,i #aai? ,,congress #a/ ,session ,h4 ,r4 #hcj ,,9 ,,! ,,h\se ,,( ,,repres5tatives ,janu>y #ca1 #bjbe,mr4 ,pappas 7= himself1 ,ms4 ,salaz>1 & ,mr4 ,ne:\se7 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 am5d ! ,controll$ ,sub/ances ,act ) respect to f5tanyl-relat$ sub/ances1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,save ,am]icans f ! ,f5tanyl ,em]g5cy ,act or ! ,,safe ,act4 #b4 ,class s*$ul+ ( f5tanyl-relat$ sub/ances ,section #bjb7;c7 ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hab7;c77 is am5d$ by add+ at ! end ( s*$ule ,i ! foll[+3 7e7 7#a7 ,unless specifically exempt$ or unless li/$ 9 ano!r s*$ule1 any mat]ial1 comp\nd1 mixture1 or prep>ation :i* conta9s any quantity ( f5tanyl-relat$ sub/ances1 or :i* conta9s _! salts1 isom]s1 & salts ( isom]s :5ev] ! exi/5ce ( su* salts1 isom]s1 & salts ( isom]s is possible )9 ! specific *emical designation4 7#b7 ,9 ?is subsection1 except z provid$ 9 p>agraph 7#c71 ! t]m f5tanyl-relat$ sub/ance means any sub/ance t is /ructurally relat$ to f5tanyl by "o or m ( ! foll[+ modifications3 7,a7 ,by replacem5t ( ! ph5yl portion ( ! ph5e?yl gr\p by any monocycle1 :e!r or n fur!r sub/itut$ 9 or on ! monocycle4 7,b7 ,by sub/itution 9 or on ! ph5e?yl gr\p ) alkyl1 alk5yl1 alkoxyl1 hydroxyl1 halo1 haloalkyl1 am9o1 or nitro gr\ps4 7,c7 ,by sub/itution 9 or on ! pip]id9e r+ ) alkyl1 alk5yl1 alkoxyl1 e/]1 e!r1 hydroxyl1 halo1 haloalkyl1 am9o1 or nitro gr\ps4 7,d7 ,by replacem5t ( ! anil9e r+ ) any aromatic monocycle :e!r or n fur!r sub/itut$ 9 or on ! aromatic monocycle4 7,e7 ,by replacem5t ( ! ,n-propionyl gr\p ) ano!r acyl gr\p4 7#c7 ,a sub/ance t meets ! crit]ia specifi$ 9 p>agraph 7#b7 to be consid]$ a f5tanyl-relat$ sub/ance %all n be s consid]$ z meet+ su* crit]ia if su* sub/ance-- 7,a7 is controll$ by action ( ! ,attorney ,g5]al pursuant to section #bja2 7,b7 is expressly li/$ 9 ?is s*$ule or ano!r s*$ule by a /atutory provision o!r ?an ?is subsection2 or 7,c7 is remov$ f ?is s*$ule1 or res*$ul$ to ano!r s*$ule1 pursuant to section #bja7k74 7#d7 ,! ,attorney ,g5]al %all publi% 9 ! ,f$]al ,regi/] a li/ ( individual sub/ances t meet ! def9ition ( f5tanyl-relat$ sub/ances 9 p>agraph 7#b7 )9 #fj days ( det]m9+ su* sub/ances meet su* def9ition4 ,! abs5ce ( a sub/ance on any su* li/ does n negate ! control /atus ( su* sub/ance if ! sub/ance meets ! crit]ia specifi$ 9 p>agraph 7#b7 to be consid]$ a f5tanyl-relat$ sub/ance4 7#e7 ,not)/&+ any o!r provision ( ?is title or title ,,iii1 f5tanyl-relat$ sub/ances %all n be subject to quantity-bas$ m&atory m9imum p5alties pursuant to subp>agraph 7,a77vi7 or 7,b77vi7 ( section #dja7;b77#a7 ( ?is title or p>agraph 7#a77;,f7 or 7#b77;,f7 ( section #ajaj7;b7 ( title ,,iii4 4 #c4 ,p5alty provisions ) respect to f5tanyl-relat$ sub/ances--dome/ic (f5ses ,section #dja7;b77#a7 ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hda7;b77#a77 is am5d$-- 7#a7 9 subp>agraph 7,a71 by /rik+ clause 7vi7 & ins]t+ ! foll[+3 7vi7 7,i7 #djj grams or m ( a mixture or sub/ance conta9+ a detectable am\nt ( f5tanyl2 or 7,,ii7 #ajj grams or m ( a mixture or sub/ance conta9+ a detectable am\nt ( any analogue ( f5tanyl t is controll$ 9 s*$ule ,i or ,,ii or t is treat$ z a s*$ule ,i controll$ sub/ance pursuant to section #bjc7;a71 except = a f5tanyl-relat$ sub/ance z def9$ 9 s*$ule ,i7e7 ( section #bjb7;c72 2 7#b7 9 subp>agraph 7,b71 by /rik+ clause 7vi7 & ins]t+ ! foll[+3 7vi7 7,i7 #dj grams or m ( a mixture or sub/ance conta9+ a detectable am\nt ( f5tanyl2 or 7,,ii7 #aj grams or m ( a mixture or sub/ance conta9+ a detectable am\nt ( any analogue ( f5tanyl t is controll$ 9 s*$ule ,i or ,,ii or t is treat$ z a s*$ule ,i controll$ sub/ance pursuant to section #bjc7;a71 except = a f5tanyl-relat$ sub/ance z def9$ 9 s*$ule ,i7e7 ( section #bjb7;c72 2 & 7#c7 9 subp>agraph 7,c71 by ins]t+ 1 includ+ a f5tanyl-relat$ sub/ance z def9$ 9 s*$ule ,i7e7 ( section #bjb7;c71 aft] a controll$ sub/ance 9 s*$ule ,i or ,,ii14 #d4 ,p5alty provisions ) respect to f5tanyl-relat$ sub/ances--import & export (f5ses ,section #ajaj7;b7 ( ! ,controll$ ,sub/ances ,import & ,export ,act 7#ba ,u4,s4,c4 #ifj7;b77 is am5d$-- 7#a7 9 p>agraph 7#a71 by /rik+ subp>agraph 7,f7 & ins]t+ ! foll[+3 7,f7 7i7 #djj grams or m ( a mixture or sub/ance conta9+ a detectable am\nt ( f5tanyl2 or 7ii7 #ajj grams or m ( a mixture or sub/ance conta9+ a detectable am\nt ( any analogue ( f5tanyl t is controll$ 9 s*$ule ,i or ,,ii or t is treat$ z a s*$ule ,i controll$ sub/ance pursuant to section #bjc7;a7 ( ! ,controll$ ,sub/ances ,act1 except = a f5tanyl-relat$ sub/ance z def9$ 9 s*$ule ,i7e7 ( section #bjb7;c7 ( ! ,controll$ ,sub/ances ,act2 2 7#b7 9 p>agraph 7#b71 by /rik+ subp>agraph 7,f7 & ins]t+ ! foll[+3 7,f7 7i7 #dj grams or m ( a mixture or sub/ance conta9+ a detectable am\nt ( f5tanyl2 or 7ii7 #aj grams or m ( a mixture or sub/ance conta9+ a detectable am\nt ( any analogue ( f5tanyl t is controll$ 9 s*$ule ,i or ,,ii or t is treat$ z a s*$ule ,i controll$ sub/ance pursuant to section #bjc7;a7 ( ! ,controll$ ,sub/ances ,act1 except = a f5tanyl-relat$ sub/ance z def9$ 9 s*$ule ,i7e7 ( section #bjb7;c7 ( ! ,controll$ ,sub/ances ,act2 2 & 7#c7 9 p>agraph 7#c71 by ins]t+ includ+ a f5tanyl-relat$ sub/ance z def9$ 9 s*$ule ,i7e7 ( section #bjb7;c7 ( ! ,controll$ ,sub/ances ,act1 aft] a controll$ sub/ance 9 s*$ule ,i or ,,ii14 #e4 ,removal f s*$ule ,i ( f5tanyl-relat$ sub/ances ,section #bja ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #haa7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7k7 ,removal f s*$ule ,i ( f5tanyl-,relat$ sub/ances 7#a7 ,det]m9ation result+ 9 removal ,if ! ,secret>y det]m9es1 tak+ into consid]ation factors z set =? 9 p>agraph 7#c71 t a f5tanyl-relat$ sub/ance has a pot5tial = abuse t is less ?an ! drugs or o!r sub/ances 9 s*$ule ,v-- 7,a7 ! ,secret>y %all submit to ! ,attorney ,g5]al a sci5tific & m$ical evaluation ( t f5tanyl-relat$ sub/ance support+ t det]m9ation2 7,b7 ! ,secret>y %all submit any su* evaluation & det]m9ation 9 writ+ & include ! bases !re=2 7,c7 ! sci5tific & m$ical det]m9ation ( ! ,secret>y conta9$ 9 su* evaluation %all be b9d+ on ! ,attorney ,g5]al2 & 7,d7 n lat] ?an #ij days aft] receiv+ su* evaluation & det]m9ation1 ! ,attorney ,g5]al %all issue an ord] remov+ su* f5tanyl-relat$ sub/ance f ! s*$ules "u section #bjb4 7#b7 ,det]m9ation result+ 9 res*$ul+ ,if ! ,secret>y det]m9es1 tak+ into consid]ation factors z set =? 9 p>agraph 7#c71 t a f5tanyl-relat$ sub/ance has a pot5tial = abuse t is less ?an ! drugs or o!r sub/ances 9 s*$ules ,i & ,,ii-- 7,a7 ! ,secret>y %all submit to ! ,attorney ,g5]al a sci5tific & m$ical evaluation ( t f5tanyl-relat$ sub/ance support+ t det]m9ation2 7,b7 ! ,secret>y %all submit any su* evaluation & det]m9ation 9 writ+ & include ! bases !re=2 7,c7 ! sci5tific & m$ical det]m9ation ( ! ,secret>y conta9$ 9 su* evaluation %all be b9d+ on ! ,attorney ,g5]al2 & 7,d7 n lat] ?an #ij days aft] receiv+ su* evaluation1 ! ,attorney ,g5]al %all issue an ord] remov+ su* f5tanyl-relat$ sub/ance f s*$ule ,i & controll+ su* sub/ance "u s*$ule ,,iii4 7#c7 ,evaluation factors 7,a7 ,9 g5]al ,9 mak+ a det]m9ation "u p>agraph 7#a7 or 7#b71 ! ,secret>y-- 7i7 %all consid]-- 7,i7 ! factor li/$ 9 p>agraph 7#b7 ( subsection 7c72 7,,ii7 ! factors li/$ 9 p>agraphs 7#a71 7#c71 & 7#f7 ( su* subsection to ! ext5t evid5ce exi/s ) respect to su* factors2 & 7,,iii7 any in=mation submitt$ to ! ,secret>y by ! ,attorney ,g5]al = purposes ( su* det]m9ation2 & 7ii7 may consid] ! factors li/$ 9 p>agraphs 7#d71 7#e71 & 7#g7 ( subsection 7c7 if ! ,secret>y f9ds t evid5ce exi/s ) respect to su* factors4 7,b7 ,consid]ation ( sci5tific evid5ce ( ph>macological effect 7i7 ,9 g5]al ,= ! purposes ( subp>agraph 7,a77i77,i71 consid]ation by ! ,secret>y ( ! results ( an assessm5t consi/+ ( ! /udies describ$ 9 clause 7ii7 %all suffice to con/itute consid]ation ( ! factor li/$ 9 p>agraph 7#b7 ( subsection 7c7 if-- 7,i7 ea* su* /udy is p]=m$ accord+ to sci5tific me?ods & protocols commonly accept$ 9 ! sci5tific community2 & 7,,ii7 ! ,secret>y det]m9es t su* assessm5t is adequate = su* purposes4 7ii7 ,describ$ /udies ,! /udies describ$ 9 ?is clause are any ( ! foll[+3 7,i7 ,a receptor b9d+ /udy t c demon/rate :e!r ! sub/ance has aff9ity = ! human mu opioid receptor4 7,,ii7 ,an 9 vitro functional assay t c demon/rate :e!r ! sub/ance has agoni/ activity at ! human mu opioid receptor4 7,,iii7 ,"o or m 9 vivo animal behavioral /udies t c demon/rate :e!r ! sub/ance has abuse-relat$ drug effects consi/5t ) mu opioid agoni/ activity1 su* z demon/rat+ simil>ity to ! effects ( morph9e4 7#d7 ,advance notice reg>d+ evaluation & conclusion ,! ,secret>y %all give ! ,attorney ,g5]al at lea/ #cj days notice be=e s5d+ ! ,attorney ,g5]al an evaluation & det]m9ation "u p>agraph 7#a7 or 7#b7 ) respect to a f5tanyl-relat$ sub/ance4 7#e7 ,exception = treaty obligations ,if a f5tanyl-relat$ sub/ance is a sub/ance t ! ,unit$ ,/ates is obligat$ to control "u int]national treaties1 conv5tions1 or protocols 9 effect on ! date ( enactm5t ( ! ,save ,am]icans f ! ,f5tanyl ,em]g5cy ,act1 ?is subsection %all n require ! ,attorney ,g5]al-- 7,a7 to remove su* sub/ance f control2 or 7,b7 to place su* sub/ance 9 a s*$ule less re/rictive ?an t :i* ! ,attorney ,g5]al det]m9es is necess>y to c>ry out su* obligations4 7#f7 ,id5tification ( f5tanyl-relat$ sub/ances ,if ! ,attorney ,g5]al or any (ficial ( ! ,dep>tm5t ( ,ju/ice det]m9es t a sub/ance is a f5tanyl-relat$ sub/ance1 ! ,attorney ,g5]al %all-- 7,a7 )9 #cj days ( su* det]m9ation1 notify ! ,secret>y2 & 7,b7 include 9 su* notification ! id5tity ( ! sub/ance1 its /ructure1 & ! basis = ! det]m9ation4 7#g7 ,petitions = remov+ a f5tanyl-relat$ sub/ance 7,a7 ,9 g5]al ,if a p]son petitions ! ,attorney ,g5]al to remove a f5tanyl-relat$ sub/ance f s*$ule ,i7e7 or to res*$ule su* a sub/ance to ano!r s*$ule1 ! ,attorney ,g5]al %all consid] su* a petition 9 accordance ) ! proc$ures & /&>ds set =? 9-- 7i7 subsections 7a7 & 7b7 ( ?is section2 & 7ii7 section #acjh4dc ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulations74 7,b7 ,attorney ,g5]al to in=m ,secret>y ,)9 #cj days ( receiv+ su* a petition1 ! ,attorney ,g5]al %all =w>d a copy ( ! petition to ! ,secret>y4 7,c7 ,det]m9ation proc$ure n preclud$ by fil+ ( petition ,! fil+ ( a petition "u ?is p>agraph %all n preclude ! ,secret>y f mak+ a det]m9ation & s5d+ an evaluation "u p>agraph 7#a7 or 7#b74 7#h7 ,rule ( con/ruction ,no?+ 9 ?is subsection %all be con/ru$ to preclude ! ,attorney ,g5]al f transf]r+ a sub/ance li/$ 9 s*$ule ,i to ano!r s*$ule1 or remov+ su* sub/ance entirely f ! s*$ules1 pursuant to o!r provisions ( ?is section & section #bjb4 7#i7 ,subsequ5t controll+ ( remov$ sub/ance ,a sub/ance remov$ f s*$ule ,i pursuant to ?is subsection may1 at any "t1 be controll$ pursuant to ! o!r provisions ( ?is section & section #bjb )\t reg>d to ! removal pursuant to ?is subsection4 7#aj7 ,evaluations or /udies ,! ,secret>y may ent] into contracts or o!r agreem5ts to conduct or support evaluations or /udies ( f5tanyl-relat$ sub/ances4 7#aa7 ,def9ition ,9 ?is subsection1 ! t]m f5tanyl-relat$ sub/ance means a f5tanyl-relat$ sub/ance z def9$ 9 s*$ule ,i7e7 ( section #bjb7;c74 4 #f4 ,pa/ cases involv+ remov$ or res*$ul$ sub/ances 7a7 ,dome/ic cases ,section #dja7;b7 ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hda7;b77 is am5d$ by add+ at ! end ! foll[+3 7#h7 ,pa/ convictions involv+ f5tanyl-,relat$ sub/ance 7,a7 ,9 g5]al ,9 ! case ( a def5dant ^: (f5se ( conviction "u ?is title involv$ a f5tanyl-relat$ sub/ance 7z def9$ 9 s*$ule ,i7e7 ( section #bjb7;c7 z ( ! date ! (f5se 0 committ$7 t has s9ce be5 remov$ f designation z a f5tanyl-relat$ sub/ance = purposes ( ?is title & has be5 plac$ on any s*$ule o!r ?an s*$ule ,i or ,,ii or has be5 remov$ f ! controll$ sub/ance s*$ules1 ! s5t5c+ c\rt may1 on motion ( ! def5dant1 ! ,bureau ( ,prisons1 ! attorney = ! ,gov]nm5t1 or on its own motion1 aft] consid]+ ! factors set =? 9 section #ceec7;a7 ( title #ah1 ,unit$ ,/ates ,code1 vacate ! previ\sly impos$ s5t5ce1 or impose a r$uc$ s5t5ce on any c\nt ( conviction z if ! removal or placem5t 0 9 effect at ! "t t ! (f5se 0 committ$4 ,no?+ 9 ?is section may be con/ru$ to require a c\rt to vacate or r$uce any s5t5ce4 7,b7 ,def5dant n requir$ to be pres5t ,not)/&+ rule #dc ( ! ,f$]al ,rules ( ,crim9al ,proc$ure1 ! def5dant is n requir$ to be pres5t at any he>+ on :e!r to vacate or r$uce a s5t5ce pursuant to ?is section4 4 7b7 ,import & export cases ,section #ajaj7;b7 ( ! ,controll$ ,sub/ances ,import & ,export ,act 7#ba ,u4,s4,c4 #ifj7;b77 is am5d$ by add+ at ! end ! foll[+3 7#h7 ,9 ! case ( a def5dant ^: (f5se ( conviction "u ?is title involv$ a f5tanyl-relat$ sub/ance 7z def9$ 9 s*$ule ,i7e7 ( section #bjb7;c7 ( ! ,controll$ ,sub/ances ,act z ( ! date ! (f5se 0 committ$7 t has s9ce be5 remov$ f designation z a f5tanyl-relat$ sub/ance = purposes ( ?is title & has be5 plac$ on any s*$ule o!r ?an s*$ule ,i or ,,ii or has be5 remov$ f ! controll$ sub/ance s*$ules1 ! s5t5c+ c\rt may1 on motion ( ! def5dant1 ! ,bureau ( ,prisons1 ! attorney = ! ,gov]nm5t1 or on its own motion1 aft] consid]+ ! factors set =? 9 section #ceec7;a7 ( title #ah1 ,unit$ ,/ates ,code1 vacate ! previ\sly impos$ s5t5ce1 or impose a r$uc$ s5t5ce on any c\nt ( conviction z if ! removal or placem5t 0 9 effect at ! "t t ! (f5se 0 committ$4 ,no?+ 9 ?is section may be con/ru$ to require a c\rt to vacate or r$uce any s5t5ce4 4 #g4 ,regi/ration requirem5ts relat$ to rese>* 7a7 ,alt]native regi/ration process = s*$ule ,i rese>* ,section #cjc ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hbc7 is am5d$ by add+ at ! end ! foll[+ new subsection3 7m7 ,special provisions = ^? conduct+ c]ta9 rese>* ) s*$ule ,i controll$ sub/ances 7#a7 ,9 g5]al ,not)/&+ subsection 7f71 a practition] may conduct rese>* t is describ$ 9 p>agraph 7#b7 & t is ) "o or m controll$ sub/ances 9 s*$ule ,i if "o ( ! foll[+ conditions is satisfi$3 7,a7 ,rese>*] ) a curr5t s*$ule ,i or ,,ii rese>* regi/ration ,if ! practition] is regi/]$ to conduct rese>* ) a controll$ sub/ance 9 s*$ule ,i or ,,ii1 ! practition] may conduct rese>* "u ?is p>agraph #cj days aft] ! practition] has s5t a notice to ! ,attorney ,g5]al conta9+ ! foll[+ in=mation1 ) respect to ea* sub/ance ) :i* ! rese>* w be conduct$3 7i7 ,! *emical "n ( ! sub/ance4 7ii7 ,! quantity ( ! sub/ance to be us$ 9 su* rese>*4 7iii7 ,demon/ration t ! rese>* is describ$ 9 p>agraph 7#b71 :i* demon/ration c be satisfi$-- 7,i7 9 ! case ( rese>* describ$ 9 p>agraph 7#b77;,a71 by supply+ ! numb] ( ! application submitt$ "u section #eje7;i7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or section #cea7;a77#c7 ( ! ,public ,heal? ,s]vice ,act & ! sponsor ( record on su* application2 or 7,,ii7 9 ! case ( rese>* describ$ 9 p>agraph 7#b77;,b71 by id5tify+ ! sponsor+ ag5cy & supply+ ! numb] ( ! grant1 contract1 coop]ative agreem5t1 o!r transaction1 or project4 7iv7 ,demon/ration t ! rese>*] is au?oriz$ to conduct rese>* ) respect to ! sub/ance "u ! laws ( ! ,/ate 9 :i* ! rese>* w take place4 7,b7 ,rese>*] )\t a curr5t s*$ule ,i or ,,ii rese>* regi/ration ,if ! practition] is n curr5tly regi/]$ to conduct rese>* ) a controll$ sub/ance 9 s*$ule ,i or ,,ii-- 7i7 ! practition] may s5d a notice to ! ,attorney ,g5]al conta9+ ! in=mation li/$ 9 subp>agraph 7,a71 ) respect to ea* sub/ance ) :i* ! rese>* w be conduct$2 7ii7 ! ,attorney ,g5]al %all treat su* notice z a suffici5t application = a rese>* regi/ration2 & 7iii7 )9 #de days aft] receiv+ su* a notice t conta9s all in=mation requir$ by subp>agraph 7,a71 ! ,attorney ,g5]al %all regi/] ! applicant1 or s]ve an ord] to %[ cause ^u ! applicant 9 accordance ) section #cjd7;c74 7,c7 ,v]ification ( in=mation ,on reque/ f ! ,attorney ,g5]al1 ! ,secret>y ( ,heal? & ,human ,s]vices or ! ,secret>y ( ,vet]ans ,affairs1 z appropriate1 %all v]ify in=mation submitt$ by an applicant "u subp>agraph 7,a77iii74 7#b7 ,rese>* subject to exp$it$ proc$ure ,rese>* describ$ 9 ?is p>agraph is rese>* t-- 7,a7 is ! subject ( an application "u section #eje7;i7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act or section #cea7;a77#c7 ( ! ,public ,heal? ,s]vice ,act = ! inve/igation ( a drug :i* is 9 effect 9 accordance ) section #cab4dj ( title #ba1 ,code ( ,f$]al ,regulations2 or 7,b7 is conduct$ by ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 ! ,dep>tm5t ( ,ju/ice1 or ! ,dep>tm5t ( ,vet]ans ,affairs or is fund$ p>tly or entirely by a grant1 contract1 coop]ative agreem5t1 or o!r transaction f ! ,dep>tm5t ( ,heal? & ,human ,s]vices1 ! ,dep>tm5t ( ,ju/ice1 or ! ,dep>tm5t ( ,vet]ans ,affairs4 7#c7 ,electronic submissions ,! ,attorney ,g5]al %all provide a means to all[ practition]s to submit notifications "u p>agraph 7#a7 electronically4 7#d7 ,limitation on am\nts ,a practition] conduct+ rese>* ) a controll$ sub/ance 9 s*$ule ,i pursuant to ?is subsection %all be all[$ to possess only ! am\nts ( ! controll$ sub/ance 9 s*$ule ,i id5tifi$ 9-- 7,a7 ! notification to ! ,attorney ,g5]al "u p>agraph 7#a72 or 7,b7 if ! practition] ne$s additional am\nts = ! rese>*1 a supplem5tal notification "u ?is subsection t includes ! practition]'s "n1 ! additional quantity ne$$ ( ! sub/ance1 & an atte/ation t ! rese>* to be conduct$ ) ! sub/ance is consi/5t ) ! scope ( ! rese>* t 0 ! subject ( ! notification "u p>agraph 7#a74 7#e7 ,importation & exportation requirem5ts n affect$ ,no?+ 9 ?is section alt]s ! requirem5ts ( "p ,a ( title ,,iii reg>d+ ! importation & exportation ( controll$ sub/ances4 4 7b7 ,sep>ate regi/rations n requir$ = additional rese>*] 9 same in/itution ,subsection 7c7 ( section #cjb ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hbb7 is am5d$ by add+ at ! end ! foll[+3 7#d7 ,an ag5t or employee ( a rese>* in/itution t is conduct+ rese>* ) a controll$ sub/ance if-- 7,a7 su* ag5t or employee is act+ )9 ! scope ( 8 or h] pr(essional practice2 7,b7 ano!r ag5t or employee ( su* in/itution is regi/]$ to conduct rese>* ) a controll$ sub/ance 9 ! same s*$ule2 7,c7 ! rese>*] :o is s regi/]$-- 7i7 in=ms ! ,attorney ,g5]al ( ! "n1 position title1 & employ+ in/itution ( ! ag5t or employee :o is n sep>ately regi/]$2 7ii7 au?orizes su* ag5t or employee to p]=m rese>* "u ! regi/]$ rese>*]'s regi/ration2 & 7iii7 affirms t all acts tak5 by su* ag5t or employee involv+ controll$ sub/ances %all be attributable to ! regi/]$ rese>*]1 z if ! rese>*] _h directly committ$ su* acts1 = purposes ( any proce$+ "u section #cjd7;a7 to susp5d or revoke ! regi/ration ( ! regi/]$ rese>*]2 & 7,d7 ! ,attorney ,g5]al does n1 )9 #cj days ( receiv+ ! in=mation1 au?orization1 & affirmation describ$ 9 subp>agraph 7,c71 refuse1 = a reason li/$ 9 section #cjd7;a71 to all[ su* ag5t or employee to possess su* sub/ance )\t a sep>ate regi/ration4 4 7c7 ,s+le regi/ration = relat$ rese>* sites ,su* section #cjb7;e7 ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hbb7;e77 is am5d$ by add+ at ! end ! foll[+3 7#d7 7,a7 ,not)/&+ p>agraph 7#a71 a p]son regi/]$ to conduct rese>* ) a controll$ sub/ance "u section #cjc7;f7 may conduct su* rese>* at multiple sites "u a s+le regi/ration if-- 7i7 su* rese>* occurs exclusively at sites :i* are all )9 ! same city or c\nty & are all "u ! control ( ! same in/itution1 organization1 or ag5cy2 & 7ii7 ! rese>*] notifies ! ,attorney ,g5]al1 prior to comm5c+ su* rese>*1 ( all sites :]e-- 7,i7 ! rese>* w be conduct$2 or 7,,ii7 ! controll$ sub/ance w be /or$ or adm9i/]$4 7,b7 ,a site describ$ by subp>agraph 7,a7 %all be includ$ 9 su* regi/ration only if ! rese>*] has notifi$ ! ,attorney ,g5]al ( su* site-- 7i7 9 ! application = su* regi/ration2 or 7ii7 be=e ! rese>* is conduct$1 or be=e ! controll$ sub/ance is /or$ or adm9i/]$1 at su* site4 7,c7 ,! ,attorney ,g5]al may1 9 consultation ) ! ,secret>y ( ,heal? & ,human ,s]vices1 issue regulations address+-- 7i7 ! mann] 9 :i* controll$ sub/ances may be deliv]$ to rese>* sites describ$ 9 subp>agraph 7,a72 7ii7 ! /orage & security ( controll$ sub/ances at su* rese>* sites2 7iii7 ! ma9t5ance ( records = su* rese>* sites2 & 7iv7 any o!r matt]s necess>y to ensure effective controls aga9/ div]sion at su* rese>* sites4 4 7d7 ,new inspection n requir$ 9 c]ta9 situations ,subsection 7f7 ( section #cjb ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hbb7 is am5d$-- 7#a7 by /rik+ 7f7 ,! & ins]t+ 7f77#a7 ,!2 & 7#b7 by add+ at ! end ! foll[+3 7#b7 7,a7 ,a new inspection by ! ,attorney ,g5]al ( a regi/]$ location is n requir$ if a p]son is regi/]$ "u ?is title to conduct rese>* ) a controll$ sub/ance & applies = a regi/ration1 or = a modification ( a regi/ration1 to conduct rese>* ) a second controll$ sub/ance t is-- 7i7 9 ! same s*$ule z ! fir/ controll$ sub/ance2 or 7ii7 is 9 a s*$ule ) a high] num]ical designation ?an ! s*$ule ( ! fir/ controll$ sub/ance4 7,b7 ,no?+ 9 ?is p>agraph %all prohibit ! ,attorney ,g5]al f conduct+ any inspection if ! ,attorney ,g5]al deems x necess>y to ensure t ! regi/rant ma9ta9s effective controls aga9/ div]sion4 4 7e7 ,cont9uation ( rese>* on sub/ances newly add$ to s*$ule ,i ,section #cjb ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hbb7 is am5d$ by add+ at ! end ! foll[+3 7h7 ,cont9uation ( rese>* on sub/ances newly add$ to s*$ule ,i ,if a p]son is conduct+ rese>* on a sub/ance at ! "t ! sub/ance is add$ to s*$ule ,i1 & su* p]son is already regi/]$ "u ?is title to conduct rese>* ) a controll$ sub/ance 9 s*$ule ,i1 !n-- 7#a7 ! p]son %all1 )9 #ij days ( ! s*$ul+ 9 s*$ule ,i1 submit a complet$ application = regi/ration "u ?is title or modification ( an exi/+ regi/ration "u ?is title1 to conduct rese>* on su* sub/ance1 9 accordance ) regulations issu$ by ! ,attorney ,g5]al2 7#b7 ! p]son may1 not)/&+ subsections 7a7 & 7b71 cont9ue to conduct ! rese>* on su* sub/ance until-- 7,a7 ! p]son )draws su* application2 or 7,b7 ! ,attorney ,g5]al s]ves on ! p]son an ord] to %[ cause propos+ ! d5ial ( ! application pursuant to section #cjd7;c72 7#c7 if ! ,attorney ,g5]al s]ves su* an ord] to %[ cause & ! p]son reque/s a he>+1 su* he>+ %all be held on an exp$it$ basis & n lat] ?an #de days aft] ! reque/ is made1 except t ! he>+ may be held at a lat] "t if s reque/$ by ! p]son2 & 7#d7 if ! p]son s5ds a copy ( ! application requir$ by p>agraph 7#a7 to a manufactur] or di/ributor ( su* sub/ance1 receipt ( su* copy by su* manufactur] or di/ributor %all con/itute suffici5t evid5ce t ! p]son is au?oriz$ to receive su* sub/ance4 4 7f7 ,treatm5t ( c]ta9 manufactur+ activities z co9cid5t to rese>* ,section #cjb ( ! ,controll$ ,sub/ances ,act 7#ba ,u4,s4,c4 #hbb71 z am5d$ by subsection 7e71 is fur!r am5d$ by add+ at ! end ! foll[+3 7i7 ,treatm5t ( c]ta9 manufactur+ activities z co9cid5t to rese>* 7#a7 ,9 g5]al ,except z specifi$ 9 p>agraph 7#c71 a p]son :o is regi/]$ to p]=m rese>* on a controll$ sub/ance may p]=m manufactur+ activities ) small quantities ( t sub/ance1 includ+ activities li/$ 9 p>agraph 7#b71 )\t be+ requir$ to obta9 a manufactur+ regi/ration1 if su* activities are p]=m$ = ! purpose ( ! rese>* & if ! activities & ! quantities ( ! sub/ance involv$ 9 ^? activities are /at$ 9-- 7,a7 a notification submitt$ to ! ,attorney ,g5]al "u section #cjc7m72 7,b7 a protocol fil$ ) an application = regi/ration approval "u section #cjc7;f72 or 7,c7 a notification to ! ,attorney ,g5]al t includes ! regi/rant's "n & an atte/ation t ! rese>* to be conduct$ ) ! small quantities ( manufactur$ sub/ance is consi/5t ) ! scope ( ! rese>* t is ! basis = ! regi/ration4 7#b7 ,activities includ$ ,activities p]mitt$ "u p>agraph 7#a7 include-- 7,a7 process+ ! sub/ance to create extracts1 t9ctures1 oils1 solutions1 d]ivatives1 or o!r =ms ( ! sub/ance consi/5t ) ! in=mation provid$ z "p ( a notification submitt$ to ! ,attorney ,g5]al "u section #cjc7m7 or a rese>* protocol fil$ ) ! application = regi/ration approval2 & 7,b7 dosage =m developm5t /udies p]=m$ = ! purpose ( satisfy+ regulatory requirem5ts ( ! ,food & ,drug ,adm9i/ration = submitt+ an inve/igational new drug application4 7#c7 ,exception reg>d+ m>ihuana ,! au?ority "u p>agraph 7#a7 to manufacture sub/ances does n include au?ority to gr[ m>ihuana4 4 7g7 ,transp>5cy reg>d+ special proc$ures ,section #cjc ( su* ,act 7#ba ,u4,s4,c4 #hbc71 z am5d$ by subsection 7a71 is fur!r am5d$ by add+ at ! end ! foll[+3 7n7 ,transp>5cy reg>d+ special proc$ures 7#a7 ,9 g5]al ,if ! ,attorney ,g5]al det]m9es1 ) respect to a controll$ sub/ance1 t an application by a practition] to conduct rese>* ) su* sub/ance %\ld be consid]$ "u a process1 or subject to crit]ia1 diff]5t f ! process or crit]ia applicable to applications to conduct rese>* ) o!r controll$ sub/ances 9 ! same s*$ule1 ! ,attorney ,g5]al %all make public1 includ+ by po/+ on ! website ( ! ,drug ,en=cem5t ,adm9i/ration-- 7,a7 ! id5tities ( all sub/ances = :i* su* det]m9ations h be5 made2 7,b7 ! process & crit]ia t w be appli$ to applications to conduct rese>* ) su* sub/ances2 & 7,c7 h[ su* process & crit]ia diff] f ^? applicable to applications to conduct rese>* ) o!r controll$ sub/ances 9 ! same s*$ule4 7#b7 ,tim+ ( po/+ ,! ,attorney ,g5]al %all make su* in=mation public ^u mak+ su* det]m9ation1 reg>dless ( :e!r a practition] has submitt$ su* an application at t "t4 4 #h4 ,rulemak+ 7a7 ,int]im f9al rules ,! ,attorney ,g5]al-- 7#a7 n lat] ?an #a ye> ( ! date ( enactm5t ( ?is ,act1 %all issue rules to implem5t ?is ,act & ! am5dm5ts made by ?is ,act2 & 7#b7 may issue su* rules z int]im f9al rules4 7b7 ,proc$ure = f9al rule ,a rule issu$ by ! ,attorney ,g5]al z an int]im f9al rule "u subsection 7a7 %all become imm$iately effective z an int]im f9al rule )\t requir+ ! ,attorney ,g5]al to demon/rate good cause !re=4 ,! int]im f9al rule %all give int]e/$ p]sons ! opportunity to comm5t & to reque/ a he>+4 ,aft] ! conclusion ( su* proce$+s1 ! ,attorney ,g5]al %all issue a f9al rule 9 accordance ) section #eec ( title #e1 ,unit$ ,/ates ,code4 #i4 ,,gao report 7a7 ,9 g5]al ,n m ?an #d ye>s aft] ! date ( enactm5t ( ?is ,act1 ! ,comptroll] ,g5]al ( ! ,unit$ ,/ates %all submit to ! ,committees on ,en]gy & ,comm]ce & ! ,judici>y ( ! ,h\se ( ,repres5tatives & ! ,committee on ! ,judici>y ( ! ,s5ate a report analyz+ ! implem5tation & impact1 to ! ext5t in=mation is available1 ( p]man5t class s*$ul+ pursuant to s*$ule ,i7e7 ( section #bjb7;c7 ( ! ,controll$ ,sub/ances ,act1 z add$ by section #b ( ?is ,act1 ( f5tanyl-relat$ sub/ances 7z def9$ 9 su* s*$ule ,i7e771 :i* report %all include-- 7#a7 an analysis ( ! impact on rese>* ( f5tanyl-relat$ sub/ances2 7#b7 an analysis ( any actions tak5 to remove or res*$ule 9 a diff]5t class any f5tanyl-relat$ sub/ance2 7#c7 an analysis ( ! impact ( p]man5t s*$ul+ on ! unlawful importation1 manufacture1 traffick+1 & use ( f5tanyl-relat$ sub/ances1 tak+ into consid]ation data collect$ conc]n+ ! prolif]ation ( f5tanyl-relat$ sub/ances s9ce class s*$ul+ 0 in/itut$2 7#d7 an analysis ( s5t5ces attributable to crim9al *>ges involv+ f5tanyl-relat$ sub/ances1 comp>+ ^? s5t5ces to s5t5ces attributable to crim9al *>ges involv+ f5tanyl & individually s*$ul$ f5tanyl analogues2 & 7#e7 an analysis ( ! efficacy ( class s*$ul+ g5]ally1 9 t]ms ( r$uc+ ! prolif]ation ( new controll$ sub/ance analogues4 7b7 ,consultations ,9 develop+ ! report requir$ by subsection 7a71 ! ,comptroll] ,g5]al-- 7#a7 %all consid] ! views ( ! ,secret>y ( ,heal? & ,human ,s]vices1 ! ,attorney ,g5]al1 ! ,secret>y ( ,homel& ,security1 ! ,secret>y ( ,/ate1 ! ,director ( ! ,(fice ( ,national ,drug ,control ,policy1 ! sci5tific & m$ical rese>* community1 ! ,/ate & local law en=cem5t community1 & ! civil rights & crim9al ju/ice re=m communities2 & 7#b7 to ! greate/ ext5t possible1 %\ld base su* report on reliable data & empirical in=mation4