,,ib ,union ,cal5d> ,no4 #egg #aaf? ,,congress #b;d ,session ,h4 ,r4 #bcgd ,report ,no4 #aaf-fid ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,april #bi1 #bjai,mr4 ,jeffries 7= himself1 ,mr4 ,s5s5br5n]1 ,mr4 ,nadl]1 ,mr4 ,coll9s ( ,georgia1 ,mr4 ,cicill9e1 & ,mr4 ,wel*7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ! ,judici>y ,decemb] #bd1 #bjbj;,additional sponsors3 ,mr4 ,coh5 & ,mr4 ,posey ,decemb] #bd1 #bjbj,report$ f ! ,committee on ! ,judici>y2 committ$ to ! ,committee ( ! ,:ole ,h\se on ! ,/ate ( ! ,union & ord]$ to be pr9t$ ,a ,,bill ,to enable ! ,f$]al ,trade ,commission to det] fil+ ( %am citiz5 petitions to cov] an attempt to int]f]e ) approval ( a compet+ g5]ic drug or biosimil>1 to fo/] competition & facilitate ! effici5t review ( petitions fil$ 9 good fai? to raise legitimate public hea? conc]ns1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,/op ,significant & ,"t-wa/+ ,abuse ,limit+ ,legitimate ,innovation ( ,new ,g5]ics ,act or ! ,/op ,,/all+ ,act4 #b4 ,f$]al ,trade ,commission en=cem5t aga9/ %am petitions 7a7 ,def9itions ,9 ?is section3 7#a7 ,commission ,! t]m ,commission means ! ,f$]al ,trade ,commission4 7#b7 ,cov]$ application ,! t]m cov]$ application means an application fil$ pursuant to subsection 7b77#b7 or 7j7 ( section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or section #cea7k7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7k774 7#c7 ,cov]$ petition ,! t]m cov]$ petition means a petition1 or a supplem5t to a petition1 fil$ "u section #eje7q7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7q774 7#d7 ,p]son ,! t]m p]son means-- 7,a7 an individual or entity2 7,b7 its directors1 (fic]s1 employees1 ag5ts1 repres5tatives1 successors1 & assigns2 & 7,c7 ! jo9t v5tures1 subsidi>ies1 p>tn]%ips1 divisions1 gr\ps1 & affiliates x controls1 & ! respective directors1 (fic]s1 employees1 ag5ts1 repres5tatives1 successors1 & assigns ( ea*4 7#e7 ,s]ies ( cov]$ petitions ,! t]m s]ies ( cov]$ petitions means any gr\p ( m ?an "o cov]$ petition4 7#f7 ,%am ,! t]m 8%am0 means a cov]$ petition t is objectively baseless & t attempts to use a gov]nm5tal process1 z oppos$ to ! outcome ( t process1 to int]f]e ) ! bus9ess ( a competitor1 or a s]ies ( cov]$ petitions1 t attempts to use a gov]nm5tal process1 z oppos$ to ! outcome ( t process1 to int]f]e ) ! bus9ess ( a competitor4 7b7 ,violation 7#a7 ,9 g5]al ,a p]son submitt+ or caus+ ! submission ( a cov]$ petition or a s]ies ( cov]$ petitions t is a %am %all be liable = engag+ 9 an unfair me?od ( competition "u section #e7;a77#a7 ( ! ,f$]al ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7;a77#a774 7c7 ,civil action 7#a7 ,9 g5]al ,if ! ,commission has reason to believe t ! submission ( a cov]$ petition or a s]ies ( cov]$ petitions con/itutes a violation ( section #e7;a77#a7 ( ! ,f$]al ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7;a77#a771 ! ,commission may comm5ce a civil action to recov] a civil p5alty & seek o!r appropriate relief 9 a di/rict c\rt ( ! ,unit$ ,/ates aga9/ any p]son t submitt$ or caus$ to be submitt$ su* cov]$ petition or su* s]ies ( cov]$ petitions1 includ+ successors or assigns4 7#b7 ,presumption ,9 a civil action "u p>agraph 7#a71 a cov]$ petition %all be presum$ to be "p ( a s]ies ( cov]$ petitions t is a %am "u subsection 7b7 ( ?is section if ! ,secret>y ( ,heal? & ,human ,s]vices has det]m9$ t ! cov]$ petition 0 submitt$ ) ! prim>y purpose ( delay+ ! approval ( a cov]$ application1 0 "p ( a s]ies ( cov]$ petitions1 & has ref]r$ su* det]m9ation to ! ,f$]al ,trade ,commission 9 writ+1 ) a reason$ basis = ! det]m9ation4 7#c7 ,exception ,! presumption 9 p>agraph 7#b7 %all n apply if ! def5dant e/abli%es1 by a prepond]ance ( ! evid5ce1 t ! s]ies ( cov]$ petitions t includes ! cov]$ petition ref]r$ to ! ,commission by ! ,secret>y ( ,heal? & ,human ,s]vices is n a %am4 7#d7 ,civil p5alty ,9 an action "u p>agraph 7#a71 any p]son t has be5 f\nd liable = a violation ( section #e7;a77#a7 ( ! ,f$]al ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7;a77#a77 %all be subject to a civil p5alty = ea* violation ( n m ?an ! great] (-- 7,a7 any rev5ue e>n$ f ! sale by su* p]son ( any drug product1 ref]5c$ 9 a cov]$ application t 0 ! subject ( a cov]$ petition or a s]ies ( cov]$ petitions t is a %am1 dur+ ! p]iod 9 :i* ! cov]$ petition or s]ies ( cov]$ petitions 0 "u review by ! ,secret>y ( ,heal? & ,human ,s]vices2 or 7,b7 #ej1jjj = ea* cal5d> day t ea* cov]$ petition t is a %am or t 0 "p ( a s]ies ( cov]$ petitions t is a %am 0 "u review by ! ,secret>y ( ,heal? & ,human ,s]vices4 7#e7 ,antitru/ laws ,no?+ 9 ?is section %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$]al ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7 to ! ext5t t x applies to unfair me?ods ( competition4 7#f7 ,rule ( con/ruction ,! civil p5alty provid$ 9 ?is subsection is 9 addition to1 & n 9 lieu (1 any o!r rem$ies provid$ by ,f$]al law1 includ+ "u section #af ( ! ,clayton ,act 7#ae ,u4,s4,c4 #bf7 or "u section #ac7;b7 ( ! ,f$]al ,trade ,commission ,act 7#ae ,u4,s4,c4 #ec7;b774 ,no?+ 9 ?is p>agraph %all be con/ru$ to affect any au?ority ( ! ,commission "u any o!r provision ( law4 7d7 ,applicability ,?is section %all apply to any cov]$ petition submitt$ on or aft] ! date ( enactm5t ( ?is ,act4 #c4 ,sev]ability ,if any provision ( ?is ,act1 an am5dm5t made by ?is ,act1 or ! application ( su* provision or am5dm5t to any p]son or circum/ance is held to be uncon/itutional1 ! rema9d] ( ?is ,act1 ! am5dm5ts made by ?is ,act1 & ! application ( ! provisions ( su* ,act or am5dm5ts to any p]son or circum/ance %all n be affect$4 ,decemb] #bd1 #bjbj;,committ$ to ! ,committee ( ! ,:ole ,h\se on ! ,/ate ( ! ,union & ord]$ to be pr9t$