[Federal Register Volume 79, Number 62 (Tuesday, April 1, 2014)]
[Notices]
[Pages 18316-18317]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-07166]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-391]


Controlled Substances: 2014 Proposed Aggregate Production Quota 
for 10 Temporarily Controlled Synthetic Cathinones

AGENCY: Drug Enforcement Administration (DEA), Department of Justice.

ACTION: Notice of a proposed 2014 aggregate production quota for ten 
synthetic cathinones.

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SUMMARY: Ten 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); naphthylpyrovalerone (naphyrone); and alpha-
pyrrolidinobutiophenone ([alpha]-PBP) were temporarily placed in 
schedule I of the Controlled Substances Act (CSA) by a final order 
published by the Drug Enforcement Administration (DEA) on March 7, 2014 
(79 FR 12938). This means that any manufacturer that wishes to 
manufacture 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, 
pentylone, 4-FMC, 3-FMC, naphyrone, or [alpha]-PBP after March 7, 2014, 
must be registered with the DEA and have obtained a manufacturing quota 
for 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-
FMC, 3-FMC, naphyrone, or [alpha]-PBP pursuant to 21 CFR part 1303.
    The DEA cannot issue individual manufacturing quotas for 4-MEC, 4-
MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, 
naphyrone, or [alpha]-PBP unless and until it establishes an aggregate 
production quota. Therefore, this notice proposes a 2014 aggregate 
production quota for 4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, 
pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]-PBP.

DATES: Comments or objections should be received on or before May 1, 
2014.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-391'' on all electronic and written correspondence. 
The DEA encourages that all comments be submitted electronically 
through www.regulations.gov using the electronic comment form provided 
on that site. An electronic copy of this document is also available at 
www.regulations.gov for easy reference. Paper comments that duplicate 
the electronic submission are not necessary as all comments submitted 
to www.regulations.gov will be posted for public review and are part of 
the official docket record. Written comments submitted via regular or 
express mail should be sent to the Drug Enforcement Administration, 
Attention: DEA Federal Register Representative/ODW, 8701 Morrissette 
Drive, Springfield, Virginia 22152.

FOR FURTHER INFORMATION CONTACT: Ruth A. Carter, 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

    The Freedom of Information Act applies to all comments received. 
All comments received are considered part of the public record and made 
available for public inspection online at www.regulations.gov and in 
the DEA's public docket. Such information includes personal identifying 
information (such as your name, address, etc.) voluntarily submitted by 
the commenter.
    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 posted online or made available in the public docket, you must 
include the phrase ``PERSONAL IDENTIFYING INFORMATION'' in the first 
paragraph of your comment. You must also place all the personal 
identifying information you do not want posted online or made available 
in the public docket 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 posted online or made available 
in the public docket, you must include the phrase ``CONFIDENTIAL 
BUSINESS INFORMATION'' in the first paragraph of your comment. You must 
also prominently identify confidential business information to be 
redacted within the comment. If a comment has so much confidential 
business information that it cannot be effectively redacted, all or 
part of that comment may not be posted online or made available in the 
public docket.
    Personal identifying information and confidential business 
information identified and located as set forth above will be redacted, 
and the comment, in redacted form, will be posted online and placed in 
the DEA's public docket file.
    If you wish to inspect the DEA's public docket file in person by 
appointment, please see the For Further Information Contact paragraph.

Background

    Section 306 of the CSA (21 U.S.C. 826) requires that the Attorney 
General establish aggregate production quotas for each basic class of 
controlled substance listed in schedules I and II each year. This 
responsibility has been delegated to the Administrator of the Drug 
Enforcement Administration (DEA) by 28 CFR 0.100. The Administrator, in 
turn, has redelegated this function to the Deputy Administrator, 
pursuant to 28 CFR 0.104.
    The DEA established the 2014 aggregate production quotas for 
substances in schedules I and II on September 9, 2013 (78 FR 55099). 
Subsequently, on January 28, 2014, the DEA published in the Federal 
Register a notice of intent to temporarily place ten 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), 
naphthylpyrovalerone (naphyrone), and alpha-pyrrolidinobutiophenone 
([alpha]-PBP) in schedule I of the CSA (79 FR 4429). On March 7, 2014, 
the DEA published in the Federal Register a final order to temporarily 
place these ten synthetic cathinones in schedule I of the CSA (79

[[Page 18317]]

FR 12938), making all regulations pertaining to schedule I controlled 
substances applicable to the manufacture of these ten synthetic 
cathinones, including the requirement to obtain a manufacturing quota 
pursuant to 21 CFR part 1303.
    4-MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-
FMC, 3-FMC, naphyrone, and [alpha]-PBP were non-controlled substances 
when the aggregate production quotas for schedule I and II substances 
were established, therefore, no aggregate production quotas for 4-MEC, 
4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3-FMC, 
naphyrone, and [alpha]-PBP were established at that time.
    In determining the 2014 aggregate production quotas of these ten 
synthetic cathinones, the Deputy Administrator considered the following 
factors in accordance with 21 U.S.C. 826(a) and 21 CFR 1303.11: (1) 
Total estimated net disposal of each substance by all manufacturers; 
(2) estimated trends in the national rate of net disposal; (3) total 
estimated inventories of the basic class and of all substances 
manufactured from the class; (4) projected demand for each class as 
indicated by procurement quotas requested pursuant to 21 CFR 1303.12; 
and (5) other factors affecting medical, scientific, research, and 
industrial needs of the United States and lawful export requirements, 
as the Deputy Administrator finds relevant. These quotas do not include 
imports of controlled substances for use in industrial processes.
    The Deputy Administrator, therefore, proposes that the year 2014 
aggregate production quotas for the following temporarily controlled 
schedule I controlled substances, expressed in grams of anhydrous acid 
or base, be established as follows:

------------------------------------------------------------------------
                                                           Proposed 2014
                 Basic class--schedule I                       quota
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1-(1,3-benzodioxol-5-yl)-2-(methylamino)butan-1-one                 15 g
 (butylone).............................................
1-(1,3-benzodioxol-5-yl)-2-(methylamino)pentan-1-one                15 g
 (pentylone)............................................
2-(methylamino)-1-phenylpentan-1-one (pentedrone).......            15 g
3-fluoro-N-methylcathinone (3-FMC)......................            15 g
4-fluoro-N-methylcathinone (4-FMC)......................            15 g
4-methyl-N-ethylcathinone (4-MEC).......................            15 g
4-methyl-[alpha]-pyrrolidinopropiophenone (4-MePPP).....            15 g
alpha-pyrrolidinobutiophenone ([alpha]-PBP).............            15 g
alpha-pyrrolidinopentiophenone ([alpha]-PVP)............            15 g
naphthylpyrovalerone (naphyrone)........................            15 g
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Comments

    Pursuant to 21 CFR 1303.11, any interested person may submit 
written comments on or objections to these proposed determinations. 
Based on comments received in response to this notice, the Deputy 
Administrator may hold a public hearing on one or more issues raised. 
In the event the Deputy Administrator decides in his sole discretion to 
hold such a hearing, the Deputy Administrator will publish a notice of 
any such hearing in the Federal Register. After consideration of any 
comments and after a hearing, if one is held, the Deputy Administrator 
will publish in the Federal Register a final order establishing the 
2014 aggregate production quota for 4-MEC, 4-MePPP, [alpha]-PVP, 
butylone, pentedrone, pentylone, 4-FMC, 3-FMC, naphyrone, and [alpha]-
PBP.

    Dated: March 24, 2014.
Thomas M. Harrigan,
Deputy Administrator.
[FR Doc. 2014-07166 Filed 3-31-14; 8:45 am]
BILLING CODE 4410-09-P