,,ii  #aaith ,,congress  #ast ,session  
,s4 #beac  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,july #bi1     
#bjbe ,mr4 ,kaine 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 transparency and reporting regarding 
over-the-counter drug monograph         
activities1 and for other purposes4  #a4
  ,short title  ,this ,act may be cited 
as the ,,otc ,monograph ,drug ,user ,fee
 ,transparency ,act4  #b4  ,,otc        
monograph drug performance reports  7a7 
,performance report  ,section #gdd,n of 
the ,federal ,food1 ,drug1 and ,cosmetic
 ,act 7#ba ,u4,s4,c4 #cgi;j-#gc7 is     
amended--  7#a7 in subsection 7a7-- 7,a7
 by striking ,beginning with and        
inserting the following3  7#a7  ,in     
general  ,beginning with  2  7,b7 by    
striking section #chfa7;b7 and inserting
 section #chfa2 and  7,c7 by adding at  

the end the following3  7#b7 ,additional
 information ,beginning with fiscal year
 #bjbf1 the annual report under this    
subsection shall include--  7,a7 the    
progress of the ,food and ,drug         
,administration in achieving the goals1 
and future plans for meeting the goals1 
including--  7i7 the number of ,tier #a 
,,otc monograph order requests for which
 a proposed order was issued1 and the   
number of such requests for which a     
final order was issued1 in the previous 
fiscal year2  7ii7 the number of ,tier  
#b ,,otc monograph order requests for   
which a proposed order was issued1 and  
the number of such requests for which a 
final order was issued1 in the previous 
fiscal year2  7iii7 the number of       
specified safety ,,otc monograph order  
requests for which a proposed order was 
issued1 and the number of such requests 
for which a final order was issued1 in  
the previous fiscal year2  7iv7 the     
number of generally recognized as safe  
and effective finalization ,,otc        

monograph order requests for which a    
proposed order was issued1 and the      
number of such requests for which a     
final order was issued1 in the previous 
fiscal year2  7v7 the average timeline  
for processing ,,otc monograph order    
requests1 in the aggregate and by       
submission type1 in the previous fiscal 
year2 and  7vi7 postmarket safety       
activities with respect to ,,otc        
monograph drugs1 including--  7,i7      
collecting1 developing1 and reviewing   
safety information on ,,otc monograph   
drugs1 including adverse event reports2 
7,,ii7 developing and using improved    
analytical tools1 adverse event         
data-collection systems1 including      
information technology systems1 to      
assess potential safety problems1       
including access to external databases2 
and  7,,iii7 activities under section   
#gfj2 and  7,b7 information regarding   
registration of ,,otc monograph drug    
facilities and contract manufacturing   
organization facilities and payment of  

registration fees by such facilities1   
including--  7i7 the ,,otc monograph    
drug facilities and contract            
manufacturing organization facilities   
that were first registered under section
 #eaj7;c7 or #eaj7;i7 in the fiscal     
year2 and  7ii7 for each ,,otc monograph
 drug facility and contract             
manufacturing organization facility that
 was assessed a facility fee under      
section #gdd,m7a7 in the fiscal year1   
whether the facility paid such fee4     
7#c7  ,confidentiality  ,nothing in     
paragraph 7#b7 shall be construed to    
authorize the disclosure of information 
that is prohibited from disclosure under
 section #cja7;j7 of this ,act or       
section #aije of title #ah1 ,united     
,states ,code1 or that is subject to    
withholding under section #eeb7;b77#d7  
of title #e1 ,united ,states ,code4  2  
and  7#b7 by adding at the end of       
subsection 7d7 the following3  7#d7     
,minutes of negotiation meetings  7,a7  
,public availability ,the ,secretary    

shall make publicly available1 on the   
public website of the ,food and ,drug   
,administration1 robust written minutes 
of all negotiation meetings conducted   
under this subsection between the ,food 
and ,drug ,administration and the       
regulated industry1 not later than #cj  
days after each such negotiation        
meeting4  7,b7  ,content  ,the robust   
written minutes described under         
subparagraph 7,a7 shall contain1 in     
detail1 any substantive proposal made by
 any party to the negotiations as well  
as significant controversies or         
differences of opinion during the       
negotiations and their resolution4  4   
7b7  ,,gao report  7#a7  ,in general    
,not later than #b years after the date 
of enactment of this ,act1 the          
,comptroller ,general of the ,united    
,states shall submit to the ,committee  
on ,health1 ,education1 ,labor1 and     
,pensions of the ,senate and the        
,committee on ,energy and ,commerce of  
the ,house of ,representatives a report 

assessing the supply chain of           
over-the-counter monograph drugs4  7#b7 
,contents  ,the report required under   
paragraph 7#a7 shall include an         
assessment of--  7,a7 information the   
,food and ,drug ,administration and     
others have reported about the overall  
stability of the supply chain of        
over-the-counter monograph drugs2  7,b7 
what information is collected by the    
,food and ,drug ,administration with    
respect to the supply chain of          
over-the-counter monograph drugs2  7,c7 
how the ,food and ,drug ,administration 
uses information collected on the supply
 chain of over-the-counter monograph    
drugs to inform regulatory decisions2   
7,d7 how the ,food and ,drug            
,administration coordinates with other  
,federal agencies to monitor and        
mitigate disruptions to the supply chain
 of over-the-counter monograph drugs2   
and  7,e7 the unique characteristics of 
the over-the-counter monograph drug     
marketplace and what additional         

authorities or information1 if any1 the 
,food and ,drug ,administration and     
others have identified as being         
necessary to ensure the stability of the
 supply chain of over-the-counter       
monograph drugs4