[Federal Register Volume 80, Number 54 (Friday, March 20, 2015)]
[Notices]
[Pages 15034-15035]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-06456]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-410]


Controlled Substances: 2015 Proposed Aggregate Production Quotas 
for Three Temporarily Controlled Synthetic Cannabinoids

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Notice with request for comments.

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SUMMARY: Three synthetic cannabinoids: N-(1-amino-3-methyl-1-oxobutan-
2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide (AB-CHMINACA), N-
(1-amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide 
(AB-PINACA), and [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-
yl)methanone (THJ-2201) were temporarily placed in schedule I of the 
Controlled Substances Act by a final order published by the Drug 
Enforcement Administration on January 30, 2015 (80 FR 5042). This means 
that any person that wishes to manufacture AB-CHMINACA, AB-PINACA, or 
THJ-2201 after January 30, 2015, must be registered with the Drug 
Enforcement Administration and have obtained a manufacturing quota 
pursuant to 21 CFR part 1303.
    The Drug Enforcement Administration cannot issue individual 
manufacturing quotas for AB-CHMINACA, AB-PINACA, or THJ-2201 until it 
establishes aggregate production quotas. Therefore, this notice 
proposes the 2015 aggregate production quotas for AB-CHMINACA, AB-
PINACA, and THJ-2201.

DATES: Interested persons may file written comments on this notice in 
accordance with 21 CFR 1303.11(c). Electronic comments must be 
submitted, and written comments must be postmarked, on or before April 
20, 2015. 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.
    Based on comments received in response to this Notice, the 
Administrator may hold a public hearing on one or more issues raised. 
In the event the Administrator decides in her sole discretion to hold 
such a hearing, the 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 Administrator will publish in 
the Federal Register a final order establishing the 2015 aggregate 
production quotas for AB-CHMINACA, AB-PINACA, and THJ-2201.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-410'' on all correspondence, including any 
attachments. 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 that duplicate an electronic submission are not 
necessary and are discouraged. 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, Attention: DEA 
Federal Register Representative/ODXL, 8701 Morrissette Drive, 
Springfield, Virginia 22152.

FOR FURTHER INFORMATION CONTACT: Imelda L. Paredes, 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 and will be made available 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 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 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 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 
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. Comments containing 
personal identifying information or confidential

[[Page 15035]]

business information identified as directed above will be made publicly 
available in redacted form.
    An electronic copy of this document is available at http://www.regulations.gov for easy reference. If you wish to personally 
inspect the comments and materials received, these materials will be 
available for public inspection by appointment. To arrange a viewing, 
please see the For Further Information Contact paragraph above.

Legal Authority and Background

    Section 306 of the Controlled Substances Act (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). 28 CFR 
0.100.
    The DEA established the 2015 aggregate production quotas for 
substances in schedules I and II on September 8, 2014 (79 FR 53216). 
Subsequently, on December 19, 2014, DEA published in the Federal 
Register a notice of intent to temporarily place 3 synthetic 
cannabinoids: N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-
(cyclohexylmethyl)-1H-indazole-3-carboxamide (AB-CHMINACA), N-(1-amino-
3-methyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (AB-
PINACA), and [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-
yl)methanone (THJ-2201) into schedule I of the CSA (79 FR 75767). On 
January 30, 2015, the DEA published in the Federal Register a final 
order to temporarily place these three synthetic cannabinoids in 
schedule I of the CSA (80 FR 5042), making all regulatory controls 
pertaining to schedule I controlled substances applicable to the 
manufacture of these three synthetic cannabinoids, including the 
requirement to establish an aggregate production quota pursuant to 21 
U.S.C. 826 and 21 CFR part 1303.
    AB-CHMINACA, AB-PINACA, and THJ-2201 were non-controlled substances 
when the aggregate production quotas for schedule I and II substances 
were established. Therefore no aggregate production quotas for AB-
CHMINACA, AB-PINACA, and THJ-2201 were established at that time.
    In determining the 2015 aggregate production quotas of these three 
synthetic cannabinoids, the Administrator considered the following 
factors in accordance with 21 U.S.C. 826(a) and 21 CFR 1303.11(b): (1) 
Total net disposal of the class by all manufacturers during the current 
and 2 preceding years; (2) trends in the national rate of net disposal 
of the class; (3) total estimated inventories of the basic class and of 
all substances manufactured from the class, and trends in inventory 
accumulation; (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 
Administrator finds relevant. These quotas do not include imports of 
controlled substances for use in industrial processes.
    The Administrator, therefore, proposes that the annual 2015 
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 2015
                 Basic class--schedule I                     quota (g)
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N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-                               15
 (cyclohexylmethyl)-1H-indazole-3-carboxamide (AB-
 CHMINACA)..............................................
N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1H-                     15
 indazole-3-carboxamide (AB-PINACA).....................
[1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-                    15
 yl)methanone (THJ-2201)................................
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    Dated: March 12, 2015.
Michele M. Leonhart,
Administrator.
[FR Doc. 2015-06456 Filed 3-19-15; 8:45 am]
 BILLING CODE 4410-09-P