[Federal Register Volume 83, Number 230 (Thursday, November 29, 2018)]
[Rules and Regulations]
[Pages 61320-61323]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-26045]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-490]


Schedules of Controlled Substances: Placement of Furanyl 
Fentanyl, 4-Fluoroisobutyryl Fentanyl, Acryl Fentanyl, 
Tetrahydrofuranyl Fentanyl, and Ocfentanil in Schedule I

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: 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 the substances furanyl fentanyl [N-(1-phenethylpiperidin-
4-yl)-N-phenylfuran-2-carboxamide], 4-fluoroisobutyryl fentanyl or 
para-fluoroisobutyryl fentanyl [N-(4-fluorophenyl)-N-(1-
phenethylpiperidin-4-yl)isobutyramide], acryl fentanyl or 
acryloylfentanyl [N-(1-phenethylpiperidin-4-yl)-N-phenylacrylamide], 
tetrahydrofuranyl fentanyl [N-(1-phenethylpiperidin-4-yl)-N-
phenyltetrahydrofuran-2-carboxamide], and ocfentanil [N-(2-
fluorophenyl)-2-methoxy-N-(1-phenethylpiperidin-4-yl)acetamide], 
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, furanyl fentanyl, 4-fluoroisobutyryl fentanyl, acryl fentanyl, 
tetrahydrofuranyl fentanyl, and ocfentanil.

DATES: Effective November 29, 2018.

FOR FURTHER INFORMATION CONTACT: Kathy L. Federico, Regulatory Drafting 
and Policy 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.

[[Page 61321]]

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 15, 2018, the Secretary-General of the United Nations 
advised the Secretary of State of the United States, that during the 
61st session of the Commission on Narcotic Drugs, furanyl fentanyl, 4-
fluoroisobutyryl fentanyl, acryl fentanyl, tetrahydrofuranyl fentanyl, 
and ocfentanil were added to Schedule I of the Single Convention on 
Narcotic Drugs (1961). This letter was prompted by a decision at the 
61st session of the Commission on Narcotic Drugs in March 2018 to 
schedule furanyl fentanyl, 4-fluoroisobutyryl fentanyl, acryl fentanyl, 
tetrahydrofuranyl fentanyl, and ocfentanil 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 furanyl fentanyl, 4-fluoroisobutyryl fentanyl, acryl fentanyl, 
tetrahydrofuranyl fentanyl, and ocfentanil 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).

Furanyl Fentanyl, 4-Fluoroisobutyryl Fentanyl, Acryl Fentanyl, 
Tetrahydrofuranyl Fentanyl, and Ocfentanil

    On November 29, 2016, May 3, 2017, July 14, 2017, October 26, 2017, 
and February 1, 2018, furanyl fentanyl (81 FR 85873), 4-
fluoroisobutyryl fentanyl (82 FR 20544), acryl fentanyl (82 FR 32453), 
tetrahydrofuranyl fentanyl (82 FR 49504), and ocfentanil (83 FR 4580), 
respectively, were temporarily placed in schedule I of the CSA upon 
finding they pose an imminent hazard to the public safety. Furanyl 
fentanyl, 4-fluoroisobutyryl fentanyl, acryl fentanyl, 
tetrahydrofuranyl fentanyl, and ocfentanil share pharmacological 
profiles similar to morphine, fentanyl, and other synthetic opioids. 
Law enforcement and public health reports demonstrate the illicit use 
and distribution of these substances, which are available on the 
internet. Furanyl fentanyl, 4-fluoroisobutyryl fentanyl, acryl 
fentanyl, tetrahydrofuranyl fentanyl, and ocfentanil are all abused for 
their opioid-like effects. Evidence suggests the pattern of abuse of 
these substances parallels that of heroin and prescription opioid 
analgesics. Because furanyl fentanyl, 4-fluoroisobutyryl fentanyl, 
acryl fentanyl, tetrahydrofuranyl fentanyl, and ocfentanil can be 
obtained through illicit sources, information on their purity and 
potency are unknown; thus these substances pose a significant adverse 
health risk to the users.
    Similar to morphine and fentanyl, furanyl fentanyl, 4-
fluoroisobutyryl fentanyl, acryl fentanyl, tetrahydrofuranyl fentanyl, 
and ocfentanil act as [micro]-opioid receptor agonists. Data obtained 
from preclinical studies (in vitro and in vivo) demonstrate that 
furanyl fentanyl, 4-fluoroisobutyryl fentanyl, acryl fentanyl, 
tetrahydrofuranyl fentanyl, and ocfentanil produce pharmacological 
effects similar to fentanyl and morphine. Specifically, in a drug 
discrimination study in animals, a behavioral test used to determine 
subjective effects and pharmacological similarity between a test 
substance and a known drug of abuse, ocfentanil substituted fully for 
morphine. Additional data obtained from in vivo (in animal) studies 
demonstrated that furanyl fentanyl, 4-fluoroisobutyryl fentanyl, acryl 
fentanyl, tetrahydrofuranyl fentanyl, and ocfentanil, similar to 
fentanyl and morphine, produced an analgesic effect which was 
attenuated by naltrexone, an opioid receptor antagonist.
    Since 2015, furanyl fentanyl has been encountered by law 
enforcement and public health officials and the adverse health effects 
and outcomes are demonstrated by fatal overdose cases. At the time of 
the temporary scheduling action for furanyl fentanyl in 2016, there 
were at least 128 confirmed fatalities associated with the misuse and/
or abuse of furanyl fentanyl in the United States. According to the 
National Forensic Laboratory Information System (NFLIS \1\) and 
STARLiMS \2\, there were 8,516 drug exhibits containing furanyl 
fentanyl since 2015. For 4-fluoroisobutyryl fentanyl, law enforcement 
submitted a total of 2,245 drug exhibits since 2016. The DEA has also 
received reports of at least 62 confirmed fatalities associated with 4-
fluoroisobutyryl fentanyl at the time of the temporary order in 2017. 
NFLIS and STARLiMS reported a total of 2,054 drug exhibits containing 
acryl fentanyl since 2016. The DEA also received reports of at least 83 
confirmed fatalities associated with acryl fentanyl occurring in 2016 
and 2017 in the United States. For tetrahydrofuranyl fentanyl, NFLIS 
and STARLiMS had a total of 23 drug reports since 2015 and there were 
two confirmed fatalities in the United States at the time of the 
temporary scheduling action in 2017. There were no reports in NFLIS and 
STARLiMS for ocfentanil at the time of this final order. However, 
ocfentanil was first reported in Belgium in 2015 and the exposure 
resulted in one death; since then, at least two additional deaths in 
Belgium and Switzerland related to ocfentanil have been reported. It is 
likely that the prevalence of these substances in opioid-related 
emergency room admissions and deaths is underreported as standard 
immunoassays may not differentiate these substances from fentanyl.
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    \1\ The National Forensic Laboratory Information System (NFLIS) 
is a national forensic laboratory reporting system that 
systematically collects results from drug chemistry analyses 
conducted by State and local forensic laboratories in the United 
States. NFLIS data were queried on October 24, 2018. NFLIS is still 
reporting data for January-July 2018 due to normal lag time in 
reporting.
    \2\ STARLiMS is a laboratory information management system that 
systematically collects results from drug chemistry analyses 
conducted by DEA laboratories. STARLiMS data were queried on October 
24, 2018.
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    The DEA is not aware of any claims or any medical or scientific 
literature suggesting that furanyl fentanyl, 4-fluoroisobutyryl 
fentanyl, acryl fentanyl, tetrahydrofuranyl fentanyl, and ocfentanil 
have a currently accepted medical use in treatment in the United 
States. In addition, the Department of Health and Human Services (HHS) 
advised DEA, by letters dated July 8, 2016, January 17, 2017, May 2, 
2017, July 14, 2017, and November 8, 2017, that there were no 
investigational new drug applications or approved new drug applications 
for furanyl fentanyl, 4-fluoroisobutyryl fentanyl, acryl fentanyl, 
tetrahydrofuranyl fentanyl, and ocfentanil, respectively.
    The DEA requested that HHS conduct a scientific and medical 
evaluation and

[[Page 61322]]

a scheduling recommendation for furanyl fentanyl (by letter dated March 
1, 2017), 4-fluoroisobutyryl fentanyl (by letter dated August 28, 
2017), acryl fentanyl (by letter dated April 18, 2018), and 
tetrahydrofuranyl fentanyl (letter dated April 18, 2018). A request for 
ocfentanil had not previously been submitted. 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 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). By letter dated June 30, 2018, 
the Acting Administrator advised HHS that the DEA no longer requires 
scientific and medical evaluations and scheduling recommendations for 
furanyl fentanyl, 4-fluoroisobutyryl fentanyl, acryl fentanyl, 
tetrahydrofuranyl fentanyl, as well as, ocfentanil, although not 
previously requested. The HHS recommendations were no longer required 
due to the placement of those substances into Schedule I of the Single 
Convention on Narcotic Drugs (1961) in March 2018. Therefore, 
consistent with the framework of 21 U.S.C. 811(d), DEA concludes that 
furanyl fentanyl, 4-fluoroisobutyryl fentanyl, acryl fentanyl, 
tetrahydrofuranyl fentanyl, and ocfentanil have no currently accepted 
medical use in treatment in the United States and are most 
appropriately placed (as it has been since May 2017, July 2017, October 
2017, November 2017, and February 2018, respectively) in schedule I of 
the CSA. Further, while the DEA temporarily scheduled these substances 
under 21 CFR 1308.11(h), a subsection 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, since 
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 furanyl fentanyl, 4-
fluoroisobutyryl fentanyl, acryl fentanyl, tetrahydrofuranyl fentanyl, 
and ocfentanil have no currently accepted medical use in treatment in 
the United States, the Acting Administrator of the Drug Enforcement 
Administration has determined that these substances should remain in 
schedule I of the Controlled Substances Act.

Requirements for Handling

    Furanyl fentanyl, 4-fluoroisobutyryl fentanyl, acryl fentanyl, 
tetrahydrofuranyl fentanyl, and ocfentanil have been controlled as 
schedule I controlled substances since November 29, 2016, May 3, 2017, 
July 14, 2017, October 26, 2017, and February 1, 2018, respectively. 
With publication of this final order, furanyl fentanyl, 4-
fluoroisobutyryl fentanyl, acryl fentanyl, tetrahydrofuranyl fentanyl, 
and ocfentanil 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, and 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, furanyl 
fentanyl, 4-fluoroisobutyryl fentanyl, acryl fentanyl, 
tetrahydrofuranyl fentanyl, and ocfentanil 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. Furanyl fentanyl, 4-fluoroisobutyryl 
fentanyl, acryl fentanyl, tetrahydrofuranyl fentanyl and ocfentanil 
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. Furanyl fentanyl, 4-fluoroisobutyryl fentanyl, acryl 
fentanyl, tetrahydrofuranyl fentanyl, and ocfentanil are 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 
1301.71-1301.93.
    4. Labeling and packaging. All labels, labeling, and packaging for 
commercial containers of furanyl fentanyl, 4-fluoroisobutyryl fentanyl, 
acryl fentanyl, tetrahydrofuranyl fentanyl, and ocfentanil must be in 
compliance with 21 U.S.C. 825, 958(e), and 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 
furanyl fentanyl, 4-fluoroisobutyryl fentanyl, acryl fentanyl, 
tetrahydrofuranyl fentanyl, and ocfentanil.
    6. Inventory. Every DEA registrant who possesses any quantity of 
furanyl fentanyl, 4-fluoroisobutyryl fentanyl, acryl fentanyl, 
tetrahydrofuranyl fentanyl, and ocfentanil was required to keep an 
inventory of all stocks of these substances on hand as of November 29, 
2016, May 3, 2017, July 14, 2017, October 26, 2017, and February 1, 
2018, respectively, pursuant to 21 U.S.C. 827 and 958, and in 
accordance with 21 CFR 1304.03, 1304.04, and 1304.11.
    7. Records and Reports. Every DEA registrant must maintain records 
and submit reports with respect to furanyl fentanyl, 4-fluoroisobutyryl 
fentanyl, acryl fentanyl, tetrahydrofuranyl fentanyl, and ocfentanil 
pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR parts 
1304 and 1312.
    8. Order Forms. All DEA registrants who distribute furanyl 
fentanyl, 4-fluoroisobutyryl fentanyl, acryl fentanyl, 
tetrahydrofuranyl fentanyl, and ocfentanil 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 
furanyl fentanyl, 4-fluoroisobutyryl fentanyl, acryl fentanyl, 
tetrahydrofuranyl fentanyl, and ocfentanil 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 furanyl fentanyl, 4-
fluoroisobutyryl fentanyl, acryl fentanyl, tetrahydrofuranyl fentanyl, 
and ocfentanil 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

[[Page 61323]]

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 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. Remove from paragraph (b) introductory text the term ``(b)(34)'' and 
add in its place the term ``(b)(39)'';
0
b. Redesignate paragraphs (b)(57) through (b)(60) as (b)(62) through 
(b)(65);
0
c. Redesignate paragraphs (b)(46) through (b)(56) as (b)(50) through 
(b)(60);
0
d. Redesignate paragraphs (b)(32) through (b)(45) as (b)(35) through 
(b)(48);
0
e. Redesignate paragraphs (b)(4) through (31) as (b)(5) through (32);
0
f. Add new paragraphs (b)(4), (b)(33), (b)(34), (b)(49), and (b)(61);
0
g. Remove and reserve paragraphs (h)(5), (h)(13), (h)(14), (h)(20), and 
(h)(29).
    The revision and additions to read as follows:


Sec.  1308.11   Schedule I.

* * * * *
    (b) * * *
    (4) Acryl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-
phenylacrylamide; other name: acryloylfentanyl) . . . 9811
* * * * *
    (33) 4-Fluoroisobutyryl fentanyl (N-(4-fluorophenyl)-N-(1-
phenethylpiperidin-4-yl)isobutyramide; other name: para-
fluoroisobutyryl fentanyl) . . . 9824
    (34) Furanyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylfuran-
2-carboxamide) . . . 9834
* * * * *
    (49) Ocfentanil (N-(2-fluorophenyl)-2-methoxy-N-(1-
phenethylpiperidin-4-yl)acetamide) . . . 9838
* * * * *
    (61) Tetrahydrofuranyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-
phenyltetrahydrofuran-2-carboxamide) . . . 9843
* * * * *

    Dated: November 26, 2018.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2018-26045 Filed 11-28-18; 8:45 am]
 BILLING CODE 4410-09-P