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



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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.

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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 
[email protected]. 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

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



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