[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1758 Introduced in House (IH)]
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118th CONGRESS
1st Session
H. R. 1758
To amend the Controlled Substances Act to list fentanyl-related
substances as schedule I controlled substances.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
March 23, 2023
Mr. Luetkemeyer (for himself, Mrs. Hinson, Mr. Bacon, Mr. DesJarlais,
and Mr. Ezell) 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 determined 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 to list fentanyl-related
substances as schedule I controlled substances.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Stopping Illicit Fentanyl
Trafficking Act of 2023'' or the ``SIFT Act of 2023''.
SEC. 2. FENTANYL-RELATED SUBSTANCES.
Section 202(c) of the Controlled Substances Act (21 U.S.C. 812) is
amended--
(1) by adding at the end of subsection (b) of Schedule I
the following:
``(23) Isobutyryl fentanyl.
``(24) Para-Methoxybutyrylfentanyl.
``(25) Valeryl fentanyl.
``(26) Cyclopentyl fentanyl.
``(27) Para-Chloroisobutyryl fentanyl.''; and
(2) by adding at the end of Schedule I the following:
``(e)(1) Unless specifically exempted or unless listed in another
schedule, any material, compound, mixture, or preparation which
contains any quantity of fentanyl-related substances, or which contains
their salts, isomers, and salts of isomers whenever the existence of
such salts, isomers, and salts of isomers is possible within the
specific chemical designation.
``(2) In paragraph (1), the term `fentanyl-related substances'
includes the following:
``(A) Any substance that is structurally related to
fentanyl by one or more of the following modifications:
``(i) By replacement of the phenyl portion of the
phenethyl group by any monocycle, whether or not
further substituted in or on the monocycle.
``(ii) By substitution in or on the phenethyl group
with alkyl, alkenyl, alkoxy, hydroxy, halo, haloalkyl,
amino or nitro groups.
``(iii) By substitution in or on the piperidine
ring with alkyl, alkenyl, alkoxy, ester, ether,
hydroxy, halo, haloalkyl, amino or nitro groups.
``(iv) By replacement of the aniline ring with any
aromatic monocycle whether or not further substituted
in or on the aromatic monocycle.
``(v) By replacement of the N-propionyl group by
another acyl group.
``(B) 4'-Methyl acetyl fentanyl.
``(C) Crotonyl fentanyl.
``(D) 2'-Fluoro ortho-fluorofentanyl.
``(E) Ortho-Methyl acetylfentanyl.
``(F) Thiofuranyl fentanyl.
``(G) Ortho-Fluorobutyryl fentanyl.
``(H) Ortho-Fluoroacryl fentanyl.
``(I) Beta-Methyl fentanyl.
``(J) Phenyl fentanyl.
``(K) Para-Methylfentanyl.
``(L) Beta'-Phenyl fentanyl.
``(M) Benzodioxole fentanyl.''.
SEC. 3. REMOVAL FROM SCHEDULE I(E) OF FENTANYL-RELATED SUBSTANCES.
Section 201 of the Controlled Substances Act (21 U.S.C. 811) is
amended by adding at the end the following new subsection:
``(k)(1) If the Secretary finds, based on the factors specified in
paragraph (4), that a substance listed in schedule I(e) has no
potential for abuse, the Secretary shall--
``(A) notify the Attorney General at least 90 days prior to
submitting an evaluation scientific and medical evaluation of
that substance supporting that conclusion; and
``(B) submit to the Attorney General such evaluation and
conclusion that--
``(i) is in writing; and
``(ii) includes the bases for such conclusion.
``(2) Not later than 90 days after the receipt of such evaluation
and conclusion, the Attorney General shall issue an order removing such
substance from the schedule.
``(3)(A) If the Secretary finds, based on the factors specified in
paragraph (4), that a substance listed in schedule I(e) does not meet
the requirements for inclusion in that schedule, and that the substance
has a low potential for abuse, the Secretary shall submit to the
Attorney General a scientific and medical evaluation of that substance
supporting those conclusions that is in writing and that includes the
bases for that conclusion.
``(B) Within 180 days of receipt of such evaluation and conclusion,
the Attorney General shall--
``(i) issue an order removing such substance from
scheduling for research purposes only; or
``(ii) notify the Secretary in writing that the Attorney
General declines to issue such an order.
``(4) In making the evaluation and conclusion described in
paragraph (1) or (3), the Secretary--
``(A) shall consider the factors specified in paragraphs
(1), (2), (3), and (6) of subsection (c) and any information
submitted to the Attorney General under paragraph (1) of this
subsection; and
``(B) may also consider factors specified in paragraphs
(4), (5), and (7) of subsection (c) if the Secretary finds that
reliable evidence exists with respect to such factors.
``(5) Nothing in this subsection shall preclude the Attorney
General from transferring a substance listed in schedule I to another
schedule, or removing such substance entirely from the schedules,
pursuant to other provisions of this section or section 202.
``(6) A substance removed from schedule I(e) pursuant to paragraph
(1) or (3) may, at any time, be controlled pursuant to the other
provisions of this section or section 202 without regard to that
removal.''.
SEC. 4. CLARIFICATION OF CERTAIN REGISTRATION REQUIREMENTS RELATED TO
RESEARCH.
(a) Exception for Agents or Employees of Registered Researchers.--
Section 302(c)(1) of the Controlled Substances Act (21 U.S.C.
822(c)(1)) is amended by striking ``or dispenser'' and inserting
``dispenser, or researcher''.
(b) Conforming Amendment.--Section 102(3) of the Controlled
Substances Act (21 U.S.C. 802(3)) is amended by striking ``or
dispenser'' and inserting ``dispenser, or researcher''.
(c) Single Registration for Contiguous Research Sites.--Section
302(e) of the Controlled Substances Act (21 U.S.C. 822(e)) is amended
by adding at the end the following new paragraph:
``(3) Notwithstanding paragraph (1), a person registered to conduct
research with a controlled substance under section 303(f) may conduct
such research under a single registration if such research occurs
exclusively on a single, contiguous campus and the registrant notifies
the Attorney General in writing of all sites on the campus where the
research will be conducted or where the controlled substance will be
stored or administered. If the registrant seeks to conduct such
research at additional sites, the registrant shall submit a new
notification before conducting such research at any such additional
sites.''.
(d) New Inspection Not Required in Certain Situations.--Section
303(f) of the Controlled Substances Act (21 U.S.C. 823(f)) is amended--
(1) by redesignating paragraphs (1) through (5) as
subparagraphs (A) through (E), respectively, and by moving the
margins of such subparagraphs (as so redesignated) two ems to
the right;
(2) by striking ``(f) The'' and inserting ``(f)(1) The'';
and
(3) by adding at the end the following new paragraph:
``(2)(A) If a person is registered to conduct research with a
controlled substance and applies to be registered, or to modify a
registration to conduct research with a second controlled substance
that is in the same schedule or in a schedule with a higher numerical
designation, a new inspection by the Attorney General of the registered
location is not required.
``(B) Nothing in this paragraph shall prohibit the Attorney General
from conducting any inspection if the Attorney General determines such
an inspection is necessary.''.
(e) Continuation of Research on Newly Added Substances; Authority
To Conduct Research With Other Substances.--Section 302 of the
Controlled Substances Act (21 U.S.C. 822), as amended by subsections
(a) and (c), is further amended by adding at the end the following new
subsection:
``(h)(1) In the case of a person who is conducting research on a
substance at the time the substance is added to schedule I and who is
already registered to conduct research with another controlled
substance in schedule I or II, the person--
``(A) within 30 days of the scheduling of such substance,
shall submit a completed application for registration or
modification of the existing registration of such person, to
conduct research on such substance, in accordance with the
regulations issued by the Attorney General; and
``(B) notwithstanding subsections (a) and (b), may continue
to conduct the research on such substance until the date on
which--
``(i) the application referred to in subparagraph
(A) is withdrawn by the applicant; or
``(ii) the Attorney General serves on the applicant
an order to show cause proposing the denial of the
application pursuant to section 304(c).
``(2) If the Attorney General serves an order to show cause under
paragraph (1)(B) and the applicant requests a hearing, such hearing
shall be held--
``(A) on an expedited basis; and
``(B) not later than 45 days after the request is made, or
such a later time as requested by the applicant.
``(3)(A) A person who is registered to conduct research with a
controlled substance in schedule I may, notwithstanding subsections (a)
and (b), conduct research with another controlled substance in schedule
I, if each of following conditions are met:
``(i) The person has applied for a modification of the
person's registration to authorize research with such other
controlled substance in accordance with the regulations issued
by the Attorney General.
``(ii) The Attorney General has obtained verification from
the Secretary that the research protocol submitted with the
application is meritorious.
``(iii) The Attorney General has determined under
subparagraph (B) that the conduct of such research is
consistent with United States obligations under the Single
Convention on Narcotic Drugs, 1961.
``(B) Not later than 30 days after receiving an application under
clause (i), the Attorney General shall determine whether the conduct of
research that is the subject of the application is consistent with
United States obligations under the Single Convention on Narcotic
Drugs, 1961.
``(C) Nothing in this section shall be construed to alter the
authority of the Attorney General to initiate proceedings to deny,
suspend, or revoke any registration in accordance with sections 303 and
304.''.
(f) Treatment of Certain Activities as Coincident to Research.--
Section 302 of the Controlled Substances Act (21 U.S.C. 822), as
amended by subsections (a), (c), and (e), is further amended by adding
at the end the following new subsection:
``(i) A person who is registered to perform research with a
controlled substance (other than marihuana) under this title may,
without being required to registered to manufacture such substance,
using small quantities of such substance, perform the following
activities:
``(1) Processing the substance to create extracts,
tinctures, oils, solutions, derivatives, or other forms of the
substance consistent with the approved research protocol.
``(2) Dosage form development for the purpose of satisfying
requirements with respect to the submission of an
investigational new drug application under section 505(i) of
the Federal Food, Drug, and Cosmetic Act.''.
SEC. 5. REVIEW OF RESEARCH REGISTRATION PROCESS.
(a) Review.--Not later than one year after the date of the
enactment of this section, the Attorney General and the Secretary of
Health and Human Services shall jointly conduct a review of the
processes used to register or modify a registration to conduct research
with controlled substances under the Controlled Substances Act (21
U.S.C. 801 et seq.), including--
(1) an evaluation of the impacts of the amendments made by
this Act on the risk of the diversion of controlled substances
used in research and related public safety considerations; and
(2) an identification of opportunities to reduce any
unnecessary burden on persons seeking registration, potential
redundancies, and inefficiencies in such processes, including--
(A) the process for obtaining a registration under
section 303 of the Controlled Substances Act (21 U.S.C.
823); and
(B) the process by which the Secretary reviews
research protocols submitted with respect to such
registration.
(b) Guidance.--Not later than 60 days after concluding the review
described in subsection (a), the Attorney General and the Secretary
shall, as appropriate, jointly issue guidance to registrants and
potential registrants clarifying the process for registration.
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