,,ii  #aafth ,,congress  #ast ,session  
,s4 #ffj  ,,in ,,the ,,senate ,,of ,,the
 ,,united ,,states  ,march #e1 #bjai    
,mr4 ,braun introduced the following    
bill2 which was read twice and referred 
to the ,committee on ,health1           
,education1 ,labor1 and ,pensions  ,a   
,,bill  ,to address abuse of the ,food  
and ,drug ,administration's citizen     
petition process by brand drug          
manufacturers4  #a4 ,short title  ,this 
,act may be cited as the ,efficiency and
 ,transparency in ,petitions ,act4  #b4 
,citizen petition amendments ,section   
#eje7q7 of the ,federal ,food1 ,drug1   
and ,cosmetic ,act 7#ba ,u4,s4,c4       
#cee7q77 is amended-- 7#a7 in paragraph 
7#a7--  7,a7 in subparagraph 7,a7-- 7i7 
in clause 7i71 by striking 2 and and    
inserting 22  7ii7 by redesignating     
clause 7ii7 as clause 7iii72 and  7iii7 
by inserting after clause 7i7 the       
following3  7ii7 7,i7 the petition is   
submitted within #a year of the         
petitioner first discovering the issue  

that is the basis for submission of such
 petition2 or  7,,ii7 the ,secretary    
grants a waiver of the #a-year period   
under subclause 7,i72 and  2 and  7,b7  
in subparagraph 7,h71 by adding at the  
end the following3 ,any subsequent      
petition or amendment to a petition with
 respect to the same application under  
subsection 7b77#b7 or 7j7 of this       
section or section #cea7k7 of the       
,public ,health ,service ,act filed by  
the same person shall include an        
explanation of why such person did not  
include the information or allegations  
contained in the subsequent petition or 
amendment in the original petition42    
7#b7 in paragraph 7#c7-- 7,a7 in        
subparagraph 7,c71 by striking 2 and and
 inserting 1 and the basis for the      
determinations of such number of days22 
7,b7 in subparagraph 7,d71 by striking  
the period and inserting a semicolon2   
and  7,c7 by adding at the end the      
following3  7,e7 as applicable1 the     
timing of submission of the petition in 

relation to the expiration of any       
patents listed under subsection 7j77#g7 
for a drug approved under subsection 7c7
 of this section that is referenced in  
the application under subsection 7b77#b7
 or 7j72 and  7,f7 the time the ,food   
and ,drug ,administration expended on   
the petition4  2 and  7#c7 by adding at 
the end the following3  7#f7            
,publication of petitions ,the          
,secretary shall annually publish a list
 of all petitions that were submitted   
during the preceding #ab-month period4  
4