,i  #aaeth ,,congress  #b;d ,session    
,h4 ,r4 #eeii  ,,in ,,the ,,house ,,of  
,,representatives  ,april #bd1 #bjah    
,mr4 ,hudson 7for himself1 ,mr4         
,schrader1 ,mr4 ,bucshon1 ,mr4          
,butterfield1 and ,mr4 ,mullin7         
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 expand the conditional approval 
pathway for more animal drugs1 and for  
other purposes4  #a4 ,short title ,this 
,act may be cited as the ,animal ,health
 and ,innovation ,act of #bjah4  #b4    
,conditional approval of new animal     
drugs ,section #ega of the ,federal     
,food1 ,drug1 and ,cosmetic ,act 7#ba   
,u4,s4,c4 #cfj;ccc7 is amended--  7#a7  
in the section heading1 by striking     
species and inserting species and       
certain new animal drugs2  7#b7 in      
subsection 7a7--  7,a7 by amending      
paragraph 7#a7 to read as follows3  7#a7
 7,a7 ,except as provided in paragraph  

7#c71 any person may file with the      
,secretary an application for           
conditional approval of--  7i7 a new    
animal drug intended for a minor use or 
a minor species2 or  7ii7 a new animal  
drug not intended for a minor use or    
minor species--  7,i7 that is intended  
to treat a serious or life-threatening  
disease or condition or addresses an    
unmet animal or human health need2 and  
7,,ii7 for which the ,secretary         
determines that a demonstration of      
effectiveness would require a complex or
 particularly difficult study or        
studies4  7,b7 ,the ,secretary shall1   
not later than ,september #cj1 #bjai1   
issue guidance or regulations further   
clarifying the criteria specified in    
subparagraph 7,a77ii74  7,c7 ,an        
application under this paragraph shall  
comply in all respects with the         
provisions of section #eab except for   
subsections 7a77#d71 7b77#b71 7c77#a71  
7c77#b71 7c77#c71 7d77#a71 7e71 7h71 and
 7n7 of such section unless otherwise   

stated in this section1 and any         
additional provisions of this section4  
7,d7 ,new animal drugs conditionally    
approved under this section are subject 
to application of the same safety       
standards that would be applied to new  
animal drugs approved under section     
#eab7;d7 7including1 for antimicrobial  
new animal drugs1 with respect to       
antimicrobial resistance74  2 and  7,b7 
in paragraph 7#c7--  7i7 in subparagraph
 7,a71 by striking the period at the end
 and inserting or a new animal drug that
 is an antibiotic drug22 and  7ii7 in   
subparagraph 7,b71 by striking 2 or and 
inserting 2 or2 and  7#c7 in subsection 
7f7-- 7,a7 in paragraph 7#a71 in the    
matter preceding subparagraph 7,a71 by  
inserting for the conditionally approved
 use after shall2 and  7,b7 in paragraph
 7#b7-- 7i7 by striking ,an intended use
 and inserting ,the ,secretary shall1   
through regulation or guidance1         
determine under what conditions an      
intended use2 and  7ii7 by striking     

shall not and inserting may4