Schedules of Controlled Substances: Placement of beta-Hydroxythiofentanyl Into Schedule I, 21826-21831 [2018-10008]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 83, Number 91 (Thursday, May 10, 2018)]
[Proposed Rules]
[Pages 21826-21831]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-10008]



[[Page 21825]]

Vol. 83

Thursday,

No. 91

May 10, 2018

Part II





Department of Justice





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





Drug Enforcement Administration





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





21 CFR Part 1308





Schedules of Controlled Substances: Placement of beta-
Hydroxythiofentanyl Into Schedule I; Proposed Rule

Federal Register / Vol. 83 , No. 91 / Thursday, May 10, 2018 / 
Proposed Rules

[[Page 21826]]


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

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-484]


Schedules of Controlled Substances: Placement of beta-
Hydroxythiofentanyl Into Schedule I

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Notice of proposed rulemaking.

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

SUMMARY: The Drug Enforcement Administration proposes placing beta-
hydroxythiofentanyl (N-[1-[2-hydroxy-2-(thiophen-2-yl)ethyl]piperidin-
4-yl]-N-phenylpropionamide) also known as N-[1-[2-hydroxy-2-(2-
thienyl)ethyl]4-piperidinyl]N-phenyl-propanamide including its isomers, 
esters, ethers, salts, and salts of isomers, esters and ethers, in 
schedule I of the Controlled Substances Act. If finalized, this action 
would impose the regulatory controls and administrative, civil, and 
criminal sanctions applicable to schedule I controlled substances on 
persons who handle (manufacture, distribute, import, export, engage in 
research, conduct instructional activities or chemical analysis, or 
possess), or propose to handle beta-hydroxythiofentanyl.

DATES: Comments must be submitted electronically or postmarked on or 
before June 11, 2018.
    Interested persons may file a request for hearing or waiver of 
hearing pursuant to 21 CFR 1308.44 and in accordance with 21 CFR 
1316.45 and/or 1316.47, as applicable. Requests for hearing and waivers 
of an opportunity for a hearing or to participate in a hearing must be 
received on or before June 11, 2018.

ADDRESSES: Interested persons may file written comments on this 
proposal in accordance with 21 CFR 1308.43(g). Commenters should be 
aware that the electronic Federal Docket Management System will not 
accept comments after 11:59 p.m. Eastern Time on the last day of the 
comment period. To ensure proper handling of comments, please reference 
``Docket No. DEA-484'' on all electronic and written correspondence, 
including any attachments.
     Electronic comments: The Drug Enforcement Administration 
encourages that all comments be submitted electronically through the 
Federal eRulemaking Portal which provides the ability to type short 
comments directly into the comment field on the web page or to attach a 
file for lengthier comments. Please go to https://www.regulations.gov 
and follow the online instructions at that site for submitting 
comments. Upon completion of your submission you will receive a Comment 
Tracking Number for your comment. Please be aware that submitted 
comments are not instantaneously available for public view on 
Regulations.gov. If you have received a Comment Tracking Number, your 
comment has been successfully submitted and there is no need to 
resubmit the same comment.
     Paper comments: Paper comments that duplicate the 
electronic submission are not necessary. Should you wish to mail a 
paper comment in lieu of an electronic comment, it should be sent via 
regular or express mail to: Drug Enforcement Administration, Attn: DEA 
Federal Register Representative/DRW, 8701 Morrissette Drive, 
Springfield, Virginia 22152.
     Hearing requests: All requests for hearing and waivers of 
participation must be sent to: Drug Enforcement Administration, Attn: 
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All 
requests for hearing and waivers of participation should be sent to: 
Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 
Morrissette Drive, Springfield, Virginia 22152; and (2) Drug 
Enforcement Administration, Attn: DEA Federal Register Representative/
DRW, 8701 Morrissette Drive, Springfield, Virginia 22152.

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: 

Posting of Public Comments

    Please note that all comments received in response to this docket 
are considered part of the public record. They will, unless reasonable 
cause is given, be made available by the Drug Enforcement 
Administration (DEA) for public inspection online at https://www.regulations.gov. Such information includes personal identifying 
information (such as your name, address, etc.) voluntarily submitted by 
the commenter. The Freedom of Information Act (FOIA) applies to all 
comments received. If you want to submit personal identifying 
information (such as your name, address, etc.) as part of your comment, 
but do not want it to be made publicly available, you must include the 
phrase ``PERSONAL IDENTIFYING INFORMATION'' in the first paragraph of 
your comment. You must also place all of the personal identifying 
information you do not want made publicly available in the first 
paragraph of your comment and identify what information you want 
redacted.
    If you want to submit confidential business information as part of 
your comment, but do not want it to be made publicly available, you 
must include the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in the 
first paragraph of your comment. You must also prominently identify 
confidential business information to be redacted within the comment.
    Comments containing personal identifying information and 
confidential business information identified as directed above will be 
made publicly available in redacted form. If a comment has so much 
confidential business information or personal identifying information 
that it cannot be effectively redacted, all or part of that comment may 
not be made publicly available. Comments posted to https://www.regulations.gov may include any personal identifying information 
(such as name, address, and phone number) included in the text of your 
electronic submission that is not identified as directed above as 
confidential.
    An electronic copy of this document and supplemental information to 
this proposed rule are available at https://www.regulations.gov for easy 
reference.

Request for Hearing or Waiver of Participation in a Hearing

    Pursuant to 21 U.S.C. 811(a), this action is a formal rulemaking 
``on the record after opportunity for a hearing.'' Such proceedings are 
conducted pursuant to the provisions of the Administrative Procedure 
Act (APA), 5 U.S.C. 551-559. 21 CFR 1308.41-1308.45; 21 CFR part 1316, 
subpart D. Such requests or notices must conform to the requirements of 
21 CFR 1308.44(a) or (b), and 1316.47 or 1316.48, as applicable, and 
include a statement of the person's interests in the proposed 
scheduling action, whether the person is adversely affected or 
aggrieved, and the objections or issues, if any, concerning which the 
person desires to be heard at a hearing. Any waiver must conform to the 
requirements of 21 CFR 1308.44(c) and may include a written statement 
regarding the interested person's position on the matters of fact and 
law involved in any hearing.
    Please note that pursuant to 21 U.S.C. 811(a), the purpose and 
subject matter of a hearing held in relation to this rulemaking are 
restricted to: ``(A) find[ing] that such drug or other substance has a 
potential for abuse, and

[[Page 21827]]

(B) mak[ing] with respect to such drug or other substance the findings 
prescribed by subsection (b) of section 812 of this title for the 
schedule in which such drug is to be placed * * *.'' All requests for 
hearing and waivers of participation must be sent to the DEA using the 
address information provided above.

Legal Authority

    The Controlled Substances Act (CSA) provides that proceedings for 
the issuance, amendment, or repeal of the scheduling of any drug or 
other substance may be initiated by the Attorney General (1) on his own 
motion; (2) at the request of the Secretary of the Department of Health 
and Human Services (HHS),\1\ or (3) on the petition of any interested 
party. 21 U.S.C. 811(a). This proposed action is supported by a 
recommendation from the Assistant Secretary for Health of the HHS 
(Assistant Secretary) and an evaluation of all other relevant data by 
the DEA. If finalized, this action would continue \2\ to impose the 
regulatory controls and administrative, civil, and criminal sanctions 
of schedule I controlled substances on any person who handles or 
proposes to handle beta-hydroxythiofentanyl.
---------------------------------------------------------------------------

    \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.
    \2\ beta-Hydroxythiofentanyl is currently subject to schedule I 
controls on a temporary basis, pursuant to 21 U.S.C. 811(b). 81 FR 
29492, May 12, 2016.
---------------------------------------------------------------------------

Background

    On May 12, 2016, the DEA published a final order in the Federal 
Register amending 21 CFR 1308.11(h) to temporarily place beta-
hydroxythiofentanyl (N-[1-[2-hydroxy-2-(thiophen-2-yl)ethyl]piperidin-
4-yl]-N-phenylpropionamide in schedule I of the CSA pursuant to the 
temporary scheduling provisions of 21 U.S.C. 811(h). 81 FR 29492. That 
temporary scheduling order was effective on the date of publication, 
and was based on findings by the Acting Administrator of the DEA 
(Acting Administrator) that the temporary scheduling of beta-
hydroxythiofentanyl was necessary to avoid an imminent hazard to public 
safety pursuant to 21 U.S.C. 811(h)(1). Section 201(h)(2) of the CSA, 
21 U.S.C. 811(h)(2), requires that the temporary control of this 
substance expire two years from the effective date of the scheduling 
order, which was May 12, 2016. However, the CSA also provides that 
during the pendency of proceedings under 21 U.S.C. 811(a)(1) with 
respect to the substance, the temporary scheduling of that substance 
could be extended for up to one year. Proceedings for the scheduling of 
a substance under 21 U.S.C. 811(a) may be initiated by the Attorney 
General (delegated to the Administrator of the DEA pursuant to 28 CFR 
0.100) on his own motion, at the request of the Secretary of HHS,\3\ or 
on the petition of any interested party. An extension of the existing 
temporary order is being ordered by the Acting Administrator in a 
separate action, and is published elsewhere in this issue of the 
Federal Register.
---------------------------------------------------------------------------

    \3\ Because the Secretary of HHS has delegated to the Assistant 
Secretary the authority to make domestic drug scheduling 
recommendations, for purposes of this proposed rulemaking, all 
subsequent references to ``Secretary'' have been replaced with 
``Assistant Secretary.''
---------------------------------------------------------------------------

    The Acting Administrator, on his own motion pursuant to 21 U.S.C. 
811(a), is initiating proceedings under 21 U.S.C. 811(a)(1) to 
permanently schedule beta-hydroxythiofentanyl. The DEA has gathered and 
reviewed the available information regarding the pharmacology, 
chemistry, trafficking, actual abuse, pattern of abuse, and the 
relative potential for abuse for beta-hydroxythiofentanyl. On December 
8, 2016, the Acting Administrator submitted a request to the Assistant 
Secretary to provide the DEA with a scientific and medical evaluation 
of available information and a scheduling recommendation for butyryl 
fentanyl and beta-hydroxythiofentanyl, in accordance with 21 U.S.C. 
811(b) and (c). In a letter dated November 1, 2017, DEA notified HHS 
that it no longer required a scientific and medical evaluation for 
butyryl fentanyl because the Commission on Narcotic Drugs (CND), at its 
60th session, added butyryl fentanyl to Schedule I of the Single 
Convention on Narcotic Drugs, 1961. On April 20, 2018, the DEA 
published a final scheduling order for butyryl fentanyl (83 FR 17486) 
to meet international treaty obligations pursuant to 21 U.S.C. 
811(d)(1).
    Upon evaluating the scientific and medical evidence, on April 27, 
2018, the Assistant Secretary submitted to the Acting Administrator 
HHS's scientific and medical evaluation and scheduling recommendation 
for beta-hydroxythiofentanyl. Upon receipt of the scientific and 
medical evaluation and scheduling recommendation from the HHS, the DEA 
reviewed the documents and all other relevant data, and conducted its 
own eight-factor analysis of the abuse potential of beta-
hydroxythiofentanyl in accordance with 21 U.S.C. 811(c).

Proposed Determination To Schedule beta-Hydroxythiofentanyl

    As discussed in the background section, the Acting Administrator is 
initiating proceedings, pursuant to 21 U.S.C. 811(a)(1), to add beta-
hydroxythiofentanyl permanently to schedule I. The DEA has reviewed the 
scientific and medical evaluations and scheduling recommendation, 
received from HHS, and all other relevant data and conducted its own 
eight-factor analysis of the abuse potential of beta-
hydroxythiofentanyl pursuant to 21 U.S.C. 811(c). Included below is a 
brief summary of each factor as analyzed by the HHS and the DEA, and as 
considered by the DEA in its proposed scheduling action. Please note 
that both the DEA 8-Factor and HHS 8-Factor analyses and the Assistant 
Secretary's April 27, 2018, letter, are available in their entirety 
under the tab ``Supporting Documents'' of the public docket for this 
action at https://www.regulations.gov under Docket Number ``DEA-484.''
    1. The Drug's Actual or Relative Potential for Abuse: The term 
``abuse'' is not defined in the CSA. However, the legislative history 
of the CSA suggests that the DEA consider the following criteria when 
determining whether a particular drug or substance has a potential for 
abuse: \4\
---------------------------------------------------------------------------

    \4\ Comprehensive Drug Abuse Prevention and Control Act of 1970, 
H.R. Rep. No. 91-1444, 91st Cong., Sess. 1 (1970); reprinted in 1970 
U.S.C.C.A.N. 4566, 4603.

    (a) There is evidence that individuals are taking the drug or 
drugs containing such a substance in amounts sufficient to create a 
hazard to their health or to the safety of other individuals or of 
the community; or
    (b) There is significant diversion of the drug or drugs 
containing such a substance from legitimate drug channels; or
    (c) Individuals are taking the drug or drugs containing such a 
substance on their own initiative rather than on the basis of 
medical advice from a practitioner licensed by law to administer 
such drugs in the course of his professional practice; or
    (d) The drug or drugs containing such a substance are new drugs 
so related in their action to a drug or drugs already listed as 
having a potential for abuse to make it likely that the drug will 
have the same potentiality for abuse as such drugs, thus making it 
reasonable to assume that there may be significant diversions from 
legitimate channels, significant use contrary to or without medical 
advice, or that it has a substantial capability of creating hazards 
to

[[Page 21828]]

the health of the user or to the safety of the community.

    The abuse potential of beta-hydroxythiofentanyl is associated with 
its pharmacological similarity to other schedule I and II mu-opioid 
receptor agonist substances which have a high potential for abuse. 
Similar to morphine, fentanyl and several schedule I opioid substances 
that are structurally related to fentanyl, beta-hydroxythiofentanyl has 
been shown to bind and act as a [mu]-opioid receptor agonist.
    beta-Hydroxythiofentanyl has no approved medical use in the United 
States and has been encountered on the illicit drug market. The use of 
beta-hydroxythiofentanyl has been associated with adverse outcomes to 
include death. Because beta-hydroxythiofentanyl is not an approved drug 
product, a practitioner may not legally prescribe it, and this 
substance cannot be dispensed to an individual. Therefore, the use of 
beta-hydroxythiofentanyl is without medical advice, and accordingly, 
leads to the conclusion that beta-hydroxythiofentanyl is abused for its 
opioidergic properties. There are no legitimate drug channels for beta-
hydroxythiofentanyl as a marketed drug product but it's available for 
purchase from legitimate chemical companies because it is used in 
scientific research. However, despite the limited legitimate use of 
this substance, reports from public health and law enforcement 
communicate that beta-hydroxythiofentanyl is being abused and taken in 
amounts sufficient to create a hazard to an individual's health. This 
is evidenced by the positive toxicological identification of beta-
hydroxythiofentanyl in several (n=25) overdose deaths. Data from 
forensic databases can be used as an indicator of illicit activity with 
drugs and abuse \5\ within the United States. According to the National 
Forensic Laboratory Information System (NFLIS) \6\ which collects and 
analyzes drug exhibits submitted to Federal, State and Local forensic 
laboratories, there were ten reports (from Florida) of beta-
hydroxythiofentanyl within this database in 2015. Consequently, the 
positive identification of beta-hydroxythiofentanyl in law enforcement 
encounters and toxicological screenings of overdose deaths indicates 
that this substance is being abused, and thus poses safety hazards to 
the health of users.
---------------------------------------------------------------------------

    \5\ While law enforcement data is not direct evidence of abuse, 
it can lead to an inference that a drug has been diverted and 
abused. See 76 FR 77330, 77332, Dec. 12, 2011.
    \6\ NFLIS is a DEA program and a national forensic laboratory 
reporting system that systematically collects results from drug 
chemistry analyses conducted by state and local forensic 
laboratories in the United States. The NFLIS database also contains 
Federal data from U.S. Customs and Border Protection (CBP). NFLIS 
only includes drug chemistry results from completed analyses.
---------------------------------------------------------------------------

    2. Scientific Evidence of the Drug's Pharmacological Effects, if 
Known: beta-Hydroxythiofentanyl is pharmacologically similar to other 
schedule I and schedule II mu-opioid receptor agonist substances. The 
abuse potential (assessed by drug discriminative study and self-
administration study) of beta-hydroxythiofentanyl has not been studied 
in non-clinical or clinical studies, however the non-clinical and 
clinical studies conducted on abuse potential of mu-opioid receptor 
agonists such as morphine and fentanyl indicate that these drugs share 
discriminative stimulus effects and that these drugs have reinforcing 
properties. Similar to schedule I and II opioid analgesics, beta-
hydroxythiofentanyl binds to and activates the mu-opioid receptor. 
Additionally, behavioral studies in animals demonstrate that similar to 
fentanyl and morphine, beta-hydroxythiofentanyl produces analgesic 
effect. Pre-treatment with naltrexone, an opioid antagonist, attenuated 
analgesic effects of beta-hydroxythiofentanyl, fentanyl and morphine. 
These data indicate that beta-hydroxythiofentanyl is a CNS active mu-
opioid receptor agonist that is about 10 times more potent than 
morphine. Thus, it is concluded from in vitro and in vivo 
pharmacological studies that effects of beta-hydroxythiofentanyl are 
similar to that of fentanyl and morphine and is mediated by mu-opioid 
receptor agonism.
    3. The State of Current Scientific Knowledge Regarding the Drug or 
Other Substance: beta-Hydroxythiofentanyl is a synthetic opioid of the 
4-anilidopiperidine structural class which includes fentanyl and 
thiofentanyl. The chemical structure of beta-hydroxythiofentanyl 
differs in substitution from fentanyl at the piperidine nitrogen atom. 
Fentanyl contains a phenyl ethyl group at the piperidine nitrogen atom 
whereas beta-hydroxythiofentanyl is substituted with a beta-hydroxy 2-
thienyl ethyl group. Also, beta-hydroxythiofentanyl structurally 
differs from the schedule I synthetic opioid, thiofentanyl, by the 
addition of a hydroxyl group at the beta-position of the thienyl ethyl 
group. Data from postmortem toxicological analysis show that a fentanyl 
metabolite, norfentanyl, was detected in one case that involved beta-
hydroxythiofentanyl. No study has been undertaken to evaluate the 
efficacy, toxicology, and safety of beta-hydroxythiofentanyl in humans. 
It can be inferred from medical examiner reports and data obtained from 
animal studies that beta-hydroxythiofentanyl has sufficient 
distribution to the brain to produce depressant effects similar to that 
of mu opioid receptor agonists.
    There is no FDA approved marketing application for a drug product 
containing beta-hydroxythiofentanyl for any therapeutic indication in 
the United States. Moreover, there are no clinical studies or 
petitioners of which has claimed an accepted medical use in the United 
States for this substance.
    4. Its History and Current Pattern of Abuse: beta-
Hydroxythiofentanyl was first encountered as a drug of abuse in 1985. 
Evidence suggests that the pattern of abuse of beta-hydroxythiofentanyl 
parallels that of prescription opioid analgesics. Beta-
hydroxythiofentanyl, like other substances structurally related to 
fentanyl is disguised as a ``legal'' alternative to fentanyl. There is 
evidence that beta-hydroxythiofentanyl is ingested with other 
substances. beta-Hydroxythiofentanyl has been identified in pills, 
presumably intended for sale on the illicit market.
    5. The Scope, Duration, and Significance of Abuse: beta-
Hydroxythiofentanyl, similar to other substances structurally related 
to fentanyl, is a recreational drug. The recreational use of beta-
hydroxythiofentanyl and other substances related to fentanyl continues 
to be of significant concern in the United States. These substances are 
distributed to users, often with unpredictable outcomes. Because users 
of beta-hydroxythiofentanyl and its associated drug products 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 abusers. The significance of abuse 
for beta-hydroxythiofentanyl is reflected in the positive 
identification of this substance in several post-mortem cases. Though 
the scope and duration of abuse data for beta-hydroxythiofentanyl were 
restricted to Florida in 2015, there is the possibility the number of 
fatalities were underreported because the capabilities of medical 
examiner offices across the country vary and many are unable to detect 
beta-hydroxythiofentanyl in their toxicological screens. Evidence that 
beta-hydroxythiofentanyl is being abused and trafficked is confirmed by 
law enforcement encounters. NFLIS contained ten reports of beta-

[[Page 21829]]

hydroxythiofentanyl from Florida from State, local, and other forensic 
laboratories. These data demonstrate that beta-hydroxythiofentanyl has 
significance of abuse that supports its scheduling under the CSA.
    Currently the United States is in the midst of a prescription and 
illicit opioid abuse epidemic. According to NFLIS, in the last few 
years, there has been marked increase in the encounters of synthetic 
opioids such as fentanyl and substances that are structurally related 
to fentanyl. In parallel to this increase in law enforcement 
encounters, there has been a corresponding marked increase in deaths 
related to synthetic opioids. beta-Hydroxythiofentanyl is a synthetic 
opioid that is structurally related to fentanyl. Therefore, the issue 
of fentanyl and substances structurally related to fentanyl abuse has 
become a major public health problem.
    6. What, if Any, Risk There is to the Public Health: Available 
evidence on the overall public health risks associated with the use of 
beta-hydroxythiofentanyl is reflected by the several cases of 
fatalities (n=25) associated with its abuse. In addition to the 
recognized harm from ingesting beta-hydroxythiofentanyl, abusers risk 
harm when they obtain these drugs through unknown sources. Since beta-
hydroxythiofentanyl shares a similar pharmacological profile with 
fentanyl and other opioid analgesics, individuals who abuse this 
substance are likely at risk of developing substance use disorder, 
overdose and death similar to other opioid analgesics. Further, poly-
substance abuse has been identified in fatalities involving fentanyl 
and other related opioids. In reported fatality cases involving beta-
hydroxythiofentanyl, other substances such as cocaine, ethanol, other 
opioids, cannabinoids, benzodiazepines, and stimulants were also co-
identified in the toxicological screening. Evidence suggests that 
products containing fentanyl related substances often do not bear 
accurate information regarding their contents and if they do, they may 
not contain the expected active ingredients or identify the health 
risks and potential hazards associated with these products. Thus, the 
limited knowledge about product contents, its purity and lack of 
information about its effects may pose another level of risk to users. 
Taken together, evidence posits that individuals experimenting with 
substances with unknown potency are at high risk of adverse health 
outcomes.
    7. Its Psychic or Physiological Dependence Liability: There are no 
pre-clinical and clinical studies that have evaluated the dependence 
potential of beta-hydroxythiofentanyl. beta-Hydroxythiofentanyl is a 
mu-opioid receptor agonist, and discontinuation of the use of mu-opioid 
receptor agonists, such as fentanyl and morphine, is well known to 
cause withdrawal indicative of physical dependence. Opioid withdrawal 
includes nausea and vomiting, depression, agitation, anxiety, craving, 
sweats, hypertension, diarrhea, and fever.
    8. Whether the Substance is an Immediate Precursor of a Substance 
Already Controlled Under the CSA: beta-Hydroxythiofentanyl is not 
considered an immediate precursor of any controlled substance of the 
CSA as defined by 21 U.S.C. 802(23).
    Conclusion: After considering the scientific and medical evaluation 
conducted by the HHS, the HHS's recommendation, and the DEA's own 
eight-factor analysis, the DEA finds that the facts and all relevant 
data constitute substantial evidence of the potential for abuse of 
beta-hydroxythiofentanyl. As such, the DEA hereby proposes to 
permanently schedule beta-hydroxythiofentanyl as a schedule I 
controlled substance under the CSA.

Proposed Determination of Appropriate Schedule

    The CSA establishes five schedules of controlled substances known 
as schedules I, II, III, IV, and V. The CSA also outlines the findings 
required to place a drug or other substance in any particular schedule. 
21 U.S.C. 812(b). After consideration of the analysis and 
recommendation of the Assistant Secretary for HHS and review of all 
other available data, the Acting Administrator of the DEA, pursuant to 
21 U.S.C. 811(a) and 21 U.S.C. 812(b)(1), finds that:
    1. beta-Hydroxythiofentanyl has a high potential for abuse;
    2. beta- Hydroxythiofentanyl has no currently accepted medical use 
in treatment in the United States; and
    3. There is a lack of accepted safety for use of beta-
hydroxythiofentanyl under medical supervision.
    Based on these findings, the Acting Administrator of the DEA 
concludes that beta-hydroxythiofentanyl (N-[1-[2-hydroxy-2-(thiophen-2-
yl)ethyl]piperidin-4-yl]-N-phenylpropionamide), including its isomers, 
esters, ethers, salts, and salts of isomers, esters and ethers, warrant 
continued control in schedule I of the CSA. 21 U.S.C. 812(b)(1).

Requirements for Handling beta-Hydroxythiofentanyl

    If this rule is finalized as proposed, beta-hydroxythiofentanyl 
would continue \7\ to be subject to the CSA's schedule I regulatory 
controls and administrative, civil, and criminal sanctions applicable 
to the manufacture, distribution, dispensing, importing, exporting, 
research, and conduct of instructional activities, including the 
following:
---------------------------------------------------------------------------

    \7\ beta-Hydroxythiofentanyl is currently subject to schedule I 
controls on a temporary basis, pursuant to 21 U.S.C. 811(h). 81 FR 
29492, May 12, 2016.
---------------------------------------------------------------------------

    1. Registration. Any person who handles (manufactures, distributes, 
dispenses, imports, exports, engages in research, or conducts 
instructional activities or chemical analysis with, or possesses) beta-
hydroxythiofentanyl, or who desires to handle beta-hydroxythiofentanyl, 
is required to be registered with the DEA to conduct such activities 
pursuant to 21 U.S.C. 822, 823, 957, and 958, and in accordance with 21 
CFR parts 1301 and 1312.
    2. Security. beta-Hydroxythiofentanyl is subject to schedule I 
security requirements and must be handled and stored pursuant to 21 
U.S.C. 821, 823, and in accordance with 21 CFR 1301.71-1301.93.
    3. Labeling and Packaging. All labels and labeling for commercial 
containers of beta-hydroxythiofentanyl must be in compliance with 21 
U.S.C. 825 and 958(e), and be in accordance with 21 CFR part 1302.
    4. Quota. Only registered manufacturers are permitted to 
manufacture beta-hydoxythiofentanyl in accordance with a quota assigned 
pursuant to 21 U.S.C. 826 and in accordance with 21 CFR part 1303.
    5. Inventory. Any person registered with the DEA to handle beta-
hydroxythiofentanyl must have an initial inventory of all stocks of 
controlled substances (including beta-hydroxythiofentanyl) on hand on 
the date the registrant first engages in the handling of controlled 
substances pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 
CFR 1304.03, 1304.04, and 1304.11.
    After the initial inventory, every DEA registrant must take a new 
inventory of all stocks of controlled substances (including beta-
hydroxythiofentanyl) on hand every two years pursuant to 21 U.S.C. 827 
and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.
    6. Records and Reports. Every DEA registrant is required to 
maintain records and submit reports with respect to beta-
hydroxythiofentanyl, pursuant to 21 U.S.C. 827 and 958(e), and in 
accordance with 21 CFR parts 1304 and 1312.
    7. Order Forms. Every DEA registrant who distributes beta-

[[Page 21830]]

hydroxythiofentanyl is required to comply with the order form 
requirements, pursuant to 21 U.S.C. 828, and 21 CFR part 1305.
    8. Importation and Exportation. All importation and exportation of 
beta-hydroxythiofentanyl must be in compliance with 21 U.S.C. 952, 953, 
957, and 958, and in accordance with 21 CFR part 1312.
    9. Liability. Any activity involving beta-hydroxythiofentanyl not 
authorized by, or in violation of, the CSA or its implementing 
regulations is unlawful, and could subject the person to 
administrative, civil, and/or criminal sanctions.

Regulatory Analyses

Executive Orders 12866, 13563, and 13771, Regulatory Planning and 
Review, Improving Regulation and Regulatory Review, and Reducing 
Regulation and Controlling Regulatory Costs

    In accordance with 21 U.S.C. 811(a), this proposed scheduling 
action is subject to formal rulemaking procedures done ``on the record 
after opportunity for a hearing,'' which are conducted pursuant to the 
provisions of 5 U.S.C. 556 and 557. The CSA sets forth the criteria for 
scheduling a drug or other substance. Such actions are exempt from 
review by the Office of Management and Budget (OMB) pursuant to section 
3(d)(1) of Executive Order 12866 and the principles reaffirmed in 
Executive Order 13563.
    This proposed rule does not meet the definition of an Executive 
Order 13771 regulatory action, and the repeal and cost offset 
requirements of Executive Order 13771 have not been triggered. OMB has 
previously determined that formal rulemaking actions concerning the 
scheduling of controlled substances, such as this rule, are not 
significant regulatory actions under Section 3(f) of Executive Order 
12866.

Executive Order 12988, Civil Justice Reform

    This proposed regulation meets the applicable standards set forth 
in sections 3(a) and 3(b)(2) of Executive Order 12988 to eliminate 
drafting errors and ambiguity, minimize litigation, provide a clear 
legal standard for affected conduct, and promote simplification and 
burden reduction.

Executive Order 13132, Federalism

    This proposed rulemaking does not have federalism implications 
warranting the application of Executive Order 13132. The proposed rule 
does not have substantial direct effects on the States, on the 
relationship between the national government and the States, or the 
distribution of power and responsibilities among the various levels of 
government.

Executive Order 13175, Consultation and Coordination With Indian Tribal 
Governments

    This proposed rule does not have tribal implications warranting the 
application of Executive Order 13175. It does not have substantial 
direct effects on one or more Indian tribes, on the relationship 
between the Federal Government and Indian tribes, or on the 
distribution of power and responsibilities between the Federal 
Government and Indian tribes.

Regulatory Flexibility Act

    The Administrator, in accordance with the Regulatory Flexibility 
Act (RFA), 5 U.S.C. 601-602, has reviewed this proposed rule and by 
approving it, certifies that it will not have a significant economic 
impact on a substantial number of small entities. On May 12, 2016, the 
DEA published a final order to temporarily place beta-
hydroxythiofentanyl in schedule I of the CSA pursuant to the temporary 
scheduling provisions of 21 U.S.C. 811(h). The DEA estimates that all 
entities handling or planning to handle beta-hydroxythiofentanyl have 
already established and implemented the systems and processes required 
to handle this substances. There are currently 15 registrations 
authorized to handle beta-hydroxythiofentanyl, as well as a number of 
registered analytical labs that are authorized to handle schedule I 
controlled substances generally. These 15 registrations represent 13 
entities, of which 10 are small entities. Therefore, the DEA estimates 
10 small entities are affected by this proposed rule.
    A review of the 15 registrations indicates that all entities that 
currently handle beta-hydroxythiofentanyl also handle other schedule I 
controlled substances, and have established and implemented (or 
maintain) the systems and processes required to handle beta-
hydroxythiofentanyl. Therefore, the DEA anticipates that this proposed 
rule will impose minimal or no economic impact on any affected 
entities; and thus, will not have a significant economic impact on any 
of the 10 affected small entities. Therefore, the DEA has concluded 
that this proposed rule will not have a significant effect on a 
substantial number of small entities.

Unfunded Mandates Reform Act of 1995

    In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995, 
2 U.S.C. 1501 et seq., the DEA has determined and certifies that this 
action would not result in any Federal mandate that may result ``in the 
expenditure by State, local, and tribal governments, in the aggregate, 
or by the private sector, of $100,000,000 or more (adjusted for 
inflation) in any one year * * *.'' Therefore, neither a Small 
Government Agency Plan nor any other action is required under UMRA of 
1995.

Paperwork Reduction Act of 1995

    This action does not impose a new collection of information under 
the Paperwork Reduction Act of 1995. 44 U.S.C. 3501-3521. This action 
would not impose recordkeeping or reporting requirements on State or 
local governments, individuals, businesses, or organizations. An agency 
may not conduct or sponsor, and a person is not required to respond to, 
a collection of information unless it displays a currently valid OMB 
control number.

[[Page 21831]]

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), 956(b), unless otherwise 
noted.

0
2. In Sec.  1308.11:
0
a. Redesignate paragraphs (b)(15) through (60) as (b)(16) through (61); 
and
0
b. Add new paragraph (b)(15);
0
c. Remove and reserve paragraph (h)(3).
    The addition to read as follows:


Sec.  1308.11   Schedule I.

* * * * *
    (b) * * *

(15) N-[1-[2-hydroxy-2-(thiophen-2-yl)ethyl]piperidin-4-yl]-N-    (9836)
 phenylpropionamide, its isomers, esters, ethers, salts and
 salts of isomers, esters and ethers (Other name: beta-
 Hydroxythiofentanyl).........................................
 

* * * * *

    Dated: May 7, 2018.
Robert W. Patterson,
Acting Administrator.
[FR Doc. 2018-10008 Filed 5-9-18; 8:45 am]
 BILLING CODE 4410-09-P