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SAFE Act of 2022

Introduced Mar 7, 2022 · Last action Nov 1, 2022 Referred to the Subcommittee on Crime, Terrorism, and Homeland Security.

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Summary

This legislation is called the SAFE Act of 2022. Referred to the Subcommittee on Crime, Terrorism, and Homeland Security.

Full bill text

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6946 Introduced in House (IH)]

<DOC>

117th CONGRESS
  2d Session
                                H. R. 6946

To amend the Controlled Substances Act with respect to fentanyl-related
                  substances, and for other purposes.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                             March 7, 2022

  Mr. Pappas (for himself, Mr. Newhouse, and Mr. Budd) 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 of 2022'' or the ``SAFE Act of 2022''.

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 of 2022, 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:
    ``(l) 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:
    ``(3)(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(l);
                    ``(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(l) 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:
    ``(m) 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>

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Status

In Committee

  1. 1Introduced
  2. 2Committee
  3. 3Floor
  4. 4Passed
  5. 5Signed

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