[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 5167 Introduced in Senate (IS)]
<DOC>
117th CONGRESS
2d Session
S. 5167
To extend the temporary order for fentanyl-related substances.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
December 1, 2022
Mr. Booker introduced the following bill; which was read twice and
referred to the Committee on the Judiciary
_______________________________________________________________________
A BILL
To extend the temporary order for fentanyl-related 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 ``Temporary Emergency Scheduling and
Testing of Fentanyl Analogues Act of 2022'' or the ``TEST Act of
2022''.
SEC. 2. DEFINITIONS.
In this Act:
(1) Evaluation.--The term ``evaluation'' means a scientific
and medical evaluation, as conducted by the Secretary of Health
and Human Services at the request of the Attorney General, and
the recommendations as to whether such drug or other substance
should be so controlled or removed as a controlled substance
from the schedules pursuant to section 201(b) of the Controlled
Substances Act (21 U.S.C. 811(b)).
(2) Fentanyl-related substance.--The term ``fentanyl-
related substance'' has the meaning given the term in section
1308.11 of title 21, Code of Federal Regulations.
SEC. 3. EXTENSION OF TEMPORARY ORDER FOR FENTANYL-RELATED SUBSTANCES.
Section 2 of the Temporary Reauthorization and Study of the
Emergency Scheduling of Fentanyl Analogues Act (Public Law 116-114; 134
Stat. 103) is amended by striking ``December 31, 2022'' and inserting
``2 years after the date of enactment of the Temporary Emergency
Scheduling and Testing of Fentanyl Analogues Act of 2022''.
SEC. 4. EVALUATION OF ENCOUNTERED FENTANYL-RELATED SUBSTANCES.
(a) Synthetic Compound.--Not later than 1 year after the date of
enactment of this Act, for each fentanyl-related substance that the
Attorney General has encountered before the date of enactment of this
Act, but not yet conducted an evaluation, the Attorney General shall
create a synthetic compound of that substance and submit the compound
to the Secretary of Health and Human Services in order to solicit a
scientific and medical evaluation of that compound from the Secretary.
(b) Deadline.--
(1) In general.--Except as provided in paragraph (2), the
Secretary of Health and Human Services shall complete the
requested scientific and medical evaluation under subsection
(a) not later than 1 year after receiving the solicitation from
the Attorney General.
(2) Extension.--If the Attorney General is unable to create
a synthetic compound before the expiration of the 1-year period
described in paragraph (1)--
(A) the Attorney General shall--
(i) notify the Committee on the Judiciary
of the Senate and the Committee on the
Judiciary of the House of Representatives of
the delay and publish the notification on a
public website; and
(ii) complete the requirements under
subsection (a) not later than 180 days after
the expiration of the 1-year period.
SEC. 5. 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 new subsection:
``(k) Determination Resulting in Removal.--
``(1) In general.--If the Secretary determines, taking into
consideration factors as 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 determination of
the Secretary contained in such evaluation shall be
binding on the Attorney General; and
``(D) 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 factors as 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) the scientific and medical determination of
the Secretary contained in such evaluation shall be
binding on the Attorney General; and
``(D) not later than 90 days after receiving such
evaluation, the Attorney General shall issue an order
removing such fentanyl-related substance from schedule
I and controlling such substance under schedule III, IV
or V.
``(3) Evaluation factors.--
``(A) In general.--In making a determination under
paragraph (1) or (2), the Secretary--
``(i) shall consider--
``(I) the factor listed in
paragraph (2) of subsection (c);
``(II) the factors listed in
paragraphs (1), (3), and (6) of such
subsection to the extent evidence
exists with respect to such factors;
and
``(III) any information submitted
to the Secretary by the Attorney
General for purposes of such
determination; and
``(ii) may consider the factors listed in
paragraphs (4), (5), and (7) of subsection (c)
if the Secretary finds that evidence exists
with respect to such factors.
``(B) Consideration of scientific evidence of
pharmacological effect.--
``(i) In general.--For the purposes of
subparagraph (A)(i)(I), consideration by the
Secretary of the results of an assessment
consisting of the studies described in clause
(ii) shall 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 are any of the
following:
``(I) A receptor binding study that
can demonstrate whether the substance
has affinity for the human mu opioid
receptor.
``(II) An in vitro functional assay
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.
``(l) Previously Analyzed Fentanyl-Related Substances.--To the
extent that the Drug Enforcement Administration or the Department of
Health and Human Services has conducted any evaluation or analysis
(even if such analysis is not an evaluation under this section) of any
fentanyl-related substance before the date of the enactment of this
subsection, the Attorney General shall publish the results and any
other information related to the evaluation or analysis on a public
website not later than 90 days after the date of enactment of this
subsection.
``(m) Fentanyl-Related Substances Research Capacity.--The Drug
Enforcement Administration and Department of Health and Human Services
shall hire, employ, or retain the staff, researchers, and other
qualified individuals necessary to carry out the requirements of
paragraphs (1) and (2) of subsection (k), including, if appropriate to
fulfill those requirements, establishing a consortium of chemists and
researchers who may be readily hired, employed, or retrained without a
request for proposals.
``(n) Evaluations or Studies.--The Secretary may enter into
contracts or other agreements to conduct or support evaluations or
studies of fentanyl-related substances.
``(o) Registration Requirements for Research Applications.--
Registration requirements for the research of fentanyl-related
substances shall be those applicable to schedule II substances pursuant
to section 1301.13 of title 21, Code of Federal Regulations.
``(p) Publication.--The Secretary shall publish on a public
website--
``(1) each evaluation conducted pursuant to an Attorney
General solicitation within 60 days of the completion of the
scientific and medical evaluation, even if such evaluation did
not result in a descheduling or rescheduling determination; and
``(2) the results and any other information related to
previously evaluated fentanyl-related services pursuant to
subsection (l).
``(q) Authorization of Appropriations.--There is authorized to be
appropriated to the Secretary $50,000,000 for fiscal years 2023 and
2024, to remain available until expended, for the evaluation fentanyl-
related substances pursuant to section 3 of the Temporary Emergency
Scheduling and Testing of Fentanyl Analogues Act of 2022.''.
SEC. 6. NOTIFICATION.
The Attorney General shall notify each individual who is the
subject of a pending prosecution for, or has been convicted or
sentenced for, an offense involving a fentanyl-related substance that
is subsequently removed or rescheduled under paragraphs (1) and (2) of
section 201(k) of the Controlled Substances Act, as added by section 5
of this Act, about the change in schedule designation not later than 90
days after the change, and provide information about the effect of the
change on their prosecution, conviction, or sentence.
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