,i  #aafth ,,congress  #ast ,session    
,h4 ,r4 #diee  ,,in ,,the ,,house ,,of  
,,representatives  ,october #ca1        
#bjai,mr4 ,engel 7for himself1 ,mr4     
,guthrie1 ,mr4 ,schrader1 and ,mr4      
,hudson7 introduced the following bill2 
which was referred to the ,committee on 
,energy and ,commerce  ,a ,,bill  ,to   
amend the ,federal ,food1 ,drug1 and    
,cosmetic ,act to clarify the meaning of
 a new chemical entity4  #a4 ,short     
title ,this ,act may be cited as the    
,protecting ,access to ,safe and        
,effective ,medicines ,act of #bjai4    
#b4 ,clarifying the meaning of new      
chemical entity ,chapter ,v of the      
,federal ,food1 ,drug1 and ,cosmetic    
,act is amended--  7#a7 in section #eje 
7#ba ,u4,s4,c4 #cee7-- 7,a7 in          
subsection 7c77#c77;,e7--  7i7 in clause
 7ii71 by striking active ingredient    
7including any ester or salt of the     
active ingredient7 and inserting active 
moiety 7as defined by the ,secretary in 
section #cad4c of title #ba1 ,code of   

,federal ,regulations 7or any successor 
regulations772 and  7ii7 in clause      
7iii71 by striking active ingredient    
7including any ester or salt of the     
active ingredient7 and inserting active 
moiety 7as defined by the ,secretary in 
section #cad4c of title #ba1 ,code of   
,federal ,regulations 7or any successor 
regulations772  7,b7 in subsection      
7j77#e77;,f7-- 7i7 in clause 7ii71 by   
striking active ingredient 7including   
any ester or salt of the active         
ingredient7 and inserting active moiety 
7as defined by the ,secretary in section
 #cad4c of title #ba1 ,code of ,federal 
,regulations 7or any successor          
regulations772 and  7ii7 in clause      
7iii71 by striking active ingredient    
7including any ester or salt of the     
active ingredient7 and inserting active 
moiety 7as defined by the ,secretary in 
section #cad4c of title #ba1 ,code of   
,federal ,regulations 7or any successor 
regulations772  7,c7 in subsection      
7l77#b77;,a77i71 by striking active     

ingredient 7including any ester or salt 
of the active ingredient7 and inserting 
active moiety 7as defined by the        
,secretary in section #cad4c of title   
#ba1 ,code of ,federal ,regulations 7or 
any successor regulations772  7,d7 in   
subsection 7s71 in the matter preceding 
paragraph 7#a71 by striking active      
ingredient 7including any ester or salt 
of the active ingredient7 and inserting 
active moiety 7as defined by the        
,secretary in section #cad4c of title   
#ba1 ,code of ,federal ,regulations 7or 
any successor regulations772 and  7,e7  
in subsection 7u77#a71 in the matter    
preceding subparagraph 7,a7-- 7i7 by    
striking active ingredient 7including   
any ester or salt of the active         
ingredient7 and inserting active moiety 
7as defined by the ,secretary in section
 #cad4c of title #ba1 ,code of ,federal 
,regulations 7or any successor          
regulations772 and  7ii7 by striking    
same active ingredient and inserting    
same active moiety2  7#b7 in section    

#eab7;c77#b77;,f7 7#ba ,u4,s4,c4        
#cfj;b7c77#b77;,f77--  7,a7 in clause   
7i71 by striking active ingredient      
7including any ester or salt of the     
active ingredient7 and inserting active 
moiety 7as defined by the ,secretary in 
section #cad4c of title #ba1 ,code of   
,federal ,regulations 7or any successor 
regulations772  7,b7 in clause 7ii71 by 
striking active ingredient 7including   
any ester or salt of the active         
ingredient7 and inserting active moiety 
7as defined by the ,secretary in section
 #cad4c of title #ba1 ,code of ,federal 
,regulations 7or any successor          
regulations772 and  7,c7 in clause 7v71 
by striking active ingredient 7including
 any ester or salt of the active        
ingredient7 and inserting active moiety 
7as defined by the ,secretary in section
 #cad4c of title #ba1 ,code of ,federal 
,regulations 7or any successor          
regulations772  7#c7 in section         
#ebd7;a77#d77;,c7 7#ba ,u4,s4,c4        
#cfjn7a77#d77;,c771 by striking active  

ingredient 7including any ester or salt 
of the active ingredient7 and inserting 
active moiety 7as defined by the        
,secretary in section #cad4c of title   
#ba1 ,code of ,federal ,regulations 7or 
any successor regulations772  7#d7 in   
section #ebi7;a77#d77;,a77ii7 7#ba      
,u4,s4,c4 #cfj;ff7a77#d77;,a77ii771 by  
striking active ingredient 7including   
any ester or salt of the active         
ingredient7 and inserting active moiety 
7as defined by the ,secretary in section
 #cad4c of title #ba1 ,code of ,federal 
,regulations 7or any successor          
regulations772 and  7#e7 in section     
#efe;,a7a77#d77;,d7 7#ba ,u4,s4,c4      
#cfj;bbb-#d;a7a77#d77;,d771 by striking 
active ingredient 7including any ester  
or salt of the active ingredient7 and   
inserting active moiety 7as defined by  
the ,secretary in section #cad4c of     
title #ba1 ,code of ,federal            
,regulations 7or any successor          
regulations774