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Notice

Controlled Substances: Adjustment to the Established 2014 Aggregate Production Quota for Marijuana

Action

Notice With Request For Comments.

Summary

This notice adjusts the established 2014 aggregate production quota for marijuana, a schedule I controlled substance under the Controlled Substances Act.

 

Table of Contents Back to Top

DATES: Back to Top

Effective date: May 5, 2014. Comment date: Interested persons may file written comments on this notice in accordance with 21 CFR 1303.13. Electronic comments must be submitted and written comments must be postmarked, on or before June 4, 2014. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after midnight Eastern Time on the last day of the comment period.

ADDRESSES: Back to Top

To ensure proper handling of comments, please reference “Docket No. DEA-378” on all electronic and written correspondence. The DEA 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. Paper comments that duplicate electronic submissions are not necessary. Should you, however, wish to submit written comments, in lieu of electronic comments, they 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: Back to Top

Ruth A. Carter, Office of Diversion Control, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152, Telephone: (202) 598-6812.

SUPPLEMENTARY INFORMATION: Back to Top

Posting of Public Comments Back to Top

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 (FOIA) 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 made publicly available, you must include the phrase “PERSONAL IDENTIFYING INFORMATION” in the first paragraph of your comment. You must also place all of the personal identifying information you do not want made 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 the 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 made publicly available. 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 or the supporting information the DEA used in preparing this action, these materials will be available for public inspection by appointment. To arrange a viewing, please see the FOR FURTHER INFORMATION CONTACT paragraph above.

Pursuant to 21 CFR 1303.13, any interested person may submit written comments on or objections to this notice. Based on comments received in response to this notice, the Administrator may hold a public hearing on one or more issues raised in the comments and objections filed. In the event the Administrator decides to hold such a hearing, the Administrator shall publish notice of the hearing in the Federal Register. After consideration of any comments or objections, or after a hearing, if one is held, the Administrator shall issue and publish in the Federal Register a notice regarding the adjustment to the established 2014 aggregate production quota for marijuana. [1]

Legal Authority Back to Top

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 the purpose 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), parts 1300 to 1321. 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 providing 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.

Section 306 of the CSA (21 U.S.C. 826) requires the Attorney General to establish aggregate production quotas for each basic class of controlled substance listed in schedules I and II each year. The Attorney General has delegated this authority under 21 U.S.C. 826 to the Administrator of the DEA, 28 CFR 0.100.

Background Back to Top

The DEA established the initial 2014 aggregate production quotas and assessments for annual need on September 9, 2013 (78 FR 55099). The notice stipulated that, as provided for in 21 CFR 1303.13, all aggregate production quotas and assessments for annual need are subject to adjustment.

Analysis for Adjusting the Established 2014 Aggregate Production Quota for Marijuana Effective on the Date of Publication Back to Top

In determining to adjust the aggregate production quota, the DEA takes into consideration, among other factors, the relevant scientific and research needs of the United States. 21 U.S.C. 826; 21 CFR 1303.13(b)(5).

The National Institute on Drug Abuse (NIDA) is a component of the National Institutes of Health and the U.S. Department of Health and Human Services, and it oversees the cultivation, production and distribution of research-grade marijuana on behalf of the United States Government, pursuant to the Single Convention on Narcotic Drugs (March 30, 1961, 18 UST 1407). NIDA recently notified the DEA that it required additional supplies of marijuana to be manufactured in 2014 to provide for current and anticipated research efforts involving marijuana. Specifically, NIDA stated that 600 kilograms is necessary to be manufactured in 2014.

The DEA was unaware of NIDA's additional need at the time the initial aggregate production quota for marijuana was established in September 2013.

The aggregate production quota for marijuana should be increased in order to provide a continuous and uninterrupted supply of marijuana in support of DEA-registered researchers who are approved by the Federal Government to utilize marijuana in their research protocols.

In the event the established aggregate production quota is increased, DEA regulations require general notice of the adjustment prior to adjusting the quota. 21 CFR 1303.13(c). Due to the manufacturing process unique to marijuana, including the length of time and conditions necessary to propagate and process the substance for distribution in 2014, it is necessary to adjust the initial, established 2014 aggregate production quota for marijuana as soon as practicable. Accordingly, the Administrator finds good cause to adjust the aggregate production quota for marijuana before accepting written comments from interested persons or holding a public hearing, pursuant to 21 CFR 1303.13(c). More specifically, the Administrator finds, based on NIDA's aforementioned submission to DEA, that it is in the public interest to adjust the aggregate production quota immediately to ensure that the cultivation of marijuana to meet NIDA's anticipated needs to supply researchers can proceed within the current grow cycle. For this same reason, the Administrator finds that delaying the adjustment to the aggregate production quota for marijuana until after the comment period would be impracticable. Any such comments shall be considered if submitted in accordance with the procedures described herein.

In issuing this adjustment, the DEA has taken into account the criteria that the DEA is required to consider in accordance with 21 CFR 1303.13(b). The DEA determines whether to adjust the aggregate production quotas for basic classes of schedule I and II controlled substances by considering: (1) Changes in demand for the basic class, changes in the national rate of net disposal for the class, and changes in the rate of net disposal by the registrants holding individual manufacturing quotas for the class; (2) whether any increased demand or changes in the national or individual rates of net disposal are temporary, short term, or long term; (3) whether any increased demand can be met through existing inventories, increased individual manufacturing quotas, or increased importation, without increasing the aggregate production quota; (4) whether any decreased demand will result in excessive inventory accumulation by all persons registered to handle the class; and (5) other factors affecting the medical, scientific, research, and industrial needs of the United States and lawful export requirements, as the Administrator finds relevant.

Based on the above, the Administrator adjusts the established 2014 aggregate production quota for marijuana, to be manufactured in the United States in 2014 to provide for the estimated scientific, research, and industrial needs of the United States, and the establishment and maintenance of reserve stocks, expressed in grams of anhydrous acid or base, as follows:

Basic class—schedule I Previously established 2014 quota (g) Adjusted 2014 Quota (g)
Marijuana 21,000 650,000

Dated: April 29, 2014.

Michele M. Leonhart,

Administrator.

[FR Doc. 2014-10202 Filed 5-2-14; 8:45 am]

BILLING CODE 4410-09-P

Footnotes Back to Top

1. Note that “marihuana” is the spelling originally used in the Controlled Substances Act (CSA). This document uses the spelling that is more common in current usage, “marijuana.”

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