[Federal Register Volume 82, Number 175 (Tuesday, September 12, 2017)]
[Proposed Rules]
[Pages 42754-42757]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-19283]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-473]


Schedules of Controlled Substances: Temporary Placement of Ortho-
Fluorofentanyl, Tetrahydrofuranyl Fentanyl, and Methoxyacetyl Fentanyl 
Into Schedule I

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Proposed amendment; notice of intent.

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SUMMARY: The Administrator of the Drug Enforcement Administration is 
issuing this notice of intent to publish a temporary order to schedule 
the synthetic opioids, N-(2-fluorophenyl)-N-(1-phenethylpiperidin-4-
yl)propionamide (ortho-fluorofentanyl or 2-fluorofentanyl), N-(1-
phenethylpiperidin-4-yl)-N-phenyltetrahydrofuran-2-carboxamide 
(tetrahydrofuranyl fentanyl), and 2-methoxy-N-(1-phenethylpiperidin-4-
yl)-N-phenylacetamide (methoxyacetyl fentanyl), into Schedule I. This 
action is based on a finding by the Administrator that the placement of 
these synthetic opioids 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 these synthetic 
opioids.

DATES: September 12, 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 contained in this 
document 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 scheduling order (in the form of a temporary 
amendment) to add ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and 
methoxyacetyl fentanyl to Schedule I under the Controlled Substances 
Act.\1\ The temporary scheduling order will be published in the Federal 
Register, but will not be issued before October 12, 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 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 ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, 
and methoxyacetyl fentanyl in Schedule I on a temporary basis to the 
Assistant Secretary for Health of HHS by letter. Notice for these 
actions was transmitted on the following dates: May 19, 2017 (ortho-
fluorofentanyl) and July 5, 2017 (tetrahydrofuranyl fentanyl and 
methoxyacetyl fentanyl). The Assistant Secretary responded by letter 
dated June 9, 2017 (ortho-fluorofentanyl) and July 14, 2017 
(tetrahydrofuranyl fentanyl and methoxyacetyl fentanyl), 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 ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, 
or methoxyacetyl fentanyl. The Assistant Secretary also stated that the 
HHS has no objection to the temporary placement of ortho-
fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl 
into Schedule I of the CSA. ortho-Fluorofentanyl, tetrahydrofuranyl 
fentanyl, and methoxyacetyl fentanyl are not

[[Page 42755]]

currently listed in any schedule under the CSA, and no exemptions or 
approvals are in effect for ortho-fluorofentanyl, tetrahydrofuranyl 
fentanyl, or methoxyacetyl fentanyl under section 505 of the FDCA, 21 
U.S.C. 355.
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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).

Ortho-Fluorofentanyl, Tetrahydrofuranyl Fentanyl, and Methoxyacetyl 
Fentanyl

    The recent identification of ortho-fluorofentanyl, 
tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl in drug evidence 
and the identification of these substances in association with fatal 
overdose events indicate that these substances are being abused for 
their opioid properties. No approved medical use has been identified 
for ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, or methoxyacetyl 
fentanyl, nor have they been approved by the FDA for human consumption.
    Available data and information for ortho-fluorofentanyl, 
tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl, summarized 
below, indicate that these synthetic opioids 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. 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-473.

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. ortho-Fluorofentanyl, tetrahydrofuranyl 
fentanyl, and methoxyacetyl fentanyl have recently been encountered by 
law enforcement and public health officials. Adverse health effects and 
outcomes are demonstrated by fatal overdose cases involving these 
substances. The documented negative effects of ortho-fluorofentanyl, 
tetrahydrofuranyl fentanyl, and methoxyacetyl 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 June 19, 2017. STARLiMS 
registered four reports containing ortho-fluorofentanyl from California 
and five reports containing tetrahydrofuranyl fentanyl from Florida and 
Missouri. According to STARLiMS, the first laboratory submissions of 
ortho-fluorofentanyl and tetrahydrofuranyl fentanyl occurred in April 
2016, and March 2017, respectively.
    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. 
Data from NFLIS was queried on June 20, 2017. NFLIS registered three 
reports containing ortho-fluorofentanyl from state or local forensic 
laboratories in Virginia.\3\ According to NFLIS, the first report of 
ortho-fluorofentanyl was reported in September 2016. NFLIS registered 
two reports containing tetrahydrofuranyl fentanyl from state or local 
forensic laboratories in New Jersey and was first reported in January 
2017. The identification of methoxyacetyl fentanyl in drug evidence 
submitted in April 2017 was reported to DEA from a local laboratory in 
Ohio.\4\ The DEA is not aware of any laboratory identifications of 
ortho-fluorofentanyl prior to 2016 or identifications of 
tetrahydrofuranyl fentanyl or methoxyacetyl fentanyl prior to 2017.
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    \3\ Data are still being collected for March 2017-June 2017 due 
to the normal lag period for labs reporting to NFLIS.
    \4\ Email from Cuyahoga County Medical Examiner's Office, to DEA 
(May 8, 2017 02:29 p.m. EST) (on file with DEA).
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    Evidence suggests that the pattern of abuse of fentanyl analogues, 
including ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and 
methoxyacetyl fentanyl, parallels that of heroin and prescription 
opioid analgesics. Seizures of ortho-fluorofentanyl, tetrahydrofuranyl 
fentanyl, and methoxyacetyl fentanyl have been encountered in powder 
form similar to fentanyl and heroin and have been connected to fatal 
overdoses.

Factor 5. Scope, Duration and Significance of Abuse

    Reports collected by the DEA demonstrate ortho-fluorofentanyl, 
tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl are being abused 
for their opioid properties. Abuse of ortho-fluorofentanyl, 
tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl have resulted in 
mortality (see DEA 3-Factor Analysis for full discussion). The DEA 
collected post-mortem toxicology and medical examiner reports on 13 
confirmed fatalities associated with ortho-fluorofentanyl which 
occurred in Georgia (1), North Carolina (11), and Texas (1), two 
confirmed fatalities associated with tetrahydrofuranyl fentanyl which 
occurred in New Jersey (1) and Wisconsin (1), and 2 confirmed 
fatalities associated with methoxyacetyl fentanyl which occurred in 
Pennsylvania. 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 fentanyl analogues from 
fentanyl.
    Ortho-Fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl 
fentanyl have been identified in drug evidence collected by law 
enforcement. NFLIS and STARLiMS have a total of seven drug reports in 
which ortho-fluorofentanyl was identified in drug exhibits submitted to 
forensic laboratories in 2016 from law enforcement encounters in 
California and Virginia and seven drug reports in which 
tetrahydrofuranyl fentanyl was identified in drug exhibits submitted to 
forensic laboratories in 2017 from law enforcement encounters in 
Florida, Missouri, and New Jersey. The identification of methoxyacetyl 
fentanyl in drug evidence submitted in April 2017 was reported to DEA 
from Ohio.
    The population likely to abuse ortho-fluorofentanyl, 
tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl overlaps with 
the population abusing prescription opioid analgesics, heroin, 
fentanyl, and other fentanyl-related substances. This is evidenced by 
the

[[Page 42756]]

routes of drug administration and drug use history documented in ortho-
fluorofentanyl and tetrahydrofuranyl fentanyl fatal overdose cases. 
Because abusers of ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, 
and methoxyacetyl fentanyl are likely to obtain these substances 
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) ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, or 
methoxyacetyl 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

    Ortho-Fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl 
fentanyl exhibit pharmacological profiles similar to that of fentanyl 
and other [micro]-opioid receptor agonists. The toxic effects of ortho-
fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl 
in humans are demonstrated by overdose fatalities involving these 
substances. Abusers of ortho-fluorofentanyl, tetrahydrofuranyl 
fentanyl, and methoxyacetyl fentanyl may not know the origin, identity, 
or purity of these substances, thus posing significant adverse health 
risks when compared to abuse of pharmaceutical preparations of opioid 
analgesics, such as morphine and oxycodone.
    Based on information received by the DEA, the misuse and abuse of 
ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl 
fentanyl lead 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.
    Ortho-Fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl 
fentanyl have been associated with numerous fatalities. At least 13 
confirmed overdose deaths involving ortho-fluorofentanyl abuse have 
been reported from Georgia (1), North Carolina (11), and Texas (1). At 
least two confirmed overdose deaths involving tetrahydrofuranyl 
fentanyl have been repored from New Jersey (1) and Wisconsin (1). At 
least two confirmed overdose deaths involving methoxyacetyl fentanyl 
have been reported from Pennsylvania. As the data demonstrates, the 
potential for fatal and non-fatal overdoses exists for ortho-
fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl 
and these substances pose 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 ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and 
methoxyacetyl fentanyl pose an imminent hazard to the public safety. 
The DEA is not aware of any currently accepted medical uses for ortho-
fluorofentanyl, tetrahydrofuranyl fentanyl, or methoxyacetyl 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 ortho-fluorofentanyl, 
tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl indicate that 
these substances 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. As required by section 
201(h)(4) of the CSA, 21 U.S.C. 811(h)(4), the Administrator, through 
letters dated May 19, 2017 (ortho-fluorofentanyl) and July 5, 2017 
(tetrahydrofuranyl fentanyl and methoxyacetyl fentanyl), notified the 
Assistant Secretary of the DEA's intention to temporarily place these 
substances in Schedule I.

Conclusion

    This notice of intent provides the 30-day notice pursuant to 
section 201(h)(1) of the CSA, 21 U.S.C. 811(h)(1), of DEA's intent to 
issue a temporary scheduling order. In accordance with the provisions 
of section 201(h)(3) of the CSA, 21 U.S.C. 811(h)(3), the Administrator 
considered available data and information, herein set forth the grounds 
for his determination that it is necessary to temporarily schedule 
ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl 
fentanyl in Schedule I of the CSA, and finds that placement of these 
synthetic opioids into Schedule I of the CSA is necessary in order to 
avoid an imminent hazard to the public safety.
    The temporary placement of ortho-fluorofentanyl, tetrahydrofuranyl 
fentanyl, and methoxyacetyl fentanyl into Schedule I of the CSA will 
take effect pursuant to a temporary scheduling order, which will not be 
issued before October 12, 2017. Because the Administrator hereby finds 
that it is necessary to temporarily place ortho-fluorofentanyl, 
tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl into Schedule I 
to avoid an imminent hazard to the public safety, the temporary order 
scheduling these substances 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 document. Upon publication 
of the temporary order, ortho-fluorofentanyl, tetrahydrofuranyl 
fentanyl, and methoxyacetyl 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

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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).
    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 took into 
consideration comments submitted by the Assistant Secretary in response 
to notice that DEA transmitted to the Assistant Secretary pursuant to 
section 811(h)(4).
    Further, the DEA believes that this notice of intent 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 hereby provides notice of 
its intent to temporarily 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 paragraphs (h)(19) through (21) to read as 
follows:


Sec.  1308.11  Schedule I.

* * * * *
    (h) * * *
    (19) N-(2-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)propionamide, 
its isomers, esters, ethers, salts and salts of isomers, esters and 
ethers (Other names: ortho-fluorofentanyl, 2-fluorofentanyl)--(9816)
    (20) N-(1-phenethylpiperidin-4-yl)-N-phenyltetrahydrofuran-2-
carboxamide, its isomers, esters, ethers, salts and salts of isomers, 
esters and ethers (Other name: tetrahydrofuranyl fentanyl)--(9843)
    (21) 2-methoxy-N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide, its 
isomers, esters, ethers, salts and salts of isomers, esters and ethers 
(Other name: methoxyacetyl fentanyl)--(9825)

    Dated: August 26, 2017.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2017-19283 Filed 9-11-17; 8:45 am]
 BILLING CODE 4410-09-P