,i  #aacth ,,congress  #ast ,session    
,h4 ,r4 #cfca  ,,in ,,the ,,house ,,of  
,,representatives  ,december #b1        
#bjac,mr4 ,hurt 7for himself and ,mr4   
,roe of ,tennessee7 introduced the      
following bill2 which was referred to   
the ,committee on ,energy and ,commerce 
,a ,,bill  ,to authorize the            
,commissioner of ,food and ,drugs to    
waive or reduce certain fees applicable 
to generic drug facilities where the    
fees would present a significant barrier
 to market entry because of limited     
resources available to such facilities  
or other circumstances4  #a4 ,short     
title ,this ,act may be cited as the    
,small ,manufacturer ,protection ,act of
 #bjac4  #b4 ,waiver or reduction of    
certain fees applicable to generic drug 
facilities  7a7 ,in general ,section    
#gdd;,b of the ,federal ,food1 ,drug1   
and ,cosmetic ,act 7#ba ,u4,s4,c4       
#cgi;j-#db7 is amended-- 7#a7 in        
subsection 7b77#a77;,b71 by inserting 1 
except as provided in subsection        

7c77#c71 after fees under paragraphs    
7#b7 through 7#d7 of subsection 7a7     
shall2 and  7#b7 in subsection 7c71 by  
adding at the end the following3  7#c7  
,fee waivers  7,a7 ,standard ,the       
,secretary shall grant to a person that 
owns a generic drug facility a waiver   
from or a reduction of one or more fees 
assessed to that person under subsection
 7a7 where the ,secretary finds that the
 assessment of the fee would present a  
significant barrier to market entry     
because of limited resources available  
to such person or other circumstances4  
7,b7 ,considerations ,in determining    
whether to grant a waiver or reduction  
of a fee under subparagraph 7,a71 the   
,secretary shall consider only the      
circumstances and assets of the person  
involved and any affiliate of the       
person4  7,c7 ,written requests ,to     
qualify for consideration for a waiver  
or reduction under subparagraph 7,a71 a 
person shall submit to the ,secretary a 
written request for such waiver or      

reduction not later than #ahj days after
 the fee is due4  7,d7 ,definition ,in  
this paragraph1 the term person that    
owns a generic drug facility means a    
person that owns a facility which is    
identified or intended to be identified 
in at least one generic drug submission 
that is pending or approved to produce  
one or more finished dosage forms of a  
human generic drug4  4  7b7             
,applicability ,the amendments made by  
this section apply with respect to fees 
authorized to be assessed and collected 
for any of fiscal years #bjad through   
#bjag4