,i #aad? ,,congress #a/ ,session ,h4 ,r4 #bdbc ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,may #ai1 #bjae ,mr4 ,%imkus introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce ,a ,,bill ,to am5d ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act ) respect to valid sci5tific evid5ce4 #a4 ,valid sci5tific evid5ce ,section #eac7;a77#c77;,b7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;c7a77#c77;,b77 is am5d$-- 7#a7 by r$esignat+ clauses 7i7 & 7ii7 z subclauses 7,i7 & 7,,ii71 respectively2 7#b7 by /rik+ 7,b7 ,if ! ,secret>y & ins]t+ 7,b77i7 ,if ! ,secret>y2 & 7#c7 by add+ at ! end ! foll[+3 7ii7 ,valid sci5tific evid5ce = purposes ( clause 7i7 may include3 7,i7 evid5ce describ$ 9 well-docum5t$ case hi/ories1 includ+ regi/ry data1 t are collect$ & monitor$ "u an acceptable protocol2 7,,ii7 /udies publi%$ 9 pe]-review$ j\rnals2 & 7,,iii7 data collect$ 9 c\ntries o!r ?an ! ,unit$ ,/ates s long z su* data o!rwise meets ! crit]ia specifi$ 9 ?is subp>agraph4 7iii7 ,9 ! case ( a /udy publi%$ 9 a pe]-review$ j\rnal t is (f]$ z valid sci5tific evid5ce = purposes ( clause 7i71 ! ,secret>y may reque/ data und]ly+ ! /udy if-- 7,i7 ! ,secret>y1 9 mak+ su* reque/1 complies ) ! requirem5t ( subp>agraph 7,d77ii7 to consid] ! lea/ burd5some appropriate means ( evaluat+ device effectiv5ess or subsection 7i77#a77;,d7 to consid] ! lea/ burd5some means ( det]m9+ sub/antial equival5ce1 z applicable2 7,,ii7 ! ,secret>y furni%es a writt5 rationale = s reque/+ ! und]ly+ data toge!r ) su* reque/2 & 7,,iii7 if ! reque/$ und]ly+ data = su* a /udy are unavailable1 ! ,secret>y %all consid] su* /udy to be "p ( ! totality ( ! evid5ce ) respect to ! device1 z ! ,secret>y det]m9es appropriate4 4