,,ii  #aadth ,,congress  #ast ,session  
,s4 #bahh  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,october #ba1  
#bjae ,mr4 ,gardner 7for himself and    
,mr4 ,donnelly7 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 with respect  
to the humanitarian device exemption4   
#a4 ,short title  ,this ,act may be     
cited as the ,rare ,disease ,innovation 
,act4  #b4 ,humanitarian device         
exemption application  7a7 ,in general  
,section #ebj7m7 of the ,federal ,food1 
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cfj;j7 is amended-- 7#a7 in paragraph 
7#a7 by striking fewer than #d1jjj and  
inserting not more than #h1jjj2  7#b7 in
 paragraph 7#b77;,a7 by striking fewer  
than #d1jjj and inserting not more than 
#h1jjj2 and  7#c7 in paragraph          
7#f77;,a77ii71 by striking #d1jjj and   
inserting #h1jjj4  7b7 ,guidance        

document on probable benefit ,not later 
than #ah months after the date of       
enactment of this ,act1 the ,secretary  
of ,health and ,human ,services1 acting 
through the ,commissioner of ,food and  
,drugs1 shall publish a draft guidance  
document that defines the criteria for  
establishing probable benefit as that   
term is used in section #ebj7m77#b77;,c7
 of the ,federal ,food1 ,drug1 and      
,cosmetic ,act 7#ba ,u4,s4,c4           
#cfj;j7m77#b77;,c774  7c7 ,reports to   
,congress ,five years after the date of 
enactment of this ,act and every #e     
years thereafter1 the ,secretary of     
,health and ,human ,services shall      
submit to ,congress a report on the     
effect of the amendments made by        
subsection 7a74