,i  #aai? ,,congress  #a/ ,session  ,h4 
,r4 #fhfh  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,decemb] #ah1         
#bjbe,mr4 ,l&sman introduc$ ! foll[+    
bill2 :i* 0 ref]r$ to ! ,committee on   
,en]gy & ,comm]ce  ,a ,,bill  ,to am5d !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act  
to direct ! ,secret>y ( ,heal? & ,human 
,s]vices to apply ! lea/ burd5some      
appropriate means = support+ c]ta9      
adm9i/rative ord] reque/s ) respect to  
ov]-!-c\nt] monograph drugs1 & = o!r    
purposes4  #a4 ,%ort title  ,?is ,act   
may be cit$ z ! ,advanc+ ,consum]       
,*oice1 ,equity1 ,safety1 & ,self-,c>e  
,?r\gh ,,otc ,innovation ,act or !      
,,access ,?r\gh ,,otc ,innovation ,act4 
#b4 ,lea/ burd5some means = support+    
c]ta9 adm9i/rative ord] reque/s )       
respect to ov]-!-c\nt] monograph drugs  
,section #eje;,g ( ! ,f$]al ,food1      
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cee;h7 is am5d$-- 7#a7 by r$esignat+   
subsection 7q7 z subsection 7r72 &  7#b7
 by ins]t+ aft] subsection 7p7 ! foll[+3

  7q7 ,lea/ burd5some means = support+  
reque/s = c]ta9 adm9i/rative ord]s  7#a7
 ,9 g5]al ,= purposes ( det]m9+ :e!r a  
drug is g5]ally recogniz$ z safe &      
effective "u section #bja7p77#a7 :5     
evaluat+ a reque/ submitt$ "u subsection
 7b77#e71 ! ,secret>y %all apply ! lea/ 
burd5some appropriate means = support+  
su* a reque/ & satisfy+ ! requirem5ts ( 
?is section4  7#b7 ,meet+ reque/s  7,a7 
,9 g5]al ,9 ! case ( an ord] reque/$ "u 
subsection 7b77#e71 & if publi%$ reports
 are insuffici5t to support ! reque/$   
f9d+s1 ! ,secret>y %all meet ) !        
reque/or1 if ! reque/or makes a         
reasonable writt5 reque/ = ! meet+1 = ! 
purpose ( provid+ recomm5dations on !   
types ( evid5ce necess>y1 includ+1 if   
appropriate1 ! pot5tial design & size ( 
any /udies to support a demon/ration t !
 drug is g5]ally recogniz$ z safe &     
effective4  7,b7 ,prep>ation &          
availability ( meet+ m9utes ,! ,secret>y
 %all prep>e1 & make available to !     
reque/or1 ! m9utes ( any su* meet+4     

7,c7 ,adm9i/rative record ,9 ! case (   
any su* meet+1 ! ,secret>y %all r$uce to
 writ+ & make a "p ( ! adm9i/rative     
record-- 7i7 any recomm5dations reg>d+ !
 p>amet]s ( /udies "u ?is p>agraph t !  
,secret>y provides to ! reque/or2 &     
7ii7 a summ>y ( ! meet+ discussion4     
7#c7 ,rule ( con/ruction ,no?+ 9 ?is    
subsection %all be con/ru$ to alt]1     
sup]s$e1 or limit ! crit]ia--  7,a7 =   
det]m9+ "u subsection 7b77#e77;,a7 :e!r 
a reque/ is suffici5tly complete &      
=matt$ to p]mit a sub/antive review2 or 
7,b7 = det]m9+ :e!r a drug is g5]ally   
recogniz$ z safe & effective "u section 
#bja7p77#a74  4