,i  #aac? ,,congress  #b;d ,session  ,h4
 ,r4 #ecah  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,july #ca1 #bjad ,mr4 
,gos> 7= himself & ,mr4 ,franks (       
,arizona7 introduc$ ! foll[+ bill2 :i* 0
 ref]r$ to ! ,committee on ,en]gy &     
,comm]ce  ,a ,,bill  ,to ensure c]ta9   
safety measures are utiliz$ 9 ! int]e/ (
 public heal? security ) respect to     
label+ & transport+ human tissue specim5
 or collection ( specim5s into int]/ate 
comm]ce4  #a4 ,%ort title ,?is ,act may 
be cit$ z ! ,label & ,transport ,tissues
 ,safely ,act ( #bjad or z ! ,,latts    
,act ( #bjad4  #b4 ,9 g5]al  7a7        
,non-,transplant ,tissue ,bank lic5se   
7#a7 ,prohibition ,no p]son may         
introduce or deliv] = introduction into 
int]/ate comm]ce any human tissue       
specim5 = m$ical rese>* or education    
unless--  7,a7 a tissue bank lic5se is 9
 effect = ! entity introduc+ ! human    
tissue specim5 into int]/ate comm]ce2   
7,b7 ea* package ( ! human tissue       
specim5 is--  7i7 label$ ) ! prop] "n ( 

! human tissue specim5 conta9$ 9 !      
package2  7ii7 ! "n1 address1 &         
applicable lic5se numb] ( ! s\rce tissue
 bank ( ! human tissue specim52  7iii7  
unique donor id5tifi]1 tissue type1     
cause ( dea?1 s]ological te/ results &  
any kn[n infecti\s disease ag5ts2  7iv7 
a /atem5t ab\t ! m&atory use ( p]sonal  
protective equipm5t & univ]sal          
precautions :5 h&l+ human tissue2 &  7v7
 label$ n = transplantation2 &  7,c7 ea*
 package ( ! human tissue specim5 is    
wrapp$ & packag$ 9 su* a mann] t--  7i7 
mitigates pot5tial contam9ation & cross 
contam9ation2  7ii7 mitigates pot5tial  
safety haz>ds2  7iii7 seal$ to prev5t   
leakage2 &  7iv7 ensures ! integrity ( !
 tissue4  7#b7 ,proc$ures e/abli%$  7,a7
 ,9 g5]al ,! ,secret>y ( ,heal? & ,human
 ,s]vices %all e/abli%1 by rule1        
requirem5ts = ! approval1 susp5sion1 &  
revocation ( non-transplant tissue bank 
lic5ses4  7,b7 ,approval ,! ,secret>y   
%all approve a non-transplant tissue    
bank lic5se application--  7i7 on !     

basis ( a demon/ration t--  7,i7 ! human
 tissue specim5 t is ! subject ( !      
application is legally donat$1 prop]ly  
scre5$ = communicable disease ag5ts1    
prop]ly label$1 transport$1 /or$ & us$  
accord+ to ! donor's donation           
au?orization2 &  7,,ii7 ! facility 9 :i*
 ! human tissue specim5 is donat$1      
recov]$1 process$1 pack$1 or held meets 
/&>ds design$ to assure t ! human tissue
 specim5 does n pose a communicable     
disease risk to ! g5]al public &_/or    
unkn[n communicable disease risk to2 &  
7ii7 if ! applicant 7or o!r appropriate 
p]son7 cons5ts to ! inspection ( !      
facility t is ! subject ( ! application1
 9 accordance ) subsection 7c7 ( ?is    
section4  7#c7 ,requirem5ts = exemption 
,! ,secret>y %all prescribe requirem5ts 
"u :i* a human tissue specim5 %all be   
exempt f ! requirem5ts ( p>agraph 7#a74 
7b7 ,falsely label+ or m>k+ package or  
conta9]2 alt]+ label or m>k ,no p]son   
%all falsely label or m>k any package or
 conta9] ( any human tissue specim5 or  

alt] any label or m>k on ! package or   
conta9] ( ! biological product s z to   
falsify ! label or m>k4  7c7 ,inspection
 ( e/abli%m5t = propagation & prep>ation
  7#a7 ,9 g5]al ,any (fic]1 ag5t1 or    
employee ( ! ,dep>tm5t ( ,heal? & ,human
 ,s]vices1 au?oriz$ by ! ,secret>y = !  
purpose1 may dur+ all reasonable h\rs   
ent] & inspect any e/abli%m5t = !       
propagation or recov]y & prep>ation (   
any human tissue specim54  7#b7         
,inspection by nationally recogniz$     
accr$it+ bodies ,any au?oriz$ ag5t ( a  
nationally recogniz$ accr$it+ body      
au?oriz$ by ! ,secret>y = ! purpose1 may
 dur+ all reasonable h\rs ent] & inspect
 any e/abli%m5t = ! propagation or      
recov]y & prep>ation ( any human tissue 
specim54  7#c7 ,rule ( con/ruction ,no?+
 9 ?is subsection or ,act limits any    
exi/+ au?ority ( ! ,attorney ,g5]al1 any
 ,/ate ,attorney ,g5]al or local law    
en=cem5t to ent] & inspect any          
e/abli%m5t = ! propagation or recov]y & 
prep>ation ( any human tissue4  7d7     

,recall ( specim5 pres5t+ imm95t haz>d2 
violations  7#a7 ,recall ,^u a          
det]m9ation t a human tissue specim5 or 
collection ( specim5s lic5s$ "u ?is     
section pres5ts an imm95t or sub/antial 
haz>d to ! public heal?1 ! ,secret>y    
%all issue an ord] imm$iately ord]+ !   
recall ( su* bat*1 lot1 or o!r quantity 
( su* product4 ,an ord] "u ?is p>agraph 
%all be issu$ 9 accordance ) section    
#eed ( title #e4  7#b7 ,violations ,any 
violation ( p>agraph 7#a7 %all subject !
 violator to a civil p5alty ( up to     
#aj1jjj p] day ( violation4 ,! am\nt ( a
 civil p5alty "u ?is p>agraph %all1     
effective ,decemb] #a ( ea* ye> beg9n+  
#a ye> aft] ! effective date ( ?is      
p>agraph1 be increas$ by ! p]c5t *ange 9
 ! ,consum] ,price ,index = ! base qu>t]
 ( su* ye> ov] ! ,consum] ,price ,index 
= ! base qu>t] ( ! prec$+ ye>1 adju/$ to
 ! ne>e/ #a_/aj ( #a p]c5t4 ,= purposes 
( ?is p>agraph1 ! t]m base qu>t]1 z us$ 
) respect to a ye>1 means ! cal5d> qu>t]
 end+ on ,septemb] #cj ( su* ye> & !    

price index = a base qu>t] is !         
ari?metical mean ( su* index = ! #c     
mon?s compris+ su* qu>t]4  7e7 ,p5alties
 = (f5ses ,:oev] violates any ( !       
provisions ( ?is section %all be        
imprison$ n m ?an #a ye>1 or f9$ n m ?an
 #ejj1 or bo?4 ,section #cega ( title   
#ah1 ,unit$ ,/ates ,code %all n apply to
 an (f5se "u ?is subsection4  7f7       
,con/ruction ) o!r laws ,no?+ conta9$ 9 
?is ,act %all be con/ru$ z 9 any way    
affect+1 modify+1 repeal+1 or sup]s$+ "u
 any exi/+ provisions "u curr5t ,f$]al  
law4  7g7 ,human tissue specim5 def9$ ,9
 ?is section1 ! t]m non-transplant      
tissue specim5 means legally donat$     
anatomical segm5ts1 cells1 collection ( 
cells1 bodily fluids1 or ! complete body
 t are recov]$ = m$ical rese>* &        
education4 ,! t]m does n include any?+ t
 w\ld qualify z a biological product "u 
! ,public ,heal? ,s]vice ,act4