2015-06456. 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.

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: [phone].

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 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:

Basic class—schedule I	Proposed 2015 quota (g)
N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide (AB-CHMINACA)	15
N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (AB-PINACA)	15
[1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone (THJ-2201)	15

Dated: March 12, 2015.

Michele M. Leonhart,

Administrator.