[Federal Register Volume 81, Number 43 (Friday, March 4, 2016)]
[Rules and Regulations]
[Pages 11429-11431]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-05004]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-386]


Schedules of Controlled Substances: Extension of Temporary 
Placement of 10 Synthetic Cathinones in Schedule I of the Controlled 
Substances Act

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final order.

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SUMMARY: The Administrator of the Drug Enforcement Administration is 
issuing this final order to extend the temporary schedule I status of 
10 synthetic cathinones pursuant to the temporary scheduling provisions 
of the Controlled Substances Act. The 10 substances are: 4-methyl-N-
ethylcathinone (4-MEC); 4-methyl-alpha-pyrrolidinopropiophenone (4-
MePPP); alpha-pyrrolidinopentiophenone ([alpha]-PVP); 1-(1,3-
benzodioxol-5-yl)-2-(methylamino)butan-1-one (butylone); 2-
(methylamino)-1-phenylpentan-1-one (pentedrone); 1-(1,3-benzodioxol-5-
yl)-2-(methylamino)pentan-1-one (pentylone); 4-fluoro-N-methylcathinone 
(4-FMC); 3-fluoro-N-methylcathinone (3-FMC); 1-(naphthalen-2-yl)-2-
(pyrrolidin-1-yl)pentan-1-one (naphyrone); and alpha-
pyrrolidinobutiophenone ([alpha]-PBP) [hereinafter 4-MEC, 4-MePPP, 
[alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, 
and [alpha]-PBP, respectively], including their optical, positional, 
and geometric isomers, salts, and salts of isomers. The current final 
order temporarily placing 4-MEC, 4-MePPP, [alpha]-PVP, butylone, 
pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]-PBP into 
schedule I is in effect through March 6, 2016. This final order will 
extend the temporary scheduling of 4-MEC, 4-MePPP, [alpha]-PVP, 
butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]-
PBP for one year, or until the permanent scheduling action for these 10 
substances is completed, whichever occurs first.

DATES: This final order is effective March 4, 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. 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 purpose of this 
action. 21 U.S.C. 801-971. The DEA published 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, every 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 drug or other 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 all scheduled 
substances is published at 21 CFR part 1308.
    Section 201 of the CSA (21 U.S.C. 811) provides the Attorney 
General with the authority to temporarily place a substance into 
schedule I of the CSA for two years without regard to the requirements 
of 21 U.S.C. 811(b) if she finds that such action is necessary to avoid 
an imminent hazard to the public safety. 21 U.S.C. 811(h)(1). In 
addition, if proceedings to control a substance are initiated under 21 
U.S.C. 811(a)(1), the Attorney General may extend the temporary 
scheduling for up to one year. 21 U.S.C. 811(h)(2).
    Where the necessary findings are made, a substance may be 
temporarily scheduled if it is not listed in any other schedule under 
section 202 of the CSA (21 U.S.C. 812) or if there is no exemption or 
approval in effect for the substance under section 505 of the Federal 
Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 355. 21 U.S.C. 
811(h)(1). The Attorney General has delegated her scheduling authority 
under 21 U.S.C. 811 to the Administrator of the DEA. 28 CFR 0.100.

Background

    On March 7, 2014, the DEA published a final order in the Federal 
Register amending 21 CFR 1308.11(h) to temporarily place the 10 
synthetic cathinones 4-methyl-N-ethylcathinone (4-MEC); 4-methyl-alpha-
pyrrolidinopropiophenone (4-MePPP); alpha-pyrrolidinopentiophenone 
([alpha]-PVP); 1-(1,3-benzodioxol-5-yl)-2-(methylamino)butan-1-one 
(butylone); 2-(methylamino)-1-phenylpentan-1-one (pentedrone); 1-(1,3-
benzodioxol-5-yl)-2-(methylamino)pentan-1-one (pentylone); 4-fluoro-N-
methylcathinone (4-FMC); 3-fluoro-N-methylcathinone (3-FMC); 1-
(naphthalen-2-yl)-2-(pyrrolidin-1-yl)pentan-1-one (naphyrone); and 
alpha-pyrrolidinobutiophenone ([alpha]-PBP) into schedule I of the CSA 
pursuant to the temporary scheduling provisions of 21 U.S.C. 811(h). 79 
FR 12938. That final order was effective on the date of publication, 
and was based on findings by the Deputy Administrator of the DEA that 
the temporary scheduling of these ten synthetic cathinones 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 (21 U.S.C. 811(h)(2)) 
requires that the temporary control of these substances expires two 
years from the effective date of the scheduling order, or on March 6, 
2016. However, the CSA also provides that during the pendency of 
proceedings under 21 U.S.C. 811(a)(1) with respect

[[Page 11430]]

to the substance, the temporary scheduling of that substance could be 
extended for up to one year. Proceedings for the permanent scheduling 
of a substance under 21 U.S.C. 811(a) may be initiated by the Attorney 
General (delegated to the Administrator of the DEA pursuant to 28 CFR 
0.100) on his or her own motion, at the request of the Secretary of 
Health and Human Services,\1\ or on the petition of any interested 
party.
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    \1\ Because the Secretary of the Department of Health and Human 
Services has delegated to the Assistant Secretary for Health of the 
Department of Health and Human Services the authority to make 
domestic drug scheduling recommendations, for purposes of this final 
order, all subsequent references to ``Secretary'' have been replaced 
with ``Assistant Secretary.''
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    The Administrator of the DEA, on his own motion pursuant to 21 
U.S.C. 811(a), has initiated proceedings under 21 U.S.C. 811(a)(1) to 
permanently schedule 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, 
pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]-PBP. The DEA has 
gathered and reviewed the available information regarding the 
pharmacology, chemistry, trafficking, actual abuse, pattern of abuse, 
and the relative potential for abuse for these 10 synthetic cathinones. 
On December 30, 2014, the DEA submitted a request to the HHS to provide 
the DEA with a scientific and medical evaluation of available 
information and a scheduling recommendation for 4-MEC, 4-MePPP, 
[alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, 
and [alpha]-PBP, in accordance with 21 U.S.C. 811 (b) and (c). Upon 
evaluating the scientific and medical evidence, on March 2, 2016, the 
HHS submitted to the Administrator of the DEA its 10 scientific and 
medical evaluations for these substances. Upon receipt of the 
scientific and medical evaluation and scheduling recommendations from 
the HHS, the DEA reviewed the documents and all other relevant data, 
and conducted its own eight-factor analysis of the abuse potential of 
4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-
FMC, naphyrone, and [alpha]-PBP in accordance with 21 U.S.C. 811(c). 
The DEA has published a notice of proposed rulemaking for the placement 
of 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 
3-FMC, naphyrone, and [alpha]-PBP into schedule I elsewhere in this 
issue of the Federal Register.
    Pursuant to 21 U.S.C. 811(h)(2), the Administrator of the DEA 
orders that the temporary scheduling of 4-MEC, 4-MePPP, [alpha]-PVP, 
butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]-
PBP, including their optical, positional, and geometric isomers, salts, 
and salts of isomers be extended for one year, or until the permanent 
scheduling proceeding is completed, whichever occurs first.
    In accordance with this final order, the schedule I requirements 
for handling 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, 
pentylone, 4-FMC, 3-FMC, naphyrone, or [alpha]-PBP, including their 
optical, positional, and geometric isomers, salts, and salts of 
isomers, will remain in effect for one year, or until the permanent 
scheduling proceeding is completed, whichever occurs first.

Regulatory Matters

    The CSA provides for an expedited temporary scheduling action where 
such action is necessary to avoid an imminent hazard to the public 
safety. 21 U.S.C. 811(h). The Attorney General may, by order, schedule 
a substance in schedule I on a temporary basis. Id. 21 U.S.C. 811(h) 
also provides that the temporary scheduling of a substance shall expire 
at the end of two years from the date of the issuance of the order 
scheduling such substance, except that the Attorney General may, during 
the pendency of proceedings to permanently schedule the substance, 
extend the temporary scheduling for up to one year.
    To the extent that 21 U.S.C. 811(h) directs that temporary 
scheduling actions be issued by order and sets forth the procedures by 
which such orders are to be issued and extended, the DEA believes that 
the notice and comment requirements of section 553 of the 
Administrative Procedure Act (APA) (5 U.S.C. 553) do not apply to this 
extension of the temporary scheduling action. In the alternative, even 
assuming that this action might be subject to section 553 of the APA, 
the Administrator finds that there is good cause to forgo the notice 
and comment requirements of section 553, as any further delays in the 
process for extending the temporary scheduling order would be 
impracticable and contrary to the public interest in view of the 
manifest urgency to avoid an imminent hazard to the public safety. 
Further, the DEA believes that this final order extending the temporary 
scheduling action is not a ``rule'' as defined by 5 U.S.C. 601(2), and, 
accordingly, is not subject to the requirements of the Regulatory 
Flexibility Act (RFA). The requirements for the preparation of an 
initial regulatory flexibility analysis in 5 U.S.C. 603(a) are not 
applicable where, as here, the DEA is not required by section 553 of 
the APA or any other law to publish a general notice of proposed 
rulemaking.
    Additionally, this action is not a significant regulatory action as 
defined by Executive Order 12866 (Regulatory Planning and Review), 
section 3(f), and, accordingly, this action has not been reviewed by 
the Office of Management and Budget (OMB).
    This action will not have substantial direct effects on the States, 
on the relationship between the national government and the States, or 
on the distribution of power and responsibilities among the various 
levels of government. Therefore, in accordance with Executive Order 
13132 (Federalism), it is determined that this action does not have 
sufficient federalism implications to warrant the preparation of a 
Federalism Assessment.
    As noted above, this action is an order, not a rule. Accordingly, 
the Congressional Review Act (CRA) is inapplicable, as it applies only 
to rules. It is in the public interest to maintain the temporary 
placement of 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, 
pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]-PBP in schedule I 
because they pose a public health risk. The temporary scheduling action 
was taken pursuant to 21 U.S.C. 811(h), which is specifically designed 
to enable the DEA to act in an expeditious manner to avoid an imminent 
hazard to the public safety. Under 21 U.S.C. 811(h), temporary 
scheduling orders are not subject to notice and comment rulemaking 
procedures. The DEA understands that the CSA frames temporary 
scheduling actions as orders rather than rules to ensure that the 
process moves swiftly, and this extension of the temporary scheduling 
order continues to serve that purpose. For the same reasons that 
underlie 21 U.S.C. 811(h), that is, the need to place these substances 
in schedule I because they pose an imminent hazard to public safety, it 
would be contrary to the public interest to delay implementation of 
this extension of the temporary scheduling order. Therefore, in 
accordance with section 808(2) of the CRA, this final order extending 
the temporary scheduling order shall take effect immediately upon its 
publication. The DEA has submitted a copy of this final order to both 
Houses of Congress and to the Comptroller General, although such filing 
is not required under the Small Business Regulatory Enforcement 
Fairness Act of 1996 (Congressional Review Act), 5 U.S.C. 801-808 
because, as noted above, this action is an order, not a rule.


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    Dated: March 2, 2016.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016-05004 Filed 3-3-16; 8:45 am]
 BILLING CODE 4410-09-P