,i  #aac? ,,congress  #a/ ,session  ,h4 
,r4 #cfca  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,decemb] #b1 #bjac,mr4
 ,hurt 7= himself & ,mr4 ,roe (         
,t5nessee7 introduc$ ! foll[+ bill2 :i* 
0 ref]r$ to ! ,committee on ,en]gy &    
,comm]ce  ,a ,,bill  ,to au?orize !     
,commission] ( ,food & ,drugs to waive  
or r$uce c]ta9 fees applicable to g5]ic 
drug facilities :]e ! fees w\ld pres5t a
 significant b>ri] to m>ket entry       
because ( limit$ res\rces available to  
su* facilities or o!r circum/ances4  #a4
 ,%ort title ,?is ,act may be cit$ z !  
,small ,manufactur] ,protection ,act (  
#bjac4  #b4 ,waiv] or r$uction ( c]ta9  
fees applicable to g5]ic drug facilities
  7a7 ,9 g5]al ,section #gdd;,b ( !     
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cgi;j-#db7 is am5d$--   
7#a7 9 subsection 7b77#a77;,b71 by      
ins]t+ 1 except z provid$ 9 subsection  
7c77#c71 aft] fees "u p>agraphs 7#b7    
?r\gh 7#d7 ( subsection 7a7 %all2 &     
7#b7 9 subsection 7c71 by add+ at ! end 

! foll[+3  7#c7 ,fee waiv]s  7,a7 ,/&>d 
,! ,secret>y %all grant to a p]son t    
owns a g5]ic drug facility a waiv] f or 
a r$uction ( "o or m fees assess$ to t  
p]son "u subsection 7a7 :]e ! ,secret>y 
f9ds t ! assessm5t ( ! fee w\ld pres5t a
 significant b>ri] to m>ket entry       
because ( limit$ res\rces available to  
su* p]son or o!r circum/ances4  7,b7    
,consid]ations ,9 det]m9+ :e!r to grant 
a waiv] or r$uction ( a fee "u          
subp>agraph 7,a71 ! ,secret>y %all      
consid] only ! circum/ances & assets ( !
 p]son involv$ & any affiliate ( !      
p]son4  7,c7 ,writt5 reque/s ,to qualify
 = consid]ation = a waiv] or r$uction "u
 subp>agraph 7,a71 a p]son %all submit  
to ! ,secret>y a writt5 reque/ = su*    
waiv] or r$uction n lat] ?an #ahj days  
aft] ! fee is due4  7,d7 ,def9ition ,9  
?is p>agraph1 ! t]m p]son t owns a g5]ic
 drug facility means a p]son t owns a   
facility :i* is id5tifi$ or int5d$ to be
 id5tifi$ 9 at lea/ "o g5]ic drug       
submission t is p5d+ or approv$ to      

produce "o or m f9i%$ dosage =ms ( a    
human g5]ic drug4  4  7b7 ,applicability
 ,! am5dm5ts made by ?is section apply )
 respect to fees au?oriz$ to be assess$ 
& collect$ = any ( fiscal ye>s #bjad    
?r\gh #bjag4