[Federal Register Volume 82, Number 105 (Friday, June 2, 2017)]
[Proposed Rules]
[Pages 25564-25567]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-11215]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-460]


Schedules of Controlled Substances: Temporary Placement of Acryl 
Fentanyl Into Schedule I

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Notice of intent.

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SUMMARY: The Administrator of the Drug Enforcement Administration is 
issuing this notice of intent to issue a temporary order to schedule 
the synthetic opioid, N-(1-phenethylpiperidin-4-yl)-N-phenylacrylamide 
(acryl fentanyl or acryloylfentanyl), into Schedule I pursuant to the 
temporary scheduling provisions of the Controlled Substances Act. This 
action is based on a finding by the Administrator that the placement of 
this synthetic opioid into Schedule I of the Controlled Substances Act 
is necessary to avoid an imminent hazard to the public safety. When it 
is issued, the temporary scheduling order will impose the 
administrative, civil, and criminal sanctions and regulatory controls 
applicable to Schedule I controlled substances under the Controlled 
Substances Act on the manufacture, distribution, reverse distribution, 
possession, importation, exportation, research, and conduct of 
instructional activities, and chemical analysis of this synthetic 
opioid.

DATES: The date of this notice of intent is June 2, 2017.

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: This notice of intent is issued pursuant to 
the temporary scheduling provisions of 21 U.S.C. 811(h). The Drug 
Enforcement Administration (DEA) intends to issue a temporary order to 
add acryl fentanyl to Schedule I under the Controlled Substances 
Act.\1\ The temporary scheduling order will be published in the Federal 
Register, but that order will not be issued before July 3, 2017.
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    \1\ Though DEA has used the term ``final order'' with respect to 
temporary scheduling orders in the past, this notice of intent 
adheres to the statutory language of 21 U.S.C. 811(h), which refers 
to a ``temporary scheduling order.'' No substantive change is 
intended.
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Legal Authority

    Section 201 of the Controlled Substances Act (CSA), 21 U.S.C. 811, 
provides the Attorney General with the authority to temporarily place a 
substance into Schedule I of the CSA for two years without regard to 
the requirements of 21 U.S.C. 811(b) if he finds that such action is 
necessary to avoid imminent hazard to the public safety. 21 U.S.C. 
811(h)(1). In addition, if proceedings to control a substance are 
initiated under 21 U.S.C. 811(a)(1), the Attorney General may extend 
the temporary scheduling for up to one year. 21 U.S.C. 811(h)(2).
    Where the necessary findings are made, a substance may be 
temporarily scheduled if it is not listed in any other

[[Page 25565]]

schedule under section 202 of the CSA, 21 U.S.C. 812, or if there is no 
exemption or approval in effect for the substance under section 505 of 
the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 355. 21 
U.S.C. 811(h)(1); 21 CFR part 1308. The Attorney General has delegated 
scheduling authority under 21 U.S.C. 811 to the Administrator of the 
DEA. 28 CFR 0.100.

Background

    Section 201(h)(4) of the CSA, 21 U.S.C. 811(h)(4), requires the 
Administrator to notify the Secretary of the Department of Health and 
Human Services (HHS) of his intention to temporarily place a substance 
into Schedule I of the CSA.\2\ The Administrator transmitted notice of 
his intent to place acryl fentanyl in Schedule I on a temporary basis 
to the Assistant Secretary for Health of HHS by letter dated April 17, 
2017. The Assistant Secretary responded to this notice by letter dated 
May 2, 2017, and advised that based on a review by the Food and Drug 
Administration (FDA), there are currently no investigational new drug 
applications or approved new drug applications for acryl fentanyl. The 
Assistant Secretary also stated that the HHS has no objection to the 
temporary placement of acryl fentanyl into Schedule I of the CSA. Acryl 
fentanyl is not currently listed in any schedule under the CSA, and no 
exemptions or approvals are in effect for acryl fentanyl under section 
505 of the FDCA, 21 U.S.C. 355. The DEA has found that the control of 
acryl fentanyl in Schedule I on a temporary basis is necessary to avoid 
an imminent hazard to the public safety.
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    \2\ As discussed in a memorandum of understanding entered into 
by the Food and Drug Administration (FDA) and the National Institute 
on Drug Abuse (NIDA), the FDA acts as the lead agency within the HHS 
in carrying out the Secretary's scheduling responsibilities under 
the CSA, with the concurrence of NIDA. 50 FR 9518, Mar. 8, 1985. The 
Secretary of the HHS has delegated to the Assistant Secretary for 
Health of the HHS the authority to make domestic drug scheduling 
recommendations. 58 FR 35460, July 1, 1993.
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    To find that placing a substance temporarily into Schedule I of the 
CSA is necessary to avoid an imminent hazard to the public safety, the 
Administrator is required to consider three of the eight factors set 
forth in 21 U.S.C. 811(c): The substance's history and current pattern 
of abuse; the scope, duration and significance of abuse; and what, if 
any, risk there is to the public health. 21 U.S.C. 811(h)(3). 
Consideration of these factors includes actual abuse, diversion from 
legitimate channels, and clandestine importation, manufacture, or 
distribution. 21 U.S.C. 811(h)(3).
    A substance meeting the statutory requirements for temporary 
scheduling may only be placed in Schedule I. 21 U.S.C. 811(h)(1). 
Substances in Schedule I are those that have a high potential for 
abuse, no currently accepted medical use in treatment in the United 
States, and a lack of accepted safety for use under medical 
supervision. 21 U.S.C. 812(b)(1).

Acryl Fentanyl

    Acryl fentanyl was first described in 1981 in the scientific 
literature where its chemical structure and its in vivo antinociceptive 
effects were reported. No approved medical use has been identified for 
acryl fentanyl, nor has it been approved by the FDA for human 
consumption. The recent identification of acryl fentanyl in drug 
evidence and the identification of this substance in association with 
fatal overdose events indicate that this substance is being abused for 
its opioid properties.
    Available data and information for acryl fentanyl, summarized 
below, indicate that this synthetic opioid has a high potential for 
abuse, no currently accepted medical use in treatment in the United 
States, and a lack of accepted safety for use under medical 
supervision. The DEA's three-factor analysis is available in its 
entirety under ``Supporting and Related Material'' of the public docket 
for this action at www.regulations.gov under Docket Number DEA-460.

Factor 4. History and Current Pattern of Abuse

    The recreational abuse of fentanyl-like substances continues to be 
a significant concern. These substances are distributed to users, often 
with unpredictable outcomes. Acryl fentanyl has recently been 
encountered by law enforcement and public health officials and the 
adverse health effects and outcomes are demonstrated by fatal overdose 
cases. The documented negative effects of acryl fentanyl are consistent 
with those of other opioids.
    On October 1, 2014, the DEA implemented STARLiMS (a web-based, 
commercial laboratory information management system) to replace the 
System to Retrieve Information from Drug Evidence (STRIDE) as its 
laboratory drug evidence data system of record. DEA laboratory data 
submitted after September 30, 2014, are reposited in STARLiMS. Data 
from STRIDE and STARLiMS were queried on May 5, 2017. STARLiMS 
registered 36 reports containing acryl fentanyl, from Alabama, 
Connecticut, Illinois, Indiana, Kentucky, Louisiana, Minnesota, 
Missouri, North Carolina, South Carolina, Tennessee, Texas, and West 
Virginia. According to STARLiMS, the first laboratory submission of 
acryl fentanyl occurred in July 2016 in Texas.
    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. 
NFLIS registered 74 reports containing acryl fentanyl from state or 
local forensic laboratories in Arkansas, California, Connecticut, Iowa, 
Kentucky, Ohio, Pennsylvania, South Carolina, Texas, and Wisconsin 
(query date: May 5, 2017).\3\ The first report of acryl fentanyl was 
reported in Wisconsin in May 2016. The DEA is not aware of any 
laboratory identifications of acryl fentanyl prior to 2016.
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    \3\ Data are still being collected for February 2017-April 2017 
due to the normal lag period for labs reporting to NFLIS.
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    Evidence suggests that the pattern of abuse of fentanyl analogues, 
including acryl fentanyl, parallels that of heroin and prescription 
opioid analgesics. Seizures of acryl fentanyl have been encountered in 
powder form, in solution, and packaged similar to that of heroin. Acryl 
fentanyl has been encountered as a single substance as well as in 
combination with other substances of abuse, including heroin, fentanyl, 
4-fluoroisobutyryl fentanyl, and furanyl fentanyl. Acryl fentanyl has 
been connected to fatal overdoses, in which insufflation and 
intravenous routes of administration are documented.

Factor 5. Scope, Duration and Significance of Abuse

    Reports collected by the DEA demonstrate acryl fentanyl is being 
abused for its opioid properties. This abuse of acryl fentanyl has 
resulted in morbidity and mortality (see DEA 3-Factor Analysis for full 
discussion). The DEA has received reports for at least 83 confirmed 
fatalities associated with acryl fentanyl. Information on these deaths, 
occurring as early as September 2016, was collected by the DEA from 
post-mortem toxicology and medical examiner reports. These deaths were 
reported from, and occurred in, Illinois (27), Maryland (22), New 
Jersey (1), Ohio (31), and Pennsylvania (2). NFLIS and STARLiMS have a 
total of 110 drug reports in which acryl fentanyl was identified in 
drug exhibits submitted to forensic laboratories in 2016 and 2017 from 
law enforcement encounters in

[[Page 25566]]

Alabama, Arkansas, California, Connecticut, Illinois, Indiana, Iowa, 
Kentucky, Louisiana, Minnesota, Missouri, North Carolina, Ohio, 
Pennsylvania, South Carolina, Tennessee, Texas, West Virginia, and 
Wisconsin. It is likely that the prevalence of acryl fentanyl in opioid 
analgesic-related emergency room admissions and deaths is underreported 
as standard immunoassays may not differentiate this substance from 
fentanyl.
    The population likely to abuse acryl fentanyl overlaps with the 
population abusing prescription opioid analgesics, heroin, fentanyl, 
and other fentanyl-related substances. This is evidenced by the routes 
of drug administration and drug use history documented in acryl 
fentanyl fatal overdose cases and encounters of the substance by law 
enforcement officials. Because abusers of acryl fentanyl are likely to 
obtain this substance through unregulated sources, the identity, 
purity, and quantity are uncertain and inconsistent, thus posing 
significant adverse health risks to the end user. Individuals who 
initiate (i.e. use a drug for the first time) acryl fentanyl abuse are 
likely to be at risk of developing substance use disorder, overdose, 
and death similar to that of other opioid analgesics (e.g., fentanyl, 
morphine, etc.).

Factor 6. What, if Any, Risk There Is to the Public Health

    Acryl fentanyl exhibits pharmacological profiles similar to that of 
fentanyl and other [micro]-opioid receptor agonists. The toxic effects 
of acryl fentanyl in humans are demonstrated by overdose fatalities 
involving this substance. Abusers of acryl fentanyl may not know the 
origin, identity, or purity of this substance, thus posing significant 
adverse health risks when compared to abuse of pharmaceutical 
preparations of opioid analgesics, such as morphine and oxycodone.
    Based on information reviewed by the DEA, the misuse and abuse of 
acryl fentanyl leads to the same qualitative public health risks as 
heroin, fentanyl, and other opioid analgesic substances. As with any 
non-medically approved opioid, the health and safety risks for users 
are high. The public health risks attendant to the abuse of heroin and 
opioid analgesics are well established and have resulted in large 
numbers of drug treatment admissions, emergency department visits, and 
fatal overdoses.
    Acryl fentanyl has been associated with numerous fatalities. At 
least 83 confirmed overdose deaths involving acryl fentanyl abuse have 
been reported from Illinois, Maryland, New Jersey, Ohio, and 
Pennsylvania in 2016 and 2017. As the data demonstrates, the potential 
for fatal and non-fatal overdoses exists for acryl fentanyl and acryl 
fentanyl poses an imminent hazard to the public safety.

Finding of Necessity of Schedule I Placement To Avoid Imminent Hazard 
to Public Safety

    In accordance with 21 U.S.C. 811(h)(3), based on the available data 
and information, summarized above, the continued uncontrolled 
manufacture, distribution, reverse distribution, importation, 
exportation, conduct of research and chemical analysis, possession, and 
abuse of acryl fentanyl poses an imminent hazard to the public safety. 
The DEA is not aware of any currently accepted medical uses for acryl 
fentanyl in the United States. A substance meeting the statutory 
requirements for temporary scheduling, 21 U.S.C. 811(h)(1), may only be 
placed in Schedule I. Substances in Schedule I are those that have a 
high potential for abuse, no currently accepted medical use in 
treatment in the United States, and a lack of accepted safety for use 
under medical supervision. Available data and information for acryl 
fentanyl indicate that this substance has a high potential for abuse, 
no currently accepted medical use in treatment in the United States, 
and a lack of accepted safety for use under medical supervision. As 
required by section 201(h)(4) of the CSA, 21 U.S.C. 811(h)(4), the 
Administrator, through a letter dated April 17, 2017, notified the 
Assistant Secretary of the DEA's intention to temporarily place this 
substance in Schedule I.

Conclusion

    This notice of intent initiates a temporary scheduling process and 
provides the 30-day notice pursuant to section 201(h) of the CSA, 21 
U.S.C. 811(h), of DEA's intent to issue a temporary scheduling order. 
In accordance with the provisions of section 201(h) of the CSA, 21 
U.S.C. 811(h), the Administrator considered available data and 
information, herein set forth the grounds for his determination that it 
is necessary to temporarily schedule acryl fentanyl in Schedule I of 
the CSA, and finds that placement of this synthetic opioid substance 
into Schedule I of the CSA is necessary in order to avoid an imminent 
hazard to the public safety.
    The temporary placement of acryl fentanyl into Schedule I of the 
CSA will take effect pursuant to a temporary scheduling order, which 
will not be issued before July 3, 2017. Because the Administrator 
hereby finds that it is necessary to temporarily place acryl fentanyl 
into Schedule I to avoid an imminent hazard to the public safety, the 
temporary order scheduling this substance will be effective on the date 
that order is published in the Federal Register, and will be in effect 
for a period of two years, with a possible extension of one additional 
year, pending completion of the regular (permanent) scheduling process. 
21 U.S.C. 811(h)(1) and (2). It is the intention of the Administrator 
to issue a temporary scheduling order as soon as possible after the 
expiration of 30 days from the date of publication of this notice. Upon 
publication of the temporary order, acryl fentanyl will then be subject 
to the regulatory controls and administrative, civil, and criminal 
sanctions applicable to the manufacture, distribution, reverse 
distribution, importation, exportation, research, conduct of 
instructional activities and chemical analysis, and possession of a 
Schedule I controlled substance.
    The CSA sets forth specific criteria for scheduling a drug or other 
substance. Regular scheduling actions in accordance with 21 U.S.C. 
811(a) are subject to formal rulemaking procedures done ``on the record 
after opportunity for a hearing'' conducted pursuant to the provisions 
of 5 U.S.C. 556 and 557. 21 U.S.C. 811. The regular scheduling process 
of formal rulemaking affords interested parties with appropriate 
process and the government with any additional relevant information 
needed to make a determination. Final decisions that conclude the 
regular scheduling process of formal rulemaking are subject to judicial 
review. 21 U.S.C. 877. Temporary scheduling orders are not subject to 
judicial review. 21 U.S.C. 811(h)(6).

Regulatory Matters

    Section 201(h) of the CSA, 21 U.S.C. 811(h), provides for a 
temporary scheduling action where such action is necessary to avoid an 
imminent hazard to the public safety. As provided in this subsection, 
the Attorney General may, by order, schedule a substance in Schedule I 
on a temporary basis. Such an order may not be issued before the 
expiration of 30 days from (1) the publication of a notice in the 
Federal Register of the intention to issue such order and the grounds 
upon which such order is to be issued, and (2) the date that notice of 
the proposed temporary scheduling order is transmitted to the Assistant 
Secretary of HHS. 21 U.S.C. 811(h)(1).

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    Inasmuch as section 201(h) of the CSA directs that temporary 
scheduling actions be issued by order and sets forth the procedures by 
which such orders are to be issued, 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 notice of intent. In the 
alternative, even assuming that this notice of intent might be subject 
to section 553 of the APA, the Administrator finds that there is good 
cause to forgo the notice and comment requirements of section 553, as 
any further delays in the process for issuance of temporary scheduling 
orders would be impracticable and contrary to the public interest in 
view of the manifest urgency to avoid an imminent hazard to the public 
safety.
    Although the DEA believes this notice of intent to issue a 
temporary scheduling order is not subject to the notice and comment 
requirements of section 553 of the APA, the DEA notes that in 
accordance with 21 U.S.C. 811(h)(4), the Administrator will take into 
consideration any comments submitted by the Assistant Secretary with 
regard to the proposed temporary scheduling order.
    Further, the DEA believes that this temporary scheduling action is 
not a ``rule'' as defined by 5 U.S.C. 601(2), and, accordingly, is not 
subject to the requirements of the Regulatory Flexibility Act (RFA). 
The requirements for the preparation of an initial regulatory 
flexibility analysis in 5 U.S.C. 603(a) are not applicable where, as 
here, the DEA is not required by section 553 of the APA or any other 
law to publish a general notice of proposed rulemaking.
    Additionally, 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.
    This action will 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.

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 proposes to amend 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), unless otherwise noted.

0
2. In Sec.  1308.11, add paragraph (h)(17) to read as follows:


Sec.  1308.11  Schedule I.

* * * * *
    (h) * * *

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(17) N-(1-phenethylpiperidin-4-yl)-N-phenylacrylamide, its        (9811)
 isomers, esters, ethers, salts and salts of isomers,
 esters and ethers (Other names: acryl fentanyl,
 acryloylfentanyl).........................................
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    Dated: May 24, 2017.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2017-11215 Filed 6-1-17; 8:45 am]
 BILLING CODE 4410-09-P