I
119THCONGRESS
1
STSESSION H. R. 830
To amend the Controlled Substances Act with respect to fentanyl-related
substances, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
JANUARY31, 2025
Mr. P
APPAS(for himself, Ms. SALAZAR, and Mr. NEWHOUSE) introduced the
following bill; which was referred to the Committee on Energy and Com-
merce, and in addition to the Committee on the Judiciary, for a period
to be subsequently determined by the Speaker, in each case for consider-
ation 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 Representa-1
tives of the United States of America in Congress assembled, 2
SECTION 1. SHORT TITLE. 3
This Act may be cited as the ‘‘Save Americans from 4
the Fentanyl Emergency Act’’ or the ‘‘SAFE Act’’. 5
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SEC. 2. CLASS SCHEDULING OF FENTANYL-RELATED SUB-1
STANCES. 2
Section 202(c) of the Controlled Substances Act (21 3
U.S.C. 812(c)) is amended by adding at the end of sched-4
ule I the following: 5
‘‘(e)(1) Unless specifically exempted or unless listed 6
in another schedule, any material, compound, mixture, or 7
preparation which contains any quantity of fentanyl-re-8
lated substances, or which contains their salts, isomers, 9
and salts of isomers whenever the existence of such salts, 10
isomers, and salts of isomers is possible within the specific 11
chemical designation. 12
‘‘(2) In this subsection, except as provided in para-13
graph (3), the term ‘fentanyl-related substance’ means 14
any substance that is structurally related to fentanyl by 15
one or more of the following modifications: 16
‘‘(A) By replacement of the phenyl portion of 17
the phenethyl group by any monocycle, whether or 18
not further substituted in or on the monocycle. 19
‘‘(B) By substitution in or on the phenethyl 20
group with alkyl, alkenyl, alkoxyl, hydroxyl, halo, 21
haloalkyl, amino, or nitro groups. 22
‘‘(C) By substitution in or on the piperidine 23
ring with alkyl, alkenyl, alkoxyl, ester, ether, 24
hydroxyl, halo, haloalkyl, amino, or nitro groups. 25
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‘‘(D) By replacement of the aniline ring with 1
any aromatic monocycle whether or not further sub-2
stituted in or on the aromatic monocycle. 3
‘‘(E) By replacement of the N-propionyl group 4
with another acyl group. 5
‘‘(3) A substance that meets the criteria specified in 6
paragraph (2) to be considered a fentanyl-related sub-7
stance shall not be so considered as meeting such criteria 8
if such substance— 9
‘‘(A) is controlled by action of the Attorney 10
General pursuant to section 201; 11
‘‘(B) is expressly listed in this schedule or an-12
other schedule by a statutory provision other than 13
this subsection; or 14
‘‘(C) is removed from this schedule, or resched-15
uled to another schedule, pursuant to section 201(k). 16
‘‘(4) The Attorney General shall publish in the Fed-17
eral Register a list of individual substances that meet the 18
definition of fentanyl-related substances in paragraph (2) 19
within 60 days of determining such substances meet such 20
definition. The absence of a substance on any such list 21
does not negate the control status of such substance if 22
the substance meets the criteria specified in paragraph (2) 23
to be considered a fentanyl-related substance. 24
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‘‘(5) Notwithstanding any other provision of this title 1
or title III, fentanyl-related substances shall not be subject 2
to quantity-based mandatory minimum penalties pursuant 3
to subparagraph (A)(vi) or (B)(vi) of section 401(b)(1) of 4
this title or paragraph (1)(F) or (2)(F) of section 1010(b) 5
of title III.’’. 6
SEC. 3. PENALTY PROVISIONS WITH RESPECT TO 7
FENTANYL-RELATED SUBSTANCES—DOMES-8
TIC OFFENSES. 9
Section 401(b)(1) of the Controlled Substances Act 10
(21 U.S.C. 841(b)(1)) is amended— 11
(1) in subparagraph (A), by striking clause (vi) 12
and inserting the following: 13
‘‘(vi)(I) 400 grams or more of a mixture or sub-14
stance containing a detectable amount of fentanyl; 15
or 16
‘‘(II) 100 grams or more of a mixture or sub-17
stance containing a detectable amount of any ana-18
logue of fentanyl that is controlled in schedule I or 19
II or that is treated as a schedule I controlled sub-20
stance pursuant to section 203(a), except for a 21
fentanyl-related substance as defined in schedule 22
I(e) of section 202(c);’’; 23
(2) in subparagraph (B), by striking clause (vi) 24
and inserting the following: 25
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‘‘(vi)(I) 40 grams or more of a mixture or sub-1
stance containing a detectable amount of fentanyl; 2
or 3
‘‘(II) 10 grams or more of a mixture or sub-4
stance containing a detectable amount of any ana-5
logue of fentanyl that is controlled in schedule I or 6
II or that is treated as a schedule I controlled sub-7
stance pursuant to section 203(a), except for a 8
fentanyl-related substance as defined in schedule 9
I(e) of section 202(c);’’; and 10
(3) in subparagraph (C), by inserting ‘‘, includ-11
ing a fentanyl-related substance as defined in sched-12
ule I(e) of section 202(c),’’ after ‘‘a controlled sub-13
stance in schedule I or II,’’. 14
SEC. 4. PENALTY PROVISIONS WITH RESPECT TO 15
FENTANYL-RELATED SUBSTANCES—IMPORT 16
AND EXPORT OFFENSES. 17
Section 1010(b) of the Controlled Substances Import 18
and Export Act (21 U.S.C. 960(b)) is amended— 19
(1) in paragraph (1), by striking subparagraph 20
(F) and inserting the following: 21
‘‘(F)(i) 400 grams or more of a mixture or sub-22
stance containing a detectable amount of fentanyl; 23
or 24
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‘‘(ii) 100 grams or more of a mixture or sub-1
stance containing a detectable amount of any ana-2
logue of fentanyl that is controlled in schedule I or 3
II or that is treated as a schedule I controlled sub-4
stance pursuant to section 203(a) of the Controlled 5
Substances Act, except for a fentanyl-related sub-6
stance as defined in schedule I(e) of section 202(c) 7
of the Controlled Substances Act;’’; 8
(2) in paragraph (2), by striking subparagraph 9
(F) and inserting the following: 10
‘‘(F)(i) 40 grams or more of a mixture or sub-11
stance containing a detectable amount of fentanyl; 12
or 13
‘‘(ii) 10 grams or more of a mixture or sub-14
stance containing a detectable amount of any ana-15
logue of fentanyl that is controlled in schedule I or 16
II or that is treated as a schedule I controlled sub-17
stance pursuant to section 203(a) of the Controlled 18
Substances Act, except for a fentanyl-related sub-19
stance as defined in schedule I(e) of section 202(c) 20
of the Controlled Substances Act;’’; and 21
(3) in paragraph (3), by inserting ‘‘including a 22
fentanyl-related substance as defined in schedule 23
I(e) of section 202(c) of the Controlled Substances 24
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Act,’’ after ‘‘a controlled substance in schedule I or 1
II,’’. 2
SEC. 5. REMOVAL FROM SCHEDULE I OF FENTANYL-RE-3
LATED SUBSTANCES. 4
Section 201 of the Controlled Substances Act (21 5
U.S.C. 811) is amended by adding at the end the following 6
new subsection: 7
‘‘(k) R
EMOVALFROMSCHEDULEI OFFENTANYL- 8
R
ELATEDSUBSTANCES.— 9
‘‘(1) D
ETERMINATION RESULTING IN RE -10
MOVAL.—If the Secretary determines, taking into 11
consideration factors as set forth in paragraph (3), 12
that a fentanyl-related substance has a potential for 13
abuse that is less than the drugs or other substances 14
in schedule V— 15
‘‘(A) the Secretary shall submit to the At-16
torney General a scientific and medical evalua-17
tion of that fentanyl-related substance sup-18
porting that determination; 19
‘‘(B) the Secretary shall submit any such 20
evaluation and determination in writing and in-21
clude the bases therefor; 22
‘‘(C) the scientific and medical determina-23
tion of the Secretary contained in such evalua-24
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tion shall be binding on the Attorney General; 1
and 2
‘‘(D) not later than 90 days after receiving 3
such evaluation and determination, the Attor-4
ney General shall issue an order removing such 5
fentanyl-related substance from the schedules 6
under section 202. 7
‘‘(2) D
ETERMINATION RESULTING IN RESCHED -8
ULING.—If the Secretary determines, taking into 9
consideration factors as set forth in paragraph (3), 10
that a fentanyl-related substance has a potential for 11
abuse that is less than the drugs or other substances 12
in schedules I and II— 13
‘‘(A) the Secretary shall submit to the At-14
torney General a scientific and medical evalua-15
tion of that fentanyl-related substance sup-16
porting that determination; 17
‘‘(B) the Secretary shall submit any such 18
evaluation and determination in writing and in-19
clude the bases therefor; 20
‘‘(C) the scientific and medical determina-21
tion of the Secretary contained in such evalua-22
tion shall be binding on the Attorney General; 23
and 24
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‘‘(D) not later than 90 days after receiving 1
such evaluation, the Attorney General shall 2
issue an order removing such fentanyl-related 3
substance from schedule I and controlling such 4
substance under schedule III. 5
‘‘(3) E
VALUATION FACTORS.— 6
‘‘(A) I
N GENERAL.—In making a deter-7
mination under paragraph (1) or (2), the Sec-8
retary— 9
‘‘(i) shall consider— 10
‘‘(I) the factor listed in para-11
graph (2) of subsection (c); 12
‘‘(II) the factors listed in para-13
graphs (1), (3), and (6) of such sub-14
section to the extent evidence exists 15
with respect to such factors; and 16
‘‘(III) any information submitted 17
to the Secretary by the Attorney Gen-18
eral for purposes of such determina-19
tion; and 20
‘‘(ii) may consider the factors listed in 21
paragraphs (4), (5), and (7) of subsection 22
(c) if the Secretary finds that evidence ex-23
ists with respect to such factors. 24
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‘‘(B) CONSIDERATION OF SCIENTIFIC EVI -1
DENCE OF PHARMACOLOGICAL EFFECT .— 2
‘‘(i) I
N GENERAL.—For the purposes 3
of subparagraph (A)(i)(I), consideration by 4
the Secretary of the results of an assess-5
ment consisting of the studies described in 6
clause (ii) shall suffice to constitute consid-7
eration of the factor listed in paragraph 8
(2) of subsection (c) if— 9
‘‘(I) each such study is per-10
formed according to scientific methods 11
and protocols commonly accepted in 12
the scientific community; and 13
‘‘(II) the Secretary determines 14
that such assessment is adequate for 15
such purposes. 16
‘‘(ii) D
ESCRIBED STUDIES .—The 17
studies described in this clause are any of 18
the following: 19
‘‘(I) A receptor binding study 20
that can demonstrate whether the 21
substance has affinity for the human 22
mu opioid receptor. 23
‘‘(II) An in vitro functional assay 24
that can demonstrate whether the 25
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substance has agonist activity at the 1
human mu opioid receptor. 2
‘‘(III) One or more in vivo ani-3
mal behavioral studies that can dem-4
onstrate whether the substance has 5
abuse-related drug effects consistent 6
with mu opioid agonist activity, such 7
as demonstrating similarity to the ef-8
fects of morphine. 9
‘‘(4) A
DVANCE NOTICE REGARDING EVALUA -10
TION AND CONCLUSION .—The Secretary shall give 11
the Attorney General at least 30 days notice before 12
sending the Attorney General an evaluation and de-13
termination under paragraph (1) or (2) with respect 14
to a fentanyl-related substance. 15
‘‘(5) E
XCEPTION FOR TREATY OBLIGATIONS .— 16
If a fentanyl-related substance is a substance that 17
the United States is obligated to control under inter-18
national treaties, conventions, or protocols in effect 19
on the date of enactment of the Save Americans 20
from the Fentanyl Emergency Act, this subsection 21
shall not require the Attorney General— 22
‘‘(A) to remove such substance from con-23
trol; or 24
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‘‘(B) to place such substance in a schedule 1
less restrictive than that which the Attorney 2
General determines is necessary to carry out 3
such obligations. 4
‘‘(6) I
DENTIFICATION OF FENTANYL -RELATED 5
SUBSTANCES.—If the Attorney General or any offi-6
cial of the Department of Justice determines that a 7
substance is a fentanyl-related substance, the Attor-8
ney General shall— 9
‘‘(A) within 30 days of such determination, 10
notify the Secretary; and 11
‘‘(B) include in such notification the iden-12
tity of the substance, its structure, and the 13
basis for the determination. 14
‘‘(7) P
ETITIONS FOR REMOVING A FENTANYL - 15
RELATED SUBSTANCE .— 16
‘‘(A) I
N GENERAL.—If a person petitions 17
the Attorney General to remove a fentanyl-re-18
lated substance from schedule I(e) or to re-19
schedule such a substance to another schedule, 20
the Attorney General shall consider such a peti-21
tion in accordance with the procedures and 22
standards set forth in— 23
‘‘(i) subsections (a) and (b) of this 24
section; and 25
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‘‘(ii) section 1308.43 of title 21, Code 1
of Federal Regulations (or any successor 2
regulations). 3
‘‘(B) A
TTORNEY GENERAL TO INFORM 4
SECRETARY.—Within 30 days of receiving such 5
a petition, the Attorney General shall forward a 6
copy of the petition to the Secretary. 7
‘‘(C) D
ETERMINATION PROCEDURE NOT 8
PRECLUDED BY FILING OF PETITION .—The fil-9
ing of a petition under this paragraph shall not 10
preclude the Secretary from making a deter-11
mination and sending an evaluation under para-12
graph (1) or (2). 13
‘‘(8) R
ULE OF CONSTRUCTION .—Nothing in 14
this subsection shall be construed to preclude the At-15
torney General from transferring a substance listed 16
in schedule I to another schedule, or removing such 17
substance entirely from the schedules, pursuant to 18
other provisions of this section and section 202. 19
‘‘(9) S
UBSEQUENT CONTROLLING OF REMOVED 20
SUBSTANCE.—A substance removed from schedule I 21
pursuant to this subsection may, at any time, be 22
controlled pursuant to the other provisions of this 23
section and section 202 without regard to the re-24
moval pursuant to this subsection. 25
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‘‘(10) EVALUATIONS OR STUDIES .—The Sec-1
retary may enter into contracts or other agreements 2
to conduct or support evaluations or studies of 3
fentanyl-related substances. 4
‘‘(11) D
EFINITION.—In this subsection, the 5
term ‘fentanyl-related substance’ means a fentanyl- 6
related substance as defined in schedule I(e) of sec-7
tion 202(c).’’. 8
SEC. 6. PAST CASES INVOLVING REMOVED OR RESCHED-9
ULED SUBSTANCES. 10
(a) D
OMESTICCASES.—Section 401(b) of the Con-11
trolled Substances Act (21 U.S.C. 841(b)) is amended by 12
adding at the end the following: 13
‘‘(8) P
ASTCONVICTIONSINVOLVINGFENTANYL-RE-14
LATEDSUBSTANCE.— 15
‘‘(A) I
N GENERAL.—In the case of a defendant 16
whose offense of conviction under this title involved 17
a fentanyl-related substance (as defined in schedule 18
I(e) of section 202(c) as of the date the offense was 19
committed) that has since been removed from des-20
ignation as a fentanyl-related substance for purposes 21
of this title and has been placed on any schedule 22
other than schedule I or II or has been removed 23
from the controlled substance schedules, the sen-24
tencing court may, on motion of the defendant, the 25
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Bureau of Prisons, the attorney for the Government, 1
or on its own motion, after considering the factors 2
set forth in section 3553(a) of title 18, United 3
States Code, vacate the previously imposed sentence, 4
or impose a reduced sentence on any count of con-5
viction as if the removal or placement was in effect 6
at the time that the offense was committed. Nothing 7
in this section may be construed to require a court 8
to vacate or reduce any sentence. 9
‘‘(B) D
EFENDANT NOT REQUIRED TO BE 10
PRESENT.—Notwithstanding rule 43 of the Federal 11
Rules of Criminal Procedure, the defendant is not 12
required to be present at any hearing on whether to 13
vacate or reduce a sentence pursuant to this sec-14
tion.’’. 15
(b) I
MPORT ANDEXPORTCASES.—Section 1010(b) 16
of the Controlled Substances Import and Export Act (21 17
U.S.C. 960(b)) is amended by adding at the end the fol-18
lowing: 19
‘‘(8) In the case of a defendant whose offense of con-20
viction under this title involved a fentanyl-related sub-21
stance (as defined in schedule I(e) of section 202(c) of 22
the Controlled Substances Act as of the date the offense 23
was committed) that has since been removed from des-24
ignation as a fentanyl-related substance for purposes of 25
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this title and has been placed on any schedule other than 1
schedule I or II or has been removed from the controlled 2
substance schedules, the sentencing court may, on motion 3
of the defendant, the Bureau of Prisons, the attorney for 4
the Government, or on its own motion, after considering 5
the factors set forth in section 3553(a) of title 18, United 6
States Code, vacate the previously imposed sentence, or 7
impose a reduced sentence on any count of conviction as 8
if the removal or placement was in effect at the time that 9
the offense was committed. Nothing in this section may 10
be construed to require a court to vacate or reduce any 11
sentence.’’. 12
SEC. 7. REGISTRATION REQUIREMENTS RELATED TO RE-13
SEARCH. 14
(a) A
LTERNATIVE REGISTRATIONPROCESS FOR 15
S
CHEDULEI RESEARCH.—Section 303 of the Controlled 16
Substances Act (21 U.S.C. 823) is amended by adding at 17
the end the following new subsection: 18
‘‘(m) S
PECIALPROVISIONS FORTHOSECONDUCTING 19
C
ERTAINRESEARCHWITHSCHEDULEI CONTROLLED 20
S
UBSTANCES.— 21
‘‘(1) I
N GENERAL.—Notwithstanding subsection 22
(f), a practitioner may conduct research that is de-23
scribed in paragraph (2) and that is with one or 24
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more controlled substances in schedule I if one of 1
the following conditions is satisfied: 2
‘‘(A) R
ESEARCHER WITH A CURRENT 3
SCHEDULE I OR II RESEARCH REGISTRATION .— 4
If the practitioner is registered to conduct re-5
search with a controlled substance in schedule 6
I or II, the practitioner may conduct research 7
under this paragraph 30 days after the practi-8
tioner has sent a notice to the Attorney General 9
containing the following information, with re-10
spect to each substance with which the research 11
will be conducted: 12
‘‘(i) The chemical name of the sub-13
stance. 14
‘‘(ii) The quantity of the substance to 15
be used in such research. 16
‘‘(iii) Demonstration that the research 17
is described in paragraph (2), which dem-18
onstration can be satisfied— 19
‘‘(I) in the case of research de-20
scribed in paragraph (2)(A), by sup-21
plying the number of the application 22
submitted under section 505(i) of the 23
Federal Food, Drug, and Cosmetic 24
Act or section 351(a)(3) of the Public 25
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Health Service Act and the sponsor of 1
record on such application; or 2
‘‘(II) in the case of research de-3
scribed in paragraph (2)(B), by iden-4
tifying the sponsoring agency and 5
supplying the number of the grant, 6
contract, cooperative agreement, other 7
transaction, or project. 8
‘‘(iv) Demonstration that the re-9
searcher is authorized to conduct research 10
with respect to the substance under the 11
laws of the State in which the research will 12
take place. 13
‘‘(B) R
ESEARCHER WITHOUT A CURRENT 14
SCHEDULE I OR II RESEARCH REGISTRATION .— 15
If the practitioner is not currently registered to 16
conduct research with a controlled substance in 17
schedule I or II— 18
‘‘(i) the practitioner may send a no-19
tice to the Attorney General containing the 20
information listed in subparagraph (A), 21
with respect to each substance with which 22
the research will be conducted; 23
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‘‘(ii) the Attorney General shall treat 1
such notice as a sufficient application for 2
a research registration; and 3
‘‘(iii) within 45 days after receiving 4
such a notice that contains all information 5
required by subparagraph (A), the Attor-6
ney General shall register the applicant, or 7
serve an order to show cause upon the ap-8
plicant in accordance with section 304(c). 9
‘‘(C) V
ERIFICATION OF INFORMATION .— 10
On request from the Attorney General, the Sec-11
retary of Health and Human Services or the 12
Secretary of Veterans Affairs, as appropriate, 13
shall verify information submitted by an appli-14
cant under subparagraph (A)(iii). 15
‘‘(2) R
ESEARCH SUBJECT TO EXPEDITED PRO -16
CEDURE.—Research described in this paragraph is 17
research that— 18
‘‘(A) is the subject of an application under 19
section 505(i) of the Federal Food, Drug, and 20
Cosmetic Act or section 351(a)(3) of the Public 21
Health Service Act for the investigation of a 22
drug which is in effect in accordance with sec-23
tion 312.40 of title 21, Code of Federal Regula-24
tions; or 25
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‘‘(B) is conducted by the Department of 1
Health and Human Services, the Department of 2
Justice, or the Department of Veterans Affairs 3
or is funded partly or entirely by a grant, con-4
tract, cooperative agreement, or other trans-5
action from the Department of Health and 6
Human Services, the Department of Justice, or 7
the Department of Veterans Affairs. 8
‘‘(3) E
LECTRONIC SUBMISSIONS .—The Attorney 9
General shall provide a means to allow practitioners 10
to submit notifications under paragraph (1) elec-11
tronically. 12
‘‘(4) L
IMITATION ON AMOUNTS .—A practitioner 13
conducting research with a controlled substance in 14
schedule I pursuant to this subsection shall be al-15
lowed to possess only the amounts of the controlled 16
substance in schedule I identified in— 17
‘‘(A) the notification to the Attorney Gen-18
eral under paragraph (1); or 19
‘‘(B) if the practitioner needs additional 20
amounts for the research, a supplemental notifi-21
cation under this subsection that includes the 22
practitioner’s name, the additional quantity 23
needed of the substance, and an attestation 24
that the research to be conducted with the sub-25
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stance is consistent with the scope of the re-1
search that was the subject of the notification 2
under paragraph (1). 3
‘‘(5) I
MPORTATION AND EXPORTATION RE -4
QUIREMENTS NOT AFFECTED .—Nothing in this sec-5
tion alters the requirements of part A of title III re-6
garding the importation and exportation of con-7
trolled substances.’’. 8
(b) S
EPARATEREGISTRATIONSNOTREQUIRED FOR 9
A
DDITIONALRESEARCHER INSAMEINSTITUTION.—Sub-10
section (c) of section 302 of the Controlled Substances Act 11
(21 U.S.C. 822) is amended by adding at the end the fol-12
lowing: 13
‘‘(4) An agent or employee of a research insti-14
tution that is conducting research with a controlled 15
substance if— 16
‘‘(A) such agent or employee is acting 17
within the scope of his or her professional prac-18
tice; 19
‘‘(B) another agent or employee of such in-20
stitution is registered to conduct research with 21
a controlled substance in the same schedule; 22
‘‘(C) the researcher who is so registered— 23
‘‘(i) informs the Attorney General of 24
the name, position title, and employing in-25
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•HR 830 IH
stitution of the agent or employee who is 1
not separately registered; 2
‘‘(ii) authorizes such agent or em-3
ployee to perform research under the reg-4
istered researcher’s registration; and 5
‘‘(iii) affirms that all acts taken by 6
such agent or employee involving controlled 7
substances shall be attributable to the reg-8
istered researcher, as if the researcher had 9
directly committed such acts, for purposes 10
of any proceeding under section 304(a) to 11
suspend or revoke the registration of the 12
registered researcher; and 13
‘‘(D) the Attorney General does not, within 14
30 days of receiving the information, authoriza-15
tion, and affirmation described in subparagraph 16
(C), refuse, for a reason listed in section 17
304(a), to allow such agent or employee to pos-18
sess such substance without a separate registra-19
tion.’’. 20
(c) S
INGLEREGISTRATION FORRELATEDRESEARCH 21
S
ITES.—Such section 302(e) of the Controlled Substances 22
Act (21 U.S.C. 822(e)) is amended by adding at the end 23
the following: 24
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‘‘(4)(A) Notwithstanding paragraph (1), a person 1
registered to conduct research with a controlled substance 2
under section 303(f) may conduct such research at mul-3
tiple sites under a single registration if— 4
‘‘(i) such research occurs exclusively at sites 5
which are all within the same city or county and are 6
all under the control of the same institution, organi-7
zation, or agency; and 8
‘‘(ii) the researcher notifies the Attorney Gen-9
eral, prior to commencing such research, of all sites 10
where— 11
‘‘(I) the research will be conducted; or 12
‘‘(II) the controlled substance will be 13
stored or administered. 14
‘‘(B) A site described by subparagraph (A) shall be 15
included in such registration only if the researcher has no-16
tified the Attorney General of such site— 17
‘‘(i) in the application for such registration; or 18
‘‘(ii) before the research is conducted, or before 19
the controlled substance is stored or administered, at 20
such site. 21
‘‘(C) The Attorney General may, in consultation with 22
the Secretary of Health and Human Services, issue regu-23
lations addressing— 24
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‘‘(i) the manner in which controlled substances 1
may be delivered to research sites described in sub-2
paragraph (A); 3
‘‘(ii) the storage and security of controlled sub-4
stances at such research sites; 5
‘‘(iii) the maintenance of records for such re-6
search sites; and 7
‘‘(iv) any other matters necessary to ensure ef-8
fective controls against diversion at such research 9
sites.’’. 10
(d) N
EWINSPECTIONNOTREQUIRED INCERTAIN 11
S
ITUATIONS.—Subsection (f) of section 302 of the Con-12
trolled Substances Act (21 U.S.C. 822) is amended— 13
(1) by striking ‘‘(f) The’’ and inserting ‘‘(f)(1) 14
The’’; and 15
(2) by adding at the end the following: 16
‘‘(2)(A) A new inspection by the Attorney General of 17
a registered location is not required if a person is reg-18
istered under this title to conduct research with a con-19
trolled substance and applies for a registration, or for a 20
modification of a registration, to conduct research with a 21
second controlled substance that is— 22
‘‘(i) in the same schedule as the first controlled 23
substance; or 24
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‘‘(ii) is in a schedule with a higher numerical 1
designation than the schedule of the first controlled 2
substance. 3
‘‘(B) Nothing in this paragraph shall prohibit the At-4
torney General from conducting any inspection if the At-5
torney General deems it necessary to ensure that the reg-6
istrant maintains effective controls against diversion.’’. 7
(e) C
ONTINUATION OF RESEARCH ONSUBSTANCES 8
N
EWLYADDED TOSCHEDULEI.—Section 302 of the 9
Controlled Substances Act (21 U.S.C. 822) is amended 10
by adding at the end the following: 11
‘‘(h) C
ONTINUATION OFRESEARCH ONSUBSTANCES 12
N
EWLYADDED TOSCHEDULEI.—If a person is con-13
ducting research on a substance at the time the substance 14
is added to schedule I, and such person is already reg-15
istered under this title to conduct research with a con-16
trolled substance in schedule I, then— 17
‘‘(1) the person shall, within 90 days of the 18
scheduling in schedule I, submit a completed appli-19
cation for registration under this title or modifica-20
tion of an existing registration under this title, to 21
conduct research on such substance, in accordance 22
with regulations issued by the Attorney General; 23
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‘‘(2) the person may, notwithstanding sub-1
sections (a) and (b), continue to conduct the re-2
search on such substance until— 3
‘‘(A) the person withdraws such applica-4
tion; or 5
‘‘(B) the Attorney General serves on the 6
person an order to show cause proposing the 7
denial of the application pursuant to section 8
304(c); 9
‘‘(3) if the Attorney General serves such an 10
order to show cause and the person requests a hear-11
ing, such hearing shall be held on an expedited basis 12
and not later than 45 days after the request is 13
made, except that the hearing may be held at a later 14
time if so requested by the person; and 15
‘‘(4) if the person sends a copy of the applica-16
tion required by paragraph (1) to a manufacturer or 17
distributor of such substance, receipt of such copy 18
by such manufacturer or distributor shall constitute 19
sufficient evidence that the person is authorized to 20
receive such substance.’’. 21
(f) T
REATMENT OF CERTAINMANUFACTURING AC-22
TIVITIES ASCOINCIDENT TORESEARCH.—Section 302 of 23
the Controlled Substances Act (21 U.S.C. 822), as amend-24
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ed by subsection (e), is further amended by adding at the 1
end the following: 2
‘‘(i) T
REATMENT OFCERTAINMANUFACTURINGAC-3
TIVITIES ASCOINCIDENT TORESEARCH.— 4
‘‘(1) I
N GENERAL.—Except as specified in 5
paragraph (3), a person who is registered to perform 6
research on a controlled substance may perform 7
manufacturing activities with small quantities of 8
that substance, including activities listed in para-9
graph (2), without being required to obtain a manu-10
facturing registration, if such activities are per-11
formed for the purpose of the research and if the ac-12
tivities and the quantities of the substance involved 13
in those activities are stated in— 14
‘‘(A) a notification submitted to the Attor-15
ney General under section 303(m); 16
‘‘(B) a protocol filed with an application 17
for registration approval under section 303(f); 18
or 19
‘‘(C) a notification to the Attorney General 20
that includes the registrant’s name and an at-21
testation that the research to be conducted with 22
the small quantities of manufactured substance 23
is consistent with the scope of the research that 24
is the basis for the registration. 25
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‘‘(2) ACTIVITIES INCLUDED.—Activities per-1
mitted under paragraph (1) include— 2
‘‘(A) processing the substance to create ex-3
tracts, tinctures, oils, solutions, derivatives, or 4
other forms of the substance consistent with the 5
information provided as part of a notification 6
submitted to the Attorney General under sec-7
tion 303(m) or a research protocol filed with 8
the application for registration approval; and 9
‘‘(B) dosage form development studies per-10
formed for the purpose of satisfying regulatory 11
requirements of the Food and Drug Adminis-12
tration for submitting an investigational new 13
drug application. 14
‘‘(3) E
XCEPTION REGARDING MARIHUANA .— 15
The authority under paragraph (1) to manufacture 16
substances does not include authority to grow mari-17
huana.’’. 18
(g) T
RANSPARENCY REGARDINGSPECIALPROCE-19
DURES.—Section 303 of such Act (21 U.S.C. 823), as 20
amended by subsection (a), is further amended by adding 21
at the end the following: 22
‘‘(n) T
RANSPARENCY REGARDINGSPECIALPROCE-23
DURES.— 24
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‘‘(1) IN GENERAL.—If the Attorney General de-1
termines, with respect to a controlled substance, that 2
an application by a practitioner to conduct research 3
with such substance should be considered under a 4
process, or subject to criteria, different from the 5
process or criteria applicable to applications to con-6
duct research with other controlled substances in the 7
same schedule, the Attorney General shall make 8
public, including by posting on the website of the 9
Drug Enforcement Administration— 10
‘‘(A) the identities of all substances for 11
which such determinations have been made; 12
‘‘(B) the process and criteria that will be 13
applied to applications to conduct research with 14
such substances; and 15
‘‘(C) how such process and criteria differ 16
from those applicable to applications to conduct 17
research with other controlled substances in the 18
same schedule. 19
‘‘(2) T
IMING OF POSTING.—The Attorney Gen-20
eral shall make such information public upon mak-21
ing such determination, regardless of whether a 22
practitioner has submitted such an application at 23
that time.’’. 24
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SEC. 8. RULEMAKING. 1
(a) I
NTERIMFINALRULES.—The Attorney Gen-2
eral— 3
(1) not later than 1 year of the date of enact-4
ment of this Act, shall issue rules to implement this 5
Act and the amendments made by this Act; and 6
(2) may issue such rules as interim final rules. 7
(b) P
ROCEDURE FORFINALRULE.—A rule issued by 8
the Attorney General as an interim final rule under sub-9
section (a) shall become immediately effective as an in-10
terim final rule without requiring the Attorney General to 11
demonstrate good cause therefor. The interim final rule 12
shall give interested persons the opportunity to comment 13
and to request a hearing. After the conclusion of such pro-14
ceedings, the Attorney General shall issue a final rule in 15
accordance with section 553 of title 5, United States Code. 16
SEC. 9. GAO REPORT. 17
(a) I
NGENERAL.—Not more than 4 years after the 18
date of enactment of this Act, the Comptroller General 19
of the United States shall submit to the Committees on 20
Energy and Commerce and the Judiciary of the House 21
of Representatives and the Committee on the Judiciary 22
of the Senate a report analyzing the implementation and 23
impact, to the extent information is available, of perma-24
nent class scheduling pursuant to schedule I(e) of section 25
202(c) of the Controlled Substances Act, as added by sec-26
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tion 2 of this Act, of fentanyl-related substances (as de-1
fined in such schedule I(e)), which report shall include— 2
(1) an analysis of the impact on research of 3
fentanyl-related substances; 4
(2) an analysis of any actions taken to remove 5
or reschedule in a different class any fentanyl-re-6
lated substance; 7
(3) an analysis of the impact of permanent 8
scheduling on the unlawful importation, manufac-9
ture, trafficking, and use of fentanyl-related sub-10
stances, taking into consideration data collected con-11
cerning the proliferation of fentanyl-related sub-12
stances since class scheduling was instituted; 13
(4) an analysis of sentences attributable to 14
criminal charges involving fentanyl-related sub-15
stances, comparing those sentences to sentences at-16
tributable to criminal charges involving fentanyl and 17
individually scheduled fentanyl analogues; and 18
(5) an analysis of the efficacy of class sched-19
uling generally, in terms of reducing the prolifera-20
tion of new controlled substance analogues. 21
(b) C
ONSULTATIONS.—In developing the report re-22
quired by subsection (a), the Comptroller General— 23
(1) shall consider the views of the Secretary of 24
Health and Human Services, the Attorney General, 25
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the Secretary of Homeland Security, the Secretary 1
of State, the Director of the Office of National Drug 2
Control Policy, the scientific and medical research 3
community, the State and local law enforcement 4
community, and the civil rights and criminal justice 5
reform communities; and 6
(2) to the greatest extent possible, should base 7
such report on reliable data and empirical informa-8
tion. 9
Æ
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