[Federal Register Volume 81, Number 91 (Wednesday, May 11, 2016)]
[Rules and Regulations]
[Pages 29142-29145]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11204]



[[Page 29142]]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-417]


Schedules of Controlled Substances: Placement of UR-144, XLR11, 
and AKB48 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 (1-pentyl-1H-indol-3-yl)(2,2,3,3-
tetramethylcyclopropyl)methanone (UR-144), [1-(5-fluoro-pentyl)-1H-
indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone (5-fluoro-UR-144, 
XLR11), and N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide 
(APINACA, AKB48), 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 UR-144, XLR11, or AKB48.

DATES: Effective: May 11, 2016.

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

SUPPLEMENTARY INFORMATION:

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 DEA Administrator on 
her 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, UR-144, 
XLR11, or AKB48.
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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 April 12, 2013, the DEA published a notice of intent to 
temporarily place (1-pentyl-1H-indol-3-yl)(2,2,3,3-
tetramethylcyclopropyl)methanone (UR-144), [1-(5-fluoro-pentyl)-1H-
indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone (5-fluoro-UR-144, 
XLR11), and N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide 
(APINACA, AKB48) into schedule I pursuant to the temporary scheduling 
provisions of the CSA. 78 FR 21858. On May 16, 2013, the DEA published 
a final order amending 21 CFR 1308.11(h) to temporarily place these 
three synthetic cannabinoids into schedule I of the CSA pursuant to the 
temporary scheduling provisions of 21 U.S.C. 811(h). 78 FR 28735. That 
final order was effective on the date of publication, and was based on 
findings by 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). Section 201(h)(2) of the 
CSA requires that the temporary control of these substances expire two 
years from the effective date of the scheduling order, or on May 15, 
2015. 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 
May 14, 2015, the DEA published a notice of proposed rulemaking (NPRM) 
to permanently control UR-144, XLR11, and AKB48 in schedule I of the 
CSA. 80 FR 27611. Specifically, the DEA proposed to add these 
substances to 21 CFR 1308.11(g), cannabimimetic agents. On May 15, 
2015, the DEA extended the temporary scheduling of UR-144, XLR11, and 
AKB48 by one year, until May 15, 2016. 80 FR 27854. On March 22, 2016, 
the DEA published a corrected notice of proposed rulemaking, proposing 
the placement of these substances as hallucinogenic substances under 21 
CFR 1308.11(d), and providing an opportunity to comment on this 
proposed change. 81 FR 15188.

[[Page 29143]]

DEA and HHS Eight Factor Analyses

    On May 11, 2015, the HHS provided the DEA with three scientific and 
medical evaluation documents prepared by the FDA entitled ``Basis for 
the recommendation to place 1-pentyl-1H-indol-3-yl-2,2,3,3-
tetramethylcyclopropyl methanone (UR-144) and its salts in Schedule 1 
of the Controlled Substances Act (CSA);'' ``Basis for the 
recommendation to place 1-(5-fluoro-pentyl)-1H-indol-3-yl 2,2,3,3-
tetramethylcyclopropyl methanone (XLR11) and its salts in Schedule 1 of 
the Controlled Substances Act (CSA);'' and ``Basis for the 
recommendation to place (N-(1-adamantyl)-1-pentyl-1H-indazole-3-
carboxamide) (AKB48; APINACA) 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 UR-144, XLR11, and 
AKB48 be controlled in schedule I of the CSA. In response, the DEA 
conducted its own eightfactor analysis of UR-144, XLR11, and AKB48. The 
DEA and HHS analyses are available in their entirety in the public 
docket for this rule (DEA-2015-0007/agency Docket Number DEA-417) at 
http://www.regulations.gov under ``Supporting Documents.''

Determination To Schedule UR-144, XLR11, and AKB48

    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 UR-144, XLR11, and AKB48 into Schedule I,'' 
proposing to control UR-144, XLR11, and AKB48 in schedule I of the CSA. 
80 FR 27611, May 14, 2015. The proposed rule provided an opportunity 
for interested persons to file a request for hearing in accordance with 
the DEA regulations on or before June 15, 2015. 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 June 15, 2015.

Comments Received

    The DEA received three comments on the proposed rule to control UR-
144, XLR11, and AKB48 in schedule I of the CSA. One commenter stated 
that the ``longwinded and unnecessarily difficult names of the chemical 
substances mentioned'' were offensive and that they should be changed 
``in the name of a truly transparent government.'' A second commenter 
questioned the safety of methadone, and the third commenter opposed the 
control of UR-144, XLR11, and AKB48.
    Two comments were received in response to the publication of the 
NPRM correction, for which comments were to be limited to addressing 
the change in the proposed placement in the CFR for the substances as 
hallucinogenic substances rather than cannabimimetic agents Both 
comments addressed whether or not these substances should be scheduled, 
with one commenter supporting scheduling and the other opposing. Thus, 
both comments were outside the scope for which comments were being 
accepted.
    Comments Received in Response to NPRM.
    Request to Shorten Chemical Names. One commenter stated that the 
chemical names for UR-144, XLR11, and AKB48 were unnecessarily 
difficult to understand and requested they be shortened.
    DEA Response: In order to ensure the public is aware of the 
specific substances that were proposed to be controlled, and are 
controlled, as schedule I substances, the DEA used both the standard 
chemical names for UR-144, XLR11, and AKB48 and the common street level 
names that correspond to each substance. All names known by the DEA for 
UR-144, XLR11, and AKB48 were provided in the NPRM, the NPRM 
correction, and in this final rule. In addition, to prevent any 
confusion with nomenclature or other references to these substances, 
the DEA also used shortened names for these substances, including UR-
144, XLR11, 5-fluoro-UR-144, AKB48, and APINACA. Each of the names 
provided in the NPRM, the NPRM correction, and this final rule are 
commonly accepted identifiers for the three substances.
    Comment Regarding Methadone. One commenter stated that methadone is 
very dangerous to use, especially with the consumption of alcohol.
    DEA Response: Methadone is a schedule II synthetic opioid and is 
not affected by this rule.
    Request Not to Control UR-144, XLR11, and AKB48. One commenter 
opposed controlling UR-144, XLR11, and AKB48 stating ``there is no 
reason to have this law.''
    DEA Response: As outlined in detail in the HHS and DEA eight-factor 
analyses, there is substantial evidence to support control of UR-144, 
XLR11, and AKB48 in schedule I of the CSA.
    The use of UR-144, XLR11, and/or AKB48 has been linked to serious 
adverse effects including vomiting, nausea, anxiety, agitation, 
seizures, hallucinations, tachycardia, and stroke, which require visits 
to emergency facilities. In addition to the serious adverse effects, 
the misuse and abuse of UR-144, XLR11, and/or AKB48 has been shown to 
result in death. As reported by the National Forensic Laboratory 
Information System (NFLIS), there have been over 46,000 reports for UR-
144, XLR11, and AKB48 since 2011 in at least 44 states. As determined 
by the HHS, there is no accepted medical use for UR-144, XLR11, and 
AKB48.

Scheduling Conclusion

    After consideration of the relevant matter presented as a result of 
public comment, the scientific and medical evaluations and accompanying 
recommendations of the HHS, and its own eight-factor analyses, the DEA 
finds that these facts and all other relevant data constitute 
substantial evidence of potential for abuse of UR-144, XLR11, and 
AKB48. As such, the DEA is permanently scheduling UR-144, XLR11, and 
AKB48 as controlled substances under the CSA.\2\
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    \2\ UR-144, XLR11, and AKB48 were initially proposed to be 
scheduled under Sec.  1308.11(g). However, they do not meet the 
structural requirement for ``cannabimimetic agents.'' Consistent 
with the analysis set forth in the DEA's 8-factor analysis, on March 
22, 2016, the DEA published a corrected notice of proposed 
rulemaking, with opportunity for comment, proposing the placement of 
these substances as hallucinogenic substances under 21 CFR 
1308.11(d). 81 FR 15188. The substances are being placed under Sec.  
1308.11(d), hallucinogenic substances, under this final rule.
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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) (1-pentyl-1H-indol-3-yl)(2,2,3,3-
tetramethylcyclopropyl)methanone (UR-144), [1-(5-fluoro-pentyl)-1H-
indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone (5-fluoro-UR-144, 
XLR11), and N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide 
(APINACA, AKB48) have a high potential for abuse that is comparable to 
other schedule I substances such as delta-9-

[[Page 29144]]

tetrahydrocannabinol ([Delta]\9\-THC) and JWH-018;
    (2) (1-pentyl-1H-indol-3-yl)(2,2,3,3-
tetramethylcyclopropyl)methanone (UR-144), [1-(5-fluoro-pentyl)-1H-
indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone (5-fluoro-UR-144, 
XLR11), and N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide 
(APINACA, AKB48) have no currently accepted medical use in treatment in 
the United States; and
    (3) There is a lack of accepted safety for use of (1-pentyl-1H-
indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone (UR-144), [1-(5-
fluoro-pentyl)-1H-indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone 
(5-fluoro-UR-144, XLR11) and N-(1-adamantyl)-1-pentyl-1H-indazole-3-
carboxamide (APINACA, AKB48) under medical supervision.
    Based on these findings, the Administrator of the DEA concludes 
that (1-pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone 
(UR-144), [1-(5-fluoro-pentyl)-1H-indol-3-yl](2,2,3,3-
tetramethylcyclopropyl)methanone (5-fluoro-UR-144, XLR11), and N-(1-
adamantyl)-1-pentyl-1H-indazole-3-carboxamide (APINACA, AKB48) 
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 UR-144, XLR11, and AKB48

    UR-144, XLR11, and AKB48 are currently scheduled on a temporary 
basis in schedule I \3\ and therefore continue 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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    \3\ UR-144, XLR11, and AKB48 are currently subject to schedule I 
controls on a temporary basis, pursuant to 21 U.S.C. 811(h). 80 FR 
27854, May 15, 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) UR-
144, XLR11, or AKB48, or who desires to handle UR-144, XLR11, or AKB48 
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.
    2. Disposal of Stocks. UR-144, XLR11, and AKB 48 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. UR-144, XLR11, and AKB48 continue to be subject to 
schedule I security requirements and must be handled and stored 
pursuant to 21 U.S.C. 821, 823, and 871(b), and in accordance with 21 
CFR 1301.71-1301.93.
    4. Labeling and Packaging. All labels, labeling, and packaging for 
commercial containers of UR-144, XLR11, and AKB48 must comply with 21 
U.S.C. 825 and 958(e), and be in accordance with 21 CFR part 1302.
    5. Quota. Only registered manufacturers are permitted to 
manufacture UR-144, XLR11, or AKB48 in accordance with a quota assigned 
pursuant to 21 U.S.C. 826 and in accordance with 21 CFR part 1303.
    6. Inventory. Every DEA registrant required to keep records and who 
possesses any quantity of UR-144, XLR11, or AKB48 is required to 
maintain an inventory of all stocks of UR-144, XLR11, and/or AKB48 on 
hand, 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, and in accordance 
with 21 CFR parts 1304, 1312, and 1317. Manufacturers and distributors 
must submit reports regarding UR-144, XLR11, and/or AKB48 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.
    8. Order Forms. Every DEA registrant who distributes UR-144, XLR11, 
and/or AKB48 must continue to comply with the order form requirements, 
pursuant to 21 U.S.C. 828 and 21 CFR part 1305.
    9. Importation and Exportation. All importation and exportation of 
UR-144, XLR11, and AKB48 must be in compliance with 21 U.S.C. 952, 953, 
957, and 958, and in accordance with 21 CFR part 1312.
    10. Liability. Any activity involving UR-144, XLR11, or AKB48 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

Administrative Procedure Act

    The Administrative Procedure Act (APA) generally requires that 
rules enacted in accordance with the procedures of 5 U.S.C. 553 to be 
effective not less than 30 days after publication of the proposed rule. 
5 U.S.C. 553(d). However, the APA provides three exceptions for when an 
agency may make a rule effective sooner than 30 days after publication, 
including if the agency finds for good cause why the rule should be 
effective sooner and publishes those reasons with the rule. 5 U.S.C. 
553(d)(3). The DEA finds that there is good cause for this scheduling 
action to be immediately effective upon publication. A delay in the 
effective date is unnecessary and contrary to the public interest. It 
is unnecessary because UR-144, XLR11, and AKB48 are already controlled 
under 21 U.S.C. 811(h). Additionally, a delay in the effective date 
could potentially temporarily eliminate these substances from being 
controlled, thereby resulting in an imminent hazard to the public 
safety. As noted above, the use of UR-144, XLR11, and/or AKB48 has been 
linked to serious adverse effects including vomiting, nausea, anxiety, 
agitation, seizures, hallucinations, tachycardia, and stroke, which 
require visits to emergency facilities. In addition to the serious 
adverse effects, the misuse and abuse of UR-144, XLR11, and/or AKB48 
has been shown to result in death.

Executive Orders 12866 and 13563, 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 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

[[Page 29145]]

promote simplification and burden reduction.

Executive Order 13132, Federalism

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

Executive Order 13175, Consultation and Coordination With Indian Tribal 
Governments

    This 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 May 16, 2013, the 
DEA published a final order amending 21 CFR 1308.11(h) to temporarily 
place these three synthetic cannabinoids into schedule I of the CSA 
pursuant to the temporary scheduling provisions of 21 U.S.C. 811(h). 78 
FR 28735. On May 15, 2015, 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). 80 FR 27854. 
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 UR-144, XLR11, 
and AKB48. Therefore, the DEA anticipates that this rule will impose 
minimal or no economic impact on businesses that currently handle UR-
144, XLR11, or AKB48 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. In Sec.  1308.11:
0
a. Add paragraphs (d) (48) through (50); and
0
b. Remove paragraphs (h)(1) through (3) and redesignate paragraphs 
(h)(4) through (25) as paragraphs (h)(1) through (22), respectively.
    The additions read as follows:


Sec.  1308.11  Schedule I.

* * * * *
    (d) * * *

 
 
 
(48) (1-pentyl-1H-indol-3-yl)(2,2,3,3-                            (7144)
 tetramethylcyclopropyl)methanone (UR-144)...................
(49) [1-(5-fluoro-pentyl)-1H-indol-3-yl](2,2,3,3-                 (7011)
 tetramethylcyclopropyl)methanone (5-fluoro-UR-144, XLR11)...
(50) N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide           (7048)
 (APINACA, AKB48)............................................
 

* * * * *

    Dated: May 6, 2016.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016-11204 Filed 5-10-16; 8:45 am]
 BILLING CODE 4410-09-P