Title: Stop the Importation and Manufacturing of Synthetic Analogues Act of 2021
Policy area: Crime and Law Enforcement

Summary:
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.
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