#aaf? ,,congress  #b;d ,session  ,9 !   
,h\se ( ,repres5tatives1 ,u4 ,s41  ,july
 #bb1 #bjbj  ,,h\se ,,am5dm5ts ,,to     
,,s5ate ,,am5dm5t3  ,t ! ,h\se agree to 
! am5dm5t ( ! ,s5ate to ! bill 7,h4,r4  
#bdhf7 entitl$ ,an ,act to reau?orize   
m&atory fund+ programs = hi/orically    
,black colleges & univ]sities & o!r     
m9ority-s]v+ in/itutions41 ) ! foll[+   
7#a7 ,9 ! matt] propos$ to be ins]t$ by 
! am5dm5t ( ! ,s5ate1 /rike sections #a1
 #b1 & #c & ins]t ! foll[+3  ,i ,,no    
,,ban ,act  #aja4 ,%ort titles ,?is     
title may be cit$ z ! ,national         
,orig9-,bas$ ,antidiscrim9ation =       
,nonimmigrants ,act or ! ,,no ,,ban     
,act4  #ajb4 ,expansion (               
nondiscrim9ation provision ,section     
#bjb7;a77#a77;,a7 ( ! ,immigration &    
,nationality ,act 7#h ,u4,s4,c4         
#aaeb7;a77#a77;,a77 is am5d$--  7#a7 by 
ins]t+ or a nonimmigrant visa1 admission
 or o!r entry into ! ,unit$ ,/ates1 or !
 approval or revocation ( any           
immigration b5efit aft] immigrant visa2 

7#b7 by ins]t+ religion1 aft] sex12 &   
7#c7 by ins]t+ 1 except if expressly    
requir$ by /atute1 or if a /atutorily   
au?oriz$ b5efit takes into consid]ation 
su* factors be=e ! p]iod at ! end4      
#ajc4 ,transf] & limitations on au?ority
 to susp5d or re/rict ! entry ( a class 
( ali5s ,section #bab7;f7 ( !           
,immigration & ,nationality ,act 7#h    
,u4,s4,c4 #aahb7;f77 is am5d$ to read z 
foll[s3  7f7 ,au?ority to susp5d or     
re/rict ! entry ( a class ( ali5s  7#a7 
,9 g5]al ,subject to p>agraph 7#b71 if !
 ,secret>y ( ,/ate1 9 consultation ) !  
,secret>y ( ,homel& ,security1 det]m9es1
 bas$ on specific & cr$ible facts1 t !  
entry ( any ali5s or any class ( ali5s  
into ! ,unit$ ,/ates w\ld und]m9e !     
security or public safety ( ! ,unit$    
,/ates or ! pres]vation ( human rights1 
democratic processes or in/itutions1 or 
int]national /ability1 ! ,presid5t may  
tempor>ily-- 7,a7 susp5d ! entry ( su*  
ali5s or class ( ali5s z immigrants or  
nonimmigrants2 or  7,b7 impose any      

re/rictions on ! entry ( su* ali5s t !  
,presid5t deems appropriate4  7#b7      
,limitations ,9 c>ry+ out p>agraph 7#a71
 ! ,presid5t1 ! ,secret>y ( ,/ate1 & !  
,secret>y ( ,homel& ,security %all--    
7,a7 only issue a susp5sion or          
re/riction :5 requir$ to address        
specific acts implicat+ a compell+      
gov]nm5t int]e/ 9 a factor id5tifi$ 9   
p>agraph 7#a72  7,b7 n>r[ly tailor !    
susp5sion or re/riction1 us+ ! lea/     
re/rictive means1 to a*ieve su* compell+
 gov]nm5t int]e/2  7,c7 specify !       
duration ( ! susp5sion or re/riction2 & 
7,d7 consid] waiv]s to any class-bas$   
re/riction or susp5sion & apply a       
rebuttable presumption 9 favor ( grant+ 
family-bas$ & humanit>ian waiv]s4  7#c7 
,congressional notification  7,a7 ,9    
g5]al ,prior to ! ,presid5t ex]cis+ !   
au?ority "u p>agraph 7#a71 ! ,secret>y (
 ,/ate & ! ,secret>y ( ,homel& ,security
 %all consult ,congress & provide       
,congress ) specific evid5ce support+ ! 
ne$ = ! susp5sion or re/riction & its   

propos$ duration4  7,b7 ,brief+ & report
 ,n lat] ?an #dh h\rs aft] ! ,presid5t  
ex]cises ! au?ority "u p>agraph 7#a71 ! 
,secret>y ( ,/ate & ! ,secret>y (       
,homel& ,security %all provide a brief+ 
& submit a writt5 report to ,congress t 
describes--  7i7 ! action tak5 pursuant 
to p>agraph 7#a7 & ! specifi$ objective 
( su* action2  7ii7 ! e/imat$ numb] (   
individuals :o w be impact$ by su*      
action2  7iii7 ! con/itutional &        
legislative au?ority "u :i* su* action  
took place2 &  7iv7 ! circum/ances      
necessitat+ su* action1 includ+ h[ su*  
action complies ) p>agraph 7#b71 z well 
z any intellig5ce in=m+ su* actions4    
7,c7 ,t]m9ation ,if ! brief+ & report   
describ$ 9 subp>agraph 7,b7 are n       
provid$ to ,congress dur+ ! #dh h\rs t  
beg9 :5 ! ,presid5t ex]cises ! au?ority 
"u p>agraph 7#a71 ! susp5sion or        
re/riction %all imm$iately t]m9ate abs5t
 int]v5+ congressional action4  7,d7    
,congressional committees ,! t]m        
,congress1 z us$ 9 ?is p>agraph1 ref]s  

to ! ,select ,committee on ,intellig5ce 
( ! ,s5ate1 ! ,committee on ,=eign      
,relations ( ! ,s5ate1 ! ,committee on !
 ,judici>y ( ! ,s5ate1 ! ,committee on  
,homel& ,security & ,gov]nm5tal ,affairs
 ( ! ,s5ate1 ! ,p]man5t ,select         
,committee on ,intellig5ce ( ! ,h\se (  
,repres5tatives1 ! ,committee on ,=eign 
,affairs ( ! ,h\se ( ,repres5tatives1 ! 
,committee on ! ,judici>y ( ! ,h\se (   
,repres5tatives1 & ! ,committee on      
,homel& ,security ( ! ,h\se (           
,repres5tatives4  7#d7 ,publication ,!  
,secret>y ( ,/ate & ! ,secret>y (       
,homel& ,security %all publicly ann\nce 
& publi% an unclassifi$ v]sion ( !      
report describ$ 9 p>agraph 7#c77;,b7 9 !
 ,f$]al ,regi/]4  7#e7 ,judicial review 
7,a7 ,9 g5]al ,not)/&+ any o!r provision
 ( law1 an individual or entity :o is   
pres5t 9 ! ,unit$ ,/ates & has be5 h>m$ 
by a violation ( ?is subsection may file
 an action 9 an appropriate di/rict c\rt
 ( ! ,unit$ ,/ates to seek decl>atory or
 injunctive relief4  7,b7 ,class action 

,no?+ 9 ?is ,act may be con/ru$ to      
preclude an action fil$ pursuant to     
subp>agraph 7,a7 f proce$+ z a class    
action4  7#f7 ,treatm5t ( comm]cial     
airl9es ,:5ev] ! ,secret>y ( ,homel&    
,security f9ds t a comm]cial airl9e has 
fail$ to comply ) regulations ( !       
,secret>y ( ,homel& ,security relat+ to 
requirem5ts ( airl9es = ! detection (   
fraudul5t docum5ts us$ by pass5g]s      
travel+ to ! ,unit$ ,/ates 7includ+ !   
tra9+ ( p]sonnel 9 su* detection71 !    
,secret>y ( ,homel& ,security may susp5d
 ! entry ( "s or all ali5s transport$ to
 ! ,unit$ ,/ates by su* airl9e4  7#g7   
,rule ( con/ruction ,no?+ 9 ?is section 
may be con/ru$ z au?oriz+ ! ,presid5t1 !
 ,secret>y ( ,/ate1 or ! ,secret>y (    
,homel& ,security to act 9 a mann]      
inconsi/5t ) ! policy decisions express$
 9 ! immigration laws4  7#h7            
,cl>ification ,= purposes ( p>agraph    
7#a71 ! t]m public safety ( ! ,unit$    
,/ates includes ef=ts necess>y to conta9
 a communicable disease ( public heal?  

significance 7z def9$ 9 section         
#cd4b7;b7 ( title #db1 ,code ( ,f$]al   
,regulations 7or any successor          
regulation774  4  #ajd4 ,t]m9ation (    
c]ta9 executive actions  7a7 ,t]m9ation 
,presid5tial ,proclamations #ifde1      
#ihbb1 & #iihc & ,executive ,ord]s      
#acgfi1 #acghj1 & #achae %all be void   
beg9n+ on ! date ( ! enactm5t ( ?is     
,act4  7b7 ,effect ,all actions tak5    
pursuant to any proclamation or         
executive ord] t]m9at$ "u subsection 7a7
 %all cease on ! date ( ! enactm5t ( ?is
 ,act4  #aje4 ,visa applicants report   
7a7 ,initial reports  7#a7 ,9 g5]al ,n  
lat] ?an #ij days aft] ! date ( !       
enactm5t ( ?is ,act1 ! ,secret>y (      
,/ate1 9 coord9ation ) ! ,secret>y (    
,homel& ,security & ! heads ( o!r       
relevant ,f$]al ag5cies1 %all submit a  
report to ! congressional committees    
ref]r$ to 9 section #bab7;f77#c77;,d7 ( 
! ,immigration & ,nationality ,act1 z   
am5d$ by section #ajc ( ?is title1 t    
describes ! implem5tation ( ea* ( !     

presid5tial proclamations & executive   
ord]s ref]r$ to 9 section #ajd4  7#b7   
,presid5tial proclamation #ifde & #iihc 
,9 addition to ! cont5t describ$ 9      
p>agraph 7#a71 ! report submitt$ )      
respect to ,presid5tial ,proclamation   
#ifde1 issu$ on ,septemb] #bd1 #bjag1 & 
,presid5tial ,proclamation #iihc1 issu$ 
on ,janu>y #ca1 #bjbj1 %all include1 =  
ea* c\ntry li/$ 9 su* proclamation--    
7,a7 ! total numb] ( individuals :o     
appli$ = a visa dur+ ! "t p]iod !       
proclamation 0 9 effect1 disaggregat$ by
 c\ntry & visa category2  7,b7 ! total  
numb] ( visa applicants describ$ 9      
subp>agraph 7,a7 :o 7 approv$1          
disaggregat$ by c\ntry & visa category2 
7,c7 ! total numb] ( visa applicants    
describ$ 9 subp>agraph 7,a7 :o 7 refus$1
 disaggregat$ by c\ntry & visa category1
 & ! reasons !y 7 refus$2  7,d7 ! total 
numb] ( visa applicants describ$ 9      
subp>agraph 7,a7 ^: applications rema9  
p5d+1 disaggregat$ by c\ntry & visa     
category2  7,e7 ! total numb] ( visa    

applicants describ$ 9 subp>agraph 7,a7  
:o 7 grant$ a waiv]1 disaggregat$ by    
c\ntry & visa category2  7,f7 ! total   
numb] ( visa applicants describ$ 9      
subp>agraph 7,a7 :o 7 d5i$ a waiv]1     
disaggregat$ by c\ntry & visa category1 
& ! reasons su* waiv] reque/s 7 d5i$2   
7,g7 ! total numb] ( refugees admitt$1  
disaggregat$ by c\ntry2 &  7,h7 !       
complete reports t h be5 submitt$ to !  
,presid5t e #ahj days 9 accordance )    
section #d ( ,presid5tial ,proclamation 
#ifde 9 its orig9al =m1 & z am5d$ by    
,presid5tial ,proclamation #iihc4  7b7  
,additional reports ,n lat] ?an #cj days
 aft] ! date on :i* ! ,presid5t ex]cises
 ! au?ority "u section #bab7;f7 ( !     
,immigration & ,nationality ,act 7#h    
,u4,s4,c4 #aahb7;f771 z am5d$ by section
 #ajc ( ?is title1 & e #cj days !reaft]1
 ! ,secret>y ( ,/ate1 9 coord9ation ) ! 
,secret>y ( ,homel& ,security & heads ( 
o!r relevant ,f$]al ag5cies1 %all submit
 a report to ! congressional committees 
ref]r$ to 9 p>agraph 7#c77;,d7 ( su*    

section #bab7;f7 t id5tifies1 ) respect 
to c\ntries affect$ by a susp5sion or   
re/riction1 ! in=mation describ$ 9      
subp>agraphs 7,a7 ?r\gh 7,h7 (          
subsection 7a77#b7 ( ?is section &      
specific evid5ce support+ ! ne$ = !     
cont9u$ ex]cise ( presid5tial au?ority  
"u su* section #bab7;f71 includ+ !      
in=mation describ$ 9 p>agraph 7#c77;,b7 
( su* section #bab7;f74 ,if ! report    
describ$ 9 ?is subsection is n provid$  
to ,congress 9 ! "t specifi$1 !         
susp5sion or re/riction %all imm$iately 
t]m9ate abs5t int]v5+ congressional     
action4 ,a f9al report ) su* in=mation  
%all be prep>$ & submitt$ to su*        
congressional committees n lat] ?an #cj 
days aft] ! susp5sion or re/riction is  
lift$4  7c7 ,=m2 availability ,! reports
 requir$ "u subsections 7a7 & 7b7 %all  
be made publicly available onl9e 9      
unclassifi$ =m4  ,,ii ,af=dable         
,prescriptions = ,pati5ts ,act ( #bjbj  
#bja4 ,%ort title ,?is title may be cit$
 z ! ,af=dable ,prescriptions = ,pati5ts

 ,act ( #bjbj4  #bjb4 ,product hopp+    
7a7 ,9 g5]al ,! ,f$]al ,trade           
,commission ,act 7#ae ,u4,s4,c4 #da et  
seq47 is am5d$ by ins]t+ aft] section   
#bf 7#ae ,u4,s4,c4 #eg;c-#b7 ! foll[+3  
#bg4 ,product hopp+  7a7 ,def9itions ,9 
?is section3 7#a7 ,abbreviat$ new drug  
application ,! t]m abbreviat$ new drug  
application means an application "u     
subsection 7b77#b7 or 7j7 ( section #eje
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   
,act 7#ba ,u4,s4,c4 #cee74  7#b7        
,biosimil> biological product ,! t]m    
biosimil> biological product means a    
biological product lic5s$ "u section    
#cea7k7 ( ! ,public ,heal? ,s]vice ,act 
7#db ,u4,s4,c4 #bfb7k774  7#c7          
,biosimil> biological product lic5se    
application ,! t]m biosimil> biological 
product lic5se application means an     
application submitt$ "u section #cea7k7 
( ! ,public ,heal? ,s]vice ,act 7#db    
,u4,s4,c4 #bfb7k774  7#d7 ,foll[-on     
product ,! t]m foll[-on product-- 7,a7  
means a drug approv$ ?r\gh an           

application or supplem5t to an          
application submitt$ "u section #eje7;b7
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   
,act 7#ba ,u4,s4,c4 #cee7;b77 or a      
biological product lic5s$ ?r\gh an      
application or supplem5t to an          
application submitt$ "u section #cea7;a7
 ( ! ,public ,heal? ,s]vice ,act 7#db   
,u4,s4,c4 #bfb7;a77 = a *ange1          
modification1 or re=mulation to ! same  
manufactur]'s previ\sly approv$ drug or 
biological product t treats ! same      
m$ical condition2 &  7,b7 excludes su*  
an application or supplem5t to an       
application = a *ange1 modification1 or 
re=mulation ( a drug or biological      
product t is reque/$ by ! ,secret>y or  
necess>y to comply ) law1 includ+       
sections #eje;,a & #eje;,b ( ! ,f$]al   
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee;a1 #cee;c74  7#e7 ,g5]ic 
drug ,! t]m g5]ic drug means a drug     
approv$ "u an application submitt$ "u   
subsection 7b77#b7 or 7j7 ( section #eje
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   

,act 7#ba ,u4,s4,c4 #cee74  7#f7 ,li/$  
drug ,! t]m li/$ drug means a drug li/$ 
"u section #eje7;j77#g7 ( ! ,f$]al      
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cee7;j77#g774  7#g7          
,manufactur] ,! t]m manufactur] means ! 
hold]1 lic5see1 or assignee (--  7,a7 an
 approv$ application = a drug "u section
 #eje7;c7 ( ! ,f$]al ,food1 ,drug1 &    
,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;c772
 or  7,b7 a biological product lic5se "u
 section #cea7;a7 ( ! ,public ,heal?    
,s]vice ,act 7#db ,u4,s4,c4 #bfb7;a774  
7#h7 ,ref]5ce product ,! t]m ref]5ce    
product has ! mean+ giv5 ! t]m 9 section
 #cea7;i7 ( ! ,public ,heal? ,s]vice    
,act 7#db ,u4,s4,c4 #bfb7;i774  7#i7    
,secret>y ,! t]m ,secret>y means !      
,secret>y ( ,heal? & ,human ,s]vices4   
7#aj7 ,ultimate p>5t entity ,! t]m      
ultimate p>5t entity has ! mean+ giv5 ! 
t]m 9 section #hja4a ( title #af1 ,code 
( ,f$]al ,regulations1 or any successor 
regulation4  7b7 ,prohibition on product
 hopp+  7#a7 ,prima facie ,except z     

provid$ 9 p>agraph 7#b71 a manufactur] (
 a ref]5ce product or li/$ drug %all be 
consid]$ to h engag$ 9 an unfair me?od (
 competition 9 or affect+ comm]ce 9     
violation ( section #e7;a7 if !         
,commission demon/rates by a            
prepond]ance ( ! evid5ce 9 a proce$+    
initiat$ by ! ,commission "u subsection 
7c77#a77;,a71 or 9 a suit br\ght "u     
subp>agraph 7,b7 or 7,c7 ( subsection   
7c77#a71 t1 dur+ ! p]iod beg9n+ on !    
date on :i* ! manufactur] ( ! ref]5ce   
product or li/$ drug fir/ receives      
notice t an applicant has submitt$ to ! 
,commission] ( ,food & ,drugs an        
abbreviat$ new drug application or      
biosimil> biological product lic5se     
application & end+ on ! date t is #ahj  
days aft] ! date on :i* t g5]ic drug or 
biosimil> biological product is fir/    
m>ket$1 ! manufactur] engag$ 9 ei!r ( ! 
foll[+ actions3  7,a7 ,! manufactur]    
engag$ 9 a h>d swit*1 :i* %all be       
e/abli%$ by demon/rat+ t ! manufactur]  
engag$ 9 ei!r ( ! foll[+ actions3 7i7   

,^u ! reque/ ( ! manufactur] ( ! li/$   
drug or ref]5ce product1 ! ,commission] 
( ,food & ,drugs )drew ! approval ( !   
application = ! li/$ drug or ref]5ce    
product or plac$ ! li/$ drug or ref]5ce 
product on ! discont9u$ products li/ & !
 manufactur] m>ket$ or sold a foll[-on  
product4  7ii7 ,! manufactur] ( ! li/$  
drug or ref]5ce product-- 7,i7 7aa7     
ann\nc$ )drawal (1 discont9uance ( !    
manufacture (1 or int5t to )draw !      
application ) respect to ! drug or      
ref]5ce product 9 a mann] t imp$es      
competition f a g5]ic drug or a         
biosimil> biological product1 z e/abli%$
 by objective circum/ances2 or  7bb7    
de/roy$ ! inv5tory ( ! li/$ drug or     
ref]5ce product 9 a mann] t imp$es      
competition f a g5]ic drug or a         
biosimil> biological product1 :i* may be
 e/abli%$ by objective circum/ances2 &  
7,,ii7 m>ket$ or sold a foll[-on        
product4  7,b7 ,! manufactur] engag$ 9 a
 s(t swit*1 :i* %all be e/abli%$ by     
demon/rat+ t ! manufactur] engag$ 9 bo? 

( ! foll[+ actions3 7i7 ,! manufactur]  
took actions ) respect to ! li/$ drug or
 ref]5ce product o!r ?an ^? describ$ 9  
subp>agraph 7,a7 t unfairly disadvantage
 ! li/$ drug or ref]5ce product relative
 to ! foll[-on product describ$ 9 clause
 7ii7 9 a mann] t imp$es competition f a
 g5]ic drug or a biosimil> biological   
product t is highly simil> to1 & has no 
cl9ically mean+ful diff]5ce ) respect to
 safety1 purity1 & pot5cy f1 ! ref]5ce  
product1 :i* may be e/abli%$ by         
objective circum/ances4  7ii7 ,!        
manufactur] m>ket$ or sold a foll[-on   
product4  7#b7 ,ju/ification  7,a7 ,9   
g5]al ,subject to p>agraph 7#c71 !      
actions describ$ 9 p>agraph 7#a7 by a   
manufactur] ( a li/$ drug or ref]5ce    
product %all n be consid]$ to be an     
unfair me?od ( competition 9 or affect+ 
comm]ce if--  7i7 ! manufactur]         
demon/rates to ! ,commission or a       
di/rict c\rt ( ! ,unit$ ,/ates1 z       
applicable1 by a prepond]ance ( !       
evid5ce 9 a proce$+ initiat$ by !       

,commission "u subsection 7c77#a77;,a71 
or 9 a suit br\ght "u subp>agraph 7,b7  
or 7,c7 ( subsection 7c77#a71 t-- 7,i7 !
 manufactur] w\ld h tak5 ! actions      
reg>dless ( :e!r a g5]ic drug t ref]5ces
 ! li/$ drug or biosimil> biological    
product t ref]5ces ! ref]5ce product _h 
already ent]$ ! m>ket2 &  7,,ii7  7aa7 )
 respect to a h>d swit* "u p>agraph     
7#a77;,a71 ! manufactur] took ! action =
 reasons relat+ to ! safety risk to     
pati5ts ( ! li/$ drug or ref]5ce        
product2  7bb7 ) respect to an action   
describ$ 9 item 7aa7 or 7bb7 ( p>agraph 
7#a77;,a77ii77,i71 !re is a supply      
disruption t-- 7,,aa7 is outside ( !    
control ( ! manufactur]2 7,,bb7 prev5ts 
! production or di/ribution ( !         
applicable li/$ drug or ref]5ce product2
 & 7,,cc7 _c be rem$i$ by reasonable    
ef=ts2 or  7cc7 ) respect to a s(t swit*
 "u p>agraph 7#a77;,b71 ! manufactur] _h
 legitimate pro-competitive reasons1    
ap>t f ! f9ancial effects ( r$uc$       
competition1 to take ! action4  7,b7    

,rule ( con/ruction ,no?+ 9 subp>agraph 
7,a7 may be con/ru$ to limit ! in=mation
 t ! ,commission may o!rwise obta9 9 any
 proce$+ or action in/itut$ ) respect to
 a violation ( ?is section4  7#c7       
,response ,) respect to a ju/ification  
(f]$ by a manufactur] "u p>agraph 7#b71 
! ,commission may--  7,a7 rebut any     
evid5ce pres5t$ by a manufactur] dur+ t 
ju/ification2 or  7,b7 e/abli% by a     
prepond]ance ( ! evid5ce t1 on balance1 
! pro-competitive b5efits f ! conduct   
describ$ 9 subp>agraph 7,a7 or 7,b7 (   
p>agraph 7#a71 z applicable1 d n        
outweigh any anticompetitive effects ( !
 conduct1 ev5 9 consid]ation ( !        
ju/ification s (f]$4  7c7 ,en=cem5t     
7#a7 ,9 g5]al ,if ! ,commission has     
reason to believe t any manufactur] has 
violat$1 is violat+1 or is ab\t to      
violate ?is section1 ! ,commission may  
take any ( ! foll[+ actions3 7,a7       
,in/itute a proce$+--  7i7 t1 except z  
provid$ 9 p>agraph 7#b71 complies ) !   
requirem5ts "u section #e7;b72 &  7ii7 9

 :i* ! ,commission may impose on !      
manufactur] any p5alty t ! ,commission  
may impose = a violation ( section #e4  
7,b7 ,9 ! same mann] & to ! same ext5t z
 provid$ 9 section #ac7;b71 br+ suit 9 a
 di/rict c\rt ( ! ,unit$ ,/ates to      
tempor>ily enjo9 ! action ( !           
manufactur]4  7,c7 ,br+ suit 9 a di/rict
 c\rt ( ! ,unit$ ,/ates1 9 :i* !        
,commission may seek--  7i7 to p]man5tly
 enjo9 ! action ( ! manufactur]2  7ii7  
any ( ! rem$ies describ$ 9 p>agraph     
7#c72 &  7iii7 any o!r equitable rem$y1 
includ+ ancill>y equitable relief4  7#b7
 ,judicial review  7,a7 ,9 g5]al        
,not)/&+ any provision ( section #e1 any
 manufactur] t is subject to a f9al ord]
 ( ! ,commission t is issu$ 9 a proce$+ 
in/itut$ "u p>agraph 7#a77;,a7 may1 n   
lat] ?an #cj days aft] ! date on :i* !  
,commission issues ! ord]1 petition =   
review ( ! ord] 9--  7i7 ! ,unit$ ,/ates
 ,c\rt ( ,appeals = ! ,di/rict (        
,columbia ,circuit2 or  7ii7 ! c\rt (   
appeals ( ! ,unit$ ,/ates = ! circuit 9 

:i* ! ultimate p>5t entity ( !          
manufactur] is incorporat$4  7,b7       
,treatm5t ( f9d+s ,9 a review ( an ord] 
issu$ by ! ,commission conduct$ by a    
c\rt ( appeals ( ! ,unit$ ,/ates "u     
subp>agraph 7,a71 ! factual f9d+s ( !   
,commission %all be conclusive if ^?    
facts are support$ by ! evid5ce4  7#c7  
,equitable rem$ies  7,a7 ,disgorgem5t   
7i7 ,9 g5]al ,9 a suit br\ght "u        
p>agraph 7#a77;,c71 ! ,commission may   
seek1 & ! c\rt may ord]1 disgorgem5t (  
any unju/ enri*m5t t a p]son obta9$ z a 
result ( ! violation t gives rise to !  
suit4  7ii7 ,calculation ,any           
disgorgem5t t is ord]$ ) respect to a   
p]son "u clause 7i7 %all be (fset by any
 am\nt ( re/itution ord]$ "u subp>agraph
 7,b74  7iii7 ,limitations p]iod ,!     
,commission may seek disgorgem5t "u ?is 
subp>agraph n lat] ?an #e ye>s aft] !   
late/ date on :i* ! p]son f :i* !       
disgorgem5t is s\ght receives any unju/ 
enri*m5t f ! effects ( ! violation t    
gives rise to ! suit 9 :i* ! ,commission

 seeks ! disgorgem5t4  7,b7 ,re/itution 
7i7 ,9 g5]al ,9 a suit br\ght "u        
p>agraph 7#a77;,c71 ! ,commission may   
seek1 & ! c\rt may ord]1 re/itution )   
respect to ! violation t gives rise to !
 suit4  7ii7 ,limitations p]iod ,!      
,commission may seek re/itution "u ?is  
subp>agraph n lat] ?an #e ye>s aft] !   
late/ date on :i* ! p]son f :i* !       
re/itution is s\ght receives any unju/  
enri*m5t f ! effects ( ! violation t    
gives rise to ! suit 9 :i* ! ,commission
 seeks ! re/itution4  7#d7 ,rules (     
con/ruction ,no?+ 9 ?is subsection may  
be con/ru$ z-- 7,a7 requir+ !           
,commission to br+ a suit seek+ a       
tempor>y injunction "u p>agraph         
7#a77;,b7 be=e br++ a suit seek+ a      
p]man5t injunction "u p>agraph          
7#a77;,c72 or  7,b7 affect+ any o!r     
au?ority ( ! ,commission "u ?is ,act to 
seek relief or obta9 a rem$y ) respect  
to a violation ( ?is ,act4  4  7b7      
,applicability ,section #bg ( ! ,f$]al  
,trade ,commission ,act1 z add$ by      

subsection 7a71 %all apply ) respect to 
any--  7#a7 conduct t occurs on or aft] 
! date ( enactm5t ( ?is ,act2 &  7#b7   
action or proce$+ t is comm5c$ on or    
aft] ! date ( enactm5t ( ?is ,act4  7c7 
,antitru/ laws ,no?+ 9 ?is section1 or !
 am5dm5ts made by ?is section1 %all     
modify1 impair1 limit1 or sup]s$e !     
applicability ( ! antitru/ laws z def9$ 
9 subsection 7a7 ( ! fir/ section ( !   
,clayton ,act 7#ae ,u4,s4,c4 #ab7;a771 &
 ( section #e ( ! ,f$]al ,trade         
,commission ,act 7#ae ,u4,s4,c4 #de7 to 
! ext5t t x applies to unfair me?ods (  
competition4  7d7 ,rulemak+ ,! ,f$]al   
,trade ,commission may issue rules "u   
section #eec ( title #e1 ,unit$ ,/ates  
,code1 to c>ry out section #bg ( !      
,f$]al ,trade ,commission ,act1 z add$  
by subsection 7a71 includ+ by def9+ any 
t]ms us$ 9 su* section #bg 7o!r ?an t]ms
 t are def9$ 9 subsection 7a7 ( su*     
section #bg74  7e7 ,confirmation ,^u !  
reque/ ( ! ,commission1 ! ,secret>y %all
 provide confirmation (-- 7#a7 any      

reque/ made by ! ,secret>y to !         
manufactur] = an application or         
supplem5t to an application = a *ange1  
modification1 or re=mulation ( a drug or
 biological product2  7#b7 any )drawal  
by ! manufactur] ( an application = a   
drug or ref]5ce product2 or  7#c7 any   
reque/ made by a manufactur] to !       
,secret>y = )drawal ( an approval ( !   
application = a drug or ref]5ce product 
or a reque/ = placem5t ( a drug or      
ref]5ce product on ! discont9u$ products
 li/4  #bjc4 ,title #ce am5dm5ts  7a7 ,9
 g5]al ,section #bga7;e7 ( title #ce1   
,unit$ ,/ates ,code1 is am5d$-- 7#a7 9  
p>agraph 7#b77;,c71 9 ! flu% text foll[+
 clause 7ii71 by add+ at ! end ! foll[+3
 ,) respect to a submission describ$ 9  
clause 7ii71 ! act ( infr+em5t %all     
ext5d to any pat5t t claims ! biological
 product1 a me?od ( us+ ! biological    
product1 or a me?od or product us$ to   
manufacture ! biological product42 &    
7#b7 by add+ at ! end ! foll[+3  7#g7   
7,a7 ,subject to subp>agraphs 7,c71     

7,d71 & 7,e71 if ! sponsor ( an approv$ 
application = a ref]5ce product1 z def9$
 9 section #cea7;i7 ( ! ,public ,heal?  
,s]vice ,act 7#db ,u4,s4,c4 #bfb7;i77   
7ref]r$ to 9 ?is p>agraph z ! ref]5ce   
product sponsor71 br+s an action =      
infr+em5t "u ?is section aga9/ an       
applicant = approval ( a biological     
product "u section #cea7k7 ( su* ,act t 
ref]5ces t ref]5ce product 7ref]r$ to 9 
?is p>agraph z ! subsection 7k7         
applicant71 ! ref]5ce product sponsor   
may ass]t 9 ! action a total ( n m ?an  
#bj pat5ts ( ! type describ$ 9          
subp>agraph 7,b71 n m ?an #aj ( :i* %all
 h issu$ aft] ! date specifi$ 9 section 
#cea7l77#g77;,a7 ( su* ,act4  7,b7 ,!   
pat5ts describ$ 9 ?is subp>agraph are   
pat5ts t satisfy ea* ( ! foll[+         
requirem5ts3 7i7 ,pat5ts t claim !      
biological product t is ! subject ( an  
application "u section #cea7k7 ( !      
,public ,heal? ,s]vice ,act 7#db        
,u4,s4,c4 #bfb7k77 7or a use ( t        
product7 or a me?od or product us$ 9 !  

manufacture ( su* biological product4   
7ii7 ,pat5ts t are includ$ on ! li/ (   
pat5ts describ$ 9 section               
#cea7l77#c77;,a7 ( ! ,public ,heal?     
,s]vice ,act 7#db ,u4,s4,c4             
#bfb7l77#c77;,a771 includ+ z provid$ "u 
section #cea7l77#g7 ( su* ,act4  7iii7  
,pat5ts t--  7,i7 h an actual fil+ date 
( m ?an #d ye>s aft] ! date on :i* !    
ref]5ce product is approv$2 or  7,,ii7  
include a claim to a me?od 9 a          
manufactur+ process t is n us$ by !     
ref]5ce product sponsor4  7,c7 ,! c\rt 9
 :i* an action describ$ 9 subp>agraph   
7,a7 is br\ght may increase ! numb] (   
pat5ts limit$ "u t subp>agraph-- 7i7 if 
! reque/ to increase t numb] is made )\t
 undue delay2 &  7ii7  7,i7 if ! int]e/ 
( ju/ice s requires2 or  7,,ii7 = good  
cause %[n1 :i*--  7aa7 %all be e/abli%$ 
if ! subsection 7k7 applicant fails to  
provide in=mation requir$ "u section    
#cea7l77#b77;,a7 ( ! ,public ,heal?     
,s]vice ,act 7#db ,u4,s4,c4             
#bfb7l77#b77;,a77 t w\ld enable !       

ref]5ce product sponsor to =m a         
reasonable belief ) respect to :e!r a   
claim ( infr+em5t "u ?is section c\ld   
reasonably be ass]t$2 &  7bb7 may be    
e/abli%$-- 7,,aa7 if !re is a mat]ial   
*ange to ! biological product 7or       
process ) respect to ! biological       
product7 ( ! subsection 7k7 applicant t 
is ! subject ( ! application2 7,,bb7 if1
 ) respect to a pat5t on ! supplem5tal  
li/ describ$ 9 section #cea7l77#g77;,a7 
( ,public ,heal? ,s]vice ,act 7#db      
,u4,s4,c4 #bfb7l77#g77;,a771 ! pat5t    
w\ld h issu$ be=e ! date specifi$ 9 su* 
section #cea7l77#g77;,a7 b = ! failure (
 ! ,(fice to issue ! pat5t or a delay 9 
! issuance ( ! pat5t1 z describ$ 9      
p>agraph 7#a7 ( section #aed7;b7 &      
subject to ! limitations "u p>agraph    
7#b7 ( su* section #aed7;b72 or 7,,cc7 =
 ano!r reason t %[s good cause1 z       
det]m9$ appropriate by ! c\rt4  7,d7 ,9 
det]m9+ :e!r good cause has be5 %[n = ! 
purposes ( subp>agraph 7,c77ii77,,ii71 a
 c\rt may consid] :e!r ! ref]5ce product

 sponsor has provid$ a reasonable       
description ( ! id5tity & relevance (   
any in=mation beyond ! subsection 7k7   
application t ! c\rt believes is        
necess>y to enable ! c\rt to =m a belief
 ) respect to :e!r a claim ( infr+em5t  
"u ?is section c\ld reasonably be       
ass]t$4  7,e7 ,! limitation impos$ "u   
subp>agraph 7,a7-- 7i7 %all apply only  
if ! subsection 7k7 applicant completes 
all actions requir$ "u p>agraphs        
7#b77;,a71 7#c77;,b77ii71 7#e71         
7#f77;,c77i71 7#g71 & 7#h77;,a7 (       
section #cea7l7 ( ! ,public ,heal?      
,s]vice ,act 7#db ,u4,s4,c4 #bfb7l772 & 
7ii7 %all n apply ) respect to any pat5t
 t claims1 ) respect to a biological    
product1 a me?od = us+ t product 9      
!rapy1 diagnosis1 or prophylaxis1 su* z 
an indication or me?od ( treatm5t or o!r
 condition ( use4  4  7b7 ,applicability
 ,! am5dm5ts made by subsection 7a7 %all
 apply ) respect to an application      
submitt$ "u section #cea7k7 ( ! ,public 
,heal? ,s]vice ,act 7#db ,u4,s4,c4      

#bfb7k77 on or aft] ! date ( enactm5t ( 
?is ,act4  7#b7 ,9 ! matt] propos$ to be
 ins]t$ by ! am5dm5t ( ! ,s5ate1 /rike  
sections #d1 #e1 & #f & ins]t ! foll[+3 
,,iii ,access to ,c\nsel ,act ( #bjbj   
#cja4 ,%ort title ,?is title may be cit$
 z ! ,access to ,c\nsel ,act ( #bjbj4   
#cjb4 ,access to c\nsel & o!r assi/ance 
at ports ( entry & def]r$ inspection    
7a7 ,access to c\nsel & o!r assi/ance   
dur+ inspection ,section #bce ( !       
,immigration & ,nationality ,act 7#h    
,u4,s4,c4 #abbe7 is am5d$ by add+ at !  
end ! foll[+3  7e7 ,access to c\nsel &  
o!r assi/ance dur+ inspection  7#a7 ,9  
g5]al ,! ,secret>y ( ,homel& ,security  
%all ensure t a cov]$ individual has a  
mean+ful opportunity to consult ) c\nsel
 & an int]e/$ p>ty dur+ ! inspection    
process4  7#b7 ,scope ( assi/ance ,!    
,secret>y ( ,homel& ,security %all--    
7,a7 provide ! cov]$ individual a       
mean+ful opportunity to consult ) c\nsel
 & an int]e/$ p>ty n lat] ?an "o h\r    
aft] ! second>y inspection process      

comm5ces & z necess>y ?r\gh\t !         
inspection process1 includ+1 z          
applicable1 dur+ def]r$ inspection2     
7,b7 all[ c\nsel & an int]e/$ p>ty to   
advocate on behalf ( ! cov]$ individual1
 includ+ by provid+ to ! exam9+         
immigration (fic] in=mation1            
docum5tation1 & o!r evid5ce 9 support ( 
! cov]$ individual2 &  7,c7 to ! greate/
 ext5t practicable1 accommodate a reque/
 by ! cov]$ individual = c\nsel or an   
int]e/$ p>ty to appe> 9-p]son at !      
second>y or def]r$ inspection site4     
7#c7 ,special rule = lawful p]man5t     
resid5ts  7,a7 ,9 g5]al ,! ,secret>y (  
,homel& ,security may n accept ,=m      
,i-#djg ,record ( ,ab&onm5t ( ,lawful   
,p]man5t ,resid5t ,/atus 7or a successor
 =m7 f a lawful p]man5t resid5t subject 
to second>y or def]r$ inspection )\t    
provid+ su* lawful p]man5t resid5t a    
reasonable opportunity to seek advice f 
c\nsel prior to ! submission ( ! =m4    
7,b7 ,exception ,! ,secret>y ( ,homel&  
,security may accept ,=m ,i-#djg ,record

 ( ,ab&onm5t ( ,lawful ,p]man5t ,resid5t
 ,/atus 7or a successor =m7 f a lawful  
p]man5t resid5t subject to second>y or  
def]r$ inspection if su* lawful p]man5t 
resid5t kn[+ly1 intellig5tly1 &         
volunt>ily waives1 9 writ+1 !           
opportunity to seek advice f c\nsel4    
7#d7 ,def9itions ,9 ?is section3 7,a7   
,c\nsel ,! t]m c\nsel means--  7i7 an   
attorney :o is a memb] 9 good /&+ ( ! b>
 ( any ,/ate1 ! ,di/rict ( ,columbia1 or
 a t]ritory or a possession ( ! ,unit$  
,/ates & is n "u an ord] susp5d+1       
enjo9+1 re/ra9+1 disb>r+1 or o!rwise    
re/rict+ ! attorney 9 ! practice ( law2 
or  7ii7 an individual accr$it$ by !    
,attorney ,g5]al1 act+ z a repres5tative
 ( an organization recogniz$ by !       
,executive ,(fice = ,immigration        
,review1 to repres5t a cov]$ individual 
9 immigration matt]s4  7,b7 ,cov]$      
individual ,! t]m cov]$ individual means
 an individual subject to second>y or   
def]r$ inspection :o is-- 7i7 a national
 ( ! ,unit$ ,/ates2  7ii7 an immigrant1 

lawfully admitt$ = p]man5t resid5ce1 :o 
is return+ f a tempor>y visit abroad2   
7iii7 an ali5 seek+ admission z an      
immigrant 9 possession ( a valid        
unexpir$ immigrant visa2  7iv7 an ali5  
seek+ admission z a non-immigrant 9     
possession ( a valid unexpir$           
non-immigrant visa2  7v7 a refugee2     
7vi7 a return+ asylee2 or  7vii7 an ali5
 :o has be5 approv$ = p>ole "u section  
#bab7;d77#e77;,a71 includ+ an ali5 :o is
 return+ to ! ,unit$ ,/ates 9 possession
 ( a valid advance p>ole docum5t4  7,c7 
,int]e/$ p>ty ,! t]m int]e/$ p>ty       
means-- 7i7 a relative ( ! cov]$        
individual2  7ii7 9 ! case ( a cov]$    
individual to :om an immigrant or       
non-immigrant visa has be5 issu$1 !     
petition] or sponsor !re( 7includ+ an   
ag5t ( su* petition] or sponsor72 or    
7iii7 a p]son1 organization1 or entity 9
 ! ,unit$ ,/ates ) a bona fide          
connection to ! cov]$ individual4  4    
7b7 ,effective date ,! am5dm5t made by  
subsection 7a7 %all take effect #ahj    

days aft] ! date ( ! enactm5t ( ?is     
,act4  7c7 ,sav+s provision ,no?+ 9 ?is 
title1 or 9 any am5dm5t made by ?is     
title1 may be con/ru$ to limit a "r to  
c\nsel or any "r to appo9t$ c\nsel "u-- 
7#a7 section #bdj7;b77#d77;,a7 7#h      
,u4,s4,c4 #abbi;a7b77#d77;,a771  7#b7   
section #bib ( ! ,immigration &         
,nationality ,act 7#h ,u4,s4,c4 #acfb71 
or  7#c7 any o!r provision ( law1       
includ+ any f9al c\rt ord] secur+ su*   
rights1  z 9 effect on ! day be=e ! date
 ( ! enactm5t ( ?is ,act4  ,cl]k4