Schedules of Controlled Substances: Placement of Acetyl Fentanyl Into Schedule I


Published: 2017-06-07

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Federal Register, Volume 82 Issue 108 (Wednesday, June 7, 2017)


[Federal Register Volume 82, Number 108 (Wednesday, June 7, 2017)]
[Rules and Regulations]
[Pages 26349-26351]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-11795]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-413]


Schedules of Controlled Substances: Placement of Acetyl Fentanyl
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 will maintain the placement of the
substance acetyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-
phenylacetamide), including its isomers, esters, ethers, salts, and
salts of isomers, esters and ethers, in schedule I of the Controlled
Substances Act. This scheduling action is pursuant to the Controlled
Substances Act and is required in order for the United States to
discharge its 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, acetyl fentanyl.

DATES: Effective June 7, 2017.

FOR FURTHER INFORMATION CONTACT: Michael J. Lewis, Diversion Control

[[Page 26350]]

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
DEA. 28 CFR 0.100.

Background

On May 17, 2016, the Secretary-General of the United Nations
advised the Secretary of State of the United States, that during the
59th session of the Commission on Narcotic Drugs, acetyl fentanyl was
added to schedule I of the Single Convention on Narcotic Drugs, 1961.
This letter was prompted by a decision at the 59th session of the
Commission on Narcotic Drugs in March 2016 to schedule acetyl 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 acetyl 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).

Acetyl Fentanyl

On July 17, 2015, acetyl fentanyl was temporarily placed in
schedule I of the CSA in order to avoid an imminent hazard to the
public safety (80 FR 42381). Acetyl fentanyl is a potent opioid
analgesic and has no accepted medical use in the United States. Since
2013, both law enforcement (DEA's NFLIS and STARLiMS databases) and
public health reports demonstrate the unregulated use and distribution
of this substance. Law enforcement reports indicate that acetyl
fentanyl is available on the illicit market as a powder or in tablet
form which mimic pharmaceutical opiate products. In powder form, the
identity of the substance may go unknown to the end user as it may be
marketed as heroin or mixed with heroin. Recent reports indicate that
acetyl fentanyl is available over the Internet.
Acetyl fentanyl exhibits a typical morphine-like profile in
animals. Data from the scientific literature show that the analgesic
potency of acetyl fentanyl is up to 15.7 times greater than that of
morphine in mice as evaluated using an acetic acid writhing method.
Since 2013, adverse effects due to acetyl fentanyl toxicity have been
reported in humans. Similar to other opioids (i.e. heroin, oxycodone,
hydrocodone, fentanyl, etc.), acetyl fentanyl induces respiratory
depression which may lead to death in an overdose event. DEA is
currently aware of at least 57 confirmed fatalities associated with
acetyl fentanyl misuse and/or abuse in the United States. The extent of
abuse and mortality associated with acetyl fentanyl is likely to be
underestimated since it is not included in most drug screens. In
addition, the identity of fentanyl and acetyl fentanyl cannot be
distinguished by commonly used drug screens including enzyme-linked
immunosorbent assay (ELISA). Further confirmatory testing (i.e. mass
spectrometry) is required to identify acetyl fentanyl.
The DEA is not aware of any claims or any medical or scientific
literature suggesting that acetyl fentanyl has a currently accepted
medical use in treatment in the United States. In addition, HHS advised
the DEA, by letter dated April 29, 2015, that there are no approved new
drug applications or investigational new drug applications for acetyl
fentanyl.
By letter, dated January 11, 2016, the DEA requested that HHS
conduct a scientific and medical evaluation of the substance's medical
utility and a scheduling recommendation for acetyl fentanyl. Regardless
of this request and any potential response 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). Therefore, consistent with the
framework of 21 U.S.C. 811(d), DEA concludes that acetyl fentanyl has
no currently accepted medical use in treatment in the United States and
is most appropriately placed (as it has been since July 2015) in
schedule I of the CSA.

Conclusion

In order to meet the obligations of the Single Convention on
Narcotic Drugs, 1961 and because acetyl fentanyl has no currently
accepted medical use in treatment in the United States, the
Administrator of the Drug Enforcement Administration has determined
that this substance should remain in schedule I of the Controlled
Substances Act.

Requirements for Handling

Acetyl fentanyl has been controlled as a schedule I controlled
substance since July 17, 2015. With publication of this final order,
acetyl fentanyl remains 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, acetyl
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. Acetyl 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. Acetyl 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 1301.71-1301.93.
4. Labeling and packaging. All labels, labeling, and packaging for
commercial containers of acetyl fentanyl 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
acetyl fentanyl.
6. Inventory. Every DEA registrant who possesses any quantity of
acetyl fentanyl must keep an inventory of all stocks of this substance
on hand pursuant to 21 U.S.C. 827 and 958, and in accordance with 21
CFR 1304.03, 1304.04, and 1304.11.

[[Page 26351]]

7. Records and Reports. Every DEA registrant must maintain records
and submit reports with respect to acetyl fentanyl 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 acetyl 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
acetyl fentanyl 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 acetyl 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

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 such action be taken to comply with the United States
obligations under the specified international agreements.

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. Therefore,
in accordance with Executive Order 13132 (Federalism) it is determined
that this action does not have sufficient federalism implications to
warrant the preparation of a Federalism Assessment.

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.

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). However, 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,
Narcotics, Prescription drugs.

For the reasons set out above, the DEA amends 21 CFR part 1308 as
follows:

PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

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. Amend Sec. 1308.11 by:
0
i. Redesignating paragraphs (b)(3) through (56) as (b)(4) through (57)
and adding a new paragraph (b)(3); and
0
ii. Removing paragraph (h)(4), redesignating paragraphs (h)(5) through
(15) as (h)(4) through (14), and adding reserved paragraph (h)(15).
The addition reads as follows:


Sec. 1308.11 Schedule I.

* * * * *
(b) * * *
(3) Acetyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-
phenylacetamide)--9821
* * * * *

Dated: May 30, 2017.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2017-11795 Filed 6-6-17; 8:45 am]
BILLING CODE 4410-09-P



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