,i  #aai? ,,congress  #b;d ,session  ,h4
 ,r4 #iggd  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,july #bj1 #bjbf,mr4  
,latta 7= himself & ,mr4 ,l&sman7       
introduc$ ! foll[+ bill2 :i* 0 ref]r$ to
 ! ,committee on ,en]gy & ,comm]ce  ,a  
,,bill  ,to am5d ! ,f$]al ,food1 ,drug1 
& ,cosmetic ,act to provide = exp$it$   
approval ( priority nonprescription     
drugs1 & = o!r purposes4  #a4 ,priority 
nonprescription drugs  7a7 ,9 g5]al ,!  
,f$]al ,food1 ,drug1 & ,cosmetic ,act is
 am5d$ by ins]t+ aft] section #ejf,l    
7#ba ,u4,s4,c4 #cefl7 ! foll[+3  #ejf,m4
 ,priority nonprescription drugs  7a7 ,9
 g5]al  7#a7 ,designation ,! ,secret>y  
may1 at ! reque/ ( ! sponsor ( a        
nonprescription drug1 designate z a     
priority nonprescription drug "u ?is    
section a drug int5d$ = nonprescription 
use t is subject to an application      
submitt$ 7or to be submitt$7 "u section 
#eje7;b71 if ! ,secret>y det]m9es t !   
drug meets ! crit]ia specifi$ 9         
subsection 7d74  7#b7 ,nonprescription  

def9$ ,9 ?is section1 ! t]m             
nonprescription means1 ) respect to a   
drug1 t su* drug is n subject to section
 #ejc7;b77#a74  7b7 ,reque/ =           
designation ,! sponsor ( a drug subject 
to a p5d+ application "u section        
#eje7;b7 = nonprescription use may      
reque/ t ! ,secret>y designate ! drug z 
a priority nonprescription drug4  7c7   
,designation ,n lat] ?an #fj cal5d> days
 aft] ! receipt ( a reque/ "u subsection
 7b71 ! ,secret>y %all det]m9e :e!r a   
drug meets ! crit]ia = designation z a  
priority nonprescription drug "u ?is    
section1 & if s1 make su* designation4  
7d7 ,crit]ia  7#a7 ,eligibility ,except 
z provid$ 9 p>agraph 7#b71 a drug       
describ$ 9 subsection 7a7 is eligible = 
designation z a priority nonprescription
 drug if--  7,a7 ! drug is int5d$ = a   
novel nonprescription indication t c\ld 
provide a mean+ful public heal? b5efit2 
7,b7 ! drug is a new molecul> entity2 or
  7,c7 ! drug conta9s an active +r$i5t t
 has nev] be5 available 9 a             

nonprescription drug4  7#b7 ,exclusion  
,a drug is n eligible = designation z a 
priority nonprescription drug if ! drug 
is subject to a risk evaluation &       
mitigation /rategy "u section #eje-a or 
if ! drug is a controll$ sub/ance 7z    
def9$ 9 section #ajb ( ! ,controll$     
,sub/ances ,act74  7e7 ,actions ,if !   
,secret>y designates a drug z a priority
 nonprescription drug1 ! ,secret>y %all 
take su* actions z are appropriate to   
facilitate ! developm5t (1 & exp$ite !  
review (1 an application or supplem5t to
 an application = su* drug1 :i* may     
include-- 7#a7 hold+ meet+s ) ! sponsor 
& ! review team ?r\gh\t ! developm5t ( !
 drug2  7#b7 provid+ timely advice to1 &
 int]active communication )1 ! sponsor  
reg>d+ ! developm5t ( ! drug to ensure t
 ! developm5t program to ga!r !         
noncl9ical & cl9ical data necess>y to   
demon/rate ! inapplicability ( ! crit]ia
 describ$ 9 section #ejc7;b77#a7 is z   
effici5t z practicable2  7#c7 involv+   
s5ior manag]s & exp]i5c$ review /aff1 z 

appropriate1 9 a collaborative1         
cross-discipl9>y review2  7#d7 assign+ a
 cross-discipl9>y project lead = ! ,food
 & ,drug ,adm9i/ration team to          
facilitate an effici5t review ( !       
developm5t program & to s]ve z a        
sci5tific liaison betwe5 ! review team &
 ! sponsor2 &  7#e7 tak+ /eps to ensure 
t ! design ( any necess>y noncl9ical or 
cl9ical trials is z effici5t z          
practicable1 :5 sci5tifically           
appropriate1 includ+ reliance on real _w
 evid5ce4  7f7 ,li/ ( conditions  7#a7  
,e/abli%m5t ,n lat] ?an #ah mon?s aft] !
 date ( enactm5t ( ?is section1 !       
,secret>y %all publi% 9 ! ,f$]al ,regi/]
 a li/ ( conditions = :i* a             
nonprescription drug1 if develop$ = !   
condition1 c\ld provide mean+ful public 
heal? b5efit4  7#b7 ,public comm5t ,!   
,secret>y %all provide a p]iod ( n less 
?an #cj days = public comm5t on--  7,a7 
! li/ "u p>agraph 7#a72 &  7,b7 any     
updates to su* li/4  4  7b7 ,rule (     
con/ruction ,! am5dm5t made by          

subsection 7a7 %all n be con/ru$ to alt]
 ! evid5ti>y /&>ds or ! in=mation       
requir$ = approval ( a nonprescription  
drug "u section #eje ( ! ,f$]al ,food1  
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee74  7c7 ,report to ,congress ,n lat]
 ?an #d ye>s aft] ! date ( enactm5t (   
?is ,act1 ! ,secret>y ( ,heal? & ,human 
,s]vices %all submit to ,congress a     
report conta9+--  7#a7 ! numb] (        
nonprescription drugs = :i* a sponsor   
reque/$ t ! ,secret>y designate su* a   
drug z a priority nonprescription drug  
"u section #ejf,m ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act1 z add$ by      
subsection 7a72  7#b7 ! numb] (         
nonprescription drugs = :i* ! ,secret>y 
approv$ su* reque/2  7#c7 ! numb] (     
priority nonprescription drugs 7z       
designat$ "u su* section7 = :i* !       
,secret>y approv$ an application "u     
section #eje ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4 #cee72    
7#d7 an ov]view ( ! res\rces us$ to     
implem5t su* section2 &  7#e7 any       

recomm5dation on fur!r improvem5t on    
increas+ ov]-!-c\nt] drug approvals us+ 
a framework simil> to ! designation     
framework e/abli%$ 9 su* section4  7d7  
,sunset date ,! au?ority provid$ to !   
,secret>y ( ,heal? & ,human ,s]vices "u 
section #ejf,m ( ! ,f$]al ,food1 ,drug1 
& ,cosmetic ,act1 z add$ by subsection  
7a71 %all cease to be effective         
,septemb] #cj1 #bjcb4