[Federal Register Volume 85, Number 192 (Friday, October 2, 2020)]
[Rules and Regulations]
[Pages 62215-62218]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-19305]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-633]


Schedules of Controlled Substances: Placement of Crotonyl 
Fentanyl in Schedule I

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final amendment; final order.

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SUMMARY: With the issuance of this final order, the Acting 
Administrator of the Drug Enforcement Administration maintains the 
placement of crotonyl fentanyl ((E)-N-(1-phenethylpiperidin-4-yl)-N-
phenylbut-2-enamide), including its isomers, esters, ethers, salts, and 
salts of isomers, esters, and ethers, in schedule I of the Controlled 
Substances Act. This scheduling action discharges the United States' 
obligations under the Single Convention on Narcotic Drugs (1961). This 
action continues to impose 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 or conduct instructional activities with, or 
possess), or propose to handle crotonyl fentanyl.

DATES: Effective October 2, 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 United States is a party to the 1961 United Nations Single 
Convention on Narcotic Drugs (``Single Convention''), March 30, 1961, 
18 U.S.T. 1407, 570 U.N.T.S. 151, as amended. Article 3, paragraph 7 of 
the Single Convention requires that if the Commission on Narcotic Drugs 
(``Commission'') adds a substance to one of the schedules of such 
Convention, and the United States receives notification of such 
scheduling decision from the Secretary-General of the United Nations 
(``Secretary-General''), the United States, as a signatory Member 
State, is obligated to control the substance under its national drug 
control legislation. Under 21 U.S.C. 811(d)(1) of the Controlled 
Substances Act (CSA), if control of a substance is required ``by United 
States' obligations under international treaties, conventions, or 
protocols in effect on October 27, 1970,'' the Attorney General must 
issue an order permanently controlling such drug under the schedule he 
deems most appropriate to carry out such obligations, without regard to 
the findings required by 21 U.S.C. 811(a) or 812(b), and without regard 
to the procedures prescribed by 21 U.S.C. 811(a) and (b). The Attorney 
General has delegated scheduling authority under 21 U.S.C. 811 to the 
Administrator of the Drug Enforcement Administration (Administrator of 
DEA or Administrator). 28 CFR 0.100.

Background

    On February 6, 2018, DEA issued a temporary scheduling order, 
placing fentanyl-related substances, as defined in the order, in 
schedule I of the CSA. 83 FR 5188. That order was based on findings by 
the former Acting Administrator that the temporary scheduling of this 
class of substances was necessary to avoid an imminent hazard to the 
public safety; the order was codified at 21 CFR 1308.11(h)(30). On 
April 19, 2019, in the Federal Register, DEA provided the chemical name 
for crotonyl fentanyl, along with four other substances, identifying 
how these individual substances met the definition for fentanyl-related 
substances,\1\ and, as such, were already covered by the February 2018 
temporary order. 84 FR 16397. Regarding crotonyl fentanyl specifically, 
this substance was not otherwise controlled in any schedule (i.e., 
listed under another Administration Substance Controlled Number) and is 
structurally related to fentanyl by the replacement of the N-propionyl 
group by another acyl group (i.e., meets definition for modification 
E). On February 6, 2020, Congress extended the temporary control of 
fentanyl-related substances, as set forth in 21 CFR 1308.11(h)(30), 
until May 6, 2021. Public Law 116-114, sec. 2, 134 Stat. 103 (2020).
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    \1\ These four other substances (2'-fluoro ortho-fluorofentanyl, 
ortho-methyl acetylfentanyl, beta'-phenyl fentanyl, and thiofuranyl 
fentanyl) will not be discussed further in this final order.
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    In November 2019, the Director-General of the World Health 
Organization recommended to the Secretary-General that crotonyl 
fentanyl and valeryl fentanyl be placed in Schedule I of the Single 
Convention, as these two substances have opioid mechanisms of action 
and similarity to drugs that are controlled in Schedule I of the Single 
Convention (i.e., crotonyl fentanyl is similar to drugs such as 
oxycodone and fentanyl; valeryl fentanyl is similar to drugs such as 
fentanyl), and have dependence and abuse potential. On May 7, 2020, the 
Secretary-General advised the Secretary of State of the United States, 
by letter, that during its 63rd session in March 2020, the Commission 
voted to place crotonyl fentanyl and valeryl fentanyl in Schedule I of 
the Single Convention (CND Mar/63/2 and Mar/63/3). Valeryl fentanyl is 
temporarily controlled in schedule I of the CSA until February 1, 2021 
(85 FR 5321, Jan. 30, 2020), and it will not be discussed in this final 
order.\2\
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    \2\ DEA issued a notice of proposed rulemaking to permanently 
control valeryl fentanyl in schedule I (85 FR 5356, Jan. 30, 2020) 
and is currently working to finalize that rule.
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Crotonyl Fentanyl

    As discussed in the background section, crotonyl fentanyl is 
temporarily controlled in schedule I of the CSA, as it meets the 
definition of fentanyl-related substances, pursuant to 21 CFR 
1308.11(h)(30). Accordingly, crotonyl fentanyl is scheduled as part of 
a class of substances.
    Crotonyl fentanyl has a pharmacological profile similar to 
morphine, fentanyl, and other synthetic opioids that act as [micro]-
opioid receptor agonists. For this reason, crotonyl fentanyl is abused 
for its opioid-like effects.
    Law enforcement reports in the United States demonstrate the 
illicit use and distribution of this substance, which are similar to 
that of heroin and prescription opioid analgesics. The National 
Forensic Laboratory Information System (NFLIS) is a national drug 
forensic laboratory reporting system that systematically collects 
results from drug chemistry analyses conducted by other federal, state, 
and local forensic laboratories across the country. According to

[[Page 62216]]

NFLIS,\3\ there have been 143 reports containing crotonyl fentanyl 
since it was first reported in June 2017.
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    \3\ NFLIS was queried on April 14, 2020. Data are still being 
collected for November 2019 to April 2020 due to the normal lag 
period for labs reporting to NFLIS.
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    DEA is not aware of any claims or any medical or scientific 
literature suggesting that crotonyl fentanyl has a currently accepted 
medical use in treatment in the United States. In addition, the 
Department of Health and Human Services (HHS) advised DEA, by letter 
dated November 29, 2017, that there were no investigational new drug 
applications or approved new drug applications for fentanyl-related 
substances, a class that, as noted, includes crotonyl fentanyl.
    DEA requested that HHS conduct a scientific and medical evaluation 
and a scheduling recommendation for several fentanyl-related 
substances, including crotonyl fentanyl, by letter dated April 3, 2019. 
In response to this request, HHS provided DEA a recommendation, dated 
July 2, 2020, to place crotonyl fentanyl in schedule I of the CSA. The 
recommendation from HHS is consistent with the placement of crotonyl 
fentanyl in Schedule I of the Single Convention in March 2020.
    Normally, 21 U.S.C. 811(b) would require DEA to secure such an HHS 
recommendation as part of the regular scheduling process. As discussed 
above, however, DEA has authority under 21 U.S.C. 811(d)(1) to control 
substances that have been added to the Single Convention without making 
any findings otherwise required by 21 U.S.C. 811(a) or 812(b), and 
without following the procedures prescribed by 21 U.S.C. 811(a) and 
(b)--including 811(b)'s requirement that DEA secure an evaluation and 
recommendation from HHS. Thus, HHS's recommendation supports scheduling 
crotonyl fentanyl, but its scheduling does not depend on that 
recommendation.
    Therefore, consistent with 21 U.S.C. 811(d)(1), DEA concludes that 
crotonyl fentanyl has no currently accepted medical use in treatment in 
the United States \4\ and is most appropriately placed in schedule I of 
the CSA, the same schedule in which it currently resides. Because 
control is required under the Single Convention, DEA will not be 
initiating regular rulemaking proceedings to schedule crotonyl fentanyl 
pursuant to 21 U.S.C. 811(a).
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    \4\ Although, as discussed above, there is no evidence 
suggesting that crotonyl fentanyl has 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 the Food and Drug Administration, 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 (March 26, 1992).
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    This action establishes a specific listing for crotonyl fentanyl in 
schedule I of the CSA within 21 CFR 1308.11(b) (the opiates category of 
schedule I), and assigns an Administration Controlled Substances Number 
for the substance: As discussed above, crotonyl fentanyl was not 
previously listed in schedule I individually, but was instead 
temporarily controlled as part of the class of fentanyl-related 
substances controlled under 21 CFR 1308.11(h)(30). This action will 
allow DEA to establish an aggregate production quota for crotonyl 
fentanyl and grant individual manufacturing and procurement quotas to 
DEA-registered manufacturers of crotonyl fentanyl who had previously 
been granted individual quotas for such purposes under the drug code 
for fentanyl-related substances.

Conclusion

    In order to meet the United States' obligations under the Single 
Convention and because crotonyl fentanyl has no currently accepted 
medical use in treatment in the United States, the Acting Administrator 
has determined that crotonyl fentanyl, including its isomers, esters, 
ethers, salts, and salts of isomers, esters, and ethers, whenever the 
existence of such isomers, esters, ethers, and salts is possible, 
should remain in schedule I of the CSA.

Requirements for Handling

    Crotonyl fentanyl has been controlled as a schedule I controlled 
substance since February 6, 2018. With publication of the final order 
contained in this document, crotonyl fentanyl remains subject to the 
CSA's schedule I regulatory controls and administrative, civil, and 
criminal sanctions applicable to the manufacture of, distribution of, 
importation of, exportation of, engagement in research or conduct of 
instructional activities with, and possession of, schedule I controlled 
substances, including the following:
    1. Registration. Any person who handles (manufactures, distributes, 
imports, exports, engages in research or conducts instructional 
activities with, or possesses), or who desires to handle, crotonyl 
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. Disposal of stocks. Crotonyl fentanyl must be disposed of in 
accordance with 21 CFR part 1317, in addition to all other applicable 
federal, state, local, and tribal laws.
    3. Security. Crotonyl fentanyl is subject to schedule I security 
requirements and must be handled and stored pursuant to 21 U.S.C. 821, 
823, 871(b), and in accordance with 21 CFR 1301.71 through 1301.93. 
Non-practitioners handling crotonyl fentanyl must also comply with the 
employee screening requirements of 21 CFR 1301.90 through 1301.93.
    4. Labeling and packaging. All labels, labeling, and packaging for 
commercial containers of crotonyl fentanyl must be in compliance with 
21 U.S.C. 825 and 958(e), and must be in accordance with 21 CFR part 
1302.
    5. Quota. Only registered manufacturers are permitted to 
manufacture crotonyl fentanyl in accordance with a quota assigned 
pursuant to 21 U.S.C. 826 and in accordance with 21 CFR part 1303.
    6. Inventory. Every DEA registrant who possesses any quantity of 
crotonyl fentanyl has been required to keep an inventory of all stocks 
of this substance on hand as of February 6, 2018, pursuant to 21 U.S.C. 
827 and 958(e), and in accordance with 21 CFR 1304.03, 1304.04, and 
1304.11.
    7. Records and Reports. DEA registrants must maintain records and 
submit reports with respect to crotonyl fentanyl pursuant to 21 U.S.C. 
827 and 958(e), and in accordance with 21 CFR parts 1304, 1312, and 
1317.
    8. Order Forms. All DEA registrants who distribute crotonyl 
fentanyl must continue to comply with order form requirements pursuant 
to 21 U.S.C. 828 and in accordance with 21 CFR part 1305.
    9. Importation and Exportation. All importation and exportation of 
crotonyl fentanyl must continue to be in compliance with 21 U.S.C. 952, 
953, 957, and 958, and in accordance with 21 CFR part 1312.
    10. Liability. Any activity involving crotonyl fentanyl not 
authorized by, or in violation of the CSA, is unlawful, and may subject 
the person to administrative, civil, and/or criminal sanctions.

Regulatory Analyses

    Executive Orders 12866, 13563, and 13771, Regulatory Planning and 
Review, Improving Regulation and Regulatory Review, and Reducing 
Regulation and Controlling Regulatory Costs

[[Page 62217]]

    This action is not a significant regulatory action as defined by 
Executive Order (E.O.) 12866 (Regulatory Planning and Review), section 
3(f), and the principles reaffirmed in E.O. 13563 (Improving Regulation 
and Regulatory Review); and, accordingly, this action has not been 
reviewed by the Office of Management and Budget (OMB). This order is 
not an E.O. 13771 regulatory action because this rule is not 
significant under E.O. 12866.

Executive Order 12988, Civil Justice Reform

    This action 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 action does not have federalism implications warranting the 
application of E.O. 13132. This action does not have substantial direct 
effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government.

Executive Order 13175, Consultation and Coordination With Indian Tribal 
Governments

    This action does not have tribal implications warranting the 
application of E.O. 13175. The action 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.

Administrative Procedure Act

    The CSA provides for an expedited scheduling action where control 
is required by the United States obligations under international 
treaties, conventions, or protocols. 21 U.S.C. 811(d)(1). If control is 
required pursuant to such international treaty, convention, or 
protocol, the Attorney General, as delegated to the Administrator, must 
issue an order controlling such drug under the schedule he deems most 
appropriate to carry out such obligations, without regard to the 
findings or procedures otherwise required for scheduling actions. Id.
    In accordance with 21 U.S.C. 811(d)(1), scheduling actions for 
drugs that are required to be controlled by the United States' 
obligations under international treaties, conventions, or protocols in 
effect on October 27, 1970, shall be issued by order (as compared to 
scheduling by rule pursuant to 21 U.S.C. 811(a)). Therefore, DEA 
believes that the notice and comment requirements of section 553 of the 
Administrative Procedure Act (APA), 5 U.S.C. 553, do not apply to this 
scheduling action. In the alternative, even if this action does 
constitute ``rule making'' under 5 U.S.C. 551(5), this action is exempt 
from the notice and comment requirements of 5 U.S.C. 553 pursuant to 5 
U.S.C. 553(a)(1) as an action involving a foreign affairs function of 
the United States because it is being done pursuant to 21 U.S.C. 
811(d)(1), which requires that the United States comply with its 
obligations under the specified international agreements.

Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) applies to 
rules that are subject to notice and comment under section 553(b) of 
the APA or any other law. As explained above, the CSA exempts this 
final order from notice and comment. Consequently, the RFA does not 
apply to this action.

Paperwork Reduction Act of 1995

    This action does not impose a new collection of information 
requirement under the Paperwork Reduction Act of 1995. 44 U.S.C. 3501-
3521. 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 action is not a major rule as defined by the Congressional 
Review Act (CRA), 5 U.S.C. 804. This order will not result in: ``an 
annual effect on the economy of $100,000,000 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 order 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, DEA amends 21 CFR part 1308 as 
follows:

PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

0
1. The authority citation for 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)(22) through (70) as (b)(23) through (71); 
and
0
b. Add new paragraph (b)(22).
    The addition reads as follows:


Sec.  1308.11   Schedule I.

* * * * *
    (b) * * *

 
 
 
(22) Crotonyl fentanyl ((E)-N-(1-phenethylpiperidin-4-              9844
 yl)-N-phenylbut-2-enamide).............................
 


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* * * * *

Timothy J. Shea,
Acting Administrator.
[FR Doc. 2020-19305 Filed 10-1-20; 8:45 am]
BILLING CODE 4410-09-P