SIFT Act of 2021

I 117TH CONGRESS 1ST SESSION H. R. 2041 To amend the Controlled Substances Act to list fentanyl-related substances as schedule I controlled substances. IN THE HOUSE OF REPRESENTATIVES MARCH 18, 2021 Mr. LUETKEMEYER (for himself, Mr. LONG, Mr. SMITH of Missouri, Mrs. HARTZLER, Mr. GRAVES of Missouri, Mr. SESSIONS, Mr. JACKSON, Mr. BABIN, Mr. CRAWFORD, Mr. ALLEN, Mr. RODNEY DAVIS of Illinois, Mr. BAIRD, Mr. RESCHENTHALER, and Mr. TIFFANY) introduced the fol- lowing bill; which was referred to the Committee on Energy and Com- merce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consider- ation 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 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 2021’’ or the ‘‘SIFT Act of 2021’’. 5 VerDate Sep 11 2014 06:23 May 18, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H2041.IH H2041 kjohnson on DSK79L0C42PROD with BILLS 2 •HR 2041 IH SEC. 2. FENTANYL-RELATED SUBSTANCES. 1 Section 202(c) of the Controlled Substances Act (21 2 U.S.C. 812) is amended— 3 (1) by adding at the end of subsection (b) of 4 Schedule I the following: 5 ‘‘(23) Isobutyryl fentanyl. 6 ‘‘(24) Para-Methoxybutyrylfentanyl. 7 ‘‘(25) Valeryl fentanyl. 8 ‘‘(26) Cyclopentyl fentanyl. 9 ‘‘(27) Para-Chloroisobutyryl fentanyl.’’; and 10 (2) by adding at the end of Schedule I the fol- 11 lowing: 12 ‘‘(e)(1) Unless specifically exempted or unless listed 13 in another schedule, any material, compound, mixture, or 14 preparation which contains any quantity of fentanyl-re- 15 lated substances, or which contains their salts, isomers, 16 and salts of isomers whenever the existence of such salts, 17 isomers, and salts of isomers is possible within the specific 18 chemical designation. 19 ‘‘(2) In paragraph (1), the term ‘fentanyl-related sub- 20 stances’ includes the following: 21 ‘‘(A) Any substance that is structurally related 22 to fentanyl by one or more of the following modifica- 23 tions: 24 ‘‘(i) By replacement of the phenyl portion 25 of the phenethyl group by any monocycle, 26 VerDate Sep 11 2014 06:23 May 18, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H2041.IH H2041 kjohnson on DSK79L0C42PROD with BILLS 3 •HR 2041 IH whether or not further substituted in or on the 1 monocycle. 2 ‘‘(ii) By substitution in or on the phenethyl 3 group with alkyl, alkenyl, alkoxy, hydroxy, halo, 4 haloalkyl, amino or nitro groups. 5 ‘‘(iii) By substitution in or on the piper- 6 idine ring with alkyl, alkenyl, alkoxy, ester, 7 ether, hydroxy, halo, haloalkyl, amino or nitro 8 groups. 9 ‘‘(iv) By replacement of the aniline ring 10 with any aromatic monocycle whether or not 11 further substituted in or on the aromatic mono- 12 cycle. 13 ‘‘(v) By replacement of the N-propionyl 14 group by another acyl group. 15 ‘‘(B) 4′-Methyl acetyl fentanyl. 16 ‘‘(C) Crotonyl fentanyl. 17 ‘‘(D) 2′-Fluoro ortho-fluorofentanyl. 18 ‘‘(E) Ortho-Methyl acetylfentanyl. 19 ‘‘(F) Thiofuranyl fentanyl. 20 ‘‘(G) Ortho-Fluorobutyryl fentanyl. 21 ‘‘(H) Ortho-Fluoroacryl fentanyl. 22 ‘‘(I) Beta-Methyl fentanyl. 23 ‘‘(J) Phenyl fentanyl. 24 ‘‘(K) Para-Methylfentanyl. 25 VerDate Sep 11 2014 06:23 May 18, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H2041.IH H2041 kjohnson on DSK79L0C42PROD with BILLS 4 •HR 2041 IH ‘‘(L) Beta′-Phenyl fentanyl. 1 ‘‘(M) Benzodioxole fentanyl.’’. 2 SEC. 3. REMOVAL FROM SCHEDULE I(e) OF FENTANYL-RE- 3 LATED SUBSTANCES. 4 Section 201 of the Controlled Substances Act (21 5 U.S.C. 811) is amended by adding at the end the following 6 new subsection: 7 ‘‘(k)(1) If the Secretary finds, based on the factors 8 specified in paragraph (4), that a substance listed in 9 schedule I(e) has no potential for abuse, the Secretary 10 shall— 11 ‘‘(A) notify the Attorney General at least 90 12 days prior to submitting an evaluation scientific and 13 medical evaluation of that substance supporting that 14 conclusion; and 15 ‘‘(B) submit to the Attorney General such eval- 16 uation and conclusion that— 17 ‘‘(i) is in writing; and 18 ‘‘(ii) includes the bases for such conclu- 19 sion. 20 ‘‘(2) Not later than 90 days after the receipt of such 21 evaluation and conclusion, the Attorney General shall 22 issue an order removing such substance from the schedule. 23 ‘‘(3)(A) If the Secretary finds, based on the factors 24 specified in paragraph (4), that a substance listed in 25 VerDate Sep 11 2014 06:23 May 18, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H2041.IH H2041 kjohnson on DSK79L0C42PROD with BILLS 5 •HR 2041 IH schedule I(e) does not meet the requirements for inclusion 1 in that schedule, and that the substance has a low poten- 2 tial for abuse, the Secretary shall submit to the Attorney 3 General a scientific and medical evaluation of that sub- 4 stance supporting those conclusions that is in writing and 5 that includes the bases for that conclusion. 6 ‘‘(B) Within 180 days of receipt of such evaluation 7 and conclusion, the Attorney General shall— 8 ‘‘(i) issue an order removing such substance 9 from scheduling for research purposes only, or 10 ‘‘(ii) notify the Secretary in writing that the At- 11 torney General declines to issue such an order. 12 ‘‘(4) In making the evaluation and conclusion de- 13 scribed in paragraph (1) or (3), the Secretary— 14 ‘‘(A) shall consider the factors specified in 15 paragraphs (1), (2), (3), and (6) of subsection (c) 16 and any information submitted to the Attorney Gen- 17 eral under paragraph (1) of this subsection; and 18 ‘‘(B) may also consider factors specified in 19 paragraphs (4), (5), and (7) of subsection (c) if the 20 Secretary finds that reliable evidence exists with re- 21 spect to such factors. 22 ‘‘(5) Nothing in this subsection shall preclude the At- 23 torney General from transferring a substance listed in 24 schedule I to another schedule, or removing such sub- 25 VerDate Sep 11 2014 06:23 May 18, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H2041.IH H2041 kjohnson on DSK79L0C42PROD with BILLS 6 •HR 2041 IH stance entirely from the schedules, pursuant to other pro- 1 visions of this section or section 202. 2 ‘‘(6) A substance removed from schedule I(e) pursu- 3 ant to paragraph (1) or (3) may, at any time, be controlled 4 pursuant to the other provisions of this section or section 5 202 without regard to that removal.’’. 6 SEC. 4. CLARIFICATION OF CERTAIN REGISTRATION RE- 7 QUIREMENTS RELATED TO RESEARCH. 8 (a) EXCEPTION FOR AGENTS OR EMPLOYEES OF 9 REGISTERED RESEARCHERS.—Section 302(c)(1) of the 10 Controlled Substances Act (21 U.S.C. 822(c)(1)) is 11 amended by striking ‘‘or dispenser’’ and inserting ‘‘dis- 12 penser, or researcher’’. 13 (b) CONFORMING AMENDMENT.—Section 102(3) of 14 the Controlled Substances Act (21 U.S.C. 802(3)) is 15 amended by striking ‘‘or dispenser’’ and inserting ‘‘dis- 16 penser, or researcher.’’ 17 (c) SINGLE REGISTRATION FOR CONTIGUOUS RE- 18 SEARCH SITES.—Section 302(e) of the Controlled Sub- 19 stances Act (21 U.S.C. 822(e)) is amended by adding at 20 the end the following new paragraph: 21 ‘‘(3) Notwithstanding paragraph (1), a person 22 registered to conduct research with a controlled sub- 23 stance under section 303(f) may conduct such re- 24 search under a single registration if such research 25 VerDate Sep 11 2014 06:23 May 18, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H2041.IH H2041 kjohnson on DSK79L0C42PROD with BILLS 7 •HR 2041 IH occurs exclusively on a single, contiguous campus 1 and the registrant notifies the Attorney General in 2 writing of all sites on the campus where the research 3 will be conducted or where the controlled substance 4 will be stored or administered. If the registrant 5 seeks to conduct such research at additional sites, 6 the registrant shall submit a new notification before 7 conducting such research at any such additional 8 sites.’’. 9 (d) NEW INSPECTION NOT REQUIRED IN CERTAIN 10 SITUATIONS.—Section 303(f) of the Controlled Sub- 11 stances Act (21 U.S.C. 823(f)) is amended— 12 (1) by redesignating paragraphs (1) through 13 (5) as subparagraphs (A) through (E), respectively, 14 and by moving the margins of such subparagraphs 15 (as so redesignated) two ems to the right; 16 (2) by striking ‘‘(f) The’’ and inserting ‘‘(f)(1) 17 The’’; and 18 (3) by adding at the end the following new 19 paragraph: 20 ‘‘(2)(A) If a person is registered to conduct research 21 with a controlled substance and applies to be registered, 22 or to modify a registration to conduct research with a sec- 23 ond controlled substance that is in the same schedule or 24 in a schedule with a higher numerical designation, a new 25 VerDate Sep 11 2014 06:23 May 18, 2021 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H2041.IH H2041 kjohnson on DSK79L0C42PROD with BILLS 8 •HR 2041 IH inspection by the Attorney General of the registered loca- 1 tion is not required. 2 ‘‘(B) Nothing in this paragraph shall prohibit the At- 3 torney General from conducting any inspection if the At- 4 torney General determines such an inspection is nec- 5 essary.’’. 6 (e) CONTINUATION OF RESEARCH ON NEWLY ADDED 7 SUBSTANCES; AUTHORITY TO CONDUCT RESEARCH WITH 8 OTHER SUBSTANCES.—Section 302 of the Controlled 9 Substances Act (21 U.S.C. 822), as amended by sub- 10 sections (a) and (c), is further amended by adding at the 11 end the following new subsection: 12 ‘‘(h)(1) In the case of a person who is conducting 13 research on a substance at the time the substance is added 14 to schedule I and who is already registered to conduct re- 15 search with another controlled substance in schedule I or 16 II, the person— 17 ‘‘(A) within 30 days of the scheduling of such 18 substance, shall submit a completed application for 19 registration or modification of the existing registra- 20 tion of such person, to conduct research on such 21 substance, in accordance with the regulations issued 22 by the Attorney General; and 23 VerDate Sep 11 2014 06:23 May 18, 2021 Jkt 019200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H2041.IH H2041 kjohnson on DSK79L0C42PROD with BILLS 9 •HR 2041 IH ‘‘(B) notwithstanding subsections (a) and (b), 1 may continue to conduct the research on such sub- 2 stance until the date on which— 3 ‘‘(i) the application referred to in subpara- 4 graph (A) is withdrawn by the applicant; or 5 ‘‘(ii) the Attorney General serves on the 6 applicant an order to show cause proposing the 7 denial of the application pursuant to section 8 304(c). 9 ‘‘(2) If the Attorney General serves an order to show 10 cause under paragraph (1)(B) and the applicant requests 11 a hearing, such hearing shall be held— 12 ‘‘(A) on an expedited basis; and 13 ‘‘(B) not later than 45 days after the request 14 is made, or such a later time as requested by the ap- 15 plicant. 16 ‘‘(3)(A) A person who is registered to conduct re- 17 search with a controlled substance in schedule I may, not- 18 withstanding subsections (a) and (b), conduct research 19 with another controlled substance in schedule I, if each 20 of following conditions are met: 21 ‘‘(i) The person has applied for a modification 22 of the person’s registration to authorize research 23 with such other controlled substance in accordance 24 with the regulations issued by the Attorney General. 25 VerDate Sep 11 2014 06:23 May 18, 2021 Jkt 019200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H2041.IH H2041 kjohnson on DSK79L0C42PROD with BILLS 10 •HR 2041 IH ‘‘(ii) The Attorney General has obtained 1 verification from the Secretary that the research 2 protocol submitted with the application is meri- 3 torious. 4 ‘‘(iii) The Attorney General has determined 5 under subparagraph (B) that the conduct of such re- 6 search is consistent with United States obligations 7 under the Single Convention on Narcotic Drugs, 8 1961. 9 ‘‘(B) Not later than 30 days after receiving an appli- 10 cation under clause (i), the Attorney General shall deter- 11 mine whether the conduct of research that is the subject 12 of the application is consistent with United States obliga- 13 tions under the Single Convention on Narcotic Drugs, 14 1961. 15 ‘‘(C) Nothing in this section shall be construed to 16 alter the authority of the Attorney General to initiate pro- 17 ceedings to deny, suspend, or revoke any registration in 18 accordance with sections 303 and 304.’’. 19 (f) TREATMENT OF CERTAIN ACTIVITIES AS COINCI- 20 DENT TO RESEARCH.—Section 302 of the Controlled Sub- 21 stances Act (21 U.S.C. 822), as amended by subsections 22 (a), (c), and (e), is further amended by adding at the end 23 the following new subsection: 24 VerDate Sep 11 2014 06:23 May 18, 2021 Jkt 019200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H2041.IH H2041 kjohnson on DSK79L0C42PROD with BILLS 11 •HR 2041 IH ‘‘(i) A person who is registered to perform research 1 with a controlled substance (other than marihuana) under 2 this title may, without being required to registered to man- 3 ufacture such substance, using small quantities of such 4 substance, perform the following activities: 5 ‘‘(1) Processing the substance to create ex- 6 tracts, tinctures, oils, solutions, derivatives, or other 7 forms of the substance consistent with the approved 8 research protocol. 9 ‘‘(2) Dosage form development for the purpose 10 of satisfying requirements with respect to the sub- 11 mission of an investigational new drug application 12 under section 505(i) of the Federal Food, Drug, and 13 Cosmetic Act.’’. 14 SEC. 5. REVIEW OF RESEARCH REGISTRATION PROCESS. 15 (a) REVIEW.—Not later than one year after the date 16 of the enactment of this section, the Attorney General and 17 the Secretary of Health and Human Services shall jointly 18 conduct a review of the processes used to register or mod- 19 ify a registration to conduct research with controlled sub- 20 stances under the Controlled Substances Act (21 U.S.C. 21 801 et seq.), including— 22 (1) an evaluation of the impacts of the amend- 23 ments made by this Act on the risk of the diversion 24 VerDate Sep 11 2014 06:23 May 18, 2021 Jkt 019200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H2041.IH H2041 kjohnson on DSK79L0C42PROD with BILLS 12 •HR 2041 IH of controlled substances used in research and related 1 public safety considerations; and 2 (2) an identification of opportunities to reduce 3 any unnecessary burden on persons seeking registra- 4 tio [Text truncated for display. Full text available on Congress.gov.]