[Federal Register Volume 81, Number 56 (Wednesday, March 23, 2016)]
[Proposed Rules]
[Pages 15485-15489]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-06468]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-434]


Schedules of Controlled Substances: Temporary Placement of 
Butyryl Fentanyl and Beta-Hydroxythiofentanyl Into Schedule I

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Notice of intent.

-----------------------------------------------------------------------

SUMMARY: The Administrator of the Drug Enforcement Administration is 
issuing this notice of intent to temporarily schedule the synthetic 
opioids, N-(1-phenethylpiperidin-4-yl)-N-phenylbutyramide (butyryl 
fentanyl) and N-[1-[2-hydroxy-2-(thiophen-2-yl)ethyl]piperidin-4-yl]-N-
phenylpropionamide (beta-hydroxythiofentanyl), 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 these synthetic opioids 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 
controlled substances under the Controlled Substances Act on the 
manufacture, distribution, possession,

[[Page 15486]]

importation, and exportation of, and research and conduct with, 
instructional activities of these synthetic opioids.

DATES: March 23, 2016.

FOR FURTHER INFORMATION CONTACT: Barbara J. Boockholdt, 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 April 22, 2016.

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, each 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.
    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 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.

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.\1\ The Administrator transmitted notice of 
his intent to place butyryl fentanyl and beta-hydroxythiofentanyl in 
schedule I on a temporary basis to the Assistant Secretary by letter 
dated December 21, 2015 (received by the HHS on December 23, 2015). The 
Assistant Secretary responded to this notice by letter dated January 
13, 2016, and advised that based on review by the Food and Drug 
Administration (FDA), there are currently no investigational new drug 
applications or approved new drug applications for butryl fentanyl or 
beta-hydroxythiofentanyl. The Assistant Secretary also stated that the 
HHS has no objection to the temporary placement of butryl fentanyl or 
beta-hydroxythiofentanyl into schedule I of the CSA. Neither butryl 
fentanyl nor beta-hydroxythiofentanyl are currently listed in any 
schedule under the CSA, and no exemptions or approvals are in effect 
for butryl fentanyl or beta-hydroxythiofentanyl under section 505 of 
the FDCA, 21 U.S.C. 355. The DEA has found that the control of butryl 
fentanyl and beta-hydroxythiofentanyl in schedule I on a temporary 
basis are necessary to avoid an imminent hazard to public safety.
---------------------------------------------------------------------------

    \1\ 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.
---------------------------------------------------------------------------

    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).

Butyryl Fentanyl and Beta-Hydroxythiofentanyl

    Available data and information for butyryl fentanyl and beta-
hydroxythiofentanyl, summarized below, indicate that these synthetic 
opioid 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. The DEA's three-
factor analysis is available in its entirety under of the public docket 
of this action as a supporting document at www.regulations.gov under 
Docket Number DEA-434.

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. 46 FR 46799. 
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

[[Page 15487]]

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. On July 17, 2015, acetyl fentanyl was temporarily 
controlled under schedule I of the CSA after a finding by the 
Administrator that it posed an imminent hazard to public safety. 80 FR 
42381.
    Prior to October 1, 2014, the System to Retrieve Information from 
Drug Evidence (STRIDE) collected the results of drug evidence analyzed 
at DEA laboratories and reflected evidence submitted by the DEA, other 
federal law enforcement agencies, and some local law enforcement 
agencies. STRIDE data were queried through September 30, 2014, by date 
submitted to federal forensic laboratories. Since October 1, 2014, 
STARLiMS (a web-based, commercial laboratory information management 
system) has replaced STRIDE as the DEA 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 December 21, 2015. The National Forensic Laboratory 
Information System (NFLIS) is a program of the DEA that collects drug 
identification results from drug cases analyzed by other federal, 
state, and local forensic laboratories. NFLIS reports from other 
federal, state, and local forensic laboratories were queried on 
December 22, 2015.\2\
---------------------------------------------------------------------------

    \2\ Data are still being reported for September-November 2015, 
due to normal lag time for laboratories to report to NFLIS.
---------------------------------------------------------------------------

    The first laboratory submission of butyryl fentanyl was recorded in 
Kansas in March 2014 according to NFLIS. STRIDE, STARLiMS and NFLIS 
registered seven reports containing butyryl fentanyl in 2014 in 
Illinois, Kansas, Minnesota, and Pennsylvania; 81 reports of butyryl 
fentanyl were recorded in 2015 in California, Connecticut, Florida, 
Indiana, North Dakota, New York, Ohio, Oregon, Tennessee, Virginia, and 
Wisconsin. A total of three reports of beta-hydroxythiofentanyl were 
recorded by STARLiMS, all of which were reported in 2015 from Florida. 
To date, beta-hydroxythiofentanyl has not been reported in NFLIS; 
however, this substance was identified in June 2015 by a forensic 
laboratory in Oregon.
    Evidence also suggests that the pattern of abuse of fentanyl 
analogues, including butyryl fentanyl and beta-hydroxythiofentanyl, 
parallels that of heroin and prescription opioid analgesics. Seizures 
of butyryl fentanyl have been encountered in tablet and powder form. 
Butyryl fentanyl was identified on bottle caps and spoons and residue 
was detected within glassine bags, on digital scales, and on sifters 
which demonstrates the abuse of this substance as a replacement for 
heroin or other opioids, either knowingly or unknowingly. Butyryl 
fentanyl has been encountered as a single substance as well as in 
combination with other illicit substances, such as acetyl fentanyl, 
heroin, cocaine, or methamphetamine. Like butyryl fentanyl, beta-
hydroxythiofentanyl has been encountered in both tablet and powder 
form. Both butyryl fentanyl and beta-hydroxythiofentanyl have caused 
fatal overdoses, in which intravenous routes of administration are 
documented.

Factor 5. Scope, Duration and Significance of Abuse

    The DEA is currently aware of at least 40 confirmed fatalities 
associated with butyryl fentanyl and 7 confirmed fatalities associated 
with beta-hydroxythiofentanyl. The information on these deaths 
occurring in 2015 was collected from toxicology and medical examiner 
reports and was reported from four states--Florida (7, beta-
hydroxythiofentanyl), Maryland (1, butyryl fentanyl), New York (38, 
butyryl fentanyl), and Oregon (1, butyryl fentanyl). STRIDE, STARLiMS, 
and NFLIS have a total of 88 drug reports in which butyryl fentanyl was 
identified in drug exhibits submitted in 2014 and 2015 from California, 
Connecticut, Florida, Illinois, Indiana, Kansas, Minnesota, North 
Dakota, New York, Ohio, Oregon, Pennsylvania, Tennessee, Virginia, and 
Wisconsin. STARLiMS has a total of three drug reports in which beta-
hydroxythiofentanyl was identified in drug exhibits submitted in 2015 
from Florida. It is likely that the prevalence of butyryl fentanyl and 
beta-hydroxythiofentanyl in opioid analgesic-related emergency room 
admissions and deaths is underreported as standard immunoassays cannot 
differentiate these substances from fentanyl.
    The population likely to abuse butyryl fentanyl and beta-
hydroxythiofentanyl overlaps with the populations abusing prescription 
opioid analgesics and heroin. This is evidenced by the routes of 
administration and drug use history documented in butyryl fentanyl and 
beta-hydroxythiofentanyl fatal overdose cases. Because abusers of these 
fentanyl analogues are likely to obtain these substances through 
illicit sources, the identity, purity, and quantity is uncertain and 
inconsistent, thus posing significant adverse health risks to abusers 
of butyryl fentanyl and beta-hydroxythiofentanyl. Individuals who 
initiate (i.e. use an illicit drug for the first time) butyryl fentanyl 
or beta-hydroxythiofentanyl 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

    Butyryl fentanyl and beta-hydroxythiofentanyl exhibit 
pharmacological profiles similar to that of fentanyl and other mu-
opioid receptor agonists. Due to limited scientific data, their potency 
and toxicity are not known; however, the toxic effects of both butyryl 
fentanyl and beta-hydroxythiofentanyl in humans are demonstrated by 
overdose fatalities involving these substances. Abusers of these 
fentanyl analogues 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 the documented case reports of overdose fatalities, the 
abuse of butyryl fentanyl and beta-hydroxythiofentanyl leads to the 
same qualitative public health risks as heroin, fentanyl and other 
opioid analgesic substances. 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.
    Butyryl fentanyl and beta-hydroxythiofentanyl have been associated 
with numerous fatalities. At least 40 confirmed overdose deaths 
involving butyryl fentanyl abuse have been reported in Maryland (1), 
New York (38), and Oregon (1) in 2015. At least seven confirmed 
overdose fatalities involving beta-hydroxythiofentanyl have been 
reported in Florida in 2015. This indicates that both butyryl fentanyl 
and beta-hydroxythiofentanyl 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 butyryl fentanyl and beta-hydroxythiofentanyl pose an imminent 
hazard to the public

[[Page 15488]]

safety. The DEA is not aware of any currently accepted medical uses for 
these substances 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 
butyryl fentanyl and beta-hydroxythiofentanyl 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 a 
letter dated December 21, 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 his 
determination that it is necessary to temporarily schedule butyryl 
fentanyl and beta-hydroxythiofentanyl in schedule I of the CSA, and 
finds that placement of these opioid substances 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 these synthetic opioids 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. Butyryl fentanyl and 
beta-hydroxythiofentanyl 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 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 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 paragraphs (h)(26) and (27) to read as 
follows:


Sec.  1308.11  Schedule I

* * * * *
    (h) * * *
    (26) N-(1-phenethylpiperidin-4-yl)-N-phenylbutyramide, its isomers, 
esters, ethers, salts and salts of isomers, esters and ethers (Other 
names: butyryl fentanyl)--(9822)
    (27) N-[1-[2-hydroxy-2-(thiophen-2-yl)ethyl]piperidin-4-yl]-N-
phenylpropionamide, its isomers, esters,

[[Page 15489]]

ethers, salts and salts of isomers, esters and ethers (Other names: 
beta-hydroxythiofentanyl)--(9836)

    Dated: March 16, 2016.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016-06468 Filed 3-22-16; 8:45 am]
 BILLING CODE 4410-09-P