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[Federal Register Volume 80, Number 67 (Wednesday, April 8, 2015)]
[Notices]
[Pages 18867-18869]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-08042]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-411N]

Controlled Substances: Proposed Adjustments to the Aggregate 
Production Quotas for Difenoxin, Diphenoxylate (for conversion), and 
Marijuana

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Notice with request for comments.

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SUMMARY: The Drug Enforcement Administration is proposing to adjust the 
established 2015 aggregate production quota for difenoxin, 
diphenoxylate (for conversion), and marijuana which are schedule I and 
II controlled substances under the Controlled Substances Act.

DATES: 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 May 8,

[[Page 18868]]

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.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-411N'' 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 electronic submissions 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. They will, unless reasonable 
cause is given, be made available by the Drug Enforcement 
Administration 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 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 
confidential business information to be redacted within the comment.
    Comments containing personal identifying information and 
confidential business information identified and located as directed 
above will generally be made available in redacted form. If a comment 
has so much confidential business information or personal identifying 
information that it cannot be effectively redacted, all or part of that 
comment may not be made publicly available. Comments posted to http://www.regulations.gov may include any personal identifying information 
(such as name, address, and phone number) included in the text of your 
electronic submission that is not identified as directed above as 
confidential.
    An electronic copy of this document is available at http://www.regulations.gov for easy reference.

Legal Authority

    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. 21 U.S.C. 801-971. 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. The DEA publishes the 
implementing regulations for these statutes in title 21 of the Code of 
Federal Regulations (CFR), chapter II. 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 function to the Administrator of 
the DEA, 28 CFR 0.100.

Background

    The DEA established the initial 2015 aggregate production quotas 
and assessments of annual need on September 8, 2014 (79 FR 53216). That 
notice stipulated that, as provided for in 21 CFR 1303.13, all 
aggregate production quotas and assessments of annual need are subject 
to adjustment.
    Based on unanticipated medical, scientific, research, and 
industrial needs of the United States the DEA proposes to adjust the 
established 2015 aggregate production quotas for the schedule I and II 
controlled substances difenoxin, diphenoxylate (for conversion), and 
marijuana to be manufactured in the United States in 2015. The 
adjustment is necessary to provide for the estimated medical, 
scientific, research, and industrial needs of the United States, lawful 
export requirements, and the establishment and maintenance of reserve 
stocks.
    In proposing the adjustment, the Administrator has taken into 
account the following criteria in accordance with 21 CFR 1303.13: (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 and/or 
individual rates of net disposal are temporary, short term, or long 
term; (3) whether any increased demand for that class 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.

Analysis for Adjusting the Established 2015 Aggregate Production Quota 
for Difenoxin and Diphenoxylate (for Conversion)

    Since the establishment of the initial 2015 aggregate production 
quotas, the DEA has received requests from DEA registered manufacturers 
to manufacture difenoxin and diphenoxylate (for conversion) to support 
the manufacture

[[Page 18869]]

of prescription drug products approved by the Food and Drug 
Administration (FDA) for the treatment of chronic diarrhea and for the 
treatment of diarrhea associated with irritable bowel syndrome 
(IBS).\1\ These FDA approved products have not been manufactured since 
2009 due to FDA-regulated manufacturing issues and there is no existing 
generic or therapeutic equivalent.
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    \1\ Difenoxin (schedule I) is the active pharmaceutical 
ingredient in the diarrhea preparation (schedule V).
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Analysis for Adjusting the Established 2015 Aggregate Production Quota 
for Marijuana

    Since the establishment of the initial 2015 aggregate production 
quotas, the DEA has received notification from DEA registered 
manufacturers that research and product development involving 
cannabidiol, is increasing beyond that previously anticipated for 2015. 
The associated product development activities are related to process 
validation and commercialization activities, including qualification 
activities related to potential U.S. Food and Drug Administration 
submission support.
    Additionally, the DEA has also received notification from the 
National Institute on Drug Abuse (NIDA) that it required additional 
supplies of marijuana to be manufactured in 2015 to provide for ongoing 
and anticipated research efforts involving marijuana. NIDA is a 
component of the National Institutes of Health and the U.S. Department 
of Health and Human Services which 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).
    The Administrator, therefore, proposes to adjust the 2015 aggregate 
production quotas for difenoxin, diphenoxylate (for conversion), and 
marijuana, expressed in grams of anhydrous acid or base, as follows:

------------------------------------------------------------------------
                                            Previously
         Basic class-schedule I             established    Adjusted 2015
                                            2015 quota         quota
------------------------------------------------------------------------
Difenoxin...............................            50 g         9,000 g
Marijuana...............................       125,000 g       400,000 g
------------------------------------------------------------------------

------------------------------------------------------------------------
                                         Previously
      Basic class-schedule II         established 2015     Adjusted 2015
                                            quota              quota
------------------------------------------------------------------------
Diphenoxylate (for conversion)....  Zero................        75,000 g
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    Dated: April 1, 2015.
Michele M. Leonhart,
Administrator.
[FR Doc. 2015-08042 Filed 4-7-15; 8:45 am]
 BILLING CODE 4410-09-P
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