ,/e]+ ,committee means !  
,sci5ce-,focus$ ,drug ,developm5t       
,multi/akehold] ,/e]+ ,committee        
e/abli%$ "u subsection 7b77#c74  7f7    
,au?orization ( appropriations  7#a7  ,9
 g5]al  ,to c>ry out ?is section1 !re is
 au?oriz$ to be appropriat$ #a1jjj1jjj =

 ea* ( fiscal ye>s #bjbe ?r\gh #bjbi4   
7#b7  ,rule ( con/ruction  ,no?+ 9 ?is  
section %all be con/ru$ to prohibit !   
,f\ndation f solicit+ or accept+ funds  
pursuant to section #ggj7;i7 = !        
purposes ( plann+ or op]at+ an          
,,el-,,sfdd meet+ au?oriz$ by ?is       
section4  #ggj;,b4  ,requir$ actions    
foll[+ ,,el-,,sfdd meet+s  7a7          
,incorporation ( input into risk-,b5efit
 assessm5ts  ,9 approv+ or lic5s+ a drug
 "u subsection 7c7 or 7j7 ( section #eje
 ( ?is ,act or subsection 7a7 or 7k7 (  
section #cea ( ! ,public ,heal? ,s]vice 
,act1 ! ,secret>y %all make public--    
7#a7 a /atem5t ( :e!r any ,,el-,,sfdd   
meet+ "u section #ggj;,a 0 held t 0     
relevant to su* approval or lic5sure2 & 
7#b7 if a meet+ describ$ 9 p>agraph 7#a7
 0 held1 a description ( h[ ! ,secret>y 
incorporat$ input f su* meet+ 9 !       
risk-b5efit assessm5t describ$ 9 section
 #eje7;d74  7b7  ,annual report  ,on an 
annual basis1 ! ,secret>y %all submit a 
report to ,congress summ>iz+--  7#a7 !  

numb] & topics ( ,,el-,,sfdd meet+s held
 dur+ ! report+ p]iod2  7#b7 ! ext5t (  
p>ticipation 9 su* meet+s f ! review    
divisions ( ! ,food & ,drug             
,adm9i/ration2  7#c7 ! impact (         
,,el-,,sfdd meet+s on ! workload &      
res\rces ( ! ,food & ,drug              
,adm9i/ration2 &  7#d7 an assessm5t ( h[
 ! input receiv$ dur+ su* meet+s 0 us$  
9-- 7,a7 delib]ations ?r\gh\t ! drug    
developm5t lifecycle2  7,b7 regulatory  
decision-mak+2 &  7,c7 =mulat+          
recomm5dations = future meet+s4  7c7    
,def9ition  ,9 ?is section1 ! t]m       
,,el-,,sfdd meet+ has ! mean+ giv5 to t 
t]m 9 section #ggj;,a4  7d7             
,au?orization ( appropriations  ,to c>ry
 out ?is section1 !re is au?oriz$ to be 
appropriat$ #a1jjj1jjj = ea* ( fiscal   
ye>s #bjbe ?r\gh #bjbi4  4