Quotas - 2014

[Federal Register Volume 79, Number 164 (Monday, August 25, 2014)]
[Notices]
[Pages 50700-50704]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-20137]

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-378]

Final Adjusted Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2014

AGENCY: Drug Enforcement Administration (DEA), Department of Justice (DOJ).

ACTION: Notice.

SUMMARY: This notice establishes the final adjusted 2014 aggregate production quotas for controlled substances in schedules I and II of the Controlled Substances Act (CSA) and the assessment of annual needs for the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, as well as the 2014 aggregate production quotas for three recently temporarily controlled substances.

DATES: Effective August 25, 2014.

FOR FURTHER INFORMATION CONTACT: Imelda Paredes, Executive Assistant, Office of Diversion Control, Drug Enforcement Administration, 8701 Morrissette Drive, Springfield, VA 22152, Telephone: (202) 598-6812.

SUPPLEMENTARY INFORMATION:

Background

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 and for ephedrine, pseudoephedrine, and phenylpropanolamine. This responsibility has been delegated to the Administrator of the Drug Enforcement Administration (DEA) through 28 CFR 0.100(b). The Administrator, in turn, has redelegated this function to the Deputy Administrator, pursuant to 28 CFR pt. 0 subpt. R, App.

The DEA published the 2014 established aggregate production quotas for controlled substances in schedules I and II and for the assessment of annual needs for the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine in the Federal Register (78 FR 55099) on September 9, 2013. That notice stated that the Deputy Administrator would adjust, as needed, the established aggregate production quotas in 2014 in accordance with 21 CFR 1303.13 and 21 CFR 1315.13. The 2014 proposed adjusted aggregate production quotas for controlled substances in schedules I and II and assessment of annual needs for the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine were subsequently published in the Federal Register on June 12, 2014 (79 FR 33780) in consideration of the outlined criteria. All interested persons were invited to comment on or object to the proposed adjusted aggregate production quotas and assessment of annual needs on or before July 14, 2014.

Analysis for Final Adjusted 2014 Aggregate Production Quotas and Assessment of Annual Needs

Consideration has been given to the criteria outlined in the June 12, 2014, notice of proposed adjusted aggregate production quotas and assessment of annual needs, in accordance with 21 CFR 1303.13 and 21 CFR 1315.13. Five companies submitted timely comments regarding a total of 11 schedule I and II controlled substances. Comments received proposed that the aggregate production quotas for 4-anilino-phenethyl- 4-piperidine (ANPP), codeine (for sale), diphenoxylate, hydromorphone, levorphanol, morphine (for conversion), oripavine, oxycodone (for sale), oxymorphone (for conversion), oxymorphone (for sale), and tetrahydrocannabinols were insufficient to provide for the estimated medical, scientific, research, and industrial needs of the United States, for export requirements, and for the establishment and maintenance of reserve stocks. The DEA did not receive any comments for the proposed adjustments to the 2014 assessment of annual needs for ephedrine, pseudoephedrine, and phenylpropanolamine.

The DEA has taken into consideration the above comments along with the relevant 2013 year-end inventories, initial 2014 manufacturing and import quotas, 2014 export requirements, actual and projected 2014 sales, research and product development requirements, and the additional applications received. Based on all of the above, the Deputy Administrator has determined that the proposed adjusted 2014 aggregate production quotas and assessment of annual needs for opium tincture, oripavine, and ephedrine (for sale) required additional consideration and hereby further adjusts the 2014 aggregate production quota and assessment of annual needs for these substances. Regarding 4-anilino- phenethyl-4-piperidine (ANPP), codeine (for sale), diphenoxylate, hydromorphone, levorphanol, morphine (for conversion), oxycodone (for sale), oxymorphone (for conversion), oxymorphone (for sale), and tetrahydrocannabinols the Deputy Administrator hereby determines that the proposed adjusted 2014 aggregate production quotas and assessment of annual needs for these substances and List I chemicals as published on June 12, 2014 (79 FR 33780) are sufficient to meet the current 2014 estimated medical, scientific, research, and industrial needs of the United States and to provide for adequate reserve stock.

As described in the previously published notice establishing the 2014 aggregate production quotas and assessment of annual needs, the DEA has specifically considered that inventory allowances granted to individual manufacturers may not always result in the availability of sufficient quantities to maintain an adequate reserve stock pursuant to 21 U.S.C. 826(a), as intended. See 21 CFR 1303.24. This would be concerning if a natural disaster or other unforeseen event resulted in substantial disruption to the amount of controlled substances available to provide for legitimate public need. As such, the DEA has included in all proposed revised schedule II aggregate production quotas, and certain schedule I aggregate production quotas, an additional 25% of the estimated medical, scientific, and research needs as part of the amount necessary to ensure the establishment and maintenance of reserve stocks. The resulting revised established aggregate production quota will reflect these included amounts. This action will not affect the ability of manufacturers to maintain inventory allowances as specified by regulation. The DEA expects that maintaining this reserve in certain established aggregate production quotas will mitigate adverse public effects if an unforeseen event results in the substantial disruption to the amount of controlled substances available to provide for legitimate public need, as determined by the DEA. The DEA does not anticipate utilizing the reserve in the absence of these circumstances.

Pursuant to the above, the Deputy Administrator hereby finalizes the 2014 aggregate production quotas for the following schedule I and II controlled substances and the 2014 assessment of annual needs for the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, expressed in grams of anhydrous acid or base, as follows:

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Aggregate production quotas for all other schedule I and II controlled substances included in 21 CFR 1308.11 and 1308.12 remain at zero.

Dated: August 15, 2014.

Thomas M. Harrigan,
Deputy Administrator.

[FR Doc. 2014-20137 Filed 8-22-14; 8:45 am]

BILLING CODE 4410-09-P

NOTICE: This is an unofficial version. An official version of this publication may be obtained directly from the Government Printing Office (GPO).