,i  #aahth ,,congress  #ast ,session    
,h4 ,r4 #fgje  ,,in ,,the ,,house ,,of  
,,representatives  ,december #aa1       
#bjbc,mr4 ,moolenaar 7for himself1 ,mrs4
 ,dingell1 and ,mr4 ,correa7 introduced 
the following bill2 which was referred  
to the ,committee on ,energy and        
,commerce  ,a ,,bill  ,to require the   
,secretary of ,health and ,human        
,services to treat certain tests for    
tuberculosis as breakthrough devices    
eligible for expedited development and  
priority review1 to require certain     
establishments that perform donor       
screening or testing to screen or test  
for active and latent tuberculosis1 and 
for other purposes4  #a4 ,short title   
,this ,act may be cited as the          
,effective ,screening and ,testing for  
,tuberculosis ,act4  #b4 ,treatment of  
certain tests for tuberculosis as       
breakthrough devices ,the ,secretary of 
,health and ,human ,services shall treat
 a device as a breakthrough device      
eligible for expedited development and  

priority review under section #eae;,b of
 the ,federal ,food1 ,drug1 and         
,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;e-#c7
 if it is a new and innovative donor    
screening test with heightened          
sensitivity to effectively screen human 
cell1 tissue1 and cellular and          
tissue-based product donors for evidence
 of active or latent tuberculosis       
infection4  #c4 ,requiring certain      
establishments that perform donor       
screening or testing to screen or test  
for active and latent tuberculosis  7a7 
,in general ,the ,secretary of ,health  
and ,human ,services1 acting through the
 ,commissioner of ,food and ,drugs1     
shall promulgate regulations revising   
part #abga of title #ba1 ,code of       
,federal ,regulations1 including        
sections #abga4ge and #abga4he1 and any 
other applicable regulations1 to        
require-- 7#a7 an establishment that    
performs donor screening to screen for  
active and latent tuberculosis2 and     
7#b7 an establishment that performs     

donor testing to test for active and    
latent tuberculosis4  7b7 ,regulations  
,the ,secretary of ,health and ,human   
,services shall-- 7#a7 not later than #a
 year after the date of enactment of    
this ,act1 propose the regulations      
required by subsection 7a72  7#b7 not   
later than #c months after the close of 
the comment period for such proposed    
regulations1 promulgate such regulations
 as final2 and  7#c7 not later than #f  
months after the date such regulations  
are promulgated as final1 begin         
implementation of such regulations4  7c7
 ,definitions ,in this section1 the     
terms establishment that performs donor 
screening and establishment that        
performs donor testing have the meanings
 given to such terms under part #abga of
 title #ba1 ,code of ,federal           
,regulations4  #d4 ,guidance on current 
good tissue practice and additional     
requirements for manufacturers of human 
cells1 tissues1 and cellular and        
tissue-based products ,not later than #f

 months after the date of enactment of  
this ,act1 the ,secretary of ,health and
 ,human ,services1 acting through the   
,commissioner of ,food and ,drugs1 and  
in coordination with the ,director of   
the ,centers for ,disease ,control and  
,prevention1 shall-- 7#a7 review the    
guidance titled ,guidance for           
,industry--,current ,good ,tissue       
,practice 7,,cgtp7 and ,additional      
,requirements for ,manufacturers of     
,human ,cells1 ,tissues1 and ,cellular  
and ,tissue-,based ,products            
7,,hct_/,ps7 7,december #bjaa72 and     
7#b7 issue an updated version of such   
guidance4  #e4 ,compliance with ,,cutgo 
,no additional funds are authorized to  
be appropriated to carry out this ,act1 
and this ,act shall be carried out using
 amounts otherwise available for such   
purpose4