,i  #aaith ,,congress  #ast ,session    
,h4 ,r4 #cdj  ,,in ,,the ,,house ,,of   
,,representatives  ,january #ac1        
#bjbe,mr4 ,crenshaw 7for himself and    
,ms4 ,barragn7 introduced the following 
bill2 which was referred to the         
,committee on ,energy and ,commerce  ,a 
,,bill  ,to direct the ,secretary of    
,health and ,human ,services carry out  
activities to streamline regulatory     
oversight of human cell and tissue      
products1 and for other purposes4  #a4  
,short title ,this ,act may be cited as 
the ,the ,,hct_/,p ,modernization ,act  
of #bjbe4  #b4 ,definitions ,in this    
,act3 7#a7 ,human cell and tissue       
product ,the terms human cell and tissue
 product and human cell and tissue      
products have the meaning given the term
 human cells1 tissues1 or cellular or   
tissue-based products in section        
#abga4c7;d7 of title #ba1 ,code of      
,federal ,regulations 7or successor     
regulations74  7#b7 ,secretary ,the term
 ,secretary means the ,secretary of     

,health and ,human ,services4  7#c7     
,tissue ,reference ,group ,the term     
,tissue ,reference ,group means the     
,tissue ,reference ,group of the ,food  
and ,drug ,administration4  #c4         
,streamlining regulatory oversight of   
human cell and tissue products  7a7     
,information on human cell and tissue   
products  7#a7 ,website ,the ,secretary1
 acting through the ,commissioner of    
,food and ,drugs1 shall publish on the  
public website of the ,food and ,drug   
,administration-- 7,a7 educational      
materials about the ,tissue ,reference  
,group2 and  7,b7 best practices for    
obtaining a timely1 accurate            
recommendation regarding human cell and 
tissue products from the ,tissue        
,reference ,group4  7#b7 ,public        
information ,not later than #a year     
after the date of the enactment of this 
,act1 and annually for the subsequent #c
 years1 the ,secretary1 acting through  
the ,commissioner of ,food and ,drugs1  
shall publish on the public website of  

the ,food and ,drug ,administration--   
7,a7 the number of human cell and tissue
 establishments that registered with the
 ,food and ,drug ,administration on or  
after ,january #a1 #bjai2  7,b7 the     
number of inspections conducted by the  
,food and ,drug ,administration of human
 cell and tissue establishments on or   
after ,january #a1 #bjai1 including a   
comparison of the number of inspections 
for blood establishments with the number
 of inspections for such human cell and 
tissue establishments2  7,c7 the number 
and type of inquiries to the ,tissue    
,reference ,group in the preceding year2
 and  7,d7 the average response time for
 submissions to the ,tissue ,reference  
,group in the preceding year1 including 
average initial and final response time4
  7#c7 ,education ,the ,secretary1      
acting through the ,commissioner of     
,food and ,drugs1 shall1 with respect to
 the regulation of human cell and tissue
 products-- 7,a7 provide information to 
relevant stakeholders1 including        

industry1 tissue establishments1        
academic health centers1 biomedical     
consortia1 research organizations1 and  
patients2 and  7,b7 conduct workshops   
and other interactive and educational   
sessions for such stakeholders to help  
support regulatory predictability and   
scientific advancement1 as appropriate4 
7b7 ,human cell and tissue product      
scientific and regulatory updates       
,section #cbje of the ,food and ,drug   
,omnibus ,reform ,act of #bjbb 7title   
,,iii of division ,,ff of ,public ,law  
#aag-cbh7 is amended by striking best   
practices and all that follows through  
other cellular therapies and inserting  
best practices on generating scientific 
data necessary to further facilitate the
 development of certain human cell-1    
tissue-1 and cellular-based medical     
products 7and the latest scientific     
information about such products71       
namely1 stem cell and other cellular    
therapies4  7c7 ,public docket ,not     
later than #fj days after the date of   

the enactment of this ,act1 the         
,secretary shall establish a public     
docket to receive written comments      
related to-- 7#a7 the approaches        
recommended for discussion during the   
public workshop described in section    
#cbje of the ,food and ,drug ,omnibus   
,reform ,act of #bjbb 7title ,,iii of   
division ,,ff of ,public ,law #aag-cbh72
 and  7#b7 modernizing the regulation of
 human cell and tissue products1        
including considerations associated with
 assessing minimal manipulation and     
homologous use 7as such terms are       
defined in section #abga4c of title #ba1
 ,code of ,federal ,regulations 7or     
successor regulations77 of human cell   
and tissue products4  7d7 ,report to    
,congress ,not later than ,september    
#cj1 #bjbf1 the ,secretary shall        
summarize the approaches discussed in   
the public workshop described in section
 #cbje of the ,food and ,drug ,omnibus  
,reform ,act of #bjbb 7title ,,iii of   
division ,,ff of ,public ,law #aag-cbh7 

and the public docket described in      
subsection 7c71 and develop             
recommendations regarding the regulation
 of human cell and tissue products1     
including provisions under sections     
#abga4aj7;a7 and #abga4c of title #ba1  
,code of ,federal ,regulations1 taking  
into account-- 7#a7 regulatory burden2  
7#b7 scientific developments2  7#c7     
access to human cell and tissue products
 regulated under section #cfa of the    
,public ,health ,service ,act 7#db      
,u4,s4,c4 #bfd72 and  7#d7 protecting   
public health4