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[Federal Register: July 5, 2011 (Volume 76, Number 128)]
[Proposed Rules]               
[Page 39039-39041]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05jy11-25]                         

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-342P]
RIN 1117-AB33

 
Establishment of a New Drug Code for Marihuana Extract

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Drug Enforcement Administration (DEA) is proposing to 
create a new Administration Controlled Substances Code Number (``Code 
Number'' or ``drug code'') under 21 CFR 1308.11 for ``Marihuana 
Extract.'' This Code Number will allow DEA and DEA-registered entities 
to track quantities of this material separately from quantities of 
marihuana. This in turn will aid in complying with relevant treaty 
provisions.
    Under international drug control treaties (administered by the 
United Nations), some differences exist between the regulatory controls 
pertaining to marihuana extract versus those for marihuana and 
tetrahydrocannabinols. DEA has established separate Code Numbers for 
marihuana and for tetrahydrocannabinols, but not for marihuana extract. 
To better track these materials and better comply with treaty 
provisions, DEA is proposing to create a separate Code Number for 
marihuana extract under 21 CFR 1308.11(d)(36): ``Marihuana Extract 
meaning extracts that have been derived from any plant of the genus 
cannabis and which contain cannabinols and cannabidiols.'' Such 
extracts of marihuana would continue to be treated as schedule I 
controlled substances.

DATES: Electronic comments must be submitted and written comments must 
be postmarked on or before September 6, 2011. 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: To ensure proper handling of comments, please reference 
``Docket No. DEA-342'' on all electronic and written correspondence. 
DEA encourages all comments be submitted electronically through http://www.regulations.gov using the electronic comment form provided on that 
site. An electronic copy of this document and supplemental information 
to this proposed rule are also available at the http://www.regulations.gov Web site for easy reference. Paper comments that 
duplicate the electronic submission are not necessary as all comments 
submitted to http://www.regulations.gov will be posted for public 
review and are part of the official docket record. Should you, however, 
wish to submit written comments via regular or express mail, they 
should be sent to the Drug Enforcement Administration, Attention: DEA 
Federal Register Representative/ODL, 8701 Morrissette Drive, 
Springfield, VA 22152.

FOR FURTHER INFORMATION CONTACT: Imelda L. Paredes, Office of Diversion 
Control, Drug Enforcement Administration, 8701 Morrissette Drive, 
Springfield, Virginia 22152; Telephone (202) 307-7165.

SUPPLEMENTARY INFORMATION:
    Posting of Public Comments: Please note that all comments received 
are considered part of the public record and made available for public 
inspection online at http://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

[[Page 39040]]

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. Please note that the Freedom of 
Information Act applies to all comments received. If you wish to 
inspect the agency's public docket file in person by appointment, 
please see the ``For Further Information'' paragraph.

Background

    As provided in 21 CFR 1308.03, each controlled substance or basic 
class thereof is assigned a four digit Code Number that is used to 
track quantities of the controlled substance imported and exported to 
and from the United States. Additionally, DEA uses these Code Numbers 
in establishing aggregate production quotas for basic classes of 
controlled substances listed in schedules I and II as required by 21 
U.S.C. 826.
    Consistent with the Controlled Substances Act (CSA), the schedules 
contained in the DEA regulations include marihuana (drug code 7360) in 
schedule I. 21 CFR 1308.11(d)(23). This listing includes (unless 
specifically excepted or unless listed in another schedule) any 
material, compound, mixture, or preparation, which contains any 
quantity of the substance, or which contains any of its salts, isomers, 
and salts of isomers that are possible within the specific chemical 
designation. Because the definition of marihuana in 21 U.S.C. 802(16) 
includes both derivatives and preparations of marihuana, DEA until now 
has used drug code 7360 for extracts of marihuana as well. In this 
proposed rule, DEA is proposing that the new drug code 7350 be used for 
extracts of marihuana.

Why a New Code Number Is Needed

    The United Nations Conventions on international drug control treat 
extracts from the cannabis plant differently than marihuana or 
tetrahydrocannabinols. The creation of a new drug code in DEA 
regulations for marihuana extracts will allow for more appropriate 
accounting of such materials consistent with treaty provisions.
    The Single Convention on Narcotic Drugs, 1961 (``Single 
Convention'') and the 1971 Convention on Psychotropic Substances 
(``Psychotropic Convention'') provide for the international control of 
marihuana constituents. Many of the CSA's provisions were drafted to 
comply with these Conventions. The CSA includes schemes of drug 
scheduling and procedures for adding, removing, and transferring drugs 
among the schedules that are similar, in some ways, to those in the 
Single Convention. With respect to those drugs that are subject to 
control under the Single Convention, the CSA mandates that DEA control 
such drugs at least as strictly as required by the Single Convention. 
21 U.S.C. 811(d).
    Somewhat similar to the CSA, the Single Convention controls 
substances through four schedules. However, under the Single 
Convention, the drugs that are subject to the most stringent controls 
are in schedule IV. Another difference between the CSA and the Single 
Convention is that, under the latter, a drug can be listed in more than 
one schedule. Cannabis and cannabis resin are listed in both schedule 
IV and schedule I of the Single Convention. Schedule I controls under 
the Single Convention include requirements for import and export 
authorization, licensing of manufacturers/distributors, recordkeeping 
requirements, requirement for prescriptions for medical use, annual 
estimate of needs, quotas, annual statistical reporting, and a 
requirement that use be limited to medical and scientific purposes. 
Schedule II of the Single Convention is similar in controls to schedule 
I with a few exceptions, and schedule III is less restrictive. All 
substances listed in schedule IV are also listed in schedule I. The 
placing of a drug into both schedule I and schedule IV therefore 
imposes the most stringent controls under the Single Convention. 
Although cannabis and cannabis resin are listed in Schedules I and IV 
of the Single Convention, cannabis extracts are listed only in Schedule 
I.

Proposed Actions

    DEA therefore proposes to update 21 CFR 1308.11(d) to include new 
subparagraph (36) which would create a new Code Number in schedule I as 
follows:

``(36) Marihuana Extract.....................................       7350

    Meaning extracts that have been derived from any plant of the 
genus cannabis and which contain cannabinols and cannabidiols.''

    The creation of a new drug code in DEA regulations for marihuana 
extracts would allow for more appropriate accounting of such materials 
consistent with treaty provisions. Such marihuana extracts remain in 
schedule I. Firms registered to handle marihuana (under drug code 7360) 
that also handle marihuana extracts, will need to apply to add the new 
drug code 7350 to their existing DEA registrations and procure quotas 
specifically for drug code 7350 each year.

Regulatory Compliance Analyses

Regulatory Flexibility Act

    In accordance with the Regulatory Flexibility Act (5 U.S.C. 601-
612), the Administrator has reviewed this regulation and by approving 
it certifies that this regulation will not have a significant economic 
impact upon a substantial number of small entities. This rule proposes 
the establishment of a new drug code for marihuana extracts. DEA 
already registers persons handling marihuana extracts, but within 
another already-established drug code. Thus, persons who handle these 
marihuana extracts have already met DEA's registration, security, and 
other statutory and regulatory requirements. The only direct effect to 
registrants who handle marihuana extracts would be the requirement to 
add the new drug code to their registration once the code is 
established.

Executive Orders 12866 and 13563

    This regulation has been drafted and reviewed in accordance with 
the principles of Executive Orders 12866 and 13563. Although this rule 
is not a ``significant regulatory action'' under Executive Order 12866 
Section 3(f), it was submitted to the Office of Management and Budget 
(OMB) and subsequently approved.

Executive Order 12988

    This proposed regulation meets the applicable standards set forth 
in Sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice 
Reform to eliminate ambiguity, minimize litigation, establish clear 
legal standards and reduce burden.

Executive Order 13132

    This rulemaking does not preempt or modify any provision of state 
law; nor does it impose enforcement responsibilities on any state; nor 
does it diminish the power of any state to enforce its own laws. 
Accordingly, this rulemaking does not have federalism

[[Page 39041]]

implications warranting the application of Executive Order 13132.

Unfunded Mandates Reform Act of 1995

    This rule will not result in the expenditure by state, local, and 
Tribal governments, in the aggregate, or by the private sector, of 
$136,000,000 or more (adjusted for inflation) in any one year, and will 
not significantly or uniquely affect small governments. Therefore, no 
actions were deemed necessary under the provisions of the Unfunded 
Mandates Reform Act of 1995.

Paperwork Reduction Act of 1995

    This action does not impose a collection of information requirement 
under the Paperwork Reduction Act of 1995, 44 U.S.C. 3501-3521.

Executive Order 13175

    This rule is not a policy that has Tribal implications under 
Executive Order 13175. It will not have substantial direct effects on 
one or more Indian Tribes, on the relationship between the Federal 
Government and Indian Tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian Tribes.

List of Subjects in 21 CFR Part 1308

    Drug traffic control, Controlled substances.

    For the reasons set out above, 21 CFR part 1308 is proposed to be 
amended as follows:

PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

    1. The authority citation for part 1308 continues to read as 
follows:

    Authority: 21 U.S.C. 811, 812, 871(b).

    2. Section 1308.11 is amended by adding new paragraph (d)(36) to 
read as follows:

Sec.  1308.11  Schedule I.

* * * * *
    (d) * * *

(36) Marihuana Extract.......................................       7350

    Meaning extracts that have been derived from any plant of the genus 
cannabis and which contain cannabinols and cannabidiols.
* * * * *

    Dated: June 14, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011-16800 Filed 7-1-11; 8:45 am]
BILLING CODE 4410-09-P
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