SIFT Act of 2019

I 116TH CONGRESS 1ST SESSION H. R. 5421 To amend the Controlled Substances Act to list fentanyl-related substances as schedule I controlled substances. IN THE HOUSE OF REPRESENTATIVES DECEMBER 12, 2019 Mr. LUETKEMEYER (for himself, Mrs. WAGNER, Mr. CLAY, Mr. SMITH of Mis- souri, Mr. LONG, Mr. GRAVES of Missouri, and Mr. CLEAVER) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a pe- riod to be subsequently determined by the Speaker, in each case for con- sideration of such provisions as fall within the jurisdiction of the com- mittee concerned A BILL To amend the Controlled Substances Act to list fentanyl- related substances as schedule I controlled substances. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Stopping Illicit Traf- 4 ficking Act of 2019’’ or the ‘‘SIFT Act of 2019’’. 5 SEC. 2. FENTANYL-RELATED SUBSTANCES. 6 Section 202(c) of the Controlled Substances Act (21 7 U.S.C. 812) is amended— 8 VerDate Sep 11 2014 01:53 Dec 18, 2019 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H5421.IH H5421 kjohnson on DSK79L0C42 with BILLS 2 •HR 5421 IH (1) by adding at the end of subsection (b) of 1 Schedule I the following: 2 ‘‘(23) Isobutyryl fentanyl. 3 ‘‘(24) Para-Methoxybutyrylfentanyl. 4 ‘‘(25) Valeryl fentanyl. 5 ‘‘(26) Cyclopentyl fentanyl. 6 ‘‘(27) Para-Chloroisobutyryl fentanyl.’’; and 7 (2) by adding at the end of Schedule I the fol- 8 lowing: 9 ‘‘(e)(1) Unless specifically exempted or unless listed 10 in another schedule, any material, compound, mixture, or 11 preparation which contains any quantity of fentanyl-re- 12 lated substances, or which contains their salts, isomers, 13 and salts of isomers whenever the existence of such salts, 14 isomers, and salts of isomers is possible within the specific 15 chemical designation. 16 ‘‘(2) In paragraph (1), the term ‘fentanyl-related sub- 17 stances’ includes the following: 18 ‘‘(A) Any substance that is structurally related 19 to fentanyl by one or more of the following modifica- 20 tions: 21 ‘‘(i) By replacement of the phenyl portion 22 of the phenethyl group by any monocycle, 23 whether or not further substituted in or on the 24 monocycle. 25 VerDate Sep 11 2014 01:53 Dec 18, 2019 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H5421.IH H5421 kjohnson on DSK79L0C42 with BILLS 3 •HR 5421 IH ‘‘(ii) By substitution in or on the phenethyl 1 group with alkyl, alkenyl, alkoxy, hydroxy, halo, 2 haloalkyl, amino or nitro groups. 3 ‘‘(iii) By substitution in or on the piper- 4 idine ring with alkyl, alkenyl, alkoxy, ester, 5 ether, hydroxy, halo, haloalkyl, amino or nitro 6 groups. 7 ‘‘(iv) By replacement of the aniline ring 8 with any aromatic monocycle whether or not 9 further substituted in or on the aromatic mono- 10 cycle. 11 ‘‘(v) By replacement of the N-propionyl 12 group by another acyl group. 13 ‘‘(B) 4′-Methyl acetyl fentanyl. 14 ‘‘(C) Crotonyl fentanyl. 15 ‘‘(D) 2′-Fluoro ortho-fluorofentanyl. 16 ‘‘(E) Ortho-Methyl acetylfentanyl. 17 ‘‘(F) Thiofuranyl fentanyl. 18 ‘‘(G) Ortho-Fluorobutyryl fentanyl. 19 ‘‘(H) Ortho-Fluoroacryl fentanyl. 20 ‘‘(I) Beta-Methyl fentanyl. 21 ‘‘(J) Phenyl fentanyl. 22 ‘‘(K) Para-Methylfentanyl. 23 ‘‘(L) Beta′-Phenyl fentanyl. 24 ‘‘(M) Benzodioxole fentanyl.’’. 25 VerDate Sep 11 2014 01:53 Dec 18, 2019 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H5421.IH H5421 kjohnson on DSK79L0C42 with BILLS 4 •HR 5421 IH SEC. 3. REMOVAL FROM SCHEDULE I(e) OF FENTANYL-RE- 1 LATED SUBSTANCES. 2 Section 201 of the Controlled Substances Act (21 3 U.S.C. 811) is amended by adding at the end the following 4 new subsection: 5 ‘‘(k)(1) If the Secretary finds, based on the factors 6 specified in paragraph (4), that a substance listed in 7 schedule I(e) has no potential for abuse, the Secretary 8 shall— 9 ‘‘(A) notify the Attorney General at least 90 10 days prior to submitting an evaluation scientific and 11 medical evaluation of that substance supporting that 12 conclusion; and 13 ‘‘(B) submit to the Attorney General such eval- 14 uation and conclusion that— 15 ‘‘(i) is in writing; and 16 ‘‘(ii) includes the bases for such conclu- 17 sion. 18 ‘‘(2) Not later than 90 days after the receipt of such 19 evaluation and conclusion, the Attorney General shall 20 issue an order removing such substance from the schedule. 21 ‘‘(3)(A) If the Secretary finds, based on the factors 22 specified in paragraph (4), that a substance listed in 23 schedule I(e) does not meet the requirements for inclusion 24 in that schedule, and that the substance has a low poten- 25 tial for abuse, the Secretary shall submit to the Attorney 26 VerDate Sep 11 2014 01:53 Dec 18, 2019 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H5421.IH H5421 kjohnson on DSK79L0C42 with BILLS 5 •HR 5421 IH General a scientific and medical evaluation of that sub- 1 stance supporting those conclusions that is in writing and 2 that includes the bases for that conclusion. 3 ‘‘(B) Within 180 days of receipt of such evaluation 4 and conclusion, the Attorney General shall— 5 ‘‘(i) issue an order removing such substance 6 from scheduling for research purposes only, or 7 ‘‘(ii) notify the Secretary in writing that the At- 8 torney General declines to issue such an order. 9 ‘‘(4) In making the evaluation and conclusion de- 10 scribed in paragraph (1) or (3), the Secretary— 11 ‘‘(A) shall consider the factors specified in 12 paragraphs (1), (2), (3), and (6) of subsection (c) 13 and any information submitted to the Attorney Gen- 14 eral under paragraph (1) of this subsection; and 15 ‘‘(B) may also consider factors specified in 16 paragraphs (4), (5), and (7) of subsection (c) if the 17 Secretary finds that reliable evidence exists with re- 18 spect to such factors. 19 ‘‘(5) Nothing in this subsection shall preclude the At- 20 torney General from transferring a substance listed in 21 schedule I to another schedule, or removing such sub- 22 stance entirely from the schedules, pursuant to other pro- 23 visions of this section or section 202. 24 VerDate Sep 11 2014 01:53 Dec 18, 2019 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H5421.IH H5421 kjohnson on DSK79L0C42 with BILLS 6 •HR 5421 IH ‘‘(6) A substance removed from schedule I(e) pursu- 1 ant to paragraph (1) or (3) may, at any time, be controlled 2 pursuant to the other provisions of this section or section 3 202 without regard to that removal.’’. 4 SEC. 4. CLARIFICATION OF CERTAIN REGISTRATION RE- 5 QUIREMENTS RELATED TO RESEARCH. 6 (a) EXCEPTION FOR AGENTS OR EMPLOYEES OF 7 REGISTERED RESEARCHERS.—Section 302(c)(1) of the 8 Controlled Substances Act (21 U.S.C. 822(c)(1)) is 9 amended by striking ‘‘or dispenser’’ and inserting ‘‘dis- 10 penser, or researcher’’. 11 (b) CONFORMING AMENDMENT.—Section 102(3) of 12 the Controlled Substances Act (21 U.S.C. 802(3)) is 13 amended by striking ‘‘or dispenser’’ and inserting ‘‘dis- 14 penser, or researcher.’’ 15 (c) SINGLE REGISTRATION FOR CONTIGUOUS RE- 16 SEARCH SITES.—Section 302(e) of the Controlled Sub- 17 stances Act (21 U.S.C. 822(e)) is amended by adding at 18 the end the following new paragraph: 19 ‘‘(3) Notwithstanding paragraph (1), a person 20 registered to conduct research with a controlled sub- 21 stance under section 303(f) may conduct such re- 22 search under a single registration if such research 23 occurs exclusively on a single, contiguous campus 24 and the registrant notifies the Attorney General in 25 VerDate Sep 11 2014 01:53 Dec 18, 2019 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H5421.IH H5421 kjohnson on DSK79L0C42 with BILLS 7 •HR 5421 IH writing of all sites on the campus where the research 1 will be conducted or where the controlled substance 2 will be stored or administered. If the registrant 3 seeks to conduct such research at additional sites, 4 the registrant shall submit a new notification before 5 conducting such research at any such additional 6 sites.’’. 7 (d) NEW INSPECTION NOT REQUIRED IN CERTAIN 8 SITUATIONS.—Section 303(f) of the Controlled Sub- 9 stances Act (21 U.S.C. 823(f)) is amended— 10 (1) by striking ‘‘(f) The’’ and inserting ‘‘(f)(1) 11 The’’; and 12 (2) by adding a new paragraph, as follows: 13 ‘‘(2)(A) If a person is registered to conduct research 14 with a controlled substance and applies to be registered, 15 or to modify a registration to conduct research with a sec- 16 ond controlled substance that is in the same schedule or 17 in a schedule with a higher numerical designation, a new 18 inspection by the Attorney General of the registered loca- 19 tion is not required. 20 ‘‘(B) Nothing in this paragraph shall prohibit the At- 21 torney General from conducting any inspection if the At- 22 torney General determines such an inspection is nec- 23 essary.’’. 24 VerDate Sep 11 2014 01:53 Dec 18, 2019 Jkt 099200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H5421.IH H5421 kjohnson on DSK79L0C42 with BILLS 8 •HR 5421 IH (e) CONTINUATION OF RESEARCH ON NEWLY ADDED 1 SUBSTANCES; AUTHORITY TO CONDUCT RESEARCH WITH 2 OTHER SUBSTANCES.—Section 302 of the Controlled 3 Substances Act (21 U.S.C. 822), as amended by sub- 4 sections (a) and (c), is further amended by adding at the 5 end the following new subsection: 6 ‘‘(h)(1) In the case of a person who is conducting 7 research on a substance at the time the substance is added 8 to schedule I and who is already registered to conduct re- 9 search with another controlled substance in schedule I or 10 II, the person— 11 ‘‘(A) within 30 days of the scheduling of such 12 substance, shall submit a completed application for 13 registration or modification of the existing registra- 14 tion of such person, to conduct research on such 15 substance, in accordance with the regulations issued 16 by the Attorney General; and 17 ‘‘(B) notwithstanding subsections (a) and (b), 18 may continue to conduct the research on such sub- 19 stance until the date on which— 20 ‘‘(i) the application referred to in subpara- 21 graph (A) is withdrawn by the applicant; or 22 ‘‘(ii) the Attorney General serves on the 23 applicant an order to show cause proposing the 24 VerDate Sep 11 2014 01:53 Dec 18, 2019 Jkt 099200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H5421.IH H5421 kjohnson on DSK79L0C42 with BILLS 9 •HR 5421 IH denial of the application pursuant to section 1 304(c). 2 ‘‘(2) If the Attorney General serves an order to show 3 cause under paragraph (1)(B) and the applicant requests 4 a hearing, such hearing shall be held— 5 ‘‘(A) on an expedited basis; and 6 ‘‘(B) not later than 45 days after the request 7 is made, or such a later time as requested by the ap- 8 plicant. 9 ‘‘(3)(A) A person who is registered to conduct re- 10 search with a controlled substance in schedule I may, not- 11 withstanding subsections (a) and (b), conduct research 12 with another controlled substance in schedule I, if each 13 of following conditions are met: 14 ‘‘(i) The person has applied for a modification 15 of the person’s registration to authorize research 16 with such other controlled substance in accordance 17 with the regulations issued by the Attorney General. 18 ‘‘(ii) The Attorney General has obtained 19 verification from the Secretary that the research 20 protocol submitted with the application is meri- 21 torious. 22 ‘‘(iii) The Attorney General has determined 23 under subparagraph (B) that the conduct of such re- 24 search is consistent with United States obligations 25 VerDate Sep 11 2014 01:53 Dec 18, 2019 Jkt 099200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H5421.IH H5421 kjohnson on DSK79L0C42 with BILLS 10 •HR 5421 IH under the Single Convention on Narcotic Drugs, 1 1961. 2 ‘‘(B) Not later than 30 days after receiving an appli- 3 cation under clause (i), the Attorney General shall deter- 4 mine whether the conduct of research that is the subject 5 of the application is consistent with United States obliga- 6 tions under the Single Convention on Narcotic Drugs, 7 1961. 8 ‘‘(C) Nothing in this section shall be construed to 9 alter the authority of the Attorney General to initiate pro- 10 ceedings to deny, suspend, or revoke any registration in 11 accordance with sections 303 and 304.’’. 12 (f) TREATMENT OF CERTAIN ACTIVITIES AS COINCI- 13 DENT TO RESEARCH.—Section 302 of the Controlled Sub- 14 stances Act (21 U.S.C. 822), as amended by subsections 15 (a), (c), and (e), is further amended by adding at the end 16 the following new subsection: 17 ‘‘(i) A person who is registered to perform research 18 with a controlled substance (other than marihuana) under 19 this title may, without being required to registered to man- 20 ufacture such substance, using small quantities of such 21 substance, perform the following activities: 22 ‘‘(1) Processing the substance to create ex- 23 tracts, tinctures, oils, solutions, derivatives, or other 24 VerDate Sep 11 2014 01:53 Dec 18, 2019 Jkt 099200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H5421.IH H5421 kjohnson on DSK79L0C42 with BILLS 11 •HR 5421 IH forms of the substance consistent with the approved 1 research protocol. 2 ‘‘(2) Dosage form development for the purpose 3 of satisfying requirements with respect to the sub- 4 mission of an investigational new drug application 5 under section 505(i) of the Federal Food, Drug, and 6 Cosmetic Act.’’. 7 SEC. 5. REVIEW OF RESEARCH REGISTRATION PROCESS. 8 (a) REVIEW.—Not later than one year after the date 9 of the enactment of this section, the Attorney General and 10 the Secretary of Health and Human Services shall jointly 11 conduct a review of the processes used to register or mod- 12 ify a registration to conduct research with controlled sub- 13 stances under the Controlled Substances Act (21 U.S.C. 14 801 et seq.), including— 15 (1) an evaluation of the impacts of the amend- 16 ments made by this Act on the risk of the diversion 17 of controlled substances used in research and related 18 public safety considerations; and 19 (2) an identification of opportunities to reduce 20 any unnecessary burden on persons seeking registra- 21 tion, potential redundancies, and inefficiencies in 22 such processes, including— 23 VerDate Sep 11 2014 01:53 Dec 18, 2019 Jkt 099200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H5421.IH H5421 kjohnson on DSK79L0C42 with BILLS 12 •HR 5421 IH (A) the process for obtaining a registration 1 under section 303 of the Controlled Substances 2 Act (21 U.S.C. 823); and 3 (B) the process by which the Secretary re- 4 views research protocols submitted with respect 5 to such registration. 6 (b) GUIDANCE.—Not later than 60 days after [Text truncated for display. 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