HR 830
SAFE Act
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Bill overview
The SAFE Act permanently classifies fentanyl-related substances as a Schedule I controlled substance, mirroring the temporary order currently in place. It limits mandatory minimum penalties for certain offenses, establishes a process for descheduling some fentanyl-related substances, and allows for reduced sentences. The bill also introduces changes to research registration requirements, including a streamlined process for researchers and enhanced transparency. Finally, it directs the GAO to analyze the long-term impact of this permanent scheduling.
Key provisions
- Permanently classifies fentanyl-related substances as Schedule I.
- Limits mandatory minimum penalties for certain fentanyl-related substance offenses.
- Establishes a process for descheduling or rescheduling certain fentanyl-related substances.
- Simplifies research registration requirements for Schedule I substances.
- Requires the Drug Enforcement Administration to publish a list of fentanyl-related substances.
- Allows for the continuation of research on newly scheduled fentanyl-related substances.
- Modifies sentencing guidelines for past convictions involving fentanyl-related substances.
- Directs the GAO to conduct a comprehensive analysis of the bill's impact.
Who is affected
- Individuals involved in the manufacture, trafficking, and use of fentanyl-related substances.
- Law enforcement agencies.
- The pharmaceutical industry (researchers and manufacturers).
- Federal courts.
- The Drug Enforcement Administration.
Sponsors
Official sponsors from legislative records.
Primary sponsor
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119th CONGRESS — 1st Session
H. R. 830
IN THE HOUSE OF REPRESENTATIVES
A BILL
To amend the Controlled Substances Act with respect to fentanyl-related substances, and for other purposes.
This Act may be cited as the Save Americans from the Fentanyl Emergency Act SAFE Act
or the
.
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:
Unless specifically exempted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of fentanyl-related substances, or which contains their salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation.
In this subsection, except as provided in paragraph (3), the term fentanyl-related substance means any substance that is structurally related to fentanyl by one or more of the following modifications:
By replacement of the phenyl portion of the phenethyl group by any monocycle, whether or not further substituted in or on the monocycle.
By substitution in or on the phenethyl group with alkyl, alkenyl, alkoxyl, hydroxyl, halo, haloalkyl, amino, or nitro groups.
By substitution in or on the piperidine ring with alkyl, alkenyl, alkoxyl, ester, ether, hydroxyl, halo, haloalkyl, amino, or nitro groups.
By replacement of the aniline ring with any aromatic monocycle whether or not further substituted in or on the aromatic monocycle.
By replacement of the N-propionyl group with another acyl group.
is controlled by action of the Attorney General pursuant to section 201;
is expressly listed in this schedule or another schedule by a statutory provision other than this subsection; or
Section 401(b)(1) of the Controlled Substances Act (21 U.S.C. 841(b)(1)) is amended—
in subparagraph (A), by striking clause (vi) and inserting the following:
400 grams or more of a mixture or substance containing a detectable amount of fentanyl; or
100 grams or more of a mixture or substance containing a detectable amount of any analogue of fentanyl that is controlled in schedule I or II or that is treated as a schedule I controlled substance pursuant to section 203(a), except for a fentanyl-related substance as defined in schedule I(e) of section 202(c);
40 grams or more of a mixture or substance containing a detectable amount of fentanyl; or
10 grams or more of a mixture or substance containing a detectable amount of any analogue of fentanyl that is controlled in schedule I or II or that is treated as a schedule I controlled substance pursuant to section 203(a), except for a fentanyl-related substance as defined in schedule I(e) of section 202(c);
, including a fentanyl-related substance as defined in schedule I(e) of section 202(c),after
a controlled substance in schedule I or II,.
Section 1010(b) of the Controlled Substances Import and Export Act (21 U.S.C. 960(b)) is amended—
in paragraph (1), by striking subparagraph (F) and inserting the following:
400 grams or more of a mixture or substance containing a detectable amount of fentanyl; or
40 grams or more of a mixture or substance containing a detectable amount of fentanyl; or
including a fentanyl-related substance as defined in schedule I(e) of section 202(c) of the Controlled Substances Act,after
a controlled substance in schedule I or II,.
Section 201 of the Controlled Substances Act (21 U.S.C. 811) is amended by adding at the end the following new subsection:
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—
the Secretary shall submit to the Attorney General a scientific and medical evaluation of that fentanyl-related substance supporting that determination;
the scientific and medical determination of the Secretary contained in such evaluation shall be binding on the Attorney General; and
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—
the Secretary shall submit to the Attorney General a scientific and medical evaluation of that fentanyl-related substance supporting that determination;
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.
In making a determination under paragraph (1) or (2), the Secretary—
shall consider—
the factor listed in paragraph (2) of subsection (c);
any information submitted to the Secretary by the Attorney General for purposes of such determination; and
each such study is performed according to scientific methods and protocols commonly accepted in the scientific community; and
the Secretary determines that such assessment is adequate for such purposes.
The studies described in this clause are any of the following:
A receptor binding study that can demonstrate whether the substance has affinity for the human mu opioid receptor.
An in vitro functional assay that can demonstrate whether the substance has agonist activity at the human mu opioid receptor.
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.
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
Save Americans from the Fentanyl Emergency Act
, this subsection shall not require the Attorney General—to remove such substance from control; or
to place such substance in a schedule less restrictive than that which the Attorney General determines is necessary to carry out such obligations.
If the Attorney General or any official of the Department of Justice determines that a substance is a fentanyl-related substance, the Attorney General shall—
within 30 days of such determination, notify the Secretary; and
include in such notification the identity of the substance, its structure, and the basis for the determination.
If a person petitions the Attorney General to remove a fentanyl-related substance from schedule I(e) or to reschedule such a substance to another schedule, the Attorney General shall consider such a petition in accordance with the procedures and standards set forth in—
subsections (a) and (b) of this section; and
section 1308.43 of title 21, Code of Federal Regulations (or any successor regulations).
Within 30 days of receiving such a petition, the Attorney General shall forward a copy of the petition to the Secretary.
The filing of a petition under this paragraph shall not preclude the Secretary from making a determination and sending an evaluation under paragraph (1) or (2).
Nothing in this subsection shall be construed to preclude the Attorney General from 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.
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.
Section 401(b) of the Controlled Substances Act (21 U.S.C. 841(b)) is amended by adding at the end the following:
Section 1010(b) of the Controlled Substances Import and Export Act (21 U.S.C. 960(b)) is amended by adding at the end the following:
Section 303 of the Controlled Substances Act (21 U.S.C. 823) is amended by adding at the end the following new subsection:
Notwithstanding subsection (f), a practitioner may conduct research that is described in paragraph (2) and that is with one or more controlled substances in schedule I if one of the following conditions is satisfied:
If the practitioner is registered to conduct research with a controlled substance in schedule I or II, the practitioner may conduct research under this paragraph 30 days after the practitioner has sent a notice to the Attorney General containing the following information, with respect to each substance with which the research will be conducted:
The chemical name of the substance.
The quantity of the substance to be used in such research.
Demonstration that the research is described in paragraph (2), which demonstration can be satisfied—
in the case of research described in paragraph (2)(A), by supplying the number of the application submitted under section 505(i) of the Federal Food, Drug, and Cosmetic Act or section 351(a)(3) of the Public Health Service Act and the sponsor of record on such application; or
in the case of research described in paragraph (2)(B), by identifying the sponsoring agency and supplying the number of the grant, contract, cooperative agreement, other transaction, or project.
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.
If the practitioner is not currently 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), with respect to each substance with which the research will be conducted;
the Attorney General shall treat such notice as a sufficient application for a research registration; and
within 45 days after receiving such a notice that contains all information required by subparagraph (A), the Attorney General shall register the applicant, or serve an order to show cause upon the applicant in accordance with section 304(c).
On 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 subparagraph (A)(iii).
Research described in this paragraph is research that—
The Attorney General shall provide a means to allow practitioners to submit notifications under paragraph (1) electronically.
A practitioner conducting research with a controlled substance in schedule I pursuant to this subsection shall be allowed to possess only the amounts of the controlled substance in schedule I identified in—
the notification to the Attorney General under paragraph (1); or
Nothing in this section alters the requirements of part A of title III regarding the importation and exportation of controlled substances.
An agent or employee of a research institution that is conducting research with a controlled substance if—
such agent or employee is acting within the scope of his or her professional practice;
another agent or employee of such institution is registered to conduct research with a controlled substance in the same schedule;
the researcher who is so registered—
informs the Attorney General of the name, position title, and employing institution of the agent or employee who is not separately registered;
authorizes such agent or employee to perform research under the registered researcher’s registration; and
affirms that all acts taken by such agent or employee involving controlled substances shall be attributable to the registered researcher, as if the researcher had directly committed such acts, for purposes of any proceeding under section 304(a) to suspend or revoke the registration of the registered researcher; and
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 such agent or employee to possess such substance without a separate registration.
Notwithstanding paragraph (1), a person registered to conduct research with a controlled substance under section 303(f) may conduct such research at multiple sites under a single registration if—
such research occurs exclusively at sites which are all within the same city or county and are all under the control of the same institution, organization, or agency; and
the research will be conducted; or
the controlled substance will be stored or administered.
A site described by subparagraph (A) shall be included in such registration only if the researcher has notified the Attorney General of such site—
in the application for such registration; or
before the research is conducted, or before the controlled substance is stored or administered, at such site.
The Attorney General may, in consultation with the Secretary of Health and Human Services, issue regulations addressing—
the manner in which controlled substances may be delivered to research sites described in subparagraph (A);
the storage and security of controlled substances at such research sites;
the maintenance of records for such research sites; and
any other matters necessary to ensure effective controls against diversion at such research sites.
by striking (f) The
and inserting (f)(1) The
; and
by adding at the end the following:
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.
Nothing in this paragraph shall prohibit the Attorney General from conducting any inspection if the Attorney General deems it necessary to ensure that the registrant maintains effective controls against diversion.
If a person is conducting research on a substance at the time the substance is added to schedule I, and such person is already registered under this title to conduct research with a controlled substance in schedule I, then—
the person shall, within 90 days of the scheduling in schedule I, submit a completed application for registration under this title or modification of an existing registration under this title, to conduct research on such substance, in accordance with regulations issued by the Attorney General;
the person may, notwithstanding subsections (a) and (b), continue to conduct the research on such substance until—
the person withdraws such application; or
the Attorney General serves on the person an order to show cause proposing the denial of the application pursuant to section 304(c);
if the Attorney General serves such an order to show cause and the person requests a hearing, such 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
if the person sends a copy of the application required by paragraph (1) to a manufacturer or distributor of such substance, receipt of such copy by such manufacturer or distributor shall constitute sufficient evidence that the person is authorized to receive such substance.
Except as specified 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 listed in paragraph (2), without being required to obtain a manufacturing registration, if such activities are performed for the purpose of the research and if the activities and the quantities of the substance involved in those activities are stated in—
a notification submitted to the Attorney General under section 303(m);
a protocol filed with an application for registration approval under section 303(f); or
a notification to the Attorney General that includes the registrant’s name and 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.
Activities permitted under paragraph (1) include—
processing the substance to create extracts, tinctures, oils, solutions, derivatives, or other forms of the substance consistent with the information provided as part of a notification submitted to the Attorney General under section 303(m) or a research protocol filed with the application for registration approval; and
dosage form development studies performed for the purpose of satisfying regulatory requirements of the Food and Drug Administration for submitting an investigational new drug application.
The authority under paragraph (1) to manufacture substances does not include authority to grow marihuana.
Section 303 of such Act (21 U.S.C. 823), as amended by subsection (a), is further amended by adding at the end the following:
If the Attorney General determines, with respect to a controlled substance, that an application by a practitioner to conduct research with such 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—
the identities of all substances for which such determinations have been made;
the process and criteria that will be applied to applications to conduct research with such substances; and
how such process and criteria differ from those applicable to applications to conduct research with other controlled substances in the same schedule.
The Attorney General shall make such information public upon making such determination, regardless of whether a practitioner has submitted such an application at that time.
may issue such rules as 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. The interim final rule shall give interested persons the opportunity to comment and to request a hearing. After the conclusion of such proceedings, the Attorney General shall issue a final rule in accordance with section 553 of title 5, United States Code.
an analysis of the impact on research of fentanyl-related substances;
an analysis of any actions taken to remove or reschedule in a different class any fentanyl-related substance;
an analysis of the impact of permanent scheduling on the unlawful importation, manufacture, trafficking, and use of fentanyl-related substances, taking into consideration data collected concerning the proliferation of fentanyl-related substances since class scheduling was instituted;
an analysis of sentences attributable to criminal charges involving fentanyl-related substances, comparing those sentences to sentences attributable to criminal charges involving fentanyl and individually scheduled fentanyl analogues; and
an analysis of the efficacy of class scheduling generally, in terms of reducing the proliferation of new controlled substance analogues.
In developing the report required by subsection (a), the Comptroller General—
shall consider the views of the Secretary of Health and Human Services, the Attorney General, the Secretary of Homeland Security, the Secretary of State, the Director of the Office of National Drug Control Policy, the scientific and medical research community, the State and local law enforcement community, and the civil rights and criminal justice reform communities; and
to the greatest extent possible, should base such report on reliable data and empirical information.