,,ii  #aai? ,,congress  #a/ ,session    
,s4 #beac  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,july #bi1 #bjbe ,mr4  
,ka9e introduc$ ! foll[+ bill2 :i* 0    
read twice & ref]r$ to ! ,committee on  
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to am5d ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act ) respect to    
transp>5cy & report+ reg>d+ ov]-!-c\nt] 
drug monograph activities1 & = o!r      
purposes4  #a4  ,%ort title  ,?is ,act  
may be cit$ z ! ,,otc ,monograph ,drug  
,us] ,fee ,transp>5cy ,act4  #b4  ,,otc 
monograph drug p]=mance reports  7a7    
,p]=mance report  ,section #gdd,n ( !   
,f$]al ,food1 ,drug1 & ,cosmetic ,act   
7#ba ,u4,s4,c4 #cgi;j-#gc7 is am5d$--   
7#a7 9 subsection 7a7-- 7,a7 by /rik+   
,beg9n+ ) & ins]t+ ! foll[+3  7#a7  ,9  
g5]al  ,beg9n+ )  2  7,b7 by /rik+      
section #chfa7;b7 & ins]t+ section      
#chfa2 &  7,c7 by add+ at ! end !       
foll[+3  7#b7 ,additional in=mation     
,beg9n+ ) fiscal ye> #bjbf1 ! annual    
report "u ?is subsection %all include-- 

7,a7 ! progress ( ! ,food & ,drug       
,adm9i/ration 9 a*iev+ ! goals1 & future
 plans = meet+ ! goals1 includ+--  7i7 !
 numb] ( ,ti] #a ,,otc monograph ord]   
reque/s = :i* a propos$ ord] 0 issu$1 & 
! numb] ( su* reque/s = :i* a f9al ord] 
0 issu$1 9 ! previ\s fiscal ye>2  7ii7 !
 numb] ( ,ti] #b ,,otc monograph ord]   
reque/s = :i* a propos$ ord] 0 issu$1 & 
! numb] ( su* reque/s = :i* a f9al ord] 
0 issu$1 9 ! previ\s fiscal ye>2  7iii7 
! numb] ( specifi$ safety ,,otc         
monograph ord] reque/s = :i* a propos$  
ord] 0 issu$1 & ! numb] ( su* reque/s = 
:i* a f9al ord] 0 issu$1 9 ! previ\s    
fiscal ye>2  7iv7 ! numb] ( g5]ally     
recogniz$ z safe & effective f9alization
 ,,otc monograph ord] reque/s = :i* a   
propos$ ord] 0 issu$1 & ! numb] ( su*   
reque/s = :i* a f9al ord] 0 issu$1 9 !  
previ\s fiscal ye>2  7v7 ! av]age       
timel9e = process+ ,,otc monograph ord] 
reque/s1 9 ! aggregate & by submission  
type1 9 ! previ\s fiscal ye>2 &  7vi7   
po/m>ket safety activities ) respect to 

,,otc monograph drugs1 includ+--  7,i7  
collect+1 develop+1 & review+ safety    
in=mation on ,,otc monograph drugs1     
includ+ adv]se ev5t reports2  7,,ii7    
develop+ & us+ improv$ analytical tools1
 adv]se ev5t data-collection sy/ems1    
includ+ in=mation te*nology sy/ems1 to  
assess pot5tial safety problems1 includ+
 access to ext]nal databases2 &  7,,iii7
 activities "u section #gfj2 &  7,b7    
in=mation reg>d+ regi/ration ( ,,otc    
monograph drug facilities & contract    
manufactur+ organization facilities &   
paym5t ( regi/ration fees by su*        
facilities1 includ+--  7i7 ! ,,otc      
monograph drug facilities & contract    
manufactur+ organization facilities t 7 
fir/ regi/]$ "u section #eaj7;c7 or     
#eaj7;i7 9 ! fiscal ye>2 &  7ii7 = ea*  
,,otc monograph drug facility & contract
 manufactur+ organization facility t 0  
assess$ a facility fee "u section       
#gdd,m7a7 9 ! fiscal ye>1 :e!r !        
facility paid su* fee4  7#c7            
,confid5tiality  ,no?+ 9 p>agraph 7#b7  

%all be con/ru$ to au?orize ! disclosure
 ( in=mation t is prohibit$ f disclosure
 "u section #cja7;j7 ( ?is ,act or      
section #aije ( title #ah1 ,unit$ ,/ates
 ,code1 or t is subject to )hold+ "u    
section #eeb7;b77#d7 ( title #e1 ,unit$ 
,/ates ,code4  2 &  7#b7 by add+ at !   
end ( subsection 7d7 ! foll[+3  7#d7    
,m9utes ( negotiation meet+s  7,a7      
,public availability ,! ,secret>y %all  
make publicly available1 on ! public    
website ( ! ,food & ,drug ,adm9i/ration1
 robu/ writt5 m9utes ( all negotiation  
meet+s conduct$ "u ?is subsection betwe5
 ! ,food & ,drug ,adm9i/ration & !      
regulat$ indu/ry1 n lat] ?an #cj days   
aft] ea* su* negotiation meet+4  7,b7   
,cont5t  ,! robu/ writt5 m9utes describ$
 "u subp>agraph 7,a7 %all conta91 9     
detail1 any sub/antive proposal made by 
any p>ty to ! negotiations z well z     
significant controv]sies or diff]5ces ( 
op9ion dur+ ! negotiations & _!         
resolution4  4  7b7  ,,gao report  7#a7 
,9 g5]al  ,n lat] ?an #b ye>s aft] !    

date ( enactm5t ( ?is ,act1 !           
,comptroll] ,g5]al ( ! ,unit$ ,/ates    
%all submit to ! ,committee on ,heal?1  
,education1 ,labor1 & ,p5sions ( !      
,s5ate & ! ,committee on ,en]gy &       
,comm]ce ( ! ,h\se ( ,repres5tatives a  
report assess+ ! supply *a9 (           
ov]-!-c\nt] monograph drugs4  7#b7      
,cont5ts  ,! report requir$ "u p>agraph 
7#a7 %all include an assessm5t (--  7,a7
 in=mation ! ,food & ,drug ,adm9i/ration
 & o!rs h report$ ab\t ! ov]all /ability
 ( ! supply *a9 ( ov]-!-c\nt] monograph 
drugs2  7,b7 :at in=mation is collect$  
by ! ,food & ,drug ,adm9i/ration )      
respect to ! supply *a9 ( ov]-!-c\nt]   
monograph drugs2  7,c7 h[ ! ,food &     
,drug ,adm9i/ration uses in=mation      
collect$ on ! supply *a9 ( ov]-!-c\nt]  
monograph drugs to in=m regulatory      
decisions2  7,d7 h[ ! ,food & ,drug     
,adm9i/ration coord9ates ) o!r ,f$]al   
ag5cies to monitor & mitigate           
disruptions to ! supply *a9 (           
ov]-!-c\nt] monograph drugs2 &  7,e7 !  

unique *>act]i/ics ( ! ov]-!-c\nt]      
monograph drug m>ketplace & :at         
additional au?orities or in=mation1 if  
any1 ! ,food & ,drug ,adm9i/ration &    
o!rs h id5tifi$ z be+ necess>y to ensure
 ! /ability ( ! supply *a9 ( ov]-!-c\nt]
 monograph drugs4