,,ii  #aahth ,,congress  #b;d ,session  
,s4 #cgcc  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,february #e1  
#bjbd,mr4 ,peters 7for himself and ,ms4 
,stabenow7 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 conduct 
a national1 evidence-based education    
campaign to increase public and health  
care provider awareness regarding the   
potential risks and benefits of human   
cell and tissue products transplants1   
and for other purposes4  #a4 ,short     
title ,this ,act may be cited as the    
,shandra ,eisenga ,human ,cell and      
,tissue ,product ,safety ,act4  #b4     
,definitions ,in this ,act3 7#a7 ,human 
cell and tissue establishment ,the term 
human cell and tissue establishment     
means an establishment 7as defined in   
section #abga4c7;b7 of title #ba1 ,code 
of ,federal ,regulations 7or a successor

 regulation77 regulated by the ,center  
for ,biologics ,evaluation and ,research
 under part #abga of title #ba1 ,code of
 ,federal ,regulations4  7#b7 ,human    
cell and tissue products ,the term human
 cell and tissue products has 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
 a successor regulation74  7#c7         
,secretary ,the term ,secretary means   
the ,secretary of ,health and ,human    
,services4  #c4 ,human cell and tissue  
products transplant public awareness    
campaign  7a7 ,in general ,the          
,secretary shall conduct a national1    
evidence-based education campaign to    
increase public and health care provider
 awareness regarding the potential risks
 and benefits of human cell and tissue  
products transplants4  7b7              
,consideration of advice of stakeholder 
experts ,the ,secretary shall develop   
the education campaign under subsection 

7a7 after taking into consideration the 
advice of stakeholder experts1 including
 the ,centers for ,disease ,control and 
,prevention and professional            
associations that represent stakeholders
 of human cell and tissue establishments
 that manufacture human cell and tissue 
products with the highest risk of       
transmitting infections to their        
patients4  7c7 ,grants  7#a7 ,in general
 ,the ,secretary may award grants to    
nonprofit organizations to carry out    
activities described in paragraph 7#b74 
7#b7 ,use of funds ,a recipient of a    
grant under paragraph 7#a7 shall use the
 grant funds-- 7,a7 to increase the     
knowledge and awareness of the public   
about the potential risks and benefits  
of human cell and tissue products       
transplants1 including the risks that   
such transplants may lead to infectious 
diseases1 including tuberculosis1 latent
 tuberculosis infection1 and sepsis2 or 
7,b7 to increase the knowledge and      
awareness of health care providers and  

health care leaders about the potential 
risks and benefits of human cell and    
tissue products transplants1 including  
the risks that such transplants may lead
 to infectious diseases1 including      
tuberculosis1 latent tuberculosis       
infection1 and sepsis4  7d7 ,media      
campaigns  7#a7 ,in general ,in carrying
 out the education campaign under       
subsection 7a71 the ,secretary1 after   
taking into consideration the advice of 
stakeholder experts1 may award grants   
to1 or enter into contracts with1       
entities to establish national          
multimedia campaigns to increase public 
and health care provider awareness      
regarding the potential risks of human  
cell and tissue products transplants4   
7#b7 ,inclusions ,the multimedia        
campaigns under paragraph 7#a7 may      
include advertising through television1 
radio1 print media1 billboards1 posters1
 all forms of existing and emerging     
social networking media1 other internet 
media1 and any other medium determined  

appropriate by the ,secretary4  #d4     
,civil penalties for violation of       
requirements for human cell and tissue  
products  7a7 ,in general ,any person   
who violates a requirement of section   
#cfa of the ,public ,health ,service    
,act 7#db ,u4,s4,c4 #bfd7 or part #abga 
of title #ba1 ,code of ,federal         
,regulations 7or successor regulations7 
with respect to human cell or tissue    
products shall be liable to the ,united 
,states for a civil penalty in an amount
 not to exceed the sum of-- 7#a7 7,a7   
#bj1jjj for each violation2 or  7,b7    
#bj1jjj for each day of a continuing    
violation2 and  7#b7 an amount equal to 
the retail value of the human cell and  
tissue products that are the subject of 
the violation4  7b7 ,maximum penalty    
,the total civil penalty under          
subsection 7a7 shall not exceed         
#aj1jjj1jjj for all such violations     
adjudicated in a single proceeding4  #e4
 ,report to ,congress ,not later than #b
 years after the date of enactment of   

this ,act1 the ,secretary shall submit  
to ,congress a report that describes    
actions ,congress and the ,food and     
,drug ,administration could take to     
improve the safety of human cell and    
tissue products1 including-- 7#a7 an    
examination of existing regulations and 
guidance relating to human cell and     
tissue products2  7#b7 documentation of 
the number of human cell and tissue     
establishments that have registered with
 the ,food and ,drug ,administration    
since #aiih2  7#c7 how often the ,food  
and ,drug ,administration has inspected 
human cell and tissue establishments    
since #aiih1 including a comparison of  
the inspection rates for blood          
establishments and ,source ,plasma      
establishments with the inspection rates
 for such human cell and tissue         
establishments1 potential causes of     
declines in such inspections1 if        
applicable1 and recommendations to      
increase ,food and ,drug ,administration
 resources1 if applicable2 and  7#d7    

recommendations on potential guidance or
 regulations that could be issued or    
promulgated1 as applicable1 to improve  
donor screening for human cell and      
tissue products4  #f4 ,review and update
 of existing guidance ,the ,secretary1  
acting through the ,commissioner of     
,food and ,drugs1 shall-- 7#a7 not later
 than #a year after the date of         
enactment of this ,act1 initiate an     
internal review of existing guidance for
 determining eligibility of donors of   
human cell and tissue products2 and     
7#b7 not later than #c years after the  
date of enactment of this ,act1 issue   
updated guidance for determining        
eligibility of donors of human cell and 
tissue products to comply with part     
#abga of title #ba1 ,code of ,federal   
,regulations 7or successor regulations71
 including compliance in determining    
donor eligibility in accordance with    
subpart ,c of part #abga of title #ba1  
,code of ,federal ,regulations 7or      
successor regulations74