,i  #aacth ,,congress  #b;d ,session    
,h4 ,r4 #dbii  ,,in ,,the ,,house ,,of  
,,representatives  ,march #bf1 #bjad    
,mr4 ,pitts 7for himself and ,mr4       
,pallone7 introduced the following bill2
 which was referred to the ,committee on
 ,energy and ,commerce1 and in addition 
to the ,committee on the ,judiciary1 for
 a period to be subsequently determined 
by the ,speaker1 in each case for       
consideration of such provisions as fall
 within the jurisdiction of the         
committee concerned  ,a ,,bill  ,to     
amend the ,controlled ,substances ,act  
with respect to drug scheduling         
recommendations by the ,secretary of    
,health and ,human ,services1 and with  
respect to registration of manufacturers
 and distributors seeking to conduct    
clinical testing4  #a4 ,short title     
,this ,act may be cited as the          
,improving ,regulatory ,transparency for
 ,new ,medical ,therapies ,act4  #b4    
,scheduling of substances included in   
new ,,fda-approved drugs ,section #bja  

of the ,controlled ,substances ,act 7#ba
 ,u4,s4,c4 #haa7 is amended by inserting
 after subsection 7h7 the following3    
7i7 ,within #de days of receiving a     
recommendation from the ,secretary to   
add a drug or substance that has never  
been marketed in the ,united ,states to 
a schedule under this title1 the        
,attorney ,general shall1 without regard
 to the findings required by subsection 
7a7 of this section or section #bjb7;b71
 issue an interim final rule1 under the 
exception for good cause described in   
subparagraph 7,b7 of section #eec7;b7 of
 title #e1 ,united ,states ,code1       
placing the drug or substance into the  
schedule recommended by the ,secretary4 
,the interim final rule shall be made   
immediately effective under section     
#eec7;d77#c7 of title #e1 ,united       
,states ,code4  4  #c4 ,enhancing new   
drug development ,section #cjb of the   
,controlled ,substances ,act 7#ba       
,u4,s4,c4 #hbb7 is amended by inserting 
after subsection 7g7 the following3  7h7

  7#a7 ,a person who submits an         
application for registration to         
manufacture or distribute a controlled  
substance in accordance with this       
section may indicate on the registration
 application that the substance will be 
used only in connection with clinical   
trials of a drug in accordance with     
section #eje7;i7 of the ,federal ,food1 
,drug1 and ,cosmetic ,act4  7#b7 ,when  
an application for registration to      
manufacture or distribute a controlled  
substance includes an indication that   
the controlled substance will be used   
only in connection with clinical trials 
of a drug in accordance with section    
#eje7;i7 of the ,federal ,food1 ,drug1  
and ,cosmetic ,act1 the ,attorney       
,general shall--  7,a7 make a final     
decision on the application for         
registration within #ahj days2 or  7,b7 
provide notice to the applicant in      
writing of--  7i7 the outstanding issues
 that must be resolved in order to reach
 a final decision on the application2   

and  7ii7 the estimated date on which a 
final decision on the application will  
be made4  4