I
118THCONGRESS
1
STSESSION H. R. 467
To amend the Controlled Substances Act with respect to the scheduling
of fentanyl-related substances, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
JANUARY24, 2023
Mr. G
RIFFITH(for himself, Mr. LATTA, Mrs. RODGERSof Washington, Mr.
G
UTHRIE, Mr. BILIRAKIS, Mr. BUCSHON, Mr. HUDSON, Mr. BURGESS,
Mr. C
ARTERof Georgia, Mr. DUNCAN, Mr. DUNNof Florida, Mr. CREN-
SHAW, Mr. JOYCEof Pennsylvania, Mr. BALDERSON, Mrs.
H
ARSHBARGER, Mrs. MILLER-MEEKS, Mrs. CAMMACK, Mr. ALLEN, Mr.
W
ALBERG, Mr. CURTIS, Mr. PALMER, Mr. BUCHANAN, Mr. BANKS, Mr.
F
ITZGERALD, and Mr. MOONEY) introduced the following bill; which was
referred to the Committee on Energy and Commerce, and in addition to
the Committee on the Judiciary, for a period to be subsequently deter-
mined by the Speaker, in each case for consideration of such provisions
as fall within the jurisdiction of the committee concerned
A BILL
To amend the Controlled Substances Act with respect to
the scheduling of fentanyl-related substances, and for
other purposes.
Be it enacted by the Senate and House of Representa-1
tives of the United States of America in Congress assembled, 2
SECTION 1. SHORT TITLE. 3
This Act may be cited as the ‘‘Halt All Lethal Traf-4
ficking of Fentanyl Act’’ or the ‘‘HALT Fentanyl Act’’. 5
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SEC. 2. CLASS SCHEDULING OF FENTANYL-RELATED SUB-1
STANCES. 2
Section 202(c) of the Controlled Substances Act (21 3
U.S.C. 812(c)) is amended by adding at the end of sched-4
ule I the following: 5
‘‘(e)(1) Unless specifically exempted or unless listed 6
in another schedule, any material, compound, mixture, or 7
preparation which contains any quantity of a fentanyl-re-8
lated substance, or which contains the salts, isomers, and 9
salts of isomers of a fentanyl-related substance whenever 10
the existence of such salts, isomers, and salts of isomers 11
is possible within the specific chemical designation. 12
‘‘(2) For purposes of paragraph (1), except as pro-13
vided in paragraph (3), the term ‘fentanyl-related sub-14
stance’ means any substance that is structurally related 15
to fentanyl by 1 or more of the following modifications: 16
‘‘(A) By replacement of the phenyl portion of 17
the phenethyl group by any monocycle, whether or 18
not further substituted in or on the monocycle. 19
‘‘(B) By substitution in or on the phenethyl 20
group with alkyl, alkenyl, alkoxyl, hydroxyl, halo, 21
haloalkyl, amino, or nitro groups. 22
‘‘(C) By substitution in or on the piperidine 23
ring with alkyl, alkenyl, alkoxyl, ester, ether, 24
hydroxyl, halo, haloalkyl, amino, or nitro groups. 25
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‘‘(D) By replacement of the aniline ring with 1
any aromatic monocycle whether or not further sub-2
stituted in or on the aromatic monocycle. 3
‘‘(E) By replacement of the N–propionyl group 4
with another acyl group. 5
‘‘(3) A substance that satisfies the definition of the 6
term ‘fentanyl-related substance’ in paragraph (2) shall 7
nonetheless not be treated as a fentanyl-related substance 8
subject to this schedule if the substance— 9
‘‘(A) is controlled by action of the Attorney 10
General under section 201; or 11
‘‘(B) is otherwise expressly listed in a schedule 12
other than this schedule. 13
‘‘(4)(A) The Attorney General may by order publish 14
in the Federal Register a list of substances that satisfy 15
the definition of the term ‘fentanyl-related substance’ in 16
paragraph (2). 17
‘‘(B) The absence of a substance from a list published 18
under subparagraph (A) does not negate the control status 19
of the substance under this schedule if the substance satis-20
fies the definition of the term ‘fentanyl-related substance’ 21
in paragraph (2).’’. 22
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SEC. 3. REGISTRATION REQUIREMENTS RELATED TO RE-1
SEARCH. 2
(a) A
LTERNATIVE REGISTRATIONPROCESS FOR 3
S
CHEDULEI RESEARCH.—Section 303 of the Controlled 4
Substances Act (21 U.S.C. 823) is amended by adding at 5
the end the following: 6
‘‘(m) S
PECIALPROVISIONS FOR PRACTITIONERS 7
C
ONDUCTINGCERTAINRESEARCHWITHSCHEDULEI 8
C
ONTROLLEDSUBSTANCES.— 9
‘‘(1) I
N GENERAL.—Notwithstanding subsection 10
(f), a practitioner may conduct research described in 11
paragraph (2) of this subsection with 1 or more 12
schedule I substances in accordance with subpara-13
graph (A) or (B) of paragraph (3) of this sub-14
section. 15
‘‘(2) R
ESEARCH SUBJECT TO EXPEDITED PRO -16
CEDURES.—Research described in this paragraph is 17
research that— 18
‘‘(A) is with respect to a drug that is the 19
subject of an investigational use exemption 20
under section 505(i) of the Federal Food, Drug, 21
and Cosmetic Act; or 22
‘‘(B) is— 23
‘‘(i) conducted by the Department of 24
Health and Human Services or the De-25
partment of Veterans Affairs; or 26
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‘‘(ii) funded partly or entirely by a 1
grant, contract, cooperative agreement, or 2
other transaction from the Department of 3
Health and Human Services or the De-4
partment of Veterans Affairs. 5
‘‘(3) E
XPEDITED PROCEDURES .— 6
‘‘(A) R
ESEARCHER WITH A CURRENT 7
SCHEDULE I OR II RESEARCH REGISTRATION .— 8
‘‘(i) I
N GENERAL.—If a practitioner is 9
registered to conduct research with a con-10
trolled substance in schedule I or II, the 11
practitioner may conduct research under 12
this subsection on and after the date that 13
is 30 days after the date on which the 14
practitioner sends a notice to the Attorney 15
General containing the following informa-16
tion, with respect to each substance with 17
which the practitioner will conduct the re-18
search: 19
‘‘(I) The chemical name of the 20
substance. 21
‘‘(II) The quantity of the sub-22
stance to be used in the research. 23
‘‘(III) Demonstration that the re-24
search is in the category described in 25
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paragraph (2), which demonstration 1
may be satisfied— 2
‘‘(aa) in the case of a grant, 3
contract, cooperative agreement, 4
or other transaction, or intra-5
mural research project, by identi-6
fying the sponsoring agency and 7
supplying the number of the 8
grant, contract, cooperative 9
agreement, other transaction, or 10
project; or 11
‘‘(bb) in the case of an ap-12
plication under section 505(i) of 13
the Federal Food, Drug, and 14
Cosmetic Act, by supplying the 15
application number and the spon-16
sor of record on the application. 17
‘‘(IV) Demonstration that the re-18
searcher is authorized to conduct re-19
search with respect to the substance 20
under the laws of the State in which 21
the research will take place. 22
‘‘(ii) V
ERIFICATION OF INFORMATION 23
BY HHS OR VA.—Upon request from the 24
Attorney General, the Secretary of Health 25
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and Human Services or the Secretary of 1
Veterans Affairs, as appropriate, shall 2
verify information submitted by an appli-3
cant under clause (i)(III). 4
‘‘(B) R
ESEARCHER WITHOUT A CURRENT 5
SCHEDULE I OR II RESEARCH REGISTRATION .— 6
‘‘(i) I
N GENERAL.—If a practitioner is 7
not registered to conduct research with a 8
controlled substance in schedule I or II, 9
the practitioner may send a notice to the 10
Attorney General containing the informa-11
tion listed in subparagraph (A)(i), with re-12
spect to each substance with which the 13
practitioner will conduct the research. 14
‘‘(ii) A
TTORNEY GENERAL ACTION .— 15
The Attorney General shall— 16
‘‘(I) treat notice received under 17
clause (i) as a sufficient application 18
for a research registration; and 19
‘‘(II) not later than 45 days of 20
receiving such a notice that contains 21
all information required under sub-22
paragraph (A)(i)— 23
‘‘(aa) register the applicant; 24
or 25
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‘‘(bb) serve an order to show 1
cause upon the applicant in ac-2
cordance with section 304(c). 3
‘‘(4) E
LECTRONIC SUBMISSIONS .—The Attorney 4
General shall provide a means to permit a practi-5
tioner to submit a notification under paragraph (3) 6
electronically. 7
‘‘(5) L
IMITATION ON AMOUNTS .—A practitioner 8
conducting research with a schedule I substance 9
under this subsection may only possess the amounts 10
of schedule I substance identified in— 11
‘‘(A) the notification to the Attorney Gen-12
eral under paragraph (3); or 13
‘‘(B) a supplemental notification that the 14
practitioner may send if the practitioner needs 15
additional amounts for the research, which sup-16
plemental notification shall include— 17
‘‘(i) the name of the practitioner; 18
‘‘(ii) the additional quantity needed of 19
the substance; and 20
‘‘(iii) an attestation that the research 21
to be conducted with the substance is con-22
sistent with the scope of the research that 23
was the subject of the notification under 24
paragraph (3). 25
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‘‘(6) IMPORTATION AND EXPORTATION RE -1
QUIREMENTS NOT AFFECTED .—Nothing in this sub-2
section alters the requirements of part A of title III, 3
regarding the importation and exportation of con-4
trolled substances.’’. 5
(b) S
EPARATEREGISTRATIONSNOTREQUIRED FOR 6
A
DDITIONALRESEARCHER INSAMEINSTITUTION.—Sec-7
tion 302(c) of the Controlled Substances Act (21 U.S.C. 8
822(c)) is amended by adding at the end the following: 9
‘‘(4) An agent or employee of a research insti-10
tution that is conducting research with a controlled 11
substance if— 12
‘‘(A) the agent or employee is acting with-13
in the scope of the professional practice of the 14
agent or employee; 15
‘‘(B) another agent or employee of the in-16
stitution is registered to conduct research with 17
a controlled substance in the same schedule; 18
‘‘(C) the researcher who is so registered— 19
‘‘(i) informs the Attorney General of 20
the name, position title, and employing in-21
stitution of the agent or employee who is 22
not separately registered; 23
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‘‘(ii) authorizes that agent or em-1
ployee to perform research under the reg-2
istration of the registered researcher; and 3
‘‘(iii) affirms that any act taken by 4
that agent or employee involving a con-5
trolled substance shall be attributable to 6
the registered researcher, as if the re-7
searcher had directly committed the act, 8
for purposes of any proceeding under sec-9
tion 304(a) to suspend or revoke the reg-10
istration of the registered researcher; and 11
‘‘(D) the Attorney General does not, within 12
30 days of receiving the information, authoriza-13
tion, and affirmation described in subparagraph 14
(C), refuse, for a reason listed in section 15
304(a), to allow the agent or employee to pos-16
sess the substance without a separate registra-17
tion.’’. 18
(c) S
INGLEREGISTRATION FORRELATEDRESEARCH 19
S
ITES.—Section 302(e) of the Controlled Substances Act 20
(21 U.S.C. 822(e)) is amended by adding at the end the 21
following: 22
‘‘(3)(A) Notwithstanding paragraph (1), a person 23
registered to conduct research with a controlled substance 24
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under section 303(f) may conduct the research under a 1
single registration if— 2
‘‘(i) the research occurs exclusively on sites all 3
of which are— 4
‘‘(I) within the same city or county; and 5
‘‘(II) under the control of the same institu-6
tion, organization, or agency; and 7
‘‘(ii) before commencing the research, the re-8
searcher notifies the Attorney General of each site 9
where— 10
‘‘(I) the research will be conducted; or 11
‘‘(II) the controlled substance will be 12
stored or administered. 13
‘‘(B) A site described in subparagraph (A) shall be 14
included in a registration described in that subparagraph 15
only if the researcher has notified the Attorney General 16
of the site— 17
‘‘(i) in the application for the registration; or 18
‘‘(ii) before the research is conducted, or before 19
the controlled substance is stored or administered, at 20
the site. 21
‘‘(C) The Attorney General may, in consultation with 22
the Secretary, issue regulations addressing, with respect 23
to research sites described in subparagraph (A)— 24
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‘‘(i) the manner in which controlled substances 1
may be delivered to the research sites; 2
‘‘(ii) the storage and security of controlled sub-3
stances at the research sites; 4
‘‘(iii) the maintenance of records for the re-5
search sites; and 6
‘‘(iv) any other matters necessary to ensure ef-7
fective controls against diversion at the research 8
sites.’’. 9
(d) N
EWINSPECTIONNOTREQUIRED INCERTAIN 10
S
ITUATIONS.—Section 302(f) of the Controlled Sub-11
stances Act (21 U.S.C. 822(f)) is amended— 12
(1) by striking ‘‘(f) The’’ and inserting ‘‘(f)(1) 13
The’’; and 14
(2) by adding at the end the following: 15
‘‘(2)(A) If a person is registered to conduct research 16
with a controlled substance and applies for a registration, 17
or for a modification of a registration, to conduct research 18
with a second controlled substance that is in the same 19
schedule as the first controlled substance, or is in a sched-20
ule with a higher numerical designation than the schedule 21
of the first controlled substance, a new inspection by the 22
Attorney General of the registered location is not required. 23
‘‘(B) Nothing in subparagraph (A) shall prohibit the 24
Attorney General from conducting an inspection that the 25
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Attorney General determines necessary to ensure that a 1
registrant maintains effective controls against diversion.’’. 2
(e) C
ONTINUATION OF RESEARCH ONSUBSTANCES 3
N
EWLYADDED TOSCHEDULEI.—Section 302 of the 4
Controlled Substances Act (21 U.S.C. 822) is amended 5
by adding at the end the following: 6
‘‘(h) C
ONTINUATION OFRESEARCH ONSUBSTANCES 7
N
EWLYADDED TOSCHEDULEI.—If a person is con-8
ducting research on a substance when the substance is 9
added to schedule I, and the person is already registered 10
to conduct research with a controlled substance in sched-11
ule I— 12
‘‘(1) not later than 90 days after the scheduling 13
of the newly scheduled substance, the person shall 14
submit a completed application for registration or 15
modification of existing registration, to conduct re-16
search on the substance, in accordance with regula-17
tions issued by the Attorney General for purposes of 18
this paragraph; 19
‘‘(2) the person may, notwithstanding sub-20
sections (a) and (b), continue to conduct the re-21
search on the substance until— 22
‘‘(A) the person withdraws the application 23
described in paragraph (1) of this subsection; 24
or 25
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‘‘(B) the Attorney General serves on the 1
person an order to show cause proposing the 2
denial of the application under section 304(c); 3
‘‘(3) if the Attorney General serves an order to 4
show cause as described in paragraph (2)(B) and 5
the person requests a hearing, the hearing shall be 6
held on an expedited basis and not later than 45 7
days after the request is made, except that the hear-8
ing may be held at a later time if so requested by 9
the person; and 10
‘‘(4) if the person sends a copy of the applica-11
tion described in paragraph (1) to a manufacturer or 12
distributor of the substance, receipt of the copy by 13
the manufacturer or distributor shall constitute suf-14
ficient evidence that the person is authorized to re-15
ceive the substance.’’. 16
(f) T
REATMENT OF CERTAINMANUFACTURING AC-17
TIVITIES ASCOINCIDENT TORESEARCH.—Section 302 of 18
the Controlled Substances Act (21 U.S.C. 822), as amend-19
ed by subsection (e), is amended by adding at the end 20
the following: 21
‘‘(i) T
REATMENT OFCERTAINMANUFACTURINGAC-22
TIVITIES ASCOINCIDENT TORESEARCH.— 23
‘‘(1) I
N GENERAL.—Except as provided in para-24
graph (3), a person who is registered to perform re-25
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search on a controlled substance may perform manu-1
facturing activities with small quantities of that sub-2
stance, including activities described in paragraph 3
(2), without being required to obtain a manufac-4
turing registration, if— 5
‘‘(A) the activities are performed for the 6
purpose of the research; and 7
‘‘(B) the activities and the quantities of 8
the substance involved in the activities are stat-9
ed in— 10
‘‘(i) a notification submitted to the 11
Attorney General under section 303(l); 12
‘‘(ii) a research protocol filed with an 13
application for registration approval under 14
section 303(f); or 15
‘‘(iii) a notification to the Attorney 16
General that includes— 17
‘‘(I) the name of the registrant; 18
and 19
‘‘(II) an attestation that the re-20
search to be conducted with the small 21
quantities of manufactured substance 22
is consistent with the scope of the re-23
search that is the basis for the reg-24
istration. 25
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‘‘(2) ACTIVITIES INCLUDED.—Activities per-1
mitted under paragraph (1) include— 2
‘‘(A) processing the substance to create ex-3
tracts, tinctures, oils, solutions, derivatives, or 4
other forms of the substance consistent with— 5
‘‘(i) the information provided as part 6
of a notification submitted to the Attorney 7
General under section 303(l); or 8
‘‘(ii) a research protocol filed with an 9
application for registration approval under 10
section 303(f); and 11
‘‘(B) dosage form development studies per-12
formed for the purpose of requesting an inves-13
tigational new drug exemption under section 14
505(i) of the Federal Food, Drug, and Cos-15
metic Act (21 U.S.C. 355(i)). 16
‘‘(3) E
XCEPTION REGARDING MARIHUANA .— 17
The authority under paragraph (1) to manufacture 18
substances does not include the authority to grow 19
marihuana.’’. 20
(g) T
RANSPARENCY REGARDINGSPECIALPROCE-21
DURES.—Section 303 of the Controlled Substances Act 22
(21 U.S.C. 823), as amended by subsection (a), is amend-23
ed by adding at the end the following: 24
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‘‘(n) TRANSPARENCY REGARDINGSPECIALPROCE-1
DURES.— 2
‘‘(1) I
N GENERAL.—If the Attorney General de-3
termines, with respect to a controlled substance, that 4
an application by a practitioner to conduct research 5
with the substance should be considered under a 6
process, or subject to criteria, different from the 7
process or criteria applicable to applications to con-8
duct research with other controlled substances in the 9
same schedule, the Attorney General shall make 10
public, including by posting on the website of the 11
Drug Enforcement Administration— 12
‘‘(A) the identities of all substances for 13
which such determinations have been made; 14
‘‘(B) the process and criteria that shall be 15
applied to applications to conduct research with 16
those substances; and 17
‘‘(C) how the process and criteria described 18
in subparagraph (B) differ from the process 19
and criteria applicable to applications to con-20
duct research with other controlled substances 21
in the same schedule. 22
‘‘(2) T
IMING OF POSTING.—The Attorney Gen-23
eral shall make information described in paragraph 24
(1) public upon making a determination described in 25
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that paragraph, regardless of whether a practitioner 1
has submitted such an application at that time.’’. 2
SEC. 4. RULEMAKING. 3
(a) I
NTERIMFINALRULES.—The Attorney Gen-4
eral— 5
(1) shall, not later than 1 year of the date of 6
enactment of this Act, issue rules to implement this 7
Act and the amendments made by this Act; and 8
(2) may issue the rules under paragraph (1) as 9
interim final rules. 10
(b) P
ROCEDURE FORFINALRULE.— 11
(1) E
FFECTIVENESS OF INTERIM FINAL 12
RULES.—A rule issued by the Attorney General as 13
an interim final rule under subsection (a) shall be-14
come immediately effective as an interim final rule 15
without requiring the Attorney General to dem-16
onstrate good cause therefor, notwithstanding sub-17
paragraph (B) of section 553(b) of title 5, United 18
States Code. 19
(2) O
PPORTUNITY FOR COMMENT AND HEAR -20
ING.—An interim final rule issued under subsection 21
(a) shall give interested persons the opportunity to 22
comment and to request a hearing. 23
(3) F
INAL RULE.—After the conclusion of such 24
proceedings, the Attorney General shall issue a final 25
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rule to implement this Act and the amendments 1
made by this Act in accordance with section 553 of 2
title 5, United States Code. 3
Æ
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