,,ii  #aagth ,,congress  #ast ,session  
,s4 #ccie  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,december #ad1 
#bjba,ms4 ,baldwin 7for herself and ,mr4
 ,cassidy7 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 records and other information        
inspections4  #a4 ,short title ,this    
,act may be cited as the ,medical       
,device ,integrity ,act4  #b4 ,records  
and other information inspection  7a7   
,in general ,section #gjd7;a77#d77;,a7  
of the ,federal ,food1 ,drug1 and       
,cosmetic ,act 7#ba ,u4,s4,c4           
#cgd7;a77#d77;,a77 is amended-- 7#a7 in 
the first sentence1 by inserting or     
device after processing of a drug2 and  
7#b7 in the second sentence1 by striking
 shall include and all that follows     
through the period at the end and       
inserting the following3 8shall         

include--  7,a7 a sufficient description
 of the records requested2 and  7,b7 a  
rationale for requesting such           
information in advance of1 or in lieu   
of1 an inspection4  4  7b7 ,guidance    
,not later than #a year after the date  
of enactment of this ,act1 the          
,secretary shall issue draft guidance   
describing the circumstances in which   
the ,secretary intends to issue requests
 for records or other information in    
advance of1 or in lieu of1 an           
inspection1 processes for responding to 
such requests electronically or in      
physical form1 and factors the          
,secretary intends to consider in       
evaluating whether such records are     
provided within a reasonable timeframe1 
within reasonable limits1 and in a      
reasonable manner1 accounting for       
resource and other limitations that may 
exist1 including for small businesses4  
,the ,secretary shall issue final       
guidance not later than #a year after   
the close of the comment period for the 

draft guidance4