Us Congress 2023-2024 Regular Session

Us Congress House Bill HB467 Compare Versions

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Version 2 (New)

Old	New		Differences
	1	+	IB
	2	+	Union Calendar No. 47
1	3		118THCONGRESS
2	4		1
3	5		STSESSION H. R. 467
4		-	AN ACT
	6	+	[Report No. 118–67, Part I]
	7	+	To amend the Controlled Substances Act with respect to the scheduling
	8	+	of fentanyl-related substances, and for other purposes.
	9	+	IN THE HOUSE OF REPRESENTATIVES
	10	+	JANUARY24, 2023
	11	+	Mr. G
	12	+	RIFFITH(for himself, Mr. LATTA, Mrs. RODGERSof Washington, Mr.
	13	+	G
	14	+	UTHRIE, Mr. BILIRAKIS, Mr. BUCSHON, Mr. HUDSON, Mr. BURGESS,
	15	+	Mr. C
	16	+	ARTERof Georgia, Mr. DUNCAN, Mr. DUNNof Florida, Mr. CREN-
	17	+	SHAW, Mr. JOYCEof Pennsylvania, Mr. BALDERSON, Mrs.
	18	+	H
	19	+	ARSHBARGER, Mrs. MILLER-MEEKS, Mrs. CAMMACK, Mr. ALLEN, Mr.
	20	+	W
	21	+	ALBERG, Mr. CURTIS, Mr. PALMER, Mr. BUCHANAN, Mr. BANKS, Mr.
	22	+	F
	23	+	ITZGERALD, and Mr. MOONEY) introduced the following bill; which was
	24	+	referred to the Committee on Energy and Commerce, and in addition to
	25	+	the Committee on the Judiciary, for a period to be subsequently deter-
	26	+	mined by the Speaker, in each case for consideration of such provisions
	27	+	as fall within the jurisdiction of the committee concerned
	28	+	M
	29	+	AY17, 2023
	30	+	Additional sponsors: Mr. P
	31	+	FLUGER, Mr. ARMSTRONG, Mr. PENCE, Mr. AUS-
	32	+	TINSCOTTof Georgia, Mr. OBERNOLTE, Mr. WOMACK, Mr. EDWARDS,
	33	+	Mr. F
	34	+	INSTAD, Mr. CARL, Mrs. LESKO, Mr. MIKEGARCIAof California,
	35	+	Mr. C
	36	+	ISCOMANI, Mr. CLINE, Mrs. BICE, Mr. CARTERof Texas, Mr.
	37	+	M
	38	+	OOLENAAR, Mr. ROGERSof Kentucky, Mr. BEANof Florida, Mr.
	39	+	M
	40	+	EUSER, Mr. BOST, Mr. BARR, Mr. VANDREW, Mr. D’ESPOSITO, Mrs.
	41	+	M
	42	+	ILLERof West Virginia, Mrs. CHAVEZ-DEREMER, Mr. WESTERMAN,
	43	+	Mr. L
	44	+	ANGWORTHY, and Mr. BURCHETT
	45	+	M
	46	+	AY17, 2023
	47	+	Reported from the Committee on Energy and Commerce with an amendment
	48	+	[Strike out all after the enacting clause and insert the part printed in italic]
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	51	+	•HR 467 RH
	52	+	MAY17, 2023
	53	+	Committee on the Judiciary discharged; committed to the Committee of the
	54	+	Whole House on the State of the Union and ordered to be printed
	55	+	[For text of introduced bill, see copy of bill as introduced on January 24, 2023]
	56	+	A BILL
5	57		To amend the Controlled Substances Act with respect to
6	58		the scheduling of fentanyl-related substances, and for
7	59		other purposes.
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8	63		Be it enacted by the Senate and House of Representa-1
9		-	tives of the United States of America in Congress assembled, 2 2
10		-	•HR 467 EH
11		-	SECTION 1. SHORT TITLE. 1
12		-	This Act may be cited as the ‘‘Halt All Lethal Traf-2
13		-	ficking of Fentanyl Act’’ or the ‘‘HALT Fentanyl Act’’. 3
14		-	SEC. 2. CLASS SCHEDULING OF FENTANYL-RELATED SUB-4
15		-	STANCES. 5
16		-	Section 202(c) of the Controlled Substances Act (21 6
17		-	U.S.C. 812(c)) is amended by adding at the end of sched-7
18		-	ule I the following: 8
19		-	‘‘(e)(1) Unless specifically exempted or unless listed 9
20		-	in another schedule, any material, compound, mixture, or 10
21		-	preparation which contains any quantity of a fentanyl-re-11
22		-	lated substance, or which contains the salts, isomers, and 12
23		-	salts of isomers of a fentanyl-related substance whenever 13
24		-	the existence of such salts, isomers, and salts of isomers 14
25		-	is possible within the specific chemical designation. 15
26		-	‘‘(2) For purposes of paragraph (1), except as pro-16
27		-	vided in paragraph (3), the term ‘fentanyl-related sub-17
28		-	stance’ means any substance that is structurally related 18
29		-	to fentanyl by 1 or more of the following modifications: 19
30		-	‘‘(A) By replacement of the phenyl portion of 20
31		-	the phenethyl group by any monocycle, whether or 21
32		-	not further substituted in or on the monocycle. 22
33		-	‘‘(B) By substitution in or on the phenethyl 23
34		-	group with alkyl, alkenyl, alkoxyl, hydroxyl, halo, 24
35		-	haloalkyl, amino, or nitro groups. 25 3
36		-	•HR 467 EH
37		-	‘‘(C) By substitution in or on the piperidine 1
38		-	ring with alkyl, alkenyl, alkoxyl, ester, ether, 2
39		-	hydroxyl, halo, haloalkyl, amino, or nitro groups. 3
40		-	‘‘(D) By replacement of the aniline ring with 4
41		-	any aromatic monocycle whether or not further sub-5
42		-	stituted in or on the aromatic monocycle. 6
43		-	‘‘(E) By replacement of the N–propionyl group 7
44		-	with another acyl group. 8
45		-	‘‘(3) A substance that satisfies the definition of the 9
46		-	term ‘fentanyl-related substance’ in paragraph (2) shall 10
47		-	nonetheless not be treated as a fentanyl-related substance 11
48		-	subject to this schedule if the substance— 12
49		-	‘‘(A) is controlled by action of the Attorney 13
50		-	General under section 201; or 14
51		-	‘‘(B) is otherwise expressly listed in a schedule 15
52		-	other than this schedule. 16
53		-	‘‘(4)(A) The Attorney General may by order publish 17
54		-	in the Federal Register a list of substances that satisfy 18
55		-	the definition of the term ‘fentanyl-related substance’ in 19
56		-	paragraph (2). 20
57		-	‘‘(B) The absence of a substance from a list published 21
58		-	under subparagraph (A) does not negate the control status 22
59		-	of the substance under this schedule if the substance satis-23
60		-	fies the definition of the term ‘fentanyl-related substance’ 24
61		-	in paragraph (2).’’. 25 4
62		-	•HR 467 EH
63		-	SEC. 3. REGISTRATION REQUIREMENTS RELATED TO RE-1
64		-	SEARCH. 2
	64	+	tives of the United States of America in Congress assembled, 2
	65	+	SECTION 1. SHORT TITLE. 3
	66	+	This Act may be cited as the ‘‘Halt All Lethal Traf-4
	67	+	ficking of Fentanyl Act’’ or the ‘‘HALT Fentanyl Act’’. 5
	68	+	SEC. 2. CLASS SCHEDULING OF FENTANYL-RELATED SUB-6
	69	+	STANCES. 7
	70	+	Section 202(c) of the Controlled Substances Act (21 8
	71	+	U.S.C. 812(c)) is amended by adding at the end of schedule 9
	72	+	I the following: 10
	73	+	‘‘(e)(1) Unless specifically exempted or unless listed in 11
	74	+	another schedule, any material, compound, mixture, or 12
	75	+	preparation which contains any quantity of a fentanyl-re-13
	76	+	lated substance, or which contains the salts, isomers, and 14
	77	+	salts of isomers of a fentanyl-related substance whenever the 15
	78	+	existence of such salts, isomers, and salts of isomers is pos-16
	79	+	sible within the specific chemical designation. 17
	80	+	‘‘(2) For purposes of paragraph (1), except as provided 18
	81	+	in paragraph (3), the term ‘fentanyl-related substance’ 19
	82	+	means any substance that is structurally related to fentanyl 20
	83	+	by 1 or more of the following modifications: 21
	84	+	‘‘(A) By replacement of the phenyl portion of the 22
	85	+	phenethyl group by any monocycle, whether or not 23
	86	+	further substituted in or on the monocycle. 24
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	90	+	‘‘(B) By substitution in or on the phenethyl 1
	91	+	group with alkyl, alkenyl, alkoxyl, hydroxyl, halo, 2
	92	+	haloalkyl, amino, or nitro groups. 3
	93	+	‘‘(C) By substitution in or on the piperidine 4
	94	+	ring with alkyl, alkenyl, alkoxyl, ester, ether, 5
	95	+	hydroxyl, halo, haloalkyl, amino, or nitro groups. 6
	96	+	‘‘(D) By replacement of the aniline ring with 7
	97	+	any aromatic monocycle whether or not further sub-8
	98	+	stituted in or on the aromatic monocycle. 9
	99	+	‘‘(E) By replacement of the N–propionyl group 10
	100	+	with another acyl group. 11
	101	+	‘‘(3) A substance that satisfies the definition of the 12
	102	+	term ‘fentanyl-related substance’ in paragraph (2) shall 13
	103	+	nonetheless not be treated as a fentanyl-related substance 14
	104	+	subject to this schedule if the substance— 15
	105	+	‘‘(A) is controlled by action of the Attorney Gen-16
	106	+	eral under section 201; or 17
	107	+	‘‘(B) is otherwise expressly listed in a schedule 18
	108	+	other than this schedule. 19
	109	+	‘‘(4)(A) The Attorney General may by order publish 20
	110	+	in the Federal Register a list of substances that satisfy the 21
	111	+	definition of the term ‘fentanyl-related substance’ in para-22
	112	+	graph (2). 23
	113	+	‘‘(B) The absence of a substance from a list published 24
	114	+	under subparagraph (A) does not negate the control status 25
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	117	+	•HR 467 RH
	118	+	of the substance under this schedule if the substance satisfies 1
	119	+	the definition of the term ‘fentanyl-related substance’ in 2
	120	+	paragraph (2).’’. 3
	121	+	SEC. 3. REGISTRATION REQUIREMENTS RELATED TO RE-4
	122	+	SEARCH. 5
65	123		(a) A
66		-	~~LTERNATIVE REGISTRATIONPROCESS~~ FOR 3
	124	+	LTERNATIVEREGISTRATIONPROCESS FOR 6
67	125		S
68		-	CHEDULEI RESEARCH.—Section 303 of the Controlled 4
69		-	Substances Act (21 U.S.C. 823) is amended— 5
70		-	(1) by redesignating the second subsection (l) 6
71		-	~~(relating~~ to required training for prescribers) as sub-7
72		-	section (m); and 8
73		-	(2) by adding at the end the following: 9
	126	+	CHEDULEI RESEARCH.—Section 303 of the Controlled 7
	127	+	Substances Act (21 U.S.C. 823) is amended— 8
	128	+	(1) by redesignating the second subsection (l) (re-9
	129	+	lating to required training for prescribers) as sub-10
	130	+	section (m); and 11
	131	+	(2) by adding at the end the following: 12
74	132		‘‘(n) S
75		-	PECIALPROVISIONS FOR PRACTITIONERS 10
76		-	C
77		-	ONDUCTINGCERTAINRESEARCHWITHSCHEDULEI 11
78		-	C
79		-	ONTROLLEDSUBSTANCES.— 12
	133	+	PECIALPROVISIONS FORPRACTITIONERSCON-13
	134	+	DUCTINGCERTAINRESEARCHWITHSCHEDULEI CON-14
	135	+	TROLLEDSUBSTANCES.— 15
80	136		‘‘(1) I
81		-	N GENERAL.—Notwithstanding subsection 13
82		-	(f), a practitioner may conduct research described in 14
83		-	paragraph (2) of this subsection with 1 or more 15
84		-	schedule I substances in accordance with subpara-16
85		-	graph (A) or (B) of paragraph (3) of this sub-17
86		-	section. 18
	137	+	N GENERAL.—Notwithstanding subsection 16
	138	+	(f), a practitioner may conduct research described in 17
	139	+	paragraph (2) of this subsection with 1 or more 18
	140	+	schedule I substances in accordance with subpara-19
	141	+	graph (A) or (B) of paragraph (3) of this subsection. 20
87	142		‘‘(2) R
88		-	ESEARCH SUBJECT TO EXPEDITED ~~PRO -19~~
89		-	~~CEDURES~~.—Research described in this paragraph is 20
90		-	~~research~~ that— 21
91		-	‘‘(A) is with respect to a drug that is the 22
92		-	subject of an investigational use exemption 23
93		-	~~under section 505(i) of the Federal Food~~, ~~Drug, 24~~
94		-	~~and Cosmetic Act;~~ ~~or 25~~
95		-	~~‘‘(B) is—~~ ~~26 5~~
96		-	~~•HR 467 EH~~
97		-	~~‘‘(i) conducted by the Department of 1~~
98		-	~~Health and Human Services, the Depart-2~~
99		-	~~ment of Defense, or~~ the Department of 3
100		-	~~Veterans Affairs;~~ or 4
101		-	~~‘‘(ii) funded partly~~ or ~~entirely by a 5~~
102		-	~~grant, contract,~~ ~~cooperative agreement,~~ or 6
103		-	~~other transaction from the Department of 7~~
104		-	~~Health and Human Services,~~ the ~~Depart-8~~
105		-	~~ment of Defense,~~ or the ~~Department of 9~~
106		-	Veterans Affairs. 10
	143	+	ESEARCH SUBJECT TO EXPEDITED PROCE -21
	144	+	DURES.—Research described in this paragraph is re-22
	145	+	search that— 23
	146	+	‘‘(A) is with respect to a drug that is the 24
	147	+	subject of an investigational use exemption under 25
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	151	+	section 505(i) of the Federal Food, Drug, and 1
	152	+	Cosmetic Act; or 2
	153	+	‘‘(B) is— 3
	154	+	‘‘(i) conducted by the Department of 4
	155	+	Health and Human Services or the Depart-5
	156	+	ment of Veterans Affairs; or 6
	157	+	‘‘(ii) funded partly or entirely by a 7
	158	+	grant, contract, cooperative agreement, or 8
	159	+	other transaction from the Department of 9
	160	+	Health and Human Services or the Depart-10
	161	+	ment of Veterans Affairs. 11
107	162		‘‘(3) E
108		-	XPEDITED PROCEDURES .— 11
	163	+	XPEDITED PROCEDURES .— 12
109	164		‘‘(A) R
110		-	ESEARCHER WITH A CURRENT 12
111		-	SCHEDULE I OR II RESEARCH REGISTRATION .— 13
	165	+	ESEARCHER WITH A CURRENT 13
	166	+	SCHEDULE I OR II RESEARCH REGISTRATION .— 14
112	167		‘‘(i) I
113		-	N GENERAL.—If a practitioner is 14
114		-	registered to conduct research with a con-15
115		-	trolled substance in schedule I or II, the 16
116		-	practitioner may conduct research under 17
117		-	this subsection on and after the date that 18
118		-	is 30 days after the date on which the 19
119		-	practitioner sends a notice to the Attorney 20
120		-	General containing the following informa-21
121		-	tion, with respect to each substance with 22
122		-	which the practitioner will conduct the re-23
123		-	search: 24 6
124		-	•HR 467 EH
	168	+	N GENERAL.—If a practitioner is 15
	169	+	registered to conduct research with a con-16
	170	+	trolled substance in schedule I or II, the 17
	171	+	practitioner may conduct research under 18
	172	+	this subsection on and after the date that is 19
	173	+	30 days after the date on which the practi-20
	174	+	tioner sends a notice to the Attorney Gen-21
	175	+	eral containing the following information, 22
	176	+	with respect to each substance with which 23
	177	+	the practitioner will conduct the research: 24
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125	181		‘‘(I) The chemical name of the 1
126	182		substance. 2
127	183		‘‘(II) The quantity of the sub-3
128	184		stance to be used in the research. 4
129	185		‘‘(III) Demonstration that the re-5
130	186		search is in the category described in 6
131	187		paragraph (2), which demonstration 7
132	188		may be satisfied— 8
133	189		‘‘(aa) in the case of a grant, 9
134	190		contract, cooperative agreement, 10
135	191		or other transaction, or intra-11
136	192		mural research project, by identi-12
137	193		fying the sponsoring agency and 13
138	194		supplying the number of the 14
139		-	grant, contract, cooperative 15
140		-	~~agreement~~, other transaction, or 16
	195	+	grant, contract, cooperative agree-15
	196	+	ment, other transaction, or 16
141	197		project; or 17
142		-	‘‘(bb) in the case of an ap-18
143		-	~~plication~~ under section 505(i) of 19
144		-	~~the~~ Federal Food, Drug, and 20
145		-	~~Cosmetic~~ Act, by supplying the 21
146		-	~~application~~ number and the ~~spon-~~22
147		-	~~sor of record~~ on the application. 23
	198	+	‘‘(bb) in the case of an appli-18
	199	+	cation under section 505(i) of the 19
	200	+	Federal Food, Drug, and Cosmetic 20
	201	+	Act, by supplying the application 21
	202	+	number and the sponsor of record 22
	203	+	on the application. 23
148	204		‘‘(IV) Demonstration that the re-24
149		-	searcher is authorized to conduct re-25 7
150		-	•HR 467 EH
	205	+	searcher is authorized to conduct re-25
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151	209		search with respect to the substance 1
152	210		under the laws of the State in which 2
153	211		the research will take place. 3
154	212		‘‘(ii) V
155	213		ERIFICATION OF INFORMATION 4
156		-	BY HHS OR VA.—Upon request from the 5
157		-	Attorney General, the Secretary of Health 6
158		-	and Human Services, the Department of 7
159		-	Defense, or the Secretary of Veterans Af-8
160		-	fairs, as appropriate, shall verify informa-9
161		-	tion submitted by an applicant under 10
162		-	clause (i)(III). 11
	214	+	BY HHS OR VA.—Upon request from the At-5
	215	+	torney General, the Secretary of Health and 6
	216	+	Human Services or the Secretary of Vet-7
	217	+	erans Affairs, as appropriate, shall verify 8
	218	+	information submitted by an applicant 9
	219	+	under clause (i)(III). 10
163	220		‘‘(B) R
164		-	ESEARCHER WITHOUT A CURRENT 12
165		-	SCHEDULE I OR II RESEARCH REGISTRATION .— 13
	221	+	ESEARCHER WITHOUT A CURRENT 11
	222	+	SCHEDULE I OR II RESEARCH REGISTRATION .— 12
166	223		‘‘(i) I
167		-	N GENERAL.—If a practitioner is 14
168		-	not registered to conduct research with a 15
169		-	controlled substance in schedule I or II, 16
170		-	~~the~~ practitioner may send a notice to the 17
171		-	~~Attorney~~ General containing the ~~informa-18~~
172		-	~~tion~~ listed in subparagraph (A)(i), with ~~re-19~~
173		-	~~spect~~ to each substance with which the 20
174		-	~~practitioner~~ will conduct the research. 21
	224	+	N GENERAL.—If a practitioner is 13
	225	+	not registered to conduct research with a 14
	226	+	controlled substance in schedule I or II, the 15
	227	+	practitioner may send a notice to the Attor-16
	228	+	ney General containing the information 17
	229	+	listed in subparagraph (A)(i), with respect 18
	230	+	to each substance with which the practi-19
	231	+	tioner will conduct the research. 20
175	232		‘‘(ii) A
176		-	TTORNEY GENERAL ACTION .— 22
177		-	The Attorney General shall— 23 8
178		-	•HR 467 EH
179		-	‘‘(I) treat notice received under 1
180		-	clause (i) as a sufficient application 2
181		-	for a research registration; and 3
182		-	‘‘(II) not later than 45 days of 4
183		-	receiving such a notice that contains 5
184		-	all information required under sub-6
185		-	paragraph (A)(i)— 7
186		-	‘‘(aa) register the applicant; 8
187		-	or 9
188		-	‘‘(bb) serve an order to show 10
189		-	cause upon the applicant in ac-11
190		-	cordance with section 304(c). 12
	233	+	TTORNEY GENERAL ACTION .— 21
	234	+	The Attorney General shall— 22
	235	+	‘‘(I) treat notice received under 23
	236	+	clause (i) as a sufficient application 24
	237	+	for a research registration; and 25
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	241	+	‘‘(II) not later than 45 days of re-1
	242	+	ceiving such a notice that contains all 2
	243	+	information required under subpara-3
	244	+	graph (A)(i)— 4
	245	+	‘‘(aa) register the applicant; 5
	246	+	or 6
	247	+	‘‘(bb) serve an order to show 7
	248	+	cause upon the applicant in ac-8
	249	+	cordance with section 304(c). 9
191	250		‘‘(4) E
192		-	LECTRONIC SUBMISSIONS .—The Attorney 13
193		-	General shall provide a means to permit a practi-14
194		-	tioner to submit a notification under paragraph (3) 15
195		-	electronically. 16
	251	+	LECTRONIC SUBMISSIONS.—The Attorney 10
	252	+	General shall provide a means to permit a practi-11
	253	+	tioner to submit a notification under paragraph (3) 12
	254	+	electronically. 13
196	255		‘‘(5) L
197		-	IMITATION ON AMOUNTS .—A practitioner 17
198		-	conducting research with a schedule I substance 18
199		-	under this subsection may only possess the amounts 19
200		-	of schedule I substance identified in— 20
201		-	‘‘(A) the notification to the Attorney Gen-21
202		-	eral under paragraph (3); or 22
203		-	‘‘(B) a supplemental notification that the 23
204		-	practitioner may send if the practitioner needs 24 9
205		-	•HR 467 EH
206		-	additional amounts for the research, which sup-1
207		-	plemental notification shall include— 2
208		-	‘‘(i) the name of the practitioner; 3
209		-	‘‘(ii) the additional quantity needed of 4
210		-	the substance; and 5
211		-	‘‘(iii) an attestation that the research 6
212		-	to be conducted with the substance is con-7
213		-	sistent with the scope of the research that 8
214		-	was the subject of the notification under 9
215		-	paragraph (3). 10
	256	+	IMITATION ON AMOUNTS .—A practitioner 14
	257	+	conducting research with a schedule I substance under 15
	258	+	this subsection may only possess the amounts of 16
	259	+	schedule I substance identified in— 17
	260	+	‘‘(A) the notification to the Attorney Gen-18
	261	+	eral under paragraph (3); or 19
	262	+	‘‘(B) a supplemental notification that the 20
	263	+	practitioner may send if the practitioner needs 21
	264	+	additional amounts for the research, which sup-22
	265	+	plemental notification shall include— 23
	266	+	‘‘(i) the name of the practitioner; 24
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	269	+	•HR 467 RH
	270	+	‘‘(ii) the additional quantity needed of 1
	271	+	the substance; and 2
	272	+	‘‘(iii) an attestation that the research 3
	273	+	to be conducted with the substance is con-4
	274	+	sistent with the scope of the research that 5
	275	+	was the subject of the notification under 6
	276	+	paragraph (3). 7
216	277		‘‘(6) I
217		-	MPORTATION AND EXPORTATION RE -11
218		-	QUIREMENTS NOT AFFECTED .—Nothing in this sub-12
219		-	section alters the requirements of part A of title III, 13
220		-	regarding the importation and exportation of con-14
221		-	trolled substances. 15
222		-	‘‘(7) I
223		-	NSPECTOR GENERAL REPORT .—Not later 16
224		-	than 1 year after the date of enactment of this Act, 17
225		-	the Inspector General of the Department of Justice 18
226		-	shall complete a study, and submit a report thereon, 19
227		-	about research described in paragraph (2) of this 20
228		-	subsection with fentanyl.’’. 21
	278	+	MPORTATION AND EXPORTATION REQUIRE -8
	279	+	MENTS NOT AFFECTED .—Nothing in this subsection 9
	280	+	alters the requirements of part A of title III, regard-10
	281	+	ing the importation and exportation of controlled sub-11
	282	+	stances.’’. 12
229	283		(b) S
230		-	EPARATEREGISTRATIONSNOTREQUIRED FOR 22
	284	+	EPARATEREGISTRATIONSNOTREQUIRED FOR 13
231	285		A
232		-	DDITIONALRESEARCHER ~~INSAMEINSTITUTION~~.—Sec-23
233		-	tion 302(c) of the Controlled Substances Act (21 U.S.C. 24
234		-	822(c)) is amended by adding at the end the following: ~~25 10~~
235		-	~~•HR 467 EH~~
236		-	~~‘‘(4) An agent or employee of~~ a ~~research insti-1~~
237		-	~~tution that is conducting research with a controlled 2~~
238		-	~~substance if—~~ 3
239		-	~~‘‘(A)~~ the agent ~~or employee is acting with-4~~
240		-	~~in the scope of the professional practice of the 5~~
241		-	agent or employee~~; 6~~
242		-	~~‘‘(B) another agent or employee of the in-7~~
243		-	~~stitution is registered to conduct research with 8~~
244		-	~~a controlled substance in the same schedule;~~ 9
245		-	~~‘‘(C) the researcher who is so registered— 10~~
246		-	~~‘‘(i) informs the Attorney General of 11~~
247		-	the ~~name, position title,~~ ~~and employing in-12~~
248		-	~~stitution~~ of ~~the agent or employee who is 13~~
249		-	~~not separately registered;~~ 14
250		-	~~‘‘(ii) authorizes that~~ agent or ~~em-15~~
251		-	~~ployee to perform research under the reg-16~~
252		-	~~istration of the registered researcher;~~ ~~and 17~~
253		-	~~‘‘(iii) affirms that any act taken by 18~~
254		-	~~that agent or employee involving a con-19~~
255		-	~~trolled substance shall be attributable to 20~~
256		-	~~the registered researcher,~~ ~~as if the re-21~~
257		-	~~searcher had directly committed~~ the ~~act, 22~~
258		-	~~for purposes of any proceeding under sec-23~~
259		-	~~tion 304(a) to suspend or revoke~~ the ~~reg-24~~
260		-	~~istration~~ of ~~the registered researcher;~~ ~~and 25 11~~
261		-	~~•HR 467 EH~~
262		-	~~‘‘(D) the Attorney General does not, within 1~~
263		-	~~30 days of receiving~~ the ~~information~~, ~~authoriza-2~~
264		-	~~tion~~, ~~and affirmation described in subparagraph 3~~
265		-	~~(C)~~, ~~refuse, for a reason listed~~ in ~~section 4~~
266		-	304(a), ~~to allow the agent or employee to pos-5~~
267		-	~~sess~~ the ~~substance without a separate registra-6~~
268		-	~~tion~~.’’. 7
	286	+	DDITIONALRESEARCHER IN SAMEINSTITUTION.—Sec-14
	287	+	tion 302(c) of the Controlled Substances Act (21 U.S.C. 15
	288	+	822(c)) is amended by adding at the end the following: 16
	289	+	‘‘(4) An agent or employee of a research institu-17
	290	+	tion that is conducting research with a controlled sub-18
	291	+	stance if— 19
	292	+	‘‘(A) the agent or employee is acting within 20
	293	+	the scope of the professional practice of the agent 21
	294	+	or employee; 22
	295	+	‘‘(B) another agent or employee of the insti-23
	296	+	tution is registered to conduct research with a 24
	297	+	controlled substance in the same schedule; 25
	298	+	VerDate Sep 11 2014 00:56 May 18, 2023 Jkt 039200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6203 E:\BILLS\H467.RH H467
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	300	+	•HR 467 RH
	301	+	‘‘(C) the researcher who is so registered— 1
	302	+	‘‘(i) informs the Attorney General of 2
	303	+	the name, position title, and employing in-3
	304	+	stitution of the agent or employee who is 4
	305	+	not separately registered; 5
	306	+	‘‘(ii) authorizes that agent or employee 6
	307	+	to perform research under the registration of 7
	308	+	the registered researcher; and 8
	309	+	‘‘(iii) affirms that any act taken by 9
	310	+	that agent or employee involving a con-10
	311	+	trolled substance shall be attributable to the 11
	312	+	registered researcher, as if the researcher 12
	313	+	had directly committed the act, for purposes 13
	314	+	of any proceeding under section 304(a) to 14
	315	+	suspend or revoke the registration of the reg-15
	316	+	istered researcher; and 16
	317	+	‘‘(D) the Attorney General does not, within 17
	318	+	30 days of receiving the information, authoriza-18
	319	+	tion, and affirmation described in subparagraph 19
	320	+	(C), refuse, for a reason listed in section 304(a), 20
	321	+	to allow the agent or employee to possess the sub-21
	322	+	stance without a separate registration.’’. 22
269	323		(c) S
270		-	INGLEREGISTRATION FORRELATEDRESEARCH 8
	324	+	INGLEREGISTRATION FORRELATEDRESEARCH 23
271	325		S
272		-	ITES.—Section 302(e) of the Controlled Substances Act 9
273		-	(21 U.S.C. 822(e)) is amended by adding at the end the 10
274		-	following: 11
275		-	‘‘(4)(A) Notwithstanding paragraph (1), a person 12
276		-	registered to conduct research with a controlled substance 13
277		-	under section 303(f) may conduct the research under a 14
278		-	single registration if— 15
279		-	‘‘(i) the research occurs exclusively on sites all 16
280		-	of which are— 17
281		-	‘‘(I) within the same city or county; and 18
282		-	‘‘(II) under the control of the same institu-19
283		-	tion, organization, or agency; and 20
284		-	‘‘(ii) before commencing the research, the re-21
285		-	searcher notifies the Attorney General of each site 22
286		-	where— 23
287		-	‘‘(I) the research will be conducted; or 24 12
288		-	•HR 467 EH
289		-	‘‘(II) the controlled substance will be 1
290		-	stored or administered. 2
291		-	‘‘(B) A site described in subparagraph (A) shall be 3
292		-	included in a registration described in that subparagraph 4
293		-	only if the researcher has notified the Attorney General 5
294		-	of the site— 6
295		-	‘‘(i) in the application for the registration; or 7
296		-	‘‘(ii) before the research is conducted, or before 8
297		-	the controlled substance is stored or administered, at 9
298		-	the site. 10
299		-	‘‘(C) The Attorney General may, in consultation with 11
300		-	the Secretary, issue regulations addressing, with respect 12
301		-	to research sites described in subparagraph (A)— 13
302		-	‘‘(i) the manner in which controlled substances 14
303		-	may be delivered to the research sites; 15
304		-	‘‘(ii) the storage and security of controlled sub-16
305		-	stances at the research sites; 17
306		-	‘‘(iii) the maintenance of records for the re-18
307		-	search sites; and 19
308		-	‘‘(iv) any other matters necessary to ensure ef-20
309		-	fective controls against diversion at the research 21
310		-	sites.’’. 22
	326	+	ITES.—Section 302(e) of the Controlled Substances Act (21 24
	327	+	VerDate Sep 11 2014 00:56 May 18, 2023 Jkt 039200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6203 E:\BILLS\H467.RH H467
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	329	+	•HR 467 RH
	330	+	U.S.C. 822(e)) is amended by adding at the end the fol-1
	331	+	lowing: 2
	332	+	‘‘(4)(A) Notwithstanding paragraph (1), a person reg-3
	333	+	istered to conduct research with a controlled substance 4
	334	+	under section 303(f) may conduct the research under a sin-5
	335	+	gle registration if— 6
	336	+	‘‘(i) the research occurs exclusively on sites all of 7
	337	+	which are— 8
	338	+	‘‘(I) within the same city or county; and 9
	339	+	‘‘(II) under the control of the same institu-10
	340	+	tion, organization, or agency; and 11
	341	+	‘‘(ii) before commencing the research, the re-12
	342	+	searcher notifies the Attorney General of each site 13
	343	+	where— 14
	344	+	‘‘(I) the research will be conducted; or 15
	345	+	‘‘(II) the controlled substance will be stored 16
	346	+	or administered. 17
	347	+	‘‘(B) A site described in subparagraph (A) shall be in-18
	348	+	cluded in a registration described in that subparagraph 19
	349	+	only if the researcher has notified the Attorney General of 20
	350	+	the site— 21
	351	+	‘‘(i) in the application for the registration; or 22
	352	+	‘‘(ii) before the research is conducted, or before 23
	353	+	the controlled substance is stored or administered, at 24
	354	+	the site. 25
	355	+	VerDate Sep 11 2014 00:56 May 18, 2023 Jkt 039200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6203 E:\BILLS\H467.RH H467
	356	+	kjohnson on DSK79L0C42PROD with BILLS 13
	357	+	•HR 467 RH
	358	+	‘‘(C) The Attorney General may, in consultation with 1
	359	+	the Secretary, issue regulations addressing, with respect to 2
	360	+	research sites described in subparagraph (A)— 3
	361	+	‘‘(i) the manner in which controlled substances 4
	362	+	may be delivered to the research sites; 5
	363	+	‘‘(ii) the storage and security of controlled sub-6
	364	+	stances at the research sites; 7
	365	+	‘‘(iii) the maintenance of records for the research 8
	366	+	sites; and 9
	367	+	‘‘(iv) any other matters necessary to ensure effec-10
	368	+	tive controls against diversion at the research sites.’’. 11
311	369		(d) N
312		-	EWINSPECTIONNOTREQUIRED INCERTAIN 23
313		-	S
314		-	ITUATIONS.—Section 302(f) of the Controlled Sub-24
315		-	stances Act (21 U.S.C. 822(f)) is amended— 25 13
316		-	•HR 467 EH
317		-	(1) by striking ‘‘(f) The’’ and inserting ‘‘(f)(1) 1
318		-	The’’; and 2
319		-	(2) by adding at the end the following: 3
320		-	‘‘(2)(A) If a person is registered to conduct research 4
321		-	with a controlled substance and applies for a registration, 5
322		-	or for a modification of a registration, to conduct research 6
323		-	with a second controlled substance that is in the same 7
324		-	schedule as the first controlled substance, or is in a sched-8
325		-	ule with a higher numerical designation than the schedule 9
326		-	of the first controlled substance, a new inspection by the 10
327		-	Attorney General of the registered location is not required. 11
328		-	‘‘(B) Nothing in subparagraph (A) shall prohibit the 12
329		-	Attorney General from conducting an inspection that the 13
330		-	Attorney General determines necessary to ensure that a 14
331		-	registrant maintains effective controls against diversion.’’. 15
	370	+	EWINSPECTIONNOTREQUIRED INCERTAINSIT-12
	371	+	UATIONS.—Section 302(f) of the Controlled Substances Act 13
	372	+	(21 U.S.C. 822(f)) is amended— 14
	373	+	(1) by striking ‘‘(f) The’’ and inserting ‘‘(f)(1) 15
	374	+	The’’; and 16
	375	+	(2) by adding at the end the following: 17
	376	+	‘‘(2)(A) If a person is registered to conduct research 18
	377	+	with a controlled substance and applies for a registration, 19
	378	+	or for a modification of a registration, to conduct research 20
	379	+	with a second controlled substance that is in the same sched-21
	380	+	ule as the first controlled substance, or is in a schedule with 22
	381	+	a higher numerical designation than the schedule of the first 23
	382	+	controlled substance, a new inspection by the Attorney Gen-24
	383	+	eral of the registered location is not required. 25
	384	+	VerDate Sep 11 2014 00:56 May 18, 2023 Jkt 039200 PO 00000 Frm 00013 Fmt 6652 Sfmt 6203 E:\BILLS\H467.RH H467
	385	+	kjohnson on DSK79L0C42PROD with BILLS 14
	386	+	•HR 467 RH
	387	+	‘‘(B) Nothing in subparagraph (A) shall prohibit the 1
	388	+	Attorney General from conducting an inspection that the 2
	389	+	Attorney General determines necessary to ensure that a reg-3
	390	+	istrant maintains effective controls against diversion.’’. 4
332	391		(e) C
333		-	ONTINUATION OF RESEARCH ~~ONSUBSTANCES 16~~
	392	+	ONTINUATION OF RESEARCH ON SUBSTANCES 5
334	393		N
335		-	EWLYADDED TOSCHEDULEI.—Section 302 of the 17
336		-	~~Controlled~~ Substances Act (21 U.S.C. 822) is amended 18
337		-	~~by adding~~ at the end the following: 19
	394	+	EWLYADDED TOSCHEDULEI.—Section 302 of the Con-6
	395	+	trolled Substances Act (21 U.S.C. 822) is amended by add-7
	396	+	ing at the end the following: 8
338	397		‘‘(h) C
339		-	ONTINUATION OFRESEARCH ONSUBSTANCES 20
	398	+	ONTINUATION OFRESEARCH ONSUBSTANCES 9
340	399		N
341		-	EWLYADDED TOSCHEDULEI.—If a person is con-21
342		-	ducting research on a substance when the substance is 22
343		-	added to schedule I, and the person is already registered 23
344		-	to conduct research with a controlled substance in sched-24
345		-	ule I— 25 14
346		-	•HR 467 EH
347		-	‘‘(1) not later than 90 days after the scheduling 1
348		-	of the newly scheduled substance, the person shall 2
349		-	submit a completed application for registration or 3
350		-	modification of existing registration, to conduct re-4
351		-	search on the substance, in accordance with regula-5
352		-	tions issued by the Attorney General for purposes of 6
353		-	this paragraph; 7
354		-	‘‘(2) the person may, notwithstanding sub-8
355		-	sections (a) and (b), continue to conduct the re-9
356		-	search on the substance until— 10
357		-	‘‘(A) the person withdraws the application 11
358		-	described in paragraph (1) of this subsection; 12
359		-	or 13
360		-	‘‘(B) the Attorney General serves on the 14
361		-	person an order to show cause proposing the 15
362		-	denial of the application under section 304(c); 16
363		-	‘‘(3) if the Attorney General serves an order to 17
364		-	show cause as described in paragraph (2)(B) and 18
365		-	the person requests a hearing, the hearing shall be 19
366		-	held on an expedited basis and not later than 45 20
367		-	days after the request is made, except that the hear-21
368		-	ing may be held at a later time if so requested by 22
369		-	the person; and 23
370		-	‘‘(4) if the person sends a copy of the applica-24
371		-	tion described in paragraph (1) to a manufacturer or 25 15
372		-	•HR 467 EH
373		-	distributor of the substance, receipt of the copy by 1
374		-	the manufacturer or distributor shall constitute suf-2
375		-	ficient evidence that the person is authorized to re-3
376		-	ceive the substance.’’. 4
	400	+	EWLYADDED TOSCHEDULEI.—If a person is conducting 10
	401	+	research on a substance when the substance is added to 11
	402	+	schedule I, and the person is already registered to conduct 12
	403	+	research with a controlled substance in schedule I— 13
	404	+	‘‘(1) not later than 90 days after the scheduling 14
	405	+	of the newly scheduled substance, the person shall sub-15
	406	+	mit a completed application for registration or modi-16
	407	+	fication of existing registration, to conduct research 17
	408	+	on the substance, in accordance with regulations 18
	409	+	issued by the Attorney General for purposes of this 19
	410	+	paragraph; 20
	411	+	‘‘(2) the person may, notwithstanding sub-21
	412	+	sections (a) and (b), continue to conduct the research 22
	413	+	on the substance until— 23
	414	+	‘‘(A) the person withdraws the application 24
	415	+	described in paragraph (1) of this subsection; or 25
	416	+	VerDate Sep 11 2014 00:56 May 18, 2023 Jkt 039200 PO 00000 Frm 00014 Fmt 6652 Sfmt 6203 E:\BILLS\H467.RH H467
	417	+	kjohnson on DSK79L0C42PROD with BILLS 15
	418	+	•HR 467 RH
	419	+	‘‘(B) the Attorney General serves on the per-1
	420	+	son an order to show cause proposing the denial 2
	421	+	of the application under section 304(c); 3
	422	+	‘‘(3) if the Attorney General serves an order to 4
	423	+	show cause as described in paragraph (2)(B) and the 5
	424	+	person requests a hearing, the hearing shall be held on 6
	425	+	an expedited basis and not later than 45 days after 7
	426	+	the request is made, except that the hearing may be 8
	427	+	held at a later time if so requested by the person; and 9
	428	+	‘‘(4) if the person sends a copy of the application 10
	429	+	described in paragraph (1) to a manufacturer or dis-11
	430	+	tributor of the substance, receipt of the copy by the 12
	431	+	manufacturer or distributor shall constitute sufficient 13
	432	+	evidence that the person is authorized to receive the 14
	433	+	substance.’’. 15
377	434		(f) T
378		-	REATMENT ~~OF CERTAINMANUFACTURING AC-5~~
379		-	~~TIVITIES~~ ASCOINCIDENT TORESEARCH.—Section 302 of 6
380		-	~~the~~ Controlled Substances Act (21 U.S.C. 822), as ~~amend-7~~
381		-	~~ed by~~ subsection (e), is amended by adding at the end 8
382		-	~~the following~~: 9
	435	+	REATMENT OFCERTAINMANUFACTURINGACTIVI-16
	436	+	TIES ASCOINCIDENT TORESEARCH.—Section 302 of the 17
	437	+	Controlled Substances Act (21 U.S.C. 822), as amended by 18
	438	+	subsection (e), is amended by adding at the end the fol-19
	439	+	lowing: 20
383	440		‘‘(i) T
384		-	REATMENT OFCERTAINMANUFACTURINGAC-10
385		-	TIVITIES ASCOINCIDENT TORESEARCH.— 11
	441	+	REATMENT OFCERTAINMANUFACTURINGAC-21
	442	+	TIVITIES ASCOINCIDENT TORESEARCH.— 22
386	443		‘‘(1) I
387		-	N GENERAL.—Except as provided in para-12
388		-	graph (3), a person who is registered to perform re-13
389		-	search on a controlled substance may perform manu-14
390		-	facturing activities with small quantities of that sub-15
391		-	stance, including activities described in paragraph 16
392		-	(2), without being required to obtain a manufac-17
393		-	turing registration, if— 18
394		-	‘‘(A) the activities are performed for the 19
395		-	purpose of the research; and 20
396		-	‘‘(B) the activities and the quantities of 21
397		-	the substance involved in the activities are stat-22
398		-	ed in— 23
399		-	‘‘(i) a notification submitted to the 24
400		-	Attorney General under section 303(l); 25 16
401		-	•HR 467 EH
402		-	‘‘(ii) a research protocol filed with an 1
403		-	application for registration approval under 2
404		-	section 303(f); or 3
405		-	‘‘(iii) a notification to the Attorney 4
406		-	General that includes— 5
407		-	‘‘(I) the name of the registrant; 6
408		-	and 7
409		-	‘‘(II) an attestation that the re-8
410		-	search to be conducted with the small 9
411		-	quantities of manufactured substance 10
412		-	is consistent with the scope of the re-11
413		-	search that is the basis for the reg-12
414		-	istration. 13
415		-	‘‘(2) A
416		-	CTIVITIES INCLUDED.—Activities per-14
417		-	mitted under paragraph (1) include— 15
418		-	‘‘(A) processing the substance to create ex-16
419		-	tracts, tinctures, oils, solutions, derivatives, or 17
420		-	other forms of the substance consistent with— 18
421		-	‘‘(i) the information provided as part 19
422		-	of a notification submitted to the Attorney 20
423		-	General under section 303(l); or 21
424		-	‘‘(ii) a research protocol filed with an 22
425		-	application for registration approval under 23
426		-	section 303(f); and 24 17
427		-	•HR 467 EH
428		-	‘‘(B) dosage form development studies per-1
429		-	formed for the purpose of requesting an inves-2
430		-	tigational new drug exemption under section 3
431		-	505(i) of the Federal Food, Drug, and Cos-4
432		-	metic Act (21 U.S.C. 355(i)). 5
	444	+	N GENERAL.—Except as provided in para-23
	445	+	graph (3), a person who is registered to perform re-24
	446	+	search on a controlled substance may perform manu-25
	447	+	VerDate Sep 11 2014 00:56 May 18, 2023 Jkt 039200 PO 00000 Frm 00015 Fmt 6652 Sfmt 6203 E:\BILLS\H467.RH H467
	448	+	kjohnson on DSK79L0C42PROD with BILLS 16
	449	+	•HR 467 RH
	450	+	facturing activities with small quantities of that sub-1
	451	+	stance, including activities described in paragraph 2
	452	+	(2), without being required to obtain a manufac-3
	453	+	turing registration, if— 4
	454	+	‘‘(A) the activities are performed for the 5
	455	+	purpose of the research; and 6
	456	+	‘‘(B) the activities and the quantities of the 7
	457	+	substance involved in the activities are stated 8
	458	+	in— 9
	459	+	‘‘(i) a notification submitted to the At-10
	460	+	torney General under section 303(l); 11
	461	+	‘‘(ii) a research protocol filed with an 12
	462	+	application for registration approval under 13
	463	+	section 303(f); or 14
	464	+	‘‘(iii) a notification to the Attorney 15
	465	+	General that includes— 16
	466	+	‘‘(I) the name of the registrant; 17
	467	+	and 18
	468	+	‘‘(II) an attestation that the re-19
	469	+	search to be conducted with the small 20
	470	+	quantities of manufactured substance 21
	471	+	is consistent with the scope of the re-22
	472	+	search that is the basis for the registra-23
	473	+	tion. 24
	474	+	VerDate Sep 11 2014 00:56 May 18, 2023 Jkt 039200 PO 00000 Frm 00016 Fmt 6652 Sfmt 6203 E:\BILLS\H467.RH H467
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	476	+	•HR 467 RH
	477	+	‘‘(2) ACTIVITIES INCLUDED.—Activities per-1
	478	+	mitted under paragraph (1) include— 2
	479	+	‘‘(A) processing the substance to create ex-3
	480	+	tracts, tinctures, oils, solutions, derivatives, or 4
	481	+	other forms of the substance consistent with— 5
	482	+	‘‘(i) the information provided as part 6
	483	+	of a notification submitted to the Attorney 7
	484	+	General under section 303(l); or 8
	485	+	‘‘(ii) a research protocol filed with an 9
	486	+	application for registration approval under 10
	487	+	section 303(f); and 11
	488	+	‘‘(B) dosage form development studies per-12
	489	+	formed for the purpose of requesting an inves-13
	490	+	tigational new drug exemption under section 14
	491	+	505(i) of the Federal Food, Drug, and Cosmetic 15
	492	+	Act (21 U.S.C. 355(i)). 16
433	493		‘‘(3) E
434		-	XCEPTION REGARDING MARIHUANA .— 6
435		-	~~The~~ authority under paragraph (1) to manufacture 7
436		-	~~substances~~ does not include the authority to grow 8
437		-	~~marihuana~~.’’. 9
	494	+	XCEPTION REGARDING MARIHUANA .—The 17
	495	+	authority under paragraph (1) to manufacture sub-18
	496	+	stances does not include the authority to grow mari-19
	497	+	huana.’’. 20
438	498		(g) T
439		-	RANSPARENCY REGARDINGSPECIALPROCE-10
440		-	DURES.—Section 303 of the Controlled Substances Act 11
441		-	(21 U.S.C. 823), as amended by subsection (a), is amend-12
442		-	ed by adding at the end the following: 13
443		-	‘‘(o) T
444		-	RANSPARENCY REGARDINGSPECIALPROCE-14
445		-	DURES.— 15
	499	+	RANSPARENCY REGARDINGSPECIALPROCE-21
	500	+	DURES.—Section 303 of the Controlled Substances Act (21 22
	501	+	U.S.C. 823), as amended by subsection (a), is amended by 23
	502	+	adding at the end the following: 24
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	505	+	•HR 467 RH
	506	+	‘‘(o) TRANSPARENCYREGARDINGSPECIALPROCE-1
	507	+	DURES.— 2
446	508		‘‘(1) I
447		-	N GENERAL.—If the Attorney General de-16
448		-	termines, with respect to a controlled substance, that 17
449		-	an application by a practitioner to conduct research 18
450		-	with the substance should be considered under a 19
451		-	process, or subject to criteria, different from the 20
452		-	process or criteria applicable to applications to con-21
453		-	duct research with other controlled substances in the 22
454		-	same schedule, the Attorney General shall make 23
455		-	public, including by posting on the website of the 24
456		-	Drug Enforcement Administration— 25 18
457		-	•HR 467 EH
458		-	‘‘(A) the identities of all substances for 1
459		-	which such determinations have been made; 2
460		-	‘‘(B) the process and criteria that shall be 3
461		-	applied to applications to conduct research with 4
462		-	those substances; and 5
463		-	‘‘(C) how the process and criteria described 6
464		-	in subparagraph (B) differ from the process 7
465		-	and criteria applicable to applications to con-8
466		-	duct research with other controlled substances 9
467		-	in the same schedule. 10
	509	+	N GENERAL.—If the Attorney General de-3
	510	+	termines, with respect to a controlled substance, that 4
	511	+	an application by a practitioner to conduct research 5
	512	+	with the substance should be considered under a proc-6
	513	+	ess, or subject to criteria, different from the process or 7
	514	+	criteria applicable to applications to conduct research 8
	515	+	with other controlled substances in the same schedule, 9
	516	+	the Attorney General shall make public, including by 10
	517	+	posting on the website of the Drug Enforcement Ad-11
	518	+	ministration— 12
	519	+	‘‘(A) the identities of all substances for 13
	520	+	which such determinations have been made; 14
	521	+	‘‘(B) the process and criteria that shall be 15
	522	+	applied to applications to conduct research with 16
	523	+	those substances; and 17
	524	+	‘‘(C) how the process and criteria described 18
	525	+	in subparagraph (B) differ from the process and 19
	526	+	criteria applicable to applications to conduct re-20
	527	+	search with other controlled substances in the 21
	528	+	same schedule. 22
468	529		‘‘(2) T
469		-	IMING OF POSTING.—The Attorney Gen-11
470		-	eral shall make information described in paragraph 12
471		-	(1) public upon making a determination described in 13
472		-	that paragraph, regardless of whether a practitioner 14
473		-	has submitted such an application at that time.’’. 15
474		-	SEC. 4. RULEMAKING. 16
	530	+	IMING OF POSTING.—The Attorney General 23
	531	+	shall make information described in paragraph (1) 24
	532	+	public upon making a determination described in 25
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	535	+	•HR 467 RH
	536	+	that paragraph, regardless of whether a practitioner 1
	537	+	has submitted such an application at that time.’’. 2
	538	+	SEC. 4. RULEMAKING. 3
475	539		(a) I
476		-	NTERIMFINALRULES.—The Attorney Gen-17
477		-	eral— 18
478		-	(1) shall, not later than 6 months after the date 19
479		-	of enactment of this Act, issue rules to implement 20
480		-	this Act and the amendments made by this Act; and 21
481		-	(2) may issue the rules under paragraph (1) as 22
482		-	interim final rules. 23
	540	+	NTERIMFINALRULES.—The Attorney General— 4
	541	+	(1) shall, not later than 1 year of the date of en-5
	542	+	actment of this Act, issue rules to implement this Act 6
	543	+	and the amendments made by this Act; and 7
	544	+	(2) may issue the rules under paragraph (1) as 8
	545	+	interim final rules. 9
483	546		(b) P
484		-	ROCEDURE FORFINALRULE.— 24 19
485		-	•HR 467 EH
486		-	(1) EFFECTIVENESS OF INTERIM FINAL 1
487		-	RULES.—A rule issued by the Attorney General as 2
488		-	an interim final rule under subsection (a) shall be-3
489		-	come immediately effective as an interim final rule 4
490		-	without requiring the Attorney General to dem-5
491		-	onstrate good cause therefor, notwithstanding sub-6
492		-	paragraph (B) of section 553(b) of title 5, United 7
493		-	States Code. 8
	547	+	ROCEDURE FORFINALRULE.— 10
	548	+	(1) E
	549	+	FFECTIVENESS OF INTERIM FINAL RULES .— 11
	550	+	A rule issued by the Attorney General as an interim 12
	551	+	final rule under subsection (a) shall become imme-13
	552	+	diately effective as an interim final rule without re-14
	553	+	quiring the Attorney General to demonstrate good 15
	554	+	cause therefor, notwithstanding subparagraph (B) of 16
	555	+	section 553(b) of title 5, United States Code. 17
494	556		(2) O
495		-	PPORTUNITY FOR COMMENT AND HEAR -9
496		-	ING.—An interim final rule issued under subsection 10
497		-	(a) shall give interested persons the opportunity to 11
498		-	comment and to request a hearing. 12
	557	+	PPORTUNITY FOR COMMENT AND HEAR -18
	558	+	ING.—An interim final rule issued under subsection 19
	559	+	(a) shall give interested persons the opportunity to 20
	560	+	comment and to request a hearing. 21
499	561		(3) F
500		-	INAL RULE.—After the conclusion of such 13
501		-	proceedings, the Attorney General shall issue a final 14
502		-	rule to implement this Act and the amendments 15
503		-	made by this Act in accordance with section 553 of 16
504		-	title 5, United States Code. 17
505		-	SEC. 5. PENALTIES. 18
	562	+	INAL RULE.—After the conclusion of such 22
	563	+	proceedings, the Attorney General shall issue a final 23
	564	+	rule to implement this Act and the amendments made 24
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	567	+	•HR 467 RH
	568	+	by this Act in accordance with section 553 of title 5, 1
	569	+	United States Code. 2
	570	+	SEC. 5. PENALTIES. 3
506	571		(a) I
507		-	NGENERAL.—Section 401(b)(1) of the Con-19
508		-	trolled Substances Act (21 U.S.C. 841(b)(1)) is amend-20
509		-	ed— 21
510		-	(1) in subparagraph (A)(vi), by inserting ‘‘or a 22
511		-	fentanyl-related substance’’ after ‘‘any analogue of 23
512		-	N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] 24
513		-	propanamide’’; and 25 20
514		-	•HR 467 EH
515		-	(2) in subparagraph (B)(vi), by inserting ‘‘or a 1
516		-	fentanyl-related substance’’ after ‘‘any analogue of 2
517		-	N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] 3
518		-	propanamide’’. 4
	572	+	NGENERAL.—Section 401(b)(1) of the Controlled 4
	573	+	Substances Act (21 U.S.C. 841(b)(1)) is amended— 5
	574	+	(1) in subparagraph (A)(vi), by inserting ‘‘or a 6
	575	+	fentanyl-related substance’’ after ‘‘any analogue of N- 7
	576	+	phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] 8
	577	+	propanamide’’; and 9
	578	+	(2) in subparagraph (B)(vi), by inserting ‘‘or a 10
	579	+	fentanyl-related substance’’ after ‘‘any analogue of N- 11
	580	+	phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] 12
	581	+	propanamide’’. 13
519	582		(b) I
520		-	MPORTATION AND EXPORTATION.—Section 5
521		-	1010(b) of the Controlled Substances Import and Export 6
522		-	Act (21 U.S.C. 960(b)) is amended— 7
523		-	(1) in paragraph (1)(F), by inserting ‘‘or a 8
524		-	fentanyl-related substance’’ after ‘‘any analogue of 9
525		-	N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] 10
526		-	propanamide’’; and 11
527		-	(2) in paragraph (2)(F), by inserting ‘‘or a 12
528		-	fentanyl-related substance’’ after ‘‘any analogue of 13
529		-	N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] 14
530		-	propanamide’’. 15
531		-	SEC. 6. APPLICABILITY; OTHER MATTERS. 16
	583	+	MPORTATION AND EXPORTATION.—Section 14
	584	+	1010(b) of the Controlled Substances Import and Export 15
	585	+	Act (21 U.S.C. 960(b)) is amended— 16
	586	+	(1) in paragraph (1)(F), by inserting ‘‘or a 17
	587	+	fentanyl-related substance’’ after ‘‘any analogue of N- 18
	588	+	phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] 19
	589	+	propanamide’’; and 20
	590	+	(2) in paragraph (2)(F), by inserting ‘‘or a 21
	591	+	fentanyl-related substance’’ after ‘‘any analogue of N- 22
	592	+	phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] 23
	593	+	propanamide’’. 24
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	596	+	•HR 467 RH
	597	+	SEC. 6. APPLICABILITY; OTHER MATTERS. 1
532	598		(a) I
533		-	NGENERAL.—Irrespective of the date on which 17
534		-	the rules required by section 4 are finalized, the amend-18
535		-	ments made by this Act apply beginning as of the enact-19
536		-	ment of this Act. 20
	599	+	NGENERAL.—Irrespective of the date on which 2
	600	+	the rules required by section 4 are finalized, the amend-3
	601	+	ments made by this Act apply beginning as of the enact-4
	602	+	ment of this Act. 5
537	603		(b) R
538		-	ULE OF CONSTRUCTION.—Nothing in the 21
539		-	amendments made by this Act may be construed as evi-22
540		-	dence that, in applying sections 401(b)(1) and 1010(b) of 23
541		-	the Controlled Substances Act (21 U.S.C. 841(b)(1) and 24
542		-	960(b)) with respect to conduct occurring before the date 25 21
543		-	•HR 467 EH
544		-	of the enactment of this Act, a fentanyl-related substance 1
545		-	(as defined by such amendments) is not an analogue of 2
546		-	N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] 3
547		-	propanamide. 4
	604	+	ULE OFCONSTRUCTION.—Nothing in the amend-6
	605	+	ments made by this Act may be construed as evidence that, 7
	606	+	in applying sections 401(b)(1) and 1010(b) of the Con-8
	607	+	trolled Substances Act (21 U.S.C. 841(b)(1) and 960(b)) 9
	608	+	with respect to conduct occurring before the date of the en-10
	609	+	actment of this Act, a fentanyl-related substance (as defined 11
	610	+	by such amendments) is not an analogue of N-phenyl-N- 12
	611	+	[1-(2-phenylethyl)-4-piperidinyl] propanamide. 13
548	612		(c) S
549		-	ENSE OFCONGRESS.—The Congress agrees with 5
550		-	the interpretation of the Controlled Substances Act (21 6
551		-	U.S.C. 801 et seq.) in United States v. McCray, 346 F. 7
552		-	Supp. 3d 363 (2018). 8
553		-	Passed the House of Representatives May 25, 2023.
554		-	Attest:
555		-	Clerk. 118
	613	+	ENSE OFCONGRESS.—The Congress agrees with 14
	614	+	the interpretation of the Controlled Substances Act (21 15
	615	+	U.S.C. 801 et seq.) in United States v. McCray, 346 F. 16
	616	+	Supp. 3d 363 (2018). 17
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	619	+	47
	620	+	118
556	621		TH
557	622		CONGRESS
558	623		1
559	624		ST
560	625		S
561	626		ESSION
562	627
563	628		H. R. 467
564		-	AN ACT
	629	+	[Report No. 118–67, Part I]
	630	+	A BILL
565	631		To amend the Controlled Substances Act with re-
566	632		spect to the scheduling of fentanyl-related sub-
567	633		stances, and for other purposes.
	634	+	M
	635	+	AY
	636	+	17, 2023
	637	+	Reported from the Committee on Energy and Commerce
	638	+	with an amendment
	639	+	M
	640	+	AY
	641	+	17, 2023
	642	+	Committee on the Judiciary discharged; committed to the
	643	+	Committee of the Whole House on the State of the
	644	+	Union and ordered to be printed
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