,i  #aac? ,,congress  #b;d ,session  ,h4
 ,r4 #dcgd  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,april #b1 #bjad ,mr4 
,roe ( ,t5nessee introduc$ ! foll[+     
bill2 :i* 0 ref]r$ to ! ,committee on   
,vet]ans' ,affairs  ,a ,,bill  ,to am5d 
title #ch1 ,unit$ ,/ates ,code1 to      
direct ! ,secret>y ( ,vet]ans ,affairs  
to adopt & implem5t a /&>d id5tification
 protocol = use 9 ! track+ & procurem5t 
( biological implants by ! ,dep>tm5t (  
,vet]ans ,affairs1 & = o!r purposes4    
#a4 ,%ort title ,?is ,act may be cit$ z 
! ,biological ,implant ,track+ & ,vet]an
 ,safety ,act ( #bjad4  #b4             
,id5tification & track+ ( biological    
implants us$ 9 ,dep>tm5t ( ,vet]ans     
,affairs m$ical facilities  7a7 ,9 g5]al
 ,sub*apt] ,,ii ( *apt] #gc ( title #ch1
 ,unit$ ,/ates ,code1 is am5d$ by add+  
at ! end ! foll[+ new section3          
#gccj;,b4 ,id5tification & track+ (     
biological implants  7a7 ,/&>d          
id5tification sy/em = biological        
implants ,! ,secret>y %all adopt !      

unique device id5tification sy/em       
develop$ = m$ical devices by ! ,food &  
,drug ,adm9i/ration pursuant to section 
#eai7;f7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act 7#ba ,u4,s4,c4           
#cfj;i7f771 or implem5t a comp>able /&>d
 id5tification sy/em1 = use 9 id5tify+  
biological implants int5d$ = use 9      
m$ical proc$ures conduct$ 9 m$ical      
facilities ( ! ,dep>tm5t4  7b7          
,biological implant track+ sy/em  7#a7  
,! ,secret>y %all implem5t a sy/em =    
track+ ! biological implants ref]r$ to 9
 subsection 7a7 f donor to implantation4
 ,su* sy/em %all be compatible ) !      
id5tification sy/em adopt$ or implem5t$ 
"u subsection 7a74  7#b7 ,! ,secret>y   
%all implem5t inv5tory controls         
compatible ) ! track+ sy/em implem5t$ "u
 p>agraph 7#a7 s t all pati5ts :o h     
receiv$1 9 a m$ical facility ( !        
,dep>tm5t1 a biological implant subject 
to a recall by ! ,food & ,drug          
,adm9i/ration c be notifi$ ( ! recall1  
if bas$ on ! evaluation ( appropriate   

m$ical p]sonnel ( ! ,dep>tm5t ( ! risks 
& b5efits1 ! ,secret>y det]m9es su*     
notification is appropriate4  7c7       
,consi/5cy ) ,food & ,drug ,adm9i/ration
 regulations ,to ! ext5t t a conflict   
arises betwe5 ?is section & a provision 
( ! ,f$]al ,food1 ,drug1 & ,cosmetic    
,act 7#ba ,u4,s4,c4 #cja et seq47 or    
sections #cea or #cfa ( ! ,public ,heal?
 ,s]vice ,act 7#db ,u4,s4,c4 #bfb7      
7includ+ any regulations issu$ "u su*   
,acts71 ! provision ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act or ,public      
,heal? ,s]vice ,act 7includ+ any        
regulations issu$ "u su* ,acts7 %all    
apply4  7d7 ,def9ition ( biological     
implant ,9 ?is section1 ! t]m biological
 implant means any human cell1 tissue1  
or cellul> or tissue-bas$ product--     
7#a7 "u ! mean+ giv5 ! t]m human cells 9
 section #abga4c ( title #ba1 ,code (   
,f$]al ,regulations1 or any successor   
regulation2 or  7#b7 t is regulat$ z a  
device "u subp>t ,a ( "p #hja ( title   
#ba1 ,code ( ,f$]al ,regulations1 or any

 successor regulation4  4  7b7 ,cl]ical 
am5dm5t ,! table ( sections at ! beg9n+ 
( su* *apt] is am5d$ by add+ at ! end ( 
! items relat+ to su* sub*apt] ! foll[+ 
new item3  #gccj;,b4 ,id5tification &   
track+ ( biological implants4  4  7c7   
,implem5tation deadl9es  7#a7 ,/&>d     
id5tification sy/em  7,a7 ,9 g5]al ,)   
respect to biological implants describ$ 
9 p>agraph 7#a7 ( subsection 7d7 (      
section #gccj;,b ( title #ch1 ,unit$    
,/ates ,code1 z add$ by subsection 7a71 
! ,secret>y ( ,vet]ans ,affairs %all    
adopt or implem5t a /&>d id5tification  
sy/em = biological implants1 z requir$  
by subsection 7a7 ( su* section1 by n   
lat] ?an ! date t is #ahj days aft] !   
date ( ! enactm5t ( ?is ,act4  7,b7     
,implants regulat$ z devices ,) respect 
to biological implants describ$ 9       
p>agraph 7#b7 ( subsection 7d7 ( su*    
section1 ! ,secret>y ( ,vet]ans ,affairs
 %all adopt or implem5t su* /&>d        
id5tification sy/em 9 compliance ) !    
compliance dates e/abli%$ by ! ,food &  

,drug ,adm9i/ration pursuant to section 
#eai7;f7 ( ! ,f$]al ,food1 ,drug1 &     
,cosmetic ,act 7#ba ,u4,s4,c4           
#cfj;i7f774  7#b7 ,track+ sy/em ,!      
,secret>y ( ,vet]ans ,affairs %all      
implem5t ! biological implant track+    
sy/em requir$ by subsection 7b7 (       
section #gccj;,b1 z add$ by subsection  
7a71 by n lat] ?an ! date t is #ahj days
 aft] ! date ( ! enactm5t ( ?is ,act4   
7d7 ,report+ requirem5t ,if ! biological
 implant track+ sy/em requir$ by        
subsection 7b7 ( su* section is n       
op]ational by ! date t is #ahj days aft]
 ! date ( ! enactm5t ( ?is ,act1 !      
,secret>y ( ,vet]ans ,affairs %all      
provide to ! ,committees on ,vet]ans'   
,affairs ( ! ,s5ate & ,h\se (           
,repres5tatives a writt5 explanation =  
ea* mon? until su* "t z ! sy/em is      
op]ational4 ,ea* su* explanation %all   
describe ea* imp$im5t to ! implem5tation
 ( ! sy/em1 /eps be+ tak5 to rem$iate   
ea* su* imp$im5t1 & t>get dates = a     
solution to ea* su* imp$im5t4  #c4      

,procurem5t ( biological implants us$ 9 
,dep>tm5t ( ,vet]ans ,affairs m$ical    
facilities  7a7 ,procurem5t  7#a7 ,9    
g5]al ,sub*apt] ,,ii ( *apt] #ha ( su*  
title is am5d$ by add+ at ! end ! foll[+
 new section3  #habi4 ,procurem5t (     
biological implants  7a7 ,9 g5]al  7#a7 
,! ,secret>y may procure biological     
implants only f v5dors t meet ! foll[+  
conditions3  7,a7 ,! v5dor uses ! /&>d  
id5tification sy/em adopt$ or implem5t$ 
by ! ,secret>y "u section #gccj;,b7a7 ( 
?is title & has safegu>ds to ensure t a 
production id5tifi] has be5 9 place at  
ea* /ep ( di/ribution ( ea* biological  
implant f its donor4  7,b7 ,! v5dor is  
regi/]$ ) ! ,food & ,drug ,adm9i/ration 
"u subp>t ,b ( "p #abga ( title #ba1    
,code ( ,f$]al ,regulations1 or any     
successor regulation1 & 9 ! case ( a    
v5dor t uses tissue di/ribution         
int]m$i>ies1 ! v5dor uses only tissue   
di/ribution int]m$i>ies t are           
appropriately regi/]$ ) ! ,food & ,drug 
,adm9i/ration4  7,c7 ,! v5dor ensures t 

donor eligibility det]m9ations & su* o!r
 records z ! ,secret>y may require      
accompany ea* biological implant at all 
times1 reg>dless ( ! c\ntry ( orig9 ( ! 
donor ( ! biological mat]ial4  7,d7 ,!  
v5dor cons5ts to p]iodic inspections &  
audits by ! ,dep>tm5t ( ,vet]ans        
,affairs reg>d+ ! accuracy ( records & !
 h&l+ ( products4  7,e7 ,! v5dor agrees 
to coop]ate ) all biological implant    
recalls conduct$ on ! v5dor's own       
initiative1 by ! reque/ ( ! ,food &     
,drug ,adm9i/ration1 or by a /atutory   
ord] ( ! ,food & ,drug ,adm9i/ration4   
7,f7 ,! v5dor agrees to provide to !    
,secret>y any adv]se ev5t report or w>n+
 lett] ( ! ,food & ,drug ,adm9i/ration  
issu$ to ! v5dor by n lat] ?an #cj days 
aft] ! v5dor receives su* report or w>n+
 lett]4  7,g7 ,! v5dor agrees to reta9  
all records associat$ ) ! procurem5t ( a
 biological implant by ! ,dep>tm5t = at 
lea/ five ye>s aft] ! date ( !          
procurem5t ( ! biological implant4  7,h7
 ,! v5dor ma9ta9s active accr$itation ) 

! ,am]ican ,association ( ,tissue ,banks
 or a simil> national accr$itation      
specific to biological implants4  7#b7  
,! ,secret>y %all procure biological    
implants "u ! ,f$]al ,supply ,s*$ules ( 
! ,g5]al ,s]vices ,adm9i/ration1 unless 
su* implants are n available "u su*     
,s*$ules4 ,= biological implants li/$ on
 ! ,f$]al ,supply ,s*$ules1 ! ,secret>y 
%all accommodate reasonable v5dor       
reque/s to und]take outrea* ef=ts to    
educate m$ical pr(essionals ( !         
,dep>tm5t ab\t ! use & efficacy ( su*   
biological implants4  7#c7 ,section     
#habc ( ?is title %all n apply to !     
procurem5t ( biological implants4  7#d7 
,9 ! case ( biological implants t are   
unavailable = procurem5t "u ! ,f$]al    
,supply ,s*$ules1 ! ,secret>y %all      
procure su* implants us+ competitive    
proc$ures 9 accordance ) applicable law 
& ! ,f$]al ,acquisition ,regulation4    
7b7 ,p5alties ,9 addition to any        
applicable p5alty "u any o!r provision (
 law1 any procurem5t employee ( !       

,dep>tm5t :o is f\nd responsible = a    
biological implant procurem5t           
transaction ) int5t to avoid or )       
reckless disreg>d ( ! requirem5ts ( ?is 
section %all be ineligible to hold a    
c]tificate ( appo9tm5t z a contract+    
(fic] or to s]ve z ! repres5tative ( an 
ord]+ (fic]1 contract+ (fic]1 or pur*ase
 c>d hold]4  7c7 ,def9itions ,9 ?is     
section3  7#a7 ,! t]m biological implant
 %all h ! mean+ giv5 su* t]m 9 section  
#gccj;,b7d7 ( ?is title4  7#b7 ,! t]m   
production id5tifi] means a di/9ct      
id5tification code t--  7,a7 relates a  
biological implant to ! donor ( !       
implant & to all records p]ta9+ to !    
implant2  7,b7 includes in=mation       
design$ to facilitate effective track+1 
us+ ! di/9ct id5tification code1 f !    
donor to ! recipi5t & f ! recipi5t to ! 
donor2 &  7,c7 satisfies ! requirem5ts (
 subsection 7c7 ( section #abga4bij (   
title #ba1 ,code ( ,f$]al ,regulations1 
or any successor regulation4  4  7#b7   
,cl]ical am5dm5t ,! table ( sections at 

! beg9n+ ( su* *apt] is am5d$ by add+ at
 ! end ( ! items relat+ to su* sub*apt] 
! foll[+ new item3  #habi4 ,procurem5t (
 biological implants4  4  7b7 ,effective
 date ,section #habi ( title #ch1 ,unit$
 ,/ates ,code1 z add$ by subsection 7a71
 %all take effect on ! date t is #ahj   
days aft] ! date on :i* ! track+ sy/em  
requir$ "u subsection 7b7 ( section     
#gccj;,b ( su* title1 z add$ by section 
#b7;a7 is implem5t$4  7c7 ,special rule 
= cryopres]v$ products ,dur+ ! ?ree-ye> 
p]iod beg9n+ on ! effective date (      
section #habi ( title #ch1 ,unit$ ,/ates
 ,code1 z add$ by subsection 7a71       
biological implants produc$ & label$    
be=e t date may be procur$ by !         
,dep>tm5t ( ,vet]ans ,affairs )\t       
relabel+ "u ! /&>d id5tification sy/em  
adopt$ or implem5t$ "u section #gccj;,b 
( su* title1 z add$ by section #b7;a74