Save Americans from the Fentanyl Emergency Act or the SAFE Act
This bill permanently places fentanyl-related substances as a class into schedule I of the Controlled Substances Act. A schedule I controlled substance is a drug, substance, or chemical that has a high potential for abuse; has no currently accepted medical value; and is subject to regulatory controls and administrative, civil, and criminal penalties under the Controlled Substances Act. Fentanyl-related substances are currently regulated under schedule I through a temporary order issued by the Drug Enforcement Administration. The temporary order expires on March 31, 2025.
It limits mandatory minimum penalties for certain offenses involving fentanyl-related substances, establishes a process to deschedule or remove certain fentanyl-related substances that have a low potential for abuse, and allows federal courts to vacate or reduce sentences for convictions involving a fentanyl-related substance that is descheduled or moved to a schedule other than schedule I or II.
The bill establishes a new, alternative registration process for schedule I research. It also makes other changes to registration requirements for conducting research with controlled substances, including
Finally, the bill requires the Government Accountability Office to analyze the implementation and impact of permanently placing fentanyl-related substances into schedule I of the Controlled Substances Act.
[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 830 Introduced in House (IH)]
<DOC>
119th CONGRESS
1st Session
H. R. 830
To amend the Controlled Substances Act with respect to fentanyl-related
substances, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
January 31, 2025
Mr. Pappas (for himself, Ms. Salazar, and Mr. Newhouse) introduced the
following bill; which was referred to the Committee on Energy and
Commerce, and in addition to the Committee on the Judiciary, for a
period to be subsequently determined by the Speaker, in each case for
consideration of such provisions as fall within the jurisdiction of the
committee concerned
_______________________________________________________________________
A BILL
To amend the Controlled Substances Act with respect to fentanyl-related
substances, and for other purposes.
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 ``Save Americans from the Fentanyl
Emergency Act'' or the ``SAFE Act''.
SEC. 2. 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 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.
``(2) 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:
``(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 meets the criteria specified in paragraph
(2) to be considered a fentanyl-related substance shall not be so
considered as meeting such criteria if such substance--
``(A) is controlled by action of the Attorney General
pursuant to section 201;
``(B) is expressly listed in this schedule or another
schedule by a statutory provision other than this subsection;
or
``(C) is removed from this schedule, or rescheduled to
another schedule, pursuant to section 201(k).
``(4) The Attorney General shall publish in the Federal Register a
list of individual substances that meet the definition of fentanyl-
related substances in paragraph (2) within 60 days of determining such
substances meet such definition. The absence of a substance on any such
list does not negate the control status of such substance if the
substance meets the criteria specified in paragraph (2) to be
considered a fentanyl-related substance.
``(5) Notwithstanding any other provision of this title or title
III, fentanyl-related substances shall not be subject to quantity-based
mandatory minimum penalties pursuant to subparagraph (A)(vi) or (B)(vi)
of section 401(b)(1) of this title or paragraph (1)(F) or (2)(F) of
section 1010(b) of title III.''.
SEC. 3. PENALTY PROVISIONS WITH RESPECT TO FENTANYL-RELATED
SUBSTANCES--DOMESTIC OFFENSES.
Section 401(b)(1) of the Controlled Substances Act (21 U.S.C.
841(b)(1)) is amended--
(1) in subparagraph (A), by striking clause (vi) and
inserting the following:
``(vi)(I) 400 grams or more of a mixture or substance
containing a detectable amount of fentanyl; or
``(II) 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);'';
(2) in subparagraph (B), by striking clause (vi) and
inserting the following:
``(vi)(I) 40 grams or more of a mixture or substance
containing a detectable amount of fentanyl; or
``(II) 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);''; and
(3) in subparagraph (C), by inserting ``, including a
fentanyl-related substance as defined in schedule I(e) of
section 202(c),'' after ``a controlled substance in schedule I
or II,''.
SEC. 4. PENALTY PROVISIONS WITH RESPECT TO FENTANYL-RELATED
SUBSTANCES--IMPORT AND EXPORT OFFENSES.
Section 1010(b) of the Controlled Substances Import and Export Act
(21 U.S.C. 960(b)) is amended--
(1) in paragraph (1), by striking subparagraph (F) and
inserting the following:
``(F)(i) 400 grams or more of a mixture or substance
containing a detectable amount of fentanyl; or
``(ii) 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) of
the Controlled Substances Act, except for a fentanyl-related
substance as defined in schedule I(e) of section 202(c) of the
Controlled Substances Act;'';
(2) in paragraph (2), by striking subparagraph (F) and
inserting the following:
``(F)(i) 40 grams or more of a mixture or substance
containing a detectable amount of fentanyl; or
``(ii) 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) of
the Controlled Substances Act, except for a fentanyl-related
substance as defined in schedule I(e) of section 202(c) of the
Controlled Substances Act;''; and
(3) in paragraph (3), by inserting ``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,''.
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) Removal From Schedule I of Fentanyl-Related Substances.--
``(1) Determination resulting in removal.--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.
``(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 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 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.
``(4) Advance notice regarding evaluation and conclusion.--
The Secretary shall give the Attorney General at least 30 days
notice before sending the Attorney General an evaluation and
determination under paragraph (1) or (2) with respect to a
fentanyl-related substance.
``(5) 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 Save
Americans from the Fentanyl Emergency 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.
``(6) Identification of fentanyl-related substances.--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--
``(A) within 30 days 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.
``(7) Petitions for removing a fentanyl-related
substance.--
``(A) In general.--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--
``(i) subsections (a) and (b) of this
section; and
``(ii) section 1308.43 of title 21, Code of
Federal Regulations (or any successor
regulations).
``(B) Attorney general to inform secretary.--Within
30 days of receiving such a petition, 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 under
this paragraph shall not preclude the Secretary from
making a determination and sending an evaluation under
paragraph (1) or (2).
``(8) Rule of construction.--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.
``(9) 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.
``(10) Evaluations or studies.--The Secretary may enter
into contracts or other agreements to conduct or support
evaluations or studies of fentanyl-related substances.
``(11) Definition.--In this subsection, the term `fentanyl-
related substance' means a fentanyl-related substance as
defined in schedule I(e) of section 202(c).''.
SEC. 6. PAST CASES INVOLVING REMOVED OR RESCHEDULED SUBSTANCES.
(a) Domestic Cases.--Section 401(b) of the Controlled Substances
Act (21 U.S.C. 841(b)) is amended by adding at the end the following:
``(8) Past Convictions Involving Fentanyl-Related Substance.--
``(A) In general.--In the case of a defendant whose offense
of conviction under this title involved a fentanyl-related
substance (as defined in schedule I(e) of section 202(c) as of
the date the offense was committed) that has since been removed
from designation as a fentanyl-related substance for purposes
of this title and has been placed on any schedule other than
schedule I or II or has been removed from the controlled
substance schedules, the sentencing court may, on motion of the
defendant, the Bureau of Prisons, the attorney for the
Government, or on its own motion, after considering the factors
set forth in section 3553(a) of title 18, United States Code,
vacate the previously imposed sentence, or impose a reduced
sentence on any count of conviction as if the removal or
placement was in effect at the time that the offense was
committed. Nothing in this section may be construed to require
a court to vacate or reduce any sentence.
``(B) Defendant not required to be present.--
Notwithstanding rule 43 of the Federal Rules of Criminal
Procedure, the defendant is not required to be present at any
hearing on whether to vacate or reduce a sentence pursuant to
this section.''.
(b) Import and Export Cases.--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:
``(8) In the case of a defendant whose offense of conviction under
this title involved a fentanyl-related substance (as defined in
schedule I(e) of section 202(c) of the Controlled Substances Act as of
the date the offense was committed) that has since been removed from
designation as a fentanyl-related substance for purposes of this title
and has been placed on any schedule other than schedule I or II or has
been removed from the controlled substance schedules, the sentencing
court may, on motion of the defendant, the Bureau of Prisons, the
attorney for the Government, or on its own motion, after considering
the factors set forth in section 3553(a) of title 18, United States
Code, vacate the previously imposed sentence, or impose a reduced
sentence on any count of conviction as if the removal or placement was
in effect at the time that the offense was committed. Nothing in this
section may be construed to require a court to vacate or reduce any
sentence.''.
SEC. 7. 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
by adding at the end the following new subsection:
``(m) Special Provisions for Those Conducting Certain Research With
Schedule I Controlled Substances.--
``(1) In general.--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:
``(A) Researcher with a current schedule i or ii
research registration.--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:
``(i) The chemical name of the substance.
``(ii) The quantity of the substance to be
used in such research.
``(iii) Demonstration that the research is
described in paragraph (2), which demonstration
can be satisfied--
``(I) 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
``(II) 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.
``(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.
``(B) Researcher without a current schedule i or ii
research registration.--If the practitioner is not
currently registered to conduct research with a
controlled substance in schedule I or II--
``(i) 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;
``(ii) the Attorney General shall treat
such notice as a sufficient application for a
research registration; and
``(iii) 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).
``(C) Verification of information.--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).
``(2) Research subject to expedited procedure.--Research
described in this paragraph is research that--
``(A) is the subject of an application under
section 505(i) of the Federal Food, Drug, and Cosmetic
Act or section 351(a)(3) of the Public Health Service
Act for the investigation of a drug which is in effect
in accordance with section 312.40 of title 21, Code of
Federal Regulations; or
``(B) is conducted by the Department of Health and
Human Services, the Department of Justice, or the
Department of Veterans Affairs or is funded partly or
entirely by a grant, contract, cooperative agreement,
or other transaction from the Department of Health and
Human Services, the Department of Justice, or the
Department of Veterans Affairs.
``(3) Electronic submissions.--The Attorney General shall
provide a means to allow practitioners to submit notifications
under paragraph (1) electronically.
``(4) Limitation on amounts.--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--
``(A) the notification to the Attorney General
under paragraph (1); or
``(B) if the practitioner needs additional amounts
for the research, a supplemental notification under
this subsection that includes the practitioner's name,
the additional quantity needed of the substance, and 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 (1).
``(5) Importation and exportation requirements not
affected.--Nothing in this section 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.--Subsection (c) of section 302 of the Controlled
Substances Act (21 U.S.C. 822) 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) such agent or employee is acting within the
scope of his or her professional practice;
``(B) another agent or employee of such 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 such agent or employee to
perform research under the registered
researcher's registration; and
``(iii) 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
``(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 such agent
or employee to possess such substance without a
separate registration.''.
(c) Single Registration for Related Research Sites.--Such 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 such research at multiple sites under a single registration
if--
``(i) 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
``(ii) the researcher notifies the Attorney General, prior
to commencing such research, of all sites where--
``(I) the research will be conducted; or
``(II) the controlled substance will be stored or
administered.
``(B) A site described by subparagraph (A) shall be included in
such registration only if the researcher has notified the Attorney
General of such site--
``(i) in the application for such registration; or
``(ii) before the research is conducted, or before the
controlled substance is stored or administered, at such site.
``(C) The Attorney General may, in consultation with the Secretary
of Health and Human Services, issue regulations addressing--
``(i) the manner in which controlled substances may be
delivered to research sites described in subparagraph (A);
``(ii) the storage and security of controlled substances at
such research sites;
``(iii) the maintenance of records for such research sites;
and
``(iv) any other matters necessary to ensure effective
controls against diversion at such research sites.''.
(d) New Inspection Not Required in Certain Situations.--Subsection
(f) of section 302 of the Controlled Substances Act (21 U.S.C. 822) is
amended--
(1) by striking ``(f) The'' and inserting ``(f)(1) The'';
and
(2) by adding at the end the following:
``(2)(A) A new inspection by the Attorney General of a registered
location is not required if a person is registered under this title 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--
``(i) in the same schedule as the first controlled
substance; or
``(ii) is in a schedule with a higher numerical designation
than the schedule of the first controlled substance.
``(B) 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.''.
(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 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--
``(1) 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;
``(2) the person may, notwithstanding subsections (a) and
(b), continue to conduct the research on such substance until--
``(A) the person withdraws such application; or
``(B) the Attorney General serves on the person an
order to show cause proposing the denial of the
application pursuant to section 304(c);
``(3) 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
``(4) 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.''.
(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 further amended by adding at the
end the following:
``(i) Treatment of Certain Manufacturing Activities as Coincident
to Research.--
``(1) In general.--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) a notification submitted to the Attorney
General under section 303(m);
``(B) a protocol filed with an application for
registration approval under section 303(f); or
``(C) 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.
``(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 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
``(B) 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.
``(3) Exception regarding marihuana.--The authority under
paragraph (1) to manufacture substances does not include
authority to grow marihuana.''.
(g) Transparency Regarding Special Procedures.--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:
``(n) 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 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--
``(A) the identities of all substances for which
such determinations have been made;
``(B) the process and criteria that will be applied
to applications to conduct research with such
substances; and
``(C) how such process and criteria differ from
those applicable to applications to conduct research
with other controlled substances in the same schedule.
``(2) Timing of posting.--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.''.
SEC. 8. RULEMAKING.
(a) Interim Final Rules.--The Attorney General--
(1) not later than 1 year of the date of enactment of this
Act, shall issue rules to implement this Act and the amendments
made by this Act; and
(2) may issue such rules as interim final rules.
(b) Procedure for Final Rule.--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.
SEC. 9. GAO REPORT.
(a) In General.--Not more than 4 years after the date of enactment
of this Act, the Comptroller General of the United States shall submit
to the Committees on Energy and Commerce and the Judiciary of the House
of Representatives and the Committee on the Judiciary of the Senate a
report analyzing the implementation and impact, to the extent
information is available, of permanent class scheduling pursuant to
schedule I(e) of section 202(c) of the Controlled Substances Act, as
added by section 2 of this Act, of fentanyl-related substances (as
defined in such schedule I(e)), which report shall include--
(1) an analysis of the impact on research of fentanyl-
related substances;
(2) an analysis of any actions taken to remove or
reschedule in a different class any fentanyl-related substance;
(3) 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;
(4) 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
(5) an analysis of the efficacy of class scheduling
generally, in terms of reducing the proliferation of new
controlled substance analogues.
(b) Consultations.--In developing the report required by subsection
(a), the Comptroller General--
(1) 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
(2) to the greatest extent possible, should base such
report on reliable data and empirical information.
<all>
Introduced in House
Introduced in House
Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
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