,i  #aaith ,,congress  #ast ,session    
,h4 ,r4 #fhfh  ,,in ,,the ,,house ,,of  
,,representatives  ,december #ah1       
#bjbe,mr4 ,landsman introduced the      
following bill2 which was referred to   
the ,committee on ,energy and ,commerce 
,a ,,bill  ,to amend the ,federal ,food1
 ,drug1 and ,cosmetic ,act to direct the
 ,secretary of ,health and ,human       
,services to apply the least burdensome 
appropriate means for supporting certain
 administrative order requests with     
respect to over-the-counter monograph   
drugs1 and for other purposes4  #a4     
,short title  ,this ,act may be cited as
 the ,advancing ,consumer ,choice1      
,equity1 ,safety1 and ,self-,care       
,through ,,otc ,innovation ,act or the  
,,access ,through ,,otc ,innovation     
,act4  #b4 ,least burdensome means for  
supporting certain administrative order 
requests with respect to                
over-the-counter monograph drugs        
,section #eje;,g of the ,federal ,food1 
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4

 #cee;h7 is amended-- 7#a7 by           
redesignating subsection 7q7 as         
subsection 7r72 and  7#b7 by inserting  
after subsection 7p7 the following3  7q7
 ,least burdensome means for supporting 
requests for certain administrative     
orders  7#a7 ,in general ,for purposes  
of determining whether a drug is        
generally recognized as safe and        
effective under section #bja7p77#a7 when
 evaluating a request submitted under   
subsection 7b77#e71 the ,secretary shall
 apply the least burdensome appropriate 
means for supporting such a request and 
satisfying the requirements of this     
section4  7#b7 ,meeting requests  7,a7  
,in general ,in the case of an order    
requested under subsection 7b77#e71 and 
if published reports are insufficient to
 support the requested findings1 the    
,secretary shall meet with the          
requestor1 if the requestor makes a     
reasonable written request for the      
meeting1 for the purpose of providing   
recommendations on the types of evidence

 necessary1 including1 if appropriate1  
the potential design and size of any    
studies to support a demonstration that 
the drug is generally recognized as safe
 and effective4  7,b7 ,preparation and  
availability of meeting minutes ,the    
,secretary shall prepare1 and make      
available to the requestor1 the minutes 
of any such meeting4  7,c7              
,administrative record ,in the case of  
any such meeting1 the ,secretary shall  
reduce to writing and make a part of the
 administrative record-- 7i7 any        
recommendations regarding the parameters
 of studies under this paragraph that   
the ,secretary provides to the          
requestor2 and  7ii7 a summary of the   
meeting discussion4  7#c7 ,rule of      
construction ,nothing in this subsection
 shall be construed to alter1 supersede1
 or limit the criteria--  7,a7 for      
determining under subsection            
7b77#e77;,a7 whether a request is       
sufficiently complete and formatted to  
permit a substantive review2 or  7,b7   

for determining whether a drug is       
generally recognized as safe and        
effective under section #bja7p77#a74  4