,i #aai? ,,congress #a/ ,session ,h4 ,r4 #fdcd ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,decemb] #d1 #bjbe,ms4 ,dean ( ,p5nsylvania 7= h]self1 ,ms4 ,mace1 ,mr4 ,correa1 ,mr4 ,khanna1 ,mr4 ,lieu1 ,mr4 ,cr5%aw1 ,mr4 ,b]gman1 & ,mr4 ,luttrell7 introduc$ ! foll[+ bill2 :i* 0 ref]r$ to ! ,committee on ,en]gy & ,comm]ce1 & 9 addition to ! ,committee on ! ,judici>y1 = a p]iod to be subsequ5tly det]m9$ by ! ,speak]1 9 ea* case = consid]ation ( su* provisions z fall )9 ! jurisdiction ( ! committee conc]n$ ,a ,,bill ,to e/abli% a special regi/ration "u ! ,controll$ ,sub/ances ,act = s*$ule ,i eligible inve/igational drugs "u ! ,f$]al ,"r to ,try law4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,fre$om to ,heal ,act ( #bjbe4 #b4 ,special regi/ration requirem5ts relat$ to "r to try ,section #cjc ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hbc7 is am5d$ by add+ at ! end ! foll[+3 7p7 ,special regi/ration = s*$ule ,i eligible inve/igational drugs "u "r ,to try 7#a7 ,def9itions ,9 ?is subsection1 ! t]ms eligible inve/igational drug & eligible pati5t h ! mean+s giv5 ^? t]ms 9 section #efa;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#j;a74 7#b7 ,special regi/ration process ,! ,attorney ,g5]al %all regi/] physicians to directly adm9i/] eligible inve/igational drugs 9 s*$ule ,i to eligible pati5ts "u section #efa;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#j;a7 9 accordance ) p>agraphs 7#c7 ?r\gh 7#h7 ( ?is subsection4 7#c7 ,requirem5ts 7,a7 ,application ,a physician desir+ a regi/ration to directly adm9i/] an eligible inve/igational drug z describ$ 9 p>agraph 7#b7 %all submit to ! ,attorney ,g5]al an application conta9+-- 7i7 evid5ce ( a valid regi/ration to disp5se or adm9i/] controll$ sub/ances 9 s*$ules ,,ii ?r\gh ,v2 7ii7 evid5ce ( compliance ) section #efa;,b ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#j;a71 includ+-- 7,i7 docum5tation f ! manufactur] or sponsor v]ify+ ! inve/igational drug 9 s*$ule ,i is an eligible inve/igational drug2 7,,ii7 an agreem5t f ! manufactur] or sponsor to supply ! eligible inve/igational drug1 along ) guidance on its adm9i/ration1 to ! reque/+ physician = ! treatm5t ( eligible pati5ts2 & 7,,iii7 an affirmation t ! physician w only directly adm9i/] ! eligible inve/igational drug to treat eligible pati5ts 9 a mann] consi/5t ) ! guidance provid$ by ! manufactur] or sponsor2 7iii7 ! quantity ( ! eligible inve/igational drug to be suppli$ by ! manufactur] or sponsor to ! physician to treat eligible pati5ts2 7iv7 evid5ce t ! physician may treat eligible pati5ts ) eligible inve/igational drugs "u ! laws ( ! ,/ate 9 :i* ! treatm5t w take place2 7v7 evid5ce ( tra9+1 cr$5tials1 or exp]i5ce relevant to treat+ pati5ts ) ! eligible inve/igational drug2 7vi7 a description ( ! site at :i* ! physician int5ds to /ore & adm9i/] ! eligible inve/igational drug2 & 7vii7 any additional in=mation ! ,attorney ,g5]al det]m9es necess>y to prev5t div]sion4 7,b7 ,approval ,n lat] ?an #de days aft] receiv+ an application conta9+ ! in=mation requir$ "u subp>agraph 7,a71 ! ,attorney ,g5]al %all-- 7i7 regi/] ! applicant2 or 7ii7 s]ve an ord] to %[ cause ^u ! applicant 9 accordance ) section #cjd7;c74 7#d7 ,electronic submissions ,! ,attorney ,g5]al %all provide a means = a physician to submit an application "u p>agraph 7#c77;,a7 electronically4 7#e7 ,limitation on am\nts ,a physician treat+ eligible pati5ts ) an eligible inve/igational drug 9 s*$ule ,i "u ?is subsection may only possess ! am\nts ( ! eligible inve/igational drug id5tifi$ 9-- 7,a7 ! application submitt$ to ! ,attorney ,g5]al "u p>agraph 7#c77;,a72 or 7,b7 a supplem5tal notification t ! physician may submit to ! ,attorney ,g5]al if ! physician ne$s additional am\nts ( ! eligible inve/igational drug = ! treatm5t ( eligible pati5ts1 :i* supplem5tal notification-- 7i7 %all include-- 7,i7 ! "n ( ! physician2 7,,ii7 ! additional quantity ( ! eligible inve/igational drug ne$$2 & 7,,iii7 an atte/ation t ! treatm5t ) ! eligible inve/igational drug is consi/5t ) ! scope ( treatm5t t 0 ! subject ( ! application "u p>agraph 7#c77;,a72 & 7ii7 %all be deem$ approv$ on ! date t is #cj days aft] ! date on :i* ! physician submits ! supplem5tal notification to ! ,attorney ,g5]al1 unless ! ,attorney ,g5]al s]ves an ord] to %[ cause ^u ! applicant 9 accordance ) section #cjd7;c74 7#f7 ,s+le regi/ration = relat$ treatm5t sites ,a physician may treat eligible pati5ts ) an eligible inve/igational drug 9 s*$ule ,i "u a s+le regi/ration "u ?is subsection if-- 7,a7 ! treatm5t occurs exclusively on sites all ( :i* are-- 7i7 )9 ! same city or c\nty2 & 7ii7 "u ! control ( ! same in/itution1 organization1 or ag5cy2 & 7,b7 be=e comm5c+ ! treatm5t1 ! physician notifies ! ,attorney ,g5]al ( ea* site :]e ! eligible inve/igational drug w be /or$ or adm9i/]$ 9 accordance ) p>agraph 7#c77;,a77vi74 7#g7 ,rulemak+ ,not)/&+ ! requirem5ts ( section #eec ( title #e1 ,unit$ ,/ates ,code1 n lat] ?an #bdj days aft] ! date ( enactm5t ( ?is subsection1 ! ,attorney ,g5]al %all issue an int]im f9al rule to implem5t ?is subsection1 includ+ ) respect to-- 7,a7 ! mann] 9 :i* an eligible inve/igational drug may be deliv]$ to an approv$ regi/rant2 7,b7 ! /orage & security ( an eligible inve/igational drug2 7,c7 ! ma9t5ance ( records = an approv$ regi/rant2 7,d7 ! process = r5ewal1 susp5sion1 or revocation ( a regi/ration2 & 7,e7 any o!r matt]s necess>y to ensure effective controls aga9/ div]sion4 7#h7 ,f9al rule ,n lat] ?an #b ye>s aft] issu+ an int]im f9al rule "u p>agraph 7#g71 ! ,attorney ,g5]al %all issue a f9al rule to implem5t ?is subsection 9 accordance ) section #eec ( title #e1 ,unit$ ,/ates ,code4 4