[Congressional Record Volume 170, Number 115 (Thursday, July 11, 2024)]
[Senate]
[Pages S5143-S5146]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
SA 2917. Mr. HEINRICH submitted an amendment intended to be proposed
by him to the bill S. 4638, to authorize appropriations for fiscal year
2025 for military activities of the Department of Defense, for military
construction, and for defense activities of the Department of Energy,
to prescribe military personnel strengths for such fiscal year, and for
other purposes; which was ordered to lie on the table; as follows:
At the end of title X, add the following:
Subtitle I--HALT FENTANYL Act
SEC. 1096. SHORT TITLE.
This subtitle may be cited as the ``Halt All Lethal
Trafficking of Fentanyl Act'' or the ``HALT Fentanyl Act''.
SEC. 1097. CLASS SCHEDULING OF FENTANYL-RELATED SUBSTANCES.
Section 202(c) of the Controlled Substances Act (21 U.S.C.
812(c)) is amended by adding at the end of schedule I the
following:
``(e)(1) Unless specifically exempted or unless listed in
another schedule, any material, compound, mixture, or
preparation which contains any quantity of a fentanyl-related
substance, or which contains the salts, isomers, and salts of
isomers of a fentanyl-related substance whenever the
existence of such salts, isomers, and salts of isomers is
possible within the specific chemical designation.
``(2) For purposes of paragraph (1), except as provided in
paragraph (3), the term `fentanyl-related substance' means
any substance that is structurally related to fentanyl by 1
or more of the following modifications:
``(A) By replacement of the phenyl portion of the phenethyl
group by any monocycle, whether or not further substituted in
or on the monocycle.
``(B) By substitution in or on the phenethyl group with
alkyl, alkenyl, alkoxyl, hydroxyl, halo, haloalkyl, amino, or
nitro groups.
``(C) By substitution in or on the piperidine ring with
alkyl, alkenyl, alkoxyl, ester, ether, hydroxyl, halo,
haloalkyl, amino, or nitro groups.
``(D) By replacement of the aniline ring with any aromatic
monocycle whether or not further substituted in or on the
aromatic monocycle.
``(E) By replacement of the N-propionyl group with another
acyl group.
``(3) A substance that satisfies the definition of the term
`fentanyl-related substance' in paragraph (2) shall
nonetheless not be treated as a fentanyl-related substance
subject to this schedule if the substance--
``(A) is controlled by action of the Attorney General under
section 201; or
``(B) is otherwise expressly listed in a schedule other
than this schedule.
``(4)(A) The Attorney General may by order publish in the
Federal Register a list of substances that satisfy the
definition of the term `fentanyl-related substance' in
paragraph (2).
``(B) The absence of a substance from a list published
under subparagraph (A) does not negate the control status of
the substance under this schedule if the substance satisfies
the definition of the term `fentanyl-related substance' in
paragraph (2).''.
SEC. 1098. 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
[[Page S5144]]
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 Veterans Affairs, or the
Department of Justice; 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
Veterans Affairs, or the Department of Justice.
``(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 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.''.
(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:
``(3)(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
[[Page S5145]]
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.''.
SEC. 1099. 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) consistent with subsection (b), the scientific and
medical matters contained 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 and has a currently
accepted medical use--
``(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 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; and
``(B) include in such notification the identity of the
substance, its structure, and the basis for the
determination.
[[Page S5146]]
``(8) Petitions for transferring a fentanyl-related
substance under the drug schedules.--
``(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 or II 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.--Not less frequently
than annually, the Secretary shall review fentanyl-related
substances identified under paragraph (8) and evaluate those
substances for potential removal or rescheduling under
paragraphs (1) and (2).''.
SEC. 1099A. RULEMAKING.
(a) Interim Final Rules.--The Attorney General--
(1) shall, not later than 1 year of the date of enactment
of this Act, issue rules to implement this subtitle and the
amendments made by this subtitle; and
(2) may issue the rules under paragraph (1) as interim
final rules.
(b) Procedure for Final Rule.--
(1) Effectiveness of interim final rules.--A rule issued by
the Attorney General as an interim final rule under
subsection (a) shall become immediately effective as an
interim final rule without requiring the Attorney General to
demonstrate good cause therefor, notwithstanding subparagraph
(B) of section 553(b) of title 5, United States Code.
(2) Opportunity for comment and hearing.--An interim final
rule issued under subsection (a) shall give interested
persons the opportunity to comment and to request a hearing.
(3) Final rule.--After the conclusion of such proceedings,
the Attorney General shall issue a final rule to implement
this subtitle and the amendments made by this subtitle in
accordance with section 553 of title 5, United States Code.
______