,i #aag? ,,congress #b;d ,session ,h4 ,r4 #figc ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,m>* #h1 #bjbb ,mr4 ,c>t] ( ,georgia introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,a ,,bill ,to am5d ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act to cl>ify ! conditions "u :i* ! ,secret>y ( ,heal? & ,human ,s]vices c approve g5]ic drug applications ) label+ tempor>ily diff]5t ?an ! br& "n drug1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,enhanc$ ,access to ,af=dable ,m$ic9es ,act ( #bjbb4 #b4 ,cl>ify+ ! conditions ( g5]ic drug application approval = la/-m9ute br& "n drug label+ *anges ,section #eje7;j77#aj77;,a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#aj77;,a77 is am5d$ by /rik+ clauses 7i7 ?r\gh 7iv7 & ins]t+ ! foll[+3 7i7 ! application is o!rwise eligible = approval "u ?is subsection except t-- 7,i7 7aa7 ! li/$ drug has an active pat5t1 ! li/$ drug has an active exclusivity p]iod1 or !re is a delay 9 approval z describ$ 9 p>agraph 7#e77;,b77iii72 & 7bb7 a revision to ! label+ ( ! li/$ drug has be5 approv$ by ! ,secret>y )9 #ij days ( expiration ( a pat5t1 exclusivity p]iod1 or delay 9 approval ref]5c$ 9 item 7aa72 or 7,,ii7 a revision to ! label+ ( ! li/$ drug has be5 approv$ by ! ,secret>y1 )9 #ij days ( :5 ! application is o!rwise eligible = approval "u ?is subsection2 7ii7 ! sponsor ( ! application agrees to submit revis$ label+ = ! drug t is ! subject ( ! application n lat] ?an #fj days aft] approval "u ?is subsection ( ! application2 & 7iii7 ! label+ revision describ$ "u clause 7i7 does n include a *ange to ! ,w>n+s section ( ! label+4 4