,i  #aac? ,,congress  #b;d ,session  ,h4
 ,r4 #ehje  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,decemb] #h1 #bjad    
,mr4 ,mc,caul introduc$ ! foll[+ bill2  
:i* 0 ref]r$ to ! ,committee on ,en]gy &
 ,comm]ce  ,a ,,bill  ,to am5d ! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act ) respect
 to exp&+ access = break?r\gh drugs1 & =
 o!r purposes4  #a4 ,%ort title ,?is    
,act may be cit$ z ! ,&rea ,sloan       
,compassionate ,use ,re=m & ,enhancem5t 
,act or ! ,&rea ,sloan ,,cure ,act4  #b4
 ,exp&$ access policy z condition (     
exp$it$ approval ,section #efa ( !      
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cfj;bbb7 is am5d$--     
7#a7 by r$esignat+ subsections 7d7 & 7e7
 z subsections 7e7 & 7f71 respectively2 
&  7#b7 by ins]t+ aft] subsection 7c7 ! 
foll[+ new subsection3  7d7 ,exp&$      
access policy requir$ = cov]$ break?r\gh
 drugs  7#a7 ,9 g5]al ,) respect to a   
qualifi$ break?r\gh drug1 n lat] ?an #cj
 days aft] ! date on :i* ! drug meets ! 
def9ition ( a cov]$ break?r\gh drug 7z  

specifi$ 9 p>agraph 7#b771 ! sponsor ( !
 cov]$ break?r\gh drug %all submit to ! 
,secret>y & make publicly available !   
policy ( ! sponsor ) respect to reque/s 
submitt$ "u subsection 7b74 ,9 ! case ( 
su* a policy "u :i* ! sponsor accepts   
su* reque/s1 su* policy %all include--  
7,a7 a s+le po9t ( contact :o receives &
 processes su* reque/s2  7,b7 proc$ures 
= mak+ su* reque/s2  7,c7 ! m9imum      
crit]ia = ! sponsor's consid]ation or   
approval ( su* reque/s2 &  7,d7 ! am\nt 
( "t ! sponsor anticipates w be necess>y
 to make a decision on su* reque/s4     
7#b7 ,cov]$ break?r\gh drug ,9 ?is      
subsection1 ! t]m cov]$ break?r\gh drug 
means a drug--  7,a7 t is designat$ z a 
break?r\gh !rapy or z a fa/ track       
product or is approv$ "u accel]at$      
approval "u section #ejf2  7,b7 t is    
designat$ "u section #eje;,e7d7 z a     
qualifi$ infecti\s disease product2 or  
7,c7 ! sponsor ( :i* is aw>d$ a priority
 review v\*] "u section #ebd or #ebi4  4
  #c4 ,notification ( submitt]s (       

compassionate use reque/s ,section #efa 
( ! ,f$]al ,food1 ,drug1 & ,cosmetic    
,act 7#ba ,u4,s4,c4 #cfj;bbb71 z am5d$  
by section #b1 is fur!r am5d$--  7#a7 by
 r$esignat+ subsections 7e7 & 7f7 7z    
r$esignat$ by section #b7a77 z          
subsections 7f7 & 7g71 respectively2 &  
7#b7 by ins]t+ aft] subsection 7d7 7z   
ins]t$ by section #b7b77 ! foll[+ new   
subsection3  7e7 ,notification (        
submitt]s ( reque/s ,9 ! case ( ! d5ial 
by a manufactur] or di/ributor ( a      
reque/ "u subsection 7b71 n lat] ?an #e 
days aft] ! date ( su* d5ial1 !         
manufactur] or di/ributor1 z applicable1
 %all submit to ! p]son 7or physician7  
:o made ! reque/ writt5 notice ( !      
d5ial1 includ+ an explanation = ! d5ial4
  4  #d4 ,,gao qualitative analysis on  
individual pati5t access to unapprov$   
!rapies & diagno/ics ,n lat] ?an #ahj   
days aft] ! date ( ! enactm5t ( ?is ,act
 & ea* ye> !reaft]1 ! ,comptroll] ,g5]al
 ( ! ,unit$ ,/ates %all submit to !     
,committee on ,en]gy & ,comm]ce ( !     

,h\se ( ,repres5tatives & ! ,committee  
on ,heal?1 ,education1 ,labor & ,p5sions
 ( ! ,s5ate a report conta9+ a          
qualitative analysis ( ! ext5t to :i*   
individual pati5ts h access to          
inve/igational drugs pursuant to        
subsection 7b7 ( section #efa ( ! ,f$]al
 ,food1 ,drug1 & ,cosmetic ,act 7#ba    
,u4,s4,c4 #cfj;bbb7 & recomm5dations =  
improv+ su* access4 ,9 prep>+ su*       
report1 ! ,comptroll] ,g5]al %all       
conduct a qualitative analysis ( !      
foll[+3  7#a7 ,:e!r !re are any         
id5tifiable patt]ns 9 reque/s submitt$  
"u subsection 7b7 ( su* section1 su* z !
 types ( indications = :i* reque/s =    
individual pati5t access are s\ght or ! 
reasons = ! d5ial ( su* reque/s4  7#b7  
,:at ! prim>y b>ri]s are to drug        
sponsors grant+ reque/s = individual    
pati5t access4  7#c7 ,h[ ! ,secret>y    
evaluates safety & efficacy data        
submitt$ 9 connection ) su* reque/s4    
7#d7 ,! am\nt ( "t t--  7,a7 a physician
 typically takes to complete ! pap]work 

necess>y to make su* a reque/2  7,b7 a  
drug sponsor takes to process su* a     
reque/ & to issue a decision ) respect  
to ! reque/2 &  7,c7 ! ,secret>y takes  
to process su* a reque/ & to issue a    
decision ) respect to ! reque/4  7#e7   
,h[ regulations1 guidance1 policies1 or 
practices may be modifi$1 /reaml9$1     
exp&$1 or discont9u$ to r$uce or prev5t 
delays 9 approv+ su* reque/s4  7#f7 ,!  
numb] ( su* reque/s t1 = ! p]iod cov]$  
by ! report--  7,a7 7 approv$ by drug   
sponsors & ! ,food & ,drug              
,adm9i/ration2  7,b7 7 approv$ by drug  
sponsors b d5i$ by ! ,food & ,drug      
,adm9i/ration2 &  7,c7 7 d5i$ by drug   
sponsors4  7#g7 ,h[ to enc\rage drug    
sponsors to grant reque/s = exp&$ access
 "u su* section #efa1 includ+ reque/s = 
em]g5cy use1 int]m$iate-size pati5t     
populations1 & l>ge pati5t populations  
"u a specifi$ indication4  7#h7 ,:e!r & 
to :at ext5t adv]se ev5ts report$ to !  
,secret>y z a result ( individual use ( 
an inve/igational drug or inve/igational

 device "u su* section #efa affect$ !   
developm5t or approval ( any drug or    
device4  #e4 ,exp&$ access task =ce  7a7
 ,e/abli%m5t ,! ,secret>y ( ,heal? &    
,human ,s]vices %all e/abli% a task =ce 
)9 ! ,dep>tm5t ( ,heal? & ,human        
,s]vices to explore me*anisms = improv+ 
! access individual pati5ts h to        
inve/igational drugs pursuant to        
subsection 7b7 ( section #efa ( ! ,f$]al
 ,food1 ,drug1 & ,cosmetic ,act 7#ba    
,u4,s4,c4 #cfj;bbb71 to be kn[n z !     
,exp&$ ,access ,task ,=ce 79 ?is section
 ref]r$ to z ! ,task ,=ce74 ,n lat] ?an 
#ij days aft] ! date on :i* !           
,comptroll] ,g5]al ( ! ,unit$ ,/ates    
submits ! fir/ report requir$ "u section
 #d1 ! ,task ,=ce %all be conv5$4  7b7  
,memb]%ip  7#a7 ,composition ,! ,task   
,=ce %all be compos$ ( n m ?an #i vot+  
memb]s appo9t$ z foll[s3  7,a7 ,"o memb]
 to s]ve z ,*airman ( ! ,task ,=ce1     
appo9t$ by ! ,speak] ( ! ,h\se (        
,repres5tatives4  7,b7 ,"o repres5tative
 f ! ,dep>tm5t ( ,heal? & ,human        

,s]vices1 appo9t$ by ! ,secret>y (      
,heal? & ,human ,s]vices4  7,c7 ,f\r    
repres5tatives appo9t$ by ! ,majority   
,lead] ( ! ,h\se ( ,repres5tatives1 9   
consultation ) ! ,m9ority ,lead] ( !    
,h\se ( ,repres5tatives1 & ! ,*airman & 
! ,rank+ ,memb] ( ! ,committee on ,en]gy
 & ,comm]ce ( ! ,h\se ( ,repres5tatives1
 includ+--  7i7 "o repres5tative ( a    
bioph>maceutical company ( less ?an #bej
 full-"t employees2  7ii7 "o            
repres5tative ( ! r>e disease pati5t    
community2  7iii7 "o repres5tative ( !  
heal? c>e provid] community2 &  7iv7 "o 
bioe?ici/4  7,d7 ,?ree repres5tatives   
appo9t$ by ,majority ,lead] ( ! ,s5ate1 
9 consultation ) ! ,m9ority ,lead] ( !  
,s5ate1 & ! ,*airman & ! ,rank+ ,memb] (
 ! ,heal?1 ,education1 ,labor & ,p5sions
 ,committee ( ! ,s5ate1 includ+--  7i7  
"o repres5tative ( ! bioph>maceutical   
indu/ry2  7ii7 "o repres5tative ( !     
pati5t community2 &  7iii7 "o           
repres5tative ( ! heal? c>e payor       
community4  7#b7 ,comp5sation ,memb]s ( 

! ,task ,=ce %all s]ve )\t comp5sation4 
7c7 ,duties ,! ,task ,=ce %all          
compreh5sively evaluate ! access        
individual pati5ts h to inve/igational  
drugs pursuant to subsection 7b7 (      
section #efa ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb71
 tak+ into acc\nt--  7#a7 ! unique      
*all5ges fac$ by *ildr5 ) likely fatal  
diseases = :i* !re is n a comp>able or  
satisfactory alt]native !rapy available2
  7#b7 possible inc5tives =             
bioph>maceutical companies & provid]s to
 approve reque/s submitt$ "u su*        
subsection2  7#c7 h[ ! ,secret>y (      
,heal? & ,human ,s]vices int]prets &    
takes into consid]ation adv]se ev5t data
 report$ 9 ! case ( data f use "u a     
reque/ submitt$ "u su* subsection2  7#d7
 ways to /reaml9e & /&>dize ! process = 
submitt+ reque/s "u su* subsection2 &   
7#e7 ! co/s incurr$ by bioph>maceutical 
companies = ! "t1 ef=t1 & deliv]y (     
inve/igational drugs to pati5ts = !     
diagnosis1 monitor+1 or treatm5t ( a    

s]i\s disease or condition "u su*       
subsection4  7d7 ,report ,n lat] ?an    
#ahj days aft] ! date on :i* ! ,task    
,=ce is conv5$1 ! ,task ,=ce %all submit
 to ! ,committee on ,en]gy & ,comm]ce ( 
! ,h\se ( ,repres5tatives & ! ,committee
 on ,heal?1 ,education1 ,labor &        
,p5sions ( ! ,s5ate a report 9 an       
electronic =mat describ+ ! specific     
recomm5dations ( ! ,task ,=ce = improv+ 
! access individual pati5ts h to        
inve/igational drugs pursuant to        
subsection 7b7 ( section #efa ( ! ,f$]al
 ,food1 ,drug1 & ,cosmetic ,act 7#ba    
,u4,s4,c4 #cfj;bbb74  7e7 ,t]m9ation ,! 
task =ce %all t]m9ate ^u submission ( ! 
report requir$ "u subsection 7d74  #f4  
,f9aliz+ draft guidance on exp&$ access 
7a7 ,9 g5]al ,n lat] ?an #ahj days aft] 
! date on :i* ! ,exp&$ ,access ,task    
,=ce e/abli%$ "u section #e submits !   
report "u subsection 7d7 ( su* section1 
! ,secret>y ( ,heal? & ,human ,s]vices  
%all f9alize ! draft guidance entitl$   
,exp&$ ,access to ,inve/igational ,drugs

 = ,treatm5t ,use--,qs  ,z & dat$ ,may  
#bjac4  7b7 ,cont5ts ,! f9al guidance   
ref]r$ to 9 subsection 7a7 %all--  7#a7 
cle>ly def9e h[ ! ,secret>y int]prets & 
uses adv]se drug ev5t data report$ by   
inve/igators 9 ! case ( data report$ f  
use "u a reque/ submitt$ "u section     
#efa7;b7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act 7#ba ,u4,s4,c4           
#cfj;bbb7b772 &  7#b7 take into acc\nt !
 report ( ! ,exp&$ ,access ,task ,=ce   
submitt$ "u section #e7;d7 & ! fir/     
report ( ! ,comptroll] ,g5]al ( ! ,unit$
 ,/ates submitt$ "u section #d4