| 1 | 1 | | II |
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| 2 | 2 | | 118THCONGRESS |
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| 3 | 3 | | 1 |
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| 4 | 4 | | STSESSION S. 1141 |
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| 5 | 5 | | To amend the Controlled Substances Act with respect to the scheduling |
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| 6 | 6 | | of fentanyl-related substances, and for other purposes. |
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| 7 | 7 | | IN THE SENATE OF THE UNITED STATES |
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| 8 | 8 | | MARCH30, 2023 |
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| 9 | 9 | | Mr. C |
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| 10 | 10 | | ASSIDY(for himself, Mr. MARSHALL, and Mr. YOUNG) introduced the |
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| 11 | 11 | | following bill; which was read twice and referred to the Committee on the |
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| 12 | 12 | | Judiciary |
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| 13 | 13 | | A BILL |
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| 14 | 14 | | To amend the Controlled Substances Act with respect to |
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| 15 | 15 | | the scheduling of fentanyl-related substances, and for |
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| 16 | 16 | | other purposes. |
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| 17 | 17 | | Be it enacted by the Senate and House of Representa-1 |
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| 18 | 18 | | tives of the United States of America in Congress assembled, 2 |
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| 19 | 19 | | SECTION 1. SHORT TITLE. 3 |
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| 20 | 20 | | This Act may be cited as the ‘‘Halt All Lethal Traf-4 |
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| 21 | 21 | | ficking of Fentanyl Act’’ or the ‘‘HALT Fentanyl Act’’. 5 |
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| 23 | 23 | | kjohnson on DSK79L0C42PROD with BILLS 2 |
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| 24 | 24 | | •S 1141 IS |
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| 25 | 25 | | SEC. 2. CLASS SCHEDULING OF FENTANYL-RELATED SUB-1 |
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| 26 | 26 | | STANCES. 2 |
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| 27 | 27 | | Section 202(c) of the Controlled Substances Act (21 3 |
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| 28 | 28 | | U.S.C. 812(c)) is amended by adding at the end of sched-4 |
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| 29 | 29 | | ule I the following: 5 |
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| 30 | 30 | | ‘‘(e)(1) Unless specifically exempted or unless listed 6 |
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| 31 | 31 | | in another schedule, any material, compound, mixture, or 7 |
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| 32 | 32 | | preparation which contains any quantity of a fentanyl-re-8 |
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| 33 | 33 | | lated substance, or which contains the salts, isomers, and 9 |
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| 34 | 34 | | salts of isomers of a fentanyl-related substance whenever 10 |
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| 35 | 35 | | the existence of such salts, isomers, and salts of isomers 11 |
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| 36 | 36 | | is possible within the specific chemical designation. 12 |
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| 37 | 37 | | ‘‘(2) For purposes of paragraph (1), except as pro-13 |
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| 38 | 38 | | vided in paragraph (3), the term ‘fentanyl-related sub-14 |
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| 39 | 39 | | stance’ means any substance that is structurally related 15 |
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| 40 | 40 | | to fentanyl by 1 or more of the following modifications: 16 |
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| 41 | 41 | | ‘‘(A) By replacement of the phenyl portion of 17 |
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| 42 | 42 | | the phenethyl group by any monocycle, whether or 18 |
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| 43 | 43 | | not further substituted in or on the monocycle. 19 |
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| 44 | 44 | | ‘‘(B) By substitution in or on the phenethyl 20 |
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| 45 | 45 | | group with alkyl, alkenyl, alkoxyl, hydroxyl, halo, 21 |
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| 46 | 46 | | haloalkyl, amino, or nitro groups. 22 |
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| 47 | 47 | | ‘‘(C) By substitution in or on the piperidine 23 |
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| 48 | 48 | | ring with alkyl, alkenyl, alkoxyl, ester, ether, 24 |
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| 49 | 49 | | hydroxyl, halo, haloalkyl, amino, or nitro groups. 25 |
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| 51 | 51 | | kjohnson on DSK79L0C42PROD with BILLS 3 |
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| 52 | 52 | | •S 1141 IS |
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| 53 | 53 | | ‘‘(D) By replacement of the aniline ring with 1 |
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| 54 | 54 | | any aromatic monocycle whether or not further sub-2 |
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| 55 | 55 | | stituted in or on the aromatic monocycle. 3 |
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| 56 | 56 | | ‘‘(E) By replacement of the N–propionyl group 4 |
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| 57 | 57 | | with another acyl group. 5 |
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| 58 | 58 | | ‘‘(3) A substance that satisfies the definition of the 6 |
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| 59 | 59 | | term ‘fentanyl-related substance’ in paragraph (2) shall 7 |
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| 60 | 60 | | nonetheless not be treated as a fentanyl-related substance 8 |
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| 61 | 61 | | subject to this schedule if the substance— 9 |
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| 62 | 62 | | ‘‘(A) is controlled by action of the Attorney 10 |
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| 63 | 63 | | General under section 201; or 11 |
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| 64 | 64 | | ‘‘(B) is otherwise expressly listed in a schedule 12 |
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| 65 | 65 | | other than this schedule. 13 |
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| 66 | 66 | | ‘‘(4)(A) The Attorney General may by order publish 14 |
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| 67 | 67 | | in the Federal Register a list of substances that satisfy 15 |
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| 68 | 68 | | the definition of the term ‘fentanyl-related substance’ in 16 |
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| 69 | 69 | | paragraph (2). 17 |
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| 70 | 70 | | ‘‘(B) The absence of a substance from a list published 18 |
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| 71 | 71 | | under subparagraph (A) does not negate the control status 19 |
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| 72 | 72 | | of the substance under this schedule if the substance satis-20 |
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| 73 | 73 | | fies the definition of the term ‘fentanyl-related substance’ 21 |
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| 74 | 74 | | in paragraph (2).’’. 22 |
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| 76 | 76 | | kjohnson on DSK79L0C42PROD with BILLS 4 |
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| 77 | 77 | | •S 1141 IS |
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| 78 | 78 | | SEC. 3. REGISTRATION REQUIREMENTS RELATED TO RE-1 |
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| 79 | 79 | | SEARCH. 2 |
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| 80 | 80 | | (a) A |
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| 81 | 81 | | LTERNATIVE REGISTRATIONPROCESS FOR 3 |
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| 82 | 82 | | S |
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| 83 | 83 | | CHEDULEI RESEARCH.—Section 303 of the Controlled 4 |
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| 84 | 84 | | Substances Act (21 U.S.C. 823) is amended— 5 |
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| 85 | 85 | | (1) by redesignating the second subsection (l) 6 |
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| 86 | 86 | | (relating to required training for prescribers) as sub-7 |
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| 87 | 87 | | section (m); and 8 |
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| 88 | 88 | | (2) by adding at the end the following: 9 |
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| 89 | 89 | | ‘‘(n) S |
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| 90 | 90 | | PECIALPROVISIONS FOR PRACTITIONERS 10 |
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| 91 | 91 | | C |
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| 92 | 92 | | ONDUCTINGCERTAINRESEARCHWITHSCHEDULEI 11 |
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| 93 | 93 | | C |
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| 94 | 94 | | ONTROLLEDSUBSTANCES.— 12 |
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| 95 | 95 | | ‘‘(1) I |
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| 96 | 96 | | N GENERAL.—Notwithstanding subsection 13 |
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| 97 | 97 | | (f), a practitioner may conduct research described in 14 |
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| 98 | 98 | | paragraph (2) of this subsection with 1 or more 15 |
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| 99 | 99 | | schedule I substances in accordance with subpara-16 |
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| 100 | 100 | | graph (A) or (B) of paragraph (3) of this sub-17 |
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| 101 | 101 | | section. 18 |
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| 102 | 102 | | ‘‘(2) R |
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| 103 | 103 | | ESEARCH SUBJECT TO EXPEDITED PRO -19 |
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| 104 | 104 | | CEDURES.—Research described in this paragraph is 20 |
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| 105 | 105 | | research that— 21 |
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| 106 | 106 | | ‘‘(A) is with respect to a drug that is the 22 |
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| 107 | 107 | | subject of an investigational use exemption 23 |
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| 108 | 108 | | under section 505(i) of the Federal Food, Drug, 24 |
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| 109 | 109 | | and Cosmetic Act (21 U.S.C. 355(i)); or 25 |
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| 110 | 110 | | ‘‘(B) is— 26 |
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| 112 | 112 | | kjohnson on DSK79L0C42PROD with BILLS 5 |
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| 113 | 113 | | •S 1141 IS |
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| 114 | 114 | | ‘‘(i) conducted by the Department of 1 |
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| 115 | 115 | | Health and Human Services or the De-2 |
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| 116 | 116 | | partment of Veterans Affairs; or 3 |
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| 117 | 117 | | ‘‘(ii) funded partly or entirely by a 4 |
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| 118 | 118 | | grant, contract, cooperative agreement, or 5 |
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| 119 | 119 | | other transaction from the Department of 6 |
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| 120 | 120 | | Health and Human Services or the De-7 |
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| 121 | 121 | | partment of Veterans Affairs. 8 |
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| 122 | 122 | | ‘‘(3) E |
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| 123 | 123 | | XPEDITED PROCEDURES .— 9 |
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| 124 | 124 | | ‘‘(A) R |
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| 125 | 125 | | ESEARCHER WITH A CURRENT 10 |
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| 126 | 126 | | SCHEDULE I OR II RESEARCH REGISTRATION .— 11 |
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| 127 | 127 | | ‘‘(i) I |
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| 128 | 128 | | N GENERAL.—If a practitioner is 12 |
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| 129 | 129 | | registered to conduct research with a con-13 |
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| 130 | 130 | | trolled substance in schedule I or II, the 14 |
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| 131 | 131 | | practitioner may conduct research under 15 |
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| 132 | 132 | | this subsection on and after the date that 16 |
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| 133 | 133 | | is 30 days after the date on which the 17 |
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| 134 | 134 | | practitioner sends a notice to the Attorney 18 |
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| 135 | 135 | | General containing the following informa-19 |
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| 136 | 136 | | tion, with respect to each substance with 20 |
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| 137 | 137 | | which the practitioner will conduct the re-21 |
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| 138 | 138 | | search: 22 |
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| 139 | 139 | | ‘‘(I) The chemical name of the 23 |
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| 140 | 140 | | substance. 24 |
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| 142 | 142 | | kjohnson on DSK79L0C42PROD with BILLS 6 |
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| 143 | 143 | | •S 1141 IS |
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| 144 | 144 | | ‘‘(II) The quantity of the sub-1 |
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| 145 | 145 | | stance to be used in the research. 2 |
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| 146 | 146 | | ‘‘(III) Demonstration that the re-3 |
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| 147 | 147 | | search is in the category described in 4 |
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| 148 | 148 | | paragraph (2), which demonstration 5 |
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| 149 | 149 | | may be satisfied— 6 |
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| 150 | 150 | | ‘‘(aa) in the case of a grant, 7 |
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| 151 | 151 | | contract, cooperative agreement, 8 |
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| 152 | 152 | | or other transaction, or intra-9 |
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| 153 | 153 | | mural research project, by identi-10 |
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| 154 | 154 | | fying the sponsoring agency and 11 |
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| 155 | 155 | | supplying the number of the 12 |
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| 156 | 156 | | grant, contract, cooperative 13 |
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| 157 | 157 | | agreement, other transaction, or 14 |
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| 158 | 158 | | project; or 15 |
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| 159 | 159 | | ‘‘(bb) in the case of an ap-16 |
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| 160 | 160 | | plication under section 505(i) of 17 |
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| 161 | 161 | | the Federal Food, Drug, and 18 |
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| 162 | 162 | | Cosmetic Act (21 U.S.C. 355(i)), 19 |
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| 163 | 163 | | by supplying the application 20 |
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| 164 | 164 | | number and the sponsor of 21 |
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| 165 | 165 | | record on the application. 22 |
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| 166 | 166 | | ‘‘(IV) Demonstration that the re-23 |
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| 167 | 167 | | searcher is authorized to conduct re-24 |
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| 168 | 168 | | search with respect to the substance 25 |
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| 170 | 170 | | kjohnson on DSK79L0C42PROD with BILLS 7 |
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| 171 | 171 | | •S 1141 IS |
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| 172 | 172 | | under the laws of the State in which 1 |
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| 173 | 173 | | the research will take place. 2 |
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| 174 | 174 | | ‘‘(ii) V |
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| 175 | 175 | | ERIFICATION OF INFORMATION 3 |
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| 176 | 176 | | BY HHS OR VA.—Upon request from the 4 |
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| 177 | 177 | | Attorney General, the Secretary of Health 5 |
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| 178 | 178 | | and Human Services or the Secretary of 6 |
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| 179 | 179 | | Veterans Affairs, as appropriate, shall 7 |
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| 180 | 180 | | verify information submitted by an appli-8 |
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| 181 | 181 | | cant under clause (i)(III). 9 |
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| 182 | 182 | | ‘‘(B) R |
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| 183 | 183 | | ESEARCHER WITHOUT A CURRENT 10 |
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| 184 | 184 | | SCHEDULE I OR II RESEARCH REGISTRATION .— 11 |
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| 185 | 185 | | ‘‘(i) I |
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| 186 | 186 | | N GENERAL.—If a practitioner is 12 |
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| 187 | 187 | | not registered to conduct research with a 13 |
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| 188 | 188 | | controlled substance in schedule I or II, 14 |
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| 189 | 189 | | the practitioner may send a notice to the 15 |
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| 190 | 190 | | Attorney General containing the informa-16 |
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| 191 | 191 | | tion listed in subparagraph (A)(i), with re-17 |
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| 192 | 192 | | spect to each substance with which the 18 |
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| 193 | 193 | | practitioner will conduct the research. 19 |
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| 194 | 194 | | ‘‘(ii) A |
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| 195 | 195 | | TTORNEY GENERAL ACTION .— 20 |
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| 196 | 196 | | The Attorney General shall— 21 |
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| 197 | 197 | | ‘‘(I) treat notice received under 22 |
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| 198 | 198 | | clause (i) as a sufficient application 23 |
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| 199 | 199 | | for a research registration; and 24 |
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| 201 | 201 | | kjohnson on DSK79L0C42PROD with BILLS 8 |
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| 202 | 202 | | •S 1141 IS |
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| 203 | 203 | | ‘‘(II) not later than 45 days of 1 |
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| 204 | 204 | | receiving such a notice that contains 2 |
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| 205 | 205 | | all information required under sub-3 |
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| 206 | 206 | | paragraph (A)(i)— 4 |
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| 207 | 207 | | ‘‘(aa) register the applicant; 5 |
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| 208 | 208 | | or 6 |
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| 209 | 209 | | ‘‘(bb) serve an order to show 7 |
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| 210 | 210 | | cause upon the applicant in ac-8 |
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| 211 | 211 | | cordance with section 304(c). 9 |
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| 212 | 212 | | ‘‘(4) E |
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| 213 | 213 | | LECTRONIC SUBMISSIONS .—The Attorney 10 |
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| 214 | 214 | | General shall provide a means to permit a practi-11 |
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| 215 | 215 | | tioner to submit a notification under paragraph (3) 12 |
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| 216 | 216 | | electronically. 13 |
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| 217 | 217 | | ‘‘(5) L |
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| 218 | 218 | | IMITATION ON AMOUNTS .—A practitioner 14 |
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| 219 | 219 | | conducting research with a schedule I substance 15 |
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| 220 | 220 | | under this subsection may only possess the amounts 16 |
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| 221 | 221 | | of schedule I substance identified in— 17 |
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| 222 | 222 | | ‘‘(A) the notification to the Attorney Gen-18 |
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| 223 | 223 | | eral under paragraph (3); or 19 |
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| 224 | 224 | | ‘‘(B) a supplemental notification that the 20 |
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| 225 | 225 | | practitioner may send if the practitioner needs 21 |
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| 226 | 226 | | additional amounts for the research, which sup-22 |
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| 227 | 227 | | plemental notification shall include— 23 |
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| 228 | 228 | | ‘‘(i) the name of the practitioner; 24 |
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| 230 | 230 | | kjohnson on DSK79L0C42PROD with BILLS 9 |
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| 231 | 231 | | •S 1141 IS |
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| 232 | 232 | | ‘‘(ii) the additional quantity needed of 1 |
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| 233 | 233 | | the substance; and 2 |
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| 234 | 234 | | ‘‘(iii) an attestation that the research 3 |
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| 235 | 235 | | to be conducted with the substance is con-4 |
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| 236 | 236 | | sistent with the scope of the research that 5 |
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| 237 | 237 | | was the subject of the notification under 6 |
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| 238 | 238 | | paragraph (3). 7 |
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| 239 | 239 | | ‘‘(6) I |
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| 240 | 240 | | MPORTATION AND EXPORTATION RE -8 |
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| 241 | 241 | | QUIREMENTS NOT AFFECTED .—Nothing in this sub-9 |
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| 242 | 242 | | section alters the requirements of part A of title III, 10 |
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| 243 | 243 | | regarding the importation and exportation of con-11 |
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| 244 | 244 | | trolled substances.’’. 12 |
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| 245 | 245 | | (b) S |
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| 246 | 246 | | EPARATEREGISTRATIONSNOTREQUIRED FOR 13 |
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| 247 | 247 | | A |
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| 248 | 248 | | DDITIONALRESEARCHER INSAMEINSTITUTION.—Sec-14 |
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| 249 | 249 | | tion 302(c) of the Controlled Substances Act (21 U.S.C. 15 |
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| 250 | 250 | | 822(c)) is amended by adding at the end the following: 16 |
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| 251 | 251 | | ‘‘(4) An agent or employee of a research insti-17 |
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| 252 | 252 | | tution that is conducting research with a controlled 18 |
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| 253 | 253 | | substance if— 19 |
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| 254 | 254 | | ‘‘(A) the agent or employee is acting with-20 |
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| 255 | 255 | | in the scope of the professional practice of the 21 |
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| 256 | 256 | | agent or employee; 22 |
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| 257 | 257 | | ‘‘(B) another agent or employee of the in-23 |
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| 258 | 258 | | stitution is registered to conduct research with 24 |
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| 259 | 259 | | a controlled substance in the same schedule; 25 |
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| 261 | 261 | | kjohnson on DSK79L0C42PROD with BILLS 10 |
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| 262 | 262 | | •S 1141 IS |
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| 263 | 263 | | ‘‘(C) the researcher who is so registered— 1 |
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| 264 | 264 | | ‘‘(i) informs the Attorney General of 2 |
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| 265 | 265 | | the name, position title, and employing in-3 |
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| 266 | 266 | | stitution of the agent or employee who is 4 |
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| 267 | 267 | | not separately registered; 5 |
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| 268 | 268 | | ‘‘(ii) authorizes that agent or em-6 |
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| 269 | 269 | | ployee to perform research under the reg-7 |
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| 270 | 270 | | istration of the registered researcher; and 8 |
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| 271 | 271 | | ‘‘(iii) affirms that any act taken by 9 |
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| 272 | 272 | | that agent or employee involving a con-10 |
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| 273 | 273 | | trolled substance shall be attributable to 11 |
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| 274 | 274 | | the registered researcher, as if the re-12 |
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| 275 | 275 | | searcher had directly committed the act, 13 |
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| 276 | 276 | | for purposes of any proceeding under sec-14 |
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| 277 | 277 | | tion 304(a) to suspend or revoke the reg-15 |
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| 278 | 278 | | istration of the registered researcher; and 16 |
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| 279 | 279 | | ‘‘(D) the Attorney General does not, within 17 |
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| 280 | 280 | | 30 days of receiving the information, authoriza-18 |
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| 281 | 281 | | tion, and affirmation described in subparagraph 19 |
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| 282 | 282 | | (C), refuse, for a reason listed in section 20 |
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| 283 | 283 | | 304(a), to allow the agent or employee to pos-21 |
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| 284 | 284 | | sess the substance without a separate registra-22 |
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| 285 | 285 | | tion.’’. 23 |
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| 286 | 286 | | (c) S |
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| 287 | 287 | | INGLEREGISTRATION FORRELATEDRESEARCH 24 |
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| 288 | 288 | | S |
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| 289 | 289 | | ITES.—Section 302(e) of the Controlled Substances Act 25 |
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| 291 | 291 | | kjohnson on DSK79L0C42PROD with BILLS 11 |
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| 292 | 292 | | •S 1141 IS |
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| 293 | 293 | | (21 U.S.C. 822(e)) is amended by adding at the end the 1 |
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| 294 | 294 | | following: 2 |
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| 295 | 295 | | ‘‘(3)(A) Notwithstanding paragraph (1), a person 3 |
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| 296 | 296 | | registered to conduct research with a controlled substance 4 |
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| 297 | 297 | | under section 303(f) may conduct the research under a 5 |
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| 298 | 298 | | single registration if— 6 |
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| 299 | 299 | | ‘‘(i) the research occurs exclusively on sites all 7 |
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| 300 | 300 | | of which are— 8 |
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| 301 | 301 | | ‘‘(I) within the same city or county; and 9 |
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| 302 | 302 | | ‘‘(II) under the control of the same institu-10 |
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| 303 | 303 | | tion, organization, or agency; and 11 |
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| 304 | 304 | | ‘‘(ii) before commencing the research, the re-12 |
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| 305 | 305 | | searcher notifies the Attorney General of each site 13 |
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| 306 | 306 | | where— 14 |
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| 307 | 307 | | ‘‘(I) the research will be conducted; or 15 |
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| 308 | 308 | | ‘‘(II) the controlled substance will be 16 |
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| 309 | 309 | | stored or administered. 17 |
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| 310 | 310 | | ‘‘(B) A site described in subparagraph (A) shall be 18 |
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| 311 | 311 | | included in a registration described in that subparagraph 19 |
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| 312 | 312 | | only if the researcher has notified the Attorney General 20 |
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| 313 | 313 | | of the site— 21 |
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| 314 | 314 | | ‘‘(i) in the application for the registration; or 22 |
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| 315 | 315 | | ‘‘(ii) before the research is conducted, or before 23 |
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| 316 | 316 | | the controlled substance is stored or administered, at 24 |
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| 317 | 317 | | the site. 25 |
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| 319 | 319 | | kjohnson on DSK79L0C42PROD with BILLS 12 |
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| 320 | 320 | | •S 1141 IS |
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| 321 | 321 | | ‘‘(C) The Attorney General may, in consultation with 1 |
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| 322 | 322 | | the Secretary, issue regulations addressing, with respect 2 |
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| 323 | 323 | | to research sites described in subparagraph (A)— 3 |
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| 324 | 324 | | ‘‘(i) the manner in which controlled substances 4 |
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| 325 | 325 | | may be delivered to the research sites; 5 |
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| 326 | 326 | | ‘‘(ii) the storage and security of controlled sub-6 |
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| 327 | 327 | | stances at the research sites; 7 |
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| 328 | 328 | | ‘‘(iii) the maintenance of records for the re-8 |
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| 329 | 329 | | search sites; and 9 |
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| 330 | 330 | | ‘‘(iv) any other matters necessary to ensure ef-10 |
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| 331 | 331 | | fective controls against diversion at the research 11 |
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| 332 | 332 | | sites.’’. 12 |
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| 333 | 333 | | (d) N |
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| 334 | 334 | | EWINSPECTIONNOTREQUIRED INCERTAIN 13 |
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| 335 | 335 | | S |
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| 336 | 336 | | ITUATIONS.—Section 302(f) of the Controlled Sub-14 |
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| 337 | 337 | | stances Act (21 U.S.C. 822(f)) is amended— 15 |
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| 338 | 338 | | (1) by striking ‘‘(f) The’’ and inserting ‘‘(f)(1) 16 |
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| 339 | 339 | | The’’; and 17 |
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| 340 | 340 | | (2) by adding at the end the following: 18 |
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| 341 | 341 | | ‘‘(2)(A) If a person is registered to conduct research 19 |
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| 342 | 342 | | with a controlled substance and applies for a registration, 20 |
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| 343 | 343 | | or for a modification of a registration, to conduct research 21 |
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| 344 | 344 | | with a second controlled substance that is in the same 22 |
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| 345 | 345 | | schedule as the first controlled substance, or is in a sched-23 |
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| 346 | 346 | | ule with a higher numerical designation than the schedule 24 |
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| 348 | 348 | | kjohnson on DSK79L0C42PROD with BILLS 13 |
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| 349 | 349 | | •S 1141 IS |
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| 350 | 350 | | of the first controlled substance, a new inspection by the 1 |
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| 351 | 351 | | Attorney General of the registered location is not required. 2 |
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| 352 | 352 | | ‘‘(B) Nothing in subparagraph (A) shall prohibit the 3 |
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| 353 | 353 | | Attorney General from conducting an inspection that the 4 |
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| 354 | 354 | | Attorney General determines necessary to ensure that a 5 |
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| 355 | 355 | | registrant maintains effective controls against diversion.’’. 6 |
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| 356 | 356 | | (e) C |
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| 357 | 357 | | ONTINUATION OF RESEARCH ONSUBSTANCES 7 |
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| 358 | 358 | | N |
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| 359 | 359 | | EWLYADDED TOSCHEDULEI.—Section 302 of the 8 |
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| 360 | 360 | | Controlled Substances Act (21 U.S.C. 822) is amended 9 |
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| 361 | 361 | | by adding at the end the following: 10 |
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| 362 | 362 | | ‘‘(h) C |
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| 363 | 363 | | ONTINUATION OFRESEARCH ONSUBSTANCES 11 |
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| 364 | 364 | | N |
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| 365 | 365 | | EWLYADDED TOSCHEDULEI.—If a person is con-12 |
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| 366 | 366 | | ducting research on a substance when the substance is 13 |
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| 367 | 367 | | added to schedule I, and the person is already registered 14 |
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| 368 | 368 | | to conduct research with a controlled substance in sched-15 |
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| 369 | 369 | | ule I— 16 |
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| 370 | 370 | | ‘‘(1) not later than 90 days after the scheduling 17 |
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| 371 | 371 | | of the newly scheduled substance, the person shall 18 |
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| 372 | 372 | | submit a completed application for registration or 19 |
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| 373 | 373 | | modification of existing registration, to conduct re-20 |
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| 374 | 374 | | search on the substance, in accordance with regula-21 |
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| 375 | 375 | | tions issued by the Attorney General for purposes of 22 |
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| 376 | 376 | | this paragraph; 23 |
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| 378 | 378 | | kjohnson on DSK79L0C42PROD with BILLS 14 |
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| 379 | 379 | | •S 1141 IS |
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| 380 | 380 | | ‘‘(2) the person may, notwithstanding sub-1 |
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| 381 | 381 | | sections (a) and (b), continue to conduct the re-2 |
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| 382 | 382 | | search on the substance until— 3 |
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| 383 | 383 | | ‘‘(A) the person withdraws the application 4 |
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| 384 | 384 | | described in paragraph (1) of this subsection; 5 |
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| 385 | 385 | | or 6 |
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| 386 | 386 | | ‘‘(B) the Attorney General serves on the 7 |
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| 387 | 387 | | person an order to show cause proposing the 8 |
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| 388 | 388 | | denial of the application under section 304(c); 9 |
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| 389 | 389 | | ‘‘(3) if the Attorney General serves an order to 10 |
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| 390 | 390 | | show cause as described in paragraph (2)(B) and 11 |
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| 391 | 391 | | the person requests a hearing, the hearing shall be 12 |
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| 392 | 392 | | held on an expedited basis and not later than 45 13 |
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| 393 | 393 | | days after the request is made, except that the hear-14 |
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| 394 | 394 | | ing may be held at a later time if so requested by 15 |
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| 395 | 395 | | the person; and 16 |
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| 396 | 396 | | ‘‘(4) if the person sends a copy of the applica-17 |
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| 397 | 397 | | tion described in paragraph (1) to a manufacturer or 18 |
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| 398 | 398 | | distributor of the substance, receipt of the copy by 19 |
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| 399 | 399 | | the manufacturer or distributor shall constitute suf-20 |
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| 400 | 400 | | ficient evidence that the person is authorized to re-21 |
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| 401 | 401 | | ceive the substance.’’. 22 |
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| 402 | 402 | | (f) T |
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| 403 | 403 | | REATMENT OF CERTAINMANUFACTURING AC-23 |
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| 404 | 404 | | TIVITIES ASCOINCIDENT TORESEARCH.—Section 302 of 24 |
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| 405 | 405 | | the Controlled Substances Act (21 U.S.C. 822), as amend-25 |
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| 407 | 407 | | kjohnson on DSK79L0C42PROD with BILLS 15 |
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| 408 | 408 | | •S 1141 IS |
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| 409 | 409 | | ed by subsection (e), is amended by adding at the end 1 |
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| 410 | 410 | | the following: 2 |
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| 411 | 411 | | ‘‘(i) T |
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| 412 | 412 | | REATMENT OFCERTAINMANUFACTURINGAC-3 |
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| 413 | 413 | | TIVITIES ASCOINCIDENT TORESEARCH.— 4 |
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| 414 | 414 | | ‘‘(1) I |
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| 415 | 415 | | N GENERAL.—Except as provided in para-5 |
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| 416 | 416 | | graph (3), a person who is registered to perform re-6 |
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| 417 | 417 | | search on a controlled substance may perform manu-7 |
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| 418 | 418 | | facturing activities with small quantities of that sub-8 |
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| 419 | 419 | | stance, including activities described in paragraph 9 |
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| 420 | 420 | | (2), without being required to obtain a manufac-10 |
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| 421 | 421 | | turing registration, if— 11 |
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| 422 | 422 | | ‘‘(A) the activities are performed for the 12 |
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| 423 | 423 | | purpose of the research; and 13 |
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| 424 | 424 | | ‘‘(B) the activities and the quantities of 14 |
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| 425 | 425 | | the substance involved in the activities are stat-15 |
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| 426 | 426 | | ed in— 16 |
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| 427 | 427 | | ‘‘(i) a notification submitted to the 17 |
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| 428 | 428 | | Attorney General under section 303(l); 18 |
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| 429 | 429 | | ‘‘(ii) a research protocol filed with an 19 |
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| 430 | 430 | | application for registration approval under 20 |
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| 431 | 431 | | section 303(f); or 21 |
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| 432 | 432 | | ‘‘(iii) a notification to the Attorney 22 |
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| 433 | 433 | | General that includes— 23 |
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| 434 | 434 | | ‘‘(I) the name of the registrant; 24 |
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| 435 | 435 | | and 25 |
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| 437 | 437 | | kjohnson on DSK79L0C42PROD with BILLS 16 |
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| 438 | 438 | | •S 1141 IS |
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| 439 | 439 | | ‘‘(II) an attestation that the re-1 |
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| 440 | 440 | | search to be conducted with the small 2 |
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| 441 | 441 | | quantities of manufactured substance 3 |
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| 442 | 442 | | is consistent with the scope of the re-4 |
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| 443 | 443 | | search that is the basis for the reg-5 |
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| 444 | 444 | | istration. 6 |
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| 445 | 445 | | ‘‘(2) A |
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| 446 | 446 | | CTIVITIES INCLUDED.—Activities per-7 |
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| 447 | 447 | | mitted under paragraph (1) include— 8 |
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| 448 | 448 | | ‘‘(A) processing the substance to create ex-9 |
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| 449 | 449 | | tracts, tinctures, oils, solutions, derivatives, or 10 |
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| 450 | 450 | | other forms of the substance consistent with— 11 |
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| 451 | 451 | | ‘‘(i) the information provided as part 12 |
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| 452 | 452 | | of a notification submitted to the Attorney 13 |
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| 453 | 453 | | General under section 303(l); or 14 |
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| 454 | 454 | | ‘‘(ii) a research protocol filed with an 15 |
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| 455 | 455 | | application for registration approval under 16 |
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| 456 | 456 | | section 303(f); and 17 |
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| 457 | 457 | | ‘‘(B) dosage form development studies per-18 |
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| 458 | 458 | | formed for the purpose of requesting an inves-19 |
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| 459 | 459 | | tigational new drug exemption under section 20 |
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| 460 | 460 | | 505(i) of the Federal Food, Drug, and Cos-21 |
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| 461 | 461 | | metic Act (21 U.S.C. 355(i)). 22 |
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| 462 | 462 | | ‘‘(3) E |
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| 463 | 463 | | XCEPTION REGARDING MARIJUANA .—The 23 |
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| 464 | 464 | | authority under paragraph (1) to manufacture sub-24 |
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| 467 | 467 | | •S 1141 IS |
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| 468 | 468 | | stances does not include the authority to grow mari-1 |
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| 469 | 469 | | juana.’’. 2 |
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| 470 | 470 | | (g) T |
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| 471 | 471 | | RANSPARENCY REGARDINGSPECIALPROCE-3 |
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| 472 | 472 | | DURES.—Section 303 of the Controlled Substances Act 4 |
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| 473 | 473 | | (21 U.S.C. 823), as amended by subsection (a), is amend-5 |
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| 474 | 474 | | ed by adding at the end the following: 6 |
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| 475 | 475 | | ‘‘(o) T |
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| 476 | 476 | | RANSPARENCY REGARDINGSPECIALPROCE-7 |
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| 477 | 477 | | DURES.— 8 |
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| 478 | 478 | | ‘‘(1) I |
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| 479 | 479 | | N GENERAL.—If the Attorney General de-9 |
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| 480 | 480 | | termines, with respect to a controlled substance, that 10 |
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| 481 | 481 | | an application by a practitioner to conduct research 11 |
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| 482 | 482 | | with the substance should be considered under a 12 |
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| 483 | 483 | | process, or subject to criteria, different from the 13 |
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| 484 | 484 | | process or criteria applicable to applications to con-14 |
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| 485 | 485 | | duct research with other controlled substances in the 15 |
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| 486 | 486 | | same schedule, the Attorney General shall make 16 |
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| 487 | 487 | | public, including by posting on the website of the 17 |
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| 488 | 488 | | Drug Enforcement Administration— 18 |
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| 489 | 489 | | ‘‘(A) the identities of all substances for 19 |
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| 490 | 490 | | which such determinations have been made; 20 |
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| 491 | 491 | | ‘‘(B) the process and criteria that shall be 21 |
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| 492 | 492 | | applied to applications to conduct research with 22 |
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| 493 | 493 | | those substances; and 23 |
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| 494 | 494 | | ‘‘(C) how the process and criteria described 24 |
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| 495 | 495 | | in subparagraph (B) differ from the process 25 |
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| 498 | 498 | | •S 1141 IS |
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| 499 | 499 | | and criteria applicable to applications to con-1 |
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| 500 | 500 | | duct research with other controlled substances 2 |
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| 501 | 501 | | in the same schedule. 3 |
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| 502 | 502 | | ‘‘(2) T |
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| 503 | 503 | | IMING OF POSTING.—The Attorney Gen-4 |
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| 504 | 504 | | eral shall make information described in paragraph 5 |
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| 505 | 505 | | (1) public upon making a determination described in 6 |
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| 506 | 506 | | that paragraph, regardless of whether a practitioner 7 |
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| 507 | 507 | | has submitted such an application at that time.’’. 8 |
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| 508 | 508 | | SEC. 4. RULEMAKING. 9 |
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| 509 | 509 | | (a) I |
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| 510 | 510 | | NTERIMFINALRULES.—The Attorney Gen-10 |
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| 511 | 511 | | eral— 11 |
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| 512 | 512 | | (1) shall, not later than 1 year of the date of 12 |
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| 513 | 513 | | enactment of this Act, issue rules to implement this 13 |
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| 514 | 514 | | Act and the amendments made by this Act; and 14 |
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| 515 | 515 | | (2) may issue the rules under paragraph (1) as 15 |
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| 516 | 516 | | interim final rules. 16 |
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| 517 | 517 | | (b) P |
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| 518 | 518 | | ROCEDURE FORFINALRULE.— 17 |
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| 519 | 519 | | (1) E |
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| 520 | 520 | | FFECTIVENESS OF INTERIM FINAL 18 |
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| 521 | 521 | | RULES.—A rule issued by the Attorney General as 19 |
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| 522 | 522 | | an interim final rule under subsection (a) shall be-20 |
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| 523 | 523 | | come immediately effective as an interim final rule 21 |
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| 524 | 524 | | without requiring the Attorney General to dem-22 |
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| 525 | 525 | | onstrate good cause therefor, notwithstanding sub-23 |
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| 526 | 526 | | paragraph (B) of section 553(b) of title 5, United 24 |
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| 527 | 527 | | States Code. 25 |
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| 530 | 530 | | •S 1141 IS |
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| 531 | 531 | | (2) OPPORTUNITY FOR COMMENT AND HEAR -1 |
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| 532 | 532 | | ING.—An interim final rule issued under subsection 2 |
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| 533 | 533 | | (a) shall give interested persons the opportunity to 3 |
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| 534 | 534 | | comment and to request a hearing. 4 |
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| 535 | 535 | | (3) F |
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| 536 | 536 | | INAL RULE.—After the conclusion of such 5 |
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| 537 | 537 | | proceedings, the Attorney General shall issue a final 6 |
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| 538 | 538 | | rule to implement this Act and the amendments 7 |
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| 539 | 539 | | made by this Act in accordance with section 553 of 8 |
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| 540 | 540 | | title 5, United States Code. 9 |
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| 541 | 541 | | Æ |
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