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Established Aggregate Production Quotas for Schedule I and II

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59980 Federal Register / Vol. 77, No. 190 / Monday, October 1, 2012 / Notices DEPARTMENT OF JUSTICE for Schedule I and II Controlled information, DEA has determined that Substances and Proposed Assessment of adjustments to the proposed aggregate Drug Enforcement Administration Annual Needs for the List I Chemicals production quotas and assessment of [Docket No. DEA–365] Ephedrine, Pseudoephedrine, and annual needs for 3,4-methylenedioxy-N- Phenylpropanolamine for 2013,’’ was methylcathinone (methylone), Established Aggregate Production published in the Federal Register (77 3,4,methylenedioxypyrovalerone Quotas for Schedule I and II Controlled FR 46519). That notice proposed the (MDPV), 4-methyl-N-methylcathinone Substances and Established 2013 aggregate production quotas for (mephedrone), N-benzylpiperazine, Assessment of Annual Needs for the each basic class of controlled substance amphetamine (for conversion), List I Chemicals Ephedrine, listed in schedules I and II and the 2013 amphetamine (for sale), hydrocodone Pseudoephedrine, and assessment of annual needs for the list (for sale), hydromorphone, Phenylpropanolamine for 2013 I chemicals ephedrine, lisdexamfetamine, methylphenidate, pseudoephedrine, and morphine (for sale), oxycodone (for AGENCY: Drug Enforcement phenylpropanolamine. All interested sale), oxymorphone (for conversion), Administration (DEA), Department of persons were invited to comment on or remifentanil, sufentanil, tapentadol, Justice. object to the proposed aggregate ephedrine (for conversion), ephedrine ACTION: Notice. production quotas and the proposed (for sale), phenylpropanolamine (for assessment of annual needs on or before sale), and pseudoephedrine (for sale) are SUMMARY: This notice establishes the September 4, 2012. warranted. This notice reflects those initial 2013 aggregate production quotas Five comments (four from DEA- adjustments. for controlled substances in schedules I registered manufacturers and one from a Regarding codeine (for conversion), and II of the Controlled Substances Act non-registrant) were received within the codeine (for sale), gamma (CSA) and assessment of annual needs published comment period, offering hydroxybutyric acid, meperidine, for the list I chemicals ephedrine, comments on a total of 20 schedule I methamphetamine, morphine (for pseudoephedrine, and and II controlled substances and one list conversion), noroxymorphone (for phenylpropanolamine. I chemical. Commenters stated that the conversion), oripavine, oxymorphone DATES: Effective Date: October 1, 2012. proposed aggregate production quotas (for sale), and phenylpropanolamine (for for amphetamine (for conversion), conversion), DEA has determined that FOR FURTHER INFORMATION CONTACT: John W. Partridge, Executive Assistant, Office amphetamine (for sale), codeine (for the proposed initial 2013 aggregate conversion), codeine (for sale), gamma production quotas and assessment of of Diversion Control, Drug Enforcement hydroxybutyric acid, hydrocodone (for annual needs are sufficient to meet the Administration, 8701 Morrissette Drive, sale), hydromorphone, current 2013 estimated medical, Springfield, VA 22152, Telephone: (202) lisdexamfetamine, meperidine, scientific, research, and industrial needs 307–4654. methamphetamine, methylphenidate, of the United States. This notice SUPPLEMENTARY INFORMATION: Section morphine (for conversion), morphine finalizes these aggregate production 306 of the CSA (21 U.S.C. 826) requires (for sale), noroxymorphone (for quotas at the same amounts as the Attorney General to establish conversion), oripavine, oxycodone (for proposed. aggregate production quotas for each sale), oxymorphone (for conversion), DEA also specifically considered that basic class of controlled substance listed oxymorphone (for sale), remifentanil, inventory allowances granted to in schedules I and II and for the list I and sufentanil were insufficient to individual manufacturers may not chemicals ephedrine, pseudoephedrine, provide for the estimated medical, always result in the availability of and phenylpropanolamine. This scientific, research, and industrial needs sufficient quantities to maintain an responsibility has been delegated to the of the United States, export adequate reserve stock pursuant to 21 Administrator of the DEA by 28 CFR requirements, and the establishment U.S.C. 826(a), as intended. See 21 CFR 0.100. The Administrator, in turn, has and maintenance of reserve stocks. One 1303.24. This would be concerning if a redelegated this function to the Deputy commenter stated that the proposed natural disaster or other unforeseen Administrator pursuant to 28 CFR assessment of annual needs quota for event resulted in substantial disruption 0.104. phenylpropanolamine (for conversion) to the amount of controlled substances The 2013 aggregate production quotas was insufficient to provide for the available to provide for legitimate and assessment of annual needs estimated medical, scientific, research, public need. As such, DEA included in represent those quantities of schedule I and industrial needs of the United all schedule II aggregate production and II controlled substances and the list States, export requirements, and the quotas, and certain schedule I aggregate I chemicals ephedrine, establishment and maintenance of production quotas, an additional 25% of pseudoephedrine, and reserve stocks. the estimated medical, scientific, and phenylpropanolamine to be In determining the 2013 aggregate research needs as part of the amount manufactured in the United States in production quotas and assessment of necessary to ensure the establishment 2013 to provide for the estimated annual needs, DEA has taken into and maintenance of reserve stocks. The medical, scientific, research, and consideration the above comments established aggregate production quotas industrial needs of the United States, along with the factors set forth at 21 reflect these included amounts. This lawful export requirements, and the CFR 1303.11 and 21 CFR 1315.11, in action will not affect the ability of establishment and maintenance of accordance with 21 U.S.C. 826(a), and manufacturers to maintain inventory reserve stocks. These quotas include other relevant factors, including the allowances as specified by regulation. imports of ephedrine, pseudoephedrine, consideration of 2012 manufacturing DEA expects that maintaining this and phenylpropanolamine but do not quotas, current 2012 sales and reserve in certain established aggregate include imports of controlled inventories, 2013 export requirements, production quotas will mitigate adverse substances for use in industrial industrial use, additional applications public effects if an unforeseen event processes. for quotas, as well as information on resulted in substantial disruption to the On August 3, 2012, a notice titled, research and product development amount of controlled substances ‘‘Proposed Aggregate Production Quotas requirements. Based on this available to provide for legitimate VerDate Mar<15>2010 16:48 Sep 28, 2012 Jkt 226001 PO 00000 Frm 00093 Fmt 4703 Sfmt 4703 E:\FR\FM\01OCN1.SGM 01OCN1 mstockstill on DSK4VPTVN1PROD with NOTICES Federal Register / Vol. 77, No. 190 / Monday, October 1, 2012 / Notices 59981 public need, as determined by DEA. Deputy Administrator hereby needs for the list I chemicals ephedrine, DEA does not anticipate utilizing the establishes the 2013 aggregate pseudoephedrine, and reserve in the absence of these production quotas for the following phenylpropanolamine, expressed in circumstances. schedule I and II controlled substances grams of anhydrous acid or base, as In accordance with 21 U.S.C. 826, 21 and the 2013 assessment of annual follows: CFR 1303.11, and 21 CFR 1315.11, the Established Basic class 2013 quotas Schedule I 1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201) ...................................................................................................................... 45 g 1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694) ..................................................................................................................... 45 g 1-[1-(2-Thienyl)cyclohexyl]piperidine ............................................................................................................................................. 5 g 1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH–200) ........................................................................................................ 45 g 1-Butyl-3-(1-naphthoyl)indole (JWH–073) ..................................................................................................................................... 45 g 1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole (SR–18 and RCS–8) ................................................................................... 45 g 1-Hexyl-3-(1-naphthoyl)indole (JWH–019) .................................................................................................................................... 45 g 1-Methyl-4-phenyl-4-propionoxypiperidine ..................................................................................................................................... 2 g 1-Pentyl-3-(1-naphthoyl)indole (JWH–018 and AM678) ............................................................................................................... 45 g 1-Pentyl-3-(2-chlorophenylacetyl)indole (JWH–203) ..................................................................................................................... 45 g 1-Pentyl-3-(2-methoxyphenylacetyl)indole
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