Schedules of Controlled Substances: Placement of 10 Specific Fentanyl-Related Substances in Schedule I
| Published date | 27 April 2021 |
| Citation | 86 FR 22113 |
| Record Number | 2021-08720 |
| Section | Rules and Regulations |
| Court | Drug Enforcement Administration |
Federal Register, Volume 86 Issue 79 (Tuesday, April 27, 2021)
[Federal Register Volume 86, Number 79 (Tuesday, April 27, 2021)]
[Rules and Regulations]
[Pages 22113-22118]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-08720]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-476]
Schedules of Controlled Substances: Placement of 10 Specific
Fentanyl-Related Substances in Schedule I
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final rule.
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SUMMARY: In this rule, the Drug Enforcement Administration places 10
specified fentanyl-related substances permanently in schedule I of the
Controlled Substances Act. These 10 specific substances all fall within
the definition of fentanyl-related substances set forth in a February
6, 2018, temporary scheduling order. Through the Temporary
Reauthorization and Study of the Emergency Scheduling of Fentanyl
Analogues Act, which became law on February 6, 2020, Congress extended
the temporary control of fentanyl-related substances until May 6, 2021.
The regulatory controls and administrative, civil, and criminal
sanctions applicable to schedule I controlled substances on persons who
handle (manufacture, distribute, reverse distribute, import, export,
engage in research, conduct instructional activities or chemical
analysis, or possess), or propose to handle any of these 10 specified
fentanyl-related substances will continue to be applicable permanently
as a result of this action.
DATES: Effective date: April 27, 2021.
FOR FURTHER INFORMATION CONTACT: Terrence L. Boos, Drug and Chemical
Evaluation Section, Diversion Control Division, Drug Enforcement
Administration; Mailing Address: 8701 Morrissette Drive, Springfield,
Virginia 22152; Telephone: (571) 362-3249.
SUPPLEMENTARY INFORMATION: This final rule imposes permanent controls
on 10 specified fentanyl-related substances, which will continue to be
listed in schedule I of the Controlled Substances Act (CSA). These 10
fentanyl-related substances are:
N-(1-(2-fluorophenethyl)piperidin-4-yl)-N-(2-
fluorophenyl)propionamide (2'-fluoro ortho-fluorofentanyl; 2'-fluoro 2-
fluorofentanyl);
N-(1-(4-methylphenethyl)piperidin-4-yl)-N-phenylacetamide
(4'-methyl acetyl fentanyl);
N-(1-phenethylpiperidin-4-yl)-N,3-diphenylpropanamide
([beta]'-phenyl fentanyl; beta'-Phenyl fentanyl; 3-phenylpropanoyl
fentanyl);
N-phenyl-N-(1-(2-phenylpropyl)piperidin-4-yl)propionamide
([beta]-methyl fentanyl);
N-(2-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)butyramide
(ortho-fluorobutyryl fentanyl; 2-fluorobutyryl fentanyl);
N-(2-methylphenyl)-N-(1-phenethylpiperidin-4-yl)acetamide
(ortho-methyl acetylfentanyl; 2-methyl acetylfentanyl);
2-methoxy-N-(2-methylphenyl)-N-(1-phenethylpiperidin-4-
yl)acetamide (ortho-methyl methoxyacetylfentanyl; 2-methyl
methoxyacetyl fentanyl);
N-(4-methylphenyl)-N-(1-phenethylpiperidin-4-
yl)propionamide (para-methylfentanyl; 4-methylfentanyl);
N-(1-phenethylpiperidin-4-yl)-N-phenylbenzamide (phenyl
fentanyl; benzoyl fentanyl); and
N-(1-phenethylpiperidin-4-yl)-N-phenylthiophene-2-
carboxamide (thiofuranyl fentanyl; 2-thiofuranyl fentanyl; thiophene
fentanyl).
The schedule I listing of these 10 fentanyl-related substances
includes their isomers, esters, ethers, salts, and salts of isomers,
esters, and ethers whenever the existence of such isomers, esters,
ethers, and salts is possible.
Legal Authority
The CSA provides that proceedings for the issuance, amendment, or
repeal of the scheduling of any drug or other substance may be
initiated by the Attorney General (delegated to the Administrator of
the Drug Enforcement Administration (DEA) pursuant to 28 CFR 0.100) on
his own motion. 21 U.S.C. 811(a). This action is supported by, inter
alia, a recommendation from the Assistant Secretary for Health of HHS
(Assistant Secretary) and an evaluation of all relevant data by DEA.
This action continues the imposition of the regulatory controls and
administrative, civil, and criminal sanctions of schedule I controlled
substances on any person who handles (manufactures, distributes,
imports, exports, engages in research, or conducts instructional
activities or chemical analysis with, or possesses) or proposes to
handle 2'-fluoro ortho-fluorofentanyl, 4'-methyl acetyl fentanyl,
[beta]'-phenyl fentanyl, [beta]-methyl fentanyl, ortho-fluorobutyryl
fentanyl, ortho-methyl acetylfentanyl, ortho-methyl methoxyacetyl
fentanyl, para-methylfentanyl, phenyl fentanyl, and thiofuranyl
fentanyl.
Background
On February 6, 2018, pursuant to 21 U.S.C. 811(h)(1), DEA published
a temporary scheduling order in the
[[Page 22114]]
Federal Register (83 FR 5188), temporarily placing fentanyl-related
substances, as defined in that order, in schedule I of the CSA based
upon a finding that these substances pose an imminent hazard to the
public safety. That temporary order was effective upon the date of
publication. Pursuant to 21 U.S.C. 811(h)(2), the temporary control of
fentanyl-related substances, a class of substances as defined in the
order, as well as the 10 specific substances already covered by that
order, was set to expire on February 6, 2020. However, as explained in
DEA's April 10, 2020, correcting amendment (85 FR 20155), Congress
overrode and extended that expiration date until May 6, 2021, by
enacting the Temporary Reauthorization and Study of the Emergency
Scheduling of Fentanyl Analogues Act (Pub. L. 116-114, sec. 2, 134
Stat. 103) (Feb. 6, 2020).
On March 3, 2021 (86 FR 12296), DEA published a notice of proposed
rulemaking (NPRM) to permanently control 10 specific fentanyl-related
substances: 2'-fluoro ortho-fluorofentanyl, 4'-methyl acetyl fentanyl,
[beta]'-phenyl fentanyl, [beta]-methyl fentanyl, ortho-fluorobutyryl
fentanyl, ortho-methyl acetylfentanyl, ortho-methyl methoxyacetyl
fentanyl, para-methylfentanyl, phenyl fentanyl, and thiofuranyl
fentanyl in schedule I of the CSA. Specifically, DEA proposed to add
these substances to the opiates list under 21 CFR 1308.11(b), and
assign paragraph numbers 17, 18, 41, 50, 61, 62, 64, 69, 75, and 83
under paragraph (b) to beta-Methyl fentanyl, beta'-Phenyl fentanyl, 2'-
Fluoro ortho-fluorofentanyl, 4'-Methyl acetyl fentanyl, ortho-
Fluorobutyryl fentanyl, ortho-Methyl acetylfentanyl, ortho-Methyl
methoxyacetyl fentanyl, para-Methylfentanyl, Phenyl fentanyl, and
Thiofuranyl fentanyl, respectively.
Since the publication of this NPRM, DEA issued a correcting
amendment which updated the numbering of all listed opiates in
paragraph (b). See 86 FR 16667, March 31, 2021. As a result, this final
rule assigns different paragraph numbers under paragraph (b) than
originally proposed, to nine of the ten substances (though the
numbering for ortho-Methyl acetylfentanyl remains the same). In
addition, after publication of the NPRM, DEA discovered that the NPRM
inadvertently assigned a duplicate drug code to 2'-fluoro ortho-
fluorofentanyl (9829). As such, with this final rule, DEA hereby
corrects this error by assigning a new drug code (9855) for 2'-fluoro
ortho-fluorofentanyl.
DEA and HHS Eight Factor Analyses
On July 2, 2020, HHS provided DEA with a scientific and medical
evaluation and scheduling recommendation, prepared by the Food and Drug
Administration (FDA), for 2'-fluoro ortho-fluorofentanyl, 4'-methyl
acetyl fentanyl, [beta]'-phenyl fentanyl, [beta]-methyl fentanyl,
ortho-fluorobutyryl fentanyl, ortho-methyl acetylfentanyl, ortho-methyl
methoxyacetyl fentanyl, para-methylfentanyl, phenyl fentanyl, and
thiofuranyl fentanyl and their salts.\1\ After considering the eight
factors in 21 U.S.C. 811(c), each substance's abuse potential, lack of
legitimate medical use in the United States, and lack of accepted
safety for use under medical supervision pursuant to 21 U.S.C. 812(b),
the Assistant Secretary recommended that these substances be placed in
schedule I of the CSA. In response, DEA conducted its own eight-factor
analysis of 2'-fluoro ortho-fluorofentanyl, 4'-methyl acetyl fentanyl,
[beta]'-phenyl fentanyl, [beta]-methyl fentanyl, ortho-fluorobutyryl
fentanyl, ortho-methyl acetylfentanyl, ortho-methyl methoxyacetyl
fentanyl, para-methylfentanyl, phenyl fentanyl, and thiofuranyl
fentanyl. Please note that both the DEA and HHS 8-Factor analyses and
the Assistant Secretary's July 2, 2020, letter are available in their
entirety under the tab ``Supporting Documents'' of the public docket
for this action at http://www.regulations.gov under Docket Number
``DEA-476.''
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\1\ Although HHS also provided information on crotonyl fentanyl,
this substance will not be discussed in this final rule since it was
permanently placed in schedule I on October 2, 2020. 85 FR 62215.
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Determination To Schedule Ten Specific Fentanyl-Related Substances
After review of the available data including the scientific and
medical evaluation and the scheduling recommendations from HHS, DEA
published an NPRM entitled ``Schedules of Controlled Substances:
Placement of 10 Specific Fentanyl-Related Substances in Schedule I.''
86 FR 12296, March 3, 2021. The NPRM provided an opportunity for
interested persons to file a request for hearing in accordance with DEA
regulations on or before April 2, 2021. No requests for such a hearing
were received by DEA. The NPRM also provided an opportunity for
interested persons to submit comments on the proposed rule on or before
April 2, 2021.
Comments Received
DEA received ten comments on the proposed rule to control 2'-fluoro
ortho-fluorofentanyl, 4'-methyl acetyl fentanyl, [beta]'-phenyl
fentanyl, [beta]-methyl fentanyl, ortho-fluorobutyryl fentanyl, ortho-
methyl acetylfentanyl, ortho-methyl methoxyacetyl fentanyl, para-
methylfentanyl, phenyl fentanyl, and thiofuranyl fentanyl in schedule 1
of the CSA. One submission was from a public health group called The
Partnership for Safe Medicines, which is made up of more than 45 non-
profit organizations committed to the safety of prescription drugs and
protection of consumers against counterfeit or unsafe medicines. Other
submissions were from individual or anonymous commenters. Nine of the
commenters provided support for the rule, and one commenter did not
state a position on the rule.
Rather, the latter commenter inquired about DEA's concern with
synthetic opioids versus natural substances, and the possibility of
reducing opioid addiction risks by managing pain differently without
the use of prescribed opioid medications. This comment is outside the
scope of this rulemaking. As such, this rule will not provide a
response to this comment.
Support of the Proposed Rule
Nine commenters supported controlling 2'-fluoro ortho-
fluorofentanyl, 4'-methyl acetyl fentanyl, [beta]'-phenyl fentanyl,
[beta]-methyl fentanyl, ortho-fluorobutyryl fentanyl, ortho-methyl
acetylfentanyl, ortho-methyl methoxyacetyl fentanyl, para-
methylfentanyl, phenyl fentanyl, and thiofuranyl fentanyl as schedule I
controlled substances. These commenters indicated support for permanent
scheduling of these substances for the reasons such as similarity in
their abuse potential to fentanyl, safety concerns with fentanyl, such
as deaths, overdoses, addiction, and trafficking, and the involvement
of fentanyl and fentanyl-related substances in the current public
health crisis associated with the opioid abuse epidemic. Most
commenters indicated that DEA needs to impose the permanent control to
help curb addiction and opioid overdose.
In addition to supporting control of these 10 substances, a
commenter highlighted the need for more specific guidelines for
regulatory controls and administrative, civil, and criminal sanctions
specific to these substances. In particular, this commenter desired
that DEA ensure that vulnerable populations (e.g., those addicted to or
dependent on opioids) would not be
[[Page 22115]]
unduly punished by broad convictions or sentencing guidelines, and
advocated for no mandatory minimums for subsequent convictions (after
the first conviction) related to simple possession or ``low level
handling'' of the 10 fentanyl-related substances.
DEA Response. DEA appreciates the support for this rulemaking.
Regarding the comment for more specific guidelines related to
regulatory control for these 10 substances, this comment is outside the
scope of this rulemaking since sentencing guidelines are set by the
CSA.
Scheduling Conclusion
After consideration of the relevant matter presented through public
comments, the scientific and medical evaluation and accompanying
recommendation of HHS, and after its own eight-factor evaluation, DEA
finds that these facts and all other relevant data constitute
substantial evidence of the potential for abuse of 2'-fluoro ortho-
fluorofentanyl, 4'-methyl acetyl fentanyl, [beta]'-phenyl fentanyl,
[beta]-methyl fentanyl, ortho-fluorobutyryl fentanyl, ortho-methyl
acetylfentanyl, ortho-methyl methoxyacetyl fentanyl, para-
methylfentanyl, phenyl fentanyl, and thiofuranyl fentanyl. DEA is
therefore permanently scheduling these 10 specific fentanyl-related
substances as controlled substances under the CSA.
Determination of Appropriate Schedule
The CSA establishes five schedules of controlled substances known
as schedules I, II, III, IV, and V. The CSA also outlines the findings
required to place a drug or other substance in any particular schedule.
21 U.S.C. 812(b). After consideration of the analysis and
recommendation of the Assistant Secretary and review of all other
available data, the Acting Administrator, pursuant to 21 U.S.C. 811(a)
and 812(b)(1), finds that:
(1) 2'-Fluoro ortho-fluorofentanyl, 4'-methyl acetyl fentanyl,
[beta]'-phenyl fentanyl, [beta]-methyl fentanyl, ortho-fluorobutyryl
fentanyl, ortho-methyl acetylfentanyl, ortho-methyl methoxyacetyl
fentanyl, para-methylfentanyl, phenyl fentanyl, and thiofuranyl
fentanyl have a high potential for abuse that is comparable to other
schedule I substances such as acetyl fentanyl and furanyl fentanyl.
(2) 2'-Fluoro ortho-fluorofentanyl, 4'-methyl acetyl fentanyl,
[beta]'-phenyl fentanyl, [beta]-methyl fentanyl, ortho-fluorobutyryl
fentanyl, ortho-methyl acetylfentanyl, ortho-methyl methoxyacetyl
fentanyl, para-methylfentanyl, phenyl fentanyl, and thiofuranyl
fentanyl have no currently accepted medical use in treatment in the
United States; \2\ and
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\2\ Although there is no evidence suggesting that 2'-fluoro
ortho-fluorofentanyl, 4'-methyl acetyl fentanyl, [beta]'-phenyl
fentanyl, [beta]-methyl fentanyl, ortho-fluorobutyryl fentanyl,
ortho-methyl acetylfentanyl, ortho-methyl methoxyacetyl fentanyl,
para-methylfentanyl, phenyl fentanyl, and thiofuranyl fentanyl have
a currently accepted medical use in treatment in the United States,
it bears noting that a drug cannot be found to have such medical use
unless DEA concludes that it satisfies a five-part test.
Specifically, with respect to a drug that has not been approved by
FDA, to have a currently accepted medical use in treatment in the
United States, all of the following must be demonstrated: i. The
drug's chemistry must be known and reproducible; ii. there must be
adequate safety studies; iii. there must be adequate and well-
controlled studies proving efficacy; iv. the drug must be accepted
by qualified experts; and v. the scientific evidence must be widely
available. 57 FR 10499 (1992), pet. for rev. denied, Alliance for
Cannabis Therapeutics v. DEA, 15 F.3d 1131, 1135 (D.C. Cir. 1994).
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(3) There is a lack of accepted safety for use of 2'-fluoro ortho-
fluorofentanyl, 4'-methyl acetyl fentanyl, [beta]'-phenyl fentanyl,
[beta]-methyl fentanyl, ortho-fluorobutyryl fentanyl, ortho-methyl
acetylfentanyl, ortho-methyl methoxyacetyl fentanyl, para-
methylfentanyl, phenyl fentanyl, and thiofuranyl fentanyl under medical
supervision. Based on these findings, the Acting Administrator
concludes that 2'-fluoro ortho-fluorofentanyl, 4'-methyl acetyl
fentanyl, [beta]'-phenyl fentanyl, [beta]-methyl fentanyl, ortho-
fluorobutyryl fentanyl, ortho-methyl acetylfentanyl, ortho-methyl
methoxyacetyl fentanyl, para-methylfentanyl, phenyl fentanyl, and
thiofuranyl fentanyl, including their isomers, esters, ethers, salts,
and salts of isomers, esters, and ethers whenever the existence of such
isomers, esters, ethers, and salts is possible, warrant continued
control in schedule I of the CSA. 21 U.S.C. 812(b)(1).
Requirements for Handling 2'-Fluoro Ortho-Fluorofentanyl, 4'-Methyl
Acetyl Fentanyl, [beta]'-Phenyl Fentanyl, [beta]-Methyl Fentanyl,
Ortho-Fluorobutyryl Fentanyl, Ortho-Methyl Acetylfentanyl, Ortho-Methyl
Methoxyacetyl Fentanyl, Para-Methylfentanyl, Phenyl Fentanyl, and
Thiofuranyl Fentanyl
2'-Fluoro ortho-fluorofentanyl, 4'-methyl acetyl fentanyl, [beta]'-
phenyl fentanyl, [beta]-methyl fentanyl, ortho-fluorobutyryl fentanyl,
ortho-methyl acetylfentanyl, ortho-methyl methoxyacetyl fentanyl, para-
methylfentanyl, phenyl fentanyl, and thiofuranyl fentanyl will continue
\3\ to be subject to the CSA's regulatory controls and administrative,
civil, and criminal sanctions applicable to the manufacture,
distribution, reverse distribution, dispensing, importation,
exportation, research, and conduct of instructional activities
involving the handling of controlled substances, including the
following:
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\3\ 2'-Fluoro ortho-fluorofentanyl, 4'-methyl acetyl fentanyl,
[beta]'-phenyl fentanyl, [beta]-methyl fentanyl, ortho-fluorobutyryl
fentanyl, ortho-methyl acetylfentanyl, ortho-methyl methoxyacetyl
fentanyl, para-methylfentanyl, phenyl fentanyl, and thiofuranyl
fentanyl are covered by the February 6, 2018, temporary scheduling
order, and are currently subject to schedule I controls on a
temporary basis, pursuant to 21 U.S.C. 811(h). 83 FR 5188.
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1. Registration. Any person who handles (manufactures, distributes,
reverse distributes, dispenses, imports, exports, engages in research,
or conducts instructional activities or chemical analysis with, or
possesses), or who desires to handle, 2'-fluoro ortho-fluorofentanyl,
4'-methyl acetyl fentanyl, [beta]'-phenyl fentanyl, [beta]-methyl
fentanyl, ortho-fluorobutyryl fentanyl, ortho-methyl acetylfentanyl,
ortho-methyl methoxyacetyl fentanyl, para-methylfentanyl, phenyl
fentanyl, and thiofuranyl fentanyl must be registered with DEA to
conduct such activities pursuant to 21 U.S.C. 822, 823, 957, and 958,
and in accordance with 21 CFR parts 1301 and 1312.
2. Security. 2'-Fluoro ortho-fluorofentanyl, 4'-methyl acetyl
fentanyl, [beta]'-phenyl fentanyl, [beta]-methyl fentanyl, ortho-
fluorobutyryl fentanyl, ortho-methyl acetylfentanyl, ortho-methyl
methoxyacetyl fentanyl, para-methylfentanyl, phenyl fentanyl, and
thiofuranyl fentanyl are subject to schedule I security requirements
and must be handled and stored pursuant to 21 U.S.C. 821, 823, and in
accordance with 21 CFR 1301.71-1301.76. Non-practitioners handling 2'-
fluoro ortho-fluorofentanyl, 4'-methyl acetyl fentanyl, [beta]'-phenyl
fentanyl, [beta]-methyl fentanyl, ortho-fluorobutyryl fentanyl, ortho-
methyl acetylfentanyl, ortho-methyl methoxyacetyl fentanyl, para-
methylfentanyl, phenyl fentanyl, and thiofuranyl fentanyl also must
comply with the employee screening requirements of 21 CFR 1301.90-
1301.93.
3. Labeling and Packaging. All labels and labeling for commercial
containers of 2'-fluoro ortho-fluorofentanyl, 4'-methyl acetyl
fentanyl, [beta]'-phenyl fentanyl, [beta]-methyl fentanyl, ortho-
fluorobutyryl fentanyl, ortho-methyl acetylfentanyl, ortho-methyl
methoxyacetyl fentanyl, para-methylfentanyl, phenyl fentanyl, and
thiofuranyl fentanyl must be in compliance with 21 U.S.C. 825 and
958(e), and be in accordance with 21 CFR part 1302.
4. Quota. Only registered manufacturers are permitted to
manufacture 2'-fluoro ortho-
[[Page 22116]]
fluorofentanyl, 4'-methyl acetyl fentanyl, [beta]'-phenyl fentanyl,
[beta]-methyl fentanyl, ortho-fluorobutyryl fentanyl, ortho-methyl
acetylfentanyl, ortho-methyl methoxyacetyl fentanyl, para-
methylfentanyl, phenyl fentanyl, and thiofuranyl fentanyl in accordance
with a quota assigned pursuant to 21 U.S.C. 826 and in accordance with
21 CFR part 1303.
5. Inventory. Any person registered with DEA to handle 2'-fluoro
ortho-fluorofentanyl, 4'-methyl acetyl fentanyl, [beta]'-phenyl
fentanyl, [beta]-methyl fentanyl, ortho-fluorobutyryl fentanyl, ortho-
methyl acetylfentanyl, ortho-methyl methoxyacetyl fentanyl, para-
methylfentanyl, phenyl fentanyl, and thiofuranyl fentanyl must have an
initial inventory of all stocks of controlled substances (including
these substances) on hand on the date the registrant first engages in
the handling of controlled substances pursuant to 21 U.S.C. 827 and
958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.
After the initial inventory, every DEA registrant must take a new
inventory of all stocks of controlled substances (including 2'-fluoro
ortho-fluorofentanyl, 4'-methyl acetyl fentanyl, [beta]'-phenyl
fentanyl, [beta]-methyl fentanyl, ortho-fluorobutyryl fentanyl, ortho-
methyl acetylfentanyl, ortho-methyl methoxyacetyl fentanyl, para-
methylfentanyl, phenyl fentanyl, and thiofuranyl fentanyl) on hand
every two years pursuant to 21 U.S.C. 827 and 958, and in accordance
with 21 CFR 1304.03, 1304.04, and 1304.11.
6. Records and Reports. Every DEA registrant is required to
maintain records and submit reports with respect to 2'-fluoro ortho-
fluorofentanyl, 4'-methyl acetyl fentanyl, [beta]'-phenyl fentanyl,
[beta]-methyl fentanyl, ortho-fluorobutyryl fentanyl, ortho-methyl
acetylfentanyl, ortho-methyl methoxyacetyl fentanyl, para-
methylfentanyl, phenyl fentanyl, and thiofuranyl fentanyl, pursuant to
21 U.S.C. 827 and 958(e), and in accordance with 21 CFR 1301.74(b) and
(c) and parts 1304, 1312, and 1317.
7. Order Forms. Every DEA registrant who distributes 2'-fluoro
ortho-fluorofentanyl, 4'-methyl acetyl fentanyl, [beta]'-phenyl
fentanyl, [beta]-methyl fentanyl, ortho-fluorobutyryl fentanyl, ortho-
methyl acetylfentanyl, ortho-methyl methoxyacetyl fentanyl, para-
methylfentanyl, phenyl fentanyl, and thiofuranyl fentanyl must comply
with the order form requirements, pursuant to 21 U.S.C. 828 and in
accordance 21 CFR part 1305.
8. Importation and Exportation. All importation and exportation of
2'-fluoro ortho-fluorofentanyl, 4'-methyl acetyl fentanyl, [beta]'-
phenyl fentanyl, [beta]-methyl fentanyl, ortho-fluorobutyryl fentanyl,
ortho-methyl acetylfentanyl, ortho-methyl methoxyacetyl fentanyl, para-
methylfentanyl, phenyl fentanyl, and thiofuranyl fentanyl must be in
compliance with 21 U.S.C. 952, 953, 957, and 958, and in accordance
with 21 CFR part 1312.
9. Liability. Any activity involving 2'-fluoro ortho-
fluorofentanyl, 4'-methyl acetyl fentanyl, [beta]'-phenyl fentanyl,
[beta]-methyl fentanyl, ortho-fluorobutyryl fentanyl, ortho-methyl
acetylfentanyl, ortho-methyl methoxyacetyl fentanyl, para-
methylfentanyl, phenyl fentanyl, and thiofuranyl fentanyl not
authorized by, or in violation of, the CSA or its implementing
regulations is unlawful, and could subject the person to
administrative, civil, and/or criminal sanctions.
Regulatory Analyses
Executive Orders 12866 (Regulatory Planning and Review) and 13563
(Improving Regulation and Regulatory Review)
In accordance with 21 U.S.C. 811(a), this final scheduling action
is subject to formal rulemaking procedures done ``on the record after
opportunity for a hearing,'' which are conducted pursuant to the
provisions of 5 U.S.C. 556 and 557. The CSA sets forth the criteria for
scheduling a drug or other substance. Such actions are exempt from
review by the Office of Management and Budget (OMB) pursuant to section
3(d)(1) of Executive Order (E.O.) 12866 and the principles reaffirmed
in E.O. 13563.
Executive Order 12988, Civil Justice Reform
This regulation meets the applicable standards set forth in
sections 3(a) and 3(b)(2) of E.O. 12988 to eliminate drafting errors
and ambiguity, minimize litigation, provide a clear legal standard for
affected conduct, and promote simplification and burden reduction.
Executive Order 13132, Federalism
This rulemaking does not have federalism implications warranting
the application of E.O. 13132. The rule does not have substantial
direct effects on the States, on the relationship between the National
Government and the States, or the distribution of power and
responsibilities among the various levels of government.
Executive Order 13175, Consultation and Coordination With Indian Tribal
Governments
This rule does not have tribal implications warranting the
application of E.O. 13175. It does not have substantial direct effects
on one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.
Regulatory Flexibility Act
The Acting Administrator, in accordance with the Regulatory
Flexibility Act, 5 U.S.C. 601-602, has reviewed this rule and by
approving it, certifies that it will not have a significant economic
impact on a substantial number of small entities. On February 6, 2018,
DEA published an order to temporarily place fentanyl-related
substances, as defined in the order, in schedule I of the CSA pursuant
to the temporary scheduling provisions of 21 U.S.C. 811(h). DEA
estimates that all entities handling or planning to handle 2'-fluoro
ortho-fluorofentanyl, 4'-methyl acetyl fentanyl, [beta]'-phenyl
fentanyl, [beta]-methyl fentanyl, ortho-fluorobutyryl fentanyl, ortho-
methyl acetylfentanyl, ortho-methyl methoxyacetyl fentanyl, para-
methylfentanyl, phenyl fentanyl, and thiofuranyl fentanyl have already
established and implemented the systems and processes required to
handle these substances which meet the definition of fentanyl-related
substances.
There are currently 57 registrations authorized to handle the
fentanyl-related substances as a class, which include 2'-fluoro ortho-
fluorofentanyl, 4'-methyl acetyl fentanyl, [beta]'-phenyl fentanyl,
[beta]-methyl fentanyl, ortho-fluorobutyryl fentanyl, ortho-methyl
acetylfentanyl, ortho-methyl methoxyacetyl fentanyl, para-
methylfentanyl, phenyl fentanyl, and thiofuranyl fentanyl, as well as a
number of registered analytical labs that are authorized to handle
schedule I controlled substances generally. These 57 registrations
represent 51 entities, of which eight are small entities. Therefore,
DEA estimates eight small entities are affected by this final rule.
A review of the 57 registrations indicates that all entities that
currently handle fentanyl-related substances, including 2'-fluoro
ortho-fluorofentanyl, 4'-methyl acetyl fentanyl, [beta]'-phenyl
fentanyl, [beta]-methyl fentanyl, ortho-fluorobutyryl fentanyl, ortho-
methyl acetylfentanyl, ortho-methyl methoxyacetyl fentanyl, para-
methylfentanyl, phenyl fentanyl, and thiofuranyl fentanyl, also handle
other schedule I controlled substances, and have established and
implemented (or maintain) the systems and processes required to handle
2'-fluoro ortho-fluorofentanyl, 4'-methyl acetyl
[[Page 22117]]
fentanyl, [beta]'-phenyl fentanyl, [beta]-methyl fentanyl, ortho-
fluorobutyryl fentanyl, ortho-methyl acetylfentanyl, ortho-methyl
methoxyacetyl fentanyl, para-methylfentanyl, phenyl fentanyl, and
thiofuranyl fentanyl. Therefore, DEA anticipates that this final rule
will impose minimal or no economic impact on any affected entities, and
thus will not have a significant economic impact on any of the eight
affected small entities. Therefore, DEA has concluded that this rule
will not have a significant effect on a substantial number of small
entities.
Unfunded Mandates Reform Act of 1995
In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995,
2 U.S.C. 1501 et seq., DEA has determined and certifies that this
action would not result in any Federal mandate that may result ``in the
expenditure by State, local, and tribal governments, in the aggregate,
or by the private sector, of $100,000,000 or more (adjusted annually
for inflation) in any 1 year. . . .'' Therefore, neither a Small
Government Agency Plan nor any other action is required under UMRA of
1995.
Congressional Review Act
This rule is not a ``major rule'' as defined in the Congressional
Review Act (CRA), 5 U.S.C. 804. However, DEA is submitting the required
reports to the Government Accountability Office, the House, and the
Senate under the CRA.
Paperwork Reduction Act of 1995
This action does not impose a new collection of information under
the Paperwork Reduction Act of 1995. 44 U.S.C. 3501-3521. This action
would not impose recordkeeping or reporting requirements on State or
local governments, individuals, businesses, or organizations. An agency
may not conduct or sponsor, and a person is not required to respond to,
a collection of information unless it displays a currently valid OMB
control number.
Determination To Make Rule Effective Immediately
As indicated above, this rule finalizes the schedule I control
status of 10 substances that has already been in effect for over three
years. These 10 substances all fall within the definition of fentanyl-
related substances set forth in the February 6, 2018, temporary
scheduling order (83 FR 5188). Through the Temporary Reauthorization
and Study of the Emergency Scheduling of Fentanyl Analogues Act, which
became law on February 6, 2020, Congress extended the temporary control
of fentanyl-related substances until May 6, 2021. The February 2018
order was effective on the date of publication, and was based on
findings by the then-Acting Administrator that the temporary scheduling
of the fentanyl-related substances was necessary to avoid an imminent
hazard to the public safety pursuant to 21 U.S.C. 811(h)(1). Because
this rule finalizes the control status of 10 substances that has
already been in effect for over three years, it does not alter the
legal obligations of any person who handles these substances. Rather,
it merely makes permanent the current scheduling status and
corresponding legal obligations. Therefore, DEA is making the rule
effective on the date of publication in the Federal Register, as any
delay in the effective date is unnecessary and would be contrary to the
public interest.
List of Subjects in 21 CFR Part 1308
Administrative practice and procedure, Drug traffic control,
Reporting and recordkeeping requirements.
For the reasons set out above, DEA amends 21 CFR part 1308 as
follows:
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES
0
1. The authority citation for 21 CFR part 1308 continues to read as
follows:
Authority: 21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise
noted.
0
2. In Sec. 1308.11:
0
a. Redesignate paragraphs (b)(73) through (b)(76) as paragraphs (b)(83)
through (b)(86);
0
b. Redesignate paragraphs (b)(66) through (b)(72) as paragraphs (b)(75)
through (b)(81);
0
c. Redesignate paragraphs (b)(61) through (b)(65) as paragraphs (b)(69)
through (b)(73);
0
d. Redesignate paragraphs (b)(57) through (b)(60) as paragraphs (b)(64)
through (b)(67);
0
e. Redesignate paragraph (b)(56) as paragraph (b)(61);
0
f. Redesignate paragraphs (b)(46) through (b)(55) as paragraphs (b)(50)
through (b)(59);
0
g. Redesignate paragraphs (b)(38) through (b)(45) as paragraphs (b)(41)
through (b)(48);
0
h. Redesignate paragraphs (b)(19) through (b)(37) as paragraphs (b)(21)
through (b)(39); and
0
i. Add new paragraphs (19), (20), (40), (49), (60), (62), (63), (68),
(74), and (82).
The additions read as follows:
Sec. 1308.11 Schedule I.
* * * * *
(b) * * *
* * * * *
(19) beta-Methyl fentanyl (N-phenyl-N-(1-(2- 9856
phenylpropyl)piperidin-4-yl)propionamide; also known as
[beta]-methyl fentanyl)......................................
(20) beta'-Phenyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N,3- 9842
diphenylpropanamide; also known as [beta]'-phenyl fentanyl; 3-
phenylpropanoyl fentanyl)....................................
* * * * * * *
(40) 2'-Fluoro ortho-fluorofentanyl (N-(1-(2- 9855
fluorophenethyl)piperidin-4-yl)-N-(2-
fluorophenyl)propionamide; also known as 2'-fluoro 2-
fluorofentanyl)..............................................
* * * * * * *
(49) 4'-Methyl acetyl fentanyl (N-(1-(4- 9819
methylphenethyl)piperidin-4-yl)-N-phenylacetamide)...........
* * * * * * *
(60) ortho-Fluorobutyryl fentanyl (N-(2-fluorophenyl)-N-(1- 9846
phenethylpiperidin-4-yl)butyramide; also known as 2-
fluorobutyryl fentanyl)......................................
* * * * * * *
(62) ortho-Methyl acetylfentanyl (N-(2-methylphenyl)-N-(1- 9848
phenethylpiperidin-4-yl)acetamide; also known as 2-methyl
acetylfentanyl)..............................................
(63) ortho-Methyl methoxyacetyl fentanyl (2-methoxy-N-(2- 9820
methylphenyl)-N-(1-phenethylpiperidin-4-yl)acetamide; also
known as 2-methyl methoxyacetyl fentanyl)....................
* * * * * * *
(68) para-Methylfentanyl (N-(4-methylphenyl)-N-(1- 9817
phenethylpiperidin-4-yl)propionamide; also known as 4-
methylfentanyl)..............................................
[[Page 22118]]
* * * * * * *
(74) Phenyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N- 9841
phenylbenzamide; also known as benzoyl fentanyl).............
* * * * * * *
(82) Thiofuranyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N- 9839
phenylthiophene-2-carboxamide; also known as 2-thiofuranyl
fentanyl; thiophene fentanyl)................................
* * * * *
D. Christopher Evans,
Acting Administrator.
[FR Doc. 2021-08720 Filed 4-26-21; 8:45 am]
BILLING CODE 4410-09-P
