,,ib  ,union ,calendar ,no4 #dea  #aacth
 ,,congress  #b;d ,session  ,h4 ,r4     
#dbii  ,report ,no4 #aac-efe1 ,parts ,i 
and ,,ii  ,,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  ,july #bi1 #bjad   
,reported from the ,committee on ,energy
 and ,commerce  ,july #bi1 #bjad        
,referral to the ,committee on the      
,judiciary extended for a period ending 
not later than ,september #ai1 #bjad    
,september #ai1 #bjad ,additional       
sponsors3 ,mr4 ,burgess1 ,mrs4          
,mc,morris ,rodgers1 ,mrs4 ,blackburn1  
,mr4 ,gingrey of ,georgia1 ,mr4         
,griffith of ,virginia1 ,mr4 ,gene      

,green of ,texas1 ,mr4 ,latta1 ,mr4     
,engel1 ,ms4 ,shea-,porter1 ,mr4        
,butterfield1 ,mr4 ,tonko1 ,mr4 ,johnson
 of ,ohio1 ,mr4 ,harper1 and ,mr4       
,collins of ,georgia  ,september #ai1   
#bjad ,reported from the ,committee on  
the ,judiciary with an amendment ,strike
 out all after the enacting clause and  
insert the part printed in italic ,for  
text of introduced bill1 see copy of    
bill as introduced on ,march #bf1 #bjad 
,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       
#bja7;a7 of the ,controlled ,substances 

,act 7#ba ,u4,s4,c4 #haa7;a77 is amended
 by adding at the end the following3    
,any such proceedings initiated at the  
request of the ,secretary under this    
subsection to control a drug or other   
substance not previously scheduled1     
where the ,secretary has recommended the
 drug or other substance be placed in   
schedule ,,ii1 ,,iii1 ,,iv1 or ,v1 shall
 be commenced not later than #abj days  
after receipt of written recommendations
 from the ,secretary4 ,the final rule   
shall be issued not later than #fj days 
after the date on which both the public 
comment period has closed and the drug  
or other substance is the subject of an 
approved new drug application under     
section #eje of the ,federal ,food1     
,drug1 and ,cosmetic ,act1 unless a     
hearing on the proposed rule is granted 
by the ,attorney ,general44  #c4        
,enhancing new drug development ,section
 #cjc of the ,controlled ,substances    
,act 7#ba ,u4,s4,c4 #hbc7 is amended by 
adding at the end the following3  7i7   

7#a7 ,for the purposes of registration  
to manufacture a controlled substance   
under subsection 7d7 of this section for
 use only in a clinical trial1 the      
,attorney ,general shall register an    
applicant or serve an order to show     
cause upon an applicant pursuant to     
section #cjd7;c7 of this ,act not later 
than #ahj days after receipt of an      
application and all information the     
,attorney ,general deems necessary to   
make a determination under subsection   
7d74  7#b7 ,for the purposes of         
registration to manufacture a controlled
 substance under subsection 7a7 for use 
only in a clinical trial1 the ,attorney 
,general shall1 in accordance with      
regulations issued by the ,attorney     
,general1 issue a notice of application 
not later than #ij days after receipt of
 an application and all information the 
,attorney ,general deems necessary to   
issue a notice of application4          
,following the close of the comment     
period and receipt of all information   

the ,attorney ,general deems necessary  
to make a determination under subsection
 7a71 the ,attorney ,general shall      
register an applicant or serve an order 
to show cause upon an applicant pursuant
 to section #cjd7;c7 of this ,act within
 #ahj days1 unless a hearing on the     
application has been granted by the     
,attorney ,general pursuant to section  
#ajjh7;i7 of the ,controlled ,substances
 ,import and ,export ,act4  4           
,september #ai1 #bjad ,reported from the
 ,committee on the ,judiciary with an   
amendment