[Federal Register Volume 84, Number 207 (Friday, October 25, 2019)]
[Rules and Regulations]
[Pages 57323-57326]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23348]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-507]
Schedules of Controlled Substances: Placement of Cyclopropyl
Fentanyl, Methoxyacetyl fentanyl, ortho-Fluorofentanyl, and para-
Fluorobutyryl 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
[[Page 57324]]
maintains the placement of the substances cyclopropyl fentanyl (N-(1-
phenethylpiperidin-4-yl)-N-phenylcyclopropanecarboxamide),
methoxyacetyl fentanyl (2-methoxy-N-(1-phenethylpiperidin-4-yl)-N-
phenylacetamide), ortho-fluorofentanyl (N-(2-fluorophenyl)-N-(1-
phenethylpiperidin-4-yl)propionamide), and para-fluorobutyryl fentanyl
(N-(4-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)butyramide), including
their 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, cyclopropyl fentanyl, methoxyacetyl fentanyl, ortho-
fluorofentanyl, and para-fluorobutyryl fentanyl.
DATES: Effective October 25, 2019.
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: (202) 598-6812.
SUPPLEMENTARY INFORMATION:
Legal Authority
Section 201(d)(1) of the Controlled Substances Act (CSA) (21 U.S.C.
811(d)(1)) states that, 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 shall
issue an order controlling such drug under the schedule he deems most
appropriate to carry out such obligations, without regard to the
findings required by [section 201(a) (21 U.S.C. 811(a)] or section
[202(b) (21 U.S.C. 812(b)) of the Act] and without regard to the
procedures prescribed by [section 201 (a) and (b) (21 U.S.C. 811(a) and
(b)].'' If a substance is added to one of the schedules of the Single
Convention on Narcotic Drugs (1961), then, in accordance with article
3, paragraph 7 of the Convention, as a signatory Member State, the
United States is obligated to control the substance under its national
drug control legislation, the CSA. The Attorney General has delegated
scheduling authority under 21 U.S.C. 811 to the Administrator of the
Drug Enforcement Administration (DEA). 28 CFR 0.100.
Background
On May 23, 2019, the Secretary-General of the United Nations send a
letter to the Secretary of State of the United States advising him that
during the 62nd session of the Commission on Narcotic Drugs,
cyclopropyl fentanyl, methoxyacetyl fentanyl, ortho-fluorofentanyl, and
para-fluorobutyryl fentanyl were added to Schedule I of the Single
Convention on Narcotic Drugs (1961). This letter was prompted by a
decision at the 62nd session of the Commission on Narcotic Drugs in
March 2019 to schedule cyclopropyl fentanyl, methoxyacetyl fentanyl,
ortho-fluorofentanyl, and para-fluorobutyryl fentanyl under Schedule I
of the Single Convention on Narcotic Drugs. As a signatory Member State
to the Single Convention on Narcotic Drugs, the United States is
obligated to control cyclopropyl fentanyl, methoxyacetyl fentanyl,
ortho-fluorofentanyl, and para-fluorobutyryl fentanyl under its
national drug control legislation, the CSA, in the schedule deemed most
appropriate to carry out its international obligations. 21 U.S.C.
811(d)(1).
Cyclopropyl Fentanyl, Methoxyacetyl Fentanyl, ortho-Fluorofentanyl, and
para-Fluorobutyryl Fentanyl
Cyclopropyl fentanyl (83 FR 469, January 4, 2018), methoxyacetyl
fentanyl and ortho-fluorofentanyl (82 FR 49504, October 26, 2017), and
para-fluorobutyryl fentanyl (83 FR 4580, February 1, 2018) were
temporarily controlled in schedule I of the CSA upon finding that they
pose an imminent hazard to the public safety. These substances share
pharmacological profiles similar to morphine, fentanyl, and other
synthetic opioids which act as [micro]-opioid receptor agonists. For
this reason, cyclopropyl fentanyl, methoxyacetyl fentanyl, ortho-
fluorofentanyl, and para-fluorobutyryl fentanyl are abused for their
opioid-like effects. Law enforcement and public health reports
demonstrate the illicit use and distribution of these substances, which
are similar to that of heroin and prescription opioid analgesics.
Cyclopropyl fentanyl, methoxyacetyl fentanyl, ortho-fluorofentanyl,
and para-fluorobutyryl fentanyl were identified in law enforcement
encounters in the United States. 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 NFLIS,\1\ cyclopropyl
fentanyl (first reported in 2016) was identified in 2,461 exhibits
submitted to forensic laboratories, methoxyacetyl fentanyl (first
reported in 2017) was identified in 1,718 exhibits, ortho-
fluorofentanyl (first reported in 2016) was identified in 13 exhibits,
and para-fluorobutyryl fentanyl (first reported in 2015) was identified
in 309 exhibits.
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\1\ NFLIS was queried on June 7, 2019. Data are still being
collected for January 2019--June 2019 due to the normal lag period
for labs reporting to NFLIS.
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The DEA is not aware of any claims or any medical or scientific
literature suggesting that cyclopropyl fentanyl, methoxyacetyl
fentanyl, ortho-fluorofentanyl, or para-fluorobutyryl fentanyl have a
currently accepted medical use in treatment in the United States. In
addition, the Department of Health and Human Services (HHS) advised the
DEA, by letters dated September 6, 2017 (cyclopropyl fentanyl), July
14, 2017 (methoxyacetyl fentanyl), June 9, 2017 (ortho-fluorofentanyl),
and November 8, 2017 (para-fluorobutyryl fentanyl) that there were no
investigational new drug applications or approved new drug applications
for these substances.
The DEA requested that HHS conduct a scientific and medical
evaluation and a scheduling recommendation for methoxyacetyl fentanyl
and ortho-fluorofentanyl (by letter dated April 18, 2018) and
cyclopropyl fentanyl and para-fluorobutyryl fentanyl (by letter dated
November 5, 2018). Regardless of these requests and any potential
responses from HHS, the DEA is not required under 21 U.S.C. 811(d)(1)
to make any findings otherwise required by 21 U.S.C. 811(a) or 812(b),
and is not required to follow the procedures prescribed by 21 U.S.C.
811(a) and (b). The Acting Administrator advised HHS, by letter dated
September 6, 2019, that the DEA no longer requires scientific and
medical evaluations and scheduling recommendations for cyclopropyl
fentanyl, methoxyacetyl fentanyl, ortho-fluorofentanyl, and para-
fluorobutyryl fentanyl. These evaluations are no longer required due to
the placement of these substances in Schedule I of the Single
Convention on Narcotic Drugs (1961) in March 2019. Therefore,
consistent with the framework of 21 U.S.C. 811(d), the DEA concludes
that cyclopropyl fentanyl, methoxyacetyl fentanyl, ortho-
fluorofentanyl, and para-fluorobutyryl fentanyl have no currently
accepted medical use in treatment in the United States and are most
[[Page 57325]]
appropriately placed in schedule I of the CSA, the same schedule in
which they currently reside. Further, while the DEA temporarily
scheduled these substances under 21 CFR 1308.11(h), a paragraph
reserved for the temporary listing of substances subject to emergency
scheduling, this order moves these substances to 21 CFR 1308.11(b). As
explained above, because control is required under the Single
Convention on Narcotic Drugs (1961), the DEA will not be initiating
regular rulemaking proceedings to schedule these substances pursuant to
21 U.S.C. 811(a).
Conclusion
In order to meet the United States' obligations under the Single
Convention on Narcotic Drugs (1961) and because cyclopropyl fentanyl,
methoxyacetyl fentanyl, ortho-fluorofentanyl, and para-fluorobutyryl
fentanyl have no currently accepted medical use in treatment in the
United States, the Acting Administrator of the DEA has determined that
these substances should remain in schedule I of the CSA.
Requirements for Handling
Cyclopropyl fentanyl, methoxyacetyl fentanyl, ortho-fluorofentanyl,
and para-fluorobutyryl fentanyl have been controlled as schedule I
controlled substances since January 4, 2018, October 26, 2017, October
26, 2017, and February 1, 2018, respectively. With publication of the
final order contained in this document, cyclopropyl fentanyl,
methoxyacetyl fentanyl, ortho-fluorofentanyl, and para-fluorobutyryl
fentanyl remain subject to the CSA's schedule I regulatory controls and
administrative, civil, and criminal sanctions applicable to the
manufacture, distribution, importation, exportation, engagement in
research, conduct of instructional activities, 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, cyclopropyl fentanyl, methoxyacetyl fentanyl, ortho-
fluorofentanyl, and para-fluorobutyryl fentanyl must be registered
with the 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. Cyclopropyl fentanyl, methoxyacetyl
fentanyl, ortho-fluorofentanyl, and para-fluorobutyryl 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. Cyclopropyl fentanyl, methoxyacetyl fentanyl,
ortho-fluorofentanyl, and para-fluorobutyryl fentanyl are subject to
schedule I security requirements and must be handled and stored in
accordance with 21 CFR 1301.71-1301.93.
4. Labeling and packaging. All labels, labeling, and packaging
for commercial containers of cyclopropyl fentanyl, methoxyacetyl
fentanyl, ortho-fluorofentanyl, and para-fluorobutyryl 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. A quota assigned pursuant to 21 U.S.C. 826 and in
accordance with 21 CFR part 1303 is required in order to manufacture
cyclopropyl fentanyl, methoxyacetyl fentanyl, ortho-fluorofentanyl,
and para-fluorobutyryl fentanyl.
6. Inventory. Every DEA registrant who possesses any quantity of
cyclopropyl fentanyl, methoxyacetyl fentanyl, ortho-fluorofentanyl,
and para-fluorobutyryl fentanyl was required to keep an inventory of
all stocks of these substances on hand as of January 4, 2018,
October 26, 2017, October 26, 2017, and February 1, 2018,
respectively, 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 cyclopropyl fentanyl,
methoxyacetyl fentanyl, ortho-fluorofentanyl, and para-fluorobutyryl
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 cyclopropyl
fentanyl, methoxyacetyl fentanyl, ortho-fluorofentanyl, and para-
fluorobutyryl fentanyl must 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 cyclopropyl fentanyl, methoxyacetyl fentanyl, ortho-
fluorofentanyl, and para-fluorobutyryl fentanyl must 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 cyclopropyl fentanyl,
methoxyacetyl fentanyl, ortho-fluorofentanyl, and para-fluorobutyryl
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 Order 12866, 13563, and 13771, Regulatory Planning and
Review, Improving Regulation and Regulatory Review, and Reducing
Regulation and Controlling Regulatory Costs
This action is not a significant regulatory action as defined by
Executive Order 12866 (Regulatory Planning and Review), section 3(f),
and the principles reaffirmed in Executive Order 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 Executive Order 13771 regulatory action.
Executive Order 12988, Civil Justice Reform
This action meets the applicable standards set forth in sections
3(a) and 3(b)(2) of Executive Order 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 Executive Order 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 Executive Order 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 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.
To the extent that 21 U.S.C. 811(d)(1) directs that if control is
required by the United States' obligations under international
treaties, conventions, or protocols in effect on October 27, 1970,
scheduling actions shall be issued by order (as compared to scheduling
pursuant to 21 U.S.C. 811(a) by rule), the 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
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action is exempt from the notice and comment requirements of 5 U.S.C.
553 pursuant to 21 U.S.C. 553(a)(1) as an action involving a foreign
affairs function of the United States given that this action is being
done in accordance with 21 U.S.C. 811(d)(1)'s requirement 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, the 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, the 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)(51) through (b)(66) as (b)(55) through
(70);
0
b. Redesignate paragraphs (b)(41) through (b)(50) as (b)(43) through
(52);
0
c. Redesignate paragraphs (b)(22) through (40) as (b)(23) through (41);
0
d. Add new paragraphs (b)(22), (42), (53), and (54); and
0
e. Remove and reserve paragraphs (h)(19), (21), (22), and (24).
The additions read as follows:
Sec. 1308.11 Schedule I.
* * * * *
(b) * * *
(22) Cyclopropyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-
phenylcyclopropanecarboxamide) 9845
* * * * *
(42) Methoxyacetyl fentanyl (2-methoxy-N-(1-phenethylpiperidin-4-
yl)-N-phenylacetamide) 9825
* * * * *
(53) ortho-Fluorofentanyl (N-(2-fluorophenyl)-N-(1-
phenethylpiperidin-4-yl)propionamide); other name: 2-fluorofentanyl)
9816
(54) para-Fluorobutyryl fentanyl (N-(4-fluorophenyl)-N-(1-
phenethylpiperidin-4-yl)butyramide) 9823
* * * * *
Dated: October 19, 2019.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2019-23348 Filed 10-24-19; 8:45 am]
BILLING CODE 4410-09-P