[Federal Register Volume 80, Number 116 (Wednesday, June 17, 2015)]
[Notices]
[Pages 34693-34695]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-14910]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-411F]
Adjusted Aggregate Production Quotas for Difenoxin, Diphenoxylate
(for Conversion), and Marijuana
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final order.
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[[Page 34694]]
SUMMARY: This final order establishes the adjusted 2015 aggregate
production quotas for difenoxin, diphenoxylate (for conversion), and
marijuana.
DATES: This order is effective June 17, 2015.
FOR FURTHER INFORMATION CONTACT: John R. Scherbenske, Office of
Diversion Control, Drug Enforcement Administration, 8701 Morrissette
Drive, Springfield, Virginia 22152, Telephone: (202) 598-6812.
SUPPLEMENTARY INFORMATION:
Legal Authority
The 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 purposes 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 Controlled Substances Act (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 for annual need on September 8, 2014 (79 FR 53216).
That notice stipulated that, as provided for in 21 CFR 1303.13 and 21
CFR 1315.13, 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 proposed 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 notice of proposed adjustment was published
in the Federal Register on Wednesday, April 8, 2015 (80 FR 18867). All
interested persons were invited to comment on or object to the proposed
adjusted aggregate production quotas on or before May 8, 2015.
Comments Received
Two companies, one institution of higher education, and five
private citizens submitted timely comments in response to the proposed
adjustment of these three controlled substances. The comments from the
institution of higher education and one of the private citizens were in
support of the proposed increases for these three controlled
substances. The two companies and one private citizen supported the
proposed adjustment and requested further increases to the APQs to
support research, additional product development efforts, and increases
in manufacturing demands. Further comments received from three private
citizens were outside the scope of the proposed APQ notice. The DEA
appreciates the support for this adjusted 2015 aggregate production
quota for difenoxin, diphenoxylate (for conversion), and marijuana,
which is intended to provide for the estimated scientific, research,
and industrial needs of the United States.
Determination for Adjusting the Aggregate Production Quotas for
Difenoxin, Diphenoxylate (for Conversion), and Marijuana
In accordance with 21 CFR 1303.13, the DEA has taken into
consideration the above comments along with the relevant 2014 year-end
inventories, initial 2015 manufacturing quotas, 2015 export
requirements, actual and projected 2015 sales, research and product
development requirements, and information derived from additional
applications for manufacturing quota received since the April 8, 2015
publication of the notice of proposed adjustments to the aggregate
production quotas for difenoxin, diphenoxylate (for conversion), and
marijuana. Upon consideration of the above, the Acting Administrator
has determined to increase the 2015 aggregate production quotas for
difenoxin and marijuana beyond that which was previously proposed.
Regarding the aggregate production quota for diphenoxylate (for
conversion), the Acting Administrator has determined that the proposed
aggregate production quota adjustment for this substance is sufficient
to meet the current 2015 estimated medical, scientific, research, and
industrial needs of the United States and to provide for adequate
reserve stock.
Pursuant to the above, the Acting Administrator hereby establishes
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 (g) quota (g)
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Difenoxin............................... 50 11,000
Marijuana............................... 125,000 658,000
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Previously
Basic class--schedule II established Adjusted 2015
2015 quota (g) quota (g)
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Diphenoxylate (for conversion).......... 0 75,000
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[[Page 34695]]
Dated: June 11, 2015.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2015-14910 Filed 6-16-15; 8:45 am]
BILLING CODE 4410-09-P