SAFE Act

Subjects: Crime and Law Enforcement

Summary:  <p><b>Save Americans from the Fentanyl Emergency Act or the SAFE Act</b></p> <p>This bill&nbsp;permanently&nbsp;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. The temporary scheduling order issued by the Drug Enforcement Administration to place fentanyl-related substances into schedule I of the Controlled Substances Act expires on December 31, 2024.</p> <p>It limits the application of 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 a federal court to vacate or reduce the sentence for convictions of offenses involving a fentanyl-related substance that is descheduled or moved to a schedule other than schedule I or II. </p> <p>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</p> <ul> <li>permitting a single registration for related research sites in certain circumstances, </li> <li>waiving the requirement for a new inspection in certain situations, and </li> <li>allowing a registered researcher to perform certain manufacturing activities with small quantities of a substance without obtaining a manufacturing registration. </li> </ul> <p>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. </p>

<html><body><pre>[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 568 Introduced in House (IH)]

&lt;DOC&gt;






118th CONGRESS
  1st Session
                                H. R. 568

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


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            January 26, 2023

Mr. Pappas (for himself, Mr. Newhouse, Mr. Tony Gonzales of Texas, and 
 Ms. Salazar) 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.
                                 &lt;all&gt;
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