,i  #aaf? ,,congress  #a/ ,session  ,h4 
,r4 #edg  ,,9 ,,! ,,h\se ,,(            
,,repres5tatives  ,janu>y #ae1 #bjai,mr4
 ,david ,p4 ,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 ( #bjai4  #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;,d4 ,id5tification & track+ (     
biological implants  7a7 ,/&>d          
id5tification sy/em = biological        

implants  7#a7 ,! ,secret>y %all adopt !
 unique device id5tification sy/em      
develop$ = m$ical devices by ! ,food &  
,drug ,adm9i/ration "u section #eai7;f7 
( ! ,f$]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$ical facilities ( !       
,dep>tm5t4  7#b7 ,9 adopt+ or implem5t+ 
a /&>d id5tification sy/em = biological 
implants "u p>agraph 7#a71 ! ,secret>y  
%all p]mit a v5dor to use any ( !       
accr$it$ entities id5tifi$ by ! ,food & 
,drug ,adm9i/ration z an issu+ ag5cy    
pursuant to section #hcj4ajj ( title    
#ba1 ,code ( ,f$]al ,regulations1 or any
 successor regulation4  7b7 ,biological 
implant track+ sy/em  7#a7 ,! ,secret>y 
%all implem5t a sy/em = track+ !        
biological implants describ$ 9          
subsection 7a7 f human donor or animal  
s\rce to implantation4  7#b7 ,! track+  
sy/em implem5t$ "u p>agraph 7#a7 %all be

 compatible ) ! id5tification sy/em     
adopt$ or implem5t$ "u subsection 7a74  
7#c7 ,! ,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 c be notifi$
 ( ! recall if1 bas$ on ! evaluation by 
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 section #cea or #cfa ( 
! ,public ,heal? ,s]vice ,act 7#db      
,u4,s4,c4 #bfb & #bfd7 7includ+ any     
regulations issu$ "u su* provisions71 ! 
provision ( ! ,f$]al ,food1 ,drug1 &    
,cosmetic ,act or ,public ,heal? ,s]vice
 ,act 7includ+ any regulations issu$ "u 
su* provisions7 %all apply4  7d7        

,biological implant def9$ ,9 ?is        
section1 ! t]m biological implant means 
any human cell1 tissue1 or cellul> or   
tissue-bas$ product or animal product-- 
7#a7 "u ! mean+ giv5 ! t]m human cells1 
tissues1 or cellul> or tissue-bas$      
products 9 section #abga4c ( title #ba1 
,code ( ,f$]al ,regulations1 or any     
successor regulation2 or  7#b7 t is     
regulat$ z a device "u section #bja7;h7 
( ! ,f$]al ,food1 ,drug1 & ,cosmetic    
,act 7#ba ,u4,s4,c4 #cba7;h774  4  7b7  
,cl]ical am5dm5t ,! table ( sections at 
! beg9n+ ( su* *apt] is am5d$ by ins]t+ 
aft] ! item relat+ to section #gccj;,c !
 foll[+ new item3  #gccj;,d4            
,id5tification & track+ ( biological    
implants4  4  7c7 ,implem5tation        
deadl9es  7#a7 ,/&>d id5tification sy/em
 ,! ,secret>y ( ,vet]ans ,affairs %all  
adopt or implem5t ! /&>d id5tification  
sy/em = biological implants requir$ by  
subsection 7a7 ( section #gccj;,c (     
title #ch1 ,unit$ ,/ates ,code1 z add$  
by subsection 7a71 ) respect to         

biological implants describ$ 9--  7,a7  
subsection 7d77#a7 ( su* section1 by n  
lat] ?an ! date t is #ahj days aft] !   
date ( ! enactm5t ( ?is ,act2 &  7,b7   
subsection 7d77#b7 ( su* section1 9     
compliance ) ! compliance dates e/abli%$
 by ! ,food & ,drug ,adm9i/ration "u    
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 section #gccj;,c7b7 (  
title #ch1 ,unit$ ,/ates ,code1 z add$  
by subsection 7a71 by n lat] ?an ! date 
t is #ahj days aft] ! date ( ! enactm5t 
( ?is ,act4  7d7 ,report+ requirem5t    
7#a7 ,9 g5]al ,if ! biological implant  
track+ sy/em requir$ by section         
#gccj;,c7b7 ( title #ch1 ,unit$ ,/ates  
,code1 z add$ by subsection 7a71 is n   
op]ational by ! date t is #ahj days aft]
 ! date ( ! enactm5t ( ?is ,act1 !      
,secret>y ( ,vet]ans ,affairs %all      
submit to ! ,committee on ,vet]ans'     

,affairs ( ! ,s5ate & ! ,committee on   
,vet]ans' ,affairs ( ! ,h\se (          
,repres5tatives a report expla9+ :y !   
sy/em is n op]ational = ea* mon? until  
su* "t z ! sy/em is op]ational4  7#b7   
,elem5ts ,ea* report submitt$ "u        
p>agraph 7#a7 %all include a description
 ( ! foll[+3 7,a7 ,ea* imp$im5t to !    
implem5tation ( ! sy/em describ$ 9 su*  
p>agraph4  7,b7 ,/eps be+ tak5 to       
rem$iate ea* su* imp$im5t4  7,c7 ,t>get 
dates = a solution to ea* su* imp$im5t4 
#c4 ,procurem5t ( biological implants   
us$ 9 ,dep>tm5t ( ,vet]ans ,affairs     
m$ical facilities  7a7 ,procurem5t  7#a7
 ,9 g5]al ,sub*apt] ,,ii ( *apt] #ha (  
title #ch1 ,unit$ ,/ates ,code1 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 ( human     
orig9 only f v5dors t meet ! foll[+     
conditions3  7,a7 ,! v5dor uses ! /&>d  
id5tification sy/em adopt$ or implem5t$ 
by ! ,secret>y "u section #gccj;,c7a7 ( 

?is title & has safegu>ds to ensure t a 
di/9ct id5tifi] has be5 9 place at ea*  
/ep ( di/ribution ( ea* biological      
implant f its donor4  7,b7 ,! v5dor is  
regi/]$ z requir$ by ! ,food & ,drug    
,adm9i/ration "u subp>t ,b ( "p #abga ( 
title #ba1 ,code ( ,f$]al ,regulations1 
or any successor regulation1 & 9 ! case 
( a v5dor t uses a tissue di/ribution   
int]m$i>y or a tissue processor1 ! v5dor
 provides assurances t ! tissue         
di/ribution int]m$i>y or tissue         
processor is regi/]$ z requir$ by !     
,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   
agrees to coop]ate ) all biological     
implant recalls conduct$ on ! initiative
 ( ! v5dor1 on ! initiative ( ! orig9al 
product manufactur] us$ by ! v5dor1 by !
 reque/ ( ! ,food & ,drug ,adm9i/ration1

 or by a /atutory ord] ( ! ,food & ,drug
 ,adm9i/ration4  7,e7 ,! v5dor agrees to
 notify ! ,secret>y ( any adv]se ev5t or
 reaction report x provides to ! ,food &
 ,drug ,adm9i/ration1 z requir$ by      
sections #abga4c & #abga4cej ( title    
#ba1 ,code ( ,f$]al ,regulations1 or any
 successor regulation1 or any w>n+ lett]
 f ! ,food & ,drug ,adm9i/ration issu$  
to ! v5dor or a tissue processor or     
tissue di/ribution int]m$i>y us$ by !   
v5dor by n lat] ?an #fj days aft] !     
v5dor receives su* report or w>n+ lett]4
  7,f7 ,! v5dor agrees to reta9 all     
records associat$ ) ! procurem5t ( a    
biological implant by ! ,dep>tm5t = at  
lea/ #aj ye>s aft] ! date ( ! procurem5t
 ( ! biological implant4  7,g7 ,! v5dor 
provides assurances t ! biological      
implants provid$ by ! v5dor are acquir$ 
only f tissue processors t ma9ta9 active
 accr$itation ) ! ,am]ican ,association 
( ,tissue ,banks or a simil> national   
accr$itation specific to biological     
implants4  7#b7 ,! ,secret>y may procure

 biological implants ( nonhuman orig9   
only f v5dors t meet ! foll[+           
conditions3  7,a7 ,! v5dor uses ! /&>d  
id5tification sy/em adopt$ or implem5t$ 
by ! ,secret>y "u section #gccj;,c7a7 ( 
?is title4  7,b7 ,! v5dor is regi/]$ z  
an e/abli%m5t z requir$ by ! ,food &    
,drug ,adm9i/ration "u sections #hjg4bj 
& #hjg4dj ( title #ba1 ,code ( ,f$]al   
,regulations1 or any successor          
regulation 7or is n requir$ to regi/]   
pursuant to section #hjg4fe7;a7 ( su*   
title1 or any successor regulation71 & 9
 ! case ( a v5dor t is n ! orig9al      
product manufactur] ( su* implants1 !   
v5dor provides assurances t ! orig9al   
product manufactur] is regi/]$ z requir$
 by ! ,food & ,drug ,adm9i/ration 7or is
 n requir$ to regi/]74  7,c7 ,! v5dor   
agrees to coop]ate ) all biological     
implant recalls conduct$ on ! initiative
 ( ! v5dor1 on ! initiative ( ! orig9al 
product manufactur] us$ by ! v5dor1 by !
 reque/ ( ! ,food & ,drug ,adm9i/ration1
 or by a /atutory ord] ( ! ,food & ,drug

 ,adm9i/ration4  7,d7 ,! v5dor agrees to
 notify ! ,secret>y ( any adv]se ev5t   
report x provides to ! ,food & ,drug    
,adm9i/ration z requir$ "u "p #hjc (    
title #ba1 ,code ( ,f$]al ,regulations1 
or any successor regulation1 or any w>n+
 lett] f ! ,food & ,drug ,adm9i/ration  
issu$ to ! v5dor or ! orig9al product   
manufactur] us$ by ! v5dor by n lat] ?an
 #fj days aft] ! v5dor receives su*     
report or w>n+ lett]4  7,e7 ,! v5dor    
agrees to reta9 all records associat$ ) 
! procurem5t ( a biological implant by !
 ,dep>tm5t = at lea/ #aj ye>s aft] !    
date ( ! procurem5t ( ! biological      
implant4  7#c7  7,a7 ,! ,secret>y %all  
procure biological implants "u ! ,f$]al 
,supply ,s*$ules ( ! ,g5]al ,s]vices    
,adm9i/ration unless su* implants are n 
available "u su* ,s*$ules4  7,b7 ,)     
respect to biological implants li/$ 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 ,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 
,regulation1 includ+ ?r\gh ! use ( a    
national contract4  7#d7 ,9 procur+     
biological implants "u ?is section1 !   
,secret>y %all p]mit a v5dor to use any 
( ! accr$it$ entities id5tifi$ by !     
,food & ,drug ,adm9i/ration z an issu+  
ag5cy pursuant to section #hcj4ajj (    
title #ba1 ,code ( ,f$]al ,regulations1 
or any successor regulation4  7#e7      
,section #habc ( ?is title %all n apply 
to ! procurem5t ( biological implants4  
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 
has ! mean+ giv5 t t]m 9 section        
#gccj;,c7d7 ( ?is title4  7#b7 ,! t]m   
di/9ct id5tifi] means a di/9ct          
id5tification code t-- 7,a7 relates a   
biological implant to ! human 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 (
 section #abga4bij7;c7 ( title #ba1     
,code ( ,f$]al ,regulations1 or any     
successor regulation4  7#c7 ,! t]m      
tissue di/ribution int]m$i>y means an   
ag5cy t acquires & /ores human tissue = 
fur!r di/ribution & p]=ms no o!r tissue 
bank+ functions4  7#d7 ,! t]m tissue    
processor means an entity process+ human

 tissue = use 9 biological implants1    
includ+ activities p]=m$ on tissue o!r  
?an donor scre5+1 donor te/+1 tissue    
recov]y & collection functions1 /orage1 
or di/ribution4  4  7#b7 ,cl]ical       
am5dm5t ,! table ( sections at ! beg9n+ 
( *apt] #ha is am5d$ by ins]t+ aft] !   
item relat+ to section #habh ! 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 section #gccj;,c7b7 ( su*    
title1 z add$ by section #b7;a71 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 effective date may be procur$ by 
! ,dep>tm5t ( ,vet]ans ,affairs )\t     
relabel+ "u ! /&>d id5tification sy/em  

adopt$ or implem5t$ "u section #gccj;,c 
( su* title1 z add$ by section #b7;a74  
#d4 ,fund+ ,no additional funds are     
au?oriz$ to c>ry out ! requirem5ts ( ?is
 ,act & ! am5dm5ts made by ?is ,act4    
,su* requirem5ts %all be c>ri$ out us+  
am\nts o!rwise au?oriz$4