[Federal Register Volume 83, Number 77 (Friday, April 20, 2018)]
[Rules and Regulations]
[Pages 17486-17488]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-08280]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-478]


Schedules of Controlled Substances: Placement of Butyryl Fentanyl 
and U-47700 Into 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 Administrator of 
the Drug Enforcement Administration maintains the placement of the 
substances butyryl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-
phenylbutanamide) and U-47700 (3,4-dichloro-N-[2-
(dimethylamino)cyclohexyl]-N-methylbenzamide), 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, butyryl fentanyl 
and U-47700.

DATES: Effective April 20, 2018.

FOR FURTHER INFORMATION CONTACT: Michael J. Lewis, 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) (Administrator). 28 CFR 0.100.

Background

    On April 21, 2017, the Secretary-General of the United Nations 
advised the Secretary of State of the United States, that during the 
60th session of the Commission on Narcotic Drugs, butyryl fentanyl and 
U-47700 were added to schedule I of the Single Convention on Narcotic 
Drugs, 1961. This letter was prompted by a decision at the 60th session 
of the Commission on Narcotic Drugs in March 2017 to schedule butyryl 
fentanyl and U-47700 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 butyryl 
fentanyl and U-47700 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).

Butyryl Fentanyl and U-47700

    On May 12, 2016, and November 14, 2016, butyryl fentanyl and U-
47700, respectively, were temporarily placed in schedule I of the CSA 
by the Administrator in order to avoid an imminent hazard to the public 
safety ((81 FR 29492-butyryl fentanyl) and (81 FR 79389-U-47700)). 
Butyryl fentanyl and U-47700 share a pharmacological profile similar to 
fentanyl, morphine, 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. Both butyryl 
fentanyl and U-47700 are abused for their opioid-like effects. Evidence 
suggests the pattern of abuse of butyryl fentanyl and U-47700 parallels 
that of heroin and prescription opioid analgesics. Because both butyryl 
fentanyl and U-47700 can be obtained through illicit sources, 
information on their purity and potency is often unknown, thus posing 
significant adverse health risks to the users.
    Similar to morphine and fentanyl, both butyryl fentanyl and U-47700 
act as [micro]-opioid receptor agonists. Data obtained from preclinical 
studies (in vitro and in vivo) demonstrate that

[[Page 17487]]

butyryl fentanyl and U-47700 produce pharmacological effects similar to 
fentanyl and morphine. Specifically, in a drug discrimination study in 
animals, a behavioral test used to determine subjective effect and 
pharmacological similarity between a test substance and a known drug of 
abuse, butyryl fentanyl substituted fully for morphine. Further, data 
obtained from a drug dependency study showed that butyryl fentanyl 
completely suppressed signs of withdrawal in morphine-dependent 
monkeys. Data obtained from in vivo (in animal) studies demonstrated 
that U-47700, similar to fentanyl and morphine, produced analgesic 
effect and functioned as a [mu] opioid receptor agonist. Specifically, 
analgesic activity of U-47700 was attenuated by naltrexone, an opioid 
receptor antagonist.
    Since 2014, butyryl fentanyl has been associated with numerous 
incidences of adverse health effects in humans. The DEA is aware of at 
least 40 confirmed fatalities associated with the misuse and/or abuse 
of butyryl fentanyl in the United States. Similarly, U-47700 has been 
associated with numerous cases of overdoses and overdose deaths.
    The DEA is not aware of any claims or any medical or scientific 
literature suggesting that butyryl fentanyl and U-47700 have a 
currently accepted medical use in treatment in the United States. In 
addition, HHS advised the DEA, by letters dated January 13, 2016, and 
April 28, 2016, that there were no investigational new drug 
applications or approved new drug applications for butyryl fentanyl and 
U-47700.
    By letters dated December 8, 2016, and March 1, 2017, the DEA 
requested that HHS conduct a scientific and medical evaluation of and a 
scheduling recommendation for butyryl fentanyl and U-47700, 
respectively. 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 November 1, 2017, the Acting Administrator advised 
HHS that the DEA no longer requires scientific and medical evaluations 
and scheduling recommendations for butyryl fentanyl and U-47700. 
Therefore, consistent with the framework of 21 U.S.C. 811(d), the DEA 
concludes that butyryl fentanyl and U-47700 have no currently accepted 
medical use in treatment in the United States and are most 
appropriately placed (as they have been since May 2016 and November 
2016, 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 both 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 butyryl fentanyl and 
U-47700 have no currently accepted medical use in treatment in the 
United States, the Administrator has determined that these substances 
should remain in schedule I of the CSA.

Requirements for Handling

    Butyryl fentanyl and U-47700 have been controlled as schedule I 
controlled substances since May 12, 2016, and November 14, 2016, 
respectively. With publication of this final order, butyryl fentanyl 
and U-47700 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, butyryl 
fentanyl and U-47700 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. Butyryl fentanyl and U-47700 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. Butyryl fentanyl and U-47700 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 butyryl fentanyl and U-47700 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 
butyryl fentanyl and U-47700.
    6. Inventory. Every DEA registrant who possesses any quantity of 
butyryl fentanyl and U-47700 were required to keep an inventory of all 
stocks of these substances on hand as of May 12, 2016, and November 14, 
2016, 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 butyryl fentanyl and U-47700 
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 butyryl fentanyl 
and U-47700 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 
butyryl fentanyl and U-47700 must be in compliance with 21 U.S.C. 952, 
953, 957, 958, and in accordance with 21 CFR part 1312.
    10. Liability. Any activity involving butyryl fentanyl and U-47700 
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

    This action is not a significant regulatory action as defined by 
Executive Order 12866 (Regulatory Planning and Review), section 3(f), 
and, accordingly, this action has not been reviewed by the Office of 
Management and Budget (OMB).

Executive Order 13132

    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

    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.

[[Page 17488]]

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 section 804 of the 
Small Business Regulatory Enforcement Fairness Act of 1996 
(Congressional Review Act (CRA)). 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)(18) through (58) as (b)(19) through (59) 
and add a new paragraph (b)(18);
0
b. Add paragraph (b)(60); and
0
c. Remove and reserve paragraphs (h)(2) and (4).
    The additions read as follows:


Sec.  1308.11  Schedule I.

* * * * *
    (b) * * *

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(18) Butyryl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-             9822
 phenylbutyramide)......................................
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* * * * *

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(60) U-47700 (3,4-Dichloro-N-[2-                                    9547
 (dimethylamino)cyclohexyl]-N-methylbenzamide)..........
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* * * * *

    Dated: April 11, 2018.
Robert W. Patterson,
Acting Administrator.
[FR Doc. 2018-08280 Filed 4-19-18; 8:45 am]
 BILLING CODE 4410-09-P