119-hr830

[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.
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