,i #aaf? ,,congress #a/ ,session ,h4 ,r4 #bchg ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,april #bi1 #bjai,mr4 ,lev9 ( ,mi*igan 7= himself & ,mr4 ,rooney ( ,florida7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,a ,,bill ,to am5d subsection 7q7 ( section #eje ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act to cl>ify ! process = d5y+ c]ta9 petitions ^: prim>y purpose is to delay ! approval ( an application submitt$ "u subsection 7b77#b7 or 7j7 ( su* section #eje1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,/op ,! ,ov]use ( ,petitions & ,get ,af=dable ,m$ic9es to ,ent] ,soon ,act ( #bjai or ! ,,/op ,,games ,act ( #bjai4 #b4 ,d5ial ( petitions ^: prim>y purpose is to delay approval ( c]ta9 applications 7a7 ,9 g5]al ,subp>agraph 7,e7 ( section #eje7q77#a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7q77#a77 is am5d$ to read z foll[s3 7,e7 ,d5ial bas$ on int5t to delay 7i7 ,9 g5]al ,if ! ,secret>y det]m9es t a petition or a supplem5t to ! petition 0 submitt$ ) ! prim>y purpose ( delay+ ! approval ( an application or ! petition does n on its face raise valid sci5tific or regulatory issues1 ! ,secret>y may d5y ! petition at any po9t bas$ on su* det]m9ation4 7ii7 ,factors ,! ,secret>y may issue guidance to describe ! factors t w be us$ to det]m9e "u ?is subp>agraph :e!r a petition is submitt$ ) ! prim>y purpose ( delay+ ! approval ( an application4 ,su* factors %all include ! foll[+3 7,i7 ,submission ( a petition :]e x appe>s1 bas$ on ! date t relevant in=mation reli$ ^u 9 ! petition became kn[n to ! petition] 7or reasonably %\ld h be5 kn[n to ! petition]71 t ! petition] has tak5 an unreasonable l5g? ( "t to submit ! petition4 7,,ii7 ,submission ( multiple or s]ial petitions rais+ issues t reasonably c\ld h be5 kn[n to ! petition] at ! "t ( submission ( ! e>li] petition or petitions4 7,,iii7 ,submission ( a petition close 9 "t to a kn[n1 fir/ date ^u :i* an application "u subsection 7b77#b7 or 7j7 ( ?is section or "u section #cea7k7 ( ! ,public ,heal? ,s]vice ,act c\ld be approv$ 7su* z submission close 9 "t to ! expiration ( a block+ pat5t or exclusivity74 7,,iv7 ,submission ( a petition )\t any data or in=mation 9 support ( ! sci5tific positions set =? 9 ! petition4 7,v7 ,submission ( a petition rais+ ! same or sub/antially simil> issues z a prior petition to :i* ! ,food & ,drug ,adm9i/ration has already sub/antively respond$1 p>ticul>ly :]e ! subsequ5t submission closely foll[s 9 "t ! e>li] response4 7,,vi7 ,submission ( a petition conc]n+ /&>ds = approval ( a drug product = :i*-- 7aa7 ! ,food & ,drug ,adm9i/ration has provid$ an opportunity = public input 7su* z :5 ! ,food & ,drug ,adm9i/ration has issu$ draft or f9al product-specific guidance applicable to ! drug product72 & 7bb7 ! petition] has n provid$ comm5t o!r ?an ?r\gh ! petition4 7,,vii7 ,submission ( a petition reque/+ t o!r applicants mu/ meet /&>ds = te/+1 data1 or label+ = _! products t are m on]\s or rigor\s ?an ! /&>ds applicable to ! applicable li/$ drug or ! petition]'s v]sion ( ! same product4 7,,viii7 ,o!r relevant consid]ations1 includ+ ! hi/ory ( ! petition] ) ! ,food & ,drug ,adm9i/ration 7su* z :e!r ! petition] has a hi/ory ( submitt+ petitions :i* ! ,food & ,drug ,adm9i/ration has det]m9$ 7 submitt$ ) ! prim>y purpose ( delay74 7iii7 ,ref]ral to ,,ftc ,if ! ,secret>y det]m9es t a petition has be5 submitt$ ) ! prim>y purpose ( delay+ ! approval ( an application1 z describ$ 9 clause 7i71 ! ,secret>y %all ref] ! matt] to ! ,f$]al ,trade ,commission4 4 7b7 ,deadl9e = submission ( petitions 7#a7 ,deadl9e ,clause 7i7 ( section #eje7q77#a77;,a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7q77#a77;,a77 is am5d$ to read z foll[s3 7i7 ! reque/ is 9 writ+1 is a petition submitt$ to ! ,secret>y pursuant to section #aj4cj1 #aj4ca1 or #aj4ce ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations71 & is submitt$ n lat] ?an #fj days aft] ! in=mation ^u :i* ! petition is bas$ fir/ became kn[n to ! p>ty on ^: behalf ! petition is submitt$2 & 4 7#b7 ,c]tification ,section #eje7q77#a77;,h7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7q77#a77 is am5d$ by /rik+ ,i fur!r c]tify t ! in=mation ^u :i* ,i h bas$ ! action reque/$ h]e9 fir/ became kn[n to ! p>ty on ^: behalf ?is petition is submitt$ on or ab\t ! foll[+ date3 4 & ins]t+ ,i fur!r c]tify t ! in=mation ^u :i* ,i h bas$ ! action reque/$ h]e9 fir/ became kn[n to ! p>ty on ^: behalf ?is petition is submitt$ on or ab\t 1 :i* date 0 n m ?an #fj days be=e ! date ( submitt+ ?is petition44 7c7 ,report+ to ,congress ,section #eje7q77#c7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7q77#c77 is am5d$-- 7#a7 9 ! matt] be=e subp>agraph 7,a71 by /rik+ specifies2 7#b7 9 subp>agraphs 7,a71 7,b71 7,c71 & 7,d71 by /rik+ ! numb] & ins]t+ specifies ! numb]2 7#c7 9 subp>agraph 7,c71 by /rik+ & at ! end2 7#d7 9 subp>agraph 7,d71 by /rik+ ! p]iod at ! end & ins]t+ 2 &2 & 7#e7 by add+ at ! end ! foll[+3 7,e7 7i7 li/s ea* petition submitt$ dur+ su* p]iod &1 = ea*1 id5tifies ! petition]2 7ii7 quantifies ! "t & res\rces exp5d$ on ea* su* petition2 7iii7 /ates ! tim+ ( ! petition relative to ! expiration date ( ! pat5ts specifi$ 9 ! p5d+ application 9 ! c]tification "u subsection 7b77#b77;,a7 or 7j77#b77;,a77vii71 z applicable2 7iv7 quantifies ! delay1 if any1 caus$ by any su* petition on ! approval ( any application submitt$ "u subsection 7b77#b7 or 7j71 includ+ a description ( h[ any su* delay is calculat$ & an e/imate ( :5 any delay$ approval w\ld h be5 grant$ abs5t ! petition2 & 7v7 9 cases 9 :i* a p5d+ application & a petition ) respect to su* p5d+ application are dispos$ ( on ! same or ne>ly ! same date1 /ates :5 ! ,food & ,drug ,adm9i/ration w\ld h dispos$ ( ! p5d+ application abs5t ! petition4 4