,,ii #aag? ,,congress #a/ ,session ,s4 #ccie ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,decemb] #ad1 #bjba,ms4 ,baldw9 7= h]self & ,mr4 ,cassidy7 introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,heal?1 ,education1 ,labor1 & ,p5sions ,a ,,bill ,to am5d ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act ) respect to records & o!r in=mation inspections4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,m$ical ,device ,integrity ,act4 #b4 ,records & o!r in=mation inspection 7a7 ,9 g5]al ,section #gjd7;a77#d77;,a7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7;a77#d77;,a77 is am5d$-- 7#a7 9 ! fir/ s5t5ce1 by ins]t+ or device aft] process+ ( a drug2 & 7#b7 9 ! second s5t5ce1 by /rik+ %all include & all t foll[s ?r\gh ! p]iod at ! end & ins]t+ ! foll[+3 8%all include-- 7,a7 a suffici5t description ( ! records reque/$2 & 7,b7 a rationale = reque/+ su* in=mation 9 advance (1 or 9 lieu (1 an inspection4 4 7b7 ,guidance ,n lat] ?an #a ye> aft] ! date ( enactm5t ( ?is ,act1 ! ,secret>y %all issue draft guidance describ+ ! circum/ances 9 :i* ! ,secret>y int5ds to issue reque/s = records or o!r in=mation 9 advance (1 or 9 lieu (1 an inspection1 processes = respond+ to su* reque/s electronically or 9 physical =m1 & factors ! ,secret>y int5ds to consid] 9 evaluat+ :e!r su* records are provid$ )9 a reasonable timeframe1 )9 reasonable limits1 & 9 a reasonable mann]1 acc\nt+ = res\rce & o!r limitations t may exi/1 includ+ = small bus9esses4 ,! ,secret>y %all issue f9al guidance n lat] ?an #a ye> aft] ! close ( ! comm5t p]iod = ! draft guidance4