[Federal Register Volume 85, Number 228 (Wednesday, November 25, 2020)]
[Rules and Regulations]
[Pages 75231-75235]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-22757]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-565]


Schedules of Controlled Substances: Placement of cyclopentyl 
fentanyl, isobutyryl fentanyl, para-chloroisobutyryl fentanyl, para-
methoxybutyryl fentanyl, and valeryl fentanyl in Schedule I

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final rule.

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SUMMARY: The Drug Enforcement Administration places cyclopentyl 
fentanyl (N-(1-phenethylpiperidin-4-yl)-N-
phenylcyclopentanecarboxamide), isobutyryl fentanyl (N-(1-
phenethylpiperidin-4-yl)-N-phenylisobutyramide), para-chloroisobutyryl 
fentanyl (N-(4-chlorophenyl)-N-(1-phenethylpiperidin-4-
yl)isobutyramide), para-methoxybutyryl fentanyl (N-(4-methoxyphenyl)-N-
(1-phenethylpiperidin-4-yl)butyramide), and valeryl fentanyl (N-(1-
phenethylpiperidin-4-yl)-N-phenylpentanamide), 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, in schedule I of the Controlled Substances Act. This action 
continues the imposition of the regulatory controls and administrative, 
civil, and criminal sanctions applicable to schedule I controlled 
substances on persons who handle (manufacture, distribute, import, 
export, engage in research, conduct instructional activities or 
chemical analysis with, or possess), or propose to handle cyclopentyl 
fentanyl, isobutyryl fentanyl, para-chloroisobutyryl fentanyl, para-
methoxybutyryl fentanyl, and valeryl fentanyl.

DATES: Effective date: November 25, 2020.

FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Regulatory Drafting 
and Policy Support Section, Diversion Control Division, Drug 
Enforcement Administration; Mailing Address: 8701 Morrissette Drive, 
Springfield, Virginia 22152; Telephone: (571) 362-3261.

SUPPLEMENTARY INFORMATION:

Legal Authority

    The Controlled Substances Act (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 (1) on his own 
motion; (2) at the request of the Secretary of the Department of Health 
and Human Services (HHS); \1\ or (3) on the petition of any interested 
party. 21 U.S.C. 811(a). This action was initiated on the Attorney 
General's own motion, as delegated to the Administrator of DEA 
(Administrator), and 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 the Drug Enforcement Administration 
(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 or proposes to handle 
cyclopentyl fentanyl, isobutyryl fentanyl, para-chloroisobutyryl 
fentanyl, para-methoxybutyryl fentanyl, and valeryl fentanyl.
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    \1\ As discussed in a memorandum of understanding entered into 
by the Food and Drug Administration (FDA) and the National Institute 
on Drug Abuse (NIDA), FDA acts as the lead agency within HHS in 
carrying out the Secretary's scheduling responsibilities under the 
CSA, with the concurrence of NIDA. 50 FR 9518, Mar. 8, 1985. The 
Secretary of HHS has delegated to the Assistant Secretary for Health 
of HHS the authority to make domestic drug scheduling 
recommendations. 58 FR 35460, July 1, 1993.
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Background

    On February 1, 2018, DEA published an order in the Federal Register 
amending 21 CFR 1308.11(h) to temporarily place cyclopentyl fentanyl 
(N-(1-phenethylpiperidin-4-yl)-N-phenylcyclopentanecarboxamide), 
isobutyryl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-
phenylisobutyramide), para-chloroisobutyryl fentanyl (N-(4-
chlorophenyl)-N-(1-phenethylpiperidin-4-yl)isobutyramide), para-
methoxybutyryl fentanyl (N-(4-methoxyphenyl)-N-(1-phenethylpiperidin-4-
yl)butyramide), and valeryl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-
phenylpentanamide), along with two other substances,\2\ in schedule I 
of the CSA pursuant to the temporary scheduling provisions of 21 U.S.C. 
811(h). 83 FR 4580. That temporary scheduling order was effective on 
the date of publication, and was based on findings by the former Acting 
Administrator that the temporary scheduling of these seven substances 
was necessary to avoid an imminent hazard to the public safety pursuant 
to 21 U.S.C. 811(h)(1). On January 30, 2020, DEA published an order to 
extend the temporary schedule I status of cyclopentyl fentanyl, 
isobutyryl fentanyl, para-chloroisobutyryl fentanyl, para-
methoxybutyryl fentanyl, and valeryl fentanyl by one year, or until 
February 1, 2021, pursuant to 21 CFR 811(h)(2). 85 FR 5321. Also, on 
that same date and in the same issue of the Federal Register, DEA 
simultaneously published a notice of proposed rulemaking (NPRM) to 
permanently control cyclopentyl fentanyl, isobutyryl fentanyl, para-
chloroisobutyryl fentanyl, para-methoxybutyryl fentanyl, and valeryl 
fentanyl in schedule I of the CSA. 85 FR 5356. Specifically, DEA 
proposed to add these five substances to the opiates list under 21 CFR 
1308.11(b).
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    \2\ Those two other substances, ocfentanil (N-(2-fluorophenyl)-
2-methoxy-N-(phenethylpiperidin-4-yl)acetamide) and para-
fluorobutyryl fentanyl (N-(4-fluorophenyl)-N-(1-phenethylpiperidin-
4-yl)butyramide, were subsequently permanently placed in schedule I 
on November 29, 2018 (83 FR 61320) and October 25, 2019 (84 FR 
57323), respectively, pursuant to 21 U.S.C. 811(d)(1).
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DEA and HHS Eight Factor Analyses

    On November 12, 2019, the Assistant Secretary submitted HHS's 
scientific and medical evaluation and scheduling recommendation for 
cyclopropyl fentanyl, para-fluorobutyryl fentanyl, cyclopentyl 
fentanyl, isobutyryl fentanyl, para-chloroisobutyryl fentanyl, para-
methoxybutyryl fentanyl, and valeryl fentanyl to the former Acting 
Administrator.\3\ 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 cyclopentyl fentanyl, isobutyryl fentanyl, 
para-chloroisobutyryl fentanyl, para-methoxybutyryl fentanyl, and 
valeryl fentanyl be controlled in schedule I of the CSA. In response, 
DEA conducted its own eight-factor analysis of cyclopentyl fentanyl, 
isobutyryl

[[Page 75232]]

fentanyl, para-chloroisobutyryl fentanyl, para-methoxybutyryl fentanyl, 
and valeryl fentanyl. DEA and HHS analyses are available in their 
entirety in the public docket for this rule (Docket Number DEA-565) at 
http://www.regulations.gov under ``Supporting Documents.''
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    \3\ Although HHS also provided information on cyclopropyl 
fentanyl and para-fluorobutyryl fentanyl, these two substances will 
not be discussed in this final rule since they were permanently 
placed in schedule I on October 25, 2019. 84 FR 57323.
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Determination To Schedule cyclopentyl fentanyl, isobutyryl fentanyl, 
para-chloroisobutyryl fentanyl, para-methoxybutyryl fentanyl, and 
valeryl fentanyl

    After a 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 cyclopentyl fentanyl, isobutyryl fentanyl, para-
chloroisobutyryl fentanyl, para-methoxybutyryl fentanyl, and valeryl 
fentanyl into schedule I.'' This rule proposed to control cyclopentyl 
fentanyl, isobutyryl fentanyl, para-chloroisobutyryl fentanyl, para-
methoxybutyryl fentanyl, and valeryl 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, in schedule I of the CSA. 85 FR 5356, January 30, 2020. The 
NPRM provided an opportunity for interested persons to file a request 
for hearing in accordance with DEA regulations on or before March 2, 
2020. No requests for such a hearing were received by DEA. The NPRM 
also provided an opportunity for interested persons to submit comments 
on or before March 2, 2020.

Comments Received

    DEA received six comments on the proposed rule to permanently 
control cyclopentyl fentanyl, isobutyryl fentanyl, para-
chloroisobutyryl fentanyl, para-methoxybutyryl fentanyl, and valeryl 
fentanyl in schedule I of the CSA. The submissions were from individual 
or anonymous commenters. Two commenters provided support for the rule, 
and one commenter opposed the rule. Three other commenters either 
supported or opposed the proposal, but misunderstood it to be 
rescheduling fentanyl from schedule II to schedule I. As such, the 
latter three comments were outside the scope of this current scheduling 
action.
    Comment: The two commenters provided different reasons for 
supporting the proposed rule. One commenter stated the proposed rule 
was beneficial and expressed displeasure with drug dealers, but did not 
elaborate further. The other commenter stated that according to the 
Centers for Disease Control and Prevention, abusing unregulated opioids 
represents a significant risk of opioid overdose to users. 
Additionally, the commenter stated that the opioid abuse epidemic is 
incurring not only financial, but also social and emotional damage. 
Lastly, this commenter stated that these five substances meet DEA's 
requirements for schedule I control, and noted they are structurally 
similar to the opioid fentanyl, lack FDA approval for treatment, and 
are of unknown quality and potency.
    DEA Response: DEA appreciates the comments in support of this 
rulemaking.
    Comment: One commenter stated that DEA's proposal to only place 
five structural variants of fentanyl in schedule I is ``stupid'' and 
will not solve the problem when ``China imports [sic] four hundred 
variants'' (taken to be asserting that China exports 400 such variants 
of fentanyl to the United States). The commenter suggested that DEA 
determine every possible ``fentanyl variant'' and place them all in 
schedule I rather than control individual substances.
    DEA Response: Similar to what this commenter suggested, the agency 
has undertaken a broad scheduling action for fentanyl-related 
substances. Specifically, on February 6, 2018, the former Acting 
Administrator of DEA published an order to temporarily schedule 
fentanyl-related substances, a class of substances as defined in the 
order, and their isomers, esters, ethers, salts, and salts of isomers, 
esters, and ethers in schedule I. 83 FR 5188. This temporary order 
defined a fentanyl-related substance to mean any substance not 
otherwise controlled in any schedule (i.e., not listed under another 
DEA Controlled Substance Code Number), and for which no exemption or 
approval is in effect under section 505 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355), that is structurally related to fentanyl 
by one or more of five specified structural modifications. The class of 
fentanyl-related substances that was the subject of the February 6, 
2018, temporary scheduling order is currently listed in 21 CFR 
1308.11(h)(30). Although the temporary scheduling of the fentanyl-
related substances was scheduled to expire on February 6, 2020, 
Congress enacted a new law to extend the temporary scheduling of all of 
those fentanyl-related substances until May 6, 2021. (Pub. L. 116-114, 
Sec. 2).
    As indicated above, the final rule being issued today applies to 
five fentanyl-related substances that were the subject of a February 1, 
2018 temporary scheduling order (which was issued five days prior to 
the class-wide temporary scheduling of fentanyl-related substances). 
These five substances will now be listed in 21 CFR 1308.11(b), as 
specified in the text of the rule that appears below.

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 cyclopentyl 
fentanyl, isobutyryl fentanyl, para-chloroisobutyryl fentanyl, para-
methoxybutyryl fentanyl, and valeryl fentanyl. DEA is permanently 
scheduling cyclopentyl fentanyl, isobutyryl fentanyl, para-
chloroisobutyryl fentanyl, para-methoxybutyryl fentanyl, and valeryl 
fentanyl as schedule I 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 specifies 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 for HHS and review of all 
other available data, the Acting Administrator of DEA, pursuant to 21 
U.S.C. 811(a) and 812(b)(1), finds the following:
    (1) The abuse potential of cyclopentyl fentanyl, isobutyryl 
fentanyl, para-chloroisobutyryl fentanyl, para-methoxybutyryl fentanyl, 
and valeryl fentanyl is associated with each substance's 
pharmacological similarity to other schedule I and II mu-opioid 
receptor agonist substances which have a high potential for abuse. 
Similar to morphine (schedule II), fentanyl (schedule II), and several 
schedule I opioid substances that are structurally related to fentanyl, 
cyclopentyl fentanyl, isobutyryl fentanyl, para-chloroisobutyryl 
fentanyl, para-methoxybutyryl fentanyl, and valeryl fentanyl have been 
shown to bind and act as mu-opioid receptor agonists;
    (2) Cyclopentyl fentanyl, isobutyryl fentanyl, para-
chloroisobutyryl fentanyl, para-methoxybutyryl fentanyl, and valeryl 
fentanyl have no currently

[[Page 75233]]

accepted medical use in treatment in the United States; \4\ and
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    \4\ Although there is no evidence suggesting that cyclopentyl 
fentanyl, isobutyryl fentanyl, para-chloroisobutyryl fentanyl, para-
methoxybutyryl fentanyl, and valeryl 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).
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    (3) There is a lack of accepted safety for use of cyclopentyl 
fentanyl, isobutyryl fentanyl, para-chloroisobutyryl fentanyl, para-
methoxybutyryl fentanyl, and valeryl fentanyl under medical 
supervision.
    Based on these findings, the Acting Administrator of DEA concludes 
that cyclopentyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-
phenylcyclopentanecarboxamide), isobutyryl fentanyl (N-(1-
phenethylpiperidin-4-yl)-N-phenylisobutyramide), para-chloroisobutyryl 
fentanyl (N-(4-chlorophenyl)-N-(1-phenethylpiperidin-4-
yl)isobutyramide), para-methoxybutyryl fentanyl (N-(4-methoxyphenyl)-N-
(1-phenethylpiperidin-4-yl)butyramide), and valeryl fentanyl (N-(1-
phenethylpiperidin-4-yl)-N-phenylpentanamide), 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 control in schedule I of the CSA. 21 U.S.C. 
812(b)(1).
    This final rule does not affect the scheduling of fentanyl itself, 
which remains a Schedule II controlled substance.

Requirements for Handling cyclopentyl fentanyl, isobutyryl fentanyl, 
para-chloroisobutyryl fentanyl, para-methoxybutyryl fentanyl, and 
valeryl fentanyl

    Cyclopentyl fentanyl, isobutyryl fentanyl, para-chloroisobutyryl 
fentanyl, para-methoxybutyryl fentanyl, and valeryl fentanyl will 
continue \5\ to be subject to the CSA's schedule I regulatory controls 
and administrative, civil, and criminal sanctions applicable to the 
manufacture, distribution, dispensing, importing, exporting, research, 
and conduct of instructional activities, including the following:
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    \5\ Cyclopentyl fentanyl, isobutyryl fentanyl, para-
chloroisobutyryl fentanyl, para-methoxybutyryl fentanyl, and valeryl 
fentanyl have been subject to schedule I controls on a temporary 
basis, pursuant to 21 U.S.C. 811(h), by virtue of the February 1, 
2018 temporary scheduling order (83 FR 4580) and the subsequent one-
year extension of that order (January 30, 2020, 85 FR 5321).
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    1. Registration. Any person who handles (manufactures, distributes, 
dispenses, imports, exports, engages in research, or conducts 
instructional activities or chemical analysis with, or possesses) 
cyclopentyl fentanyl, isobutyryl fentanyl, para-chloroisobutyryl 
fentanyl, para-methoxybutyryl fentanyl, and valeryl fentanyl, or who 
desires to handle cyclopentyl fentanyl, isobutyryl fentanyl, para-
chloroisobutyryl fentanyl, para-methoxybutyryl fentanyl, and valeryl 
fentanyl, is required to 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. Cyclopentyl fentanyl, isobutyryl fentanyl, para-
chloroisobutyryl fentanyl, para-methoxybutyryl fentanyl, and valeryl 
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 1301.71-1301.93. Non-practitioners handling these five 
substances must also 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 cyclopentyl fentanyl, isobutyryl fentanyl, para-
chloroisobutyryl fentanyl, para-methoxybutyryl fentanyl, and valeryl 
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 cyclopentyl fentanyl, isobutyryl fentanyl, para-
chloroisobutyryl fentanyl, para-methoxybutyryl fentanyl, and valeryl 
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 cyclopentyl 
fentanyl, isobutyryl fentanyl, para-chloroisobutyryl fentanyl, para-
methoxybutyryl fentanyl, and valeryl 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 cyclopentyl 
fentanyl, isobutyryl fentanyl, para-chloroisobutyryl fentanyl, para-
methoxybutyryl fentanyl, and valeryl 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 cyclopentyl 
fentanyl, isobutyryl fentanyl, para-chloroisobutyryl fentanyl, para-
methoxybutyryl fentanyl, and valeryl fentanyl, pursuant to 21 U.S.C. 
827 and 958(e), and in accordance with 21 CFR parts 1304 and 1312.
    7. Order Forms. Every DEA registrant who distributes cyclopentyl 
fentanyl, isobutyryl fentanyl, para-chloroisobutyryl fentanyl, para-
methoxybutyryl fentanyl, and valeryl fentanyl is required to comply 
with the order form requirements, pursuant to 21 U.S.C. 828, and 21 CFR 
part 1305.
    8. Importation and Exportation. All importation and exportation of 
cyclopentyl fentanyl, isobutyryl fentanyl, para-chloroisobutyryl 
fentanyl, para-methoxybutyryl fentanyl, and valeryl 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 cyclopentyl fentanyl, 
isobutyryl fentanyl, para-chloroisobutyryl fentanyl, para-
methoxybutyryl fentanyl, and valeryl fentanyl not authorized by, or in 
violation of, the CSA or its implementing regulations is unlawful, and 
may subject the person to administrative, civil, and/or criminal 
sanctions.

Regulatory Analyses

Executive Orders (E.O.) 12866, 13563, and 13771, Regulatory Planning 
and Review, Improving Regulation and Regulatory Review, and Reducing 
Regulation and Controlling Regulatory Costs

    In accordance with 21 U.S.C. 811(a), this final scheduling action 
is subject to formal rulemaking procedures performed ``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

[[Page 75234]]

or other substance. Such actions are exempt from review by the Office 
of Management and Budget (OMB) pursuant to section 3(d)(1) of E.O. 
12866 and the principles reaffirmed in E.O. 13563.
    This final rule does not meet the definition of an E.O. 13771 
regulatory action. OMB has previously determined that formal rulemaking 
actions concerning the scheduling of controlled substances, such as 
this rule, are not significant regulatory actions under section 3(f) of 
E.O. 12866.

Executive Order 12988

    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

    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

    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 (RFA), 5 U.S.C. 601-602, has reviewed this final rule 
and, by approving it, certifies that it will not have a significant 
economic impact on a substantial number of small entities. On February 
1, 2018, DEA published an order to temporarily place cyclopentyl 
fentanyl, isobutyryl fentanyl, para-chloroisobutyryl fentanyl, para-
methoxybutyryl fentanyl, and valeryl fentanyl 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 
cyclopentyl fentanyl, isobutyryl fentanyl, para-chloroisobutyryl 
fentanyl, para-methoxybutyryl fentanyl, and valeryl fentanyl have 
already established and implemented the systems and processes required 
to handle these substances.
    As discussed in the NPRM, there are 34 registrations authorized to 
handle one or more of the following substances: cyclopentyl fentanyl, 
isobutyryl fentanyl, para-chloroisobutyryl fentanyl, para-
methoxybutyryl fentanyl, or valeryl fentanyl, as well as a number of 
registered analytical labs that are authorized to handle schedule I 
controlled substances generally. These 34 registrations represent 26 
entities, of which eight are small entities. Therefore, DEA estimates 
eight small entities are affected by this rule.
    A review of the 34 registrations indicates that all entities that 
currently handle cyclopentyl fentanyl, isobutyryl fentanyl, para-
chloroisobutyryl fentanyl, para-methoxybutyryl fentanyl, and valeryl 
fentanyl also handle other schedule I controlled substances and have 
established and implemented (or maintain) the systems and processes 
required to handle these substances. 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 final rule will not have a significant economic 
impact 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 million 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.

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.

Congressional Review Act

    This rule is not a major rule as defined by the Congressional 
Review Act (CRA), 5 U.S.C. 804. This rule will not result in: ``an 
annual effect on the economy of $100 million or more; a major increase 
in costs or prices for consumers, individual industries, Federal, 
State, or local government agencies, or geographic regions; or 
significant adverse effects on competition, employment, investment, 
productivity, innovation, or on the ability of United States-based 
enterprises to compete with foreign-based enterprises in domestic and 
export markets.'' However, pursuant to the CRA, DEA has submitted a 
copy of this final rule to both Houses of Congress and to the 
Comptroller General.

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, 21 CFR part 1308 is amended 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. Revise paragraphs (b)(22), (40), (56), and (59);
0
b. Add paragraph (b)(75);
0
c. Remove and reserve paragraphs (h)(23), and (h)(25) through (h)(28).
    The revisions and addition read as follows:


Sec.  1308.11   Schedule I.

* * * * *
    (b) * * *

(22) Cyclopentyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-         9847
 phenylcyclopentanecarboxamide)............................
 
                              * * * * * * *
(40) Isobutyryl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-          9827
 phenylisobutyramide)......................................
 
                              * * * * * * *
(56) para-Chloroisobutyryl fentanyl (N-(4-chlorophenyl)-N-          9826
 (1-phenethylpiperidin-4-yl)isobutyramide..................

[[Page 75235]]

 
 
                              * * * * * * *
(59) para-Methoxybutyryl fentanyl (N-(4-methoxyphenyl)-N-(1-        9837
 phenethylpiperidin-4-yl)butyramide).......................
 
                              * * * * * * *
(75) Valeryl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-             9840
 phenylpentanamide)........................................
 

* * * * *

Timothy J. Shea,
Acting Administrator.
[FR Doc. 2020-22757 Filed 11-24-20; 8:45 am]
BILLING CODE 4410-09-P