I 
116TH CONGRESS 
1ST SESSION H. R. 4963 
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 
OCTOBER 31, 2019 
Mr. KATKO (for himself, Miss RICE of New York, Mr. WALDEN, Mr. CORREA, 
and Mr. SOTO) 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 con-
trolled 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 Representa-
tives 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 2019’’ or ‘‘SIMSA’’. 
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(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 importers and exporters of 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 sub-
stantially similar to the chemical structure 
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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 sub-
stance 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 per-
son, subject to an exemption that is in ef-
fect 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 purposes of this 
paragraph, a predicted stimulant, depressant, or hal-
lucinogenic effect on the central nervous system may 
be based on— 
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‘‘(i)(I) the chemical structure; and 
‘‘(II)(aa) the structure activity relation-
ships; or 
‘‘(bb) binding receptor assays and other 
relevant scientific information about the sub-
stance; 
‘‘(ii)(I) the current or relative potential for 
abuse of the substance; and 
‘‘(II) the clandestine importation, manu-
facture, or distribution, or diversion from legiti-
mate 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 sched-
uled by the Attorney General in accordance with section 
201(k).’’. 
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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 fol-
lowing: 
‘‘(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 inten-
tion 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, 
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