[Federal Register Volume 82, Number 17 (Friday, January 27, 2017)]
[Proposed Rules]
[Pages 8593-8598]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-01514]


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 Proposed Rules
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
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  Federal Register / Vol. 82, No. 17 / Friday, January 27, 2017 / 
Proposed Rules  

[[Page 8593]]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-402]


Schedules of Controlled Substances: Placement of AB-CHMINACA, AB-
PINACA and THJ-2201 Into Schedule I

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Drug Enforcement Administration proposes placing N-(1-
amino-3-methyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-
carboxamide (AB-CHMINACA), N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-
pentyl-1H-indazole-3-carboxamide (AB-PINACA) and [1-(5-fluoropentyl)-
1H-indazol-3-yl](naphthalen-1-yl)methanone (THJ-2201), including their 
salts, isomers, and salts of isomers whenever the existence of such 
salts, isomers, and salts of isomers is possible, into schedule I of 
the Controlled Substances Act. This proposed scheduling action is 
pursuant to the Controlled Substances Act which requires that such 
actions be made on the record after opportunity for a hearing through 
formal rulemaking. If finalized, this action would continue to 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 AB-CHMINACA, AB-PINACA and THJ-2201.

DATES: Interested persons may file written comments on this proposal in 
accordance with 21 CFR 1308.43(g). Comments must be submitted 
electronically or postmarked on or before February 27, 2017. 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.
    Interested persons, defined at 21 CFR 1300.01 as those ``adversely 
affected or aggrieved by any rule or proposed rule issuable pursuant to 
section 201 of the Act (21 U.S.C. 811),'' 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 February 27, 
2017.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-402'' 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 attach a 
file for lengthier comments. Please go to http://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 a 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: (1) 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 http://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 the 
confidential business information to be redacted within the comment.
    Comments containing personal identifying information or 
confidential business information identified as directed above will be 
made publicly available in redacted form. If a comment has so much 
confidential business information that it cannot be effectively 
redacted, all or part of that comment may not be made publicly 
available. Comments posted to http://www.regulations.gov may include 
any personal identifying information (such

[[Page 8594]]

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 http://www.regulations.gov for easy 
reference.

Request for Hearing, or Waiver of Participation in 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. In accordance with 21 CFR 1308.44(a)-(c), requests for 
hearing, notices of appearance, and waivers of an opportunity for a 
hearing or to participate in a hearing may be submitted only by 
interested persons, defined as those ``adversely affected or aggrieved 
by any rule or proposed rule issuable pursuant to section 201 of the 
Act (21 U.S.C. 811).'' 21 CFR 1300.01. 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 interest of the 
person in the proceeding and the objections or issues, if any, 
concerning which the person desires to be heard. 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 is 
restricted to: ``(A) find[ing] that such drug or other substance has a 
potential for abuse, and (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 DEA implements and enforces Titles II and III of the 
Comprehensive Drug Abuse Prevention and Control Act of 1970, as 
amended. 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. 21 U.S.C. 801-971. 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, controlled substances are classified into one of 
five schedules based upon their potential for abuse, their currently 
accepted medical use in treatment in the United States, and the degree 
of dependence the 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 scheduled substances is 
published at 21 CFR part 1308.
    Pursuant to 21 U.S.C. 811(a)(1), the Attorney General may, by rule, 
``add to such a schedule or transfer between such schedules any drug or 
other substance if he (A) finds that such drug or other substance has a 
potential for abuse, and (B) makes 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 * * *.'' 
The Attorney General has delegated scheduling authority under 21 U.S.C. 
811 to the Administrator of the DEA. 28 CFR 0.100.
    The 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 her 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 of the HHS and an evaluation of all other relevant 
data by the DEA. If finalized, this action would continue 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 AB-CHMINACA, AB-PINACA and THJ-2201.
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    \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.
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Background

    On January 30, 2015, the DEA published a final order in the Federal 
Register amending 21 CFR 1308.11(h) to temporarily place the three 
synthetic cannabinoids [1-(5-Fluoropentyl)-1H-indazol-3-yl](naphthalen-
1-yl)methanone (THJ-2201); N-1-Amino-3-methyl-1-oxo-2-butanyl]-1-
pentyl-1H-indazole-3-carboxamide (AB-PINACA); and N-[1-Amino-3-methyl-
1-oxo-2-butanyl]-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide (AB-
CHMINACA) into schedule I of the CSA pursuant to the temporary 
scheduling provisions of 21 U.S.C. 811(h). 80 FR 5042. That final 
order, which became effective on the date of publication, was based on 
findings by the Administrator of the DEA that the temporary scheduling 
of these three synthetic cannabinoids was necessary to avoid an 
imminent hazard to the public safety pursuant to 21 U.S.C. 811(h)(1). 
At the time the final order took effect, section 201(h)(2) of the CSA, 
21 U.S.C. 811(h)(2), required that the temporary scheduling of a 
substance expire at the end of two years from the date of the 
scheduling order, and it provided that, during the pendency of 
proceedings under 21 U.S.C. 811(a)(1) with respect to the substance, 
temporary scheduling of that substance could be extended for up to 1 
year. Pursuant to 21 U.S.C. 811(h)(2), the temporary scheduling of THJ-
2201, AB-PINACA, and AB-CHMINACA expires on January 29, 2017, unless 
extended. An extension of the temporary order is being ordered by the 
DEA Administrator in a separate action.
    The Administrator of the DEA, on his own motion pursuant to 21 
U.S.C. 811(a), has initiated proceedings under 21 U.S.C. 811(a)(1) to 
permanently schedule THJ-2201, AB-PINACA and AB-CHMINACA. 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 these three synthetic 
cannabinoids. In accordance with 21 U.S.C. 811(b) and (c), on August 
26, 2015, the DEA submitted a request to the HHS to provide the DEA 
with a scientific and medical evaluation of available information and a 
scheduling recommendation for THJ-2201, AB-PINACA and AB-CHMINACA. Upon 
evaluating the scientific and medical evidence, on November 14, 2016, 
the

[[Page 8595]]

HHS submitted to the Administrator of the DEA its three scientific and 
medical evaluations for these substances. Upon receipt of the 
scientific and medical evaluations and scheduling recommendations 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 
THJ-2201, AB-PINACA and AB-CHMINACA in accordance with 21 U.S.C. 
811(c). The DEA has published a temporary order for the extension of 
the placement of THJ-2201, AB-PINACA and AB-CHMINACA into schedule I 
elsewhere in this issue of the Federal Register.

Proposed Determination To Schedule THJ-2201, AB-PINACA and AB-CHMINACA

    Pursuant to 21 U.S.C. 811(a)(1), proceedings to add a drug or 
substance to those controlled under the CSA may be initiated by the 
Attorney General, or her delegate, the DEA Administrator. On August 26, 
2015, the DEA requested scientific and medical evaluations and 
scheduling recommendations from the Assistant Secretary of Health for 
the U.S. Department of Health and Human Services (HHS) for THJ-2201, 
AB-PINACA and AB-CHMINACA pursuant to 21 U.S.C. 811(b). Upon receipt of 
the scientific and medical evaluations and scheduling recommendations 
from the HHS dated November 14, 2016, the DEA reviewed the documents 
and all other relevant data and conducted its own eight-factor analysis 
of the abuse potential of THJ-2201, AB-PINACA and AB-CHMINACA 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 November 14, 2016, 
letter, are available in their entirety under the tab ``Supporting 
Documents'' of the public docket of this action at http://www.regulations.gov, under Docket Number ``DEA-402.''
    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 in 
determining whether a particular drug or substance has a potential for 
abuse: \2\
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    \2\ 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.
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    (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 the health 
of the user or to the safety of the community.
    Through epidemiological and case report data, HHS has demonstrated 
that the ingestion of AB-CHMINACA, AB-PINACA and/or THJ-2201 in 
sufficient amounts is creating a hazard to the health and safety of 
both the individual users and others within the community. Adverse 
effects observed following the ingestion of synthetic cannabinoids 
(SCs), including AB-CHMINACA, AB-PINACA and THJ-2201, include nausea 
and vomiting, shortness of breath or depressed breathing, hypertension, 
tachycardia, chest pain, muscle twitching, acute renal failure, 
anxiety, agitation, psychosis, suicidal ideation, and cognitive 
impairment. The HHS also stated that SCs like AB-CHMINACA, AB-PINACA 
and THJ-2201 are easily accessible and difficult to detect in standard 
urine drug screens, which contributes to their popularity and high 
rates of abuse.
    The American Association of Poison Control Centers (AAPCC) reported 
7,779 calls to poison centers about exposures to SCs from January 1, 
2015 through December 31, 2015. This number is significantly higher 
than the number of calls in all of 2014 (3,682), or all of 2013 
(2,668). In 2015, there was a notable increase in calls during April 
(1,512) and May (1,205), falling to a stable, but higher baseline for 
the rest of the year: A seasonal pattern not seen in previous years. In 
2016, the numbers of exposure calls (2,695) have dropped again, 
mirroring those of 2013 (2,668). Although the AAPCC does not identify 
specific cannabinoid substances, their data do support the high 
prevalence of toxic exposures to SCs in general. In 2015, at least 15 
calls to Poison Centers regarding SCs exposures were associated with 
deaths, which is triple the 5 deaths associated with such calls for all 
of 2014.
    The HHS stated that there are no FDA-approved drug products 
containing AB-CHMINACA, AB-PINACA and THJ-2201 in the United States and 
there appear to be no legitimate sources for these substances as 
marketed drugs. Therefore, this criterion for assessing the abuse 
potential of these SCs is not applicable. According to the HHS, because 
AB-CHMINACA, AB-PINACA and THJ-2201 are not approved for medical use 
and are not formulated or available for clinical use, the human use of 
these substances is assumed to be on an individual's own initiative, 
rather than on the basis of medical advice from a practitioner licensed 
by law to administer drugs. Further, published scientific and medical 
literature, and reports from AAPCC and law enforcement, indicate that 
individuals are taking these SCs on their own initiative, rather than 
on the basis of medical advice of a licensed practitioner. As noted by 
the HHS, pharmacological studies sponsored by the National Institute on 
Drug Abuse (NIDA) have demonstrated that AB-CHMINACA, AB-PINACA and 
THJ-2201 are similar to other schedule I SCs. All three of these 
substances, similar to schedule I SCs, display high affinity binding 
and potent agonist functional activity at the cannabinoid (CB1) 
receptor, while drug discrimination studies have demonstrated the 
ability of all three substances to substitute for [Delta]\9\-
tetrahydrocannabinol ([Delta]\9\-THC) (see factor 2). The HHS stated in 
their review that AB-CHMINACA, AB-PINACA and THJ-2201 are markedly more 
potent at CB1 receptors than the natural phytocannabinoids 
(cannabinoids that occur naturally in the cannabis plant, i.e. 
[Delta]\9\-THC).
    2. Scientific Evidence of the Drug's Pharmacological Effects, if 
Known: In vitro receptor binding and functional assays were conducted 
with AB-CHMINACA, AB-PINACA and THJ-2201. In addition, drug 
discrimination assays using Sprague Dawley rats were performed to 
identify drugs with similar subjective effects to [Delta]\9\-THC. The 
tetrad assay was also conducted for AB-CHMINACA and AB-PINACA. These 
results indicate that AB-CHMINACA, AB-PINACA and THJ-2201, similar to 
other schedule I SCs, bind to CB1

[[Page 8596]]

receptors with high affinity and act as agonists at CB1 receptors.
    Based on results from the receptor binding (Ki), CB1 functional 
assay, and drug discrimination studies, the HHS concluded that AB-
CHMINACA, AB-PINACA and THJ-2201 act as full psychoactive cannabinoid 
agonists with no antagonist activity, and that these three substances 
are more potent than [Delta]\9\-THC (schedule I), and are similar in 
activity to JWH-018, AM2201, ADB-PINACA, and AB-FUBINACA (schedule I). 
As stated by the HHS, these data indicate that AB-CHMINACA, AB-PINACA 
and THJ-2201 are more potent at producing behavioral pharmacological 
effects that are recognizable as those produced by the schedule I 
cannabinoid [Delta]\9\-THC.
    3. The State of Current Scientific Knowledge Regarding the Drug or 
Other Substance: The DEA is not aware of any currently accepted medical 
uses for AB-CHMINACA, AB-PINACA and THJ-2201. A letter dated September 
17, 2014 was sent from the DEA Deputy Administrator to the Acting 
Assistant Secretary for Health, of the Department for Health and Human 
Services as notification of intent to temporarily place these three 
substances in schedule I and solicited comments, including whether an 
exemption or approval was in effect for the substances in question 
under the Federal Food, Drug and Cosmetic Act. The Acting Assistant 
Secretary of Health responded that there were no current INDs or NDAs 
for these synthetic cannabinoids in a letter to the DEA Deputy 
Administrator dated September 30, 2014. The HHS in its scientific and 
medical evaluation and scheduling recommendation dated November 14, 
2016 reiterated that these three SCs are not the subjects of any 
approved new drug applications (NDAs) or investigational new drug 
applications (INDs); are not currently marketed as approved drug 
products; and have no accepted medical uses in the United States.
    4. Its History and Current Pattern of Abuse: Synthetic cannabinoids 
intended for illicit use were first encountered in the United States in 
November 2008 during seizure and analysis by the United States Customs 
and Border Protection (CBP) of a shipment of ``Spice'' in Dayton, Ohio. 
The popularity of these cannabinoids and their associated products has 
increased since January 2010 in the United States as evidenced by the 
increasing number of seizures and public health and media reports. The 
HHS noted that SC abuse has been repeatedly noted in athletes, military 
personnel, employees who undergo frequent drug testing, and other 
individuals seeking intoxication while hoping to evade detection. AB-
CHMINACA, AB-PINACA and THJ-2201 are another generation of SCs 
encountered by law enforcement. These substances and their products are 
commonly marketed as ``legal highs'' with a disclaimer of ``not for 
human consumption.'' As detailed in reports, law enforcement and public 
health officials are encountering the abuse of these substances.
    Most users of SCs abuse these substances by smoking the product 
following application to plant material. Recently, law enforcement has 
also been encountering new variations of SCs in liquid form. The 
liquids contain one or more SC(s), including AB-CHMINACA and AB-PINACA, 
as well as previously controlled substances including AB-FUBINACA and 
XLR11. Users have been identified as applying the liquid to hookahs (an 
instrument for vaporizing and smoking a given material whereby the 
smoke or vapor passes through a water basin prior to inhalation), 
vaporizers (also known as ``vaping'' or an ``e-cigarette,'' which 
allows the user to administer a liquid to be aerosolized and then 
inhaled), and hookah pens (a type of vaporizer, often much smaller and 
intended for increased discretion while smoking). As reported by users, 
specifically adolescents, this method of vaporizing and inhaling SCs is 
viewed as being safer than traditional smoking (blunt, pipe, cigarette, 
etc.). In a recent study, 91% of SC users reported inhalation of the 
product via a cigarette or blunt, 27% of the respondents also reported 
using methods that included vaporization, water pipe, bong, or hookah 
as a delivery method.
    5. The Scope, Duration, and Significance of Abuse: AB-CHMINACA, AB-
PINACA and THJ-2201 are SCs that have pharmacological effects similar 
to the schedule I hallucinogen [Delta]\9\-THC. Poison control centers 
continue to report toxic exposures to SCs and their associated 
products. These substances remain a threat to both the short- and long-
term public health and safety. THJ-2201 was first reported in September 
2013 while AB-CHMINACA was first reported in February of 2014. AB-
PINACA was encountered on the illicit drug market as early as March 
2013. From December 2013 through May 2015, CBP reported select 
encounters of these substances with most shipments originating in China 
and intended for destinations within the United States: AB-CHMINACA-50 
seizures involving 56.29 kg; AB-PINACA-11 seizures involving 15 kg; 
THJ-2201-6 seizures involving 5.5 kg. The DEA has reported multiple 
encounters of large quantities of AB-CHMINACA, AB-PINACA and THJ-2201 
that have been confirmed by forensic laboratories.
    6. What, if Any, Risk There is to the Public Health: Clinical 
symptoms as reported from overdoses with AB-CHMINACA and AB-PINACA in 
particular have included excited delirium, seizure, coma, agitation, 
myocardial infarction, convulsions, difficulty breathing, and an 
altered state of consciousness. The HHS reported that despite the 
increasing public recognition of the harms of SCs, multiple groups, 
including athletes, military personnel, employees who undergo frequent 
drug testing, and individuals seeking intoxication, continue to abuse 
these substances while hoping to evade detection.
    Since abusers obtain these drugs through unknown sources, the 
purity of these drugs is uncertain, thus posing significant adverse 
health risks to these users. From October 2013 through the present, 
multiple deaths and severe overdoses have occurred involving AB-
CHMINACA, AB-PINACA and/or THJ-2201.
    7. Its Psychic or Physiological Dependence Liability: As stated by 
the HHS, AB-CHMINACA, AB-PINACA and THJ-2201 have pharmacological 
profiles that are similar to other schedule I SCs. Although there are 
no clinical studies evaluating dependence liabilities specific for AB-
CHMINACA, AB-PINACA and THJ-2201, the pharmacological profiles of these 
substances strongly suggest that they possess dependence liabilities 
that are qualitatively similar to, and potentially stronger than 
[Delta]\9\-THC (schedule I) or marijuana (schedule I) and likely to be 
similar to other schedule I synthetic cannabinoids such as, JWH-018.
    8. Whether the Substance is an Immediate Precursor of a Substance 
Already Controlled Under the CSA: AB-CHMINACA, AB-PINACA and THJ-2201 
are not immediate precursors of any controlled substance of the CSA.
    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 AB-
CHMINACA, AB-PINACA and THJ-2201. As such, the DEA hereby proposes to 
schedule AB-CHMINACA, AB-PINACA and THJ-2201 as controlled substances 
under the CSA.

Proposed Determination of Appropriate Schedule

    The CSA establishes five schedules of controlled substances known 
as

[[Page 8597]]

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 Administrator of the DEA, pursuant to 21 
U.S.C. 811(a) and 21 U.S.C. 812(b)(1), finds that:
    1. AB-CHMINACA, AB-PINACA and THJ-2201 have a high potential for 
abuse that is comparable to other schedule I substances such as delta 
9-tetrahydrocannabinol ([Delta]\9\-THC) and JWH-018;
    2. AB-CHMINACA, AB-PINACA and THJ-2201 have no currently accepted 
medical use in treatment in the United States; and
    3. There is a lack of accepted safety for use of AB-CHMINACA, AB-
PINACA and THJ-2201 under medical supervision.
    Based on these findings, the Administrator of the DEA concludes 
that N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-
indazole-3-carboxamide (AB-CHMINACA), N-(1-amino-3-methyl-1-oxobutan-2-
yl)-1-pentyl-1H-indazole-3-carboxamide (AB-PINACA) and [1-(5-
fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone (THJ-2201), 
including their salts, isomers and salts of isomers, whenever the 
existence of such salts, isomers, and salts of isomers is possible, 
warrant continued control in schedule I of the CSA. 21 U.S.C. 
812(b)(1).

Requirements for Handling AB-CHMINACA, AB-PINACA and THJ-2201

    If this rule is finalized as proposed, AB-CHMINACA, AB-PINACA and 
THJ-2201 would continue \3\ to be subject to the regulatory controls 
and administrative, civil, and criminal sanctions applicable to the 
manufacture, distribution, dispensing, importing, exporting, research, 
and conduct of instructional activities, of schedule I substances 
including the following:
---------------------------------------------------------------------------

    \3\ AB-CHMINACA, AB-PINACA and THJ-2201 are currently subject to 
schedule I controls on a temporary basis, pursuant to 21 U.S.C. 
811(h). 80 FR 5042, Jan. 30, 2015.
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    1. Registration. Any person who handles (manufactures, distributes, 
imports, exports, engages in research, or conducts instructional 
activities or chemical analysis with, or possesses) AB-CHMINACA, AB-
PINACA or THJ-2201, or who desires to handle AB-CHMINACA, AB-PINACA or 
THJ-2201, would continue to be 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. AB-CHMINACA, AB-PINACA or THJ-2201 would continue to 
be subject to schedule I security requirements and would need to 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, labeling, and packaging for 
commercial containers of AB-CHMINACA, AB-PINACA or THJ-2201would 
continue to need to be in compliance with 21 U.S.C. 825 and 958(e), and 
continue to be in accordance with 21 CFR part 1302.
    4. Quota. Only registered manufacturers would continue to be 
permitted to manufacture AB-CHMINACA, AB-PINACA or THJ-2201 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 who becomes registered with the DEA on or 
after the effective date of the final rule must take an initial 
inventory of all stocks of controlled substances (including AB-
CHMINACA, AB-PINACA and THJ-2201) 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 AB-
CHMINACA, AB-PINACA and THJ-2201) 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 would continue to be 
required to maintain records and submit reports with respect to AB-
CHMINACA, AB-PINACA and/or THJ-2201 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 AB-CHMINACA, 
AB-PINACA or THJ-2201 would continue to be 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 
AB-CHMINACA, AB-PINACA or THJ-2201 would continue to need to 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 AB-CHMINACA, AB-PINACA or THJ-
2201 not authorized by, or in violation of, the CSA or its implementing 
regulations would continue to be unlawful, and could subject the person 
to administrative, civil, and/or criminal sanctions.

Regulatory Analyses

Executive Orders 12866 and 13563

    In accordance with 21 U.S.C. 811(a), this proposed scheduling 
action is subject to formal rulemaking procedures performed ``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.

Executive Order 12988

    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

    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

    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 January 30, 2015, 
the DEA published a final order to temporarily place these three SCs 
into 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

[[Page 8598]]

planning to handle AB-CHMINACA, AB-PINACA or THJ-2201 have already 
established and implemented the systems and processes required to 
handle AB-CHMINACA, AB-PINACA or THJ-2201. There are currently 25 
registrations authorized to handle AB-CHMINACA, AB-PINACA and/or THJ-
2201 specifically, as well as a number of registered analytical labs 
that are authorized to handle schedule I controlled substances 
generally. These 25 registrations represent 18 entities, of which 8 are 
small entities. Therefore, the DEA estimates eight small entities are 
affected by this proposed rule.
    A review of the 25 registrations indicates that all entities that 
currently handle AB-CHMINACA, AB-PINACA or THJ-2201 also handle other 
schedule I controlled substances, and have established and implemented 
(or maintain) the systems and processes required to handle AB-CHMINACA, 
AB-PINACA or THJ-2201. 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 eight 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.

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:

PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

0
1. The authority citation for 21 CFR 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,
0
a. Add new paragraphs (d)(59) through (61); and
0
b. Remove paragraphs (h)(11) through (13); and
0
c. Redesignate paragraphs (h)(14) through (19) as (h)(11) through (16);
    The additions to read as follows:


Sec.  1308.11   Schedule I.

* * * * *
    (d) * * *

------------------------------------------------------------------------
 
------------------------------------------------------------------------
(59) N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-                      (7031)
 (cyclohexylmethyl)-1H-indazole-3-carboxamide (AB-
 CHMINACA)..............................................
(60) N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1H-            (7023)
 indazole-3-carboxamide (AB-PINACA).....................
(61) [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-           (7024)
 yl)methanone (THJ-2201)................................
------------------------------------------------------------------------

* * * * *

    Dated: January 17, 2017.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2017-01514 Filed 1-26-17; 8:45 am]
 BILLING CODE 4410-09-P