Stop the Importation and Manufacturing of Synthetic Analogues Act of 2021 or SIMSA
This bill establishes a process and requirements for regulating substances that have a similar chemical structure and actual or predicted effect as a controlled substance that is currently subject to such regulation because of its potential for abuse or dependence.
[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4459 Introduced in House (IH)]
<DOC>
117th CONGRESS
1st Session
H. R. 4459
To amend the Controlled Substances Act to clarify how controlled
substance analogues that are imported or offered for import are to be
regulated, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
July 16, 2021
Mr. Katko (for himself and Miss Rice of New York) 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 clarify how controlled
substance analogues that are imported or offered for import are to be
regulated, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Stop the
Importation and Manufacturing of Synthetic Analogues Act of 2021'' or
``SIMSA''.
(b) Table of Contents.--The table of contents of this Act is as
follows:
Sec. 1. Short title; table of contents.
Sec. 2. Establishment of schedule A.
Sec. 3. Temporary and permanent scheduling of schedule A substances.
Sec. 4. Penalties.
Sec. 5. False labeling of schedule A controlled substances.
Sec. 6. Registration requirements for schedule A substances.
Sec. 7. Additional conforming amendments.
Sec. 8. Sentencing review.
Sec. 9. Rules of construction.
SEC. 2. ESTABLISHMENT OF SCHEDULE A.
Section 202 of the Controlled Substances Act (21 U.S.C. 812) is
amended--
(1) in subsection (a), by striking ``five schedules of
controlled substances, to be known as schedules I, II, III, IV,
and V'' and inserting ``six schedules of controlled substances,
to be known as schedules I, II, III, IV, V, and A'';
(2) in subsection (b), by adding at the end the following:
``(6) Schedule A.--
``(A) In general.--The drug or substance--
``(i) is or has been imported, or is offered for
import, into the United States;
``(ii) has--
``(I) a chemical structure that is
substantially similar to the chemical structure
of a controlled substance in schedule I, II,
III, IV, or V; and
``(II) an actual or predicted stimulant,
depressant, or hallucinogenic effect on the
central nervous system that is substantially
similar to or greater than the stimulant,
depressant, or hallucinogenic effect on the
central nervous system of a controlled
substance in schedule I, II, III, IV, or V; and
``(iii) is not--
``(I) listed or otherwise included in any
other schedule in this section or by regulation
of the Attorney General; and
``(II) with respect to a particular person,
subject to an exemption that is in effect for
investigational use, for that person, under
section 505 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355) to the extent
conduct with respect to such substance is
pursuant to such exemption.
``(B) Predicted stimulant, depressant, or hallucinogenic
effect.--For purpose of this paragraph, a predicted stimulant,
depressant, or hallucinogenic effect on the central nervous
system may be based on--
``(i)(I) the chemical structure; and
``(II)(aa) the structure activity relationships; or
``(bb) binding receptor assays and other relevant
scientific information about the substance;
``(ii)(I) the current or relative potential for
abuse of the substance; and
``(II) the clandestine importation, manufacture, or
distribution, or diversion from legitimate channels, of
the substance; or
``(iii) the capacity of the substance to cause a
state of dependence, including physical or
psychological dependence that is similar to or greater
than that of a controlled substance in schedule I, II,
III, IV, or V.''; and
(3) in subsection (c)--
(A) in the matter preceding schedule I, by striking
``IV, and V'' and inserting ``IV, V, and A''; and
(B) by adding at the end the following:
``schedule a
``Any substance temporarily or permanently scheduled by the
Attorney General in accordance with section 201(k).''.
SEC. 3. TEMPORARY AND PERMANENT SCHEDULING OF SCHEDULE A SUBSTANCES.
Section 201 of the Controlled Substances Act (21 U.S.C. 811) is
amended by adding at the end the following:
``(k) Temporary and Permanent Scheduling of Schedule A
Substances.--
``(1) In general.--The Attorney General may issue a
temporary order adding a drug or substance to schedule A if the
Attorney General finds that--
``(A) the drug or other substance satisfies the
criteria for being considered a schedule A substance;
and
``(B) adding such drug or substance to schedule A
will assist in preventing abuse of the drug or other
substance.
``(2) Duration of temporary scheduling order.--A temporary
scheduling order issued under paragraph (1) shall--
``(A) not take effect until 30 days after the date
of the publication by the Attorney General of a notice
in the Federal Register of the intention to issue such
order and the grounds upon which such order is to be
issued; and
``(B) expire not later than 5 years after the date
on which the order becomes effective, except that the
Attorney General may, during the pendency of
proceedings under paragraph (5), extend the temporary
scheduling order for up to 180 days.
``(3) Effect of issuance of permanent scheduling order.--A
temporary scheduling order issued under paragraph (1) shall be
vacated upon the issuance of a permanent order issued under
paragraph (5) with regard to the same substance, or upon the
subsequent issuance of any scheduling order under this section.
``(4) Limitation on judicial review.--A temporary
scheduling order issued under paragraph (1) shall not be
subject to judicial review.
``(5) Permanent scheduling order.--
``(A) In general.--Except as provided in
subparagraph (B), not earlier than 3 years after the
date on which the Attorney General issues an order
temporarily scheduling a drug or substance under this
subsection, the Attorney General may, by rule, issue a
permanent order adding the drug or other substance to
schedule A if such drug or substance satisfies the
criteria for being considered a schedule A substance.
``(B) Limitation.--If the Secretary of Health and
Human Services has determined, based on relevant
scientific studies and necessary data requested by the
Secretary of Health and Human Services and gathered by
the Attorney General, that a drug or other substance
that has been temporarily placed in schedule A does not
have sufficient potential for abuse to warrant control
in any schedule, and provides written notice of such
determination to the Attorney General, the Attorney
General--
``(i) may not issue a permanent scheduling
order under subparagraph (A); and
``(ii) not later than 30 days after the
date on which the Attorney General receives
such notice, shall issue an order immediately
terminating the temporary scheduling order for
the drug or other substance.
``(6) Notice to hhs.--Before initiating proceedings under
paragraph (1), the Attorney General shall transmit notice of a
temporary order proposed to be issued to the Secretary of
Health and Human Services. In issuing an order under paragraph
(1), the Attorney General shall take into consideration any
comments submitted by the Secretary of Health and Human
Services in response to a notice transmitted pursuant to this
paragraph.''.
SEC. 4. PENALTIES.
Section 1010 of the Controlled Substances Import and Export Act (21
U.S.C. 960) is amended--
(1) in subsection (a), by inserting ``or a drug or
substance in schedule A'' after ``controlled substance'' each
place it appears; and
(2) in subsection (b), by adding at the end the following:
``(8) In the case of a violation under subsection (a) involving a
controlled substance in schedule A, the person committing such
violation shall be sentenced to a term of imprisonment of not more than
20 years and if death or serious bodily injury results from the use of
such substance shall be sentenced to a term of imprisonment for any
term of years or for life, a fine not to exceed the greater of that
authorized in accordance with the provisions of title 18, United States
Code, or $1,000,000 if the defendant is an individual or $5,000,000 if
the defendant is other than an individual, or both. If any person
commits such a violation after a prior conviction for a felony drug
offense has become final, such person shall be sentenced to a term of
imprisonment of not more than 30 years and if death or serious bodily
injury results from the use of such substance shall be sentenced to a
term of imprisonment for any term of years or for life, a fine not to
exceed the greater of twice that authorized in accordance with the
provisions of title 18, United States Code, or $2,000,000 if the
defendant is an individual or $10,000,000 if the defendant is other
than an individual, or both. Notwithstanding section 3583 of title 18,
United States Code, any sentence imposing a term of imprisonment under
this paragraph shall, in the absence of such a prior conviction, impose
a term of supervised release of not less than 3 years in addition to
such term of imprisonment and shall, if there was such a prior
conviction, impose a term of supervised release of not less than 6
years in addition to such term of imprisonment. Notwithstanding the
prior sentence, and notwithstanding any other provision of law, the
court shall not place on probation or suspend the sentence of any
person sentenced under the provisions of this paragraph which provide
for a mandatory term of imprisonment if death or serious bodily injury
results.''.
SEC. 5. FALSE LABELING OF SCHEDULE A CONTROLLED SUBSTANCES.
(a) In General.--Section 305 of the Controlled Substances Act (21
U.S.C. 825) is amended by adding at the end the following:
``(f) False Labeling of Schedule A Controlled Substances.--
``(1) It shall be unlawful to import or export, with intent
to manufacture, distribute, or dispense, a schedule A substance
or product containing a schedule A substance, unless the
substance or product bears a label clearly identifying a
schedule A substance or product containing a schedule A
substance by the nomenclature used by the International Union
of Pure and Applied Chemistry (IUPAC).
``(2)(A) A product described in subparagraph (B) is exempt
from the International Union of Pure and Applied Chemistry
nomenclature requirement of this subsection if such product is
labeled in the manner required under the Federal Food, Drug,
and Cosmetic Act.
``(B) A product is described in this subparagraph if the
product--
``(i) is the subject of an approved application as
described in section 505(b) or (j) of the Federal Food,
Drug, and Cosmetic Act; or
``(ii) is exempt from the provisions of section 505
of such Act relating to new drugs because--
``(I) it is intended solely for
investigational use as described in section
505(i) of such Act; and
``(II) such product is being used
exclusively for purposes of a clinical trial
that is the subject of an effective
investigational new drug application.''.
(b) Penalties.--Section 402 of the Controlled Substances Act (21
U.S.C. 842) is amended--
(1) in subsection (a)--
(A) in paragraph (16), by striking ``or'' at the
end;
(B) by redesignating paragraph (17) as paragraph
(18); and
(C) by inserting after paragraph (16) the
following:
``(17) to violate section 305(f); or''; and
(2) in subsection (c)--
(A) in paragraph (1)--
(i) in subparagraph (B)(i), by striking
``(17)'' and inserting ``(18)''; and
(ii) in subparagraph (C), by inserting ``or
(17)'' after ``paragraph (16)'' each place it
appears; and
(B) in paragraph (2)(D), by striking ``(17)'' and
inserting ``(18)''.
SEC. 6. REGISTRATION REQUIREMENTS FOR SCHEDULE A SUBSTANCES.
(a) Registration Requirements for Importers and Exporters of
Schedule A Substances.--Section 1008 of the Controlled Substances
Import and Export Act (21 U.S.C. 958) is amended by adding at the end
the following:
``(j)(1) The Attorney General shall register an applicant to import
or export a schedule A substance if--
``(A) the applicant demonstrates that the schedule A
substance will be used for research, analytical, or industrial
purposes approved by the Attorney General; and
``(B) the Attorney General determines that such
registration is consistent with the public interest and with
the United States obligations under international treaties,
conventions, or protocols in effect on the date of enactment of
this subsection.
``(2) In determining the public interest under paragraph (1)(B),
the Attorney General shall consider--
``(A) maintenance of effective controls against diversion
of particular controlled substances and any controlled
substance in schedule A compounded therefrom into other than
legitimate medical, scientific, research, or industrial
channels, by limiting the importation and bulk manufacture of
such controlled substances to a number of establishments which
can produce an adequate and uninterrupted supply of these
substances under adequately competitive conditions for
legitimate medical, scientific, research, and industrial
purposes;
``(B) compliance with applicable State and local law;
``(C) promotion of technical advances in the art of
manufacturing substances described in subparagraph (A) and the
development of new substances;
``(D) prior conviction record of applicant under Federal
and State laws relating to the importation, manufacture,
distribution, or dispensing of substances described in
subparagraph (A);
``(E) past experience in the importation and manufacture of
controlled substances, and the existence in the establishment
of effective control against diversion; and
``(F) such other factors as may be relevant to and
consistent with the public health and safety.
``(3) If an applicant is registered to import or export a
controlled substance in schedule I or II under subsection (a), the
applicant shall not be required to apply for a separate registration
under this subsection.''.
(b) Continuation of Research on Substances Newly Added to Schedule
A.--Section 302(e) of the Controlled Substances Act (21 U.S.C. 822(e))
is amended by adding at the end the following:
``(3)(A) If a person is conducting research on a substance at the
time the substance is added to schedule A, and such person is already
registered to conduct research with a controlled substance in schedule
I or II, then--
``(i) the person shall, within 30 days of the scheduling of
the newly scheduled substance, submit a completed application
for registration or modification of existing registration, to
conduct research on such substance, in accordance with the
regulations issued by the Attorney General;
``(ii) the person may continue to conduct the research on
such substance until the application described in clause (i) is
withdrawn by the applicant or until the Attorney General serves
on the applicant an order to show cause proposing the denial of
the application pursuant to section 304(c); and
``(iii) if the Attorney General serves order to show cause
under clause (ii) and the applicant requests a hearing, such
hearing shall be held on an expedited basis and not later than
45 days after the request is made, except that the hearing may
be held at a later time if so requested by the applicant.
``(B) A person who is registered to conduct research with a
controlled substance in schedule A may conduct research with another
controlled substance in schedule I, only if--
``(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; and
``(iii) the Attorney General has determined, not later than
30 days after receiving the application described in clause
(i), that such activity is consistent with United States
obligations under the Single Convention on Narcotic Drugs,
1961.
``(C) Nothing in this paragraph 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.''.
SEC. 7. ADDITIONAL CONFORMING AMENDMENTS.
The Controlled Substances Import and Export Act (21 U.S.C. 951 et
seq.) is amended--
(1) in section 1002(a) (21 U.S.C. 952(a))--
(A) in the matter preceding paragraph (1), by
inserting ``or drug or substance in schedule A'' after
``schedule I or II''; and
(B) in paragraph (2), by inserting ``or drug or
substances in schedule A'' after ``schedule I or II'';
(2) in section 1003 (21 U.S.C. 953)--
(A) in subsection (c), in the matter preceding
paragraph (1), by inserting ``or drug or substance in
schedule A'' after ``schedule I or II''; and
(B) in subsection (d), by inserting ``or drug or
substance in schedule A'' after ``schedule I or II'';
(3) in section 1004(1) (21 U.S.C. 954(1)), in the matter
preceding subparagraph (A), by inserting ``or drug or substance
in schedule A'' after ``schedule I'';
(4) in section 1005 (21 U.S.C. 955), by inserting ``or drug
or substance in schedule A'' after ``schedule I or II''; and
(5) in section 1009(a) (21 U.S.C. 959(a)), by inserting
``or drug or substance in schedule A'' after ``schedule I or
II''.
SEC. 8. SENTENCING REVIEW.
(a) Covered Offense Defined.--In this section, the term ``covered
offense'' means an offense involving a schedule A substance for which
the penalty was established under section 4 or 5 of this Act.
(b) Sentencing Review.--
(1) Petition for review.--If a schedule A substance that is
temporarily or permanently scheduled under section 201(k) of
the Controlled Substances Act, as added by this Act, is
subsequently descheduled or rescheduled on a schedule with
lower penalties, any individual convicted of a covered offense
involving such schedule A substance who is awaiting sentencing
or is still serving a term of imprisonment for such covered
offense on the date of the descheduling or rescheduling may
petition the court that imposed the sentence for a sentencing
reduction hearing for such covered offense.
(2) Sentencing review.--Not later than 30 days after the
date on which a petition is filed under paragraph (1), the
court shall conduct a sentencing reduction hearing and may
modify the sentence of the petitioner as if the descheduling or
rescheduling described in paragraph (1) had been in effect on
the date the covered offense was committed.
SEC. 9. RULES OF CONSTRUCTION.
Nothing in this Act, or the amendments made by this Act, may be
construed to limit--
(1) the prosecution of offenses involving controlled
substance analogues under the Controlled Substances Act (21
U.S.C. 801 et seq.); or
(2) the authority of the Attorney General to temporarily or
permanently schedule, reschedule, or decontrol controlled
substances under provisions of section 201 of the Controlled
Substances Act (21 U.S.C. 811) that are in effect on the day
before the date of enactment of this Act.
<all>
Introduced in House
Introduced in House
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.
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.
Referred to the Subcommittee on Health.
Referred to the Subcommittee on Crime, Terrorism, and Homeland Security.
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