Controlled Substances: Final Adjusted Aggregate Production Quotas for 2011, 77016-77019 [2011-31621]

Download as PDF srobinson on DSK4SPTVN1PROD with NOTICES 77016 Federal Register / Vol. 76, No. 237 / Friday, December 9, 2011 / Notices of this notice and report are being provided to the Committee on Government Reform of the House of Representatives, the Committee on Homeland Security and Governmental Affairs of the Senate, and the Office of Management and Budget. Authority: This matching program is being conducted under the authority of the Internal Revenue Code (IRC) 6103(m)(2). This provides for disclosure, upon written request, of a taxpayer’s mailing address for use by officers, employees, or agents of a Federal agency for the purpose of locating such taxpayer to collect or compromise a Federal claim against the taxpayer in accordance with sections 3711, 3717, and 3718 of title 31 of the United States Code, statutory provisions which authorize DOJ to collect debts on behalf of the United States through litigation. Objectives To Be Met by the Matching Program: The purpose of this program is to provide DOJ with the most current addresses of taxpayers to notify debtors of legal actions that may be taken by DOJ and the rights afforded them in the litigation to enforce collection of debts owed to the United States. Records To Be Matched: DOJ will provide records from the Debt Collection Management System, JUSTICE/JMD–006, last published in its entirety at 58 FR 60058–60060 (November 12, 1993), and from the Debt Collection Enforcement System, JUSTICE/USA–015, last published in its entirety at 71 FR 42118–42122 (July 25, 2006). These systems of records contain information on persons who owe debts to the United States and whose debts have been referred to the DOJ for litigation and/or enforced collection. DOJ records will be matched against records contained in the Privacy Act System of Records: Customer Account Data Engine (CADE) Individual Master File (IMF), Treasury/IRS 24.030, last published at 73 FR 13304 (March 12, 2008). This system of records, among other information, contains the taxpayer’s name, Social Security Number (SSN), and most recent address known by IRS. Categories of Records/Individuals Involved: DOJ will submit the nine-digit Social Security Number (SSN) and four character Name Control (the first four letters of the surname) of each individual whose current address is requested. IRS will provide an address for each taxpayer whose SSN and Name Control matches the record submitted by DOJ or a code explaining that no match was found on the IMF. Notice Procedures: IRS provides direct notice to taxpayers in the VerDate Mar<15>2010 18:35 Dec 08, 2011 Jkt 226001 instructions to Forms 1040, 1040A, and 1040EZ, and constructive notice in the Federal Register system of records notice, that information provided on U.S. Individual Income Tax Returns may be given to other Federal agencies, as provided by law. For the records involved in this match, both IRS and DOJ have provided constructive notice to records subjects through the publication, in the Federal Register, of system of record notices that contain routine uses permitting disclosures for this matching program. Address for Receipt of Public Comments or Inquiries: Interested persons are invited to submit written comments regarding this notice to Holley B. O’Brien, Director, Debt Collection Management Staff, Justice Management Division, 145 N St. NE., Rm 5E.101, Washington, DC 20530. Lee Lofthus, Assistant Attorney General for Administration. [FR Doc. 2011–31673 Filed 12–8–11; 8:45 am] BILLING CODE 4410–NW–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–343F] Controlled Substances: Final Adjusted Aggregate Production Quotas for 2011 Drug Enforcement Administration (DEA), Department of Justice. ACTION: Notice. AGENCY: This notice establishes final adjusted 2011 aggregate production quotas for controlled substances in Schedules I and II of the Controlled Substances Act (CSA). FOR FURTHER INFORMATION CONTACT: John W. Partridge, Chief, Liaison and Policy Section, Drug Enforcement Administration, 8701 Morrissette Drive, Springfield, VA 22152, Telephone: (202) 307–4564. SUPPLEMENTARY INFORMATION: SUMMARY: Background Section 306 of the Controlled Substances Act (CSA) (21 U.S.C. 826) requires that the Attorney General establish aggregate production quotas for each basic class of controlled substance listed in Schedules I and II. This responsibility has been delegated to the Administrator of the DEA by 28 CFR 0.100. In accordance with 21 U.S.C. 826 and 21 CFR 1303.11, DEA published in the Federal Register on December 20, 2010, notice of the PO 00000 Frm 00083 Fmt 4703 Sfmt 4703 established 2011 aggregate production quotas for controlled substances in Schedules I and II (75 FR 79404). That notice stated that the Administrator would adjust, as needed, the established aggregate production quotas in 2011 as provided for in 21 CFR 1303.13. The 2011 proposed adjusted aggregate production quotas were subsequently published in the Federal Register on September 14, 2011, (76 FR 56810) in consideration of the outlined criteria. All interested persons were invited to comment on or object to the proposed adjusted aggregate production quotas on or before October 14, 2011. The September 14, 2011, proposed adjusted aggregate production quotas also included proposed aggregate production quotas for five newly scheduled substances. On March 1, 2011, the DEA Administrator published a final order (76 FR 11075) which temporarily placed five synthetic cannabinoids in Schedule I: 1-[2-(4Morpholinyl)ethyl]-3-(1naphthoyl)indole (JWH-200); 1-Butyl-3(1-naphthoyl)indole (JWH-073); 1Pentyl-3-(1-naphthoyl)indole (JWH018); 5-(1,1-Dimethylheptyl)-2-[(1R,3S)3-hydroxycyclohexyl]-phenol; and 5(1,1-Dimethyloctyl)-2-[(1R,3S)-3hydroxycyclohexyl]-phenol. That final order stated that quotas for the five substances would be ‘‘established based on registrations granted and quota applications received pursuant to part 1303 of Title 21 of the Code of Federal Regulations.’’ 76 FR 11077. Aggregate production quotas for these newly scheduled substances had not been previously established and were initially proposed in the above referenced notice published in the Federal Register on September 14, 2011 (76 FR 56810). All interested persons were invited to comment on or object to the proposed aggregate production quotas on or before October 14, 2011. Analysis for Final Adjusted 2011 Aggregate Production Quotas Consideration has been given to the criteria outlined in the September 14, 2011, notice of proposed adjusted aggregate production quotas in accordance with 21 CFR 1303.13. In addition, six companies, four DEA registered manufacturers and two nonregistrants, submitted timely comments regarding a total of 22 Schedule I and II controlled substances. Comments received proposed that the aggregate production quotas for 4-anilino-Nphenethyl-4-piperidine (ANPP), alfentanil, amphetamine (for sale), diphenoxylate, fentanyl, gamma hydroxybutyric acid, hydrocodone, meperidine, methadone, methadone E:\FR\FM\09DEN1.SGM 09DEN1 Federal Register / Vol. 76, No. 237 / Friday, December 9, 2011 / Notices intermediate, methylphenidate, morphine (for conversion), morphine (for sale), noroxymorphone (for conversion), noroxymorphone (for sale), oxycodone (for sale), oxymorphone (for conversion), oxymorphone (for sale), pentobarbital, secobarbital, sufentanil, and thebaine 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. DEA has taken into consideration the above comments along with the relevant 2010 year-end inventories, initial 2011 manufacturing quotas, 2011 export requirements, actual and projected 2011 sales, research and product development requirements, and additional applications received. Based on all of the above, the Administrator has determined that the proposed adjusted 2011 aggregate production quotas for alfentanil, diphenoxylate, gamma hydroxybutyric acid, meperidine, and pentobarbital required additional consideration and hereby further adjusts the 2011 aggregate production quotas for those substances. Regarding 4-anilino-N-phenethyl-4piperidine (ANPP), amphetamine (for sale), fentanyl, hydrocodone, methadone, methadone intermediate, methylphenidate, morphine (for conversion), morphine (for sale), noroxymorphone (for conversion), noroxymorphone (for sale), oxycodone (for sale), oxymorphone (for conversion), oxymorphone (for sale), secobarbital, sufentanil, and thebaine, the Administrator hereby determines that the proposed adjusted 2011 aggregate production quotas for these substances as published on September 14, 2011, at 76 FR 56810 are sufficient to meet the current 2011 estimated medical, scientific, research, and industrial needs of the United States and to provide for adequate inventories. Pursuant to the above, the Administrator hereby establishes the 2011 final aggregate production quotas for Schedule I and II controlled substances, including the five newly scheduled substances previously referenced, expressed in grams of anhydrous acid or base, as follows: Final adjusted 2011 quotas srobinson on DSK4SPTVN1PROD with NOTICES Basic class—Schedule I 1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH–200) ............................................................................................................ 1-Butyl-3-(1-naphthoyl)indole (JWH–073) ......................................................................................................................................... 1-Methyl-4-phenyl-4-propionoxypiperidine ......................................................................................................................................... 1-Pentyl-3-(1-naphthoyl)indole (JWH–018) ....................................................................................................................................... 2,5-Dimethoxyamphetamine .............................................................................................................................................................. 2,5-Dimethoxy-4-ethylamphetamine (DOET) .................................................................................................................................... 2,5-Dimethoxy-4-n-propylthiophenethylamine ................................................................................................................................... 3-Methylfentanyl ................................................................................................................................................................................. 3-Methylthiofentanyl ........................................................................................................................................................................... 3,4-Methylenedioxyamphetamine (MDA) .......................................................................................................................................... 3,4-Methylenedioxy-N-ethylamphetamine (MDEA) ........................................................................................................................... 3,4-Methylenedioxymethamphetamine (MDMA) ............................................................................................................................... 3,4,5-Trimethoxyamphetamine .......................................................................................................................................................... 4-Bromo-2,5-dimethoxyamphetamine (DOB) .................................................................................................................................... 4-Bromo-2,5-dimethoxyphenethylamine (2–CB) ............................................................................................................................... 4-Methoxyamphetamine .................................................................................................................................................................... 4-Methylaminorex .............................................................................................................................................................................. 4-Methyl-2,5-dimethoxyamphetamine (DOM) .................................................................................................................................... 5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol ....................................................................................................... 5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol ......................................................................................................... 5-Methoxy-3,4-methylenedioxyamphetamine .................................................................................................................................... 5-Methoxy-N,N-diisopropyltryptamine ................................................................................................................................................ Acetyl-alpha-methylfentanyl ............................................................................................................................................................... Acetyldihydrocodeine ......................................................................................................................................................................... Acetylmethadol .................................................................................................................................................................................. Allylprodine ........................................................................................................................................................................................ Alphacetylmethadol ............................................................................................................................................................................ Alpha-ethyltryptamine ........................................................................................................................................................................ Alphameprodine ................................................................................................................................................................................. Alphamethadol ................................................................................................................................................................................... Alpha-methylfentanyl ......................................................................................................................................................................... Alpha-methylthiofentanyl .................................................................................................................................................................... Alpha-methyltryptamine (AMT) .......................................................................................................................................................... Aminorex ............................................................................................................................................................................................ Benzylmorphine ................................................................................................................................................................................. Betacetylmethadol ............................................................................................................................................................................. Beta-hydroxy-3-methylfentanyl .......................................................................................................................................................... Beta-hydroxyfentanyl ......................................................................................................................................................................... Betameprodine ................................................................................................................................................................................... Betamethadol ..................................................................................................................................................................................... Betaprodine ........................................................................................................................................................................................ Bufotenine .......................................................................................................................................................................................... Cathinone ........................................................................................................................................................................................... Codeine-N-oxide ................................................................................................................................................................................ Diethyltryptamine ............................................................................................................................................................................... Difenoxin ............................................................................................................................................................................................ Dihydromorphine ................................................................................................................................................................................ Dimethyltryptamine ............................................................................................................................................................................ Gamma-hydroxybutyric acid .............................................................................................................................................................. Heroin ................................................................................................................................................................................................ VerDate Mar<15>2010 18:35 Dec 08, 2011 Jkt 226001 PO 00000 Frm 00084 Fmt 4703 Sfmt 4703 77017 E:\FR\FM\09DEN1.SGM 09DEN1 45 45 2 45 2 2 2 2 2 22 15 22 2 2 2 77 2 2 68 53 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 3 4 602 2 50 3,608,000 7 5,772,000 20 g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g 77018 Federal Register / Vol. 76, No. 237 / Friday, December 9, 2011 / Notices Final adjusted 2011 quotas Basic class—Schedule I Hydromorphinol .................................................................................................................................................................................. Hydroxypethidine ............................................................................................................................................................................... Ibogaine ............................................................................................................................................................................................. Lysergic acid diethylamide (LSD) ...................................................................................................................................................... Marihuana .......................................................................................................................................................................................... Mescaline ........................................................................................................................................................................................... Methaqualone .................................................................................................................................................................................... Methcathinone ................................................................................................................................................................................... Methyldihydromorphine ...................................................................................................................................................................... Morphine-N-oxide .............................................................................................................................................................................. N-Benzylpiperazine ............................................................................................................................................................................ N,N-Dimethylamphetamine ................................................................................................................................................................ N-Ethylamphetamine ......................................................................................................................................................................... N-Hydroxy-3,4-methylenedioxyamphetamine .................................................................................................................................... Noracymethadol ................................................................................................................................................................................. Norlevorphanol ................................................................................................................................................................................... Normethadone ................................................................................................................................................................................... Normorphine ...................................................................................................................................................................................... Para-fluorofentanyl ............................................................................................................................................................................. Phenomorphan .................................................................................................................................................................................. Pholcodine ......................................................................................................................................................................................... Psilocybin ........................................................................................................................................................................................... Psilocyn .............................................................................................................................................................................................. Tetrahydrocannabinols ...................................................................................................................................................................... Thiofentanyl ....................................................................................................................................................................................... Tilidine ................................................................................................................................................................................................ Trimeperidine ..................................................................................................................................................................................... 2 2 5 16 21,000 5 10 4 2 605 2 2 2 2 2 52 2 18 2 2 2 2 2 393,000 2 10 2 g g g g g g g g g g g g g g g g g g g g g g g g g g g srobinson on DSK4SPTVN1PROD with NOTICES Basic class—Schedule II Final adjusted 2011 quotas 1-Phenylcyclohexylamine .................................................................................................................................................................. 1-Piperdinocyclohexanecarbonitrile ................................................................................................................................................... 4-Anilino-N-phenethyl-4-piperidine (ANPP) ....................................................................................................................................... Alfentanil ............................................................................................................................................................................................ Alphaprodine ...................................................................................................................................................................................... Amobarbital ........................................................................................................................................................................................ Amphetamine (for conversion) .......................................................................................................................................................... Amphetamine (for sale) ..................................................................................................................................................................... Cocaine .............................................................................................................................................................................................. Codeine (for conversion) ................................................................................................................................................................... Codeine (for sale) .............................................................................................................................................................................. Dextropropoxyphene .......................................................................................................................................................................... Dihydrocodeine .................................................................................................................................................................................. Diphenoxylate .................................................................................................................................................................................... Ecgonine ............................................................................................................................................................................................ Ethylmorphine .................................................................................................................................................................................... Fentanyl ............................................................................................................................................................................................. Glutethimide ....................................................................................................................................................................................... Hydrocodone (for sale) ...................................................................................................................................................................... Hydromorphone ................................................................................................................................................................................. Isomethadone .................................................................................................................................................................................... Levo-alphacetylmethadol (LAAM) ...................................................................................................................................................... Levomethorphan ................................................................................................................................................................................ Levorphanol ....................................................................................................................................................................................... Lisdexamfetamine .............................................................................................................................................................................. Meperidine ......................................................................................................................................................................................... Meperidine Intermediate-A ................................................................................................................................................................ Meperidine Intermediate-B ................................................................................................................................................................ Meperidine Intermediate-C ................................................................................................................................................................ Metazocine ......................................................................................................................................................................................... Methadone (for sale) ......................................................................................................................................................................... Methadone Intermediate .................................................................................................................................................................... Methamphetamine ............................................................................................................................................................................. Methylphenidate ................................................................................................................................................................................. Morphine (for conversion) .................................................................................................................................................................. Morphine (for sale) ............................................................................................................................................................................ Nabilone ............................................................................................................................................................................................. Noroxymorphone (for conversion) ..................................................................................................................................................... Noroxymorphone (for sale) ................................................................................................................................................................ Opium (powder) ................................................................................................................................................................................. Opium (tincture) ................................................................................................................................................................................. Oripavine ............................................................................................................................................................................................ 2 2 1,800,000 12,800 2 40,007 8,500,000 25,300,000 216,000 65,000,000 39,605,000 7 255,000 730,000 83,000 2 1,428,000 2 59,000,000 3,455,000 2 3 2 3,600 10,400,000 5,500,000 3 7 3 5 20,000,000 26,000,000 3,130,000 56,000,000 70,000,000 39,000,000 10,502 7,200,000 401,000 63,000 1,000,000 8,000,000 VerDate Mar<15>2010 18:35 Dec 08, 2011 Jkt 226001 PO 00000 Frm 00085 Fmt 4703 Sfmt 4703 E:\FR\FM\09DEN1.SGM 09DEN1 g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g Federal Register / Vol. 76, No. 237 / Friday, December 9, 2011 / Notices 77019 Basic class—Schedule II Final adjusted 2011 quotas Oxycodone (for conversion) .............................................................................................................................................................. Oxycodone (for sale) ......................................................................................................................................................................... Oxymorphone (for conversion) .......................................................................................................................................................... Oxymorphone (for sale) ..................................................................................................................................................................... Pentobarbital ...................................................................................................................................................................................... Phenazocine ...................................................................................................................................................................................... Phencyclidine ..................................................................................................................................................................................... Phenmetrazine ................................................................................................................................................................................... Phenylacetone ................................................................................................................................................................................... Racemethorphan ............................................................................................................................................................................... Remifentanil ....................................................................................................................................................................................... Secobarbital ....................................................................................................................................................................................... Sufentanil ........................................................................................................................................................................................... Tapentadol ......................................................................................................................................................................................... Thebaine ............................................................................................................................................................................................ 5,600,000 98,000,000 12,800,000 3,070,000 34,000,000 5 24 2 8,000,000 2 2,500 336,002 5,000 403,000 116,000,000 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: December 1, 2011. Michele M. Leonhart, Administrator. [FR Doc. 2011–31621 Filed 12–8–11; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA 350F] Final Adjusted Assessment of Annual Needs for the List I Chemicals: Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2011 Drug Enforcement Administration (DEA), Department of Justice. ACTION: Notice. AGENCY: This notice establishes the Final Adjusted 2011 assessment of annual needs for the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. DATES: Effective Date: December 9, 2011. FOR FURTHER INFORMATION CONTACT: John W. Partridge, Chief, Liaison and Policy Section, Drug Enforcement Administration (DEA), Springfield, Virginia 22152, Telephone: (202) 307– 4564. SUPPLEMENTARY INFORMATION: The 2011 assessment of annual needs represents those quantities of ephedrine, pseudoephedrine, and phenylpropanolamine which may be manufactured domestically and imported into the United States in 2011 to provide adequate supplies of each chemical for the estimated medical, scientific, research, and industrial needs of the United States, lawful export srobinson on DSK4SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 18:35 Dec 08, 2011 Jkt 226001 requirements, and the establishment and maintenance of reserve stocks of such chemicals. Section 306 of the Controlled Substances Act (CSA) (21 U.S.C. 826) requires that the Attorney General establish an assessment of annual needs for ephedrine, pseudoephedrine, and phenylpropanolamine. This responsibility has been delegated to the Administrator of the DEA by 28 CFR 0.100. On September 14, 2011, a notice entitled ‘‘Proposed Adjustment of the Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2011’’ was published in the Federal Register (76 FR 56807). That notice proposed to adjust the 2011 assessment of annual needs for ephedrine (for sale), ephedrine (for conversion), pseudoephedrine (for sale), phenylpropanolamine (for sale) and phenylpropanolamine (for conversion). All interested persons were invited to comment on or object to the proposed assessments on or before October 14, 2011. Comments Received DEA did not receive any comments to the proposed adjustment of the assessment of annual needs for ephedrine (for sale), ephedrine (for conversion), pseudoephedrine (for sale), phenylpropanolamine (for sale) and phenylpropanolamine (for conversion). Conclusion In determining the adjusted 2011 assessments, DEA used the calculation methodology previously described in the 2010 and 2011 assessment of annual needs (74 FR 60294 and 75 FR 79407 respectively). DEA considered changes in demand, changes in the national rate of net disposal, and changes in the rate of net disposal by the registrants holding individual manufacturing or PO 00000 Frm 00086 Fmt 4703 Sfmt 4703 g g g g g g g g g g g g g g g import quotas for the chemical; whether any increased demand or changes in the national and/or individual rates of net disposal are temporary, short term, or long term; whether any increased demand could be met through existing inventories, increased individual manufacturing quotas, or increased importation without increasing the assessment of annual needs; whether any decreased demand would result in excessive inventory accumulation by all persons registered to handle the particular chemical; and other factors affecting the medical, scientific, research, industrial, and importation needs in the United States, lawful export requirements, and reserve stocks, as found relevant. Other factors that DEA considered include trends as derived from information provided in applications for import, manufacturing, and procurement quotas and in import and export declarations. The inventory, acquisition (purchases), and disposition (sales) data as provided by DEA registered manufacturers and importers reflects the most current information available to DEA at the time of publication of this Notice. The underlying data used to determine the final 2011 assessment of annual needs is the same as that used in determining the proposed 2011 assessment of annual needs, as published on September 14, 2011, at 76 FR 56807. In accordance with 21 U.S.C. 826(a) and 21 CFR 1315.13, the Administrator hereby orders that the 2011 assessment of annual needs for ephedrine, pseudoephedrine, and phenylpropanolamine, expressed in kilograms of anhydrous acid or base, is adjusted and established as follows: E:\FR\FM\09DEN1.SGM 09DEN1

Agencies

[Federal Register Volume 76, Number 237 (Friday, December 9, 2011)]
[Notices]
[Pages 77016-77019]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-31621]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-343F]


Controlled Substances: Final Adjusted Aggregate Production Quotas 
for 2011

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

ACTION: Notice.

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

SUMMARY: This notice establishes final adjusted 2011 aggregate 
production quotas for controlled substances in Schedules I and II of 
the Controlled Substances Act (CSA).

FOR FURTHER INFORMATION CONTACT: John W. Partridge, Chief, Liaison and 
Policy Section, Drug Enforcement Administration, 8701 Morrissette 
Drive, Springfield, VA 22152, Telephone: (202) 307-4564.

SUPPLEMENTARY INFORMATION: 

Background

    Section 306 of the Controlled Substances Act (CSA) (21 U.S.C. 826) 
requires that the Attorney General establish aggregate production 
quotas for each basic class of controlled substance listed in Schedules 
I and II. This responsibility has been delegated to the Administrator 
of the DEA by 28 CFR 0.100. In accordance with 21 U.S.C. 826 and 21 CFR 
1303.11, DEA published in the Federal Register on December 20, 2010, 
notice of the established 2011 aggregate production quotas for 
controlled substances in Schedules I and II (75 FR 79404). That notice 
stated that the Administrator would adjust, as needed, the established 
aggregate production quotas in 2011 as provided for in 21 CFR 1303.13. 
The 2011 proposed adjusted aggregate production quotas were 
subsequently published in the Federal Register on September 14, 2011, 
(76 FR 56810) in consideration of the outlined criteria. All interested 
persons were invited to comment on or object to the proposed adjusted 
aggregate production quotas on or before October 14, 2011.
    The September 14, 2011, proposed adjusted aggregate production 
quotas also included proposed aggregate production quotas for five 
newly scheduled substances. On March 1, 2011, the DEA Administrator 
published a final order (76 FR 11075) which temporarily placed five 
synthetic cannabinoids in Schedule I: 1-[2-(4-Morpholinyl)ethyl]-3-(1-
naphthoyl)indole (JWH-200); 1-Butyl-3-(1-naphthoyl)indole (JWH-073); 1-
Pentyl-3-(1-naphthoyl)indole (JWH-018); 5-(1,1-Dimethylheptyl)-2-
[(1R,3S)-3-hydroxycyclohexyl]-phenol; and 5-(1,1-Dimethyloctyl)-2-
[(1R,3S)-3-hydroxycyclohexyl]-phenol. That final order stated that 
quotas for the five substances would be ``established based on 
registrations granted and quota applications received pursuant to part 
1303 of Title 21 of the Code of Federal Regulations.'' 76 FR 11077. 
Aggregate production quotas for these newly scheduled substances had 
not been previously established and were initially proposed in the 
above referenced notice published in the Federal Register on September 
14, 2011 (76 FR 56810). All interested persons were invited to comment 
on or object to the proposed aggregate production quotas on or before 
October 14, 2011.

Analysis for Final Adjusted 2011 Aggregate Production Quotas

    Consideration has been given to the criteria outlined in the 
September 14, 2011, notice of proposed adjusted aggregate production 
quotas in accordance with 21 CFR 1303.13. In addition, six companies, 
four DEA registered manufacturers and two non-registrants, submitted 
timely comments regarding a total of 22 Schedule I and II controlled 
substances. Comments received proposed that the aggregate production 
quotas for 4-anilino-N-phenethyl-4-piperidine (ANPP), alfentanil, 
amphetamine (for sale), diphenoxylate, fentanyl, gamma hydroxybutyric 
acid, hydrocodone, meperidine, methadone, methadone

[[Page 77017]]

intermediate, methylphenidate, morphine (for conversion), morphine (for 
sale), noroxymorphone (for conversion), noroxymorphone (for sale), 
oxycodone (for sale), oxymorphone (for conversion), oxymorphone (for 
sale), pentobarbital, secobarbital, sufentanil, and thebaine 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. DEA has taken into consideration the above comments along with 
the relevant 2010 year-end inventories, initial 2011 manufacturing 
quotas, 2011 export requirements, actual and projected 2011 sales, 
research and product development requirements, and additional 
applications received.
    Based on all of the above, the Administrator has determined that 
the proposed adjusted 2011 aggregate production quotas for alfentanil, 
diphenoxylate, gamma hydroxybutyric acid, meperidine, and pentobarbital 
required additional consideration and hereby further adjusts the 2011 
aggregate production quotas for those substances.
    Regarding 4-anilino-N-phenethyl-4-piperidine (ANPP), amphetamine 
(for sale), fentanyl, hydrocodone, methadone, methadone intermediate, 
methylphenidate, morphine (for conversion), morphine (for sale), 
noroxymorphone (for conversion), noroxymorphone (for sale), oxycodone 
(for sale), oxymorphone (for conversion), oxymorphone (for sale), 
secobarbital, sufentanil, and thebaine, the Administrator hereby 
determines that the proposed adjusted 2011 aggregate production quotas 
for these substances as published on September 14, 2011, at 76 FR 56810 
are sufficient to meet the current 2011 estimated medical, scientific, 
research, and industrial needs of the United States and to provide for 
adequate inventories.
    Pursuant to the above, the Administrator hereby establishes the 
2011 final aggregate production quotas for Schedule I and II controlled 
substances, including the five newly scheduled substances previously 
referenced, expressed in grams of anhydrous acid or base, as follows:

------------------------------------------------------------------------
                                                          Final adjusted
                Basic class--Schedule I                    2011 quotas
------------------------------------------------------------------------
1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH-              45 g
 200)..................................................
1-Butyl-3-(1-naphthoyl)indole (JWH-073)................             45 g
1-Methyl-4-phenyl-4-propionoxypiperidine...............              2 g
1-Pentyl-3-(1-naphthoyl)indole (JWH-018)...............             45 g
2,5-Dimethoxyamphetamine...............................              2 g
2,5-Dimethoxy-4-ethylamphetamine (DOET)................              2 g
2,5-Dimethoxy-4-n-propylthiophenethylamine.............              2 g
3-Methylfentanyl.......................................              2 g
3-Methylthiofentanyl...................................              2 g
3,4-Methylenedioxyamphetamine (MDA)....................             22 g
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)...........             15 g
3,4-Methylenedioxymethamphetamine (MDMA)...............             22 g
3,4,5-Trimethoxyamphetamine............................              2 g
4-Bromo-2,5-dimethoxyamphetamine (DOB).................              2 g
4-Bromo-2,5-dimethoxyphenethylamine (2-CB).............              2 g
4-Methoxyamphetamine...................................             77 g
4-Methylaminorex.......................................              2 g
4-Methyl-2,5-dimethoxyamphetamine (DOM)................              2 g
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-             68 g
 phenol................................................
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-              53 g
 phenol................................................
5-Methoxy-3,4-methylenedioxyamphetamine................              2 g
5-Methoxy-N,N-diisopropyltryptamine....................              2 g
Acetyl-alpha-methylfentanyl............................              2 g
Acetyldihydrocodeine...................................              2 g
Acetylmethadol.........................................              2 g
Allylprodine...........................................              2 g
Alphacetylmethadol.....................................              2 g
Alpha-ethyltryptamine..................................              2 g
Alphameprodine.........................................              2 g
Alphamethadol..........................................              2 g
Alpha-methylfentanyl...................................              2 g
Alpha-methylthiofentanyl...............................              2 g
Alpha-methyltryptamine (AMT)...........................              2 g
Aminorex...............................................              2 g
Benzylmorphine.........................................              2 g
Betacetylmethadol......................................              2 g
Beta-hydroxy-3-methylfentanyl..........................              2 g
Beta-hydroxyfentanyl...................................              2 g
Betameprodine..........................................              2 g
Betamethadol...........................................              2 g
Betaprodine............................................              2 g
Bufotenine.............................................              3 g
Cathinone..............................................              4 g
Codeine-N-oxide........................................            602 g
Diethyltryptamine......................................              2 g
Difenoxin..............................................             50 g
Dihydromorphine........................................      3,608,000 g
Dimethyltryptamine.....................................              7 g
Gamma-hydroxybutyric acid..............................      5,772,000 g
Heroin.................................................             20 g

[[Page 77018]]

 
Hydromorphinol.........................................              2 g
Hydroxypethidine.......................................              2 g
Ibogaine...............................................              5 g
Lysergic acid diethylamide (LSD).......................             16 g
Marihuana..............................................         21,000 g
Mescaline..............................................              5 g
Methaqualone...........................................             10 g
Methcathinone..........................................              4 g
Methyldihydromorphine..................................              2 g
Morphine-N-oxide.......................................            605 g
N-Benzylpiperazine.....................................              2 g
N,N-Dimethylamphetamine................................              2 g
N-Ethylamphetamine.....................................              2 g
N-Hydroxy-3,4-methylenedioxyamphetamine................              2 g
Noracymethadol.........................................              2 g
Norlevorphanol.........................................             52 g
Normethadone...........................................              2 g
Normorphine............................................             18 g
Para-fluorofentanyl....................................              2 g
Phenomorphan...........................................              2 g
Pholcodine.............................................              2 g
Psilocybin.............................................              2 g
Psilocyn...............................................              2 g
Tetrahydrocannabinols..................................        393,000 g
Thiofentanyl...........................................              2 g
Tilidine...............................................             10 g
Trimeperidine..........................................              2 g
------------------------------------------------------------------------


------------------------------------------------------------------------
                                                          Final adjusted
                Basic class--Schedule II                   2011 quotas
------------------------------------------------------------------------
1-Phenylcyclohexylamine................................              2 g
1-Piperdinocyclohexanecarbonitrile.....................              2 g
4-Anilino-N-phenethyl-4-piperidine (ANPP)..............      1,800,000 g
Alfentanil.............................................         12,800 g
Alphaprodine...........................................              2 g
Amobarbital............................................         40,007 g
Amphetamine (for conversion)...........................      8,500,000 g
Amphetamine (for sale).................................     25,300,000 g
Cocaine................................................        216,000 g
Codeine (for conversion)...............................     65,000,000 g
Codeine (for sale).....................................     39,605,000 g
Dextropropoxyphene.....................................              7 g
Dihydrocodeine.........................................        255,000 g
Diphenoxylate..........................................        730,000 g
Ecgonine...............................................         83,000 g
Ethylmorphine..........................................              2 g
Fentanyl...............................................      1,428,000 g
Glutethimide...........................................              2 g
Hydrocodone (for sale).................................     59,000,000 g
Hydromorphone..........................................      3,455,000 g
Isomethadone...........................................              2 g
Levo-alphacetylmethadol (LAAM).........................              3 g
Levomethorphan.........................................              2 g
Levorphanol............................................          3,600 g
Lisdexamfetamine.......................................     10,400,000 g
Meperidine.............................................      5,500,000 g
Meperidine Intermediate-A..............................              3 g
Meperidine Intermediate-B..............................              7 g
Meperidine Intermediate-C..............................              3 g
Metazocine.............................................              5 g
Methadone (for sale)...................................     20,000,000 g
Methadone Intermediate.................................     26,000,000 g
Methamphetamine........................................      3,130,000 g
Methylphenidate........................................     56,000,000 g
Morphine (for conversion)..............................     70,000,000 g
Morphine (for sale)....................................     39,000,000 g
Nabilone...............................................         10,502 g
Noroxymorphone (for conversion)........................      7,200,000 g
Noroxymorphone (for sale)..............................        401,000 g
Opium (powder).........................................         63,000 g
Opium (tincture).......................................      1,000,000 g
Oripavine..............................................      8,000,000 g

[[Page 77019]]

 
Oxycodone (for conversion).............................      5,600,000 g
Oxycodone (for sale)...................................     98,000,000 g
Oxymorphone (for conversion)...........................     12,800,000 g
Oxymorphone (for sale).................................      3,070,000 g
Pentobarbital..........................................     34,000,000 g
Phenazocine............................................              5 g
Phencyclidine..........................................             24 g
Phenmetrazine..........................................              2 g
Phenylacetone..........................................      8,000,000 g
Racemethorphan.........................................              2 g
Remifentanil...........................................          2,500 g
Secobarbital...........................................        336,002 g
Sufentanil.............................................          5,000 g
Tapentadol.............................................        403,000 g
Thebaine...............................................    116,000,000 g
------------------------------------------------------------------------

    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: December 1, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011-31621 Filed 12-8-11; 8:45 am]
BILLING CODE 4410-09-P

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