,,ii  #aahth ,,congress  #ast ,session  
,s4 #bfgb  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,july #bg1     
#bjbc,ms4 ,smith 7for herself and ,ms4  
,collins7 introduced the following bill2
 which was read twice and referred to   
the ,committee on ,health1 ,education1  
,labor1 and ,pensions  ,a ,,bill  ,to   
require the ,secretary of ,health and   
,human ,services to develop a strategic 
framework to improve the development and
 distribution of diagnostic tests in    
response to chemical1 biological1       
radiological1 or nuclear threats4  #a4  
,short title ,this ,act may be cited as 
the ,improving ,development and         
,distribution of ,diagnostic ,tests     
,act4  #b4 ,improving development and   
distribution of diagnostic tests        
,section #cai;,b of the ,public ,health 
,service ,act 7#db ,u4,s4,c4 #bdg;d-#b7 
is amended to read as follows3  #cai;,b4
 ,improving development and distribution
 of diagnostic tests  7a7 ,framework    
,the ,secretary shall develop1 make     

publicly available not later than #a    
year after the date of enactment of the 
,improving ,development and             
,distribution of ,diagnostic ,tests     
,act1 and update not less frequently    
than every #c years thereafter1 a       
strategic framework for the rapid       
development1 validation1 authorization1 
manufacture1 procurement1 and           
distribution of diagnostic tests1 and   
for rapid scaling of testing capacity1  
in response to chemical1 biological1    
radiological1 or nuclear threats1       
including infectious diseases for which 
a public health emergency is declared   
under section #cai1 or that has         
significant potential to cause such a   
public health emergency4 ,such strategic
 framework shall take into              
consideration-- 7#a7 domestic capacity1 
including any such capacity established 
through partnerships with public and    
private entities pursuant to subsection 
7c71 to support the development1        
validation1 authorization1 manufacture1 

procurement1 and distribution of tests2 
7#b7 novel technologies and platforms   
that may be used to improve testing     
capabilities1 including high-throughput 
laboratory diagnostics1 and             
point-of-care diagnostics1 and any such 
technologies to improve the             
accessibility of such tests1 and        
facilitate the development and          
manufacture of diagnostic tests2  7#c7  
medical supply needs related to testing1
 including diagnostic testing1          
equipment1 supplies1 and component      
parts1 and any potential vulnerabilities
 related to the availability of such    
medical supplies and related planning1  
consistent with section                 
#bhaa7;b77#d77;,j72  7#d7 strategies for
 the rapid and efficient distribution of
 tests locally1 regionally1 or          
nationwide and scaling laboratory       
testing capacity2 and  7#e7 assessing   
such strategies through drills and      
operational exercises carried out under 
section #bhaa7;b77#d77;,g71 as          

appropriate4  7b7 ,coordination ,to     
inform the development and update of the
 framework under subsection 7a71 and in 
carrying out activities to implement    
such framework1 the ,secretary shall    
coordinate with industry1 ,states1 local
 governmental entities1 ,indian ,tribes 
and ,tribal organizations1 ,urban       
,indian organizations1 and other        
relevant public and private entities4   
7c7 ,capacity building ,the ,secretary  
may contract with public and private    
entities1 as appropriate1 to increase   
domestic capacity in the rapid          
development1 validation1 authorization1 
manufacture1 procurement1 and           
distribution of diagnostic tests1 as    
appropriate1 to ,state1 local1 and      
,tribal health departments and other    
appropriate entities for immediate      
public health response activities to    
address an infectious disease with      
respect to which a public health        
emergency is declared under section     
#cai1 or that has significant potential 

to cause such a public health emergency4
  4