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[Federal Register Volume 80, Number 98 (Thursday, May 21, 2015)]
[Proposed Rules]
[Pages 29227-29230]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-12331]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-413]

Schedules of Controlled Substances: Temporary Placement of Acetyl 
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 temporarily schedule the synthetic 
opioid, N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide (acetyl 
fentanyl), 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 opioid 
substance into schedule I of the Controlled Substances Act is necessary 
to avoid an imminent hazard to the public safety. Any final order will 
impose the administrative, civil, and criminal sanctions and regulatory 
controls applicable to schedule I substances under the Controlled 
Substances Act on the manufacture, distribution, possession, 
importation, exportation, research, and conduct of instructional 
activities of this opioid substance.

DATES: May 21, 2015.

FOR FURTHER INFORMATION CONTACT: John R. Scherbenske, Office of 
Diversion Control, Drug Enforcement Administration; Mailing Address: 
8701 Morrissette Drive, Springfield, Virginia 22152, Telephone: (202) 
598-6812.

SUPPLEMENTARY INFORMATION: Any final order will be published in the 
Federal Register and may not be effective prior to June 22, 2015.

Legal Authority

    The Drug Enforcement Administration (DEA) implements and enforces 
titles II and III of the Comprehensive Drug Abuse Prevention and 
Control Act of 1970, as amended. 21 U.S.C. 801-971. Titles II and III 
are referred to as the ``Controlled Substances Act'' and the 
``Controlled Substances Import and Export Act,'' respectively, and are 
collectively referred to as the ``Controlled Substances Act'' or the 
``CSA'' for the purpose of this action. The DEA publishes the 
implementing regulations for these statutes in title 21 of the Code of 
Federal Regulations (CFR), chapter II. The CSA and its implementing 
regulations are designed to prevent, detect, and eliminate the 
diversion of controlled substances and listed chemicals into the 
illicit market while providing for the legitimate medical, scientific, 
research, and industrial needs of the United States. Controlled 
substances have the potential for abuse and dependence and are 
controlled to protect the public health and safety.
    Under the CSA, every controlled substance is classified into one of 
five schedules based upon its potential for abuse, its currently 
accepted medical use in treatment in the United States, and the degree 
of dependence the drug or other substance may cause. 21 U.S.C. 812. The 
initial schedules of controlled substances established by Congress are 
found at 21 U.S.C. 812(c), and the current list of all scheduled 
substances is published at 21 CFR part 1308. 21 U.S.C. 812(a).
    Section 201 of the 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 or she 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). The Attorney General has delegated scheduling authority 
under 21 U.S.C. 811 to the Administrator of the DEA. 28 CFR 0.100.

[[Page 29228]]

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 her intention to temporarily place a substance 
into schedule I of the CSA.\1\ The Administrator transmitted notice of 
her intent to place acetyl fentanyl in schedule I on a temporary basis 
to the Assistant Secretary by letter dated April 7, 2015. Any comments 
submitted by the Assistant Secretary in response to the notice 
transmitted to the Assistant Secretary shall be taken into 
consideration before a final order is published. 21 U.S.C. 811(h)(4).
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    \1\ Because the Secretary of the HHS has delegated to the 
Assistant Secretary for Health of the HHS the authority to make 
domestic drug scheduling recommendations, for purposes of this 
notice of intent, all subsequent references to ``Secretary'' have 
been replaced with ``Assistant Secretary.'' As set forth in a 
memorandum of understanding entered into by the HHS, the Food and 
Drug Administration (FDA), and the National Institute on Drug Abuse 
(NIDA), FDA acts as the lead agency within HHS in carrying out the 
Assistant Secretary's scheduling responsibilities under the CSA, 
with the concurrence of NIDA. 50 FR 9518, Mar. 8, 1985.
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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 section 201(c) of the CSA, 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).

Acetyl Fentanyl

    Available data and information for acetyl fentanyl indicate that 
this opioid 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.

Factor 4. History and Current Pattern of Abuse

    Clandestinely produced substances structurally related to the 
schedule II opioid analgesic fentanyl were trafficked and abused on the 
West Coast in the late 1970s and 1980s. These clandestinely produced 
fentanyl-like substances were commonly known as designer drugs and 
recently, there has been a reemergence in the trafficking and abuse of 
designer drug substances including fentanyl-like substances. Alpha-
methylfentanyl, the first fentanyl analogue identified in California, 
was placed into schedule I of the CSA in September 1981. Following the 
control of alpha-methylfentanyl, the DEA identified several other 
fentanyl analogues (3-methylthiofentanyl, acetyl-alpha-methylfentanyl, 
beta-hydroxy-3-methylfentanyl, alpha-methylthiofentanyl, thiofentanyl, 
beta-hydroxyfentanyl, para-fluorofentanyl and 3-methylfentanyl) in 
submissions to forensic laboratories. These substances were temporarily 
controlled under schedule I of the CSA after finding that they posed an 
imminent hazard to public safety and were subsequently permanently 
placed in schedule I of the CSA.
    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 State and 
local forensic laboratories across the country. The first laboratory 
submission of acetyl fentanyl was recorded in Maine in April 2013 
according to NFLIS. NFLIS registered eight reports containing acetyl 
fentanyl in 2013 in Louisiana, Maine, and North Dakota; and 30 reports 
in 2014 in Florida, Illinois, Louisiana, Maine, New Jersey, Ohio, 
Oregon, Pennsylvania, and Virginia.
    The System to Retrieve Information from Drug Evidence (STRIDE) is a 
database of drug exhibits sent to DEA laboratories for analysis. 
Exhibits from the database are from the DEA, other Federal agencies, 
and some local law enforcement agencies. Acetyl fentanyl was first 
reported to STRIDE in September 2013 from exhibits obtained through a 
controlled purchase in Louisiana. In October 2013, an exhibit collected 
from a controlled purchase of suspected oxycodone tablets in Rhode 
Island contained acetyl fentanyl as the primary substance. In 2014, 
STARLiMS (a web-based, commercial laboratory information management 
system that is in transition to replace STRIDE) and STRIDE reported 
eight additional seizures in Colorado, Florida, Georgia, and 
Washington.
    In August 2013, the Centers for Disease Control and Prevention 
(CDC) published an article in its Morbidity and Mortality Weekly Report 
documenting a series of 14 fatalities related to acetyl fentanyl that 
occurred between March and May 2013. In December 2013, another fatality 
associated with acetyl fentanyl was reported in Rhode Island for a 
total of 15 fatalities. In February 2014, the North Carolina Department 
of Health and Human Services issued a health advisory related to acetyl 
fentanyl following at least three deaths related to this synthetic 
drug. Toxicologists at the North Carolina Office of the Chief Medical 
Examiner detected acetyl fentanyl in specimens associated with deaths 
that occurred in January 2014 in Sampson, Person, and Transylvania 
counties. In July and August 2014, four additional fatalities involving 
acetyl fentanyl were reported for a total of seven fatalities in North 
Carolina. Deaths involving acetyl fentanyl have also been reported in 
California (1), Louisiana (14), Oregon (1), and Pennsylvania (1).
    A significant seizure of acetyl fentanyl occurred in April 2013 
during a law enforcement investigation in Montreal, Canada. 
Approximately three kilograms of acetyl fentanyl in powder form and 
approximately 11,000 tablets containing acetyl fentanyl were seized. 
Given that a typical dose of acetyl fentanyl is in the microgram range, 
a three kilogram quantity could potentially produce millions of dosage 
units. In the United States, tablets that mimic pharmaceutical opioid 
products have been reported in multiple states, including Colorado, 
Florida, Georgia, Rhode Island, and Washington. Recent reports indicate 
that acetyl fentanyl in powder form is available over the Internet and 
has been imported to addresses within the United States.
    Evidence also suggests that the pattern of abuse of fentanyl 
analogues, including acetyl fentanyl, parallels that of heroin and 
prescription opioid analgesics. Seizures of acetyl fentanyl have been 
encountered both in powder and in tablet form. It is also known to have 
caused many fatal overdoses, in which intravenous routes of 
administration and histories of drug abuse are documented.

Factor 5. Scope, Duration and Significance of Abuse

    DEA is currently aware of at least 39 fatalities associated with 
acetyl fentanyl. These deaths have been reported in 2013 and 2014 from 
six states including California, Louisiana, North Carolina,

[[Page 29229]]

Oregon, Pennsylvania, and Rhode Island. STARLiMS and STRIDE, databases 
capturing drug evidence information from DEA forensic laboratories, 
have a total of 10 drug reports in which acetyl fentanyl was identified 
in six cases for analyzed drugs submitted from January 2010--December 
2014 from Colorado, Florida, Georgia, Louisiana, Rhode Island, and 
Washington. It is likely that the prevalence of acetyl fentanyl in 
opioid analgesic-related emergency room admissions and deaths is 
underreported as standard immunoassays cannot differentiate acetyl 
fentanyl from fentanyl.
    The population likely to abuse acetyl fentanyl overlaps with the 
populations abusing prescription opioid analgesics and heroin. This is 
evidenced by the routes of administration and drug use history 
documented in acetyl fentanyl fatal overdose cases. Because abusers of 
acetyl fentanyl are likely to obtain the drug through illicit sources, 
the identity, purity, and quantity is uncertain and inconsistent, thus 
posing significant adverse health risks to its abusers. This risk is 
particularly heightened by the fact that acetyl fentanyl is a highly 
potent opioid (15.7-fold more than that of morphine as tested in mice 
using an acetic acid writhing method). Thus small changes in the amount 
and purity of the substance could potentially lead to overdose and 
death.

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

    Acetyl fentanyl exhibits a pharmacological profile similar to that 
of fentanyl and other opioid analgesic compounds and it is a potent 
opioid analgesic reported to be \1/3\ as potent as fentanyl and 15.7 
times as potent as morphine in mice tested in an acetic acid writhing 
method. In addition, studies also showed that the range between the 
effective dose (ED50) and the lethal dose (LD50) of acetyl fentanyl is 
narrower than that of morphine and fentanyl, increasing the risk of 
fatal overdose. Thus, its abuse is likely to pose quantitatively 
greater risks to the public health and safety than abuse of traditional 
opioid analgesics such as morphine.
    Based on the above pharmacological data, the abuse of acetyl 
fentanyl at least leads to the same qualitative public health risks as 
heroin, fentanyl and other opioid analgesic compounds. The public 
health risks attendant to the abuse of heroin and opioid analgesics are 
well established. The abuse of opioid analgesics has resulted in large 
numbers of drug treatment admissions, emergency department visits, and 
fatal overdoses.
    Acetyl fentanyl has been associated with numerous fatalities. At 
least 39 overdose deaths due to acetyl fentanyl abuse have been 
reported in six states in 2013 and 2014, including California, 
Louisiana, North Carolina, Oregon, Pennsylvania, and Rhode Island. This 
indicates that acetyl fentanyl poses an imminent hazard to public 
safety.

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

    Based on the above summarized data and information, the continued 
uncontrolled manufacture, distribution, importation, exportation, and 
abuse of acetyl fentanyl pose an imminent hazard to the public safety. 
The DEA is not aware of any currently accepted medical uses for this 
substance 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 acetyl 
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 7, 2015, notified the 
Assistant Secretary of the DEA's intention to temporarily place this 
substance in schedule I.

Conclusion

    This notice of intent initiates an expedited temporary scheduling 
action and provides the 30-day notice pursuant to section 201(h) of the 
CSA, 21 U.S.C. 811(h). 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 her 
determination that it is necessary to temporarily schedule acetyl 
fentanyl in schedule I of the CSA, and finds that placement of this 
opioid substance into schedule I of the CSA is necessary in order to 
avoid an imminent hazard to the public safety.
    Because the Administrator hereby finds that it is necessary to 
temporarily place this synthetic opioid into schedule I to avoid an 
imminent hazard to the public safety, any subsequent final order 
temporarily scheduling these substances will be effective on the date 
of publication 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 such a final order as soon as possible after the expiration of 30 
days from the date of publication of this notice. Acetyl fentanyl will 
then be subject to the regulatory controls and administrative, civil, 
and criminal sanctions applicable to the manufacture, distribution, 
possession, importation, exportation, research, and conduct of 
instructional activities 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 an 
expedited 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).
    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

[[Page 29230]]

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 (OMB).
    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)(24) to read as follows:

Sec.  1308.11  Schedule I.

* * * * *
    (h) * * *
    (24) N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide, its optical, 
positional, and geometric isomers, salts and salts of isomers (Other 
names: Acetyl fentanyl)--(9821)
* * * * *

    Dated: May 14, 2015.
Michele M. Leonhart,
Administrator.
[FR Doc. 2015-12331 Filed 5-20-15; 8:45 am]
 BILLING CODE 4410-09-P
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