,i  #aafth ,,congress  #ast ,session    
,h4 ,r4 #dfcc  ,,in ,,the ,,house ,,of  
,,representatives  ,october #aa1        
#bjai,ms4 ,eshoo 7for herself and ,mr4  
,peters7 introduced the following bill2 
which was referred to the ,committee on 
,energy and ,commerce  ,a ,,bill  ,to   
amend the #bast ,century ,cures ,act to 
reauthorize funding for ,,fda innovation
 projects1 and for other purposes4  #a4 
,short title ,this ,act may be cited as 
the ,investing in ,safety and           
,innovation ,act of #bjai4  #b4         
,reauthorization of ,,fda ,innovation   
,projects  7a7 ,transfer of direct      
spending savings ,section               
#ajjb7;b77#b77;,a7 of the #bast ,century
 ,cures ,act 7,public ,law #aad-bee7 is 
amended--  7#a7 in the matter preceding 
clause 7i71 by striking #bjbe and       
inserting #bjbi2 and  7#b7 by striking  
clauses 7iv7 through 7ix7 and inserting 
the following3  7iv7 ,for fiscal year   
#bjbj1 #gdf1jjj1jjj4  7v7 ,for fiscal   
year #bjba1 #eea1jjj1jjj4  7vi7 ,for    

each of fiscal years #bjbb through      
#bjbd1 #eca1jjj1jjj4  7vii7 ,for fiscal 
year #bjbe1 #ecf1jjj1jjj4  7viii7 ,for  
each of fiscal years #bjbf through      
#bjbi1 #eca1jjj1jjj4  4  7b7 ,,fda      
,activities ,paragraph 7#d7 of section  
#ajjb7;b7 of the #bast ,century ,cures  
,act 7,public ,law #aad-bee7 is amended 
to read as follows3  7#d7 ,,fda         
activities ,the activities authorized to
 be funded under this section shall     
consist of the following1 and of the    
total amounts authorized to be          
appropriated under paragraph 7#c7 there 
are authorized to be appropriated to    
each category of activities a total     
amount not to exceed the following3 7,a7
 ,in addition to the allocations        
specified in subparagraphs 7,b7 through 
7,k71 for the activities under subtitles
 ,a through ,f 7including the amendments
 made by such subtitles7 of title ,,iii 
of this ,act and section #ajad of the   
,federal ,food1 ,drug1 and ,cosmetic    
,act1 as added by section #cjgc of this 

,act3  7i7 ,for fiscal year #bjbj1      
#ge1jjj1jjj4  7ii7 ,for fiscal year     
#bjba1 #gj1jjj1jjj4  7iii7 ,for each of 
fiscal years #bjbb through #bjbd1       
#ej1jjj1jjj4  7iv7 ,for fiscal year     
#bjbe1 #ee1jjj1jjj4  7v7 ,for each of   
fiscal years #bjbf through #bjbi1       
#ej1jjj1jjj4  7,b7 ,for modernization of
 the technical infrastructure of the    
,food and ,drug ,administration1        
including enhancements such as          
interoperability across the agency1 and 
additional capabilities to develop an   
advanced information technology         
infrastructure to support the agency's  
regulatory mission3  7i7 ,for fiscal    
year #bjbj1 #cjj1jjj1jjj4  7ii7 ,for    
each of fiscal years #bjba through      
#bjbi1 #bjj1jjj1jjj4  7,c7 ,for support 
for continuous manufacturing of drugs   
and biological products1 including      
complex biological products such as     
regenerative medicine therapies1 through
 grants to institutions of higher       
education and nonprofit organizations   

and other appropriate mechanisms1 for   
each of fiscal years #bjbj through      
#bjbi1 #ej1jjj1jjj4  7,d7 ,for support  
for the ,commissioner of ,food and      
,drugs to engage experts1 such as       
through the formation and operation of  
public-private partnerships or other    
appropriate collaborative efforts1 to   
advance the development and delivery of 
individualized human gene therapy       
products3  7i7 ,for fiscal year #bjbj1  
#ej1jjj1jjj4  7ii7 ,for each of fiscal  
years #bjba through #bjbi1 #aj1jjj1jjj4 
7,e7 ,for support for inspections and   
enforcement activities across the ,food 
and ,drug ,administration1 including    
foreign and domestic facility           
inspections across products1 for each of
 fiscal years #bjbj through #bjbi1      
#hb1ejj1jjj4  7,f7 ,for support for     
activities of the ,food and ,drug       
,administration related to customs and  
border protection to provide            
improvements to technologies1 inspection
 capacity1 and international mail       

facilities in which the ,food and ,drug 
,administration operates1 for each of   
fiscal years #bjbj through #bjbi1       
#be1jjj1jjj4  7,g7 ,to further advance  
the development of a coordinated        
postmarket surveillance system for all  
medical products1 including drugs1      
biological products1 and devices1 linked
 to electronic health records in        
furtherance of the ,food and ,drug      
,administration's postmarket            
surveillance capabilities3 7i7 ,for     
fiscal year #bjbj1 #ajj1jjj1jjj4  7ii7  
,for each of fiscal years #bjba through 
#bjbi1 #ej1jjj1jjj4  7,h7 ,for support  
for ,food and ,drug ,administration     
activities to keep pace with the        
projected product development of        
regenerative therapies1 including human 
somatic cellular and gene therapies1 for
 each of fiscal years #bjbj through     
#bjbi1 #be1jjj1jjj4  7,i7 ,for support  
for the development of non-opioid       
pharmacological therapies as            
alternatives for opioids1 for each of   

fiscal years #bjbj through #bjbi1       
#c1ejj1jjj4  7,j7 ,for carrying out     
section #gad;,a of the ,federal ,food1  
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cgi;d-#c;a2 relating to hiring        
authority for scientific1 technical1 and
 professional personnel71 for each of   
fiscal years #bjbj through #bjbi1       
#bj1jjj1jjj4  7,k7 ,for the ,food and   
,drug ,administration to support        
improvements to the technological       
infrastructure for reporting and        
analysis of adverse events associated   
with the use of drugs and biological    
products1 for each of fiscal years #bjbj
 through #bjbi1 #ae1jjj1jjj4  4  7c7    
,annual reports ,section                
#ajjb7;c77#b77;,a7 of the #bast ,century
 ,cures ,act 7,public ,law #aad-bee7 is 
amended by striking #bjbf and inserting 
#bjbi4  7d7 ,sunset ,section #ajjb7;e7  
of the #bast ,century ,cures ,act       
7,public ,law #aad-bee7 is amended by   
striking ,september #cj1 #bjbf and      
inserting ,september #cj1 #bjbi4