| 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. 568 |
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| 5 | 5 | | To amend the Controlled Substances Act with respect to fentanyl-related |
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| 6 | 6 | | substances, and for other purposes. |
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| 7 | 7 | | IN THE HOUSE OF REPRESENTATIVES |
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| 8 | 8 | | JANUARY26, 2023 |
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| 9 | 9 | | Mr. P |
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| 10 | 10 | | APPAS(for himself, Mr. NEWHOUSE, Mr. TONYGONZALESof Texas, |
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| 11 | 11 | | and Ms. S |
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| 12 | 12 | | ALAZAR) introduced the following bill; which was referred to |
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| 13 | 13 | | the Committee on Energy and Commerce, and in addition to the Com- |
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| 14 | 14 | | mittee on the Judiciary, for a period to be subsequently determined by |
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| 15 | 15 | | the Speaker, in each case for consideration of such provisions as fall with- |
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| 16 | 16 | | in 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 with respect to |
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| 19 | 19 | | fentanyl-related substances, and for other purposes. |
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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 ‘‘Save Americans from 4 |
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| 24 | 24 | | the Fentanyl Emergency Act’’ or the ‘‘SAFE Act’’. 5 |
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| 26 | 26 | | kjohnson on DSK79L0C42PROD with BILLS 2 |
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| 27 | 27 | | •HR 568 IH |
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| 28 | 28 | | SEC. 2. CLASS SCHEDULING OF FENTANYL-RELATED SUB-1 |
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| 29 | 29 | | STANCES. 2 |
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| 30 | 30 | | Section 202(c) of the Controlled Substances Act (21 3 |
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| 31 | 31 | | U.S.C. 812(c)) is amended by adding at the end of sched-4 |
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| 32 | 32 | | ule I the following: 5 |
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| 33 | 33 | | ‘‘(e)(1) Unless specifically exempted or unless listed 6 |
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| 34 | 34 | | in another schedule, any material, compound, mixture, or 7 |
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| 35 | 35 | | preparation which contains any quantity of fentanyl-re-8 |
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| 36 | 36 | | lated substances, or which contains their salts, isomers, 9 |
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| 37 | 37 | | and salts of isomers whenever the existence of such salts, 10 |
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| 38 | 38 | | isomers, and salts of isomers is possible within the specific 11 |
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| 39 | 39 | | chemical designation. 12 |
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| 40 | 40 | | ‘‘(2) In this subsection, except as provided in para-13 |
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| 41 | 41 | | graph (3), the term ‘fentanyl-related substance’ means 14 |
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| 42 | 42 | | any substance that is structurally related to fentanyl by 15 |
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| 43 | 43 | | one or more of the following modifications: 16 |
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| 44 | 44 | | ‘‘(A) By replacement of the phenyl portion of 17 |
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| 45 | 45 | | the phenethyl group by any monocycle, whether or 18 |
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| 46 | 46 | | not further substituted in or on the monocycle. 19 |
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| 47 | 47 | | ‘‘(B) By substitution in or on the phenethyl 20 |
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| 48 | 48 | | group with alkyl, alkenyl, alkoxyl, hydroxyl, halo, 21 |
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| 49 | 49 | | haloalkyl, amino, or nitro groups. 22 |
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| 50 | 50 | | ‘‘(C) By substitution in or on the piperidine 23 |
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| 51 | 51 | | ring with alkyl, alkenyl, alkoxyl, ester, ether, 24 |
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| 52 | 52 | | hydroxyl, halo, haloalkyl, amino, or nitro groups. 25 |
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| 54 | 54 | | kjohnson on DSK79L0C42PROD with BILLS 3 |
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| 55 | 55 | | •HR 568 IH |
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| 56 | 56 | | ‘‘(D) By replacement of the aniline ring with 1 |
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| 57 | 57 | | any aromatic monocycle whether or not further sub-2 |
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| 58 | 58 | | stituted in or on the aromatic monocycle. 3 |
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| 59 | 59 | | ‘‘(E) By replacement of the N-propionyl group 4 |
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| 60 | 60 | | with another acyl group. 5 |
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| 61 | 61 | | ‘‘(3) A substance that meets the criteria specified in 6 |
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| 62 | 62 | | paragraph (2) to be considered a fentanyl-related sub-7 |
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| 63 | 63 | | stance shall not be so considered as meeting such criteria 8 |
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| 64 | 64 | | if such substance— 9 |
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| 65 | 65 | | ‘‘(A) is controlled by action of the Attorney 10 |
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| 66 | 66 | | General pursuant to section 201; 11 |
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| 67 | 67 | | ‘‘(B) is expressly listed in this schedule or an-12 |
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| 68 | 68 | | other schedule by a statutory provision other than 13 |
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| 69 | 69 | | this subsection; or 14 |
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| 70 | 70 | | ‘‘(C) is removed from this schedule, or resched-15 |
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| 71 | 71 | | uled to another schedule, pursuant to section 201(k). 16 |
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| 72 | 72 | | ‘‘(4) The Attorney General shall publish in the Fed-17 |
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| 73 | 73 | | eral Register a list of individual substances that meet the 18 |
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| 74 | 74 | | definition of fentanyl-related substances in paragraph (2) 19 |
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| 75 | 75 | | within 60 days of determining such substances meet such 20 |
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| 76 | 76 | | definition. The absence of a substance on any such list 21 |
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| 77 | 77 | | does not negate the control status of such substance if 22 |
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| 78 | 78 | | the substance meets the criteria specified in paragraph (2) 23 |
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| 79 | 79 | | to be considered a fentanyl-related substance. 24 |
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| 81 | 81 | | kjohnson on DSK79L0C42PROD with BILLS 4 |
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| 82 | 82 | | •HR 568 IH |
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| 83 | 83 | | ‘‘(5) Notwithstanding any other provision of this title 1 |
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| 84 | 84 | | or title III, fentanyl-related substances shall not be subject 2 |
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| 85 | 85 | | to quantity-based mandatory minimum penalties pursuant 3 |
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| 86 | 86 | | to subparagraph (A)(vi) or (B)(vi) of section 401(b)(1) of 4 |
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| 87 | 87 | | this title or paragraph (1)(F) or (2)(F) of section 1010(b) 5 |
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| 88 | 88 | | of title III.’’. 6 |
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| 89 | 89 | | SEC. 3. PENALTY PROVISIONS WITH RESPECT TO 7 |
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| 90 | 90 | | FENTANYL-RELATED SUBSTANCES—DOMES-8 |
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| 91 | 91 | | TIC OFFENSES. 9 |
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| 92 | 92 | | Section 401(b)(1) of the Controlled Substances Act 10 |
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| 93 | 93 | | (21 U.S.C. 841(b)(1)) is amended— 11 |
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| 94 | 94 | | (1) in subparagraph (A), by striking clause (vi) 12 |
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| 95 | 95 | | and inserting the following: 13 |
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| 96 | 96 | | ‘‘(vi)(I) 400 grams or more of a mixture or sub-14 |
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| 97 | 97 | | stance containing a detectable amount of fentanyl; 15 |
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| 98 | 98 | | or 16 |
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| 99 | 99 | | ‘‘(II) 100 grams or more of a mixture or sub-17 |
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| 100 | 100 | | stance containing a detectable amount of any ana-18 |
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| 101 | 101 | | logue of fentanyl that is controlled in schedule I or 19 |
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| 102 | 102 | | II or that is treated as a schedule I controlled sub-20 |
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| 103 | 103 | | stance pursuant to section 203(a), except for a 21 |
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| 104 | 104 | | fentanyl-related substance as defined in schedule 22 |
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| 105 | 105 | | I(e) of section 202(c);’’; 23 |
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| 106 | 106 | | (2) in subparagraph (B), by striking clause (vi) 24 |
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| 107 | 107 | | and inserting the following: 25 |
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| 109 | 109 | | kjohnson on DSK79L0C42PROD with BILLS 5 |
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| 110 | 110 | | •HR 568 IH |
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| 111 | 111 | | ‘‘(vi)(I) 40 grams or more of a mixture or sub-1 |
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| 112 | 112 | | stance containing a detectable amount of fentanyl; 2 |
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| 113 | 113 | | or 3 |
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| 114 | 114 | | ‘‘(II) 10 grams or more of a mixture or sub-4 |
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| 115 | 115 | | stance containing a detectable amount of any ana-5 |
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| 116 | 116 | | logue of fentanyl that is controlled in schedule I or 6 |
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| 117 | 117 | | II or that is treated as a schedule I controlled sub-7 |
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| 118 | 118 | | stance pursuant to section 203(a), except for a 8 |
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| 119 | 119 | | fentanyl-related substance as defined in schedule 9 |
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| 120 | 120 | | I(e) of section 202(c);’’; and 10 |
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| 121 | 121 | | (3) in subparagraph (C), by inserting ‘‘, includ-11 |
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| 122 | 122 | | ing a fentanyl-related substance as defined in sched-12 |
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| 123 | 123 | | ule I(e) of section 202(c),’’ after ‘‘a controlled sub-13 |
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| 124 | 124 | | stance in schedule I or II,’’. 14 |
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| 125 | 125 | | SEC. 4. PENALTY PROVISIONS WITH RESPECT TO 15 |
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| 126 | 126 | | FENTANYL-RELATED SUBSTANCES—IMPORT 16 |
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| 127 | 127 | | AND EXPORT OFFENSES. 17 |
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| 128 | 128 | | Section 1010(b) of the Controlled Substances Import 18 |
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| 129 | 129 | | and Export Act (21 U.S.C. 960(b)) is amended— 19 |
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| 130 | 130 | | (1) in paragraph (1), by striking subparagraph 20 |
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| 131 | 131 | | (F) and inserting the following: 21 |
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| 132 | 132 | | ‘‘(F)(i) 400 grams or more of a mixture or sub-22 |
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| 133 | 133 | | stance containing a detectable amount of fentanyl; 23 |
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| 134 | 134 | | or 24 |
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| 136 | 136 | | kjohnson on DSK79L0C42PROD with BILLS 6 |
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| 137 | 137 | | •HR 568 IH |
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| 138 | 138 | | ‘‘(ii) 100 grams or more of a mixture or sub-1 |
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| 139 | 139 | | stance containing a detectable amount of any ana-2 |
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| 140 | 140 | | logue of fentanyl that is controlled in schedule I or 3 |
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| 141 | 141 | | II or that is treated as a schedule I controlled sub-4 |
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| 142 | 142 | | stance pursuant to section 203(a) of the Controlled 5 |
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| 143 | 143 | | Substances Act, except for a fentanyl-related sub-6 |
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| 144 | 144 | | stance as defined in schedule I(e) of section 202(c) 7 |
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| 145 | 145 | | of the Controlled Substances Act;’’; 8 |
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| 146 | 146 | | (2) in paragraph (2), by striking subparagraph 9 |
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| 147 | 147 | | (F) and inserting the following: 10 |
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| 148 | 148 | | ‘‘(F)(i) 40 grams or more of a mixture or sub-11 |
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| 149 | 149 | | stance containing a detectable amount of fentanyl; 12 |
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| 150 | 150 | | or 13 |
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| 151 | 151 | | ‘‘(ii) 10 grams or more of a mixture or sub-14 |
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| 152 | 152 | | stance containing a detectable amount of any ana-15 |
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| 153 | 153 | | logue of fentanyl that is controlled in schedule I or 16 |
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| 154 | 154 | | II or that is treated as a schedule I controlled sub-17 |
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| 155 | 155 | | stance pursuant to section 203(a) of the Controlled 18 |
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| 156 | 156 | | Substances Act, except for a fentanyl-related sub-19 |
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| 157 | 157 | | stance as defined in schedule I(e) of section 202(c) 20 |
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| 158 | 158 | | of the Controlled Substances Act;’’; and 21 |
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| 159 | 159 | | (3) in paragraph (3), by inserting ‘‘including a 22 |
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| 160 | 160 | | fentanyl-related substance as defined in schedule 23 |
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| 161 | 161 | | I(e) of section 202(c) of the Controlled Substances 24 |
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| 163 | 163 | | kjohnson on DSK79L0C42PROD with BILLS 7 |
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| 164 | 164 | | •HR 568 IH |
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| 165 | 165 | | Act,’’ after ‘‘a controlled substance in schedule I or 1 |
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| 166 | 166 | | II,’’. 2 |
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| 167 | 167 | | SEC. 5. REMOVAL FROM SCHEDULE I OF FENTANYL-RE-3 |
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| 168 | 168 | | LATED SUBSTANCES. 4 |
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| 169 | 169 | | Section 201 of the Controlled Substances Act (21 5 |
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| 170 | 170 | | U.S.C. 811) is amended by adding at the end the following 6 |
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| 171 | 171 | | new subsection: 7 |
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| 172 | 172 | | ‘‘(k) R |
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| 173 | 173 | | EMOVALFROMSCHEDULEI OFFENTANYL- 8 |
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| 174 | 174 | | R |
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| 175 | 175 | | ELATEDSUBSTANCES.— 9 |
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| 176 | 176 | | ‘‘(1) D |
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| 177 | 177 | | ETERMINATION RESULTING IN RE -10 |
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| 178 | 178 | | MOVAL.—If the Secretary determines, taking into 11 |
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| 179 | 179 | | consideration factors as set forth in paragraph (3), 12 |
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| 180 | 180 | | that a fentanyl-related substance has a potential for 13 |
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| 181 | 181 | | abuse that is less than the drugs or other substances 14 |
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| 182 | 182 | | in schedule V— 15 |
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| 183 | 183 | | ‘‘(A) the Secretary shall submit to the At-16 |
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| 184 | 184 | | torney General a scientific and medical evalua-17 |
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| 185 | 185 | | tion of that fentanyl-related substance sup-18 |
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| 186 | 186 | | porting that determination; 19 |
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| 187 | 187 | | ‘‘(B) the Secretary shall submit any such 20 |
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| 188 | 188 | | evaluation and determination in writing and in-21 |
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| 189 | 189 | | clude the bases therefor; 22 |
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| 190 | 190 | | ‘‘(C) the scientific and medical determina-23 |
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| 191 | 191 | | tion of the Secretary contained in such evalua-24 |
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| 193 | 193 | | kjohnson on DSK79L0C42PROD with BILLS 8 |
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| 194 | 194 | | •HR 568 IH |
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| 195 | 195 | | tion shall be binding on the Attorney General; 1 |
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| 196 | 196 | | and 2 |
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| 197 | 197 | | ‘‘(D) not later than 90 days after receiving 3 |
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| 198 | 198 | | such evaluation and determination, the Attor-4 |
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| 199 | 199 | | ney General shall issue an order removing such 5 |
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| 200 | 200 | | fentanyl-related substance from the schedules 6 |
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| 201 | 201 | | under section 202. 7 |
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| 202 | 202 | | ‘‘(2) D |
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| 203 | 203 | | ETERMINATION RESULTING IN RESCHED -8 |
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| 204 | 204 | | ULING.—If the Secretary determines, taking into 9 |
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| 205 | 205 | | consideration factors as set forth in paragraph (3), 10 |
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| 206 | 206 | | that a fentanyl-related substance has a potential for 11 |
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| 207 | 207 | | abuse that is less than the drugs or other substances 12 |
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| 208 | 208 | | in schedules I and II— 13 |
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| 209 | 209 | | ‘‘(A) the Secretary shall submit to the At-14 |
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| 210 | 210 | | torney General a scientific and medical evalua-15 |
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| 211 | 211 | | tion of that fentanyl-related substance sup-16 |
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| 212 | 212 | | porting that determination; 17 |
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| 213 | 213 | | ‘‘(B) the Secretary shall submit any such 18 |
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| 214 | 214 | | evaluation and determination in writing and in-19 |
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| 215 | 215 | | clude the bases therefor; 20 |
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| 216 | 216 | | ‘‘(C) the scientific and medical determina-21 |
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| 217 | 217 | | tion of the Secretary contained in such evalua-22 |
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| 218 | 218 | | tion shall be binding on the Attorney General; 23 |
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| 219 | 219 | | and 24 |
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| 221 | 221 | | kjohnson on DSK79L0C42PROD with BILLS 9 |
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| 222 | 222 | | •HR 568 IH |
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| 223 | 223 | | ‘‘(D) not later than 90 days after receiving 1 |
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| 224 | 224 | | such evaluation, the Attorney General shall 2 |
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| 225 | 225 | | issue an order removing such fentanyl-related 3 |
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| 226 | 226 | | substance from schedule I and controlling such 4 |
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| 227 | 227 | | substance under schedule III. 5 |
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| 228 | 228 | | ‘‘(3) E |
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| 229 | 229 | | VALUATION FACTORS.— 6 |
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| 230 | 230 | | ‘‘(A) I |
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| 231 | 231 | | N GENERAL.—In making a deter-7 |
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| 232 | 232 | | mination under paragraph (1) or (2), the Sec-8 |
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| 233 | 233 | | retary— 9 |
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| 234 | 234 | | ‘‘(i) shall consider— 10 |
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| 235 | 235 | | ‘‘(I) the factor listed in para-11 |
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| 236 | 236 | | graph (2) of subsection (c); 12 |
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| 237 | 237 | | ‘‘(II) the factors listed in para-13 |
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| 238 | 238 | | graphs (1), (3), and (6) of such sub-14 |
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| 239 | 239 | | section to the extent evidence exists 15 |
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| 240 | 240 | | with respect to such factors; and 16 |
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| 241 | 241 | | ‘‘(III) any information submitted 17 |
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| 242 | 242 | | to the Secretary by the Attorney Gen-18 |
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| 243 | 243 | | eral for purposes of such determina-19 |
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| 244 | 244 | | tion; and 20 |
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| 245 | 245 | | ‘‘(ii) may consider the factors listed in 21 |
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| 246 | 246 | | paragraphs (4), (5), and (7) of subsection 22 |
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| 247 | 247 | | (c) if the Secretary finds that evidence ex-23 |
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| 248 | 248 | | ists with respect to such factors. 24 |
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| 250 | 250 | | kjohnson on DSK79L0C42PROD with BILLS 10 |
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| 251 | 251 | | •HR 568 IH |
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| 252 | 252 | | ‘‘(B) CONSIDERATION OF SCIENTIFIC EVI -1 |
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| 253 | 253 | | DENCE OF PHARMACOLOGICAL EFFECT .— 2 |
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| 254 | 254 | | ‘‘(i) I |
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| 255 | 255 | | N GENERAL.—For the purposes 3 |
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| 256 | 256 | | of subparagraph (A)(i)(I), consideration by 4 |
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| 257 | 257 | | the Secretary of the results of an assess-5 |
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| 258 | 258 | | ment consisting of the studies described in 6 |
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| 259 | 259 | | clause (ii) shall suffice to constitute consid-7 |
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| 260 | 260 | | eration of the factor listed in paragraph 8 |
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| 261 | 261 | | (2) of subsection (c) if— 9 |
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| 262 | 262 | | ‘‘(I) each such study is per-10 |
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| 263 | 263 | | formed according to scientific methods 11 |
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| 264 | 264 | | and protocols commonly accepted in 12 |
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| 265 | 265 | | the scientific community; and 13 |
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| 266 | 266 | | ‘‘(II) the Secretary determines 14 |
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| 267 | 267 | | that such assessment is adequate for 15 |
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| 268 | 268 | | such purposes. 16 |
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| 269 | 269 | | ‘‘(ii) D |
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| 270 | 270 | | ESCRIBED STUDIES .—The 17 |
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| 271 | 271 | | studies described in this clause are any of 18 |
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| 272 | 272 | | the following: 19 |
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| 273 | 273 | | ‘‘(I) A receptor binding study 20 |
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| 274 | 274 | | that can demonstrate whether the 21 |
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| 275 | 275 | | substance has affinity for the human 22 |
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| 276 | 276 | | mu opioid receptor. 23 |
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| 277 | 277 | | ‘‘(II) An in vitro functional assay 24 |
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| 278 | 278 | | that can demonstrate whether the 25 |
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| 280 | 280 | | kjohnson on DSK79L0C42PROD with BILLS 11 |
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| 281 | 281 | | •HR 568 IH |
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| 282 | 282 | | substance has agonist activity at the 1 |
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| 283 | 283 | | human mu opioid receptor. 2 |
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| 284 | 284 | | ‘‘(III) One or more in vivo ani-3 |
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| 285 | 285 | | mal behavioral studies that can dem-4 |
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| 286 | 286 | | onstrate whether the substance has 5 |
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| 287 | 287 | | abuse-related drug effects consistent 6 |
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| 288 | 288 | | with mu opioid agonist activity, such 7 |
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| 289 | 289 | | as demonstrating similarity to the ef-8 |
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| 290 | 290 | | fects of morphine. 9 |
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| 291 | 291 | | ‘‘(4) A |
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| 292 | 292 | | DVANCE NOTICE REGARDING EVALUA -10 |
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| 293 | 293 | | TION AND CONCLUSION .—The Secretary shall give 11 |
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| 294 | 294 | | the Attorney General at least 30 days notice before 12 |
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| 295 | 295 | | sending the Attorney General an evaluation and de-13 |
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| 296 | 296 | | termination under paragraph (1) or (2) with respect 14 |
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| 297 | 297 | | to a fentanyl-related substance. 15 |
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| 298 | 298 | | ‘‘(5) E |
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| 299 | 299 | | XCEPTION FOR TREATY OBLIGATIONS .— 16 |
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| 300 | 300 | | If a fentanyl-related substance is a substance that 17 |
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| 301 | 301 | | the United States is obligated to control under inter-18 |
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| 302 | 302 | | national treaties, conventions, or protocols in effect 19 |
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| 303 | 303 | | on the date of enactment of the Save Americans 20 |
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| 304 | 304 | | from the Fentanyl Emergency Act, this subsection 21 |
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| 305 | 305 | | shall not require the Attorney General— 22 |
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| 306 | 306 | | ‘‘(A) to remove such substance from con-23 |
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| 307 | 307 | | trol; or 24 |
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| 309 | 309 | | kjohnson on DSK79L0C42PROD with BILLS 12 |
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| 310 | 310 | | •HR 568 IH |
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| 311 | 311 | | ‘‘(B) to place such substance in a schedule 1 |
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| 312 | 312 | | less restrictive than that which the Attorney 2 |
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| 313 | 313 | | General determines is necessary to carry out 3 |
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| 314 | 314 | | such obligations. 4 |
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| 315 | 315 | | ‘‘(6) I |
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| 316 | 316 | | DENTIFICATION OF FENTANYL -RELATED 5 |
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| 317 | 317 | | SUBSTANCES.—If the Attorney General or any offi-6 |
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| 318 | 318 | | cial of the Department of Justice determines that a 7 |
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| 319 | 319 | | substance is a fentanyl-related substance, the Attor-8 |
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| 320 | 320 | | ney General shall— 9 |
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| 321 | 321 | | ‘‘(A) within 30 days of such determination, 10 |
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| 322 | 322 | | notify the Secretary; and 11 |
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| 323 | 323 | | ‘‘(B) include in such notification the iden-12 |
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| 324 | 324 | | tity of the substance, its structure, and the 13 |
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| 325 | 325 | | basis for the determination. 14 |
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| 326 | 326 | | ‘‘(7) P |
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| 327 | 327 | | ETITIONS FOR REMOVING A FENTANYL - 15 |
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| 328 | 328 | | RELATED SUBSTANCE .— 16 |
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| 329 | 329 | | ‘‘(A) I |
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| 330 | 330 | | N GENERAL.—If a person petitions 17 |
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| 331 | 331 | | the Attorney General to remove a fentanyl-re-18 |
|---|
| 332 | 332 | | lated substance from schedule I(e) or to re-19 |
|---|
| 333 | 333 | | schedule such a substance to another schedule, 20 |
|---|
| 334 | 334 | | the Attorney General shall consider such a peti-21 |
|---|
| 335 | 335 | | tion in accordance with the procedures and 22 |
|---|
| 336 | 336 | | standards set forth in— 23 |
|---|
| 337 | 337 | | ‘‘(i) subsections (a) and (b) of this 24 |
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| 338 | 338 | | section; and 25 |
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| 340 | 340 | | kjohnson on DSK79L0C42PROD with BILLS 13 |
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| 341 | 341 | | •HR 568 IH |
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| 342 | 342 | | ‘‘(ii) section 1308.43 of title 21, Code 1 |
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| 343 | 343 | | of Federal Regulations (or any successor 2 |
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| 344 | 344 | | regulations). 3 |
|---|
| 345 | 345 | | ‘‘(B) A |
|---|
| 346 | 346 | | TTORNEY GENERAL TO INFORM 4 |
|---|
| 347 | 347 | | SECRETARY.—Within 30 days of receiving such 5 |
|---|
| 348 | 348 | | a petition, the Attorney General shall forward a 6 |
|---|
| 349 | 349 | | copy of the petition to the Secretary. 7 |
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| 350 | 350 | | ‘‘(C) D |
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| 351 | 351 | | ETERMINATION PROCEDURE NOT 8 |
|---|
| 352 | 352 | | PRECLUDED BY FILING OF PETITION .—The fil-9 |
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| 353 | 353 | | ing of a petition under this paragraph shall not 10 |
|---|
| 354 | 354 | | preclude the Secretary from making a deter-11 |
|---|
| 355 | 355 | | mination and sending an evaluation under para-12 |
|---|
| 356 | 356 | | graph (1) or (2). 13 |
|---|
| 357 | 357 | | ‘‘(8) R |
|---|
| 358 | 358 | | ULE OF CONSTRUCTION .—Nothing in 14 |
|---|
| 359 | 359 | | this subsection shall be construed to preclude the At-15 |
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| 360 | 360 | | torney General from transferring a substance listed 16 |
|---|
| 361 | 361 | | in schedule I to another schedule, or removing such 17 |
|---|
| 362 | 362 | | substance entirely from the schedules, pursuant to 18 |
|---|
| 363 | 363 | | other provisions of this section and section 202. 19 |
|---|
| 364 | 364 | | ‘‘(9) S |
|---|
| 365 | 365 | | UBSEQUENT CONTROLLING OF REMOVED 20 |
|---|
| 366 | 366 | | SUBSTANCE.—A substance removed from schedule I 21 |
|---|
| 367 | 367 | | pursuant to this subsection may, at any time, be 22 |
|---|
| 368 | 368 | | controlled pursuant to the other provisions of this 23 |
|---|
| 369 | 369 | | section and section 202 without regard to the re-24 |
|---|
| 370 | 370 | | moval pursuant to this subsection. 25 |
|---|
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| 372 | 372 | | kjohnson on DSK79L0C42PROD with BILLS 14 |
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| 373 | 373 | | •HR 568 IH |
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| 374 | 374 | | ‘‘(10) EVALUATIONS OR STUDIES .—The Sec-1 |
|---|
| 375 | 375 | | retary may enter into contracts or other agreements 2 |
|---|
| 376 | 376 | | to conduct or support evaluations or studies of 3 |
|---|
| 377 | 377 | | fentanyl-related substances. 4 |
|---|
| 378 | 378 | | ‘‘(11) D |
|---|
| 379 | 379 | | EFINITION.—In this subsection, the 5 |
|---|
| 380 | 380 | | term ‘fentanyl-related substance’ means a fentanyl- 6 |
|---|
| 381 | 381 | | related substance as defined in schedule I(e) of sec-7 |
|---|
| 382 | 382 | | tion 202(c).’’. 8 |
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| 383 | 383 | | SEC. 6. PAST CASES INVOLVING REMOVED OR RESCHED-9 |
|---|
| 384 | 384 | | ULED SUBSTANCES. 10 |
|---|
| 385 | 385 | | (a) D |
|---|
| 386 | 386 | | OMESTICCASES.—Section 401(b) of the Con-11 |
|---|
| 387 | 387 | | trolled Substances Act (21 U.S.C. 841(b)) is amended by 12 |
|---|
| 388 | 388 | | adding at the end the following: 13 |
|---|
| 389 | 389 | | ‘‘(8) P |
|---|
| 390 | 390 | | ASTCONVICTIONSINVOLVINGFENTANYL-RE-14 |
|---|
| 391 | 391 | | LATEDSUBSTANCE.— 15 |
|---|
| 392 | 392 | | ‘‘(A) I |
|---|
| 393 | 393 | | N GENERAL.—In the case of a defendant 16 |
|---|
| 394 | 394 | | whose offense of conviction under this title involved 17 |
|---|
| 395 | 395 | | a fentanyl-related substance (as defined in schedule 18 |
|---|
| 396 | 396 | | I(e) of section 202(c) as of the date the offense was 19 |
|---|
| 397 | 397 | | committed) that has since been removed from des-20 |
|---|
| 398 | 398 | | ignation as a fentanyl-related substance for purposes 21 |
|---|
| 399 | 399 | | of this title and has been placed on any schedule 22 |
|---|
| 400 | 400 | | other than schedule I or II or has been removed 23 |
|---|
| 401 | 401 | | from the controlled substance schedules, the sen-24 |
|---|
| 402 | 402 | | tencing court may, on motion of the defendant, the 25 |
|---|
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| 404 | 404 | | kjohnson on DSK79L0C42PROD with BILLS 15 |
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| 405 | 405 | | •HR 568 IH |
|---|
| 406 | 406 | | Bureau of Prisons, the attorney for the Government, 1 |
|---|
| 407 | 407 | | or on its own motion, after considering the factors 2 |
|---|
| 408 | 408 | | set forth in section 3553(a) of title 18, United 3 |
|---|
| 409 | 409 | | States Code, vacate the previously imposed sentence, 4 |
|---|
| 410 | 410 | | or impose a reduced sentence on any count of con-5 |
|---|
| 411 | 411 | | viction as if the removal or placement was in effect 6 |
|---|
| 412 | 412 | | at the time that the offense was committed. Nothing 7 |
|---|
| 413 | 413 | | in this section may be construed to require a court 8 |
|---|
| 414 | 414 | | to vacate or reduce any sentence. 9 |
|---|
| 415 | 415 | | ‘‘(B) D |
|---|
| 416 | 416 | | EFENDANT NOT REQUIRED TO BE 10 |
|---|
| 417 | 417 | | PRESENT.—Notwithstanding rule 43 of the Federal 11 |
|---|
| 418 | 418 | | Rules of Criminal Procedure, the defendant is not 12 |
|---|
| 419 | 419 | | required to be present at any hearing on whether to 13 |
|---|
| 420 | 420 | | vacate or reduce a sentence pursuant to this sec-14 |
|---|
| 421 | 421 | | tion.’’. 15 |
|---|
| 422 | 422 | | (b) I |
|---|
| 423 | 423 | | MPORT ANDEXPORTCASES.—Section 1010(b) 16 |
|---|
| 424 | 424 | | of the Controlled Substances Import and Export Act (21 17 |
|---|
| 425 | 425 | | U.S.C. 960(b)) is amended by adding at the end the fol-18 |
|---|
| 426 | 426 | | lowing: 19 |
|---|
| 427 | 427 | | ‘‘(8) In the case of a defendant whose offense of con-20 |
|---|
| 428 | 428 | | viction under this title involved a fentanyl-related sub-21 |
|---|
| 429 | 429 | | stance (as defined in schedule I(e) of section 202(c) of 22 |
|---|
| 430 | 430 | | the Controlled Substances Act as of the date the offense 23 |
|---|
| 431 | 431 | | was committed) that has since been removed from des-24 |
|---|
| 432 | 432 | | ignation as a fentanyl-related substance for purposes of 25 |
|---|
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| 434 | 434 | | kjohnson on DSK79L0C42PROD with BILLS 16 |
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| 435 | 435 | | •HR 568 IH |
|---|
| 436 | 436 | | this title and has been placed on any schedule other than 1 |
|---|
| 437 | 437 | | schedule I or II or has been removed from the controlled 2 |
|---|
| 438 | 438 | | substance schedules, the sentencing court may, on motion 3 |
|---|
| 439 | 439 | | of the defendant, the Bureau of Prisons, the attorney for 4 |
|---|
| 440 | 440 | | the Government, or on its own motion, after considering 5 |
|---|
| 441 | 441 | | the factors set forth in section 3553(a) of title 18, United 6 |
|---|
| 442 | 442 | | States Code, vacate the previously imposed sentence, or 7 |
|---|
| 443 | 443 | | impose a reduced sentence on any count of conviction as 8 |
|---|
| 444 | 444 | | if the removal or placement was in effect at the time that 9 |
|---|
| 445 | 445 | | the offense was committed. Nothing in this section may 10 |
|---|
| 446 | 446 | | be construed to require a court to vacate or reduce any 11 |
|---|
| 447 | 447 | | sentence.’’. 12 |
|---|
| 448 | 448 | | SEC. 7. REGISTRATION REQUIREMENTS RELATED TO RE-13 |
|---|
| 449 | 449 | | SEARCH. 14 |
|---|
| 450 | 450 | | (a) A |
|---|
| 451 | 451 | | LTERNATIVE REGISTRATIONPROCESS FOR 15 |
|---|
| 452 | 452 | | S |
|---|
| 453 | 453 | | CHEDULEI RESEARCH.—Section 303 of the Controlled 16 |
|---|
| 454 | 454 | | Substances Act (21 U.S.C. 823) is amended by adding at 17 |
|---|
| 455 | 455 | | the end the following new subsection: 18 |
|---|
| 456 | 456 | | ‘‘(m) S |
|---|
| 457 | 457 | | PECIALPROVISIONS FORTHOSECONDUCTING 19 |
|---|
| 458 | 458 | | C |
|---|
| 459 | 459 | | ERTAINRESEARCHWITHSCHEDULEI CONTROLLED 20 |
|---|
| 460 | 460 | | S |
|---|
| 461 | 461 | | UBSTANCES.— 21 |
|---|
| 462 | 462 | | ‘‘(1) I |
|---|
| 463 | 463 | | N GENERAL.—Notwithstanding subsection 22 |
|---|
| 464 | 464 | | (f), a practitioner may conduct research that is de-23 |
|---|
| 465 | 465 | | scribed in paragraph (2) and that is with one or 24 |
|---|
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| 467 | 467 | | kjohnson on DSK79L0C42PROD with BILLS 17 |
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| 468 | 468 | | •HR 568 IH |
|---|
| 469 | 469 | | more controlled substances in schedule I if one of 1 |
|---|
| 470 | 470 | | the following conditions is satisfied: 2 |
|---|
| 471 | 471 | | ‘‘(A) R |
|---|
| 472 | 472 | | ESEARCHER WITH A CURRENT 3 |
|---|
| 473 | 473 | | SCHEDULE I OR II RESEARCH REGISTRATION .— 4 |
|---|
| 474 | 474 | | If the practitioner is registered to conduct re-5 |
|---|
| 475 | 475 | | search with a controlled substance in schedule 6 |
|---|
| 476 | 476 | | I or II, the practitioner may conduct research 7 |
|---|
| 477 | 477 | | under this paragraph 30 days after the practi-8 |
|---|
| 478 | 478 | | tioner has sent a notice to the Attorney General 9 |
|---|
| 479 | 479 | | containing the following information, with re-10 |
|---|
| 480 | 480 | | spect to each substance with which the research 11 |
|---|
| 481 | 481 | | will be conducted: 12 |
|---|
| 482 | 482 | | ‘‘(i) The chemical name of the sub-13 |
|---|
| 483 | 483 | | stance. 14 |
|---|
| 484 | 484 | | ‘‘(ii) The quantity of the substance to 15 |
|---|
| 485 | 485 | | be used in such research. 16 |
|---|
| 486 | 486 | | ‘‘(iii) Demonstration that the research 17 |
|---|
| 487 | 487 | | is described in paragraph (2), which dem-18 |
|---|
| 488 | 488 | | onstration can be satisfied— 19 |
|---|
| 489 | 489 | | ‘‘(I) in the case of research de-20 |
|---|
| 490 | 490 | | scribed in paragraph (2)(A), by sup-21 |
|---|
| 491 | 491 | | plying the number of the application 22 |
|---|
| 492 | 492 | | submitted under section 505(i) of the 23 |
|---|
| 493 | 493 | | Federal Food, Drug, and Cosmetic 24 |
|---|
| 494 | 494 | | Act or section 351(a)(3) of the Public 25 |
|---|
| 495 | 495 | | VerDate Sep 11 2014 04:25 Feb 09, 2023 Jkt 039200 PO 00000 Frm 00017 Fmt 6652 Sfmt 6201 E:\BILLS\H568.IH H568 |
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| 497 | 497 | | •HR 568 IH |
|---|
| 498 | 498 | | Health Service Act and the sponsor of 1 |
|---|
| 499 | 499 | | record on such application; or 2 |
|---|
| 500 | 500 | | ‘‘(II) in the case of research de-3 |
|---|
| 501 | 501 | | scribed in paragraph (2)(B), by iden-4 |
|---|
| 502 | 502 | | tifying the sponsoring agency and 5 |
|---|
| 503 | 503 | | supplying the number of the grant, 6 |
|---|
| 504 | 504 | | contract, cooperative agreement, other 7 |
|---|
| 505 | 505 | | transaction, or project. 8 |
|---|
| 506 | 506 | | ‘‘(iv) Demonstration that the re-9 |
|---|
| 507 | 507 | | searcher is authorized to conduct research 10 |
|---|
| 508 | 508 | | with respect to the substance under the 11 |
|---|
| 509 | 509 | | laws of the State in which the research will 12 |
|---|
| 510 | 510 | | take place. 13 |
|---|
| 511 | 511 | | ‘‘(B) R |
|---|
| 512 | 512 | | ESEARCHER WITHOUT A CURRENT 14 |
|---|
| 513 | 513 | | SCHEDULE I OR II RESEARCH REGISTRATION .— 15 |
|---|
| 514 | 514 | | If the practitioner is not currently registered to 16 |
|---|
| 515 | 515 | | conduct research with a controlled substance in 17 |
|---|
| 516 | 516 | | schedule I or II— 18 |
|---|
| 517 | 517 | | ‘‘(i) the practitioner may send a no-19 |
|---|
| 518 | 518 | | tice to the Attorney General containing the 20 |
|---|
| 519 | 519 | | information listed in subparagraph (A), 21 |
|---|
| 520 | 520 | | with respect to each substance with which 22 |
|---|
| 521 | 521 | | the research will be conducted; 23 |
|---|
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| 523 | 523 | | kjohnson on DSK79L0C42PROD with BILLS 19 |
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| 524 | 524 | | •HR 568 IH |
|---|
| 525 | 525 | | ‘‘(ii) the Attorney General shall treat 1 |
|---|
| 526 | 526 | | such notice as a sufficient application for 2 |
|---|
| 527 | 527 | | a research registration; and 3 |
|---|
| 528 | 528 | | ‘‘(iii) within 45 days after receiving 4 |
|---|
| 529 | 529 | | such a notice that contains all information 5 |
|---|
| 530 | 530 | | required by subparagraph (A), the Attor-6 |
|---|
| 531 | 531 | | ney General shall register the applicant, or 7 |
|---|
| 532 | 532 | | serve an order to show cause upon the ap-8 |
|---|
| 533 | 533 | | plicant in accordance with section 304(c). 9 |
|---|
| 534 | 534 | | ‘‘(C) V |
|---|
| 535 | 535 | | ERIFICATION OF INFORMATION .— 10 |
|---|
| 536 | 536 | | On request from the Attorney General, the Sec-11 |
|---|
| 537 | 537 | | retary of Health and Human Services or the 12 |
|---|
| 538 | 538 | | Secretary of Veterans Affairs, as appropriate, 13 |
|---|
| 539 | 539 | | shall verify information submitted by an appli-14 |
|---|
| 540 | 540 | | cant under subparagraph (A)(iii). 15 |
|---|
| 541 | 541 | | ‘‘(2) R |
|---|
| 542 | 542 | | ESEARCH SUBJECT TO EXPEDITED PRO -16 |
|---|
| 543 | 543 | | CEDURE.—Research described in this paragraph is 17 |
|---|
| 544 | 544 | | research that— 18 |
|---|
| 545 | 545 | | ‘‘(A) is the subject of an application under 19 |
|---|
| 546 | 546 | | section 505(i) of the Federal Food, Drug, and 20 |
|---|
| 547 | 547 | | Cosmetic Act or section 351(a)(3) of the Public 21 |
|---|
| 548 | 548 | | Health Service Act for the investigation of a 22 |
|---|
| 549 | 549 | | drug which is in effect in accordance with sec-23 |
|---|
| 550 | 550 | | tion 312.40 of title 21, Code of Federal Regula-24 |
|---|
| 551 | 551 | | tions; or 25 |
|---|
| 552 | 552 | | VerDate Sep 11 2014 04:25 Feb 09, 2023 Jkt 039200 PO 00000 Frm 00019 Fmt 6652 Sfmt 6201 E:\BILLS\H568.IH H568 |
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| 553 | 553 | | kjohnson on DSK79L0C42PROD with BILLS 20 |
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| 554 | 554 | | •HR 568 IH |
|---|
| 555 | 555 | | ‘‘(B) is conducted by the Department of 1 |
|---|
| 556 | 556 | | Health and Human Services, the Department of 2 |
|---|
| 557 | 557 | | Justice, or the Department of Veterans Affairs 3 |
|---|
| 558 | 558 | | or is funded partly or entirely by a grant, con-4 |
|---|
| 559 | 559 | | tract, cooperative agreement, or other trans-5 |
|---|
| 560 | 560 | | action from the Department of Health and 6 |
|---|
| 561 | 561 | | Human Services, the Department of Justice, or 7 |
|---|
| 562 | 562 | | the Department of Veterans Affairs. 8 |
|---|
| 563 | 563 | | ‘‘(3) E |
|---|
| 564 | 564 | | LECTRONIC SUBMISSIONS .—The Attorney 9 |
|---|
| 565 | 565 | | General shall provide a means to allow practitioners 10 |
|---|
| 566 | 566 | | to submit notifications under paragraph (1) elec-11 |
|---|
| 567 | 567 | | tronically. 12 |
|---|
| 568 | 568 | | ‘‘(4) L |
|---|
| 569 | 569 | | IMITATION ON AMOUNTS .—A practitioner 13 |
|---|
| 570 | 570 | | conducting research with a controlled substance in 14 |
|---|
| 571 | 571 | | schedule I pursuant to this subsection shall be al-15 |
|---|
| 572 | 572 | | lowed to possess only the amounts of the controlled 16 |
|---|
| 573 | 573 | | substance in schedule I identified in— 17 |
|---|
| 574 | 574 | | ‘‘(A) the notification to the Attorney Gen-18 |
|---|
| 575 | 575 | | eral under paragraph (1); or 19 |
|---|
| 576 | 576 | | ‘‘(B) if the practitioner needs additional 20 |
|---|
| 577 | 577 | | amounts for the research, a supplemental notifi-21 |
|---|
| 578 | 578 | | cation under this subsection that includes the 22 |
|---|
| 579 | 579 | | practitioner’s name, the additional quantity 23 |
|---|
| 580 | 580 | | needed of the substance, and an attestation 24 |
|---|
| 581 | 581 | | that the research to be conducted with the sub-25 |
|---|
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| 584 | 584 | | •HR 568 IH |
|---|
| 585 | 585 | | stance is consistent with the scope of the re-1 |
|---|
| 586 | 586 | | search that was the subject of the notification 2 |
|---|
| 587 | 587 | | under paragraph (1). 3 |
|---|
| 588 | 588 | | ‘‘(5) I |
|---|
| 589 | 589 | | MPORTATION AND EXPORTATION RE -4 |
|---|
| 590 | 590 | | QUIREMENTS NOT AFFECTED .—Nothing in this sec-5 |
|---|
| 591 | 591 | | tion alters the requirements of part A of title III re-6 |
|---|
| 592 | 592 | | garding the importation and exportation of con-7 |
|---|
| 593 | 593 | | trolled substances.’’. 8 |
|---|
| 594 | 594 | | (b) S |
|---|
| 595 | 595 | | EPARATEREGISTRATIONSNOTREQUIRED FOR 9 |
|---|
| 596 | 596 | | A |
|---|
| 597 | 597 | | DDITIONALRESEARCHER INSAMEINSTITUTION.—Sub-10 |
|---|
| 598 | 598 | | section (c) of section 302 of the Controlled Substances Act 11 |
|---|
| 599 | 599 | | (21 U.S.C. 822) is amended by adding at the end the fol-12 |
|---|
| 600 | 600 | | lowing: 13 |
|---|
| 601 | 601 | | ‘‘(4) An agent or employee of a research insti-14 |
|---|
| 602 | 602 | | tution that is conducting research with a controlled 15 |
|---|
| 603 | 603 | | substance if— 16 |
|---|
| 604 | 604 | | ‘‘(A) such agent or employee is acting 17 |
|---|
| 605 | 605 | | within the scope of his or her professional prac-18 |
|---|
| 606 | 606 | | tice; 19 |
|---|
| 607 | 607 | | ‘‘(B) another agent or employee of such in-20 |
|---|
| 608 | 608 | | stitution is registered to conduct research with 21 |
|---|
| 609 | 609 | | a controlled substance in the same schedule; 22 |
|---|
| 610 | 610 | | ‘‘(C) the researcher who is so registered— 23 |
|---|
| 611 | 611 | | ‘‘(i) informs the Attorney General of 24 |
|---|
| 612 | 612 | | the name, position title, and employing in-25 |
|---|
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| 614 | 614 | | kjohnson on DSK79L0C42PROD with BILLS 22 |
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| 615 | 615 | | •HR 568 IH |
|---|
| 616 | 616 | | stitution of the agent or employee who is 1 |
|---|
| 617 | 617 | | not separately registered; 2 |
|---|
| 618 | 618 | | ‘‘(ii) authorizes such agent or em-3 |
|---|
| 619 | 619 | | ployee to perform research under the reg-4 |
|---|
| 620 | 620 | | istered researcher’s registration; and 5 |
|---|
| 621 | 621 | | ‘‘(iii) affirms that all acts taken by 6 |
|---|
| 622 | 622 | | such agent or employee involving controlled 7 |
|---|
| 623 | 623 | | substances shall be attributable to the reg-8 |
|---|
| 624 | 624 | | istered researcher, as if the researcher had 9 |
|---|
| 625 | 625 | | directly committed such acts, for purposes 10 |
|---|
| 626 | 626 | | of any proceeding under section 304(a) to 11 |
|---|
| 627 | 627 | | suspend or revoke the registration of the 12 |
|---|
| 628 | 628 | | registered researcher; and 13 |
|---|
| 629 | 629 | | ‘‘(D) the Attorney General does not, within 14 |
|---|
| 630 | 630 | | 30 days of receiving the information, authoriza-15 |
|---|
| 631 | 631 | | tion, and affirmation described in subparagraph 16 |
|---|
| 632 | 632 | | (C), refuse, for a reason listed in section 17 |
|---|
| 633 | 633 | | 304(a), to allow such agent or employee to pos-18 |
|---|
| 634 | 634 | | sess such substance without a separate registra-19 |
|---|
| 635 | 635 | | tion.’’. 20 |
|---|
| 636 | 636 | | (c) S |
|---|
| 637 | 637 | | INGLEREGISTRATION FORRELATEDRESEARCH 21 |
|---|
| 638 | 638 | | S |
|---|
| 639 | 639 | | ITES.—Such section 302(e) of the Controlled Substances 22 |
|---|
| 640 | 640 | | Act (21 U.S.C. 822(e)) is amended by adding at the end 23 |
|---|
| 641 | 641 | | the following: 24 |
|---|
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| 643 | 643 | | kjohnson on DSK79L0C42PROD with BILLS 23 |
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| 644 | 644 | | •HR 568 IH |
|---|
| 645 | 645 | | ‘‘(4)(A) Notwithstanding paragraph (1), a person 1 |
|---|
| 646 | 646 | | registered to conduct research with a controlled substance 2 |
|---|
| 647 | 647 | | under section 303(f) may conduct such research at mul-3 |
|---|
| 648 | 648 | | tiple sites under a single registration if— 4 |
|---|
| 649 | 649 | | ‘‘(i) such research occurs exclusively at sites 5 |
|---|
| 650 | 650 | | which are all within the same city or county and are 6 |
|---|
| 651 | 651 | | all under the control of the same institution, organi-7 |
|---|
| 652 | 652 | | zation, or agency; and 8 |
|---|
| 653 | 653 | | ‘‘(ii) the researcher notifies the Attorney Gen-9 |
|---|
| 654 | 654 | | eral, prior to commencing such research, of all sites 10 |
|---|
| 655 | 655 | | where— 11 |
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| 656 | 656 | | ‘‘(I) the research will be conducted; or 12 |
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| 657 | 657 | | ‘‘(II) the controlled substance will be 13 |
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| 658 | 658 | | stored or administered. 14 |
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| 659 | 659 | | ‘‘(B) A site described by subparagraph (A) shall be 15 |
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| 660 | 660 | | included in such registration only if the researcher has no-16 |
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| 661 | 661 | | tified the Attorney General of such site— 17 |
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| 662 | 662 | | ‘‘(i) in the application for such registration; or 18 |
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| 663 | 663 | | ‘‘(ii) before the research is conducted, or before 19 |
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| 664 | 664 | | the controlled substance is stored or administered, at 20 |
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| 665 | 665 | | such site. 21 |
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| 666 | 666 | | ‘‘(C) The Attorney General may, in consultation with 22 |
|---|
| 667 | 667 | | the Secretary of Health and Human Services, issue regu-23 |
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| 668 | 668 | | lations addressing— 24 |
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| 671 | 671 | | •HR 568 IH |
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| 672 | 672 | | ‘‘(i) the manner in which controlled substances 1 |
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| 673 | 673 | | may be delivered to research sites described in sub-2 |
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| 674 | 674 | | paragraph (A); 3 |
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| 675 | 675 | | ‘‘(ii) the storage and security of controlled sub-4 |
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| 676 | 676 | | stances at such research sites; 5 |
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| 677 | 677 | | ‘‘(iii) the maintenance of records for such re-6 |
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| 678 | 678 | | search sites; and 7 |
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| 679 | 679 | | ‘‘(iv) any other matters necessary to ensure ef-8 |
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| 680 | 680 | | fective controls against diversion at such research 9 |
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| 681 | 681 | | sites.’’. 10 |
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| 682 | 682 | | (d) N |
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| 683 | 683 | | EWINSPECTIONNOTREQUIRED INCERTAIN 11 |
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| 684 | 684 | | S |
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| 685 | 685 | | ITUATIONS.—Subsection (f) of section 302 of the Con-12 |
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| 686 | 686 | | trolled Substances Act (21 U.S.C. 822) is amended— 13 |
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| 687 | 687 | | (1) by striking ‘‘(f) The’’ and inserting ‘‘(f)(1) 14 |
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| 688 | 688 | | The’’; and 15 |
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| 689 | 689 | | (2) by adding at the end the following: 16 |
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| 690 | 690 | | ‘‘(2)(A) A new inspection by the Attorney General of 17 |
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| 691 | 691 | | a registered location is not required if a person is reg-18 |
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| 692 | 692 | | istered under this title to conduct research with a con-19 |
|---|
| 693 | 693 | | trolled substance and applies for a registration, or for a 20 |
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| 694 | 694 | | modification of a registration, to conduct research with a 21 |
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| 695 | 695 | | second controlled substance that is— 22 |
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| 696 | 696 | | ‘‘(i) in the same schedule as the first controlled 23 |
|---|
| 697 | 697 | | substance; or 24 |
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| 700 | 700 | | •HR 568 IH |
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| 701 | 701 | | ‘‘(ii) is in a schedule with a higher numerical 1 |
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| 702 | 702 | | designation than the schedule of the first controlled 2 |
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| 703 | 703 | | substance. 3 |
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| 704 | 704 | | ‘‘(B) Nothing in this paragraph shall prohibit the At-4 |
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| 705 | 705 | | torney General from conducting any inspection if the At-5 |
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| 706 | 706 | | torney General deems it necessary to ensure that the reg-6 |
|---|
| 707 | 707 | | istrant maintains effective controls against diversion.’’. 7 |
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| 708 | 708 | | (e) C |
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| 709 | 709 | | ONTINUATION OF RESEARCH ONSUBSTANCES 8 |
|---|
| 710 | 710 | | N |
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| 711 | 711 | | EWLYADDED TOSCHEDULEI.—Section 302 of the 9 |
|---|
| 712 | 712 | | Controlled Substances Act (21 U.S.C. 822) is amended 10 |
|---|
| 713 | 713 | | by adding at the end the following: 11 |
|---|
| 714 | 714 | | ‘‘(h) C |
|---|
| 715 | 715 | | ONTINUATION OFRESEARCH ONSUBSTANCES 12 |
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| 716 | 716 | | N |
|---|
| 717 | 717 | | EWLYADDED TOSCHEDULEI.—If a person is con-13 |
|---|
| 718 | 718 | | ducting research on a substance at the time the substance 14 |
|---|
| 719 | 719 | | is added to schedule I, and such person is already reg-15 |
|---|
| 720 | 720 | | istered under this title to conduct research with a con-16 |
|---|
| 721 | 721 | | trolled substance in schedule I, then— 17 |
|---|
| 722 | 722 | | ‘‘(1) the person shall, within 90 days of the 18 |
|---|
| 723 | 723 | | scheduling in schedule I, submit a completed appli-19 |
|---|
| 724 | 724 | | cation for registration under this title or modifica-20 |
|---|
| 725 | 725 | | tion of an existing registration under this title, to 21 |
|---|
| 726 | 726 | | conduct research on such substance, in accordance 22 |
|---|
| 727 | 727 | | with regulations issued by the Attorney General; 23 |
|---|
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| 730 | 730 | | •HR 568 IH |
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| 731 | 731 | | ‘‘(2) the person may, notwithstanding sub-1 |
|---|
| 732 | 732 | | sections (a) and (b), continue to conduct the re-2 |
|---|
| 733 | 733 | | search on such substance until— 3 |
|---|
| 734 | 734 | | ‘‘(A) the person withdraws such applica-4 |
|---|
| 735 | 735 | | tion; or 5 |
|---|
| 736 | 736 | | ‘‘(B) the Attorney General serves on the 6 |
|---|
| 737 | 737 | | person an order to show cause proposing the 7 |
|---|
| 738 | 738 | | denial of the application pursuant to section 8 |
|---|
| 739 | 739 | | 304(c); 9 |
|---|
| 740 | 740 | | ‘‘(3) if the Attorney General serves such an 10 |
|---|
| 741 | 741 | | order to show cause and the person requests a hear-11 |
|---|
| 742 | 742 | | ing, such hearing shall be held on an expedited basis 12 |
|---|
| 743 | 743 | | and not later than 45 days after the request is 13 |
|---|
| 744 | 744 | | made, except that the hearing may be held at a later 14 |
|---|
| 745 | 745 | | time if so requested by the person; and 15 |
|---|
| 746 | 746 | | ‘‘(4) if the person sends a copy of the applica-16 |
|---|
| 747 | 747 | | tion required by paragraph (1) to a manufacturer or 17 |
|---|
| 748 | 748 | | distributor of such substance, receipt of such copy 18 |
|---|
| 749 | 749 | | by such manufacturer or distributor shall constitute 19 |
|---|
| 750 | 750 | | sufficient evidence that the person is authorized to 20 |
|---|
| 751 | 751 | | receive such substance.’’. 21 |
|---|
| 752 | 752 | | (f) T |
|---|
| 753 | 753 | | REATMENT OF CERTAINMANUFACTURING AC-22 |
|---|
| 754 | 754 | | TIVITIES ASCOINCIDENT TORESEARCH.—Section 302 of 23 |
|---|
| 755 | 755 | | the Controlled Substances Act (21 U.S.C. 822), as amend-24 |
|---|
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| 758 | 758 | | •HR 568 IH |
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| 759 | 759 | | ed by subsection (e), is further amended by adding at the 1 |
|---|
| 760 | 760 | | end the following: 2 |
|---|
| 761 | 761 | | ‘‘(i) T |
|---|
| 762 | 762 | | REATMENT OFCERTAINMANUFACTURINGAC-3 |
|---|
| 763 | 763 | | TIVITIES ASCOINCIDENT TORESEARCH.— 4 |
|---|
| 764 | 764 | | ‘‘(1) I |
|---|
| 765 | 765 | | N GENERAL.—Except as specified in 5 |
|---|
| 766 | 766 | | paragraph (3), a person who is registered to perform 6 |
|---|
| 767 | 767 | | research on a controlled substance may perform 7 |
|---|
| 768 | 768 | | manufacturing activities with small quantities of 8 |
|---|
| 769 | 769 | | that substance, including activities listed in para-9 |
|---|
| 770 | 770 | | graph (2), without being required to obtain a manu-10 |
|---|
| 771 | 771 | | facturing registration, if such activities are per-11 |
|---|
| 772 | 772 | | formed for the purpose of the research and if the ac-12 |
|---|
| 773 | 773 | | tivities and the quantities of the substance involved 13 |
|---|
| 774 | 774 | | in those activities are stated in— 14 |
|---|
| 775 | 775 | | ‘‘(A) a notification submitted to the Attor-15 |
|---|
| 776 | 776 | | ney General under section 303(m); 16 |
|---|
| 777 | 777 | | ‘‘(B) a protocol filed with an application 17 |
|---|
| 778 | 778 | | for registration approval under section 303(f); 18 |
|---|
| 779 | 779 | | or 19 |
|---|
| 780 | 780 | | ‘‘(C) a notification to the Attorney General 20 |
|---|
| 781 | 781 | | that includes the registrant’s name and an at-21 |
|---|
| 782 | 782 | | testation that the research to be conducted with 22 |
|---|
| 783 | 783 | | the small quantities of manufactured substance 23 |
|---|
| 784 | 784 | | is consistent with the scope of the research that 24 |
|---|
| 785 | 785 | | is the basis for the registration. 25 |
|---|
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| 788 | 788 | | •HR 568 IH |
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| 789 | 789 | | ‘‘(2) ACTIVITIES INCLUDED.—Activities per-1 |
|---|
| 790 | 790 | | mitted under paragraph (1) include— 2 |
|---|
| 791 | 791 | | ‘‘(A) processing the substance to create ex-3 |
|---|
| 792 | 792 | | tracts, tinctures, oils, solutions, derivatives, or 4 |
|---|
| 793 | 793 | | other forms of the substance consistent with the 5 |
|---|
| 794 | 794 | | information provided as part of a notification 6 |
|---|
| 795 | 795 | | submitted to the Attorney General under sec-7 |
|---|
| 796 | 796 | | tion 303(m) or a research protocol filed with 8 |
|---|
| 797 | 797 | | the application for registration approval; and 9 |
|---|
| 798 | 798 | | ‘‘(B) dosage form development studies per-10 |
|---|
| 799 | 799 | | formed for the purpose of satisfying regulatory 11 |
|---|
| 800 | 800 | | requirements of the Food and Drug Adminis-12 |
|---|
| 801 | 801 | | tration for submitting an investigational new 13 |
|---|
| 802 | 802 | | drug application. 14 |
|---|
| 803 | 803 | | ‘‘(3) E |
|---|
| 804 | 804 | | XCEPTION REGARDING MARIHUANA .— 15 |
|---|
| 805 | 805 | | The authority under paragraph (1) to manufacture 16 |
|---|
| 806 | 806 | | substances does not include authority to grow mari-17 |
|---|
| 807 | 807 | | huana.’’. 18 |
|---|
| 808 | 808 | | (g) T |
|---|
| 809 | 809 | | RANSPARENCY REGARDINGSPECIALPROCE-19 |
|---|
| 810 | 810 | | DURES.—Section 303 of such Act (21 U.S.C. 823), as 20 |
|---|
| 811 | 811 | | amended by subsection (a), is further amended by adding 21 |
|---|
| 812 | 812 | | at the end the following: 22 |
|---|
| 813 | 813 | | ‘‘(n) T |
|---|
| 814 | 814 | | RANSPARENCY REGARDINGSPECIALPROCE-23 |
|---|
| 815 | 815 | | DURES.— 24 |
|---|
| 816 | 816 | | VerDate Sep 11 2014 04:25 Feb 09, 2023 Jkt 039200 PO 00000 Frm 00028 Fmt 6652 Sfmt 6201 E:\BILLS\H568.IH H568 |
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| 818 | 818 | | •HR 568 IH |
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| 819 | 819 | | ‘‘(1) IN GENERAL.—If the Attorney General de-1 |
|---|
| 820 | 820 | | termines, with respect to a controlled substance, that 2 |
|---|
| 821 | 821 | | an application by a practitioner to conduct research 3 |
|---|
| 822 | 822 | | with such substance should be considered under a 4 |
|---|
| 823 | 823 | | process, or subject to criteria, different from the 5 |
|---|
| 824 | 824 | | process or criteria applicable to applications to con-6 |
|---|
| 825 | 825 | | duct research with other controlled substances in the 7 |
|---|
| 826 | 826 | | same schedule, the Attorney General shall make 8 |
|---|
| 827 | 827 | | public, including by posting on the website of the 9 |
|---|
| 828 | 828 | | Drug Enforcement Administration— 10 |
|---|
| 829 | 829 | | ‘‘(A) the identities of all substances for 11 |
|---|
| 830 | 830 | | which such determinations have been made; 12 |
|---|
| 831 | 831 | | ‘‘(B) the process and criteria that will be 13 |
|---|
| 832 | 832 | | applied to applications to conduct research with 14 |
|---|
| 833 | 833 | | such substances; and 15 |
|---|
| 834 | 834 | | ‘‘(C) how such process and criteria differ 16 |
|---|
| 835 | 835 | | from those applicable to applications to conduct 17 |
|---|
| 836 | 836 | | research with other controlled substances in the 18 |
|---|
| 837 | 837 | | same schedule. 19 |
|---|
| 838 | 838 | | ‘‘(2) T |
|---|
| 839 | 839 | | IMING OF POSTING.—The Attorney Gen-20 |
|---|
| 840 | 840 | | eral shall make such information public upon mak-21 |
|---|
| 841 | 841 | | ing such determination, regardless of whether a 22 |
|---|
| 842 | 842 | | practitioner has submitted such an application at 23 |
|---|
| 843 | 843 | | that time.’’. 24 |
|---|
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| 846 | 846 | | •HR 568 IH |
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| 847 | 847 | | SEC. 8. RULEMAKING. 1 |
|---|
| 848 | 848 | | (a) I |
|---|
| 849 | 849 | | NTERIMFINALRULES.—The Attorney Gen-2 |
|---|
| 850 | 850 | | eral— 3 |
|---|
| 851 | 851 | | (1) not later than 1 year of the date of enact-4 |
|---|
| 852 | 852 | | ment of this Act, shall issue rules to implement this 5 |
|---|
| 853 | 853 | | Act and the amendments made by this Act; and 6 |
|---|
| 854 | 854 | | (2) may issue such rules as interim final rules. 7 |
|---|
| 855 | 855 | | (b) P |
|---|
| 856 | 856 | | ROCEDURE FORFINALRULE.—A rule issued by 8 |
|---|
| 857 | 857 | | the Attorney General as an interim final rule under sub-9 |
|---|
| 858 | 858 | | section (a) shall become immediately effective as an in-10 |
|---|
| 859 | 859 | | terim final rule without requiring the Attorney General to 11 |
|---|
| 860 | 860 | | demonstrate good cause therefor. The interim final rule 12 |
|---|
| 861 | 861 | | shall give interested persons the opportunity to comment 13 |
|---|
| 862 | 862 | | and to request a hearing. After the conclusion of such pro-14 |
|---|
| 863 | 863 | | ceedings, the Attorney General shall issue a final rule in 15 |
|---|
| 864 | 864 | | accordance with section 553 of title 5, United States Code. 16 |
|---|
| 865 | 865 | | SEC. 9. GAO REPORT. 17 |
|---|
| 866 | 866 | | (a) I |
|---|
| 867 | 867 | | NGENERAL.—Not more than 4 years after the 18 |
|---|
| 868 | 868 | | date of enactment of this Act, the Comptroller General 19 |
|---|
| 869 | 869 | | of the United States shall submit to the Committees on 20 |
|---|
| 870 | 870 | | Energy and Commerce and the Judiciary of the House 21 |
|---|
| 871 | 871 | | of Representatives and the Committee on the Judiciary 22 |
|---|
| 872 | 872 | | of the Senate a report analyzing the implementation and 23 |
|---|
| 873 | 873 | | impact, to the extent information is available, of perma-24 |
|---|
| 874 | 874 | | nent class scheduling pursuant to schedule I(e) of section 25 |
|---|
| 875 | 875 | | 202(c) of the Controlled Substances Act, as added by sec-26 |
|---|
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| 878 | 878 | | •HR 568 IH |
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| 879 | 879 | | tion 2 of this Act, of fentanyl-related substances (as de-1 |
|---|
| 880 | 880 | | fined in such schedule I(e)), which report shall include— 2 |
|---|
| 881 | 881 | | (1) an analysis of the impact on research of 3 |
|---|
| 882 | 882 | | fentanyl-related substances; 4 |
|---|
| 883 | 883 | | (2) an analysis of any actions taken to remove 5 |
|---|
| 884 | 884 | | or reschedule in a different class any fentanyl-re-6 |
|---|
| 885 | 885 | | lated substance; 7 |
|---|
| 886 | 886 | | (3) an analysis of the impact of permanent 8 |
|---|
| 887 | 887 | | scheduling on the unlawful importation, manufac-9 |
|---|
| 888 | 888 | | ture, trafficking, and use of fentanyl-related sub-10 |
|---|
| 889 | 889 | | stances, taking into consideration data collected con-11 |
|---|
| 890 | 890 | | cerning the proliferation of fentanyl-related sub-12 |
|---|
| 891 | 891 | | stances since class scheduling was instituted; 13 |
|---|
| 892 | 892 | | (4) an analysis of sentences attributable to 14 |
|---|
| 893 | 893 | | criminal charges involving fentanyl-related sub-15 |
|---|
| 894 | 894 | | stances, comparing those sentences to sentences at-16 |
|---|
| 895 | 895 | | tributable to criminal charges involving fentanyl and 17 |
|---|
| 896 | 896 | | individually scheduled fentanyl analogues; and 18 |
|---|
| 897 | 897 | | (5) an analysis of the efficacy of class sched-19 |
|---|
| 898 | 898 | | uling generally, in terms of reducing the prolifera-20 |
|---|
| 899 | 899 | | tion of new controlled substance analogues. 21 |
|---|
| 900 | 900 | | (b) C |
|---|
| 901 | 901 | | ONSULTATIONS.—In developing the report re-22 |
|---|
| 902 | 902 | | quired by subsection (a), the Comptroller General— 23 |
|---|
| 903 | 903 | | (1) shall consider the views of the Secretary of 24 |
|---|
| 904 | 904 | | Health and Human Services, the Attorney General, 25 |
|---|
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| 907 | 907 | | •HR 568 IH |
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| 908 | 908 | | the Secretary of Homeland Security, the Secretary 1 |
|---|
| 909 | 909 | | of State, the Director of the Office of National Drug 2 |
|---|
| 910 | 910 | | Control Policy, the scientific and medical research 3 |
|---|
| 911 | 911 | | community, the State and local law enforcement 4 |
|---|
| 912 | 912 | | community, and the civil rights and criminal justice 5 |
|---|
| 913 | 913 | | reform communities; and 6 |
|---|
| 914 | 914 | | (2) to the greatest extent possible, should base 7 |
|---|
| 915 | 915 | | such report on reliable data and empirical informa-8 |
|---|
| 916 | 916 | | tion. 9 |
|---|
| 917 | 917 | | Æ |
|---|
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