[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

[[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:

------------------------------------------------------------------------
                                            Previously
         Basic class--schedule I            established    Adjusted 2015
                                          2015 quota (g)     quota (g)
------------------------------------------------------------------------
Difenoxin...............................              50          11,000
Marijuana...............................         125,000         658,000
------------------------------------------------------------------------


------------------------------------------------------------------------
                                            Previously
        Basic class--schedule II            established    Adjusted 2015
                                          2015 quota (g)     quota (g)
------------------------------------------------------------------------
Diphenoxylate (for conversion)..........               0          75,000
------------------------------------------------------------------------



[[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