Controlled Substances: Proposed Aggregate Production Quotas for 2011, 56137-56140 [2010-22905]

Download as PDF Federal Register / Vol. 75, No. 178 / Wednesday, September 15, 2010 / Notices DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–343P] Controlled Substances: Proposed Aggregate Production Quotas for 2011 Drug Enforcement Administration (DEA), Justice. ACTION: Notice of proposed year 2011 aggregate production quotas. AGENCY: This notice proposes initial year 2011 aggregate production quotas for controlled substances in schedules I and II of the Controlled Substances Act (CSA). DATES: Written comments must be postmarked and electronic comments must be submitted on or before October 15, 2010. ADDRESSES: To ensure proper handling of comments, please reference ‘‘Docket No. DEA–343P’’ on all written and electronic correspondence. Written comments sent via regular or express mail should be sent to the Drug Enforcement Administration, Attention: DEA Federal Register Representative/ ODL, 8701 Morrissette Drive, Springfield, Virginia 22152. Comments may be sent to DEA by sending an electronic message to dea.diversion.policy@usdoj.gov. DEA will accept attachments to electronic comments in Microsoft Word, WordPerfect, Adobe PDF, or Excel file formats only. DEA will not accept any file format other than those specifically listed here. Please note that DEA is requesting that electronic comments be submitted before midnight Eastern Time on the day the comment period closes. Commenters in time zones other than Eastern Time may want to consider this so that their electronic comments are received timely. All comments sent via regular or express mail will be considered timely if postmarked on the day the comment period closes. FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, PhD, Chief, Drug and Chemical Evaluation Section, 8701 Morrissette Drive, Springfield, Virginia 22152, Telephone: (202) 307–7183. srobinson on DSKHWCL6B1PROD with NOTICES SUMMARY: Availability Of Public Comments: Please note that all comments received are considered part of the public record and made available for public inspection in the Drug Enforcement Administration’s public docket. Such information includes personal identifying information (such as your name, address, etc.) voluntarily submitted by the commenter. If you want to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be made available in the public docket, you must include the phrase ‘‘PERSONAL IDENTIFYING INFORMATION’’ in the first paragraph of your comment. You must also place all the personal identifying information you do not want made available in the public docket in the first paragraph of your comment and identify what information you want redacted. If you want to submit confidential business information as part of your comment, but do not want it made available in the public docket, you must include the phrase ‘‘CONFIDENTIAL BUSINESS INFORMATION’’ in the first paragraph of your comment. You must also prominently identify confidential business information to be redacted within the comment. If a comment has so much confidential business information that it cannot be effectively redacted, all or part of that comment may not be made available in the public docket. Personal identifying information and confidential business information identified and located as set forth above will be redacted and the comment, in redacted form, will be placed in the Drug Enforcement Administration’s public docket file. Please note that the Freedom of Information Act applies to all comments received. If you wish to inspect the agency’s public docket file in person by appointment, please see the FOR FURTHER INFORMATION paragraph. SUPPLEMENTARY INFORMATION: Section 306 of the 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. The Administrator, in turn, has redelegated this function to the Deputy Administrator, pursuant to 28 CFR 0.104. The proposed year 2011 aggregate production quotas represent those quantities of controlled substances that may be produced in the United States in 2011 to provide adequate supplies of each substance 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 do not include imports of controlled substances for use in industrial processes. In determining the year 2011 aggregate production quotas, the Deputy Administrator considered the following factors: total actual 2009 and estimated 2010 and 2011 net disposals of each substance by all manufacturers; estimates of 2010 year-end inventories of each substance and of any substance manufactured from it and trends in accumulation of such inventories; product development requirements of both bulk and finished dosage form manufacturers; projected demand as indicated by procurement quota applications filed pursuant to 21 CFR 1303.12; and other pertinent information. Pursuant to 21 CFR 1303, the Deputy Administrator of the DEA will adjust the 2011 aggregate production quotas and individual manufacturing quotas allocated for the year based upon 2010 year-end inventory and actual 2010 disposition data supplied by quota recipients for each basic class of schedules I or II controlled substances. Therefore, under the authority vested in the Attorney General by Section 306 of the CSA of 1970 (21 U.S.C. 826), and delegated to the Administrator of the DEA by 28 CFR 0.100, and redelegated to the Deputy Administrator pursuant to 28 CFR 0.104, the Deputy Administrator hereby proposes that the year 2011 aggregate production quotas for the following controlled substances, expressed in grams of anhydrous acid or base, be established as follows: Proposed 2011 quotas (g) Basic Class—Schedule I 1-Methyl-4-phenyl-4-propionoxypiperidine ........................................................................................................................................... 2,5-Dimethoxyamphetamine ................................................................................................................................................................ 2,5-Dimethoxy-4-ethylamphetamine (DOET) ...................................................................................................................................... 2,5-Dimethoxy-4-n-propylthiophenethylamine ..................................................................................................................................... 3-Methylfentanyl ................................................................................................................................................................................... 3-Methylthiofentanyl ............................................................................................................................................................................. VerDate Mar<15>2010 18:57 Sep 14, 2010 Jkt 220001 PO 00000 Frm 00087 Fmt 4703 Sfmt 4703 56137 E:\FR\FM\15SEN1.SGM 15SEN1 2 2 2 2 2 2 56138 Federal Register / Vol. 75, No. 178 / Wednesday, September 15, 2010 / Notices Proposed 2011 quotas (g) srobinson on DSKHWCL6B1PROD with NOTICES Basic Class—Schedule I 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-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 .................................................................................................................................................................................................. 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 ....................................................................................................................................................................................... VerDate Mar<15>2010 18:57 Sep 14, 2010 Jkt 220001 PO 00000 Frm 00088 Fmt 4703 Sfmt 4703 E:\FR\FM\15SEN1.SGM 15SEN1 20 10 20 2 2 2 77 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 3 3 602 2 3,000 3,608,000 3 3,000,000 20 2 2 1 15 21,000 5 7 4 2 605 2 2 2 2 2 52 2 16 2 2 2 2 2 264,000 2 10 2 Federal Register / Vol. 75, No. 178 / Wednesday, September 15, 2010 / Notices 56139 Proposed 2011 quotas (g) Basic Class—Schedule II 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 ............................................................................................................................................................................... 2 2 2,500,000 8,000 2 40,003 7,500,000 18,600,000 247,000 65,000,000 39,605,000 92,000,000 800,000 827,000 83,000 2 1,428,000 2 55,000,000 3,455,000 11 3 5 10,000 9,000,000 6,600,000 3 7 3 1 20,000,000 26,000,000 3,130,000 [750,000 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 2,331,000 grams for methamphetamine mostly for conversion to a schedule III product; and 49,000 grams for methamphetamine (for sale)] srobinson on DSKHWCL6B1PROD with NOTICES Methylphenidate ................................................................................................................................................................................... Morphine (for conversion) .................................................................................................................................................................... Morphine (for sale) .............................................................................................................................................................................. Nabilone ............................................................................................................................................................................................... Noroxymorphone (for conversion) ....................................................................................................................................................... Noroxymorphone (for sale) .................................................................................................................................................................. Opium (powder) ................................................................................................................................................................................... Opium (tincture) ................................................................................................................................................................................... Oripavine .............................................................................................................................................................................................. Oxycodone (for conversion) ................................................................................................................................................................ Oxycodone (for sale) ........................................................................................................................................................................... Oxymorphone (for conversion) ............................................................................................................................................................ Oxymorphone (for sale) ....................................................................................................................................................................... Pentobarbital ........................................................................................................................................................................................ Phenazocine ........................................................................................................................................................................................ Phencyclidine ....................................................................................................................................................................................... Phenmetrazine ..................................................................................................................................................................................... Phenylacetone ..................................................................................................................................................................................... Racemethorphan ................................................................................................................................................................................. Remifentanil ......................................................................................................................................................................................... Secobarbital ......................................................................................................................................................................................... Sufentanil ............................................................................................................................................................................................. Tapentadol ........................................................................................................................................................................................... Thebaine .............................................................................................................................................................................................. The Deputy Administrator further proposes that aggregate production quotas for all other schedules I and II controlled substances included in 21 VerDate Mar<15>2010 18:57 Sep 14, 2010 Jkt 220001 CFR 1308.11 and 1308.12 be established at zero. All interested persons are invited to submit their comments in writing or electronically regarding this proposal PO 00000 Frm 00089 Fmt 4703 Sfmt 4703 50,000,000 83,000,000 39,000,000 9,002 9,000,000 41,000 230,000 1,500,000 15,000,000 5,600,000 105,500,000 12,800,000 3,070,000 28,000,000 1 14 2 8,000,000 2 2,500 67,000 7,000 1,000,000 126,000,000 following the procedures in the section of this document. A person may object to or comment on the proposal relating to any of the abovementioned substances without filing ADDRESSES E:\FR\FM\15SEN1.SGM 15SEN1 srobinson on DSKHWCL6B1PROD with NOTICES 56140 Federal Register / Vol. 75, No. 178 / Wednesday, September 15, 2010 / Notices comments or objections regarding the others. If a person believes that one or more of these issues warrant a hearing, the individual should so state and summarize the reasons for this belief. In the event that comments or objections to this proposal raise one or more issues which the Deputy Administrator finds warrant a hearing, the Deputy Administrator shall order a public hearing by notice in the Federal Register, summarizing the issues to be heard and setting the time for the hearing. The Office of Management and Budget has determined that notices of aggregate production quotas are not subject to centralized review under Executive Order 12866. This action does not preempt or modify any provision of state law; nor does it impose enforcement responsibilities on any state; nor does it diminish the power of any state to enforce its own laws. Accordingly, this action does not have federalism implications warranting the application of Executive Order 13132. The Deputy Administrator hereby certifies that this action will have no significant impact upon small entities whose interests must be considered under the Regulatory Flexibility Act, 5 U.S.C. 601 et seq. The establishment of aggregate production quotas for schedules I and II controlled substances is mandated by law and by international treaty obligations. The quotas are necessary to provide for the estimated medical, scientific, research and industrial needs of the United States, for export requirements and the establishment and maintenance of reserve stocks. While aggregate production quotas are of primary importance to large manufacturers, their impact upon small entities is neither negative nor beneficial. Accordingly, the Deputy Administrator has determined that this action does not require a regulatory flexibility analysis. This action meets the applicable standards set forth in Sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform. This action will not result in the expenditure by state, local, and tribal governments, in the aggregate, or by the private sector, of $129,400,000 or more in any one year, and will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995. This action is not a major rule as defined by Section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996. This action will VerDate Mar<15>2010 18:57 Sep 14, 2010 Jkt 220001 not result in an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreignbased companies in domestic and export markets. Dated: September 3, 2010. Michele M. Leonhart, Deputy Administrator. [FR Doc. 2010–22905 Filed 9–14–10; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Office of Justice Programs [OJP (BJA) Docket No. 1531] Meeting of the Department of Justice’s (DOJ’s) National Motor Vehicle Title Information System (NMVTIS) Federal Advisory Committee Office of Justice Programs (OJP), Justice. ACTION: Notice of meeting. AGENCY: This is an announcement of a meeting of DOJ’s National Motor Vehicle Title Information System (NMVTIS) Federal Advisory Committee to discuss the role of the NMVTIS Federal Advisory Committee Members and various issues relating to the operation and implementation of NMVTIS. SUMMARY: The meeting will take place on Thursday, October 7th, 2010 from 8:30 a.m. to 4 p.m. ET and on Friday, October 8th, 2010 from 8:30 a.m. to 12 p.m. ET. ADDRESSES: The meeting will take place at the Omni Shoreham Hotel, 2500 Calvert Street, NW., Washington, DC 20008; Phone: (202) 234–0700. FOR FURTHER INFORMATION CONTACT: Alissa Huntoon, Designated Federal Employee (DFE), Bureau of Justice Assistance, Office of Justice Programs, 810 7th Street Northwest, Washington, DC 20531; Phone: (202) 305–1661 [note: this is not a toll-free number]; E-mail: Alissa.Huntoon@usdoj.gov. DATES: This meeting is open to the public. Members of the public who wish to attend this meeting must register with Ms. Alissa Huntoon at the above address at least seven (7) days in advance of the meeting. Registrations will be accepted on a space available basis. Access to the meeting will not be allowed without registration. Please bring photo SUPPLEMENTARY INFORMATION: PO 00000 Frm 00090 Fmt 4703 Sfmt 4703 identification and allow extra time prior to the meeting. Interested persons whose registrations have been accepted may be permitted to participate in the discussions at the discretion of the meeting chairman and with approval of the DFE. Anyone requiring special accommodations should notify Ms. Huntoon at least seven (7) days in advance of the meeting. Purpose The NMVTIS Federal Advisory Committee will provide input and recommendations to the Office of Justice Programs (OJP) regarding the operations and administration of NMVTIS. The primary duties of the NMVTIS Federal Advisory Committee will be to advise the Bureau of Justice Assistance (BJA) Director on NMVTIS-related issues, including but not limited to: Implementation of a system that is selfsustainable with user fees; options for alternative revenue-generating opportunities; determining ways to enhance the technological capabilities of the system to increase its flexibility; and options for reducing the economic burden on current and future reporting entities and users of the system. Alissa Huntoon, NMVTIS DFE, Bureau of Justice Assistance, Office of Justice Programs. [FR Doc. 2010–22917 Filed 9–14–10; 8:45 am] BILLING CODE 4410–18–P DEPARTMENT OF LABOR Employment and Training Administration Comment Request for Information Collection for the YouthBuild (YB) Reporting System (OMB Control No. 1205–0464), Extension Without Revisions Employment and Training Administration. ACTION: Notice. AGENCY: The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden conducts a preclearance consultation program to provide the general public and federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) [44 U.S.C. 3506(c)(2)(A)]. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, SUMMARY: E:\FR\FM\15SEN1.SGM 15SEN1

Agencies

[Federal Register Volume 75, Number 178 (Wednesday, September 15, 2010)]
[Notices]
[Pages 56137-56140]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-22905]



[[Page 56137]]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-343P]


Controlled Substances: Proposed Aggregate Production Quotas for 
2011

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of proposed year 2011 aggregate production quotas.

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

SUMMARY: This notice proposes initial year 2011 aggregate production 
quotas for controlled substances in schedules I and II of the 
Controlled Substances Act (CSA).

DATES: Written comments must be postmarked and electronic comments must 
be submitted on or before October 15, 2010.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-343P'' on all written and electronic correspondence. 
Written comments sent via regular or express mail should be sent to the 
Drug Enforcement Administration, Attention: DEA Federal Register 
Representative/ODL, 8701 Morrissette Drive, Springfield, Virginia 
22152. Comments may be sent to DEA by sending an electronic message to 
dea.diversion.policy@usdoj.gov. DEA will accept attachments to 
electronic comments in Microsoft Word, WordPerfect, Adobe PDF, or Excel 
file formats only. DEA will not accept any file format other than those 
specifically listed here.
    Please note that DEA is requesting that electronic comments be 
submitted before midnight Eastern Time on the day the comment period 
closes. Commenters in time zones other than Eastern Time may want to 
consider this so that their electronic comments are received timely. 
All comments sent via regular or express mail will be considered timely 
if postmarked on the day the comment period closes.

FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, PhD, Chief, 
Drug and Chemical Evaluation Section, 8701 Morrissette Drive, 
Springfield, Virginia 22152, Telephone: (202) 307-7183.
    Availability Of Public Comments: Please note that all comments 
received are considered part of the public record and made available 
for public inspection in the Drug Enforcement Administration's public 
docket. Such information includes personal identifying information 
(such as your name, address, etc.) voluntarily submitted by the 
commenter.
    If you want to submit personal identifying information (such as 
your name, address, etc.) as part of your comment, but do not want it 
to be made available in the public docket, you must include the phrase 
``PERSONAL IDENTIFYING INFORMATION'' in the first paragraph of your 
comment. You must also place all the personal identifying information 
you do not want made available in the public docket in the first 
paragraph of your comment and identify what information you want 
redacted.
    If you want to submit confidential business information as part of 
your comment, but do not want it made available in the public docket, 
you must include the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in 
the first paragraph of your comment. You must also prominently identify 
confidential business information to be redacted within the comment.
    If a comment has so much confidential business information that it 
cannot be effectively redacted, all or part of that comment may not be 
made available in the public docket.
    Personal identifying information and confidential business 
information identified and located as set forth above will be redacted 
and the comment, in redacted form, will be placed in the Drug 
Enforcement Administration's public docket file. Please note that the 
Freedom of Information Act applies to all comments received. If you 
wish to inspect the agency's public docket file in person by 
appointment, please see the FOR FURTHER INFORMATION paragraph.

SUPPLEMENTARY INFORMATION: Section 306 of the 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. The Administrator, in turn, has redelegated 
this function to the Deputy Administrator, pursuant to 28 CFR 0.104.
    The proposed year 2011 aggregate production quotas represent those 
quantities of controlled substances that may be produced in the United 
States in 2011 to provide adequate supplies of each substance 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 do not include imports of 
controlled substances for use in industrial processes.
    In determining the year 2011 aggregate production quotas, the 
Deputy Administrator considered the following factors: total actual 
2009 and estimated 2010 and 2011 net disposals of each substance by all 
manufacturers; estimates of 2010 year-end inventories of each substance 
and of any substance manufactured from it and trends in accumulation of 
such inventories; product development requirements of both bulk and 
finished dosage form manufacturers; projected demand as indicated by 
procurement quota applications filed pursuant to 21 CFR 1303.12; and 
other pertinent information.
    Pursuant to 21 CFR 1303, the Deputy Administrator of the DEA will 
adjust the 2011 aggregate production quotas and individual 
manufacturing quotas allocated for the year based upon 2010 year-end 
inventory and actual 2010 disposition data supplied by quota recipients 
for each basic class of schedules I or II controlled substances.
    Therefore, under the authority vested in the Attorney General by 
Section 306 of the CSA of 1970 (21 U.S.C. 826), and delegated to the 
Administrator of the DEA by 28 CFR 0.100, and redelegated to the Deputy 
Administrator pursuant to 28 CFR 0.104, the Deputy Administrator hereby 
proposes that the year 2011 aggregate production quotas for the 
following controlled substances, expressed in grams of anhydrous acid 
or base, be established as follows:

------------------------------------------------------------------------
                                                           Proposed 2011
                 Basic Class--Schedule I                    quotas (g)
------------------------------------------------------------------------
1-Methyl-4-phenyl-4-propionoxypiperidine................               2
2,5-Dimethoxyamphetamine................................               2
2,5-Dimethoxy-4-ethylamphetamine (DOET).................               2
2,5-Dimethoxy-4-n-propylthiophenethylamine..............               2
3-Methylfentanyl........................................               2
3-Methylthiofentanyl....................................               2

[[Page 56138]]

 
3,4-Methylenedioxyamphetamine (MDA).....................              20
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)............              10
3,4-Methylenedioxymethamphetamine (MDMA)................              20
3,4,5-Trimethoxyamphetamine.............................               2
4-Bromo-2,5-dimethoxyamphetamine (DOB)..................               2
4-Bromo-2,5-dimethoxyphenethylamine (2-CB)..............               2
4-Methoxyamphetamine....................................              77
4-Methylaminorex........................................               2
4-Methyl-2,5-dimethoxyamphetamine (DOM).................               2
5-Methoxy-3,4-methylenedioxyamphetamine.................               2
5-Methoxy-N,N-diisopropyltryptamine.....................               2
Acetyl-alpha-methylfentanyl.............................               2
Acetyldihydrocodeine....................................               2
Acetylmethadol..........................................               2
Allylprodine............................................               2
Alphacetylmethadol......................................               2
Alpha-ethyltryptamine...................................               2
Alphameprodine..........................................               2
Alphamethadol...........................................               2
Alpha-methylfentanyl....................................               2
Alpha-methylthiofentanyl................................               2
Alpha-methyltryptamine (AMT)............................               2
Aminorex................................................               2
Benzylmorphine..........................................               2
Betacetylmethadol.......................................               2
Beta-hydroxy-3-methylfentanyl...........................               2
Beta-hydroxyfentanyl....................................               2
Betameprodine...........................................               2
Betamethadol............................................               2
Betaprodine.............................................               2
Bufotenine..............................................               3
Cathinone...............................................               3
Codeine-N-oxide.........................................             602
Diethyltryptamine.......................................               2
Difenoxin...............................................           3,000
Dihydromorphine.........................................       3,608,000
Dimethyltryptamine......................................               3
Gamma-hydroxybutyric acid...............................       3,000,000
Heroin..................................................              20
Hydromorphinol..........................................               2
Hydroxypethidine........................................               2
Ibogaine................................................               1
Lysergic acid diethylamide (LSD)........................              15
Marihuana...............................................          21,000
Mescaline...............................................               5
Methaqualone............................................               7
Methcathinone...........................................               4
Methyldihydromorphine...................................               2
Morphine-N-oxide........................................             605
N-Benzylpiperazine......................................               2
N,N-Dimethylamphetamine.................................               2
N-Ethylamphetamine......................................               2
N-Hydroxy-3,4-methylenedioxyamphetamine.................               2
Noracymethadol..........................................               2
Norlevorphanol..........................................              52
Normethadone............................................               2
Normorphine.............................................              16
Para-fluorofentanyl.....................................               2
Phenomorphan............................................               2
Pholcodine..............................................               2
Psilocybin..............................................               2
Psilocyn................................................               2
Tetrahydrocannabinols...................................         264,000
Thiofentanyl............................................               2
Tilidine................................................              10
Trimeperidine...........................................               2
------------------------------------------------------------------------



[[Page 56139]]



------------------------------------------------------------------------
                                                           Proposed 2011
                Basic Class--Schedule II                    quotas (g)
------------------------------------------------------------------------
1-Phenylcyclohexylamine.................................               2
1-piperdinocyclohexanecarbonitrile......................               2
4-Anilino-N-phenethyl-4-piperidine (ANPP)...............       2,500,000
Alfentanil..............................................           8,000
Alphaprodine............................................               2
Amobarbital.............................................          40,003
Amphetamine (for conversion)............................       7,500,000
Amphetamine (for sale)..................................      18,600,000
Cocaine.................................................         247,000
Codeine (for conversion)................................      65,000,000
Codeine (for sale)......................................      39,605,000
Dextropropoxyphene......................................      92,000,000
Dihydrocodeine..........................................         800,000
Diphenoxylate...........................................         827,000
Ecgonine................................................          83,000
Ethylmorphine...........................................               2
Fentanyl................................................       1,428,000
Glutethimide............................................               2
Hydrocodone (for sale)..................................      55,000,000
Hydromorphone...........................................       3,455,000
Isomethadone............................................              11
Levo-alphacetylmethadol (LAAM)..........................               3
Levomethorphan..........................................               5
Levorphanol.............................................          10,000
Lisdexamfetamine........................................       9,000,000
Meperidine..............................................       6,600,000
Meperidine Intermediate-A...............................               3
Meperidine Intermediate-B...............................               7
Meperidine Intermediate-C...............................               3
Metazocine..............................................               1
Methadone (for sale)....................................      20,000,000
Methadone Intermediate..................................      26,000,000
Methamphetamine.........................................       3,130,000
------------------------------------------------------------------------
[750,000 grams of levo-desoxyephedrine for use in a non-controlled,
non-prescription product; 2,331,000 grams for methamphetamine mostly for
 conversion to a schedule III product; and 49,000 grams for
 methamphetamine (for sale)]
------------------------------------------------------------------------
Methylphenidate.........................................      50,000,000
Morphine (for conversion)...............................      83,000,000
Morphine (for sale).....................................      39,000,000
Nabilone................................................           9,002
Noroxymorphone (for conversion).........................       9,000,000
Noroxymorphone (for sale)...............................          41,000
Opium (powder)..........................................         230,000
Opium (tincture)........................................       1,500,000
Oripavine...............................................      15,000,000
Oxycodone (for conversion)..............................       5,600,000
Oxycodone (for sale)....................................     105,500,000
Oxymorphone (for conversion)............................      12,800,000
Oxymorphone (for sale)..................................       3,070,000
Pentobarbital...........................................      28,000,000
Phenazocine.............................................               1
Phencyclidine...........................................              14
Phenmetrazine...........................................               2
Phenylacetone...........................................       8,000,000
Racemethorphan..........................................               2
Remifentanil............................................           2,500
Secobarbital............................................          67,000
Sufentanil..............................................           7,000
Tapentadol..............................................       1,000,000
Thebaine................................................     126,000,000
------------------------------------------------------------------------

    The Deputy Administrator further proposes that aggregate production 
quotas for all other schedules I and II controlled substances included 
in 21 CFR 1308.11 and 1308.12 be established at zero.
    All interested persons are invited to submit their comments in 
writing or electronically regarding this proposal following the 
procedures in the addresses section of this document. A person may 
object to or comment on the proposal relating to any of the above-
mentioned substances without filing

[[Page 56140]]

comments or objections regarding the others. If a person believes that 
one or more of these issues warrant a hearing, the individual should so 
state and summarize the reasons for this belief.
    In the event that comments or objections to this proposal raise one 
or more issues which the Deputy Administrator finds warrant a hearing, 
the Deputy Administrator shall order a public hearing by notice in the 
Federal Register, summarizing the issues to be heard and setting the 
time for the hearing.
    The Office of Management and Budget has determined that notices of 
aggregate production quotas are not subject to centralized review under 
Executive Order 12866.
    This action does not preempt or modify any provision of state law; 
nor does it impose enforcement responsibilities on any state; nor does 
it diminish the power of any state to enforce its own laws. 
Accordingly, this action does not have federalism implications 
warranting the application of Executive Order 13132.
    The Deputy Administrator hereby certifies that this action will 
have no significant impact upon small entities whose interests must be 
considered under the Regulatory Flexibility Act, 5 U.S.C. 601 et seq. 
The establishment of aggregate production quotas for schedules I and II 
controlled substances is mandated by law and by international treaty 
obligations. The quotas are necessary to provide for the estimated 
medical, scientific, research and industrial needs of the United 
States, for export requirements and the establishment and maintenance 
of reserve stocks. While aggregate production quotas are of primary 
importance to large manufacturers, their impact upon small entities is 
neither negative nor beneficial. Accordingly, the Deputy Administrator 
has determined that this action does not require a regulatory 
flexibility analysis.
    This action meets the applicable standards set forth in Sections 
3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform.
    This action will not result in the expenditure by state, local, and 
tribal governments, in the aggregate, or by the private sector, of 
$129,400,000 or more in any one year, and will not significantly or 
uniquely affect small governments. Therefore, no actions were deemed 
necessary under the provisions of the Unfunded Mandates Reform Act of 
1995.
    This action is not a major rule as defined by Section 804 of the 
Small Business Regulatory Enforcement Fairness Act of 1996. This action 
will not result in an annual effect on the economy of $100,000,000 or 
more; a major increase in costs or prices; or significant adverse 
effects on competition, employment, investment, productivity, 
innovation, or on the ability of United States-based companies to 
compete with foreign-based companies in domestic and export markets.

    Dated: September 3, 2010.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 2010-22905 Filed 9-14-10; 8:45 am]
BILLING CODE 4410-09-P