[Federal Register Volume 81, Number 24 (Friday, February 5, 2016)]
[Proposed Rules]
[Pages 6190-6196]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-02305]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-433]


Schedules of Controlled Substances: Placement of PB-22, 5F-PB-22, 
AB-FUBINACA and ADB-PINACA 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 quinolin-
8-yl 1-pentyl-1H-indole-3-carboxylate (PB-22; QUPIC), quinolin-8-yl 1-
(5-fluoropentyl)-1H-indole-3-carboxylate (5-fluoro-PB-22; 5F-PB-22), N-
(1-amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-
carboxamide (AB-FUBINACA) and N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-
1-pentyl-1H-indazole-3-carboxamide (ADB-PINACA), 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 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 PB-
22, 5F-PB-22, AB-FUBINACA, or ADB-PINACA.

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 March 7, 2016. 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 March 7, 2016.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-433'' 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/ODW, 8701 Morrissette Drive, 
Springfield, Virginia 22152.
     Hearing requests: All requests for a hearing and waivers 
of participation must be sent to: Drug Enforcement

[[Page 6191]]

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/ODW, 8701 Morrissette Drive, Springfield, 
Virginia 22152.

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:

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 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 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, 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 impose the regulatory 
controls and administrative, civil, and criminal

[[Page 6192]]

sanctions of schedule I controlled substances on any person who handles 
or proposes to handle PB-22, 5F-PB-22, AB-FUBINACA, or ADB-PINACA.
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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 February 10, 2014, the DEA published a final order in the 
Federal Register amending 21 CFR 1308.11(h) to temporarily place 
quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate (PB-22; QUPIC); 
quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate (5-fluoro-PB-
22; 5F-PB-22); N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-
1H-indazole-3-carboxamide (AB-FUBINACA); and N-(1-amino-3,3-dimethyl-1-
oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (ADB-PINACA) into 
schedule I of the CSA pursuant to the temporary scheduling provisions 
of 21 U.S.C. 811(h). 79 FR 7577. That final order, which became 
effective on the date of publication, was based on findings by the 
Deputy Administrator of the DEA that the temporary scheduling of these 
four synthetic cannabinoids (SCs) 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 issuance 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 PB-
22; QUPIC, 5F-PB-22, AB-FUBINACA, and ADB-PINACA expires on February 9, 
2016, unless extended. An extension of the temporary order is being 
ordered by the DEA Administrator in a separate action.
    These four SCs have not been investigated for medical use nor are 
they intended for human use. With no known legitimate use and safety 
information, manufacturers are surreptitiously adulterating plant 
material with these SCs and distributors are selling the associated 
products which pose potentially dangerous consequences to the consumer.
    The Assistant Secretary of Health for the U.S. Department of Health 
and Human Services (HHS) has advised that there are no exemptions or 
approvals in effect for PB-22, 5F-PB-22, AB-FUBINACA, or ADB-PINACA 
under section 505 (21 U.S.C. 355) of the Federal Food, Drug, and 
Cosmetic Act. As stated by the HHS, PB-22, 5F-PB-22, AB-FUBINACA, and 
ADB-PINACA have no known accepted medical use. They are not the subject 
of any approved new drug applications (NDAs) or investigational new 
drug applications (INDs), and are not currently marketed as approved 
drug products. The HHS recommends that PB-22, 5F-PB-22, AB-FUBINACA, 
ADB-PINACA, and their salts be placed into schedule I of the Controlled 
Substances Act (CSA).

Proposed Determination To Schedule PB-22, 5F-PB-22, AB-FUBINACA, and 
ADB-PINACA

    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 December 
30, 2014, 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 PB-22, 5F-
PB-22, AB-FUBINACA and ADB-PINACA pursuant to 21 U.S.C. 811(b). Upon 
receipt of the scientific and medical evaluations and scheduling 
recommendations from the HHS dated January 19, 2016, the DEA reviewed 
the documents and all other relevant data and conducted its own eight-
factor analysis of the abuse potential of PB-22, 5F-PB-22, AB-FUBINACA 
and ADB-PINACA 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 January 19, 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-433.''
    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.
    Review of scientific and medical literature indicates that the 
ingestion of synthetic cannabinoids leads to adverse health effects. 
Specifically, adverse effects following ingestion have included: 
Seizures, neurotoxicity and death for PB-22; respiratory failure, organ 
failure, and death for 5F-PB-22; diaphoresis, nausea, confusion, 
tachycardia and death for AB-FUBINACA; and anxiety, delirium, 
psychosis, aggression, seizures and death for ADB-PINACA.
    The American Association of Poison Control Centers (AAPCC) has 
reported 7,779 exposures to SCs from January 1 through December 31, 
2015. The significance of this value is based upon reporting of human 
exposures to SCs since 2011. While 2012-2014 saw a reduction in 
exposure calls to the AAPCC, 2015 records demonstrate resurgence in 
calls to poison centers regarding SCs. In addition, the largest monthly 
tally ever recorded by AAPCC in reference to SCs occurred in April 
2015, with 1,511 calls.
    The HHS stated that there are no FDA-approved drug products 
containing PB-22, 5F-PB-22, AB-FUBINACA, and ADB-PINACA in the United 
States and there appear to be no legitimate sources for these 
substances as marketed drugs. According to the HHS, because PB-22, 5F-
PB-22, AB-FUBINACA and ADB-PINACA 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, AAPCC reports, published 
scientific and medical literature, and law enforcement reports indicate 
that individuals are

[[Page 6193]]

taking these SCs on their own initiative, rather than on the medical 
advice of a licensed practitioner. As noted by the HHS, pharmacological 
studies sponsored by NIDA have demonstrated that PB-22, 5F-PB-22, AB-
FUBINACA, and ADB-PINACA are similar to other schedule I SCs. All four 
of these substances, similar to other 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 four substances to substitute for 
delta-9-tetrahydrocannabinol (THC) (see Factor 2). The results 
supporting CB1 agonist activity of PB-22 and 5F-PB-22 are consistent 
with the similar findings reported in published literature.
    2. Scientific Evidence of the Drug's Pharmacological Effects, if 
Known: In vitro receptor binding and functional assays were conducted 
with PB-22, 5F-PB-22, AB-FUBINACA, and ADB-PINACA. In addition, drug 
discrimination assays using Sprague Dawley rats were performed to 
identify drugs with similar subjective effects to THC. These results 
indicate that PB-22, 5F-PB-22, AB-FUBINACA, and ADB-PINACA, similar to 
other schedule I SCs, bind to CB1 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 PB-22, 
5F-PB-22, AB-FUBINACA, and ADB-PINACA act as full psychoactive 
cannabinoid agonists with no antagonist activity and that these four 
substances are more potent than THC, the principal psychoactive 
chemical in marijuana (schedule I), and are similar in activity to JWH-
018 (schedule I).
    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 PB-22, 5F-PB-22, AB-FUBINACA or ADB-PINACA. A letter dated 
November 7, 2013 was sent from the DEA Deputy Administrator to the 
Assistant Secretary for Health of the Department for Health and Human 
Services as notification of intent to temporarily place these four 
substances in schedule I and solicited information, including whether 
there was an exemption or approval in effect for the substances in 
question under the Federal Food, Drug and Cosmetic Act. The Assistant 
Secretary of Health responded that there were no current INDs or NDAs 
for these synthetic cannabinoids in a letter to the DEA Assistant 
Administrator dated January 27, 2014. The scientific and medical 
evaluations provided by the HHS also stated that PB-22, 5F-PB-22, AB-
FUBINACA, and ADB-PINACA have no currently accepted medical use. These 
SCs are not the subject of an approved NDAs or INDs, and are not 
currently marketed as approved drug products. In recent overdoses, PB-
22, 5F-PB-22, AB-FUBINACA, and ADB-PINACA have been found to be laced 
on green plant material, similar to the SCs that have been previously 
encountered.
    4. Its History and Current Pattern of Abuse: Since the initial 
identification of JWH-018 (November 2008), many additional synthetic 
cannabinoids have been found to be applied on plant material and 
encountered as designer drug products. A major concern, as reiterated 
by public health officials and medical professionals, remains the 
targeting and direct marketing of SCs and SC-containing products to 
adolescents and youth. The Monitoring the Future project, begun in 
1975, studies changes in beliefs, attitudes, and behavior of young 
people in the United States. While the Monitoring the Future survey 
reported decreases in prevalence amongst 8th, 10th, and 12th grade 
students over the past two years, AAPCC reports for SCs in 2015 were 
the highest observed since reporting began in 2011. Reports in 2015 
more than doubled compared to those shown for 2011. Smoking mixtures of 
these substances abused for the purpose of achieving intoxication has 
resulted in numerous emergency department visits and calls to poison 
control centers. As reported by the AAPCC, adverse effects including 
severe agitation, anxiety, racing heartbeat, high blood pressure, 
nausea, vomiting, seizures, tremors, intense hallucinations, psychotic 
episodes, suicide, and other harmful thoughts and/or actions can occur 
following ingestion of SCs. Presentations at emergency departments 
directly linked to the abuse of PB-22, 5F-PB-22, AB-FUBINACA, and ADB-
PINACA have resulted in similar symptoms, including severe agitation, 
seizures, and/or death.
    5. The Scope, Duration, and Significance of Abuse: PB-22 and 5F-PB-
22 are synthetic cannabinoids that have pharmacological effects similar 
to the schedule I hallucinogen THC. PB-22 and 5F-PB-22 were not 
reported in the scientific literature prior to their appearance on the 
illicit drug market. A report from March 2013 identified PB-22 as a 
component of dried plant material obtained via the Internet between 
July 2012 and January 2013 in Japan.
    AB-FUBINACA is also a synthetic cannabinoid that has 
pharmacological effects similar to the schedule I hallucinogen THC. 
First appearing in a 2009 patent filed by the pharmaceutical 
manufacturer Pfizer, AB-FUBINACA was first reported in the scientific 
literature as a component of so-called ``herbal products'' purchased 
via the Internet in July 2012.
    ADB-PINACA was first encountered in the United States following 
reports of serious adverse events in Georgia on August 23, 2013. 
Reports of ADB-PINACA were not found in the scientific literature prior 
to its emergence on the designer drug market. The Georgia Bureau of 
Investigation (GBI) reported on September 12, 2013 that ADB-PINACA, was 
detected in ``herbal incense'' products sold under the brand name 
``Crazy Clown.'' It was later confirmed by the Centers for Disease 
Control and Prevention (CDC) as the substance responsible for severe 
adverse events in at least 22 persons who consumed the product. In 
addition, on August 30, 2013, the Colorado Department of Public Health 
and Environment (CDPHE) was notified by several hospitals of an 
increase in the number of patients visiting their emergency departments 
with altered mental status after using synthetic cannabinoids. On 
September 8, 2013, the CDPHE, with the assistance of the CDC, began an 
epidemiologic investigation whereby 221 cases of severe illness due to 
ingestion of a synthetic cannabinoid were identified. Those that 
presented at emergency rooms in the Denver, Colorado area around 
September 1, 2013 had symptoms similar to those found in the August 
2013 Georgia incident. Laboratory analysis of samples from the Colorado 
incident confirmed that the substance abused in the ``herbal incense'' 
products was ADB-PINACA.
    The AAPCC report published on April 23, 2015 showed a marked spike 
in poison center exposure calls throughout the United States in 2015 
related to SCs. The AAPCC reported 1,512 exposure calls in April 2015, 
representing an almost three-fold increase in exposures to SCs as 
compared to the previous largest monthly tally (657 exposures in 
January 2012) since reporting began in 2011. For the first time since 
reporting began by the AAPCC in 2011, the number of SC cases in 2015 
has dramatically risen, more than doubling those reported in 2014. The 
numbers of SC cases reported in 2015 were the highest ever recorded.
    6. What, if Any, Risk There is to the Public Health: As stated by 
the HHS, based solely on their pharmacological similarity to JWH-018 
and THC and their potency, the subjective risks to the

[[Page 6194]]

public health of PB-22, 5F-PB-22, AB-FUBINACA, and ADB-PINACA are 
similar to those of other SCs, which are controlled in schedule I of 
the CSA. Warnings regarding the dangers associated with abuse of 
synthetic cannabinoids and their products have been issued by numerous 
state public health departments and poison control centers and private 
organizations. Some of the common clinical effects reported in 
emergency rooms in response to the abuse of synthetic cannabinoids 
include vomiting, anxiety, agitation, irritability, seizures, 
hallucinations, tachycardia, elevated blood pressure, and loss of 
consciousness.
    At least ten deaths have been reported involving the four SCs, 
including at least 3 involving PB-22, 5 involving 5F-PB-22, 1 involving 
AB-FUBINACA, and 1 involving ADB-PINACA. As mentioned above, there are 
reported instances of emergency department admissions in association 
with the abuse of PB-22 and 5F-PB-22. Additional deaths involving a 
variety of SCs have been reported, along with additional instances of 
severe toxic effects following ingestion of SCs.
    7. Its Psychic or Physiological Dependence Liability: As stated by 
the HHS, PB-22, 5F-PB-22, AB-FUBINACA and ADB-PINACA have 
pharmacological profiles that are similar to other schedule I SCs. Thus 
it is reasonable to assume that PB-22, 5F-PB-22, AB-FUBINACA and ADB-
PINACA possess physiological and psychological dependence liability 
that is similar to that of other schedule I cannabinoids (THC and JWH-
018). While PB-22, 5F-PB-22, AB-FUBINACA and ADB-PINACA are 
pharmacologically related to JWH-018, no studies regarding the psychic 
or physiological dependence liability of PB-22, 5F-PB-22, AB-FUBINACA, 
or ADB-PINACA have been identified.
    8. Whether the Substance is an Immediate Precursor of a Substance 
Already Controlled Under the CSA: PB-22, 5F-PB-22, AB-FUBINACA, and 
ADB-PINACA are not considered an immediate precursor 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 PB-
22, 5F-PB-22, AB-FUBINACA and ADB-PINACA. As such, the DEA hereby 
proposes to schedule PB-22, 5F-PB-22, AB-FUBINACA and ADB-PINACA as 
controlled substances 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 Administrator of the DEA, pursuant to 21 
U.S.C. 811(a) and 21 U.S.C. 812(b)(1), finds that:
    1. PB-22, 5F-PB-22, AB-FUBINACA and ADB-PINACA have a high 
potential for abuse that is comparable to other schedule I substances 
such as delta 9-tetrahydrocannabinol (THC) and JWH-018;
    2. PB-22, 5F-PB-22, AB-FUBINACA and ADB-PINACA have no currently 
accepted medical use in treatment in the United States; and
    3. There is a lack of accepted safety for use of PB-22, 5F-PB-22, 
AB-FUBINACA and ADB-PINACA under medical supervision.
    Based on these findings, the Administrator of the DEA concludes 
that quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate (PB-22; QUPIC), 
quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate (5-fluoro-PB-
22; 5F-PB-22), N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-
1H-indazole-3-carboxamide (AB-FUBINACA), and N-(1-amino-3,3-dimethyl-1-
oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (ADB-PINACA), 
including their salts, isomers and salts of isomers, whenever the 
existence of such salts, isomers, and salts of isomers is possible, 
warrant control in schedule I of the CSA. 21 U.S.C. 812(b)(1).

Requirements for Handling PB-22, 5F-PB-22, AB-FUBINACA and ADB-PINACA

    If this rule is finalized as proposed, PB-22, 5F-PB-22, AB-
FUBINACA, and ADB-PINACA would continue \3\ 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:
---------------------------------------------------------------------------

    \3\ PB-22, 5F-PB-22, AB-FUBINACA and ADB-PINACA are currently 
subject to schedule I controls on a temporary basis, pursuant to 21 
U.S.C. 811(h). 79 FR 7577, Feb. 10, 2014.
---------------------------------------------------------------------------

    1. Registration. Any person who handles (manufactures, distributes, 
dispenses, imports, exports, engages in research, or conducts 
instructional activities or chemical analysis with, or possesses) PB-
22, 5F-PB-22, AB-FUBINACA, or ADB-PINACA, or who desires to handle PB-
22, 5F-PB-22, AB-FUBINACA, or ADB-PINACA, would 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. PB-22, 5F-PB-22, AB-FUBINACA, or ADB-PINACA would 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 and labeling for commercial 
containers of PB-22, 5F-PB-22, AB-FUBINACA, or ADB-PINACA would need to 
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 would be permitted to 
manufacture PB-22, 5F-PB-22, AB-FUBINACA, or ADB-PINACA 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 after 
the effective date of the final rule must take an initial inventory of 
all stocks of controlled substances (including PB-22, 5F-PB-22, AB-
FUBINACA, and ADB-PINACA) 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 PB-22, 5F-
PB-22, AB-FUBINACA, and ADB-PINACA) 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 be required to 
maintain records and submit reports with respect to PB-22, 5F-PB-22, 
AB-FUBINACA, and/or ADB-PINACA 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 PB-22, 5F-PB-
22, AB-FUBINACA, or ADB-PINACA would 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 
PB-22, 5F-PB-22, AB-FUBINACA, or ADB-PINACA would need to be in

[[Page 6195]]

compliance with 21 U.S.C. 952, 953, 957, and 958, and in accordance 
with 21 CFR part 1312.
    9. Liability. Any activity involving PB-22, 5F-PB-22, AB-FUBINACA, 
or ADB-PINACA not authorized by, or in violation of, the CSA or its 
implementing regulations would 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 February 10, 2014, 
the DEA published a final order to temporarily place these four 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 planning to handle these SCs have already established and 
implemented the systems and processes required to handle PB-22, 5F-PB-
22, AB-FUBINACA, or ADB-PINACA. There are currently 25 registrations 
authorized to handle PB-22, 5F-PB-22, AB-FUBINACA, and/or ADB-PINACA 
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 PB-22, 5F-PB-22, AB-FUBINACA, or ADB-PINACA also 
handle other schedule I controlled substances, and have established and 
implemented (or maintain) the systems and processes required to handle 
PB-22, 5F-PB-22, AB-FUBINACA, or ADB-PINACA. 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 as follows:

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)(48) through (d)(51); and
0
b. Remove paragraphs (h)(7) through (10); and
0
c. Redesignate paragraphs (h)(11) through (24) as (h)(7) through (20).
    The additions to read as follows:


Sec.  1308.11  Schedule I.

* * * * *
    (d) * * *

------------------------------------------------------------------------
 
------------------------------------------------------------------------
(48) quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate (PB-          (7222)
 22)....................................................
(49) quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-                (7225)
 carboxylate (5-fluoro-PB-22; 5F-PB-22).................
(50) N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(4-                   (7012)
 fluorobenzyl)-1H-indazole-3-carboxamide (AB-FUBINACA)..
(51) N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-           (7035)
 1H-indazole-3-carboxamide (ADB-PINACA).................
------------------------------------------------------------------------

* * * * *

[[Page 6196]]


    Dated: February 2, 2016.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016-02305 Filed 2-4-16; 8:45 am]
 BILLING CODE 4410-09-P