[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