,,ii  #aah? ,,congress  #a/ ,session    
,s4 #aabj  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,m>* #cj1 #bjbc,ms4    
,hassan 7= h]self & ,mr4 ,braun7        
introduc$ ! foll[+ bill2 :i* 0 read     
twice & ref]r$ to ! ,committee on       
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to improve ! actions        
available to eligible product develop]s 
9 ! ev5t ( delays 9 receiv+ cov]$       
product = purposes ( g5]ic drug or      
biosimil> biological product developm5t4
  #a4 ,%ort title ,?is ,act may be cit$ 
z ! ,improv$ ,access to ,af=dable       
,m$ications ,act4  #b4 ,am5dm5ts to     
actions = delays ( g5]ic drugs &        
biosimil> biological products ,section  
#faj ( division ,n ( ! ,fur!r           
,consolidat$ ,appropriations ,act1 #bjbj
 7,public ,law #aaf-id2 #ba ,u4,s4,c4   
#cee-b7 is am5d$-- 7#a7 9 subsection    
7a7-- 7,a7 9 p>agraph 7#a77;,c7-- 7i7 by
 ins]t+ or contractual t]ms aft]        
additional conditions2 &  7ii7 by ins]t+
 by ! lic5se hold] aft] cov]$ product2  

7,b7 9 p>agraph 7#b77;,a77iii71 by /rik+
 includ+ any device & ins]t+ includ+ any
 packag+1 device1 or accessory2  7,c7 by
 r$esignat+ p>agraphs 7#c7 ?r\gh 7#aj7 z
 p>agraphs 7#d7 ?r\gh 7#aa71            
respectively2  7,d7 by ins]t+ aft]      
p>agraph 7#c7 ! foll[+3  7#d7 ! t]m     
designat$ deliv]y s]vice means any      
deliv]y s]vice provid$ by a trade or    
bus9ess t ! ,secret>y det]m9es-- 7,a7 is
 available to ! g5]al public ?r\gh\t !  
,unit$ ,/ates2  7,b7 records            
electronically to its database1 kept 9 !
 regul> c\rse ( its bus9ess1 or m>ks on 
! cov] 9 :i* any item ref]r$ to 9 ?is   
section is to be deliv]$1 ! date on :i* 
su* item 0 giv5 to su* trade or bus9ess 
= deliv]y2 &  7,c7 provides ov]night or 
#b-;day deliv]y s]vice ?r\gh\t ! ,unit$ 
,/ates2  2  7,e7 9 p>agraph 7#f71 z s   
r$esignat$1 by ins]t+ includ+ ! p>5t    
company ( su* hold] aft] cov]$ product2 
&  7,f7 9 p>agraph 7#aa71 z s           
r$esignat$-- 7i7 9 subp>agraph 7,a71 9 !
 matt] prec$+ clause 7i71 by ins]t+ 1 at

 any "t1 aft] conduct te/+2 &  7ii7 9   
subp>agraph 7,b71 by ins]t+ 1 at any "t1
 aft] fulfill2  7#b7 9 subsection       
7b77#b7-- 7,a7 9 subp>agraph 7,a77iii7--
 7i7 9 ! matt] prec$+ subclause 7,i71 by
 /rik+ a writt5 reque/ to pur*ase       
suffici5t quantities ( ! cov]$ product  
to ! lic5se hold]1 & su* reque/-- &     
ins]t+ "o or m writt5 reque/s to pur*ase
 suffici5t quantities ( ! cov]$ product 
to ! lic5se hold] = ! relevant /age (   
developm5t1 & ea* su* reque/--2 &  7ii7 
9 subclause 7,,ii71 by ins]t+ or by a   
designat$ deliv]y s]vice be=e !         
semicolon at ! end2 &  7,b7 9           
subp>agraph 7,b71 by am5d+ clause 7ii7  
to read z foll[s3  7ii7 ,au?orization ,!
 ,secret>y %all1 by writt5 notice1      
au?orize ! eligible product develop] to 
obta9 suffici5t quantities ( an         
individual cov]$ product subject to a   
,,rems ) ,,etasu = purposes ( developm5t
 & te/+-- 7,i7 9 ! case ( developm5t &  
te/+ t does n involve human cl9ical     
trials1 n lat] ?an #fj days aft] ! date 

on :i* a reque/ "u clause 7i7 is        
receiv$1 if ! eligible product develop] 
has agre$ to comply ) any conditions !  
,secret>y det]m9es necess>y2 or  7,,ii7 
9 ! case ( developm5t & te/+ t involves 
human cl9ical trials1 n lat] ?an #abj   
days aft] ! date on :i* a reque/ "u     
clause 7i7 is receiv$1 if ! eligible    
product develop] has-- 7aa7 7,,aa7      
submitt$ protocols1 in=m$ cons5t        
docum5ts1 & in=mational mat]ials = te/+ 
t include protections t provide safety  
protections comp>able to ^? provid$ by !
 ,,rems = ! cov]$ product2 or 7,,bb7    
o!rwise satisfi$ ! ,secret>y t su*      
protections w be provid$2 &  7bb7 met   
any o!r requirem5ts ! ,secret>y may     
e/abli%4  2 &  7#c7 by add+ at ! end !  
foll[+3  7h7 ,samples access policy ,n  
lat] ?an #de days aft] ! date ( approval
 ( a cov]$ product1 or1 9 ! case ( a    
cov]$ product approv$ be=e ! date (     
enactm5t ( ! ,improv$ ,access to        
,af=dable ,m$ications ,act1 n lat] ?an  
#de days aft] su* date ( enactm5t1 ea*  

lic5se hold] ( a cov]$ product %all make
 available its policy on evaluat+ &     
respond+ to reque/s submitt$ "u         
subsection 7b77#b77;,a74 ,su* policy    
%all-- 7#a7 be made public & readily    
available1 su* z by po/+ su* policy on a
 publicly available website2 &  7#b7    
%all include-- 7,a7 contact in=mation = 
! lic5se hold] to facilitate            
communication ab\t writt5 reque/s       
describ$ 9 subsection 7b77#b77;,a77iii72
  7,b7 proc$ures = mak+ su* reque/s2    
7,c7 ! address to :i* su* reque/s %\ld  
be s5t2  7,d7 ! (ficial lic5se hold] =  
ea* m>ket$ product2 &  7,e7 ! nam$      
corporate (fic] :o is responsible =     
receiv+ su* reque/s4  4