Quotas - 2016
[Federal Register Volume 81, Number 193 (Wednesday, October 5, 2016)]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-23988]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-443F]
Established 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 2017
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final order.
SUMMARY: This final order establishes the initial 2017 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.
DATES: Effective October 5, 2016.
FOR FURTHER INFORMATION CONTACT: Michael J. Lewis, Diversion Control Division, Drug Enforcement Administration, 8701 Morrissette Drive, Springfield, VA 22152, Telephone: (202) 598-6812.
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 the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. The Attorney General has delegated this function to the Administrator of the DEA pursuant to 28 CFR 0.100.
The 2017 aggregate production quotas and assessment of annual needs represent those quantities of schedule I and II controlled substances and the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine that may be manufactured in the United States in 2017 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. These quotas include imports of ephedrine, pseudoephedrine, and phenylpropanolamine, but do not include imports of controlled substances for use in industrial processes.
On July 22, 2016, a notice titled "Proposed 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 2017" was published in the Federal Register. 81 FR 47821. This notice proposed the 2017 aggregate production quotas for each basic class of controlled substance listed in schedules I and II and the 2017 assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. All interested persons were invited to comment on or object to the proposed aggregate production quotas and the proposed assessment of annual needs on or before August 22, 2016.
Thirteen comments were received from five DEA-registered manufacturers and four non-DEA registered entities within the published comment period regarding 22 different schedule I and II controlled substances. The DEA received two comments from two non-DEA registered entities within the published comment period regarding the proposed assessment of annual needs for the list I chemical ephedrine (for sale). Commenters stated that the proposed aggregate production quotas for acetyl fentanyl, AH-7921, amphetamine (for conversion), amphetamine (for sale), beta-hydroxythiofentanyl, butyryl fentanyl, cocaine, codeine (for conversion), codeine (for sale), dihydrocodeine, ecgonine, hydrocodone (for sale), hydromorphone, levorphanol, lisdexamfetamine, marihuana, meperidine, methylphenidate, nabilone, opium tincture, oxycodone (for sale), and sufentanil, as well as, the proposed assessment of annual needs for ephedrine (for sale) were insufficient to provide for the estimated medical, scientific, research, and industrial needs
of the United States, export requirements, and the establishment and maintenance of reserve stocks.
The DEA received one comment from a DEA-registrant and three comments by non-DEA registered entities regarding the proposed removal of the additional 25% of the estimated medical, scientific, and research needs for the United States. Two of the commenters requested that the DEA continue to include the additional 25%, one commenter requested transparency in the process of setting aggregate production quotas, and the last commenter agreed with the DEA that the additional 25% should not be included in aggregate production quotas values. The DEA has considered these comments, as well as the ones for specific controlled substances and ephedrine (for sale), in establishing the 2017 aggregate production quotas and assessment of annual needs.
Determination of 2017 Aggregate Production Quotas and Assessment of Annual Needs
In determining the 2017 aggregate production quotas and assessment of annual needs, the DEA has taken into consideration the above comments along with the factors set forth in 21 CFR 1303.11 and 21 CFR 1315.11, in accordance with 21 U.S.C. 826(a), and other relevant factors, including the 2016 manufacturing quotas, current 2016 sales and inventories, anticipated 2017 export requirements, industrial use, and additional applications for 2017 quotas, as well as information on research and product development requirements. Based on this information, the DEA has removed the additional 25% from the aggregate production quotas before determining that adjustments to the proposed aggregate production quotas for 4-anilino-n-phenethyl-piperidine, amphetamine (for conversion), amphetamine (for sale), cocaine, dihydrocodeine, ecgonine, etorphine hydrochloride, hydromorphone, levorphanol, lysergic acid dimethylamide, nabilone, opium tincture, and oripavine are warranted. Adjustment to the proposed annual assessment of needs for ephedrine (for sale) was also determined to be warranted. This final order reflects those adjustments.
Regarding acetyl fentanyl, AH-7921, beta-hydroxythiofentanyl, butyryl fentanyl, codeine (for conversion), codeine (for sale), hydrocodone (for sale), lisdexamfetamine, marihuana, meperidine, methylphenidate, oxycodone (for sale), and sufentanil, the DEA has determined that the proposed aggregate production quotas are sufficient to provide for the 2017 estimated medical, scientific, research, and industrial needs of the United States, export requirements, and the establishment and maintenance of reserve stocks. This final order establishes these aggregate production quotas at the same amounts as proposed.
In accordance with 21 U.S.C. 826, 21 CFR 1303.11, and 21 CFR 1315.11, the Administrator hereby establishes the 2017 aggregate production quotas for the following schedule I and II controlled substances and the 2017 assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, expressed in grams of anhydrous acid or base, as follows:
|1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole (SR-18 and RCS-8)||45|
|1-Pentyl-3-(1-naphthoyl)indole (JWH-018 and AM678)||35|
|1-Pentyl-3-[(4-methoxy)-benzoyl]indole (SR-19, RCS-4)||30|
|2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25B-NBOMe; 2C-B-NBOMe; 25B; Cimbi-36)||25|
|2-(4-Chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25C-NBOMe; 2C-C-NBOMe; 25C; Cimbi-82)||25|
|2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25I-NBOMe; 2C-I-NBOMe; 25I; Cimbi-5)||5|
|5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP-47,497 C8-homolog)||40|
|Lysergic acid diethylamide (LSD)||15|
|N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide (acetyl fentanyl)||100|
|Quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate (5-fluoro-PB-22; 5F-PB-22)||20|
|Quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate (PB-22; QUPIC)||20|
|Amphetamine (for conversion)||12,000,000|
|Amphetamine (for sale)||42,400,000|
|Codeine (for conversion)||40,000,000|
|Codeine (for sale)||45,000,000|
|Diphenoxylate (for conversion)||15,000|
|Diphenoxylate (for sale)||820,000|
|Hydrocodone (for conversion)||122,000|
|Hydrocodone (for sale)||58,410,000|
|Methadone (for sale)||23,700,000|
|[900,000 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 600,000 grams for methamphetamine mostly for conversion to a schedule III product; and 39,100 grams for methamphetamine (for sale)]|
|Morphine (for conversion)||27,300,000|
|Morphine (for sale)||41,000,000|
|Noroxymorphone (for conversion)||17,700,000|
|Noroxymorphone (for sale)||400,000|
|Oxycodone (for conversion)||2,610,000|
|Oxycodone (for sale)||108,510,000|
|Oxymorphone (for conversion)||22,300,000|
|Oxymorphone (for sale)||4,200,000|
|List I Chemicals|
|Ephedrine (for conversion)||50,000|
|Ephedrine (for sale)||5,360,000|
|Phenylpropanolamine (for conversion)||15,000,000|
|Phenylpropanolamine (for sale)||8,500,000|
|Pseudoephedrine (for conversion)||40|
|Pseudoephedrine (for sale)||200,000,000|
The Administrator also establishes aggregate production quotas for all other schedule I and II controlled substances included in 21 CFR 1308.11 and 1308.12 at zero. In accordance with 21 CFR 1303.13 and 21 CFR 1315.13, upon consideration of the relevant factors, the Administrator may adjust the 2017 aggregate production quotas and assessment of annual needs as needed.
Dated: September 26, 2016.
[FR Doc. 2016-23988 Filed 10-4-16; 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 Publishing Office (GPO).