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