,,ii  #aae? ,,congress  #a/ ,session    
,s4 #bjeg  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,novemb] #a1 #bjag ,ms4
 ,baldw9 7= h]self1 ,mrs4 ,fe9/e91 ,ms4 
,h>ris1 ,ms4 ,hassan1 ,mr4 ,m>key1 ,mrs4
 ,%ahe51 & ,mr4 ,udall7 introduc$ !     
foll[+ bill2 :i* 0 read twice & ref]r$  
to ! ,committee on ,homel& ,security &  
,gov]nm5tal ,affairs  ,a ,,bill  ,to    
prev5t conflicts ( int]e/ t /em f !     
revolv+ door t raises conc]ns ab\t !    
indep5d5ce ( ph>maceutical regulators4  
#a4 ,%ort title  ,?is ,act may be cit$ z
 ! ,ph>maceutical ,regulation ,conflict 
( ,int]e/ ,act4  #b4 ,requirem5ts relat+
 to sl[+ ! revolv+ door among           
ph>maceutical regulators ,! ,e?ics 9    
,gov]nm5t ,act ( #aigh 7#e ,u4,s4,c4    
,app47 is am5d$ by add+ at ! end !      
foll[+3  ,,vi ,special requirem5ts =    
ph>maceutical regulators  #fja4         
,def9itions  7a7 ,9 g5]al ,9 ?is title1 
! t]ms designat$ ag5cy e?ics (ficial &  
executive bran* h ! mean+s giv5 ^? t]ms 
"u section #aji4  7b7 ,o!r def9itions ,9

 ?is title3 7#a7 ,cov]$ ph>maceutical   
regulator ,! t]m cov]$ ph>maceutical    
regulator means an (fic] or employee ( a
 cov]$ ph>maceutical regulatory ag5cy :o
 occupies--  7,a7 a sup]visory position 
classifi$ at or above ,,gs-#ac ( !      
,g5]al ,s*$ule2  7,b7 9 ! case ( a      
position n "u ! ,g5]al ,s*$ule1 a       
sup]visory position = :i* ! rate ( basic
 pay is n less ?an ! m9imum rate ( basic
 pay = ,,gs-#ac ( ! ,g5]al ,s*$ule2 or  
7,c7 any o!r sup]visory position det]m9$
 to be ( equal classification by !      
,director4  7#b7 ,cov]$ ph>maceutical   
regulatory ag5cy ,! t]m cov]$           
ph>maceutical regulatory ag5cy--  7,a7  
means an ag5cy ^: prim>y responsibility 
is to regulate ! manufacture1           
di/ribution1 or sale ( drugs 7z def9$ 9 
section #bja ( ! ,f$]al ,food1 ,drug1 & 
,cosmetic ,act 7#ba ,u4,s4,c4 #cba77 or 
biological products 7z def9$ 9 section  
#cea ( ! ,public ,heal? ,s]vice ,act    
7#db ,u4,s4,c4 #bfb772 &  7,b7          
includes-- 7i7 ! ,drug ,en=cem5t        

,adm9i/ration2 &  7ii7 ! ,food & ,drug  
,adm9i/ration4  7#c7 ,director ,! t]m   
,director means ! ,director ( ! ,(fice (
 ,gov]nm5t ,e?ics4  7#d7 ,=m] cli5t ,!  
t]m =m] cli5t-- 7,a7 means a p]son = :om
 ! cov]$ ph>maceutical regulator s]v$   
p]sonally z an ag5t1 attorney1 or       
consultant dur+ ! #b-ye> p]iod end+ on !
 date 7aft] su* s]vice7 on :i* ! cov]$  
ph>maceutical regulator beg9s s]vice 9 !
 ,f$]al ,gov]nm5t2 &  7,b7 does n       
include-- 7i7 in/ances 9 :i* ! s]vice   
provid$ 0 limit$ to a spee* or simil>   
appe>ance2 or  7ii7 a cli5t ( ! =m]     
employ] ( ! cov]$ ph>maceutical         
regulator to :om ! cov]$ ph>maceutical  
regulator did n p]sonally provide su*   
s]vices4  7#e7 ,=m] employ] ,! t]m =m]  
employ]-- 7,a7 means a p]son = :om a    
cov]$ ph>maceutical regulator s]v$ z an 
employee1 (fic]1 director1 tru/ee1 or   
g5]al p>tn] dur+ ! #b-ye> p]iod end+ on 
! date 7aft] su* s]vice7 on :i* ! cov]$ 
ph>maceutical regulator beg9s s]vice 9 !
 ,f$]al ,gov]nm5t2 &  7,b7 does n       

include-- 7i7 any entity 9 ! ,f$]al     
,gov]nm5t1 includ+ an executive bran*   
ag5cy2  7ii7 a ,/ate or local gov]nm5t2 
7iii7 ! ,di/rict ( ,columbia2  7iv7 an  
,indian tribe1 z def9$ 9 section #d ( ! 
,indian ,self-,det]m9ation & ,education 
,assi/ance ,act 7#be ,u4,s4,c4 #ecjd72  
or  7v7 ! gov]nm5t ( a t]ritory or      
possession ( ! ,unit$ ,/ates4  #fjb4    
,conflict ( int]e/ & eligibility /&>ds =
 ph>maceutical regulators  7a7 ,9 g5]al 
,a cov]$ ph>maceutical regulator %all n 
make1 p>ticipate 9 mak+1 or 9 any way   
attempt to use ! (ficial position ( !   
cov]$ ph>maceutical regulator to        
influ5ce a p>ticul> matt] t provides a  
direct & sub/antial pecuni>y b5efit = a 
=m] employ] or =m] cli5t ( ! cov]$      
ph>maceutical regulator4  7b7 ,recusal  
,a cov]$ ph>maceutical regulator %all   
recuse himself or h]self f any (ficial  
action t w\ld violate subsection 7a74   
7c7 ,waiv]  7#a7 ,9 g5]al ,! head ( !   
cov]$ ph>maceutical regulatory ag5cy    
employ+ a cov]$ ph>maceutical regulator1

 9 consultation ) ! ,director1 may grant
 a writt5 waiv] ( ! re/rictions "u      
subsection 7a7 if1 & to ! ext5t t1 !    
head ( ! cov]$ ph>maceutical regulatory 
ag5cy c]tifies 9 writ+ t--  7,a7 !      
application ( ! re/riction to ! p>ticul>
 matt] is inconsi/5t ) ! purposes ( !   
re/riction2 or  7,b7 x is 9 ! public    
int]e/ to grant ! waiv]4  7#b7          
,publication ,! ,director %all make ea* 
waiv] "u p>agraph 7#a7 publicly         
available on ! ,web site ( ! ,(fice (   
,gov]nm5t ,e?ics4  #fjc4 ,negotiat+     
future private sector employm5t  7a7    
,prohibition ,except z provid$ 9        
subsection 7c71 & not)/&+ any o!r       
provision ( law1 a cov]$ ph>maceutical  
regulator may n p>ticipate 9 any        
p>ticul> matt] :i* involves1 to ! k ( ! 
cov]$ ph>maceutical regulator1 an       
individual or entity ) :om ! cov]$      
ph>maceutical regulator is 9            
negotiations ( future employm5t or has  
an arrangem5t conc]n+ prospective       
employm5t4  7b7 ,disclosure ( employm5t 

negotiations  7#a7 ,9 g5]al ,if a cov]$ 
ph>maceutical regulator beg9s any       
negotiations ( future employm5t ) ano!r 
p]son1 or an ag5t or int]m$i>y ( ano!r  
p]son1 or o!r discussion or             
communication ) ano!r p]son1 or an ag5t 
or int]m$i>y ( ano!r p]son1 mutually    
conduct$ ) a view t[>d rea*+ an agreem5t
 reg>d+ possible employm5t ( ! cov]$    
ph>maceutical regulator1 ! cov]$        
ph>maceutical regulator %all notify !   
designat$ ag5cy e?ics (ficial ( ! cov]$ 
ph>maceutical regulatory ag5cy employ+ !
 cov]$ ph>maceutical regulator reg>d+ ! 
negotiations1 discussions1 or           
communications4  7#b7 ,in=mation ,a     
designat$ ag5cy e?ics (ficial receiv+   
notice "u p>agraph 7#a71 aft]           
consultation ) ! ,director1 %all in=m ! 
cov]$ ph>maceutical regulator ( any     
pot5tial conflicts ( int]e/ involv$ 9   
any negotiations1 discussions1 or       
communications ) ! o!r p]son & !        
applicable prohibitions4  7#c7          
,publication ,! ,director1 aft] receiv+ 

notice "u p>agraph 7#a71 %all make      
publicly available on ! ,web site ( !   
,(fice ( ,gov]nm5t ,e?ics ! "n ( ! cov]$
 ph>maceutical regulator & ! "n ( !     
private p]son involv$ 9 ! negotiations  
or arrangem5t conc]n+ prospective       
employm5t ( ! cov]$ ph>maceutical       
regulator4  7c7 ,waiv]s only :5         
exceptional circum/ances exi/  7#a7 ,9  
g5]al ,! head ( a cov]$ ph>maceutical   
regulatory ag5cy may only grant a waiv] 
( ! prohibition "u subsection 7a7 if !  
head det]m9es t exceptional circum/ances
 exi/4  7#b7 ,review & publication ,=   
any waiv] grant$ "u p>agraph 7#a71 !    
,director %all-- 7,a7 review !          
circum/ances relat+ to ! waiv] & !      
det]m9ation t exceptional circum/ances  
exi/2 &  7,b7 make ! waiv] publicly     
available on ! ,web site ( ! ,(fice (   
,gov]nm5t ,e?ics1 :i* %all include--    
7i7 ! "n ( ! private p]son involv$ 9 !  
negotiations or arrangem5t conc]n+      
prospective employm5t ( ! cov]$         
ph>maceutical regulator2 &  7ii7 ! date 

on :i* ! negotiations or arrangem5t     
comm5c$4  7d7 ,scope ,= ! purposes ( ?is
 section1 ! t]m negotiations ( future   
employm5t is n limit$ to discussions (  
specific t]ms or conditions ( employm5t 
9 a specific position4  #fjd4           
,recordkeep+ ,! ,director %all-- 7#a7   
receive all employm5t hi/ories1 recusal 
& waiv] records1 & o!r disclosure       
records = cov]$ ph>maceutical regulators
 necess>y = monitor+ compliance ) ?is   
title1 & make ^? records publicly       
available on ! ,web site ( ! ,(fice (   
,gov]nm5t ,e?ics2  7#b7 promulgate rules
 & regulations1 9 consultation ) !      
,director ( ! ,(fice ( ,p]sonnel        
,managem5t & ! ,attorney ,g5]al1 to     
implem5t ?is title2  7#c7 provide       
guidance & assi/ance :]e appropriate to 
facilitate compliance ) ?is title2  7#d7
 review &1 :]e necess>y1 assi/ designat$
 ag5cy e?ics (ficials 9 provid+ advice  
to cov]$ ph>maceutical regulators reg>d+
 compliance ) ?is title2 &  7#e7 if !   
,director det]m9es t a violation ( ?is  

title may h occurr$1 & 9 consultation ) 
! designat$ ag5cy e?ics (ficial & !     
,c\nsel to ! ,presid5t1 ref] !          
compliance case to ! ,unit$ ,/ates      
,attorney = ! ,di/rict ( ,columbia =    
en=cem5t action4  #fje4 ,p5alties &     
injunctions  7a7 ,crim9al p5alties  7#a7
 ,9 g5]al ,any p]son :o violates section
 #fjb or #fjc %all be f9$ "u title #ah1 
,unit$ ,/ates ,code1 imprison$ = n m ?an
 #a ye>1 or bo?4  7#b7 ,willful         
violations ,any p]son :o willfully      
violates section #fjb or #fjc %all be   
f9$ "u title #ah1 ,unit$ ,/ates ,code1  
imprison$ = n m ?an #e ye>s1 or bo?4    
7b7 ,civil en=cem5t  7#a7 ,9 g5]al ,!   
,attorney ,g5]al may br+ a civil action 
9 an appropriate di/rict c\rt ( ! ,unit$
 ,/ates aga9/ any p]son :o violates1 or 
:om ! ,attorney ,g5]al has reason to    
believe is engag+ 9 conduct t violates1 
section #fjb or #fjc4  7#b7 ,civil      
p5alty  7,a7 ,9 g5]al ,^u pro( by a     
prepond]ance ( ! evid5ce t a p]son      
violat$ section #fjb or #fjc1 ! c\rt    

%all impose a civil p5alty ( n m ?an !  
great] (--  7i7 #ajj1jjj = ea*          
violation2 or  7ii7 ! am\nt (           
comp5sation ! p]son receiv$ or 0 (f]$ = 
! conduct con/itut+ ! violation4  7,b7  
,rule ( con/ruction ,a civil p5alty "u  
?is subsection %all be 9 addition to any
 o!r crim9al or civil /atutory1 common  
law1 or adm9i/rative rem$y available to 
! ,unit$ ,/ates or any o!r p]son4  7#c7 
,injunctive relief  7,a7 ,9 g5]al ,9 a  
civil action br\ght "u p>agraph 7#a7    
aga9/ a p]son1 ! ,attorney ,g5]al may   
petition ! c\rt = an ord] prohibit+ !   
p]son f engag+ 9 conduct t violates     
section #fjb or #fjc4  7,b7 ,/&>d ,!    
c\rt may issue an ord] "u subp>agraph   
7,a7 if ! c\rt f9ds by a prepond]ance ( 
! evid5ce t ! conduct ( ! p]son violates
 section #fjb or #fjc4  7,c7 ,rule (    
con/ruction ,! fil+ ( a petition seek+  
injunctive relief "u ?is p>agraph %all n
 preclude any o!r rem$y t is available  
by law to ! ,unit$ ,/ates or any o!r    
p]son4  4  #c4 ,sl[+ ! revolv+ door f   

ph>maceutical regulatory ag5cy into     
private sector repres5tational          
activities  7a7 ,9 g5]al ,section #bjg (
 title #ah1 ,unit$ ,/ates ,code1 is     
am5d$-- 7#a7 by r$esignat+ subsections  
7e7 ?r\gh 7l7 z subsections 7f7 ?r\gh   
7m71 respectively2 &  7#b7 by ins]t+    
aft] subsection 7d7 ! foll[+3  7e7      
,re/rictions on employm5t =             
ph>maceutical regulators  7#a7 ,9 g5]al 
,9 addition to ! re/rictions set =? 9   
subsections 7a71 7b71 7c71 & 7d71 a     
cov]$ ph>maceutical regulator %all n--  
7,a7 dur+ ! #b-ye> p]iod beg9n+ on !    
date on :i* 8 or h] employm5t z a cov]$ 
ph>maceutical regulator ceases--  7i7   
kn[+ly act z ag5t or attorney =1 or     
o!rwise repres5t1 any o!r p]son =       
comp5sation 7except ! ,unit$ ,/ates7 9  
any =mal or in=mal appe>ance be=e2  7ii7
 ) ! int5t to influ5ce1 make any oral or
 writt5 communication on behalf ( any   
o!r p]son 7except ! ,unit$ ,/ates7 to2  
or  7iii7 kn[+ly aid1 advise1 or assi/  
9-- 7,i7 repres5t+ any o!r p]son 7except

 ! ,unit$ ,/ates7 9 any =mal or in=mal  
appe>ance be=e2 or  7,,ii7 mak+1 ) !    
int5t to influ5ce1 any oral or writt5   
communication on behalf ( any o!r p]son 
7except ! ,unit$ ,/ates7 to1  any c\rt (
 ! ,unit$ ,/ates1 or any (fic] or       
employee !re(1 9 connection ) any       
judicial or o!r proce$+1 :i* 0 actually 
p5d+ "u 8 or h] (ficial responsibility z
 a cov]$ ph>maceutical regulator dur+ ! 
#a-ye> p]iod end+ on ! date on :i* 8 or 
h] employm5t z a cov]$ ph>maceutical    
regulator ceases or 9 :i* he or %e      
p>ticipat$ p]sonally & sub/antially z a 
cov]$ ph>maceutical regulator2 or  7,b7 
dur+ ! #b-ye> p]iod beg9n+ on ! date on 
:i* 8 or h] employm5t z a cov]$         
ph>maceutical regulator ceases--  7i7   
kn[+ly act z a lobbyi/ or ag5t =1 or    
o!rwise repres5t1 any o!r p]son =       
comp5sation 7except ! ,unit$ ,/ates7 9  
any =mal or in=mal appe>ance be=e2  7ii7
 ) ! int5t to influ5ce1 make any oral or
 writt5 communication or conduct any    
lobby+ activities on behalf ( any o!r   

p]son 7except ! ,unit$ ,/ates7 to2 or   
7iii7 kn[+ly aid1 advise1 or assi/ 9--  
7,i7 repres5t+ any o!r p]son 7except !  
,unit$ ,/ates7 9 any =mal or in=mal     
appe>ance be=e2 or  7,,ii7 mak+1 ) !    
int5t to influ5ce1 any oral or writt5   
communication or conduct any lobby+     
activities on behalf ( any o!r p]son    
7except ! ,unit$ ,/ates7 to1  any       
dep>tm5t or ag5cy ( ! executive bran* or
 ,congress 7includ+ any committee (     
,congress71 or any (fic] or employee    
!re(1 9 connection ) any matt] t is p5d+
 be=e ! dep>tm5t1 ! ag5cy1 or ,congress4
  7#b7 ,p5alty ,any p]son :o violates   
p>agraph 7#a7 %all be puni%$ z provid$ 9
 section #baf4  7#c7 ,def9itions ,9 ?is 
subsection--  7,a7 ! t]m cov]$          
ph>maceutical regulator has ! mean+ giv5
 t t]m 9 section #fja ( ! ,e?ics 9      
,gov]nm5t ,act ( #aigh 7#e ,u4,s4,c4    
,app472 &  7,b7 ! t]ms lobby+ activities
 & lobbyi/ h ! mean+s giv5 ^? t]ms 9    
section #c ( ! ,lobby+ ,disclosure ,act 
( #aiie 7#b ,u4,s4,c4 #afjb74  4  7b7   

,te*nical & con=m+ am5dm5ts  7#a7       
,section #ajc7;a7 ( ! ,hone/ ,lead]%ip &
 ,op5 ,gov]nm5t ,act ( #bjjg 7#b        
,u4,s4,c4 #dgjb7;a77 is am5d$ by /rik+  
section #bjg7;e7 ea* place x appe>s &   
ins]t+ section #bjg7;f74  7#b7 ,section 
#bjg ( title #ah1 ,unit$ ,/ates ,code1 z
 am5d$ by subsection 7a71 is am5d$--    
7,a7 9 subsection 7g77#a71 z s          
r$esignat$1 by /rik+ or 7e7 & ins]t+ or 
7f72  7,b7 9 subsection 7j77#a77;,b71 z 
s r$esignat$1 by /rik+ subsection 7f7 & 
ins]t+ subsection 7g72 &  7,c7 9        
subsection 7k71 z s r$esignat$--  7i7 9 
p>agraph 7#a77;,b71 by /rik+ 7#be       
,u4,s4,c4 #dej;i7j77 & ins]t+ 7#be      
,u4,s4,c4 #ecbc7;j772  7ii7 9 p>agraph  
7#b71 9 ! matt] prec$+ subp>agraph 7,a71
 by /rik+ & 7e7 & ins]t+ 7e71 & 7f72    
7iii7 9 p>agraph 7#d71 by /rik+ & 7e7 & 
ins]t+ 7e71 & 7f72 &  7iv7 9 p>agraph   
7#g7--  7,i7 9 subp>agraph 7,a71 by     
/rik+ & 7e7 & ins]t+ 7e71 & 7f72 &      
7,,ii7 9 subp>agraph 7,b77ii71 9 ! matt]
 prec$+ subclause 7,i71 by /rik+        

subsections 7c71 7d71 or 7e7 & ins]t+   
subsection 7c71 7d71 7e71 or 7f74  7#c7 
,section #ada7;b77#d7 ( ! ,trade ,act ( 
#aigd 7#ai ,u4,s4,c4 #baga7;b77#d77 is  
am5d$ by /rik+ section #bjg7;f77#c7 &   
ins]t+ #bjg7;g77#c74  7#d7 ,section     
#ghjb7;b77#c77;,b7 ( ! ,int]nal ,rev5ue 
,code ( #aihf is am5d$ by /rik+ & 7f7 ( 
section #bjg & ins]t+ & 7g7 ( section   
#bjg4  7#e7 ,section #caje7;c7 ( !      
,,usec ,privatization ,act 7#db         
,u4,s4,c4 #bbig;h-#c7;c77 is am5d$ by   
/rik+ & 7d7 & ins]t+ 7d71 & 7e74  7#f7  
,section #ajf7p77#f77;,i77ii7 ( title   
#di1 ,unit$ ,/ates ,code1 is am5d$ by   
/rik+ & 7f7 ( section #bjg & ins]t+ &   
7g7 ( section #bjg4  #d4 ,sev]ability   
,if any provision ( ?is ,act or any     
am5dm5t made by ?is ,act1 or any        
application ( su* provision or am5dm5t  
to any p]son or circum/ance1 is held to 
be uncon/itutional1 ! rema9d] ( !       
provisions ( ?is ,act & ! am5dm5ts made 
by ?is ,act & ! application ( !         
provision or am5dm5t to any o!r p]son or

 circum/ance %all n be affect$4