,i #aafth ,,congress #ast ,session ,h4 ,r4 #edba ,,in ,,the ,,house ,,of ,,representatives ,december #ab1 #bjai,mr4 ,luetkemeyer 7for himself1 ,mrs4 ,wagner1 ,mr4 ,clay1 ,mr4 ,smith of ,missouri1 ,mr4 ,long1 ,mr4 ,graves of ,missouri1 and ,mr4 ,cleaver7 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 to list fentanyl-related substances as schedule ,i controlled substances4 #a4 ,short title ,this ,act may be cited as the ,stopping ,illicit ,trafficking ,act of #bjai or the ,,sift ,act of #bjai4 #b4 ,fentanyl-related substances ,section #bjb7;c7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hab7 is amended-- 7#a7 by adding at the end of subsection 7b7 of ,schedule ,i the following3 7#bc7 ,isobutyryl fentanyl4 7#bd7 ,para-,methoxybutyrylfentanyl4 7#be7 ,valeryl fentanyl4 7#bf7 ,cyclopentyl fentanyl4 7#bg7 ,para-,chloroisobutyryl fentanyl4 2 and 7#b7 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 paragraph 7#a71 the term fentanyl-related substances includes the following3 7,a7 ,any substance that is structurally related to fentanyl by one or more of the following modifications3 7i7 ,by replacement of the phenyl portion of the phenethyl group by any monocycle1 whether or not further substituted in or on the monocycle4 7ii7 ,by substitution in or on the phenethyl group with alkyl1 alkenyl1 alkoxy1 hydroxy1 halo1 haloalkyl1 amino or nitro groups4 7iii7 ,by substitution in or on the piperidine ring with alkyl1 alkenyl1 alkoxy1 ester1 ether1 hydroxy1 halo1 haloalkyl1 amino or nitro groups4 7iv7 ,by replacement of the aniline ring with any aromatic monocycle whether or not further substituted in or on the aromatic monocycle4 7v7 ,by replacement of the ,n-propionyl group by another acyl group4 7,b7 #d-,methyl acetyl fentanyl4 7,c7 ,crotonyl fentanyl4 7,d7 #b-;,fluoro ortho-fluorofentanyl4 7,e7 ,ortho-,methyl acetylfentanyl4 7,f7 ,thiofuranyl fentanyl4 7,g7 ,ortho-,fluorobutyryl fentanyl4 7,h7 ,ortho-,fluoroacryl fentanyl4 7,i7 ,beta-,methyl fentanyl4 7,j7 ,phenyl fentanyl4 7,k7 ,para-,methylfentanyl4 7,l7 ,beta-,phenyl fentanyl4 7,m7 ,benzodioxole fentanyl4 4 #c4 ,removal from schedule ,i7e7 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 7#a7 ,if the ,secretary finds1 based on the factors specified in paragraph 7#d71 that a substance listed in schedule ,i7e7 has no potential for abuse1 the ,secretary shall-- 7,a7 notify the ,attorney ,general at least #ij days prior to submitting an evaluation scientific and medical evaluation of that substance supporting that conclusion2 and 7,b7 submit to the ,attorney ,general such evaluation and conclusion that-- 7i7 is in writing2 and 7ii7 includes the bases for such conclusion4 7#b7 ,not later than #ij days after the receipt of such evaluation and conclusion1 the ,attorney ,general shall issue an order removing such substance from the schedule4 7#c7 7,a7 ,if the ,secretary finds1 based on the factors specified in paragraph 7#d71 that a substance listed in schedule ,i7e7 does not meet the requirements for inclusion in that schedule1 and that the substance has a low potential for abuse1 the ,secretary shall submit to the ,attorney ,general a scientific and medical evaluation of that substance supporting those conclusions that is in writing and that includes the bases for that conclusion4 7,b7 ,within #ahj days of receipt of such evaluation and conclusion1 the ,attorney ,general shall-- 7i7 issue an order removing such substance from scheduling for research purposes only1 or 7ii7 notify the ,secretary in writing that the ,attorney ,general declines to issue such an order4 7#d7 ,in making the evaluation and conclusion described in paragraph 7#a7 or 7#c71 the ,secretary-- 7,a7 shall consider the factors specified in paragraphs 7#a71 7#b71 7#c71 and 7#f7 of subsection 7c7 and any information submitted to the ,attorney ,general under paragraph 7#a7 of this subsection2 and 7,b7 may also consider factors specified in paragraphs 7#d71 7#e71 and 7#g7 of subsection 7c7 if the ,secretary finds that reliable evidence exists with respect to such factors4 7#e7 ,nothing in this subsection shall 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 or section #bjb4 7#f7 ,a substance removed from schedule ,i7e7 pursuant to paragraph 7#a7 or 7#c7 may1 at any time1 be controlled pursuant to the other provisions of this section or section #bjb without regard to that removal4 4 #d4 ,clarification of certain registration requirements related to research 7a7 ,exception for agents or employees of registered researchers ,section #cjb7;c77#a7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbb7;c77#a77 is amended by striking or dispenser and inserting dispenser1 or researcher4 7b7 ,conforming amendment ,section #ajb7c7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hjb7c77 is amended by striking or dispenser and inserting dispenser1 or researcher4 7c7 ,single registration for contiguous research sites ,section #cjb7;e7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbb7;e77 is amended by adding at the end the following new paragraph3 7#c7 ,notwithstanding paragraph 7#a71 a person registered to conduct research with a controlled substance under section #cjc7;f7 may conduct such research under a single registration if such research occurs exclusively on a single1 contiguous campus and the registrant notifies the ,attorney ,general in writing of all sites on the campus where the research will be conducted or where the controlled substance will be stored or administered4 ,if the registrant seeks to conduct such research at additional sites1 the registrant shall submit a new notification before conducting such research at any such additional sites4 4 7d7 ,new inspection not required in certain situations ,section #cjc7;f7 of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbc7;f77 is amended-- 7#a7 by striking 7f7 ,the and inserting 7f77#a7 ,the2 and 7#b7 by adding a new paragraph1 as follows3 7#b7 7,a7 ,if a person is registered to conduct research with a controlled substance and applies to be registered1 or to modify a registration to conduct research with a second controlled substance that is in the same schedule or in a schedule with a higher numerical designation1 a new inspection by the ,attorney ,general of the registered location is not required4 7,b7 ,nothing in this paragraph shall prohibit the ,attorney ,general from conducting any inspection if the ,attorney ,general determines such an inspection is necessary4 4 7e7 ,continuation of research on newly added substances2 authority ,to conduct research with other substances ,section #cjb of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbb71 as amended by subsections 7a7 and 7c71 is further amended by adding at the end the following new subsection3 7h7 7#a7 ,in the case of a person who is conducting research on a substance at the time the substance is added to schedule ,i and who is already registered to conduct research with another controlled substance in schedule ,i or ,,ii1 the person-- 7,a7 within #cj days of the scheduling of such substance1 shall submit a completed application for registration or modification of the existing registration of such person1 to conduct research on such substance1 in accordance with the regulations issued by the ,attorney ,general2 and 7,b7 notwithstanding subsections 7a7 and 7b71 may continue to conduct the research on such substance until the date on which-- 7i7 the application referred to in subparagraph 7,a7 is withdrawn by the applicant2 or 7ii7 the ,attorney ,general serves on the applicant an order to show cause proposing the denial of the application pursuant to section #cjd7;c74 7#b7 ,if the ,attorney ,general serves an order to show cause under paragraph 7#a77;,b7 and the applicant requests a hearing1 such hearing shall be held-- 7,a7 on an expedited basis2 and 7,b7 not later than #de days after the request is made1 or such a later time as requested by the applicant4 7#c7 7,a7 ,a person who is registered to conduct research with a controlled substance in schedule ,i may1 notwithstanding subsections 7a7 and 7b71 conduct research with another controlled substance in schedule ,i1 if each of following conditions are met3 7i7 ,the person has applied for a modification of the person's registration to authorize research with such other controlled substance in accordance with the regulations issued by the ,attorney ,general4 7ii7 ,the ,attorney ,general has obtained verification from the ,secretary that the research protocol submitted with the application is meritorious4 7iii7 ,the ,attorney ,general has determined under subparagraph 7,b7 that the conduct of such research is consistent with ,united ,states obligations under the ,single ,convention on ,narcotic ,drugs1 #aifa4 7,b7 ,not later than #cj days after receiving an application under clause 7i71 the ,attorney ,general shall determine whether the conduct of research that is the subject of the application is consistent with ,united ,states obligations under the ,single ,convention on ,narcotic ,drugs1 #aifa4 7,c7 ,nothing in this section shall be construed to alter the authority of the ,attorney ,general to initiate proceedings to deny1 suspend1 or revoke any registration in accordance with sections #cjc and #cjd4 4 7f7 ,treatment of certain activities as coincident to research ,section #cjb of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbb71 as amended by subsections 7a71 7c71 and 7e71 is further amended by adding at the end the following new subsection3 7i7 ,a person who is registered to perform research with a controlled substance 7other than marihuana7 under this title may1 without being required to registered to manufacture such substance1 using small quantities of such substance1 perform the following activities3 7#a7 ,processing the substance to create extracts1 tinctures1 oils1 solutions1 derivatives1 or other forms of the substance consistent with the approved research protocol4 7#b7 ,dosage form development for the purpose of satisfying requirements with respect to the submission of an investigational new drug application under section #eje7;i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act4 4 #e4 ,review of research registration process 7a7 ,review ,not later than one year after the date of the enactment of this section1 the ,attorney ,general and the ,secretary of ,health and ,human ,services shall jointly conduct a review of the processes used to register or modify a registration to conduct research with controlled substances under the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hja et seq471 including-- 7#a7 an evaluation of the impacts of the amendments made by this ,act on the risk of the diversion of controlled substances used in research and related public safety considerations2 and 7#b7 an identification of opportunities to reduce any unnecessary burden on persons seeking registration1 potential redundancies1 and inefficiencies in such processes1 including-- 7,a7 the process for obtaining a registration under section #cjc of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbc72 and 7,b7 the process by which the ,secretary reviews research protocols submitted with respect to such registration4 7b7 ,guidance ,not later than #fj days after concluding the review described in subsection 7a71 the ,attorney ,general and the ,secretary shall1 as appropriate1 jointly issue guidance to registrants and potential registrants clarifying the process for registration4