,,ii  #aaeth ,,congress  #ast ,session  
,s4 #def  ,,in ,,the ,,senate ,,of ,,the
 ,,united ,,states  ,february #bg1      
#bjag,mr4 ,bennet 7for himself1 ,mr4    
,rubio1 ,mr4 ,van ,hollen1 and ,mr4     
,gardner7 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 to establish a program to
 increase the development of new drugs  
to treat pediatric cancers1 and for     
other purposes4  #a4 ,short title ,this 
,act may be cited as the ,research to   
,accelerate ,cures and ,equity for      
,children ,act or the ,,race for        
,children ,act4  #b4 ,drug development  
for pediatric cancer  7a7 ,molecular    
targets regarding cancer drugs ,section 
#eje;,b of the ,federal ,food1 ,drug1   
and ,cosmetic ,act 7#ba ,u4,s4,c4       
#cee;c7 is amended--  7#a7 in subsection
 7a77#b77;,a77i7 by striking product for
 the claimed indications in all relevant

 pediatric subpopulations2 and and      
inserting 8product in all relevant      
pediatric subpopulations--  7,i7 for the
 claimed indications2 or  2  7,,ii7 for 
a pediatric cancer indication1 if the   
drug is intended for the treatment of an
 adult cancer and is directed at a      
molecular target considered to be       
germane to the growth and progression of
 such pediatric cancer2 and  2  7#b7 in 
subsection 7b77#a7-- 7,a7 by amending   
subparagraph 7,a77i7 to read as follows3
  7,a7 7i7 the drug or biological       
product is used for a substantial number
 of pediatric patients-- 7,i7 for the   
labeled indications2 or  7,,ii7 for a   
pediatric cancer indication1 if the drug
 is intended for the treatment of an    
adult cancer and is directed at a       
molecular target considered to be       
germane to the growth and progression of
 such pediatric cancer2 and  2 and  7,b7
 by amending subparagraph 7,b7 to read  
as follows3  7,b7 there is reason to    
believe that the drug or biological     

product would represent a meaningful    
therapeutic benefit over existing       
therapies for pediatric patients--  7i7 
for one or more of the claimed          
indications2 or  7ii7 for a pediatric   
cancer indication1 if the drug is       
intended for the treatment of an adult  
cancer and is directed at a molecular   
target considered to be germane to the  
growth and progression of such pediatric
 cancer2 or  2 and  7#c7 by amending    
paragraph 7#b7 of subsection 7c7 to read
 as follows3  7#b7 the drug or          
biological product is in a class of     
products1 is for an indication1 or is   
directed at a specific molecular target 
in an adult cancer and such molecular   
target is germane to the growth or      
progression of cancer in a pediatric    
cancer1 for which there is need for     
additional options4  4  7b7 ,early      
meeting on pediatric study plan  7#a7   
,in general ,clause 7i7 of section      
#eje;,b7e77#b77;,c7 of the ,federal     
,food1 ,drug1 and ,cosmetic ,act 7#ba   

,u4,s4,c4 #cee;c7e77#b77;,c77 is amended
 to read as follows3  7i7 shall meet    
with the applicant-- 7,i7 if requested  
by the applicant with respect to a drug 
that is intended to treat a serious or  
life-threatening disease or condition1  
to discuss preparation of the initial   
pediatric study plan1 not later than the
 end-of-,phase #a meeting 7as such term 
is used in section #cab4dg7;b7 of title 
#ba1 ,code of ,federal ,regulations1 or 
successor regulations7 or within #cj    
days of receipt of such request1        
whichever is later2  7,,ii7 to discuss  
the initial pediatric study plan as soon
 as practicable1 but not later than #ij 
calendar days after the receipt of such 
plan under subparagraph 7,a72 and       
7,,iii7 to discuss any scientific or    
operational challenges that may be the  
basis of a deferral under subsection    
7a77#c7 or a full or partial waiver     
under subsection 7a77#d72  4  7#b7      
,conforming changes ,section #eje;,b7e7 
of the ,federal ,food1 ,drug1 and       

,cosmetic ,act 7#ba ,u4,s4,c4 #cee;c7e77
 is amended-- 7,a7 in the heading of    
paragraph 7#b71 by striking meeting and 
inserting meetings2  7,b7 in the heading
 of paragraph 7#b77;,c71 by striking    
,meeting and inserting ,meetings2  7,c7 
in clauses 7ii7 and 7iii7 of paragraph  
7#b77;,c71 by striking no meeting each  
place it appears and inserting no       
meeting under clause 7i77,,ii72 and     
7,d7 in paragraph 7#c7 by striking      
meeting under paragraph 7#b77;,c77i7 and
 inserting meeting under paragraph      
7#b77;,c77i77,,ii74  7c7 ,orphan drugs  
,section #eje;,b7k7 of the ,federal     
,food1 ,drug1 and ,cosmetic ,act 7#ba   
,u4,s4,c4 #cee;c7k77 is amended by      
inserting except in the case of a drug  
or biological product that is intended  
for the treatment of an adult cancer and
 is directed at a molecular target      
considered to be germane to the growth  
and progression of a pediatric cancer1  
after regulation14  7d7 ,guidance ,not  
later than #a year after the date of    

enactment of this ,act1 the ,secretary  
of ,health and ,human ,services1 acting 
through the ,commissioner of ,food and  
,drugs1 shall issue guidance on the     
implementation of the amendments to     
section #eje;,b of the ,federal ,food1  
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cee;c7 made by this section1          
including--  7#a7 study designs2  7#b7  
molecular targets considered to be      
germane to the growth and progression   
present in one or more cancers in       
pediatric populations that may be       
appropriate for assessment under such   
section #eje;,b1 as so amended2 and     
7#c7 considerations for implementation  
of such section #eje;,b1 as so amended1 
and waivers of the requirements of such 
section #eje;,b with regard to molecular
 targets for which several drugs may be 
under investigation4  7e7 ,applicability
 ,this section and the amendments made  
by this section apply with respect to   
applications for a drug submitted under 
section #eje of the ,federal ,food1     

,drug1 or ,cosmetic ,act 7#ba ,u4,s4,c4 
#cee7 or section #cea of the ,public    
,health ,service ,act 7#db ,u4,s4,c4    
#bfb7 on or after the date that is #ah  
months after the date of enactment of   
this ,act4  7f7 ,report to ,congress    
,section #ejh7;b7 of the ,,fda ,safety  
and ,innovation ,act 7#ba ,u4,s4,c4     
#cee;c-#a7;b77 is amended-- 7#a7 in     
paragraph 7#aj71 by striking 2 and and  
inserting 22 and  7#b7 by striking      
paragraph 7#aa7 and inserting the       
following3  7#aa7 an assessment of the  
impact of the amendments to such section
 #eje;,b made by the ,,race for         
,children ,act on pediatric labeling of 
drugs and pediatric labeling of         
molecularly targeted drugs for the      
treatment of cancer2  7#ab7 an          
assessment of the efforts of the        
,secretary to implement the plan        
developed under section #eje;,c-#a of   
the ,federal ,food1 ,drug1 and ,cosmetic
 ,act1 regarding earlier submission of  
pediatric studies under sections #eje;,a

 and #eje;,b1 including--  7,a7 the     
average length of time after the        
approval of an application under section
 #eje7;b77#a7 of the ,federal ,food1    
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cee7;b77#a77 before studies conducted 
pursuant to such sections #eje;,a or    
#eje;,b are completed1 submitted1 and   
incorporated into labeling2  7,b7 the   
average length of time after the receipt
 of a proposed pediatric study request  
before the ,secretary responds to such  
request2  7,c7 the average length of    
time after the submission of a proposed 
pediatric study request before the      
,secretary issues a written request for 
such studies2  7,d7 the number of       
written requests issued for each        
investigational new drug prior to the   
submission of an application under      
section #eje7;b77#a7 of the ,federal    
,food1 ,drug1 and ,cosmetic ,act2 and   
7,e7 the average number1 and range of   
numbers1 of amendments to written       
requests issued2  7#ac7 a list of       

sponsors of applications or holders of  
approved applications who received      
exclusivity under such section #eje;,a  
after receiving a letter issued under   
such section #eje;,b7d77#a7 and before  
the studies referred to in such letter  
were completed and submitted2 and  7#ad7
 a list of assessments required under   
subsection 7a77#b77;,a77i77,,ii71 and   
7b77#a77;,b77ii7 of section #eje;,b4  4 
7g7 ,rule of construction ,nothing in   
this section1 including the amendments  
made by this section1 shall limit the   
authority of the ,secretary of ,health  
and ,human ,services to issue written   
requests under section #eje;,a of the   
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cee;a74  #c4       
,improving the timeliness of pediatric  
studies  7a7 ,informing internal review 
committee ,section #eje;,a7f7 of the    
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cee;a7f77 is       
amended by adding at the end the        
following3  7#g7 ,informing internal    

review committee ,the ,secretary shall  
provide to the committee referred to in 
paragraph 7#a7 any response issued to an
 applicant or holder with respect to a  
proposed pediatric study request4  4    
7b7 ,action on submissions ,section     
#eje;,a7d7 of the ,federal ,food1 ,drug1
 and ,cosmetic ,act 7#ba ,u4,s4,c4      
#cee;a7d77 is amended-- 7#a7 by         
redesignating paragraphs 7#c7 through   
7#e7 as paragraphs 7#d7 through 7#f71   
respectively2 and  7#b7 by inserting    
after paragraph 7#b7 the following3     
7#c7 ,action on submissions ,the        
,secretary shall review and act upon a  
submission of a proposed pediatric study
 request or a sponsor's proposed        
amendment to a written request for      
pediatric studies within #abj days of   
the submission4  4  7c7 ,study ,the     
,secretary of ,health and ,human        
,services1 acting through the internal  
review committee established under      
section #eje;,c of the ,federal ,food1  
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4

 #cee;d7 shall1 not later than one year 
after the date of enactment of this     
,act1 develop and implement a plan to   
achieve1 when appropriate1 earlier      
submission of pediatric studies under   
section #eje;,a of the ,federal ,food1  
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cee;a74 ,such plan shall include      
recommendations to achieve--  7#a7      
earlier discussion of proposed pediatric
 study requests and written requests    
with sponsors1 and if appropriate1 at   
the meeting required under section      
#eje;,b7e77#b77;,c7 of the ,federal     
,food1 ,drug1 and ,cosmetic ,act 7#ba   
,u4,s4,c4 #cee;c7e77#b77;,c771 as       
amended by section #b2  7#b7 earlier    
issuance of written requests for a      
pediatric study under such section      
#eje;,a1 including for investigational  
new drugs prior to the submission of an 
application under section #eje7;b77#a7  
of the ,federal ,food1 ,drug1 and       
,cosmetic ,act 7#ba ,u4,s4,c4           
#cee7;b77#a772 and  7#c7 shorter        

timelines1 when appropriate1 for the    
completion of studies pursuant to a     
written request under such section      
#eje;,a4  #d4 ,neonatology expertise    
,section #f7;d7 of the ,best            
,pharmaceuticals for ,children ,act 7#ba
 ,u4,s4,c4 #cic;a7d77 is amended by     
striking ,for the #e-year period        
beginning on the date of enactment of   
this subsection1 at and inserting ,at4