,i  #aae? ,,congress  #a/ ,session  ,h4 
,r4 #bjbb  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,april #f1 #bjag,mr4  
,gos> 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 ( #bjag or z ! ,,latts    
,act ( #bjag4  #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$ical rese>* or education    
unless--  7,a7 a non-transplant tissue  
bank lic5se is 9 effect = ! entity      
introduc+ ! human tissue specim5 into   
int]/ate comm]ce2  7,b7 ea* package ( ! 
human tissue specim5 is label$ )-- 7i7 !
 prop] "n ( ! human tissue specim5      

conta9$ 9 ! package2  7ii7 ! "n1        
address1 & applicable lic5se numb] ( !  
s\rce tissue bank ( ! human tissue      
specim52  7iii7 a unique donor id5tifi]1
 ! tissue type1 ! cause ( dea?1         
s]ological te/ results1 & 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 ! /atem5t n =     
transplantation2 &  7,c7 ea* package ( !
 human tissue specim5 is wrapp$ &       
packag$ 9 a mann] t--  7i7 mitigates    
pot5tial contam9ation & cross           
contam9ation2  7ii7 mitigates pot5tial  
safety haz>ds2  7iii7 is 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 specim5s ( ! applicant are       
legally donat$1 prop]ly scre5$ =        
communicable disease ag5ts1 prop]ly     
label$1 transport$1 & /or$1 & us$       
accord+ to ! donor's donation           
au?orization2  7,,ii7 ea* facility 9 :i*
 ! human tissue specim5s ( ! applicant  
are donat$1 recov]$1 process$1 pack$1 or
 held meets /&>ds design$ to ensure t ! 
human tissue specim5s d n pose a        
communicable disease risk to ! g5]al    
public2 &  7,,iii7 ! applicant creates1 
compiles1 & ma9ta9s a complete record on
 ea* donor f :i* x recov]s a human body 
or human tissue specim5 = educational or
 rese>* purposes1 :i* record %all       
include1 at a m9imum--  7aa7            
docum5tation demon/rat+ t ! donor or !  
ag5t mak+ ! donation on ! donor's behalf
 has kn[+ly cons5t$ to ! anatomical     
donation = educational or rese>*        
purposes2  7bb7 docum5tation %[+ t !    
donor or ! ag5t mak+ ! donation on !    
donor's behalf has be5 in=m$ z to :e!r !

 body or human tissue specim5s %all be  
return$ to a relative or p]sonal        
repres5tative or :e!r ! applicant %all  
arrange & c>ry out ! disposition ( !    
human body or human tissue specim5s2    
7cc7 docum5tation ( ! id5tity & address 
( ea* entity :i* has be5 9 possession ( 
! human body or human tissue specim5    
be=e ! applicant took possession1 su* z 
a fun]al home1 coron]1 hospital1 organ  
procurem5t organization1 or tissue bank2
 &  7dd7 docum5tation on ! use &        
disposition ( ea* human body or human   
tissue specim51 includ+ ! "n & address (
 ea* p]son or entity t receives ! human 
body or human tissue specim5 directly f 
! applicant2 &  7ii7 only if ! applicant
 7or o!r appropriate p]son7 cons5ts to !
 inspection ( ! facility t is ! subject 
( ! application1 9 accordance )         
subsection 7c74  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] ( ! human tissue
 specim5 s z to falsify ! label or m>k4 
7c7 ,inspection ( facilities  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 facility t is subject to a         
non-transplant tissue bank lic5se "u ?is
 section4  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 su*  
facility4  7#c7 ,rule ( con/ruction     
,no?+ 9 ?is ,act limits any exi/+       
au?ority ( ! ,attorney ,g5]al1 any ,/ate
 ,attorney ,g5]al1 or local law en=cem5t
 to ent] & inspect any su* facility4    
7d7 ,recall ( specim5 pres5t+ imm95t    

haz>d2 violations  7#a7 ,recall ,^u a   
det]m9ation t a human tissue specim5 or 
collection ( specim5s ( a tissue bank   
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 #e1 ,unit$ ,/ate   
,code4  7#b7 ,violations ,any violation 
( a recall ord] "u 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* cal5d>
 ye> beg9n+ #a ye> or m 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>1 & ! price index = a base 
qu>t] is ! ari?metical mean ( su* index 
= ! #c mon?s compris+ su* qu>t]4  7e7   
,prohibitions ( sales & pur*ases ( human
 tissue specim5 ,x %all be unlawful =   
any p]son to kn[+ly sell1 acquire1      
receive1 or o!rwise transf] any human   
tissue specim5 = valuable consid]ation  
if ! transf] affects int]/ate comm]ce4  
7f7 ,p5alties = (f5ses ,:oev] violates  
any ( ! provisions ( ?is section %all be
 imprison$ n m ?an #a ye>1 or f9$ n m   
?an #aj1jjj1 or bo?4 ,section #cega (   
title #ah1 ,unit$ ,/ates ,code1 %all n  
apply to an (f5se "u ?is section4  7g7  
,con/ruction ) o!r laws ,no?+ 9 ?is ,act
 7o!r ?an subsection 7f77 %all be       
con/ru$ z 9 any way affect+1 modify+1   
repeal+1 or sup]s$+ any o!r provision ( 
,f$]al law4  7h7 ,def9itions ,= !       
purposes ( ?is section3 7#a7 ,unless !  
context indicates o!rwise1 ! t]m ag5t   
means ! p]son :o is expressly au?oriz$  
to make an anatomical donation on !     
donor's behalf "u ,/ate law4  7#b7 ,!   

t]m donor means a p]son ^: body or ^:   
human tissue specim5 is ! subject ( an  
anatomical donation4  7#c7 ,! t]m human 
tissue specim5--  7,a7 means legally    
donat$ anatomical segm5ts1 cells1 or    
body fluids 7includ+ a complete body7 t 
are recov]$ = m$ical rese>* or          
education2 &  7,b7 does n include a     
biological product 7z def9$ 9 section   
#cea ( ! ,public ,heal? ,s]vices ,act   
7#db ,u4,s4,c4 #bfb774  7#d7 ,! t]m     
valuable consid]ation means some?+ (    
value1 b does n include ! reasonable    
paym5ts associat$ ) ! removal1          
transportation1 process+1 pres]vation1  
quality control1 /orage1 & lawful       
disposition ( human tissue specim5s4