[Congressional Record Volume 171, Number 44 (Monday, March 10, 2025)]
[Senate]
[Pages S1637-S1638]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
SA 1242. Mr. COONS submitted an amendment intended to be proposed by
him to the bill S. 331, to amend the Controlled Substances Act with
respect to the scheduling of fentanyl-related substances, and for other
purposes; which was ordered to lie on the table; as follows:
At the appropriate place, insert the following:
SEC. ___. REMOVAL FROM SCHEDULE I 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:
``(k) Removal From Schedule I of Fentanyl-related
Substances.--
``(1) Determination resulting in removal from all
schedules.--If the Secretary determines, taking into
consideration the factors set forth in paragraph (3), that a
fentanyl-related substance has a potential for abuse that is
less than the drugs or other substances in schedule V--
``(A) the Secretary shall submit to the Attorney General a
scientific and medical evaluation of that fentanyl-related
substance supporting that determination;
``(B) the Secretary shall submit any such evaluation and
determination in writing and include the bases therefor;
``(C) the scientific and medical matters contained in the
evaluation of the Secretary shall be binding on the Attorney
General; and
``(D) except as provided in paragraph (4), not later than
90 days after receiving such evaluation and determination,
the Attorney General shall issue an order removing such
fentanyl-related substance from the schedules under section
202.
``(2) Determination resulting in rescheduling.--If the
Secretary determines, taking into consideration the factors
set forth in paragraph (3), that a fentanyl-related substance
has a potential for abuse that is less than the drugs or
other substances in schedules I and II--
``(A) the Secretary shall submit to the Attorney General a
scientific and medical evaluation of that fentanyl-related
substance supporting that determination;
``(B) the Secretary shall submit any such evaluation and
determination in writing and include the bases therefor;
``(C) consistent with subsection (b), the scientific and
medical matters contained in the evaluation of the Secretary
shall be binding on the Attorney General; and
``(D) except as provided in paragraph (4), not later than
90 days after receiving such evaluation and determination,
the Attorney General shall issue an order removing such
fentanyl-related substance from schedule I and controlling
such substance under schedule III.
``(3) Evaluation factors.--
``(A) In general.--In making a determination under
paragraph (1) or (2), the Secretary--
``(i) shall consider the factor listed in paragraph (2) of
subsection (c), as established by the assessment described in
subparagraph (B) of this paragraph;
``(ii) shall consider the factors listed in paragraphs (1),
(3), and (6) of subsection (c); and
``(iii) may consider the factors listed in paragraphs (4),
(5), and (7) of subsection (c) if the Secretary finds that
evidence exists with respect to those factors.
``(B) Consideration of scientific evidence of
pharmacological effect.--
``(i) In general.--For the purposes of subparagraph (A)(i),
consideration by the Secretary of the results of an
assessment consisting of the studies described in clause (ii)
of this subparagraph shall only suffice to constitute
consideration of the factor listed in paragraph (2) of
subsection (c) if--
``(I) each such study is performed according to scientific
methods and protocols commonly accepted in the scientific
community; and
``(II) the Secretary determines that such assessment is
adequate for such purposes.
``(ii) Described studies.--The studies described in this
clause include the following:
``(I) One or more receptor binding studies that can--
``(aa) demonstrate whether the substance has affinity for
the human mu opioid receptor and assess the duration and
intensity of the binding; and
``(bb) establish displacement by antagonists such as
naloxone.
``(II) One or more in vitro functional assays that can
demonstrate whether the substance has agonist activity at the
human mu opioid receptor.
``(III) One or more in vivo animal behavioral studies that
can demonstrate whether the substance has abuse-related drug
effects consistent with mu opioid agonist activity, such as
demonstrating similarity to the effects of morphine.
``(iii) Guidance.--Not later than 90 days after the date of
enactment of the Halt All Lethal Trafficking of Fentanyl Act,
the Secretary shall publish guidance describing the
parameters for studies that meet the criteria established
under clause (ii).
``(4) Attorney general review.--
``(A) In general.--Notwithstanding a determination by the
Secretary resulting in removal or rescheduling under
paragraph (1) or (2), the Attorney General may not issue an
order of removal or rescheduling if, not later than 90 days
after receiving the applicable evaluation and determination
from the Secretary, the Attorney General finds under the
processes described in subsection (h) that maintaining the
scheduling of the substance is necessary to avoid an imminent
hazard to the public safety.
``(B) Temporary scheduling.--Upon a finding under
subparagraph (A), the substance shall be deemed temporarily
scheduled for the time period described in subsection (h)(2),
which may be extended as provided in that subsection.
``(C) Expiration of temporary scheduling.--Not later than
30 days after the expiration of the time period described in
subparagraph (B) and any extension thereof as described in
that subparagraph, the Attorney General shall issue an order
to remove or reschedule the substance pursuant to the
Secretary's determination unless the substance has otherwise
been scheduled under the processes described in this section.
``(5) Notice from secretary to attorney general.--
``(A) Notice of initiation of proceedings.--Not later than
30 days after the date on which the Secretary initiates
proceedings to evaluate a substance under paragraph (1) or
(2), the Secretary shall notify the Attorney General of the
initiation of the proceedings.
``(B) Advance notice regarding evaluation and conclusion.--
Not later than 30 days before the date on which the Secretary
sends the Attorney General an evaluation and determination
under paragraph (1) or (2), the Secretary shall notify the
Attorney General with respect to the evaluation and
determination.
``(6) Exception for treaty obligations.--If a fentanyl-
related substance is a substance that the United States is
obligated to control under international treaties,
conventions, or protocols in effect on the date of enactment
of the Halt All Lethal Trafficking of Fentanyl Act, this
subsection shall not require the Attorney General--
``(A) to remove such substance from control; or
``(B) to place such substance in a schedule less
restrictive than that which the Attorney General determines
is necessary to carry out such obligations.
``(7) Identification of fentanyl-related substances.--If
the Attorney General determines that a substance is a
fentanyl-related substance, the Attorney General shall--
``(A) not later than 30 days after the date of such
determination, notify the Secretary;
``(B) include in such notification the identity of the
substance, its structure, and the basis for the
determination; and
``(C) as soon as practicable, publish in the Federal
Register an updated list under subsection (e)(4) of schedule
I that includes the fentanyl-related substance, unless good
cause exists not to do so.
``(8) Petitions for transferring a fentanyl-related
substance under the drug schedules.--
[[Page S1638]]
``(A) In general.--If a person petitions the Attorney
General to remove a fentanyl-related substance from schedule
I, to reschedule a fentanyl-related substance to another
schedule, or to place a fentanyl-related substance under
schedule I, the Attorney General shall consider such a
petition in accordance with the procedures and standards set
forth in--
``(i) subsections (a) and (b) of this section; and
``(ii) section 1308.43 of title 21, Code of Federal
Regulations (or any successor regulation).
``(B) Attorney general to inform secretary.--Not later than
30 days after the date of accepting a petition described in
subparagraph (A), the Attorney General shall forward a copy
of the petition to the Secretary.
``(C) Determination procedure not precluded by filing of
petition.--The filing of a petition described in this
paragraph shall not preclude the Secretary from making a
determination and sending an evaluation under paragraph (1)
or (2).
``(9) Rules of construction.--Nothing in this subsection
shall be construed to preclude the Attorney General from--
``(A) 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
and section 202; or
``(B) transferring a fentanyl-related substance from a
schedule other than schedule I to schedule I if information
supports such a transfer.
``(10) Subsequent controlling of removed substance.--A
substance removed from schedule I pursuant to this subsection
may, at any time, be controlled pursuant to the other
provisions of this section and section 202 without regard to
the removal pursuant to this subsection.
``(11) Evaluations or studies.--The Secretary may enter
into contracts or other agreements to conduct or support
evaluations or studies of fentanyl-related substances.
``(12) Annual review by secretary.--
``(A) In general.--Not less frequently than annually, the
Secretary shall review fentanyl-related substances identified
under paragraph (7), including a review of available evidence
and any analysis or data in the possession of the Attorney
General with regard to those substances.
``(B) Evaluation for removal or rescheduling.--In carrying
out subparagraph (A), if the Secretary determines, with
respect to a fentanyl-related substance, that removing the
fentanyl-related substance from the schedules under section
202 or rescheduling the fentanyl-related substance may be
appropriate, the Secretary shall evaluate the fentanyl-
related substance for potential removal or rescheduling under
paragraphs (1) and (2).''.
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