[Federal Register Volume 81, Number 172 (Tuesday, September 6, 2016)]
[Rules and Regulations]
[Pages 61130-61133]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21345]


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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: Final rule.

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SUMMARY: With the issuance of this final rule, the Drug Enforcement 
Administration places 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 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. This action 
imposes the regulatory controls and administrative, civil, and criminal 
sanctions applicable to schedule I controlled substances on persons who 
handle (manufacture, distribute, reverse 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: Effective date: September 6, 2016.

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

SUPPLEMENTARY INFORMATION: 

Legal Authority

    The Drug Enforcement Administration (DEA) implements and enforces 
titles II and III of the Comprehensive Drug Abuse Prevention and 
Control Act of 1970, as amended. 21 U.S.C. 801-971. Titles II and III 
are referred to as the ``Controlled Substances Act'' and the 
``Controlled Substances Import and Export Act,'' respectively, and are 
collectively referred to as the ``Controlled Substances Act'' or the 
``CSA'' for the purposes 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 ensuring an adequate supply is 
available for the legitimate medical, scientific, research, and 
industrial needs of the United States. Controlled substances have the 
potential for abuse and dependence and are controlled to protect the 
public health and safety.
    Under the CSA, each controlled substance is classified into one of 
five schedules based upon its potential for abuse, its currently 
accepted medical use in treatment in the United States, and the degree 
of dependence the 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. 21 U.S.C. 812(a).
    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 * * * finds that such drug or other substance has 
a potential for abuse, and * * * 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, who in turn 
has redelegated that authority to the Deputy Administrator of the DEA, 
28 CFR part 0, appendix to subpart R.
    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 action was initiated by the former Deputy Administrator of 
the DEA on his own motion and is supported by a recommendation from the 
Assistant Secretary of the HHS and an evaluation of all other relevant 
data by the DEA. This action imposes the regulatory controls and 
administrative, civil, and criminal 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 set forth 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. Accordingly, all 
subsequent references to ``Secretary'' have been replaced with 
``Assistant Secretary.''
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Background

    On January 10, 2014, the DEA published a notice of intent 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 pursuant to the temporary scheduling provisions 
of the CSA. 79 FR 1776. On February 10, 2014, the DEA published a final 
order amending 21 CFR 1308.11(h) to temporarily place these four 
synthetic cannabinoids into schedule I of the CSA. 79 FR 7577. That 
final order was effective on the date of publication, and was based on 
findings by the DEA that the temporary scheduling of these four 
synthetic cannabinoids was necessary to avoid an imminent hazard to the 
public safety pursuant to 21 U.S.C. 811(h)(1).

[[Page 61131]]

Section 201(h)(2) of the CSA requires that the temporary control of 
these substances expires two years from the effective date of the 
scheduling order, or on or before February 9, 2016. 21 U.S.C. 
811(h)(2). However, the CSA also provides that the temporary scheduling 
may be extended for up to one year during the pendency of proceedings 
under 21 U.S.C. 811(a)(1). Id. Accordingly, on February 5, 2016, the 
DEA extended the temporary scheduling of PB-22, 5F-PB-22, AB-FUBINACA, 
and ADB-PINACA by one year, until February 9, 2017. 81 FR 6175. Also, 
on February 5, 2016, DEA published a notice of proposed rulemaking 
(NPRM) to permanently control PB-22, 5F-PB-22, AB-FUBINACA, and ADB-
PINACA in schedule I of the CSA. 81 FR 6190.

DEA and HHS Eight Factor Analyses

    On January 19, 2016, the HHS provided the DEA with four scientific 
and medical evaluation documents prepared by the FDA entitled ``Basis 
for the recommendation to place 1-pentyl-1H-indole-3-carboxylic acid 8-
quinolinyl ester or quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate (PB-
22) and its salts in Schedule 1 of the Controlled Substances Act 
(CSA);'' ``Basis for the recommendation to place quinolin-8-yl 1-(5-
fluoropentyl)-1H-indole-3-carboxylate (5F-PB-22) and its salts in 
Schedule 1 of the Controlled Substances Act (CSA);'' ``Basis for the 
recommendation to place N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(4-
fluorobenzyl)-1H-indazole-3-carboxamide (AB-FUBINACA) and its salts in 
Schedule 1 of the Controlled Substances Act (CSA);'' and ``Basis for 
the recommendation to place N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-
pentyl-1H-indazole-3-carboxamide (ADB-PINACA) and its salts in Schedule 
1 of the Controlled Substances Act (CSA).'' After considering the eight 
factors in 21 U.S.C. 811(c), including consideration of each 
substance's abuse potential, legitimate medical use, and dependence 
liability, the Assistant Secretary of the HHS recommended that PB-22, 
5F-PB-22, AB-FUBINACA, and ADB-PINACA be controlled in schedule I of 
the CSA. In response, the DEA conducted its own eight-factor analysis 
of PB-22, 5F-PB-22, AB-FUBINACA, and ADB-PINACA and concluded that 
these substances warrant control in schedule I of the CSA. Both the DEA 
and HHS analyses are available in their entirety in the public docket 
for this rule (Docket Number DEA-433/DEA-2016-0002) at http://www.regulations.gov under ``Supporting Documents.''

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

    After a review of the available data, including the scientific and 
medical evaluations and the scheduling recommendations from the HHS, 
the DEA published an NPRM entitled ``Schedules of Controlled 
Substances: Placement of PB-22, 5F-PB-22, AB-FUBINACA, and ADB-PINACA 
into Schedule I,'' proposing to control PB-22, 5F-PB-22, AB-FUBINACA, 
and ADB-PINACA in schedule I of the CSA. 81 FR 6190. The proposed rule 
provided an opportunity for interested persons to file a request for 
hearing in accordance with the DEA regulations on or before March 7, 
2016. No requests for such a hearing were received by the DEA. The NPRM 
also provided an opportunity for interested persons to submit written 
comments on the proposal on or before March 7, 2016.

Comments Received

    The DEA received three comments on the proposed rule to control PB-
22, 5F-PB-22, AB-FUBINACA, and ADB-PINACA in schedule I of the CSA.
    1. Request for Alternate Manufacturing/Packaging of Opiate Pills: 
One commenter stated that alternate manufacturing and packaging of 
opiate pills would reduce access to these drugs. The comment was 
addressed to the FDA.
     DEA Response: PB-22, 5F-PB-22, AB-FUBINACA, and ADB-PINACA 
are synthetic cannabinoid substances. Opiate pills are not addressed or 
affected by this rulemaking.
    2. Support for rulemaking: One commenter gave support for the 
rulemaking stating that the rule was a step in the right direction.
     DEA Response: The DEA appreciates the comment in support 
of this rulemaking.
    3. Mixed Support and Dissent: One commenter supported in part and 
dissented in part, suggesting that research into potential medical uses 
of these substances be conducted prior to scheduling.
     DEA Response: On February 10, 2014, the DEA published a 
final order amending 21 CFR 1308.11(h) to temporarily place these four 
synthetic cannabinoids into schedule I of the CSA. 79 FR 7577. That 
final order was based on findings by the DEA that the temporary 
scheduling of these four synthetic cannabinoids was necessary to avoid 
an imminent hazard to the public safety pursuant to 21 U.S.C. 
811(h)(1). Adverse effects following ingestion of these substances 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, and seizures for ADB-PINACA. There is 
no currently accepted medical use for these four substances in 
treatment in the United States, and the substances fulfill all 
requirements for placement into schedule I of the CSA.
    After considering the eight factors in 21 U.S.C. 811(c), including 
consideration of each substance's abuse potential, legitimate medical 
use, and dependence liability, the Assistant Secretary of the HHS 
recommended that PB-22, 5F-PB-22, AB-FUBINACA, and ADB-PINACA be 
controlled in schedule I of the CSA. In response, the DEA reviewed the 
scientific and medical evaluations of HHS and all other relevant data 
on PB-22, 5F-PB-22, AB-FUBINACA, and ADB-PINACA and concurs with the 
HHS evaluations and findings. The current scientific, medical and other 
evidence on PB-22, 5F-PB-22, AB-FUBINACA, and ADB-PINACA warrant 
control of these substances in schedule I of the CSA.

Scheduling Conclusion

    Based on consideration of all comments, the scientific and medical 
evaluations and accompanying recommendations of the HHS, and the DEA's 
consideration of its own eight-factor analyses, the DEA finds that 
these facts and all other relevant data constitute substantial evidence 
of potential for abuse of PB-22, 5F-PB-22, AB-FUBINACA, and ADB-PINACA. 
As such, the DEA is scheduling PB-22, 5F-PB-22, AB-FUBINACA, and ADB-
PINACA as controlled substances under the CSA.

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 analyses and 
recommendations 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) 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-

[[Page 61132]]

pentyl-1H-indazole-3-carboxamide (ADB-PINACA) 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) 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) have no 
currently accepted medical use in treatment in the United States; and
    (3) There is a lack of accepted safety for use of 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) 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, including optical, 
positional and geometric isomers, whenever the existence of such salts, 
isomers, salts of isomers, optical isomers, positional isomers, and 
geometric 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

    Upon the effective date of this final rule, any person who handles 
PB-22, 5F-PB-22, AB-FUBINACA, and ADB-PINACA continues \2\ to be 
subject to the regulatory controls and administrative, civil, and 
criminal sanctions applicable to the manufacture, distribution, reverse 
distribution, importation, exportation, engagement in research and 
conduct of instructional activities or chemical analysis, and 
possession of schedule I controlled substances, including those listed 
below. These controls will continue on a permanent basis:
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    \2\ 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). 81 FR 6175, Feb. 5, 2016.
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    1. Registration. Any person who handles (manufactures, distributes, 
reverse distributes, 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 must 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 as of September 
6, 2016. Any person who currently handles PB-22, 5F-PB-22, AB-FUBINACA, 
or ADB-PINACA and is not registered with the DEA must submit an 
application for registration and may not continue to handle PB-22, 5F-
PB-22, AB-FUBINACA, or ADB-PINACA as of September 6, 2016 unless the 
DEA has approved that application, pursuant to 21 U.S.C. 822, 823, 957, 
and 958, and in accordance with 21 CFR parts 1301 and 1312.
    2. Disposal of Stocks. PB-22, 5F-PB-22, AB-FUBINACA, and ADB-PINACA 
must be disposed of in accordance with 21 CFR part 1317, in addition to 
all other applicable federal, state, local, and tribal laws.
    3. Security. PB-22, 5F-PB-22, AB-FUBINACA, and ADB-PINACA continue 
to be subject to schedule I security requirements and must be handled 
and stored pursuant to 21 U.S.C. 823, and and in accordance with 21 CFR 
1301.71-1301.93 as of September 6, 2016.
    4. Labeling and Packaging. All labels, labeling, and packaging for 
commercial containers of PB-22, 5F-PB-22, AB-FUBINACA, or ADB-PINACA 
must continue to comply with 21 U.S.C. 825 and 958(e), and be in 
accordance with 21 CFR part 1302 as of September 6, 2016.
    5. Quota. Only registered manufacturers are 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 as of September 6, 2016.
    6. Inventory. Every DEA registrant whose registration currently 
authorizes handling of these substances and who possesses any quantity 
of PB-22, 5F-PB-22, AB-FUBINACA, and/or ADB-PINACA on the effective 
date of this final rule is required to continue to maintain an 
inventory of all stocks of PB-22, 5F-PB-22, AB-FUBINACA, and/or ADB-
PINACA on hand, pursuant to 21 U.S.C. 827 and 958, and in accordance 
with 21 CFR 1304.03, 1304.04, and 1304.11.
    Any person who becomes registered with the DEA on or after the 
effective date of the final rule is required to take an initial 
inventory of all stocks of PB-22, 5F-PB-22, AB-FUBINACA, and/or ADB-
PINACA on hand 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/or 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.
    7. Records and Reports. Every DEA registrant must maintain records 
and submit reports pursuant to 21 U.S.C. 827 and 958(e), and in 
accordance with 21 CFR parts 1304, 1312, and 1317 as of September 6, 
2016. Manufacturers and distributors must submit reports regarding PB-
22, 5F-PB-22, AB-FUBINACA, and/or ADB-PINACA to the Automation of 
Reports and Consolidated Order System (ARCOS) pursuant to 21 U.S.C. 827 
and in accordance with 21 CFR 1304 and 1312 as of September 6, 2016.
    8. Order Forms. Every DEA registrant who distributes PB-22, 5F-PB-
22, AB-FUBINACA, and/or ADB-PINACA must continue to comply with the 
order form requirements, pursuant to 21 U.S.C. 828 and 21 CFR part 
1305, as of September 6, 2016.
    9. Importation and Exportation. All importation and exportation of 
PB-22, 5F-PB-22, AB-FUBINACA, and ADB-PINACA must continue to be in 
compliance with 21 U.S.C. 952, 953, 957, and 958, and in accordance 
with 21 CFR part 1312 as of September 6, 2016.
    10. 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 continues to be unlawful, and may subject the 
person to administrative, civil, and/or criminal sanctions.

Regulatory Analyses

Executive Orders 12866, Regulatory Planning and Review, and 13563, 
Improving Regulation and Regulatory Review

    In accordance with 21 U.S.C. 811(a), this scheduling action is 
subject to formal rulemaking procedures done ``on the record after 
opportunity for a

[[Page 61133]]

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, Civil Justice Reform

    This 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 rulemaking does not have federalism implications warranting 
the application of Executive Order 13132. The 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 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 final 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 amending 21 CFR 1308.11(h) to 
temporarily place these four synthetic cannabinoids into schedule I of 
the CSA pursuant to the temporary scheduling provisions of 21 U.S.C. 
811(h). 79 FR 7577. On February 5, 2016, the DEA published a final 
order extending the temporary placement of these substances in schedule 
I of the CSA for up to one year pursuant to 21 U.S.C. 811(h)(2). 81 FR 
6175. Accordingly, all entities that currently handle or plan to handle 
these synthetic cannabinoids are estimated to have already established 
and implemented the systems and processes required to handle PB-22, 5F-
PB-22, AB-FUBINACA, and ADB-PINACA. Therefore, the DEA anticipates that 
this rule will impose minimal or no economic impact on businesses that 
currently handle PB-22, 5F-PB-22, AB-FUBINACA, or ADB-PINACA for lawful 
purposes. This estimate applies to entities large and small. 
Accordingly, the DEA has concluded that this rule will not have a 
significant effect on a substantial number of small entities.

Unfunded Mandates Reform Act of 1995

    On the basis of information contained in the ``Regulatory 
Flexibility Act'' section above, the DEA has determined and certifies 
pursuant to the Unfunded Mandates Reform Act (UMRA) of 1995, 2 U.S.C. 
1501 et seq., that this action will 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 provisions of the 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.

Congressional Review Act

    This rule is not a major rule as defined by section 804 of the 
Small Business Regulatory Enforcement Fairness Act of 1996 
(Congressional Review Act (CRA)). This rule will not result in: ``an 
annual effect on the economy of $100,000,000 or more; a major increase 
in costs or prices for consumers, individual industries, Federal, 
State, or local government agencies, or geographic regions; or 
significant adverse effects on competition, employment, investment, 
productivity, innovation, or on the ability of U.S.-based companies to 
compete with foreign based companies in domestic and export markets.'' 
However, pursuant to the CRA, the DEA has submitted a copy of this 
final rule to both Houses of Congress and to the Comptroller General.

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, 21 CFR part 1308 is amended 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. Amend Sec.  1308.11 as follows:
0
a. Add paragraphs (d)(51) through (54);
0
b. Remove paragraphs (h)(4) through (7);
0
c. Redesignate paragraphs (h)(8) through (22) as paragraphs (h)(4) 
through (18); and
0
d. Redesignate paragraphs (h)(26) and (27) as paragraphs (h)(19) and 
(20).
    The additions read as follows:


Sec.  1308.11  Schedule I.

* * * * *
    (d) * * *

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

* * * * *

    Dated: August 30, 2016.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016-21345 Filed 9-2-16; 8:45 am]
 BILLING CODE 4410-09-P