,,ii  #aagth ,,congress  #ast ,session  
,s4 #aagf  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,april #ae1    
#bjba,ms4 ,smith 7for herself and ,mr4  
,cassidy7 introduced the following bill2
 which was read twice and referred to   
the ,committee on ,health1 ,education1  
,labor1 and ,pensions  ,a ,,bill  ,to   
establish a grant program to support the
 manufacture and stockpiling of         
essential generic antibiotic drugs4  #a4
 ,short title ,this ,act may be cited as
 the ,onshoring ,essential ,antibiotics 
,act4  #b4 ,essential generic antibiotic
 program  7a7 ,grant program  7#a7      
,establishment ,not later than #fj days 
after the date of enactment of this     
,act1 the ,secretary shall establish a  
program to provide grants to            
manufacturers of essential generic      
antibiotic drugs1 or the active         
pharmaceutical ingredient or key        
starting material of an essential       
generic antibiotic drug1 to support     
activities described in paragraph 7#c74 

7#b7 ,eligible entities ,the ,secretary 
shall award grants under this subsection
 to not more than #c manufacturers of an
 essential generic antibiotic drug4     
,each such recipient shall be a         
manufacturer that-- 7,a7 has implemented
 and maintains an effective quality     
management system1 under parts #baj and 
#baa of title #ba1 ,code of ,federal    
,regulations 7or any successor          
regulations72  7,b7 has a strong record 
of compliance with the requirements of  
the ,federal ,food1 ,drug1 and ,cosmetic
 ,act 7#ba ,u4,s4,c4 #cja et seq472     
7,c7 uses complex pharmaceutical        
manufacturing to produce a finished drug
 product or active pharmaceutical       
ingredient pursuant to an application   
approved under section subsection 7c7 or
 7j7 of section #eje of the ,federal    
,food1 ,drug1 and ,cosmetic ,act 7#ba   
,u4,s4,c4 #cee72  7,d7 commits to using 
advanced manufacturing in its           
manufacturing operations2 and  7,e7 has 
existing manufacturing facilities and   

operations in the ,united ,states4  7#c7
 ,use of funds ,a recipient of a grant  
under this subsection may use such grant
 funds to-- 7,a7 with respect to        
manufacturing an essential generic      
antibiotic drug-- 7i7 expand1 upgrade1  
or recommission an existing             
manufacturing facility located in the   
,united ,states2 or  7ii7 construct a   
new manufacturing facility in the       
,united ,states2 and  7,b7 manufacture  
essential generic antibiotic drugs4  7b7
 ,use of funds ,to purchase essential   
generic antibiotic drugs for stockpiling
 ,the ,secretary may use amounts        
appropriated under this section to      
purchase1 store1 stockpile1 or          
disposition essential generic antibiotic
 drugs manufactured in the ,united      
,states4  7c7 ,definitions ,for purposes
 of this section3 7#a7 ,active          
pharmaceutical ingredient ,the term     
active pharmaceutical ingredient has the
 meaning given such term in section     
#gdd;,a of the ,federal ,food1 ,drug1   

and ,cosmetic ,act 7#ba ,u4,s4,c4       
#cgi;j-#da74  7#b7 ,essential generic   
antibiotic drug ,the term essential     
generic antibiotic drug means an        
antibacterial or antifungal drug        
approved by the ,food and ,drug         
,administration under section #eje7;j7  
of the ,federal ,food1 ,drug1 and       
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77 
that the ,secretary determines to be    
medically necessary to have available at
 all times in an amount adequate to     
serve patient needs1 including          
beta-lactams 7including penicillin and  
cephalosporin derivatives7 and non-beta 
lactams 7including tetracycline and     
aminoglycoside derivatives74  7#c7 ,key 
starting material ,the term key starting
 material means any component of a drug 
that the ,secretary determines to be    
critical to the safety and effectiveness
 of the drug4  7#d7 ,secretary ,the term
 ,secretary means the ,secretary of     
,health and ,human ,services4  7#e7     
,united ,states ,the term ,united       

,states means the #ej ,states1 the      
,district of ,columbia1 territories1 and
 ,tribal lands4  7d7 ,funding ,for      
purposes of carrying out this section1  
there is appropriated1 out of amounts in
 the ,treasury not otherwise            
appropriated1 #ejj1jjj1jjj for fiscal   
year #bjba1 to remain available through 
,september #cj1 #bjbc4  #c4 ,study and  
report  7a7 ,in general ,the ,secretary 
of ,health and ,human ,services         
7referred to in this section as the     
,secretary7 shall enter into a contract 
with an entity under which such entity  
carries out a study on the manufacture  
of essential generic antibiotic drugs   
and issues a report that includes-- 7#a7
 recommendations about which antibiotics
 the ,secretary should prioritize for   
purposes of the program under section   
#b1 based on factors that include       
necessity of use1 vulnerability to      
foreign supply chain disruptions1 and   
availability of alternatives2 and  7#b7 
the expected effect of increased        

domestic manufacturing of drugs on drug 
costs to consumers4  7b7 ,authorization 
,to carry out this section1 there is    
authorized to be appropriated #b1jjj1jjj
 for fiscal year #bjba1 to remain       
available until ,september #cj1 #bjbb4