,i  #aaf? ,,congress  #a/ ,session  ,h4 
,r4 #diee  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,octob] #ca1 #bjai,mr4
 ,engel 7= himself1 ,mr4 ,gu?rie1 ,mr4  
,s*rad]1 & ,mr4 ,hudson7 introduc$ !    
foll[+ bill2 :i* 0 ref]r$ to !          
,committee on ,en]gy & ,comm]ce  ,a     
,,bill  ,to am5d ! ,f$]al ,food1 ,drug1 
& ,cosmetic ,act to cl>ify ! mean+ ( a  
new *emical entity4  #a4 ,%ort title    
,?is ,act may be cit$ z ! ,protect+     
,access to ,safe & ,effective ,m$ic9es  
,act ( #bjai4  #b4 ,cl>ify+ ! mean+ (   
new *emical entity ,*apt] ,v ( ! ,f$]al 
,food1 ,drug1 & ,cosmetic ,act is       
am5d$--  7#a7 9 section #eje 7#ba       
,u4,s4,c4 #cee7-- 7,a7 9 subsection     
7c77#c77;,e7--  7i7 9 clause 7ii71 by   
/rik+ active +r$i5t 7includ+ any e/] or 
salt ( ! active +r$i5t7 & ins]t+ active 
moiety 7z def9$ by ! ,secret>y 9 section
 #cad4c ( title #ba1 ,code ( ,f$]al     
,regulations 7or any successor          
regulations772 &  7ii7 9 clause 7iii71  
by /rik+ active +r$i5t 7includ+ any e/] 

or salt ( ! active +r$i5t7 & ins]t+     
active moiety 7z def9$ by ! ,secret>y 9 
section #cad4c ( title #ba1 ,code (     
,f$]al ,regulations 7or any successor   
regulations772  7,b7 9 subsection       
7j77#e77;,f7-- 7i7 9 clause 7ii71 by    
/rik+ active +r$i5t 7includ+ any e/] or 
salt ( ! active +r$i5t7 & ins]t+ active 
moiety 7z def9$ by ! ,secret>y 9 section
 #cad4c ( title #ba1 ,code ( ,f$]al     
,regulations 7or any successor          
regulations772 &  7ii7 9 clause 7iii71  
by /rik+ active +r$i5t 7includ+ any e/] 
or salt ( ! active +r$i5t7 & ins]t+     
active moiety 7z def9$ by ! ,secret>y 9 
section #cad4c ( title #ba1 ,code (     
,f$]al ,regulations 7or any successor   
regulations772  7,c7 9 subsection       
7l77#b77;,a77i71 by /rik+ active +r$i5t 
7includ+ any e/] or salt ( ! active     
+r$i5t7 & ins]t+ active moiety 7z def9$ 
by ! ,secret>y 9 section #cad4c ( title 
#ba1 ,code ( ,f$]al ,regulations 7or any
 successor regulations772  7,d7 9       
subsection 7s71 9 ! matt] prec$+        

p>agraph 7#a71 by /rik+ active +r$i5t   
7includ+ any e/] or salt ( ! active     
+r$i5t7 & ins]t+ active moiety 7z def9$ 
by ! ,secret>y 9 section #cad4c ( title 
#ba1 ,code ( ,f$]al ,regulations 7or any
 successor regulations772 &  7,e7 9     
subsection 7u77#a71 9 ! matt] prec$+    
subp>agraph 7,a7-- 7i7 by /rik+ active  
+r$i5t 7includ+ any e/] or salt ( !     
active +r$i5t7 & ins]t+ active moiety 7z
 def9$ by ! ,secret>y 9 section #cad4c (
 title #ba1 ,code ( ,f$]al ,regulations 
7or any successor regulations772 &  7ii7
 by /rik+ same active +r$i5t & ins]t+   
same active moiety2  7#b7 9 section     
#eab7;c77#b77;,f7 7#ba ,u4,s4,c4        
#cfj;b7c77#b77;,f77--  7,a7 9 clause    
7i71 by /rik+ active +r$i5t 7includ+ any
 e/] or salt ( ! active +r$i5t7 & ins]t+
 active moiety 7z def9$ by ! ,secret>y 9
 section #cad4c ( title #ba1 ,code (    
,f$]al ,regulations 7or any successor   
regulations772  7,b7 9 clause 7ii71 by  
/rik+ active +r$i5t 7includ+ any e/] or 
salt ( ! active +r$i5t7 & ins]t+ active 

moiety 7z def9$ by ! ,secret>y 9 section
 #cad4c ( title #ba1 ,code ( ,f$]al     
,regulations 7or any successor          
regulations772 &  7,c7 9 clause 7v71 by 
/rik+ active +r$i5t 7includ+ any e/] or 
salt ( ! active +r$i5t7 & ins]t+ active 
moiety 7z def9$ by ! ,secret>y 9 section
 #cad4c ( title #ba1 ,code ( ,f$]al     
,regulations 7or any successor          
regulations772  7#c7 9 section          
#ebd7;a77#d77;,c7 7#ba ,u4,s4,c4        
#cfjn7a77#d77;,c771 by /rik+ active     
+r$i5t 7includ+ any e/] or salt ( !     
active +r$i5t7 & ins]t+ active moiety 7z
 def9$ by ! ,secret>y 9 section #cad4c (
 title #ba1 ,code ( ,f$]al ,regulations 
7or any successor regulations772  7#d7 9
 section #ebi7;a77#d77;,a77ii7 7#ba     
,u4,s4,c4 #cfj;ff7a77#d77;,a77ii771 by  
/rik+ active +r$i5t 7includ+ any e/] or 
salt ( ! active +r$i5t7 & ins]t+ active 
moiety 7z def9$ by ! ,secret>y 9 section
 #cad4c ( title #ba1 ,code ( ,f$]al     
,regulations 7or any successor          
regulations772 &  7#e7 9 section        

#efe;,a7a77#d77;,d7 7#ba ,u4,s4,c4      
#cfj;bbb-#d;a7a77#d77;,d771 by /rik+    
active +r$i5t 7includ+ any e/] or salt (
 ! active +r$i5t7 & ins]t+ active moiety
 7z def9$ by ! ,secret>y 9 section      
#cad4c ( title #ba1 ,code ( ,f$]al      
,regulations 7or any successor          
regulations774