,i  #aaf? ,,congress  #b;d ,session  ,h4
 ,r4 #fhci  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,may #ab1 #bjbj,ms4   
,spanb]g] 7= h]self & ,mr4 ,gonzalez (  
,ohio7 introduc$ ! foll[+ bill2 :i* 0   
ref]r$ to ! ,committee on ,en]gy &      
,comm]ce  ,a ,,bill  ,to direct !       
,comptroll] ,g5]al ( ! ,unit$ ,/ates to 
submit a report describ+ ! response (   
c]ta9 entities to ! ,,covid-#ai p&emic )
 respect to ! developm5t1 regulatory    
evaluation1 & deploym5t ( diagno/ic     
te/s4  #a4 ,,gao report on diagno/ic    
te/s  7a7 ,,gao /udy ,n lat] ?an #ah    
mon?s aft] ! date ( enactm5t ( ?is ,act1
 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates 
%all submit to ! ,committee on ,en]gy & 
,comm]ce ( ! ,h\se ( ,repres5tatives & !
 ,committee on ,heal?1 ,education1      
,labor & ,p5sions ( ! ,s5ate a report   
describ+ ! response ( entities describ$ 
9 subsection 7b7 to ! ,,covid-#ai p&emic
 ) respect to ! developm5t1 regulatory  
evaluation1 & deploym5t ( diagno/ic     
te/s4  7b7 ,entities describ$ ,entities 

describ$ 9 ?is subsection include-- 7#a7
 laboratories1 includ+ public heal?1    
academic1 cl9ical1 & comm]cial          
laboratories2  7#b7 diagno/ic te/       
manufactur]s2  7#c7 ,/ate1 local1       
,tribal1 & t]ritorial gov]nm5ts2 &  7#d7
 ! ,food & ,drug ,adm9i/ration1 ! ,c5t]s
 = ,disease ,control & ,prev5tion1 !    
,c5t]s = ,m$ic>e  ,m$icaid ,s]vices1 !  
,national ,in/itutes ( ,heal?1 & o!r    
relevant ,f$]al ag5cies1 z appropriate4 
7c7 ,cont5ts ,! report "u subsection 7a7
 %all include-- 7#a7 a description (    
actions tak5 by entities describ$ 9     
subsection 7b7 to develop1 evaluate1 &  
deploy diagno/ic te/s2  7#b7 an         
assessm5t ( ! coord9ation ( ,f$]al      
ag5cies 9 ! developm5t1 regulatory      
evaluation1 & deploym5t ( diagno/ic     
te/s2  7#c7 an assessm5t ( ! /&>ds us$  
by ! ,food & ,drug ,adm9i/ration to     
evaluate diagno/ic te/s2  7#d7 an       
assessm5t ( ! cl>ity ( ,f$]al ag5cy     
guidance relat$ to te/+1 includ+ !      
ability = individuals )\t m$ical tra9+  

to und]/& :i* diagno/ic te/s _h be5     
evaluat$ by ! ,food & ,drug             
,adm9i/ration2  7#e7 a description (--  
7,a7 actions tak5 & cl9ical processes   
employ$ by ,/ates & t]ritories t h      
au?oriz$ laboratories to develop & p]=m 
diagno/ic te/s n au?oriz$1 approv$1 or  
cle>$ by ! ,food & ,drug ,adm9i/ration1 
includ+ actions ( su* ,/ates &          
t]ritories to evaluate ! accuracy &     
s5sitivity ( su* te/s2 &  7,b7 ! /&>ds  
us$ by ,/ates & t]ritories :5 decid+ :5 
to au?orize laboratories to develop or  
p]=m diagno/ic te/s2  7#f7 an assessm5t 
( ! /eps tak5 by laboratories &         
diagno/ic te/ manufactur]s to validate  
diagno/ic te/s1 z well z ! evid5ce      
collect$ by su* entities to support     
validation2 &  7#g7 bas$ on available   
reports1 an assessm5t ( ! accuracy &    
s5sitivity ( a repres5tative sample (   
available diagno/ic te/s4  7d7          
,def9ition ,9 ?is section1 ! t]m        
diagno/ic te/ means an 9 vitro diagno/ic
 product 7z def9$ 9 section #hji4c7;a7 (

 title #ba1 ,code ( ,f$]al ,regulations7
 =-- 7#a7 ! detection ( ,,s>s-,co,v-#b2 
7#b7 ! diagnosis ( ! virus t causes     
,,covid-#ai2 or  7#c7 ! detection (     
antibodies specific to ,,s>s-,co,v-#b1  
su* z a s]ological te/4