[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 1950 Introduced in Senate (IS)]
<DOC>
118th CONGRESS
1st Session
S. 1950
To extend the temporary order for fentanyl-related substances.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
June 13, 2023
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 2023'' or the ``TEST Act''.
SEC. 2. FINDINGS.
Congress finds the following:
(1) Passed in 1970, the Controlled Substances Act (21
U.S.C. 801 et seq.) created 5 schedules for controlled
substances. To schedule a substance, the Drug Enforcement
Administration must make a finding of the potential for abuse
and currently accepted medical use of the substance.
(2) Under section 201(b) of the Controlled Substances Act
(21 U.S.C. 811(b)), the Attorney General must request a
scheduling recommendation from the Secretary of Health and
Human Services based on an 8-factor medical and scientific
analysis.
(3) The Secretary is required to return a recommendation to
the Attorney General within a reasonable amount of time and the
recommendation shall be binding on the Attorney General as to
scientific and medical matters.
(4) The scientific and medical evaluation conducted by the
Secretary is necessary to understand the characteristics of any
substance, including whether the substance may be harmful,
harmless, or have potential medical uses.
(5) Since October 2016, the Drug Enforcement Administration
has identified 36 fentanyl-related substances to be scheduled
pursuant to section 201(b) of the Controlled Substances Act (21
U.S.C. 811(b)).
(6) As of April 2023, of the 36 fentanyl-related substances
described in paragraph (5), 24 have been subjected to
scientific and medical analysis. There remain 12 fentanyl-
related substances for which the Drug Enforcement
Administration has yet to begin or complete a scientific
medical evaluation.
(7) In the midst of the fentanyl crisis that is ravaging
communities across the United States, it is imperative that the
Federal Government analyze and study fentanyl-related
substances expeditiously and that the scientific community be
able to research these substances in order to develop life-
saving antidotes and treatments. The most promising life-saving
antidotes and treatments for fentanyl addiction and overdose
are likely to share molecular properties with fentanyl and its
related substances.
SEC. 3. 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. 4. EVALUATION OF ENCOUNTERED FENTANYL-RELATED SUBSTANCES.
(a) Identified Substances.--
(1) In general.--The Attorney General shall complete the
proceedings to schedule or transfer between schedules, or
remove any fentanyl-related substances from the schedules
pursuant to subsection (k) of section 201 of the Controlled
Substances Act (21 U.S.C. 811), as added by section 5 of this
Act--
(A) not later than 1 year after the date of
enactment of this Act for each fentanyl-related
substance that--
(i) the Drug Enforcement Administration has
identified, as of the date of enactment of this
Act; and
(ii) is not permanently scheduled; and
(B) not later than 3 years after the date on which
a fentanyl-related substance is identified if the
fentanyl-related substance--
(i) is identified after the date of
enactment of this Act; and
(ii) is not permanently scheduled.
(2) Extension.--If the Attorney General is unable to
complete the proceedings described in paragraph (1) within the
required time period the Attorney General shall--
(A) 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
(B) complete the proceedings described in paragraph
(1) not later than 1 year after the notification
required under subparagraph (A) of this paragraph.
(b) Temporary Scheduling.--Notwithstanding any other provision of
law, the Attorney General may schedule a fentanyl-related substance
identified after the date of enactment of this Act in schedule I of
section 202(c) of the Controlled Substances Act (21 U.S.C. 812(c)) in
accordance with section 201(h) of that Act (21 U.S.C. 811(h)) for not
longer than 3 years after the date on which the order scheduling the
fentanyl-related substance is issued.
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 include 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) Publication.--
``(1) In general.--The Secretary shall publish on a public
website--
``(A) information related to each evaluation
conducted pursuant to subsection (k)(3) 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
``(B) the results and any other information related
to previously evaluated fentanyl-related services
pursuant to subsection (l).
``(2) Applicability.--Paragraph (1) shall not apply to an
evaluation conducted for an application for a new drug under
section 505 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355).
``(m) 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 this section.''.
SEC. 6. REGISTRATION REQUIREMENTS RELATED TO RESEARCH.
(a) Alternative Registration Process for Schedule I Research.--
Section 303 of the Controlled Substances Act (21 U.S.C. 823) is
amended--
(1) by redesignating the second subsection (l) (relating to
required training for prescribers) as subsection (m); and
(2) by adding at the end the following:
``(n) Special Provisions for Practitioners Conducting Certain
Research With Schedule I Controlled Substances.--
``(1) In general.--Notwithstanding subsection (f), a
practitioner may conduct research described in paragraph (2) of
this subsection with 1 or more schedule I substances in
accordance with subparagraph (A) or (B) of paragraph (3) of
this subsection.
``(2) Research subject to expedited procedures.--Research
described in this paragraph is research that--
``(A) is with respect to a drug that is the subject
of an investigational use exemption under section
505(i) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(i)); or
``(B) is--
``(i) conducted by the Department of Health
and Human Services, the Department of Defense,
or the Department of Veterans Affairs; or
``(ii) funded partly or entirely by a
grant, contract, cooperative agreement, or
other transaction from the Department of Health
and Human Services, the Department of Defense,
or the Department of Veterans Affairs.
``(3) Expedited procedures.--
``(A) Researcher with a current schedule i or ii
research registration.--
``(i) In general.--If a practitioner is
registered to conduct research with a
controlled substance in schedule I or II, the
practitioner may conduct research under this
subsection on and after the date that is 30
days after the date on which the practitioner
sends a notice to the Attorney General
containing the following information, with
respect to each substance with which the
practitioner will conduct the research:
``(I) The chemical name of the
substance.
``(II) The quantity of the
substance to be used in the research.
``(III) Demonstration that the
research is in the category described
in paragraph (2), which demonstration
may be satisfied--
``(aa) in the case of a
grant, contract, cooperative
agreement, or other
transaction, or intramural
research project, by
identifying the sponsoring
agency and supplying the number
of the grant, contract,
cooperative agreement, other
transaction, or project; or
``(bb) in the case of an
application under section
505(i) of the Federal Food,
Drug, and Cosmetic Act (21
U.S.C. 355(i)), by supplying
the application number and the
sponsor of record on the
application.
``(IV) Demonstration that the
researcher is authorized to conduct
research with respect to the substance
under the laws of the State in which
the research will take place.
``(ii) Verification of information by hhs
or va.--Upon request from the Attorney General,
the Secretary of Health and Human Services, the
Secretary of Defense, or the Secretary of
Veterans Affairs, as appropriate, shall verify
information submitted by an applicant under
clause (i)(III).
``(B) Researcher without a current schedule i or ii
research registration.--
``(i) In general.--If a practitioner is not
registered to conduct research with a
controlled substance in schedule I or II, the
practitioner may send a notice to the Attorney
General containing the information listed in
subparagraph (A)(i), with respect to each
substance with which the practitioner will
conduct the research.
``(ii) Attorney general action.--The
Attorney General shall--
``(I) treat notice received under
clause (i) as a sufficient application
for a research registration; and
``(II) not later than 45 days of
receiving such a notice that contains
all information required under
subparagraph (A)(i)--
``(aa) register the
applicant; or
``(bb) serve an order to
show cause upon the applicant
in accordance with section
304(c).
``(4) Electronic submissions.--The Attorney General shall
provide a means to permit a practitioner to submit a
notification under paragraph (3) electronically.
``(5) Limitation on amounts.--A practitioner conducting
research with a schedule I substance under this subsection may
only possess the amounts of schedule I substance identified
in--
``(A) the notification to the Attorney General
under paragraph (3); or
``(B) a supplemental notification that the
practitioner may send if the practitioner needs
additional amounts for the research, which supplemental
notification shall include--
``(i) the name of the practitioner;
``(ii) the additional quantity needed of
the substance; and
``(iii) an attestation that the research to
be conducted with the substance is consistent
with the scope of the research that was the
subject of the notification under paragraph
(3).
``(6) Importation and exportation requirements not
affected.--Nothing in this subsection alters the requirements
of part A of title III, regarding the importation and
exportation of controlled substances.
``(7) Inspector general report.--Not later than 1 year
after the date of enactment of this Act, the Inspector General
of the Department of Justice shall complete a study, and submit
to Congress a report thereon, about research described in
paragraph (2) of this subsection with fentanyl.''.
(b) Separate Registrations Not Required for Additional Researcher
in Same Institution.--Section 302(c) of the Controlled Substances Act
(21 U.S.C. 822(c)) is amended by adding at the end the following:
``(4) An agent or employee of a research institution that
is conducting research with a controlled substance if--
``(A) the agent or employee is acting within the
scope of the professional practice of the agent or
employee;
``(B) another agent or employee of the institution
is registered to conduct research with a controlled
substance in the same schedule;
``(C) the researcher who is so registered--
``(i) informs the Attorney General of the
name, position title, and employing institution
of the agent or employee who is not separately
registered;
``(ii) authorizes that agent or employee to
perform research under the registration of the
registered researcher; and
``(iii) affirms that any act taken by that
agent or employee involving a controlled
substance shall be attributable to the
registered researcher, as if the researcher had
directly committed the act, for purposes of any
proceeding under section 304(a) to suspend or
revoke the registration of the registered
researcher; and
``(D) the Attorney General does not, within 30 days
of receiving the information, authorization, and
affirmation described in subparagraph (C), refuse, for
a reason listed in section 304(a), to allow the agent
or employee to possess the substance without a separate
registration.''.
(c) Single Registration for Related Research Sites.--Section 302(e)
of the Controlled Substances Act (21 U.S.C. 822(e)) is amended by
adding at the end the following:
``(4)(A) Notwithstanding paragraph (1), a person registered to
conduct research with a controlled substance under section 303(f) may
conduct the research under a single registration if--
``(i) the research occurs exclusively on sites all of which
are--
``(I) within the same city or county; and
``(II) under the control of the same institution,
organization, or agency; and
``(ii) before commencing the research, the researcher
notifies the Attorney General of each site where--
``(I) the research will be conducted; or
``(II) the controlled substance will be stored or
administered.
``(B) A site described in subparagraph (A) shall be included in a
registration described in that subparagraph only if the researcher has
notified the Attorney General of the site--
``(i) in the application for the registration; or
``(ii) before the research is conducted, or before the
controlled substance is stored or administered, at the site.
``(C) The Attorney General may, in consultation with the Secretary,
issue regulations addressing, with respect to research sites described
in subparagraph (A)--
``(i) the manner in which controlled substances may be
delivered to the research sites;
``(ii) the storage and security of controlled substances at
the research sites;
``(iii) the maintenance of records for the research sites;
and
``(iv) any other matters necessary to ensure effective
controls against diversion at the research sites.''.
(d) New Inspection Not Required in Certain Situations.--Section
302(f) of the Controlled Substances Act (21 U.S.C. 822(f)) is amended--
(1) by striking ``(f) The'' and inserting ``(f)(1) The'';
and
(2) by adding at the end the following:
``(2)(A) If a person is registered to conduct research with a
controlled substance and applies for a registration, or for a
modification of a registration, to conduct research with a second
controlled substance that is in the same schedule as the first
controlled substance, or is in a schedule with a higher numerical
designation than the schedule of the first controlled substance, a new
inspection by the Attorney General of the registered location is not
required.
``(B) Nothing in subparagraph (A) shall prohibit the Attorney
General from conducting an inspection that the Attorney General
determines necessary to ensure that a registrant maintains effective
controls against diversion.''.
(e) Continuation of Research on Substances Newly Added to Schedule
I.--Section 302 of the Controlled Substances Act (21 U.S.C. 822) is
amended by adding at the end the following:
``(h) Continuation of Research on Substances Newly Added to
Schedule I.--If a person is conducting research on a substance when the
substance is added to schedule I, and the person is already registered
to conduct research with a controlled substance in schedule I--
``(1) not later than 90 days after the scheduling of the
newly scheduled substance, the person shall submit a completed
application for registration or modification of existing
registration, to conduct research on the substance, in
accordance with regulations issued by the Attorney General for
purposes of this paragraph;
``(2) the person may, notwithstanding subsections (a) and
(b), continue to conduct the research on the substance until--
``(A) the person withdraws the application
described in paragraph (1) of this subsection; or
``(B) the Attorney General serves on the person an
order to show cause proposing the denial of the
application under section 304(c);
``(3) if the Attorney General serves an order to show cause
as described in paragraph (2)(B) and the person requests a
hearing, the 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
person; and
``(4) if the person sends a copy of the application
described in paragraph (1) to a manufacturer or distributor of
the substance, receipt of the copy by the manufacturer or
distributor shall constitute sufficient evidence that the
person is authorized to receive the substance.''.
(f) Treatment of Certain Manufacturing Activities as Coincident to
Research.--Section 302 of the Controlled Substances Act (21 U.S.C.
822), as amended by subsection (e), is amended by adding at the end the
following:
``(i) Treatment of Certain Manufacturing Activities as Coincident
to Research.--
``(1) In general.--Except as provided in paragraph (3), a
person who is registered to perform research on a controlled
substance may perform manufacturing activities with small
quantities of that substance, including activities described in
paragraph (2), without being required to obtain a manufacturing
registration, if--
``(A) the activities are performed for the purpose
of the research; and
``(B) the activities and the quantities of the
substance involved in the activities are stated in--
``(i) a notification submitted to the
Attorney General under section 303(n);
``(ii) a research protocol filed with an
application for registration approval under
section 303(f); or
``(iii) a notification to the Attorney
General that includes--
``(I) the name of the registrant;
and
``(II) an attestation that the
research to be conducted with the small
quantities of manufactured substance is
consistent with the scope of the
research that is the basis for the
registration.
``(2) Activities included.--Activities permitted under
paragraph (1) include--
``(A) processing the substance to create extracts,
tinctures, oils, solutions, derivatives, or other forms
of the substance consistent with--
``(i) the information provided as part of a
notification submitted to the Attorney General
under section 303(n); or
``(ii) a research protocol filed with an
application for registration approval under
section 303(f); and
``(B) dosage form development studies performed for
the purpose of requesting an investigational new drug
exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(i)).
``(3) Exception regarding marijuana.--The authority under
paragraph (1) to manufacture substances does not include the
authority to grow marijuana.''.
(g) Transparency Regarding Special Procedures.--Section 303 of the
Controlled Substances Act (21 U.S.C. 823), as amended by subsection
(a), is amended by adding at the end the following:
``(o) Transparency Regarding Special Procedures.--
``(1) In general.--If the Attorney General determines, with
respect to a controlled substance, that an application by a
practitioner to conduct research with the substance should be
considered under a process, or subject to criteria, different
from the process or criteria applicable to applications to
conduct research with other controlled substances in the same
schedule, the Attorney General shall make public, including by
posting on the website of the Drug Enforcement Administration--
``(A) the identities of all substances for which
such determinations have been made;
``(B) the process and criteria that shall be
applied to applications to conduct research with those
substances; and
``(C) how the process and criteria described in
subparagraph (B) differ from the process and criteria
applicable to applications to conduct research with
other controlled substances in the same schedule.
``(2) Timing of posting.--The Attorney General shall make
information described in paragraph (1) public upon making a
determination described in that paragraph, regardless of
whether a practitioner has submitted such an application at
that time.''.
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