| 1 | 1 | | I |
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| 2 | 2 | | 118THCONGRESS |
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| 3 | 3 | | 1 |
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| 4 | 4 | | STSESSION H. R. 1758 |
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| 5 | 5 | | To amend the Controlled Substances Act to list fentanyl-related substances |
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| 6 | 6 | | as schedule I controlled substances. |
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| 7 | 7 | | IN THE HOUSE OF REPRESENTATIVES |
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| 8 | 8 | | MARCH23, 2023 |
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| 9 | 9 | | Mr. L |
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| 10 | 10 | | UETKEMEYER (for himself, Mrs. HINSON, Mr. BACON, Mr. DESJARLAIS, |
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| 11 | 11 | | and Mr. E |
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| 12 | 12 | | ZELL) introduced the following bill; which was referred to the |
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| 13 | 13 | | Committee on Energy and Commerce, and in addition to the Committee |
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| 14 | 14 | | on the Judiciary, for a period to be subsequently determined by the |
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| 15 | 15 | | Speaker, in each case for consideration of such provisions as fall within |
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| 16 | 16 | | the jurisdiction of the committee concerned |
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| 17 | 17 | | A BILL |
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| 18 | 18 | | To amend the Controlled Substances Act to list fentanyl- |
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| 19 | 19 | | related substances as schedule I controlled substances. |
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| 20 | 20 | | Be it enacted by the Senate and House of Representa-1 |
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| 21 | 21 | | tives of the United States of America in Congress assembled, 2 |
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| 22 | 22 | | SECTION 1. SHORT TITLE. 3 |
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| 23 | 23 | | This Act may be cited as the ‘‘Stopping Illicit 4 |
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| 24 | 24 | | Fentanyl Trafficking Act of 2023’’ or the ‘‘SIFT Act of 5 |
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| 25 | 25 | | 2023’’. 6 |
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| 27 | 27 | | kjohnson on DSK79L0C42PROD with BILLS 2 |
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| 28 | 28 | | •HR 1758 IH |
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| 29 | 29 | | SEC. 2. FENTANYL-RELATED SUBSTANCES. 1 |
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| 30 | 30 | | Section 202(c) of the Controlled Substances Act (21 2 |
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| 31 | 31 | | U.S.C. 812) is amended— 3 |
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| 32 | 32 | | (1) by adding at the end of subsection (b) of 4 |
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| 33 | 33 | | Schedule I the following: 5 |
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| 34 | 34 | | ‘‘(23) Isobutyryl fentanyl. 6 |
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| 35 | 35 | | ‘‘(24) Para-Methoxybutyrylfentanyl. 7 |
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| 36 | 36 | | ‘‘(25) Valeryl fentanyl. 8 |
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| 37 | 37 | | ‘‘(26) Cyclopentyl fentanyl. 9 |
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| 38 | 38 | | ‘‘(27) Para-Chloroisobutyryl fentanyl.’’; and 10 |
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| 39 | 39 | | (2) by adding at the end of Schedule I the fol-11 |
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| 40 | 40 | | lowing: 12 |
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| 41 | 41 | | ‘‘(e)(1) Unless specifically exempted or unless listed 13 |
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| 42 | 42 | | in another schedule, any material, compound, mixture, or 14 |
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| 43 | 43 | | preparation which contains any quantity of fentanyl-re-15 |
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| 44 | 44 | | lated substances, or which contains their salts, isomers, 16 |
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| 45 | 45 | | and salts of isomers whenever the existence of such salts, 17 |
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| 46 | 46 | | isomers, and salts of isomers is possible within the specific 18 |
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| 47 | 47 | | chemical designation. 19 |
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| 48 | 48 | | ‘‘(2) In paragraph (1), the term ‘fentanyl-related sub-20 |
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| 49 | 49 | | stances’ includes the following: 21 |
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| 50 | 50 | | ‘‘(A) Any substance that is structurally related 22 |
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| 51 | 51 | | to fentanyl by one or more of the following modifica-23 |
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| 52 | 52 | | tions: 24 |
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| 53 | 53 | | ‘‘(i) By replacement of the phenyl portion 25 |
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| 54 | 54 | | of the phenethyl group by any monocycle, 26 |
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| 56 | 56 | | kjohnson on DSK79L0C42PROD with BILLS 3 |
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| 57 | 57 | | •HR 1758 IH |
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| 58 | 58 | | whether or not further substituted in or on the 1 |
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| 59 | 59 | | monocycle. 2 |
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| 60 | 60 | | ‘‘(ii) By substitution in or on the phenethyl 3 |
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| 61 | 61 | | group with alkyl, alkenyl, alkoxy, hydroxy, halo, 4 |
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| 62 | 62 | | haloalkyl, amino or nitro groups. 5 |
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| 63 | 63 | | ‘‘(iii) By substitution in or on the piper-6 |
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| 64 | 64 | | idine ring with alkyl, alkenyl, alkoxy, ester, 7 |
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| 65 | 65 | | ether, hydroxy, halo, haloalkyl, amino or nitro 8 |
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| 66 | 66 | | groups. 9 |
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| 67 | 67 | | ‘‘(iv) By replacement of the aniline ring 10 |
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| 68 | 68 | | with any aromatic monocycle whether or not 11 |
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| 69 | 69 | | further substituted in or on the aromatic mono-12 |
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| 70 | 70 | | cycle. 13 |
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| 71 | 71 | | ‘‘(v) By replacement of the N-propionyl 14 |
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| 72 | 72 | | group by another acyl group. 15 |
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| 73 | 73 | | ‘‘(B) 4′-Methyl acetyl fentanyl. 16 |
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| 74 | 74 | | ‘‘(C) Crotonyl fentanyl. 17 |
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| 75 | 75 | | ‘‘(D) 2′-Fluoro ortho-fluorofentanyl. 18 |
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| 76 | 76 | | ‘‘(E) Ortho-Methyl acetylfentanyl. 19 |
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| 77 | 77 | | ‘‘(F) Thiofuranyl fentanyl. 20 |
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| 78 | 78 | | ‘‘(G) Ortho-Fluorobutyryl fentanyl. 21 |
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| 79 | 79 | | ‘‘(H) Ortho-Fluoroacryl fentanyl. 22 |
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| 80 | 80 | | ‘‘(I) Beta-Methyl fentanyl. 23 |
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| 81 | 81 | | ‘‘(J) Phenyl fentanyl. 24 |
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| 82 | 82 | | ‘‘(K) Para-Methylfentanyl. 25 |
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| 84 | 84 | | kjohnson on DSK79L0C42PROD with BILLS 4 |
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| 85 | 85 | | •HR 1758 IH |
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| 86 | 86 | | ‘‘(L) Beta′-Phenyl fentanyl. 1 |
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| 87 | 87 | | ‘‘(M) Benzodioxole fentanyl.’’. 2 |
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| 88 | 88 | | SEC. 3. REMOVAL FROM SCHEDULE I(e) OF FENTANYL-RE-3 |
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| 89 | 89 | | LATED SUBSTANCES. 4 |
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| 90 | 90 | | Section 201 of the Controlled Substances Act (21 5 |
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| 91 | 91 | | U.S.C. 811) is amended by adding at the end the following 6 |
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| 92 | 92 | | new subsection: 7 |
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| 93 | 93 | | ‘‘(k)(1) If the Secretary finds, based on the factors 8 |
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| 94 | 94 | | specified in paragraph (4), that a substance listed in 9 |
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| 95 | 95 | | schedule I(e) has no potential for abuse, the Secretary 10 |
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| 96 | 96 | | shall— 11 |
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| 97 | 97 | | ‘‘(A) notify the Attorney General at least 90 12 |
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| 98 | 98 | | days prior to submitting an evaluation scientific and 13 |
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| 99 | 99 | | medical evaluation of that substance supporting that 14 |
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| 100 | 100 | | conclusion; and 15 |
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| 101 | 101 | | ‘‘(B) submit to the Attorney General such eval-16 |
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| 102 | 102 | | uation and conclusion that— 17 |
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| 103 | 103 | | ‘‘(i) is in writing; and 18 |
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| 104 | 104 | | ‘‘(ii) includes the bases for such conclu-19 |
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| 105 | 105 | | sion. 20 |
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| 106 | 106 | | ‘‘(2) Not later than 90 days after the receipt of such 21 |
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| 107 | 107 | | evaluation and conclusion, the Attorney General shall 22 |
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| 108 | 108 | | issue an order removing such substance from the schedule. 23 |
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| 109 | 109 | | ‘‘(3)(A) If the Secretary finds, based on the factors 24 |
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| 110 | 110 | | specified in paragraph (4), that a substance listed in 25 |
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| 112 | 112 | | kjohnson on DSK79L0C42PROD with BILLS 5 |
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| 113 | 113 | | •HR 1758 IH |
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| 114 | 114 | | schedule I(e) does not meet the requirements for inclusion 1 |
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| 115 | 115 | | in that schedule, and that the substance has a low poten-2 |
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| 116 | 116 | | tial for abuse, the Secretary shall submit to the Attorney 3 |
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| 117 | 117 | | General a scientific and medical evaluation of that sub-4 |
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| 118 | 118 | | stance supporting those conclusions that is in writing and 5 |
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| 119 | 119 | | that includes the bases for that conclusion. 6 |
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| 120 | 120 | | ‘‘(B) Within 180 days of receipt of such evaluation 7 |
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| 121 | 121 | | and conclusion, the Attorney General shall— 8 |
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| 122 | 122 | | ‘‘(i) issue an order removing such substance 9 |
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| 123 | 123 | | from scheduling for research purposes only; or 10 |
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| 124 | 124 | | ‘‘(ii) notify the Secretary in writing that the At-11 |
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| 125 | 125 | | torney General declines to issue such an order. 12 |
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| 126 | 126 | | ‘‘(4) In making the evaluation and conclusion de-13 |
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| 127 | 127 | | scribed in paragraph (1) or (3), the Secretary— 14 |
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| 128 | 128 | | ‘‘(A) shall consider the factors specified in 15 |
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| 129 | 129 | | paragraphs (1), (2), (3), and (6) of subsection (c) 16 |
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| 130 | 130 | | and any information submitted to the Attorney Gen-17 |
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| 131 | 131 | | eral under paragraph (1) of this subsection; and 18 |
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| 132 | 132 | | ‘‘(B) may also consider factors specified in 19 |
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| 133 | 133 | | paragraphs (4), (5), and (7) of subsection (c) if the 20 |
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| 134 | 134 | | Secretary finds that reliable evidence exists with re-21 |
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| 135 | 135 | | spect to such factors. 22 |
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| 136 | 136 | | ‘‘(5) Nothing in this subsection shall preclude the At-23 |
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| 137 | 137 | | torney General from transferring a substance listed in 24 |
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| 138 | 138 | | schedule I to another schedule, or removing such sub-25 |
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| 140 | 140 | | kjohnson on DSK79L0C42PROD with BILLS 6 |
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| 141 | 141 | | •HR 1758 IH |
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| 142 | 142 | | stance entirely from the schedules, pursuant to other pro-1 |
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| 143 | 143 | | visions of this section or section 202. 2 |
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| 144 | 144 | | ‘‘(6) A substance removed from schedule I(e) pursu-3 |
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| 145 | 145 | | ant to paragraph (1) or (3) may, at any time, be controlled 4 |
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| 146 | 146 | | pursuant to the other provisions of this section or section 5 |
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| 147 | 147 | | 202 without regard to that removal.’’. 6 |
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| 148 | 148 | | SEC. 4. CLARIFICATION OF CERTAIN REGISTRATION RE-7 |
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| 149 | 149 | | QUIREMENTS RELATED TO RESEARCH. 8 |
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| 150 | 150 | | (a) E |
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| 151 | 151 | | XCEPTION FOR AGENTS OREMPLOYEES OF 9 |
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| 152 | 152 | | R |
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| 153 | 153 | | EGISTEREDRESEARCHERS.—Section 302(c)(1) of the 10 |
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| 154 | 154 | | Controlled Substances Act (21 U.S.C. 822(c)(1)) is 11 |
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| 155 | 155 | | amended by striking ‘‘or dispenser’’ and inserting ‘‘dis-12 |
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| 156 | 156 | | penser, or researcher’’. 13 |
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| 157 | 157 | | (b) C |
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| 158 | 158 | | ONFORMINGAMENDMENT.—Section 102(3) of 14 |
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| 159 | 159 | | the Controlled Substances Act (21 U.S.C. 802(3)) is 15 |
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| 160 | 160 | | amended by striking ‘‘or dispenser’’ and inserting ‘‘dis-16 |
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| 161 | 161 | | penser, or researcher’’. 17 |
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| 162 | 162 | | (c) S |
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| 163 | 163 | | INGLEREGISTRATION FOR CONTIGUOUSRE-18 |
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| 164 | 164 | | SEARCHSITES.—Section 302(e) of the Controlled Sub-19 |
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| 165 | 165 | | stances Act (21 U.S.C. 822(e)) is amended by adding at 20 |
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| 166 | 166 | | the end the following new paragraph: 21 |
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| 167 | 167 | | ‘‘(3) Notwithstanding paragraph (1), a person reg-22 |
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| 168 | 168 | | istered to conduct research with a controlled substance 23 |
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| 169 | 169 | | under section 303(f) may conduct such research under a 24 |
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| 170 | 170 | | single registration if such research occurs exclusively on 25 |
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| 172 | 172 | | kjohnson on DSK79L0C42PROD with BILLS 7 |
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| 173 | 173 | | •HR 1758 IH |
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| 174 | 174 | | a single, contiguous campus and the registrant notifies the 1 |
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| 175 | 175 | | Attorney General in writing of all sites on the campus 2 |
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| 176 | 176 | | where the research will be conducted or where the con-3 |
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| 177 | 177 | | trolled substance will be stored or administered. If the reg-4 |
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| 178 | 178 | | istrant seeks to conduct such research at additional sites, 5 |
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| 179 | 179 | | the registrant shall submit a new notification before con-6 |
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| 180 | 180 | | ducting such research at any such additional sites.’’. 7 |
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| 181 | 181 | | (d) N |
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| 182 | 182 | | EWINSPECTIONNOTREQUIRED INCERTAIN 8 |
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| 183 | 183 | | S |
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| 184 | 184 | | ITUATIONS.—Section 303(f) of the Controlled Sub-9 |
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| 185 | 185 | | stances Act (21 U.S.C. 823(f)) is amended— 10 |
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| 186 | 186 | | (1) by redesignating paragraphs (1) through 11 |
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| 187 | 187 | | (5) as subparagraphs (A) through (E), respectively, 12 |
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| 188 | 188 | | and by moving the margins of such subparagraphs 13 |
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| 189 | 189 | | (as so redesignated) two ems to the right; 14 |
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| 190 | 190 | | (2) by striking ‘‘(f) The’’ and inserting ‘‘(f)(1) 15 |
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| 191 | 191 | | The’’; and 16 |
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| 192 | 192 | | (3) by adding at the end the following new 17 |
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| 193 | 193 | | paragraph: 18 |
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| 194 | 194 | | ‘‘(2)(A) If a person is registered to conduct research 19 |
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| 195 | 195 | | with a controlled substance and applies to be registered, 20 |
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| 196 | 196 | | or to modify a registration to conduct research with a sec-21 |
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| 197 | 197 | | ond controlled substance that is in the same schedule or 22 |
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| 198 | 198 | | in a schedule with a higher numerical designation, a new 23 |
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| 199 | 199 | | inspection by the Attorney General of the registered loca-24 |
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| 200 | 200 | | tion is not required. 25 |
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| 202 | 202 | | kjohnson on DSK79L0C42PROD with BILLS 8 |
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| 203 | 203 | | •HR 1758 IH |
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| 204 | 204 | | ‘‘(B) Nothing in this paragraph shall prohibit the At-1 |
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| 205 | 205 | | torney General from conducting any inspection if the At-2 |
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| 206 | 206 | | torney General determines such an inspection is nec-3 |
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| 207 | 207 | | essary.’’. 4 |
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| 208 | 208 | | (e) C |
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| 209 | 209 | | ONTINUATION OFRESEARCH ONNEWLYADDED 5 |
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| 210 | 210 | | S |
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| 211 | 211 | | UBSTANCES; AUTHORITYTOCONDUCTRESEARCHWITH 6 |
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| 212 | 212 | | O |
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| 213 | 213 | | THERSUBSTANCES.—Section 302 of the Controlled 7 |
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| 214 | 214 | | Substances Act (21 U.S.C. 822), as amended by sub-8 |
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| 215 | 215 | | sections (a) and (c), is further amended by adding at the 9 |
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| 216 | 216 | | end the following new subsection: 10 |
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| 217 | 217 | | ‘‘(h)(1) In the case of a person who is conducting 11 |
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| 218 | 218 | | research on a substance at the time the substance is added 12 |
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| 219 | 219 | | to schedule I and who is already registered to conduct re-13 |
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| 220 | 220 | | search with another controlled substance in schedule I or 14 |
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| 221 | 221 | | II, the person— 15 |
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| 222 | 222 | | ‘‘(A) within 30 days of the scheduling of such 16 |
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| 223 | 223 | | substance, shall submit a completed application for 17 |
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| 224 | 224 | | registration or modification of the existing registra-18 |
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| 225 | 225 | | tion of such person, to conduct research on such 19 |
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| 226 | 226 | | substance, in accordance with the regulations issued 20 |
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| 227 | 227 | | by the Attorney General; and 21 |
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| 228 | 228 | | ‘‘(B) notwithstanding subsections (a) and (b), 22 |
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| 229 | 229 | | may continue to conduct the research on such sub-23 |
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| 230 | 230 | | stance until the date on which— 24 |
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| 232 | 232 | | kjohnson on DSK79L0C42PROD with BILLS 9 |
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| 233 | 233 | | •HR 1758 IH |
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| 234 | 234 | | ‘‘(i) the application referred to in subpara-1 |
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| 235 | 235 | | graph (A) is withdrawn by the applicant; or 2 |
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| 236 | 236 | | ‘‘(ii) the Attorney General serves on the 3 |
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| 237 | 237 | | applicant an order to show cause proposing the 4 |
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| 238 | 238 | | denial of the application pursuant to section 5 |
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| 239 | 239 | | 304(c). 6 |
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| 240 | 240 | | ‘‘(2) If the Attorney General serves an order to show 7 |
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| 241 | 241 | | cause under paragraph (1)(B) and the applicant requests 8 |
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| 242 | 242 | | a hearing, such hearing shall be held— 9 |
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| 243 | 243 | | ‘‘(A) on an expedited basis; and 10 |
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| 244 | 244 | | ‘‘(B) not later than 45 days after the request 11 |
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| 245 | 245 | | is made, or such a later time as requested by the ap-12 |
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| 246 | 246 | | plicant. 13 |
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| 247 | 247 | | ‘‘(3)(A) A person who is registered to conduct re-14 |
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| 248 | 248 | | search with a controlled substance in schedule I may, not-15 |
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| 249 | 249 | | withstanding subsections (a) and (b), conduct research 16 |
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| 250 | 250 | | with another controlled substance in schedule I, if each 17 |
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| 251 | 251 | | of following conditions are met: 18 |
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| 252 | 252 | | ‘‘(i) The person has applied for a modification 19 |
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| 253 | 253 | | of the person’s registration to authorize research 20 |
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| 254 | 254 | | with such other controlled substance in accordance 21 |
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| 255 | 255 | | with the regulations issued by the Attorney General. 22 |
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| 256 | 256 | | ‘‘(ii) The Attorney General has obtained 23 |
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| 257 | 257 | | verification from the Secretary that the research 24 |
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| 259 | 259 | | kjohnson on DSK79L0C42PROD with BILLS 10 |
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| 260 | 260 | | •HR 1758 IH |
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| 261 | 261 | | protocol submitted with the application is meri-1 |
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| 262 | 262 | | torious. 2 |
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| 263 | 263 | | ‘‘(iii) The Attorney General has determined 3 |
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| 264 | 264 | | under subparagraph (B) that the conduct of such re-4 |
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| 265 | 265 | | search is consistent with United States obligations 5 |
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| 266 | 266 | | under the Single Convention on Narcotic Drugs, 6 |
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| 267 | 267 | | 1961. 7 |
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| 268 | 268 | | ‘‘(B) Not later than 30 days after receiving an appli-8 |
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| 269 | 269 | | cation under clause (i), the Attorney General shall deter-9 |
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| 270 | 270 | | mine whether the conduct of research that is the subject 10 |
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| 271 | 271 | | of the application is consistent with United States obliga-11 |
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| 272 | 272 | | tions under the Single Convention on Narcotic Drugs, 12 |
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| 273 | 273 | | 1961. 13 |
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| 274 | 274 | | ‘‘(C) Nothing in this section shall be construed to 14 |
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| 275 | 275 | | alter the authority of the Attorney General to initiate pro-15 |
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| 276 | 276 | | ceedings to deny, suspend, or revoke any registration in 16 |
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| 277 | 277 | | accordance with sections 303 and 304.’’. 17 |
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| 278 | 278 | | (f) T |
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| 279 | 279 | | REATMENT OFCERTAINACTIVITIES ASCOINCI-18 |
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| 280 | 280 | | DENT TORESEARCH.—Section 302 of the Controlled Sub-19 |
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| 281 | 281 | | stances Act (21 U.S.C. 822), as amended by subsections 20 |
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| 282 | 282 | | (a), (c), and (e), is further amended by adding at the end 21 |
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| 283 | 283 | | the following new subsection: 22 |
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| 284 | 284 | | ‘‘(i) A person who is registered to perform research 23 |
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| 285 | 285 | | with a controlled substance (other than marihuana) under 24 |
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| 286 | 286 | | this title may, without being required to registered to man-25 |
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| 288 | 288 | | kjohnson on DSK79L0C42PROD with BILLS 11 |
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| 289 | 289 | | •HR 1758 IH |
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| 290 | 290 | | ufacture such substance, using small quantities of such 1 |
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| 291 | 291 | | substance, perform the following activities: 2 |
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| 292 | 292 | | ‘‘(1) Processing the substance to create ex-3 |
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| 293 | 293 | | tracts, tinctures, oils, solutions, derivatives, or other 4 |
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| 294 | 294 | | forms of the substance consistent with the approved 5 |
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| 295 | 295 | | research protocol. 6 |
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| 296 | 296 | | ‘‘(2) Dosage form development for the purpose 7 |
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| 297 | 297 | | of satisfying requirements with respect to the sub-8 |
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| 298 | 298 | | mission of an investigational new drug application 9 |
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| 299 | 299 | | under section 505(i) of the Federal Food, Drug, and 10 |
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| 300 | 300 | | Cosmetic Act.’’. 11 |
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| 301 | 301 | | SEC. 5. REVIEW OF RESEARCH REGISTRATION PROCESS. 12 |
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| 302 | 302 | | (a) R |
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| 303 | 303 | | EVIEW.—Not later than one year after the date 13 |
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| 304 | 304 | | of the enactment of this section, the Attorney General and 14 |
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| 305 | 305 | | the Secretary of Health and Human Services shall jointly 15 |
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| 306 | 306 | | conduct a review of the processes used to register or mod-16 |
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| 307 | 307 | | ify a registration to conduct research with controlled sub-17 |
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| 308 | 308 | | stances under the Controlled Substances Act (21 U.S.C. 18 |
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| 309 | 309 | | 801 et seq.), including— 19 |
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| 310 | 310 | | (1) an evaluation of the impacts of the amend-20 |
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| 311 | 311 | | ments made by this Act on the risk of the diversion 21 |
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| 312 | 312 | | of controlled substances used in research and related 22 |
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| 313 | 313 | | public safety considerations; and 23 |
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| 314 | 314 | | (2) an identification of opportunities to reduce 24 |
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| 315 | 315 | | any unnecessary burden on persons seeking registra-25 |
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| 317 | 317 | | kjohnson on DSK79L0C42PROD with BILLS 12 |
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| 318 | 318 | | •HR 1758 IH |
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| 319 | 319 | | tion, potential redundancies, and inefficiencies in 1 |
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| 320 | 320 | | such processes, including— 2 |
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| 321 | 321 | | (A) the process for obtaining a registration 3 |
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| 322 | 322 | | under section 303 of the Controlled Substances 4 |
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| 323 | 323 | | Act (21 U.S.C. 823); and 5 |
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| 324 | 324 | | (B) the process by which the Secretary re-6 |
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| 325 | 325 | | views research protocols submitted with respect 7 |
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| 326 | 326 | | to such registration. 8 |
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| 327 | 327 | | (b) G |
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| 328 | 328 | | UIDANCE.—Not later than 60 days after con-9 |
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| 329 | 329 | | cluding the review described in subsection (a), the Attor-10 |
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| 330 | 330 | | ney General and the Secretary shall, as appropriate, joint-11 |
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| 331 | 331 | | ly issue guidance to registrants and potential registrants 12 |
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| 332 | 332 | | clarifying the process for registration. 13 |
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| 333 | 333 | | Æ |
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| 335 | 335 | | kjohnson on DSK79L0C42PROD with BILLS |
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