,i  #aaith ,,congress  #ast ,session    
,h4 ,r4 #hcj  ,,in ,,the ,,house ,,of   
,,representatives  ,january #ca1        
#bjbe,mr4 ,pappas 7for himself1 ,ms4    
,salazar1 and ,mr4 ,newhouse7 introduced
 the following bill2 which was referred 
to the ,committee on ,energy and        
,commerce1 and in addition to the       
,committee on the ,judiciary1 for a     
period to be subsequently determined by 
the ,speaker1 in each case for          
consideration of such provisions as fall
 within the jurisdiction of the         
committee concerned  ,a ,,bill  ,to     
amend the ,controlled ,substances ,act  
with respect to fentanyl-related        
substances1 and for other purposes4  #a4
 ,short title ,this ,act may be cited as
 the ,save ,americans from the ,fentanyl
 ,emergency ,act or the ,,safe ,act4    
#b4 ,class scheduling of                
fentanyl-related substances ,section    
#bjb7;c7 of the ,controlled ,substances 
,act 7#ba ,u4,s4,c4 #hab7;c77 is amended
 by adding at the end of schedule ,i the

 following3  7e7 7#a7 ,unless           
specifically exempted or unless listed  
in another schedule1 any material1      
compound1 mixture1 or preparation which 
contains any quantity of                
fentanyl-related substances1 or which   
contains their salts1 isomers1 and salts
 of isomers whenever the existence of   
such salts1 isomers1 and salts of       
isomers is possible within the specific 
chemical designation4  7#b7 ,in this    
subsection1 except as provided in       
paragraph 7#c71 the term                
fentanyl-related substance means any    
substance that is structurally related  
to fentanyl by one or more of the       
following modifications3 7,a7 ,by       
replacement of the phenyl portion of the
 phenethyl group by any monocycle1      
whether or not further substituted in or
 on the monocycle4  7,b7 ,by            
substitution in or on the phenethyl     
group with alkyl1 alkenyl1 alkoxyl1     
hydroxyl1 halo1 haloalkyl1 amino1 or    
nitro groups4  7,c7 ,by substitution in 

or on the piperidine ring with alkyl1   
alkenyl1 alkoxyl1 ester1 ether1         
hydroxyl1 halo1 haloalkyl1 amino1 or    
nitro groups4  7,d7 ,by replacement of  
the aniline ring with any aromatic      
monocycle whether or not further        
substituted in or on the aromatic       
monocycle4  7,e7 ,by replacement of the 
,n-propionyl group with another acyl    
group4  7#c7 ,a substance that meets the
 criteria specified in paragraph 7#b7 to
 be considered a fentanyl-related       
substance shall not be so considered as 
meeting such criteria if such           
substance-- 7,a7 is controlled by action
 of the ,attorney ,general pursuant to  
section #bja2  7,b7 is expressly listed 
in this schedule or another schedule by 
a statutory provision other than this   
subsection2 or  7,c7 is removed from    
this schedule1 or rescheduled to another
 schedule1 pursuant to section #bja7k74 
7#d7 ,the ,attorney ,general shall      
publish in the ,federal ,register a list
 of individual substances that meet the 

definition of fentanyl-related          
substances in paragraph 7#b7 within #fj 
days of determining such substances meet
 such definition4 ,the absence of a     
substance on any such list does not     
negate the control status of such       
substance if the substance meets the    
criteria specified in paragraph 7#b7 to 
be considered a fentanyl-related        
substance4  7#e7 ,notwithstanding any   
other provision of this title or title  
,,iii1 fentanyl-related substances shall
 not be subject to quantity-based       
mandatory minimum penalties pursuant to 
subparagraph 7,a77vi7 or 7,b77vi7 of    
section #dja7;b77#a7 of this title or   
paragraph 7#a77;,f7 or 7#b77;,f7 of     
section #ajaj7;b7 of title ,,iii4  4    
#c4 ,penalty provisions with respect to 
fentanyl-related substances--domestic   
offenses ,section #dja7;b77#a7 of the   
,controlled ,substances ,act 7#ba       
,u4,s4,c4 #hda7;b77#a77 is amended--    
7#a7 in subparagraph 7,a71 by striking  
clause 7vi7 and inserting the following3

  7vi7 7,i7 #djj grams or more of a     
mixture or substance containing a       
detectable amount of fentanyl2 or       
7,,ii7 #ajj grams or more of a mixture  
or substance containing a detectable    
amount of any analogue of fentanyl that 
is controlled in schedule ,i or ,,ii or 
that is treated as a schedule ,i        
controlled substance pursuant to section
 #bjc7;a71 except for a fentanyl-related
 substance as defined in schedule ,i7e7 
of section #bjb7;c72  2  7#b7 in        
subparagraph 7,b71 by striking clause   
7vi7 and inserting the following3  7vi7 
7,i7 #dj grams or more of a mixture or  
substance containing a detectable amount
 of fentanyl2 or  7,,ii7 #aj grams or   
more of a mixture or substance          
containing a detectable amount of any   
analogue of fentanyl that is controlled 
in schedule ,i or ,,ii or that is       
treated as a schedule ,i controlled     
substance pursuant to section #bjc7;a71 
except for a fentanyl-related substance 
as defined in schedule ,i7e7 of section 

#bjb7;c72  2 and  7#c7 in subparagraph  
7,c71 by inserting 1 including a        
fentanyl-related substance as defined in
 schedule ,i7e7 of section #bjb7;c71    
after a controlled substance in schedule
 ,i or ,,ii14  #d4 ,penalty provisions  
with respect to fentanyl-related        
substances--import and export offenses  
,section #ajaj7;b7 of the ,controlled   
,substances ,import and ,export ,act    
7#ba ,u4,s4,c4 #ifj7;b77 is amended--   
7#a7 in paragraph 7#a71 by striking     
subparagraph 7,f7 and inserting the     
following3  7,f7 7i7 #djj grams or more 
of a mixture or substance containing a  
detectable amount of fentanyl2 or  7ii7 
#ajj grams or more of a mixture or      
substance containing a detectable amount
 of any analogue of fentanyl that is    
controlled in schedule ,i or ,,ii or    
that is treated as a schedule ,i        
controlled substance pursuant to section
 #bjc7;a7 of the ,controlled ,substances
 ,act1 except for a fentanyl-related    
substance as defined in schedule ,i7e7  

of section #bjb7;c7 of the ,controlled  
,substances ,act2  2  7#b7 in paragraph 
7#b71 by striking subparagraph 7,f7 and 
inserting the following3  7,f7 7i7 #dj  
grams or more of a mixture or substance 
containing a detectable amount of       
fentanyl2 or  7ii7 #aj grams or more of 
a mixture or substance containing a     
detectable amount of any analogue of    
fentanyl that is controlled in schedule 
,i or ,,ii or that is treated as a      
schedule ,i controlled substance        
pursuant to section #bjc7;a7 of the     
,controlled ,substances ,act1 except for
 a fentanyl-related substance as defined
 in schedule ,i7e7 of section #bjb7;c7  
of the ,controlled ,substances ,act2  2 
and  7#c7 in paragraph 7#c71 by         
inserting including a fentanyl-related  
substance as defined in schedule ,i7e7  
of section #bjb7;c7 of the ,controlled  
,substances ,act1 after a controlled    
substance in schedule ,i or ,,ii14  #e4 
,removal from schedule ,i of            
fentanyl-related substances ,section    

#bja of the ,controlled ,substances ,act
 7#ba ,u4,s4,c4 #haa7 is amended by     
adding at the end the following new     
subsection3  7k7 ,removal from schedule 
,i of fentanyl-,related substances  7#a7
 ,determination resulting in removal ,if
 the ,secretary determines1 taking into 
consideration factors as set forth in   
paragraph 7#c71 that a fentanyl-related 
substance has a potential for abuse that
 is less than the drugs or other        
substances in schedule ,v-- 7,a7 the    
,secretary shall submit to the ,attorney
 ,general a scientific and medical      
evaluation of that fentanyl-related     
substance supporting that determination2
  7,b7 the ,secretary shall submit any  
such evaluation and determination in    
writing and include the bases therefor2 
7,c7 the scientific and medical         
determination of the ,secretary         
contained in such evaluation shall be   
binding on the ,attorney ,general2 and  
7,d7 not later than #ij days after      
receiving such evaluation and           

determination1 the ,attorney ,general   
shall issue an order removing such      
fentanyl-related substance from the     
schedules under section #bjb4  7#b7     
,determination resulting in rescheduling
 ,if the ,secretary determines1 taking  
into consideration factors as set forth 
in paragraph 7#c71 that a               
fentanyl-related substance has a        
potential for abuse that is less than   
the drugs or other substances in        
schedules ,i and ,,ii-- 7,a7 the        
,secretary shall submit to the ,attorney
 ,general a scientific and medical      
evaluation of that fentanyl-related     
substance supporting that determination2
  7,b7 the ,secretary shall submit any  
such evaluation and determination in    
writing and include the bases therefor2 
7,c7 the scientific and medical         
determination of the ,secretary         
contained in such evaluation shall be   
binding on the ,attorney ,general2 and  
7,d7 not later than #ij days after      
receiving such evaluation1 the ,attorney

 ,general shall issue an order removing 
such fentanyl-related substance from    
schedule ,i and controlling such        
substance under schedule ,,iii4  7#c7   
,evaluation factors  7,a7 ,in general   
,in making a determination under        
paragraph 7#a7 or 7#b71 the ,secretary--
 7i7 shall consider-- 7,i7 the factor   
listed in paragraph 7#b7 of subsection  
7c72  7,,ii7 the factors listed in      
paragraphs 7#a71 7#c71 and 7#f7 of such 
subsection to the extent evidence exists
 with respect to such factors2 and      
7,,iii7 any information submitted to the
 ,secretary by the ,attorney ,general   
for purposes of such determination2 and 
7ii7 may consider the factors listed in 
paragraphs 7#d71 7#e71 and 7#g7 of      
subsection 7c7 if the ,secretary finds  
that evidence exists with respect to    
such factors4  7,b7 ,consideration of   
scientific evidence of pharmacological  
effect  7i7 ,in general ,for the        
purposes of subparagraph 7,a77i77,i71   
consideration by the ,secretary of the  

results of an assessment consisting of  
the studies described in clause 7ii7    
shall suffice to constitute             
consideration of the factor listed in   
paragraph 7#b7 of subsection 7c7 if--   
7,i7 each such study is performed       
according to scientific methods and     
protocols commonly accepted in the      
scientific community2 and  7,,ii7 the   
,secretary determines that such         
assessment is adequate for such         
purposes4  7ii7 ,described studies ,the 
studies described in this clause are any
 of the following3 7,i7 ,a receptor     
binding study that can demonstrate      
whether the substance has affinity for  
the human mu opioid receptor4  7,,ii7   
,an in vitro functional assay that can  
demonstrate whether the substance has   
agonist activity at the human mu opioid 
receptor4  7,,iii7 ,one or more in vivo 
animal behavioral studies that can      
demonstrate whether the substance has   
abuse-related drug effects consistent   
with mu opioid agonist activity1 such as

 demonstrating similarity to the effects
 of morphine4  7#d7 ,advance notice     
regarding evaluation and conclusion ,the
 ,secretary shall give the ,attorney    
,general at least #cj days notice before
 sending the ,attorney ,general an      
evaluation and determination under      
paragraph 7#a7 or 7#b7 with respect to a
 fentanyl-related substance4  7#e7      
,exception for treaty obligations ,if a 
fentanyl-related substance is a         
substance that the ,united ,states is   
obligated to control under international
 treaties1 conventions1 or protocols in 
effect on the date of enactment of the  
,save ,americans from the ,fentanyl     
,emergency ,act1 this subsection shall  
not require the ,attorney ,general--    
7,a7 to remove such substance from      
control2 or  7,b7 to place such         
substance in a schedule less restrictive
 than that which the ,attorney ,general 
determines is necessary to carry out    
such obligations4  7#f7 ,identification 
of fentanyl-related substances ,if the  

,attorney ,general or any official of   
the ,department of ,justice determines  
that a substance is a fentanyl-related  
substance1 the ,attorney ,general       
shall-- 7,a7 within #cj days of such    
determination1 notify the ,secretary2   
and  7,b7 include in such notification  
the identity of the substance1 its      
structure1 and the basis for the        
determination4  7#g7 ,petitions for     
removing a fentanyl-related substance   
7,a7 ,in general ,if a person petitions 
the ,attorney ,general to remove a      
fentanyl-related substance from schedule
 ,i7e7 or to reschedule such a substance
 to another schedule1 the ,attorney     
,general shall consider such a petition 
in accordance with the procedures and   
standards set forth in-- 7i7 subsections
 7a7 and 7b7 of this section2 and  7ii7 
section #acjh4dc of title #ba1 ,code of 
,federal ,regulations 7or any successor 
regulations74  7,b7 ,attorney ,general  
to inform ,secretary ,within #cj days of
 receiving such a petition1 the         

,attorney ,general shall forward a copy 
of the petition to the ,secretary4  7,c7
 ,determination procedure not precluded 
by filing of petition ,the filing of a  
petition under this paragraph shall not 
preclude the ,secretary from making a   
determination and sending an evaluation 
under paragraph 7#a7 or 7#b74  7#h7     
,rule of construction ,nothing in this  
subsection shall be construed to        
preclude the ,attorney ,general from    
transferring a substance listed in      
schedule ,i to another schedule1 or     
removing such substance entirely from   
the schedules1 pursuant to other        
provisions of this section and section  
#bjb4  7#i7 ,subsequent controlling of  
removed substance ,a substance removed  
from schedule ,i pursuant to this       
subsection may1 at any time1 be         
controlled pursuant to the other        
provisions of this section and section  
#bjb without regard to the removal      
pursuant to this subsection4  7#aj7     
,evaluations or studies ,the ,secretary 

may enter into contracts or other       
agreements to conduct or support        
evaluations or studies of               
fentanyl-related substances4  7#aa7     
,definition ,in this subsection1 the    
term fentanyl-related substance means a 
fentanyl-related substance as defined in
 schedule ,i7e7 of section #bjb7;c74  4 
#f4 ,past cases involving removed or    
rescheduled substances  7a7 ,domestic   
cases ,section #dja7;b7 of the          
,controlled ,substances ,act 7#ba       
,u4,s4,c4 #hda7;b77 is amended by adding
 at the end the following3  7#h7 ,past  
convictions involving fentanyl-,related 
substance  7,a7 ,in general ,in the case
 of a defendant whose offense of        
conviction under this title involved a  
fentanyl-related substance 7as defined  
in schedule ,i7e7 of section #bjb7;c7 as
 of the date the offense was committed7 
that has since been removed from        
designation as a fentanyl-related       
substance for purposes of this title and
 has been placed on any schedule other  

than schedule ,i or ,,ii or has been    
removed from the controlled substance   
schedules1 the sentencing court may1 on 
motion of the defendant1 the ,bureau of 
,prisons1 the attorney for the          
,government1 or on its own motion1 after
 considering the factors set forth in   
section #ceec7;a7 of title #ah1 ,united 
,states ,code1 vacate the previously    
imposed sentence1 or impose a reduced   
sentence on any count of conviction as  
if the removal or placement was in      
effect at the time that the offense was 
committed4 ,nothing in this section may 
be construed to require a court to      
vacate or reduce any sentence4  7,b7    
,defendant not required to be present   
,notwithstanding rule #dc of the        
,federal ,rules of ,criminal ,procedure1
 the defendant is not required to be    
present at any hearing on whether to    
vacate or reduce a sentence pursuant to 
this section4  4  7b7 ,import and export
 cases ,section #ajaj7;b7 of the        
,controlled ,substances ,import and     

,export ,act 7#ba ,u4,s4,c4 #ifj7;b77 is
 amended by adding at the end the       
following3  7#h7 ,in the case of a      
defendant whose offense of conviction   
under this title involved a             
fentanyl-related substance 7as defined  
in schedule ,i7e7 of section #bjb7;c7 of
 the ,controlled ,substances ,act as of 
the date the offense was committed7 that
 has since been removed from designation
 as a fentanyl-related substance for    
purposes of this title and has been     
placed on any schedule other than       
schedule ,i or ,,ii or has been removed 
from the controlled substance schedules1
 the sentencing court may1 on motion of 
the defendant1 the ,bureau of ,prisons1 
the attorney for the ,government1 or on 
its own motion1 after considering the   
factors set forth in section #ceec7;a7  
of title #ah1 ,united ,states ,code1    
vacate the previously imposed sentence1 
or impose a reduced sentence on any     
count of conviction as if the removal or
 placement was in effect at the time    

that the offense was committed4 ,nothing
 in this section may be construed to    
require a court to vacate or reduce any 
sentence4  4  #g4 ,registration         
requirements related to research  7a7   
,alternative registration process for   
schedule ,i research ,section #cjc of   
the ,controlled ,substances ,act 7#ba   
,u4,s4,c4 #hbc7 is amended by adding at 
the end the following new subsection3   
7m7 ,special provisions for those       
conducting certain research with        
schedule ,i controlled substances  7#a7 
,in general ,notwithstanding subsection 
7f71 a practitioner may conduct research
 that is described in paragraph 7#b7 and
 that is with one or more controlled    
substances in schedule ,i if one of the 
following conditions is satisfied3 7,a7 
,researcher with a current schedule ,i  
or ,,ii research registration ,if the   
practitioner is registered to conduct   
research with a controlled substance in 
schedule ,i or ,,ii1 the practitioner   
may conduct research under this         

paragraph #cj days after the            
practitioner has sent a notice to the   
,attorney ,general containing the       
following information1 with respect to  
each substance with which the research  
will be conducted3 7i7 ,the chemical    
name of the substance4  7ii7 ,the       
quantity of the substance to be used in 
such research4  7iii7 ,demonstration    
that the research is described in       
paragraph 7#b71 which demonstration can 
be satisfied-- 7,i7 in the case of      
research described in paragraph         
7#b77;,a71 by supplying the number of   
the application submitted under section 
#eje7;i7 of the ,federal ,food1 ,drug1  
and ,cosmetic ,act or section           
#cea7;a77#c7 of the ,public ,health     
,service ,act and the sponsor of record 
on such application2 or  7,,ii7 in the  
case of research described in paragraph 
7#b77;,b71 by identifying the sponsoring
 agency and supplying the number of the 
grant1 contract1 cooperative agreement1 
other transaction1 or project4  7iv7    

,demonstration that the researcher is   
authorized to conduct research with     
respect to the substance under the laws 
of the ,state in which the research will
 take place4  7,b7 ,researcher without a
 current schedule ,i or ,,ii research   
registration ,if the practitioner is not
 currently registered to conduct        
research with a controlled substance in 
schedule ,i or ,,ii-- 7i7 the           
practitioner may send a notice to the   
,attorney ,general containing the       
information listed in subparagraph 7,a71
 with respect to each substance with    
which the research will be conducted2   
7ii7 the ,attorney ,general shall treat 
such notice as a sufficient application 
for a research registration2 and  7iii7 
within #de days after receiving such a  
notice that contains all information    
required by subparagraph 7,a71 the      
,attorney ,general shall register the   
applicant1 or serve an order to show    
cause upon the applicant in accordance  
with section #cjd7;c74  7,c7            

,verification of information ,on request
 from the ,attorney ,general1 the       
,secretary of ,health and ,human        
,services or the ,secretary of ,veterans
 ,affairs1 as appropriate1 shall verify 
information submitted by an applicant   
under subparagraph 7,a77iii74  7#b7     
,research subject to expedited procedure
 ,research described in this paragraph  
is research that-- 7,a7 is the subject  
of an application under section #eje7;i7
 of the ,federal ,food1 ,drug1 and      
,cosmetic ,act or section #cea7;a77#c7  
of the ,public ,health ,service ,act for
 the investigation of a drug which is in
 effect in accordance with section      
#cab4dj of title #ba1 ,code of ,federal 
,regulations2 or  7,b7 is conducted by  
the ,department of ,health and ,human   
,services1 the ,department of ,justice1 
or the ,department of ,veterans ,affairs
 or is funded partly or entirely by a   
grant1 contract1 cooperative agreement1 
or other transaction from the           
,department of ,health and ,human       

,services1 the ,department of ,justice1 
or the ,department of ,veterans         
,affairs4  7#c7 ,electronic submissions 
,the ,attorney ,general shall provide a 
means to allow practitioners to submit  
notifications under paragraph 7#a7      
electronically4  7#d7 ,limitation on    
amounts ,a practitioner conducting      
research with a controlled substance in 
schedule ,i pursuant to this subsection 
shall be allowed to possess only the    
amounts of the controlled substance in  
schedule ,i identified in-- 7,a7 the    
notification to the ,attorney ,general  
under paragraph 7#a72 or  7,b7 if the   
practitioner needs additional amounts   
for the research1 a supplemental        
notification under this subsection that 
includes the practitioner's name1 the   
additional quantity needed of the       
substance1 and an attestation that the  
research to be conducted with the       
substance is consistent with the scope  
of the research that was the subject of 
the notification under paragraph 7#a74  

7#e7 ,importation and exportation       
requirements not affected ,nothing in   
this section alters the requirements of 
part ,a of title ,,iii regarding the    
importation and exportation of          
controlled substances4  4  7b7 ,separate
 registrations not required for         
additional researcher in same           
institution ,subsection 7c7 of section  
#cjb of the ,controlled ,substances ,act
 7#ba ,u4,s4,c4 #hbb7 is amended by     
adding at the end the following3  7#d7  
,an agent or employee of a research     
institution that is conducting research 
with a controlled substance if-- 7,a7   
such agent or employee is acting within 
the scope of his or her professional    
practice2  7,b7 another agent or        
employee of such institution is         
registered to conduct research with a   
controlled substance in the same        
schedule2  7,c7 the researcher who is so
 registered-- 7i7 informs the ,attorney 
,general of the name1 position title1   
and employing institution of the agent  

or employee who is not separately       
registered2  7ii7 authorizes such agent 
or employee to perform research under   
the registered researcher's             
registration2 and  7iii7 affirms that   
all acts taken by such agent or employee
 involving controlled substances shall  
be attributable to the registered       
researcher1 as if the researcher had    
directly committed such acts1 for       
purposes of any proceeding under section
 #cjd7;a7 to suspend or revoke the      
registration of the registered          
researcher2 and  7,d7 the ,attorney     
,general does not1 within #cj days of   
receiving the information1              
authorization1 and affirmation described
 in subparagraph 7,c71 refuse1 for a    
reason listed in section #cjd7;a71 to   
allow such agent or employee to possess 
such substance without a separate       
registration4  4  7c7 ,single           
registration for related research sites 
,such section #cjb7;e7 of the           
,controlled ,substances ,act 7#ba       

,u4,s4,c4 #hbb7;e77 is amended by adding
 at the end the following3  7#d7 7,a7   
,notwithstanding paragraph 7#a71 a      
person registered to conduct research   
with a controlled substance under       
section #cjc7;f7 may conduct such       
research at multiple sites under a      
single registration if-- 7i7 such       
research occurs exclusively at sites    
which are all within the same city or   
county and are all under the control of 
the same institution1 organization1 or  
agency2 and  7ii7 the researcher        
notifies the ,attorney ,general1 prior  
to commencing such research1 of all     
sites where-- 7,i7 the research will be 
conducted2 or  7,,ii7 the controlled    
substance will be stored or             
administered4  7,b7 ,a site described by
 subparagraph 7,a7 shall be included in 
such registration only if the researcher
 has notified the ,attorney ,general of 
such site-- 7i7 in the application for  
such registration2 or  7ii7 before the  
research is conducted1 or before the    

controlled substance is stored or       
administered1 at such site4  7,c7 ,the  
,attorney ,general may1 in consultation 
with the ,secretary of ,health and      
,human ,services1 issue regulations     
addressing-- 7i7 the manner in which    
controlled substances may be delivered  
to research sites described in          
subparagraph 7,a72  7ii7 the storage and
 security of controlled substances at   
such research sites2  7iii7 the         
maintenance of records for such research
 sites2 and  7iv7 any other matters     
necessary to ensure effective controls  
against diversion at such research      
sites4  4  7d7 ,new inspection not      
required in certain situations          
,subsection 7f7 of section #cjb of the  
,controlled ,substances ,act 7#ba       
,u4,s4,c4 #hbb7 is amended-- 7#a7 by    
striking 7f7 ,the and inserting 7f77#a7 
,the2 and  7#b7 by adding at the end the
 following3  7#b7 7,a7 ,a new inspection
 by the ,attorney ,general of a         
registered location is not required if a

 person is registered under this title  
to conduct research with a controlled   
substance and applies for a             
registration1 or for a modification of a
 registration1 to conduct research with 
a second controlled substance that is-- 
7i7 in the same schedule as the first   
controlled substance2 or  7ii7 is in a  
schedule with a higher numerical        
designation than the schedule of the    
first controlled substance4  7,b7       
,nothing in this paragraph shall        
prohibit the ,attorney ,general from    
conducting any inspection if the        
,attorney ,general deems it necessary to
 ensure that the registrant maintains   
effective controls against diversion4  4
  7e7 ,continuation of research on      
substances newly added to schedule ,i   
,section #cjb of the ,controlled        
,substances ,act 7#ba ,u4,s4,c4 #hbb7 is
 amended by adding at the end the       
following3  7h7 ,continuation of        
research on substances newly added to   
schedule ,i ,if a person is conducting  

research on a substance at the time the 
substance is added to schedule ,i1 and  
such person is already registered under 
this title to conduct research with a   
controlled substance in schedule ,i1    
then-- 7#a7 the person shall1 within #ij
 days of the scheduling in schedule ,i1 
submit a completed application for      
registration under this title or        
modification of an existing registration
 under this title1 to conduct research  
on such substance1 in accordance with   
regulations issued by the ,attorney     
,general2  7#b7 the person may1         
notwithstanding subsections 7a7 and 7b71
 continue to conduct the research on    
such substance until-- 7,a7 the person  
withdraws such application2 or  7,b7 the
 ,attorney ,general serves on the person
 an order to show cause proposing the   
denial of the application pursuant to   
section #cjd7;c72  7#c7 if the ,attorney
 ,general serves such an order to show  
cause and the person requests a hearing1
 such hearing shall be held on an       

expedited basis and not later than #de  
days after the request is made1 except  
that the hearing may be held at a later 
time if so requested by the person2 and 
7#d7 if the person sends a copy of the  
application required by paragraph 7#a7  
to a manufacturer or distributor of such
 substance1 receipt of such copy by such
 manufacturer or distributor shall      
constitute sufficient evidence that the 
person is authorized to receive such    
substance4  4  7f7 ,treatment of certain
 manufacturing activities as coincident 
to research ,section #cjb of the        
,controlled ,substances ,act 7#ba       
,u4,s4,c4 #hbb71 as amended by          
subsection 7e71 is further amended by   
adding at the end the following3  7i7   
,treatment of certain manufacturing     
activities as coincident to research    
7#a7 ,in general ,except as specified in
 paragraph 7#c71 a person who is        
registered to perform research on a     
controlled substance may perform        
manufacturing activities with small     

quantities of that substance1 including 
activities listed in paragraph 7#b71    
without being required to obtain a      
manufacturing registration1 if such     
activities are performed for the purpose
 of the research and if the activities  
and the quantities of the substance     
involved in those activities are stated 
in-- 7,a7 a notification submitted to   
the ,attorney ,general under section    
#cjc7m72  7,b7 a protocol filed with an 
application for registration approval   
under section #cjc7;f72 or  7,c7 a      
notification to the ,attorney ,general  
that includes the registrant's name and 
an attestation that the research to be  
conducted with the small quantities of  
manufactured substance is consistent    
with the scope of the research that is  
the basis for the registration4  7#b7   
,activities included ,activities        
permitted under paragraph 7#a7 include--
 7,a7 processing the substance to create
 extracts1 tinctures1 oils1 solutions1  
derivatives1 or other forms of the      

substance consistent with the           
information provided as part of a       
notification submitted to the ,attorney 
,general under section #cjc7m7 or a     
research protocol filed with the        
application for registration approval2  
and  7,b7 dosage form development       
studies performed for the purpose of    
satisfying regulatory requirements of   
the ,food and ,drug ,administration for 
submitting an investigational new drug  
application4  7#c7 ,exception regarding 
marihuana ,the authority under paragraph
 7#a7 to manufacture substances does not
 include authority to grow marihuana4  4
  7g7 ,transparency regarding special   
procedures ,section #cjc of such ,act   
7#ba ,u4,s4,c4 #hbc71 as amended by     
subsection 7a71 is further amended by   
adding at the end the following3  7n7   
,transparency regarding special         
procedures  7#a7 ,in general ,if the    
,attorney ,general determines1 with     
respect to a controlled substance1 that 
an application by a practitioner to     

conduct research with such substance    
should be considered under a process1 or
 subject to criteria1 different from the
 process or criteria applicable to      
applications to conduct research with   
other controlled substances in the same 
schedule1 the ,attorney ,general shall  
make public1 including by posting on the
 website of the ,drug ,enforcement      
,administration-- 7,a7 the identities of
 all substances for which such          
determinations have been made2  7,b7 the
 process and criteria that will be      
applied to applications to conduct      
research with such substances2 and  7,c7
 how such process and criteria differ   
from those applicable to applications to
 conduct research with other controlled 
substances in the same schedule4  7#b7  
,timing of posting ,the ,attorney       
,general shall make such information    
public upon making such determination1  
regardless of whether a practitioner has
 submitted such an application at that  
time4  4  #h4 ,rulemaking  7a7 ,interim 

final rules ,the ,attorney ,general--   
7#a7 not later than #a year of the date 
of enactment of this ,act1 shall issue  
rules to implement this ,act and the    
amendments made by this ,act2 and  7#b7 
may issue such rules as interim final   
rules4  7b7 ,procedure for final rule ,a
 rule issued by the ,attorney ,general  
as an interim final rule under          
subsection 7a7 shall become immediately 
effective as an interim final rule      
without requiring the ,attorney ,general
 to demonstrate good cause therefor4    
,the interim final rule shall give      
interested persons the opportunity to   
comment and to request a hearing4 ,after
 the conclusion of such proceedings1 the
 ,attorney ,general shall issue a final 
rule in accordance with section #eec of 
title #e1 ,united ,states ,code4  #i4   
,,gao report  7a7 ,in general ,not more 
than #d years after the date of         
enactment of this ,act1 the ,comptroller
 ,general of the ,united ,states shall  
submit to the ,committees on ,energy and

 ,commerce and the ,judiciary of the    
,house of ,representatives and the      
,committee on the ,judiciary of the     
,senate a report analyzing the          
implementation and impact1 to the extent
 information is available1 of permanent 
class scheduling pursuant to schedule   
,i7e7 of section #bjb7;c7 of the        
,controlled ,substances ,act1 as added  
by section #b of this ,act1 of          
fentanyl-related substances 7as defined 
in such schedule ,i7e771 which report   
shall include-- 7#a7 an analysis of the 
impact on research of fentanyl-related  
substances2  7#b7 an analysis of any    
actions taken to remove or reschedule in
 a different class any fentanyl-related 
substance2  7#c7 an analysis of the     
impact of permanent scheduling on the   
unlawful importation1 manufacture1      
trafficking1 and use of fentanyl-related
 substances1 taking into consideration  
data collected concerning the           
proliferation of fentanyl-related       
substances since class scheduling was   

instituted2  7#d7 an analysis of        
sentences attributable to criminal      
charges involving fentanyl-related      
substances1 comparing those sentences to
 sentences attributable to criminal     
charges involving fentanyl and          
individually scheduled fentanyl         
analogues2 and  7#e7 an analysis of the 
efficacy of class scheduling generally1 
in terms of reducing the proliferation  
of new controlled substance analogues4  
7b7 ,consultations ,in developing the   
report required by subsection 7a71 the  
,comptroller ,general-- 7#a7 shall      
consider the views of the ,secretary of 
,health and ,human ,services1 the       
,attorney ,general1 the ,secretary of   
,homeland ,security1 the ,secretary of  
,state1 the ,director of the ,office of 
,national ,drug ,control ,policy1 the   
scientific and medical research         
community1 the ,state and local law     
enforcement community1 and the civil    
rights and criminal justice reform      
communities2 and  7#b7 to the greatest  

extent possible1 should base such report
 on reliable data and empirical         
information4