,i  #aaith ,,congress  #ast ,session    
,h4 ,r4 #aajh  ,,in ,,the ,,house ,,of  
,,representatives  ,february #g1        
#bjbe,mrs4 ,miller-,meeks 7for herself1 
,ms4 ,schrier1 ,mr4 ,crenshaw1 and ,mr4 
,carson7 introduced the following bill2 
which was referred to the ,committee on 
,energy and ,commerce  ,a ,,bill  ,to   
amend the ,public ,health ,service ,act 
to direct the ,secretary of ,health and 
,human ,services to develop a plan to   
improve the development and distribution
 of diagnostic tests during a public    
health emergency1 and for other         
purposes4  #a4 ,short title ,this ,act  
may be cited as the ,diagnostics        
,testing ,preparedness ,plan ,act of    
#bjbe4  #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 ,diagnostic   
testing preparedness plan ,the          

,secretary shall develop1 make publicly 
available1 and update a plan 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 emerging infectious  
diseases1 for which a public health     
emergency is declared under section     
#cai1 or that has significant potential 
to cause such a public health emergency4
  7b7 ,purposes ,the purpose of the plan
 under subsection 7a7 shall be to-- 7#a7
 facilitate the development and         
utilization of diagnostic tests2  7#b7  
describe the processes for the rapid    
development1 validation1 authorization1 
manufacture1 procurement1 and           
distribution of diagnostic tests1 and   
for rapid scaling of testing capacity2  
and  7#c7 facilitate coordination and   
collaboration among public and private  
entities to improve the rapid           

development and utilization of          
diagnostic testing during a public      
health emergency4  7c7 ,considerations  
,the plan under subsection 7a7 shall    
take into consideration-- 7#a7 domestic 
capacity1 including any such capacity   
established through partnerships with   
public and private entities pursuant to 
subsection 7e71 to support the          
development1 validation1 manufacture1   
procurement1 and distribution of tests1 
and the rapid scaling of testing        
capacity2  7#b7 novel technologies and  
platforms that-- 7,a7 may be used to    
improve testing capabilities1           
including-- 7i7 high-throughput         
laboratory diagnostics2  7ii7           
point-of-care diagnostics2 and  7iii7   
rapid at-home diagnostics2  7,b7 improve
 the accessibility of diagnostic tests2 
and  7,c7 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 planning   
needs1 consistent with section          
#bhaa7;b77#d77;,j72  7#d7 strategies for
 the rapid and efficient distribution of
 tests locally1 regionally1 or          
nationwide and appropriate scaling of   
laboratory testing capacity2 and  7#e7  
assessment of such strategies through   
drills and operational exercises carried
 out under section #bhaa7;b77#d77;,g71  
as appropriate4  7d7 ,coordination ,to  
inform the development and update of the
 plan under subsection 7a71 and in      
carrying out activities to implement    
such plan1 the ,secretary shall         
coordinate with industry1 such as device
 manufacturers1 clinical and reference  
laboratories1 and medical product       
distributors1 ,states1 local            
governmental entities1 ,indian ,tribes  
and ,tribal organizations1 and other    
relevant public and private entities4   
7e7 ,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
  7f7 ,deadlines for plan  7#a7 ,public 
release ,not later than one year after  
the date of enactment of the            
,diagnostics ,testing ,preparedness     
,plan ,act of #bjbe1 the ,secretary     
shall publicly release the plan         
developed under subsection 7a74  7#b7   
,updates ,the ,secretary shall update   
such plan not less frequently than once 
every #c years after the date of the    

initial public release of the plan4  4