,i  #aai? ,,congress  #b;d ,session  ,h4
 ,r4 #ghed  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,m>* #e1 #bjbf ,ms4   
,tlaib 7= h]self1 ,ms4 ,lee (           
,p5nsylvania1 & ,mrs4                   
,*]filus-,mc,cormick7 introduc$ ! foll[+
 bill2 :i* 0 ref]r$ to ! ,committee on  
,en]gy & ,comm]ce1 & 9 addition to !    
,committee on ! ,judici>y1 = a p]iod to 
be subsequ5tly det]m9$ by ! ,speak]1 9  
ea* case = consid]ation ( su* provisions
 z fall )9 ! jurisdiction ( ! committee 
conc]n$  ,a ,,bill  ,to am5d ! ,public  
,heal? ,s]vice ,act to e/abli% a        
,national ,in/itute = ,biom$ical ,rese>*
 & ,developm5t1 & = o!r purposes4  #a4  
,%ort title ,?is ,act may be cit$ z !   
,m$ic9es = ! ,p ,act4  #b4 ,e/abli%m5t  
7a7 ,9 g5]al ,"p ,c ( title ,,iv ( !    
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bhe et seq47 is am5d$ by add+
 at ! end ! foll[+3  #ba ,national      
,in/itute = ,biom$ical ,rese>* &        
,developm5t  #dfdz-#aa4 ,purpose &      
functions ( ,in/itute  7a7 ,9 g5]al ,!  

g5]al purposes ( ! ,national ,in/itute =
 ,biom$ical ,rese>* & ,developm5t       
7ref]r$ to 9 ?is subp>t z ! ,in/itute7  
are-- 7#a7 to engage 9 full-cycle       
developm5t ( drugs1 devices1 &          
biological products to promote long-t]m 
access to m$ic9es1 fo/] innovation1 &   
ensure prioritization ( public heal?    
ne$s2 &  7#b7 to make su* drugs1        
devices1 & biological products available
 to ! public at equitable & accessible  
prices4  7b7 ,rese>* & developm5t       
program  7#a7 ,9 g5]al ,! ,director ( ! 
,in/itute 7ref]r$ to 9 ?is subp>t z !   
,director7 %all c>ry out a program = !  
rese>* & developm5t ( drugs1 devices1 & 
biological products = approval1         
lic5sure1 cle>ance1 or au?orization "u  
section #eje1 #eaj7k71 #eac7;f77#b71 or 
#eae ( ! ,f$]al ,food1 ,drug1 &         
,cosmetic ,act or section #cea ( ?is    
,act4  7#b7 ,activities ,! ,director    
%all c>ry out ! program describ$ 9      
p>agraph 7#a7 ?r\gh-- 7,a7 manag+ direct
 rese>* & developm5t at ,f$]al          

laboratories ( ! ,national ,in/itutes ( 
,heal?2  7,b7 contract+ ) public or     
private entities = rese>* & developm5t2 
7,c7 acquisition ( rese>* & developm5t1 
includ+ te*nologies & relat$ sci5tific  
data1 f public or private entities2     
7,d7 lic5s+ ( pat5ts "u subsection 7f72 
7,e7 e/abli%m5t ( sep>ate facilities to 
conduct ! "w ( ! ,in/itute1 includ+1 at 
! discretion ( ! ,director1 !           
con/ruction ( facilities & ! acquisition
 ( l&1 = ! purposes ( ! e/abli%m5t or   
op]ation ( ! ,in/itute2  7,f7 %>+       
sci5tific data 9 a timely mann] = use by
 rese>* communities & ,f$]al & ,/ate    
ag5cies2  7,g7 coord9at+ ! activities ( 
! ,in/itute ) relat$ activities ( ! o!r 
ag5cies ( ! ,national ,in/itutes (      
,heal? & ) relat$ activities ( o!r      
,f$]al ag5cies2  7,h7 conduct+ or       
sponsor+ rese>* necess>y to obta9       
approval f ! ,food & ,drug              
,adm9i/ration1 includ+ cl9ical trials to
 g5]ate safety & effectiv5ess data &    
in=mation2  7,i7 conduct+ heal?         

te*nology assessm5ts 9 accordance )     
p>agraph 7#c7 = drug1 devices1 &        
biological products ! rese>* or         
developm5t ( :i* is conduct$ or fund$ "u
 ?is section2  7,j7 c>ry+ out any o!r   
activities necess>y = ! successful      
comm]cialization ( drugs1 devices1 &    
biological products ! rese>* or         
developm5t ( :i* is conduct$ or fund$ "u
 ?is section2 &  7,k7 implem5t+ goals1  
priorities1 objectives1 policies1 &     
proc$ures e/abli%$ by ! ,bo>d4  7#c7    
,requirem5ts = heal? te*nology          
assessm5ts  7,a7 ,9 g5]al ,9 conduct+   
heal? te*nology assessm5ts ( drugs1     
devices1 & biological products =        
purposes ( p>agraph 7#b77;,i71 !        
,director %all ensure t su* heal?       
te*nology assessm5ts-- 7i7 are conduct$ 
9 a =mal1 sy/ematic1 & transp>5t mann]2 
7ii7 use /ate-(-!-art me?ods to consid] 
! be/ available evid5ce2  7iii7 exam9e !
 direct1 int5d$ consequ5ces & indirect1 
un9t5d$ consequ5ces ( ! use ( !         
applicable drug1 device1 or biological  

product1 z comp>$ to exi/+ alt]natives2 
&  7iv7 consid] factors su* z cl9ical   
effectiv5ess1 safety1 co/s & economic   
implications1 e?ical1 social1 cultural &
 legal issues1 organizational &         
environm5tal aspects1 & implications =  
pati5ts1 relatives1 c>egiv]s1 & ! broad]
 public4  7,b7 ,def9ition ( heal?       
te*nology assessm5t ,9 ?is section1 !   
t]m heal? te*nology assessm5t means a   
multidiscipl9>y process t uses explicit 
me?ods to det]m9e ! value ( a drug1     
device1 or biological product4  7c7     
,rese>* monitor+2 acquisition  7#a7 ,9  
g5]al ,! ,director %all monitor !       
results ( rese>* conduct$ or support$ by
 ! ,national ,in/itutes ( ,heal? & by   
o!r appropriate public & private        
entities1 su* z ! ,biom$ical ,advanc$   
,rese>* & ,developm5t ,au?ority ( !     
,dep>tm5t ( ,heal? & ,human ,s]vices or 
! ,walt] ,re$ ,pilot ,bioproduction     
,facility ( ! ,dep>tm5t ( ,def5se1 to   
id5tify inv5tions t1 if subject$ to     
appropriate rese>* & developm5t         

activities1 may be suitable = approval1 
lic5sure1 cle>ance1 or au?orization "u  
section #eje1 #eaj7k71 #eac7;f77#b71 or 
#eae ( ! ,f$]al ,food1 ,drug1 &         
,cosmetic ,act or section #cea ( ?is    
,act z a drug1 biological product1 or   
device4  7#b7 ,acquisition ,not)/&+     
*apt] #ah ( title #ce1 ,unit$ ,/ates    
,code1 ! ,director may acquire1 & %all h
 ! "r ( fir/ refusal =1 ! rights to an  
inv5tion id5tifi$ "u p>agraph 7#a7 t is 
! result ( rese>* conduct$ or support$  
by ! ,national ,in/itutes ( ,heal?4  7d7
 ,prioritization ,9 allocat+ ! res\rces 
( ! ,in/itute1 ! ,bo>d %all e/abli%     
priorities = rese>* & developm5t t      
reflect ! magnitude ( ! pot5tial public 
heal? impact1 unmet ne$s 9 curr5t       
product developm5t1 & ! pot5tial =      
sci5tific break?r\gh4  7e7 ,transp>5cy  
7#a7 ,9 g5]al ,! ,director %all ensure t
 ! ,in/itute adh]es to ! highe/ /&>ds ( 
transp>5cy by--  7,a7 %>+ ) rese>*]s1   
manufactur]s1 & ! public precl9ical &   
cl9ical trial data & data on co/s 9 an  

op5 & timely mann]1 :i* data-- 7i7 %all 
include all safety & effectiv5ess data &
 in=mation t has be5 submitt$ 9 an      
application to ! ,food & ,drug          
,adm9i/ration1 includ+ an application   
submitt$ "u section #eje ( ! ,f$]al     
,food1 ,drug1 & ,cosmetic ,act or       
section #cea ( ?is ,act2 &  7ii7 %all be
 deid5tifi$ to protect pati5t privacy1 b
 may n o!rwise be )held f disclosure on 
any basis2  7,b7 mak+ in=mation reg>d+  
activities c>ri$ out by ! ,in/itute     
publicly available onl9e1 includ+--  7i7
 in=mation reg>d+ rese>* & developm5t t 
is receiv+ priority2  7ii7 all data     
develop$ 9 c>ry+ out rese>* & developm5t
 activities2  7iii7 summ>y f9d+s made 9 
c>ry+ out su* activities2 &  7iv7 copies
 ( all lic5s+ agreem5ts & contracts     
ent]$ into ) public & private entities2 
&  7,c7 requir+ any entity t conducts   
rese>* fund$ by ! ,in/itute-- 7i7 to %>e
 sci5tific data g5]at$ f su* rese>* n   
lat] ?an ! e>li] ( ! date ( ! fir/      
associat$ publication or ! end ( ! p]iod

 ( ! aw>d ( su* funds2  7ii7 :5 select+ 
a repository1 to give priority to-- 7,i7
 data repositories support$ by or       
affiliat$ ) ! ,national ,in/itutes (    
,heal?2 &  7,,ii7 data repositories t-- 
7aa7 assign datasets unique p]si/5t     
id5tifi]s2  7bb7 provide free & easy    
access to datasets & _! metadata2  7cc7 
make datasets & metadata available =    
broad reuse2  7dd7 h capabilities =     
ensur+ confid5tiality = s5sitive data2  
7ee7 h docum5t$ security & integrity    
measures2 &  7ff7 h docum5t$ proc$ures  
to re/rict dataset access & use t are   
consi/5t ) p>ticipant cons5t & *anges 9 
cons5t1 9 ! case ( human p>ticipant     
data2  7iii7 to take reasonable /eps to 
ensure data is made available = z long z
 su* data may be useful = ! l>g] rese>* 
community1 in/itutions1 or ! public2 &  
7iv7 on acceptance = publication &      
consi/5t ) applicable copyright law1 to 
submit1 or h submitt$ on _! behalf1 to !
 ,pub,med ,c5tral database ( ! ,national
 ,libr>y ( ,m$ic9e 7or any successor    

ar*ive or database71 an electronic      
v]sion ( ! f9al1 pe]-review$ manuscript 
describ+ su* rese>*1 :i* manuscript %all
 be made publicly available by !        
,national ,libr>y ( ,m$ic9e n lat] ?an  
#a ye> aft] ! date on :i* su* manuscript
 is (ficially publi%$4  7#b7 ,def9ition 
( sci5tific data ,9 ?is subsection1 !   
t]m sci5tific data means data commonly  
accept$ 9 ! sci5tific community z (     
suffici5t quality to validate &         
replicate rese>* f9d+s1 reg>dless ( :e!r
 ! data are us$ to support s*ol>ly      
publications4  7f7 ,pat5ts & trade      
secrets  7#a7 ,9 g5]al ,not)/&+ *apt]   
#ah ( title #ce1 ,unit$ ,/ates ,code1 ! 
,director %all ensure t ! ,f$]al        
,gov]nm5t owns ! rights to any pat5ts & 
trade secrets relat+ to drugs1 devices1 
& biological products ! rese>* or       
developm5t ( :i* is conduct$ or fund$ "u
 ?is section1 includ+ any rese>* or     
developm5t conduct$ ?r\gh contract+ ) a 
private entity or acquir$ f a private   
entity "u ?is section4  7#b7 ,managem5t 

,! ,director %all manage ! pat5ts &     
trade secrets relat+ to rese>* &        
developm5t conduct$ or fund$ "u ?is     
section 9 ! public int]e/4  7#c7 ,pat5ts
  7,a7 ,9 g5]al ,! ,director %all obta9 
pat5ts1 z appropriate1 = inv5tions      
result+ f rese>* & developm5t conduct$  
or fund$ "u ?is section4  7,b7 ,/&>d    
pat5t lic5s+ policy ,unless o!rwise     
det]m9$ by ! ,director1 pat5ts held by !
 ,in/itute %all be lic5s$ to ! ,m$ic9es 
,pat5t ,pool4  7,c7 ,access ,not)/&+    
*apt] #ah ( title #ce1 ,unit$ ,/ates    
,code1 ! ,director %all ensure public   
int]e/ access1 9 t]ms ( bo? price &     
supply1 consid]$ indep5d5tly1 includ+ 9 
l[- & middle-income c\ntry m>kets1 to   
pat5ts & trade secrets relat+ to drugs1 
devices1 & biological products ! rese>* 
or developm5t ( :i* is conduct$ or fund$
 "u ?is section1 includ+ ?r\gh-- 7i7    
/ipulat+1 z a condition ( receipt (     
,f$]al extramural biom$ical rese>* fund+
 aw>d$ ?r\gh ! ,dep>tm5t ( ,heal? &     
,human ,s]vices1 t ! ,in/itute %all be  

grant$ rights to all ! data & te*nical  
in=mation develop$ "u a contract1       
includ+ all necess>y intellectual       
prop]ty1 te*nology1 "k-h[1 & o!r        
in=mation 7includ+ ma/] bat* records1   
/&>d op]at+ proc$ures1 quality assurance
 & quality control in=mation1 detail$   
bill ( mat]ials = ! drug1 device1 or    
biological product & o!r manufactur+    
docum5tation7 relat+ to ! drug1 device1 
or biological product necess>y =        
op]ationaliz+ te*nology transf]2  7ii7  
at ! discretion ( ! ,director1 /ipulat+ 
9 any contract ! ,in/itute ent]s into ) 
an extramural p>ty t su* p>ty w provide 
comm]cially reasonable support =        
te*nology transf] activities2 &  7iii7  
non-exclusive lic5s+ to public1         
nonpr(it1 & =-pr(it entities "u         
subp>agraph 7,d74  7,d7 ,lic5s+ ,9 any  
lic5se ( ! rights to a pat5t held by !  
,in/itute1 ! ,director %all lic5se      
pat5ts-- 7i7 to public entities1 free ( 
co/2  7ii7 to nonpr(it organizations1   
free ( co/2 &  7iii7 to =-pr(it entities

 ) t]ms t protect ! public int]e/1      
includ+ non-exclusivity provisions1     
co/-plus pric+ t]ms1 & reciprocity      
rules4  7#d7 ,trade secrets &           
confid5tial comm]cial in=mation  7,a7 ,9
 g5]al ,! ,director may n claim trade   
secrets or confid5tial comm]cial        
in=mation ) respect to any drugs1       
devices1 or biological products ! rese>*
 or developm5t ( :i* is conduct$ or     
fund$ "u ?is section1 includ+ any rese>*
 or developm5t conduct$ ?r\gh contract+ 
) a private entity or acquir$ f a       
private entity "u ?is section4  7,b7    
,confid5tial comm]cial in=mation def9$  
,9 ?is p>agraph1 ! t]m confid5tial      
comm]cial in=mation means in=mation t   
conta9s mat]ial exempt f disclosure "u  
subsection 7b77#d7 ( section #eeb (     
title #e1 ,unit$ ,/ates ,code 7commonly 
kn[n z ! ,fre$om ( ,in=mation ,act74    
7g7 ,public & private manufactur+2      
lic5s+2 royalties  7#a7 ,9 g5]al ,)     
respect to a drug1 biological product1  
or device ! pat5t = :i* is held by !    

,f$]al ,gov]nm5t "u ?is section & t is  
approv$1 lic5s$1 cle>$1 or au?oriz$ "u  
section #eje1 #eaj7k71 #eac7;f77#b71 or 
#eae ( ! ,f$]al ,food1 ,drug1 &         
,cosmetic ,act or section #cea ( ?is    
,act1 ! ,director %all provide =-- 7,a7 
! public manufactur+ ( su* drug1        
biological product1 or device1 if       
practicable2 &  7,b7 su* drugs1         
biological products1 & devices s        
manufactur$ to be sold at co/4  7#b7    
,lic5s+2 royalties ,if ! ,director      
det]m9es t public manufactur+ = a drug1 
biological product1 or device describ$ 9
 p>agraph 7#a7 is n practicable1 !      
,director--  7,a7 may lic5se ! pat5t =  
su* drug1 biological product1 or device 
to a private entity1 bas$ on ! value    
e/abli%$ by a heal? te*nology assessm5t 
conduct$ "u subsection 7b77#b77;,i72    
7,b7 %all give pref]5ce to ! manufactur+
 ( su* drug1 biological product1 or     
device1 by a nonpr(it organization be=e 
seek+ any manufactur+ by =-pr(it        
companies2  7,c7 %all1 consi/5t )       

section #ad ( ! ,/ev5son-,wydl]         
,te*nology ,innovation ,act ( #aihj1    
re9ve/ ! royalties receiv$ f su* lic5s+ 
into rese>* & developm5t "u ?is section2
 &  7,d7 may consid] ! ne$ = div]sifi$1 
regional production ( m$ic9es to ensure 
access1 or = o!r purposes1 :5 grant+    
lic5ses4  7h7 ,sup]vision ,! "w ( !     
,director %all be direct$ & sup]vis$ by 
! ,secret>y1 :o %all h ! au?ority1 aft] 
consult+ ) ! vot+ memb]s ( ! ,bo>d1 to  
remove ! ,director4  7i7 ,use ( exi/+   
res\rces ,9 provid+ = ! e/abli%m5t &    
op]ations ( ! ,in/itute1 ! ,director (  
,,nih may1 on reque/ ( ! ,director ( !  
,in/itute--  7#a7 transf] to ! ,in/itute
 su* p]sonnel ( ! ,national ,in/itutes (
 ,heal? z ! ,director ( ,,nih det]m9es  
to be appropriate2  7#b7 all[ !         
,in/itute to use su* facilities ( !     
,national ,in/itutes ( ,heal? z !       
,director ( ,,nih det]m9es to be        
appropriate2 &  7#c7 obta9 adm9i/rative 
support = ! ,in/itute f ! o!r ag5cies ( 
! ,national ,in/itutes ( ,heal?1 includ+

 ! o!r national rese>* in/itutes4       
#dfdz-#ab4 ,gov]n+ bo>d  7a7 ,9 g5]al ,n
 lat] ?an #ahj days aft] ! date (       
enactm5t ( ! ,m$ic9es = ! ,p ,act1 !    
,secret>y %all e/abli% a gov]n+ bo>d    
7ref]r$ to 9 ?is subp>t z ! ,bo>d7 to   
assi/ ! ,secret>y 9 e/abli%+ high-level 
policy1 conduct+ long-t]m plann+1 &     
provid+ ov]all direction = ! ,in/itute4 
7b7 ,memb]%ip  7#a7 ,9 g5]al ,! ,bo>d   
%all consi/ ( #ae vot+ memb]s1 to be    
appo9t$ by ! ,secret>y1 includ+-- 7,a7 n
 few] ?an #b civil society              
repres5tatives ) a backgr\nd 9 id5tify+ 
& address+ b>ri]s to ! ability (        
individuals & populations to acquire    
m$ic9es ne$$ to a*ieve heal?2  7,b7 n   
few] ?an #b pati5t advocates f indep5d5t
 pati5t organizations t take no fund+ f 
=-pr(it companies 7or f\ndations or     
nonpr(it organizations affiliat$ )      
=-pr(it companies7 involv$ 9 !          
production or sale ( any drug1          
biological product1 or device & d n h   
executives f su* companies 7or affiliat$

 f\ndations or nonpr(it organizations7  
on _! gov]n+ bo>ds2  7,c7 n few] ?an #b 
curr5t or =m] public heal? (ficials2    
7,d7 n few] ?an #b curr5t or =m] memb]s 
( ! ,in/itute1 except 9 ! case ( !      
initial memb]%ip ( ! ,bo>d2 &  7,e7 su* 
o!r memb]s z ! ,secret>y det]m9es       
appropriate4  7#b7 ,*air ,! memb]s ( !  
,bo>d %all elect f among su* memb]s a   
,*air ( ! ,bo>d4  7#c7 ,nonvot+ memb]s  
,! ,secret>y may1 aft] consult+ ) ! vot+
 memb]s ( ! ,bo>d1 appo9t n m ?an #d    
nonvot+ memb]s ( ! ,bo>d4 ,su* nonvot+  
memb]s %all h relevant exp]i5ce or      
exp]tise n already repres5t$ on ! ,bo>d4
  7#d7 ,t]ms  7,a7 ,memb]s ,! t]m ( ea* 
memb] ( ! ,bo>d %all be n m ?an #f ye>s1
 & ! ,secret>y %all designate /agg]$    
t]ms = ! memb]s fir/ appo9t$4 ,memb]s   
may s]ve #a additional t]m at !         
discretion ( ! ,secret>y4  7,b7 ,*air ,!
 t]m ( ! position ( ,*air ( ! ,bo>d %all
 n exce$ #f ye>s4  7#e7 ,limitations ,9 
appo9t+ memb]s "u p>agraph 7#a71 !      
,secret>y %all ensure t-- 7,a7 n m ?an  

#e memb]s are f ! =-pr(it sector2  7,b7 
no memb] is1 or has be5 dur+ ! #f-ye>   
p]iod prec$+ ! date ( appo9tm5t1 a      
lobbyi/1 z def9$ 9 section #c ( !       
,lobby+ ,disclosure ,act ( #aiie1       
regi/]$ "u section #d ( t ,act = a      
=-pr(it ph>maceutical manufactur]2  7,c7
 no memb] is a curr5t or =m] s5ior      
executive (fic] ( a cov]$ entity2  7,d7 
no memb] is a curr5t or =m] s5ior       
executive (fic] ( a cov]$ entity dur+ ! 
#f-ye> p]iod beg9n+ on ! lat] (-- 7i7 ! 
date ( a ,f$]al settlem5t relat+ to a   
violation ( sections #cgbi ?r\gh #cgcc (
 title #ca1 ,unit$ ,/ates ,code         
7commonly kn[n z ! ,false ,claims ,act71
 ! ,f$]al ,food1 ,drug1 & ,cosmetic     
,act1 includ+ a ,f$]al cons5t decree1 ! 
,%]man ,act1 ! ,clayton ,act1 or !      
,f$]al ,trade ,commission ,act t 0 ent]$
 into by ! relevant cov]$ entity2 &     
7ii7 ! date on :i* an en=cem5t action   
relat+ to a violation by ! cov]$ entity 
( sections #cgbi ?r\gh #cgcc ( title    
#ca1 ,unit$ ,/ates ,code 7commonly kn[n 

z ! ,false ,claims ,act71 ! ,f$]al      
,food1 ,drug1 & ,cosmetic ,act1 ! ,%]man
 ,act1 ! ,clayton ,act1 or ! ,f$]al     
,trade ,commission ,act 9 a c\rt ( !    
,unit$ ,/ates or by an ,executive ag5cy 
has conclud$2 &  7,e7 no memb] dur+ ! "t
 p]iod describ$ 9 p>agraph 7#f71 ) !    
int5t to influ5ce or ) ! int5t to ga9   
in=mation = use 9 analyz+ securities or 
commodities m>kets or 9 in=m+ inve/m5t  
decisions 9 any securities or           
commodities m>ket ( ! ,unit$ ,/ates1    
makes any communication to or appe>ance 
be=e ! =m] public (fice or ,executive   
ag5cy ( ! memb] = comp5sation1 provid$ t
 any su* violation %all be subject to ! 
p5alties set =? 9 section #baf ( title  
#ah1 ,unit$ ,/ates ,code4  7#f7 ,"t     
p]iod ,! "t p]iod describ$ 9 ?is        
p>agraph is z foll[s3 7,a7 ,) respect to
 an (fic] or employee ( an ,executive   
ag5cy1 ! lat] (--  7i7 ! date on :i* a  
,presid5t o!r ?an ! ,presid5t s]v+ at ! 
"t ( ! t]m9ation ( s]vice or employm5t (
 ! (fic] or employee takes (fice2 &     

7ii7 ! date on :i* ! #b-ye> p]iod beg9n+
 on ! date ( ! t]m9ation ( s]vice or    
employm5t z an (fic] or employee        
expires4  7,b7 ,) respect to an (fic] or
 employee ( an ,executive ag5cy :o      
becomes a corporate lobbyi/1 ! lat] (-- 
7i7 ! date on :i* a ,presid5t o!r ?an ! 
,presid5t s]v+ at ! "t ( ! t]m9ation (  
s]vice or employm5t ( ! (fic] or        
employee takes (fice2 &  7ii7 ! date on 
:i* ! #f-ye> p]iod beg9n+ on ! date ( ! 
t]m9ation ( s]vice or employm5t z an    
(fic] or employee expires4  7c7 ,duties 
,! ,bo>d1 subject to ! sup]vision ( !   
,secret>y "u subsection 7e71 %all--     
7#a7 e/abli% goals1 priorities1         
objectives1 policies1 & proc$ures relat+
 to ! op]ation & developm5t ( !         
,in/itute1 includ+ id5tify+ promis+     
inv5tions "u subsection 7c77#a7 (       
section #dfdz-#aa2  7#b7 ensure t !     
,in/itute effectively c>ries out !      
purposes specifi$ 9 section             
#dfdz-#aa7;a71 includ+ t drugs1 devices1
 or biological products ! rese>* or     

developm5t ( :i* is conduct$ or fund$ "u
 section #dfdz-#aa are successfully     
comm]cializ$ & available to ! public2   
7#c7 e/abli% su* committees or bodies z 
may be necess>y to facilitate or c>ry   
out ! duties ( ! ,bo>d2 &  7#d7 p]=m su*
 o!r duties & responsibilities z may be 
necess>y to c>ry out ?is section4  7d7  
,def9itions ,9 ?is section3 7#a7        
,corporate lobbyi/ ,! t]m corporate     
lobbyi/ means a lobbyi/1 z def9$ 9      
section #c ( ! ,lobby+ ,disclosure ,act 
( #aiie1 :o is regi/]$ "u section #d ( t
 ,act & :o is employ$ by a corporation1 
z def9$ 9 section #aja7i7 ( title #aa1  
,unit$ ,/ates ,code4  7#b7 ,cov]$ entity
 ,! t]m cov]$ entity means any entity t 
is-- 7,a7 7i7 a =-pr(it company2 or     
7ii7 a bank hold+ company1 a sav+s &    
loan hold+ company1 or any o!r f9ancial 
in/itution2 &  7,b7 7i7 op]at+ "u a     
,f$]al settlem5t relat+ to a violation (
 sections #cgbi ?r\gh #cgcc ( title #ca1
 ,unit$ ,/ates ,code 7commonly kn[n z ! 
,false ,claims ,act71 ! ,f$]al ,food1   

,drug1 & ,cosmetic ,act1 includ+ a      
,f$]al cons5t decree1 ! ,%]man ,act1 !  
,clayton ,act1 or ! ,f$]al ,trade       
,commission ,act2 or  7ii7 ! subject (  
an en=cem5t action relat+ to a violation
 ( sections #cgbi ?r\gh #cgcc ( title   
#ca1 ,unit$ ,/ates ,code 7commonly kn[n 
z ! ,false ,claims ,act71 ! ,f$]al      
,food1 ,drug1 & ,cosmetic ,act1 ! ,%]man
 ,act1 ! ,clayton ,act1 or ! ,f$]al     
,trade ,commission ,act 9 a c\rt ( !    
,unit$ ,/ates or by an ,executive ag5cy4
  7#c7 ,executive ag5cy ,! t]m          
,executive ag5cy--  7,a7 has ! mean+    
giv5 ! t]m 9 section #aje ( title #e1   
,unit$ ,/ates ,code2 &  7,b7 includes-- 
7i7 ! ,executive ,(fice ( ! ,presid5t & 
all compon5ts !re(1 includ+ ! ,:ite     
,h\se ,(fice2 &  7ii7 ! ,(fice ( ! ,vice
 ,presid5t4  7#d7 ,rights to an inv5tion
 ,! t]m rights to an inv5tion includes  
all rights1 title1 & int]e/s 9 an       
inv5tion1 includ+-- 7,a7 any sale1      
assignm5t1 or o!r transf] ( a pat5t on !
 inv5tion1 ,unit$ ,/ates or =eign2 &    

7,b7 any exclusive lic5se to a pat5t on 
an inv5tion1 ,unit$ ,/ates or =eign4    
7e7 ,sup]vision ,! "w ( ! ,bo>d %all be 
direct$ & sup]vis$ by ! ,secret>y :o    
%all--  7#a7 consult ) ! ,bo>d2  7#b7 h 
! au?ority to review1 approve1 modify1  
or reject any decision ! ,bo>d makes    
pursuant to ! duties ( ! ,bo>d "u       
subsection 7c72 &  7#c7 make public any 
reasons :y ! ,secret>y reject$ or       
mat]ially modifi$ ! decisions ( ! ,bo>d 
p]ta9+ to su* duties4  7f7 ,p[]s  7#a7  
,he>+s & sessions ,! ,bo>d may1 = !     
purpose ( c>ry+ out ?is section1 hold   
he>+s1 sit & act at times & places1 take
 te/imony1 adm9i/] oa?s or affirmations 
to witnesses appe>+ be=e ! ,bo>d1 &     
receive evid5ce z ! ,bo>d consid]s      
appropriate4  7#b7 ,obta9+ (ficial data 
,! ,bo>d may secure directly f any      
dep>tm5t or ag5cy ( ! ,unit$ ,/ates     
in=mation necess>y to enable ! ,bo>d to 
c>ry out ! duties ( ! ,bo>d "u ?is      
section4  7#c7 ,adm9i/rative support    
s]vices ,on reque/ ( ! ,bo>d1 !         

,adm9i/rator ( ! ,g5]al ,s]vices        
,adm9i/ration %all provide to ! ,bo>d1  
on a reimbursable basis1 ! adm9i/rative 
support s]vices necess>y = ! ,bo>d to   
c>ry out ! duties ( ! ,bo>d "u ?is      
section4  7#d7 ,/aff ,on reque/ ( !     
,bo>d & on a reimbursable basis1 = !    
purpose ( assi/+ ! ,bo>d 9 c>ry+ out !  
duties ( ! ,bo>d1 ! ,secret>y may detail
 to ! ,bo>d any p]sonnel ( _! dep>tm5t4 
7g7 ,t]ms ( (fice  7#a7 ,vacancies ,a   
memb] appo9t$ by ! ,secret>y to fill a  
vacancy on ! ,bo>d occurr+ be=e !       
expiration ( ! t]m = :i* ! pr$ecessor ( 
! memb] 0 appo9t$ %all be appo9t$ = !   
rema9d] ( su* t]m4  7#b7 ,removal ,a    
memb] may be remov$ f ! ,bo>d by !      
,secret>y only = ineffici5cy1 neglect ( 
duty1 or malfeasance 9 (fice4  7h7 ,pay 
7#a7 ,rates ( pay ,memb]s ( ! ,bo>d %all
 ea* be entitl$ to receive ! daily      
equival5t ( ! annual rate ( basic pay = 
level ,,iv ( ! ,executive ,s*$ule "u    
section #ecae ( title #e1 ,unit$ ,/ates 
,code1 = ea* day 7includ+ travel "t7    

dur+ :i* su* memb]s are engag$ 9 !      
p]=mance ( duties ( ! ,bo>d4  7#b7      
,prohibition ( comp5sation ( ,f$]al     
employees ,not)/&+ p>agraph 7#a71 !     
memb]s ( ! ,bo>d :o are full-"t (fic]s  
or employees ( ! ,unit$ ,/ates =        
purposes ( title #e1 ,unit$ ,/ates      
,code1 may n receive additional pay1    
all[ances1 or b5efits by reason ( _!    
s]vice on ! ,bo>d4  7#c7 ,travel exp5ses
 ,ea* memb] %all receive travel exp5ses1
 includ+ p] diem 9 lieu ( subsi/5ce1 9  
accordance ) applicable provisions (    
sub*apt] ,i ( *apt] #eg ( title #e1     
,unit$ ,/ates ,code4  7i7 ,application (
 ,f$]al ,advisory ,committee ,act ,!    
,bo>d %all be subject to *apt] #aj (    
title #e1 ,unit$ ,/ates ,code 7commonly 
ref]r$ to z ! ,f$]al ,advisory          
,committee ,act71 except t section      
#ajac7;a77#b7 ( su* title %all n apply4 
#dfdz-#ac4 ,evaluation2 reports  7a7 ,9 
g5]al ,n lat] ?an #e ye>s aft] ! date ( 
enactm5t ( ! ,m$ic9es = ! ,p ,act1 &    
annually !reaft]1 ! ,director %all      

evaluate ! activities ( ! ,in/itute4    
,su* evaluation %all include ! foll[+   
metrics3  7#a7 ,numb] ( applications or 
submissions "u section #eje1 #eaj7k71   
#eac7;f77#b71 or #eae ( ! ,f$]al ,food1 
,drug1 & ,cosmetic ,act or section #cea 
( ?is ,act4  7#b7 ,numb] ( cl9ical trial
 data sets publi%$ 9 ! public doma94    
7#c7 ,numb] ( new drugs1 biological     
products1 & devices develop$ or br\ght  
to m>ket1 directly or indirectly4  7#d7 
,numb] ( lic5ses acquir$ f public1      
nonpr(it1 & =-pr(it entities4  7#e7     
,numb] ( pat5ts lic5s$1 disaggregat$ by 
public1 nonpr(it1 or private entity4    
7#f7 ,numb] ( pat5ts fil$4  7#g7 ,numb] 
( pat5ts pur*as$ or acquir$4  7#h7      
,e/imat$ sav+s to public heal? c>e      
programs due to ! activities ( !        
,in/itute4  7b7 ,annual reports ,n lat] 
?an #e ye>s aft] ! date ( enactm5t ( !  
,m$ic9es = ! ,p ,act1 & annually        
!reaft]1 ! ,director %all submit to     
,congress1 & make publicly available1 a 
report describ+ ! results ( ! applicable

 annual evaluation c>ri$ out "u         
subsection 7a71 includ+1 = pat5ts       
lic5s$1 fil$1 pur*as$1 or acquir$1 !    
pat5t application numb]s1 fil+ dates1   
names ( lic5sees1 dates ( lic5ses1 & :]e
 lic5se agreem5ts may be f\nd4          
#dfdz-#ad4 ,au?orization (              
appropriations ,!re is au?oriz$ to be   
appropriat$ to c>ry out ?is subp>t      
#ij1jjj1jjj1jjj = fiscal ye> #bjbg1 to  
rema9 available until exp5d$4  4  7b7   
,con=m+ am5dm5ts  7#a7 ,section #dja ( !
 ,public ,heal? ,s]vice ,act 7#db       
,u4,s4,c4 #bha7 is am5d$-- 7,a7 9       
subsection 7b7--  7ii7 by r$esignat+    
p>agraph 7#be7 z p>agraph 7#bf72 &      
7iii7 by ins]t+ aft] p>agraph 7#bd7 !   
foll[+3  7#be7 ,! ,national ,in/itute = 
,biom$ical ,rese>* & ,developm5t4  2 &  
7,b7 9 subsection 7d77#a71 by /rik+ #bg 
& ins]t+ #bh4  7#b7 ,section #dje ( !   
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bhd7 is am5d$-- 7,a7 9       
subsection 7b77#b77;,b77ii71 by ins]t+  
or gov]n+ bo>d aft] advisory c\ncil2 &  

7,b7 9 subsection 7c77#c71 by ins]t+ or 
gov]n+ bo>d aft] advisory c\ncil4  7c7  
,p5alties & injunctions ,section #baf ( 
title #ah1 ,unit$ ,/ates ,code1 is      
am5d$--  7#a7 9 subsection 7a71 9 !     
matt] prec$+ p>agraph 7#a71 by ins]t+ or
 section #dfdz-#ab ( ! ,public ,heal?   
,s]vice ,act aft] ( ?is title2  7#b7 9  
subsection 7b71 by ins]t+ or section    
#dfdz-#ab ( ! ,public ,heal? ,s]vice    
,act aft] ( ?is title2 &  7#c7 9        
subsection 7c71 by ins]t+ or section    
#dfdz-#ab ( ! ,public ,heal? ,s]vice    
,act aft] ( ?is title4