[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]
[[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.
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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:
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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
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[[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
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[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)]
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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
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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