,,ii  #aad? ,,congress  #b;d ,session   
,s4 #cdeg  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,septemb] #bh1         
#bjaf,mr4 ,g>dn] 7= himself & ,mr4      
,coons7 introduc$ ! foll[+ bill2 :i* 0  
read twice & ref]r$ to ! ,committee on  
,f9ance  ,a ,,bill  ,to e/abli% ,c5t]s =
 ,m$ic>e  ,m$icaid ,s]vices ,,sbir or   
,,/tr program grants :i* %all be kn[n z 
,m$ic>e comm]cialization grants4  #a4   
,%ort title ,?is ,act may be cit$ z !   
,r$uc+ ,m$ic>e ,co/s ?r\gh ,innovation  
,act4  #b4 ,m$ic>e comm]cialization     
grants  7a7 ,def9itions ,9 ?is section3 
7#a7 ,! t]m-- 7,a7 ,adm9i/rator means ! 
,adm9i/rator ( ! ,c5t]s = ,m$ic>e       
,m$icaid ,s]vices2 &  7,b7 ,secret>y    
means ! ,secret>y ( ,heal? & ,human     
,s]vices4  7#b7 ,! t]ms                 
comm]cialization1 ,phase ,i1 ,phase     
,,ii1 ,phase ,,iii1 ,,sbir1 & ,,/tr h ! 
mean+s giv5 ^? t]ms 9 section #i7;e7 ( !
 ,small ,bus9ess ,act 7#ae ,u4,s4,c4    
#fch7;e774  7#c7 ,! t]m eligible m$ical 
product means a product-- 7,a7 = :i* a  

grant recipi5t receiv$ a ,m$ic>e        
comm]cialization grant2  7,b7 :i* w     
ma9ta9 or improve quality ( c>e :ile    
r$uc+ co/s 7z det]m9$ by ! ,secret>y72 &
  7,c7 7i7 t is a drug1 z def9$ "u      
section #bja7;g77#a7 ( ,f$]al ,food1    
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cba7;g77#a772  7ii7 t is a biological  
product1 z def9$ 9 section #cea ( !     
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bfb72  7iii7 t is a          
comb9ation product1 z describ$ 9 section
 #ejc7;g7 ( ! ,f$]al ,food1 ,drug1 &    
,cosmetic ,act 7#ba ,u4,s4,c4 #cec7;g772
 or  7iv7 t is a device1 z def9$ 9      
section #bja7;h7 ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cba7;h771 = :i* approval "u section    
#eae ( su* ,act is requir$4  7#d7 ,! t]m
 eligible small bus9ess conc]n means a  
small bus9ess conc]n t-- 7,a7 has a     
focus on ! diseases or conditions t are 
! top #aj co/ driv]s 9 ! ,m$ic>e program
 "u title ,,xviii ( ! ,social ,security 
,act 7#db ,u4,s4,c4 #acie et seq471 z   

det]m9$ by ! ,secret>y 9 accordance )   
subsection 7b77#c72  7,b7 is o!rwise    
eligible = a ,c5t]s = ,m$ic>e  ,m$icaid 
,s]vices ,,sbir or ,,/tr program grant2 
7,c7 has complet$ ,phase ,i activities2 
&  7,d7 has fund+ = ,phase ,,ii         
activities4  7#e7 ,! t]m small bus9ess  
conc]n has ! mean+ giv5 ! t]m 9 section 
#c ( ! ,small ,bus9ess ,act 7#ae        
,u4,s4,c4 #fcb74  7b7 ,m$ic>e           
comm]cialization grants  7#a7           
,e/abli%m5t ( program ,! ,secret>y %all 
e/abli% )9 ! ,c5t]s = ,m$ic>e  ,m$icaid 
,s]vices ,,sbir or ,,/tr program a grant
 program ref]r$ to z ! ,m$ic>e          
comm]cialization grant program ?r\gh :i*
 ! ,secret>y %all aw>d grants to        
eligible small bus9ess conc]ns ) approv$
 applications to assi/ su* small bus9ess
 conc]ns 9 ,phase ,,iii activities      
relat$ to develop+ novel eligible m$ical
 products & receiv+ approval or cle>ance
 by ! ,food & ,drug ,adm9i/ration = su* 
eligible m$ical products 9 accordance ) 
p>agraph 7#b74  7#b7 ,approval process =

 grant recipi5t's novel drugs1 devices1 
or diagno/ics ,a grantee may *oose to   
submit an application = approval ( novel
 drugs1 devices1 or diagno/ics ?r\gh a  
traditional approval process or ?r\gh ! 
pilot program = p>allel review ( m$ical 
products describ$ 9 subsection 7c74     
7#c7 ,applications  7,a7 ,solicitation (
 applications ,! ,secret>y %all issue an
 annual solicitation ( applications = ! 
grant program "u p>agraph 7#a71 ) a     
focus on ! diseases or conditions t are 
! top #aj co/ driv]s 9 ! ,m$ic>e program
 "u title ,,xviii ( ! ,social ,security 
,act 7#db ,u4,s4,c4 #acie et seq471 z   
det]m9$ by ! ,secret>y 9 accordance )   
subp>agraph 7,b74  7,b7 ,co/ driv]s 9   
,m$ic>e ,! ,secret>y %all assess1 9     
consultation ) /akehold]s1 & take into  
consid]ation = purposes ( det]m9+ su*   
co/ driv]s & ! eligibility ( a small    
bus9ess conc]n1 z describ$ 9 subsection 
7a77#d77;,a7--  7i7 high volume m$ical  
proc$ures t are paid = "u ! ,m$ic>e     
program2  7ii7 diseases or conditions t 

a high numb] ( ,m$ic>e b5efici>ies are  
affect$ by2  7iii7 high co/ m$ical      
proc$ures t are paid = "u ! ,m$ic>e     
program2  7iv7 diseases or conditions t 
,m$ic>e b5efici>ies are affect$ by t    
result 9 a high co/ to ! ,m$ic>e        
program2 &  7v7 areas describ$ 9 clauses
 7i7 ?r\gh 7iv7 = :i* !re is a high     
pot5tial = innovation or co/ r$uction4  
7,c7 ,application requirem5t ,ea*       
eligible small bus9ess conc]n t applies 
= a ,m$ic>e comm]cialization grant %all 
include 9 ! application = su* grant a   
description ( ea* s\rce ( fund+ = !     
eligible bus9ess conc]n & ! am\nt (     
fund+ f ea* su* s\rce4  7#d7 ,duration  
,an eligible small bus9ess conc]n may   
receive a ,m$ic>e comm]cialization grant
 = a p]iod ( n less ?an #a ye> & n m ?an
 #c ye>s4  7#e7 ,no limit on numb] (    
recipi5ts ,! ,secret>y %all n limit !   
numb] ( eligible small bus9ess conc]ns t
 may receive a ,m$ic>e comm]cialization 
grant4  7#f7 ,p]iodic assessm5t ,at !   
completion ( ! ?ird ye> = :i* grants are

 aw>d$ "u ?is subsection1 ! ,secret>y   
%all prep>e an assessm5t conta9+        
in=mation ab\t ! co/ r$uctions &        
improvem5ts 9 c>e t result f su* grants1
 includ+--  7,a7 a g5]al assessm5t ( !  
co/ driv]s t ! grants 7 int5d$ to       
address2  7,b7 in=mation ab\t ! novel   
eligible m$ical products t ! grantees   
develop$ or receiv$ approval or cle>ance
 = ) ! aid ( grant fund+ "u ?is         
subsection2 &  7,c7 ! pot5tial = a      
r$uction 9 co/s t may result if su*     
novel eligible m$ical products 7 us$    
nationwide4  7#g7 ,report ,! ,secret>y  
%all prep>e & submit to ,congress1 at ! 
completion ( ! ?ird ye> = :i* grants are
 aw>d$ "u ?is subsection & foll[+ !     
assessm5t describ$ 9 p>agraph 7#f71 a   
summ>y report conta9+ ! in=mation       
describ$ 9 p>agraph 7#f74 ,! ,secret>y  
%all also po/ ea* su* report on !       
website ( ! ,dep>tm5t ( ,heal? & ,human 
,s]vices4  7#h7 ,fund+ ,to c>ry out !   
grant program "u ?is subsection1 !      
,secret>y %all use am\nts allocat$ = !  

,,sbir & ,,/tr programs ( ! ,dep>tm5t ( 
,heal? & ,human ,s]vices "u subsections 
7f7 & 7n71 respectively1 ( section #i ( 
! ,small ,bus9ess ,act 7#ae ,u4,s4,c4   
#fch74  7#i7 ,collaboration ,! ,secret>y
 %all collaborate ) ! heads ( o!r       
divisions )9 ! ,dep>tm5t ( ,heal? &     
,human ,s]vices z ! ,secret>y det]m9es  
necess>y to c>ry out ?is subsection4    
7c7 ,pilot program = p>allel review (   
m$ical products  7#a7 ,9 ,g5]al ,n lat] 
?an #fj days aft] ! date ( enactm5t (   
?is section1 ! ,secret>y & !            
,adm9i/rator %all jo9tly e/abli% a pilot
 program = p>allel review ( eligible    
m$ical products t is simil> to ! ,pilot 
,program = ,p>allel ,review ( ,m$ical   
,products describ$ 9 ! notice ( ! ,c5t]s
 = ,m$ic>e  ,m$icaid ,s]vices1 publi%$ 9
 ! ,f$]al ,regi/] on ,octob] #aa1 #bjaa 
7#gf ,f$4 ,reg4 #fbhjh7 7ref]r$ to 9 ?is
 subsection z ! pilot program74 ,su*    
pilot program %all n affect ! applicable
 crit]ia or /&>ds = approv+1 cle>+1 or  
classify+ m$ical products "u ! ,f$]al   

,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cja7 & %all n affect !       
crit]ia & /&>ds relat+ to det]m9ations  
ab\t a reimbursem5t designation or a    
national cov]age det]m9ation "u !       
,m$ic>e program "u title ,,xviii ( !    
,social ,security ,act4  7#b7 ,purpose  
,! purposes ( ! pilot program are to--  
7,a7 r$uce ! timel9e ( ! review         
processes = purposes ( approval by !    
,food & ,drug ,adm9i/ration "u ! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cja7 & a reimbursem5t        
designation & a national cov]age        
det]m9ation "u ! ,m$ic>e program "u     
title ,,xviii ( ! ,social ,security ,act
 = c]ta9 m$ical products develop$ by    
,m$ic>e comm]cialization grant          
recipi5ts2 &  7,b7 increase ! effici5cy 
(1 & communication betwe51 ! ,dep>tm5t (
 ,heal? & ,human ,s]vices & ! ,c5t]s =  
,m$ic>e  ,m$icaid ,s]vices4  7#c7       
,eligible p>ticipants ,! pilot program  
e/abli%$ "u ?is subsection %all be      
available-- 7,a7 only to recipi5ts ( a  

,m$ic>e comm]cialization grant "u ?is   
subsection 7b7 :o *oose to p>ticipate 9 
su* pilot program2 &  7,b7 only = !     
review ( eligible m$ical products4  7#d7
 ,p>allel review process ,z "p ( ! pilot
 program--  7,a7 to ! ext5t practicable1
 ! ,secret>y & ! ,adm9i/rator %all      
notify p>ticipat+ grant recipi5ts ( !   
data t may be necess>y = ! grant        
recipi5t to submit at ! beg9n+ ( !      
review process2 &  7,b7 ! ,adm9i/rator  
%all beg9 review = purposes ( a         
reimbursem5t designation & a national   
cov]age det]m9ation "u ! ,m$ic>e program
 "u title ,,xviii ( ! ,social ,security 
,act = an eligible m$ical product :ile !
 ,secret>y ( ,heal? & ,human ,s]vices is
 review+ t eligible m$ical product =    
approval "u ! ,f$]al ,food1 ,drug1 &    
,cosmetic ,act 7#ba ,u4,s4,c4 #cja74    
7#e7 ,allocation ( res\rces ,!          
,adm9i/rator %all allocate ! res\rces   
necess>y to c>ry out ! pilot program4