,i  #aagth ,,congress  #b;d ,session    
,h4 ,r4 #fihj  ,,in ,,the ,,house ,,of  
,,representatives  ,march #h1 #bjbb,mr4 
,hudson 7for himself and ,ms4 ,eshoo7   
introduced the following bill2 which was
 referred to the ,committee on ,energy  
and ,commerce  ,a ,,bill  ,to direct the
 ,secretary of ,health and ,human       
,services to conduct a pilot program    
under which the ,secretary increases the
 conduct of unannounced inspections of  
foreign human drug establishments and   
evaluates the differences between       
inspections of domestic and foreign     
human drug establishments1 including the
 impact of announcing inspections to    
persons who own or operate foreign human
 drug establishments in advance of an   
inspection4  #a4 ,unannounced foreign   
facility inspections pilot program  7a7 
,in general ,the ,secretary of ,health  
and ,human ,services 7referred to in    
this section as the ,secretary7 shall   
conduct a pilot program under which the 
,secretary increases the conduct of     

unannounced inspections of foreign human
 drug establishments and evaluates the  
differences between inspections of      
domestic and foreign human drug         
establishments1 including the impact of 
announcing inspections to persons who   
own or operate foreign human drug       
establishments in advance of an         
inspection4 ,such pilot program shall   
evaluate-- 7#a7 differences in the      
number and type of violations of section
 #eja7;a77#b77;,b7 of the ,federal      
,food1 ,drug1 and ,cosmetic ,act 7#ba   
,u4,s4,c4 #cea7;a77#b77;,b77 identified 
during unannounced and announced        
inspections of foreign human drug       
establishments and any other significant
 differences between each type of       
inspection2  7#b7 costs and benefits    
associated with conducting announced and
 unannounced inspections of foreign     
human drug establishments2  7#c7        
barriers to conducting unannounced      
inspections of foreign human drug       
establishments and any challenges to    

achieving parity between domestic and   
foreign human drug establishment        
inspections2 and  7#d7 approaches for   
mitigating any negative effects of      
conducting announced inspections of     
foreign human drug establishments4  7b7 
,pilot program initiation ,the          
,secretary shall initiate the pilot     
program under this section not later    
than #ahj days after the date of        
enactment of this ,act4  7c7 ,report    
,the ,secretary shall1 not later than   
#ahj days following the completion of   
the pilot program1 make available on the
 website of the ,food and ,drug         
,administration a final report on the   
pilot program under this section1       
including-- 7#a7 findings and any       
associated recommendations with respect 
to the evaluation under subsection 7a71 
including any recommendations to address
 identified barriers to conducting      
unannounced inspections of foreign human
 drug establishments2  7#b7 findings and
 any associated recommendations         

regarding how the ,secretary may achieve
 parity between domestic and foreign    
human drug inspections2 and  7#c7 the   
number of unannounced inspections during
 the pilot that would not be unannounced
 under existing practices4