,,ii  #aagth ,,congress  #b;d ,session  
,s4 #dche  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,june #ac1     
#bjbb,mr4 ,braun introduced the         
following bill2 which was read twice and
 referred to the ,committee on ,health1 
,education1 ,labor1 and ,pensions  ,a   
,,bill  ,to amend the ,federal ,food1   
,drug1 and ,cosmetic ,act to allow      
waivers of annual establishment         
registration fees for small businesses1 
and for other purposes4  #a4 ,short     
title ,this ,act may be cited as the    
,small ,business ,establishment         
,registration ,waiver ,act4  #b4 ,waiver
 of annual establishment registration   
fees for small businesses ,section #gch 
of the ,federal ,food1 ,drug1 and       
,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j7 is
 amended-- 7#a7 in subsection           
7a77#c77;,b7-- 7,a7 by striking ,no fee 
and inserting the following3  7i7 ,in   
general ,no fee  2 and  7,b7 by adding  
at the end the following3  7ii7 ,small  
businesses fee waiver  7,i7 ,definition 

of small business ,for the purposes of  
this clause1 the term small business    
means an entity that reported #a1jjj1jjj
 or less of gross receipts or sales in  
its most recent ,federal income tax     
return for a taxable year1 including    
such returns of all of its affiliates4  
7,,ii7 ,waiver ,the ,secretary may grant
 a waiver of the fee required under     
subparagraph 7,a7 for the annual        
registration 7excluding the initial     
registration7 of an establishment for a 
year1 if the ,secretary finds that the  
establishment is a small business and   
paying the fee for such year represents 
a financial hardship to the             
establishment as determined on the basis
 of criteria established by the         
,secretary4  7,,iii7 ,firms submitting  
tax returns to the united states        
internal revenue service ,the           
establishment shall support its claim   
that it meets the definition under      
subclause 7,i7 by submission of a copy  
of its most recent ,federal income tax  

return for a taxable year1 and a copy of
 such returns of its affiliates1 which  
show an amount of gross sales or        
receipts that is less than the maximum  
established in subclause 7,i74 ,the     
establishment1 and each of such         
affiliates1 shall certify that the      
information provided is a true and      
accurate copy of the actual tax forms   
they submitted to the ,internal ,revenue
 ,service4 ,if no tax forms are         
submitted for any affiliate1 the        
establishment shall certify that the    
establishment has no affiliates4  7,,iv7
 ,firms not submitting tax returns to   
the united states internal revenue      
service ,in the case of an establishment
 that has not previously submitted a    
,federal income tax return1 the         
establishment and each of its affiliates
 shall demonstrate that it meets the    
definition under subclause 7,i7 by      
submission of a signed certification1 in
 such form as the ,secretary may direct 
through a notice published in the       

,federal ,register1 that the            
establishment or affiliate meets the    
criteria for a small business and a     
certification1 in ,english1 from the    
national taxing authority1 if extant1 of
 the country in which the establishment 
or1 if applicable1 affiliate is         
headquartered4 ,the certification from  
such taxing authority shall bear the    
official seal of such taxing authority  
and shall provide the establishment's or
 affiliate's gross receipts or sales for
 the most recent year in both the local 
currency of such country and in ,united 
,states dollars1 the exchange rate used 
in converting such local currency to    
dollars1 and the dates during which     
these receipts or sales were collected4 
,the establishment shall also submit a  
statement signed by the head of the     
establishment's firm or by its chief    
financial officer that the establishment
 has submitted certifications for all of
 its affiliates1 or that the            
establishment has no affiliates4  7,v7  

,request for waiver ,an establishment   
seeking a fee waiver for a year under   
this clause shall submit supporting     
information to the ,secretary at least  
#fj days before the fee is required     
pursuant to subparagraph 7,c74 ,the     
decision of the ,secretary regarding    
whether an entity may receive the waiver
 for such year is not reviewable4  2    
7#b7 in subsection 7d77#b77;,b77iii71 by
 inserting 1 if extant1 after national  
taxing authority2 and  7#c7 in          
subsection 7e77#b77;,b77iii71 by        
inserting 1 if extant1 after national   
taxing authority4