[Federal Register Volume 75, Number 120 (Wednesday, June 23, 2010)]
[Notices]
[Pages 35838-35841]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-15159]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-318R]
Controlled Substances: Proposed Revised Aggregate Production
Quotas for 2010
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of proposed revised 2010 aggregate production quotas.
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SUMMARY: This notice proposes revised 2010 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 sent, on or before July 23, 2010.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-318R'' on all written and electronic correspondence.
Written comments should be sent to the DEA Headquarters, Attention: DEA
Federal Register Representative/ODL, 8701 Morrissette Drive,
Springfield, VA 22152. Comments may be directly sent to DEA
electronically by sending an electronic message to
[email protected]. An electronic copy of this document is
also available at the http://www.regulations.gov Web site. However,
persons wishing to request a hearing should note that such requests
must be written and manually signed; requests for a hearing will not be
accepted via electronic means. 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.
FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, PhD, Chief,
Drug and Chemical Evaluation Section, Drug Enforcement Administration,
8701 Morrissette Drive, Springfield, VA 22152, Telephone: (202) 307-
7183.
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.
On May 21, 2009, a notice of proposed 2010 aggregate production
quotas for certain controlled substances in schedules I and II was
published in the Federal Register (74 FR 23881). This notice stipulated
that the DEA would adjust the quotas in 2010 as provided for in 21 CFR
part 1303. The 2010 established aggregate production quotas were
published in the Federal Register (74 FR 54080) on October 21, 2010.
The proposed revised 2010 aggregate production quotas represent
those quantities of controlled substances in schedules I and II that
may be produced in the United States in 2010 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.
The proposed revisions are based on a review of 2009 year-end
inventories, 2009 disposition data submitted by quota applicants,
estimates of the medical needs of the United States, product
development, and other information available to the DEA.
Therefore, under the authority vested in the Attorney General by
Section 306 of the CSA (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 the following revised 2010 aggregate production quotas for the
following controlled substances, expressed in grams of anhydrous acid
or base:
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Previously
established Proposed revised
Basic class initial 2010 2010 quotas
quotas
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Schedule I
----------------------------------------------------------------------------------------------------------------
2,5-Dimethoxyamphetamine.................................................. 2 g 2 g
2,5-Dimethoxy-4-ethylamphetamine (DOET)................................... 2 g 2 g
3-Methylfentanyl.......................................................... 2 g 2 g
3-Methylthiofentanyl...................................................... 2 g 2 g
3,4-Methylenedioxyamphetamine (MDA)....................................... 25 g 20 g
3,4-Methylenedioxy-N-ethylamphetamine (MDEA).............................. 10 g 10 g
3,4-Methylenedioxymethamphetamine (MDMA).................................. 20 g 20 g
3,4,5-Trimethoxyamphetamine............................................... 2 g 2 g
4-Bromo-2,5-dimethoxyamphetamine (DOB).................................... 2 g 2 g
4-Bromo-2,5-dimethoxyphenethylamine (2-CB)................................ 2 g 2 g
4-Methoxyamphetamine...................................................... 77 g 77 g
4-Methylaminorex.......................................................... 2 g 2 g
4-Methyl-2,5-dimethoxyamphetamine (DOM)................................... 2 g 2 g
5-Methoxy-3,4-methylenedioxyamphetamine................................... 2 g 2 g
5-Methoxy-N,N-diisopropyltryptamine....................................... 5 g 0 g
Acetyl-alpha-methylfentanyl............................................... 2 g 2 g
Acetyldihydrocodeine...................................................... 2 g 2 g
Acetylmethadol............................................................ 2 g 2 g
Allylprodine.............................................................. 2 g 2 g
Alphacetylmethadol........................................................ 2 g 2 g
Alpha-ethyltryptamine..................................................... 2 g 2 g
Alphameprodine............................................................ 2 g 2 g
Alphamethadol............................................................. 2 g 2 g
Alpha-methylfentanyl...................................................... 2 g 2 g
Alpha-methylthiofentanyl.................................................. 2 g 2 g
[[Page 35839]]
Alpha-methyltryptamine (AMT).............................................. 2 g 2 g
Aminorex.................................................................. 2 g 2 g
Benzylmorphine............................................................ 2 g 2 g
Betacetylmethadol......................................................... 2 g 2 g
Beta-hydroxy-3-methylfentanyl............................................. 2 g 2 g
Beta-hydroxyfentanyl...................................................... 2 g 2 g
Betameprodine............................................................. 2 g 2 g
Betamethadol.............................................................. 2 g 2 g
Betaprodine............................................................... 2 g 2 g
Bufotenine................................................................ 3 g 3 g
Cathinone................................................................. 3 g 3 g
Codeine-N-oxide........................................................... 602 g 602 g
Diethyltryptamine......................................................... 2 g 2 g
Difenoxin................................................................. 3,000 g 3,000 g
Dihydromorphine........................................................... 3,300,000 g 3,500,000 g
Dimethyltryptamine........................................................ 3 g 3 g
Gamma-hydroxybutyric acid................................................. 24,200,000 g 52,156,000 g
Heroin.................................................................... 20 g 20 g
Hydromorphinol............................................................ 2 g 2 g
Hydroxypethidine.......................................................... 2 g 2 g
Ibogaine.................................................................. 1 g 1 g
Lysergic acid diethylamide (LSD).......................................... 15 g 15 g
Marihuana................................................................. 4,500,000 g 11,000 g
Mescaline................................................................. 7 g 5 g
Methaqualone.............................................................. 7 g 7 g
Methcathinone............................................................. 4 g 4 g
Methyldihydromorphine..................................................... 2 g 2 g
Morphine-N-oxide.......................................................... 605 g 605 g
N-Benzylpiperazine........................................................ 2 g 2 g
N,N-Dimethylamphetamine................................................... 7 g 2 g
N-Ethylamphetamine........................................................ 2 g 2 g
N-Hydroxy-3,4-methylenedioxyamphetamine................................... 2 g 2 g
Noracymethadol............................................................ 2 g 2 g
Norlevorphanol............................................................ 52 g 52 g
Normethadone.............................................................. 2 g 2 g
Normorphine............................................................... 16 g 16 g
Para-fluorofentanyl....................................................... 2 g 2 g
Phenomorphan.............................................................. 2 g 2 g
Pholcodine................................................................ 2 g 2 g
Psilocybin................................................................ 7 g 2 g
Psilocyn.................................................................. 7 g 2 g
Tetrahydrocannabinols..................................................... 312,500 g 216,000 g
Thiofentanyl.............................................................. 2 g 2 g
Trimeperidine............................................................. 2 g 2 g
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Schedule II
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1-Phenylcyclohexylamine................................................... 2 g 2 g
1-Piperdinocyclohexanecarbonitrile........................................ 2 g 0 g
Alfentanil................................................................ 8,000 g 6,300 g
Alphaprodine.............................................................. 2 g 2 g
Amobarbital............................................................... 3 g 3 g
Amphetamine (for sale).................................................... 17,000,000 g 17,000,000 g
Amphetamine (for conversion).............................................. 6,500,000 g 6,500,000 g
Cocaine................................................................... 247,000 g 247,000 g
Codeine (for sale)........................................................ 39,605,000 g 39,605,000 g
Codeine (for conversion).................................................. 65,000,000 g 65,000,000 g
Dextropropoxyphene........................................................ 106,000,000 g 92,000,000 g
Dihydrocodeine............................................................ 1,200,000 g 800,000 g
Diphenoxylate............................................................. 947,000 g 627,000 g
Ecgonine.................................................................. 83,000 g 83,000 g
Ethylmorphine............................................................. 2 g 2 g
Fentanyl.................................................................. 1,428,000 g 1,428,000 g
Glutethimide.............................................................. 2 g 2 g
Hydrocodone (for sale).................................................... 55,000,000 g 55,000,000 g
Hydromorphone............................................................. 3,300,000 g 3,455,000 g
Isomethadone.............................................................. 11 g 11 g
Levo-alphacetylmethadol (LAAM)............................................ 3 g 3 g
Levomethorphan............................................................ 5 g 5 g
Levorphanol............................................................... 10,000 g 10,000 g
Lisdexamfetamine.......................................................... 9,000,000 g 9,000,000 g
Meperidine................................................................ 8,600,000 g 6,600,000 g
[[Page 35840]]
Meperidine Intermediate-A................................................. 3 g 3 g
Meperidine Intermediate-B................................................. 7 g 7 g
Meperidine Intermediate-C................................................. 3 g 3 g
Metazocine................................................................ 1 g 1 g
Methadone (for sale)...................................................... 25,000,000 g 20,000,000 g
Methadone Intermediate.................................................... 26,000,000 g 26,000,000 g
Methamphetamine........................................................... 3,130,000 g 3,130,000 g
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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 g 50,000,000 g
Morphine (for sale)....................................................... 35,000,000 g 35,000,000 g
Morphine (for conversion)................................................. 100,000,000 g 83,000,000 g
Nabilone.................................................................. 9,002 g 9,002 g
Noroxymorphone (for sale)................................................. 10,000 g 5,000 g
Noroxymorphone (for conversion)........................................... 9,000,000 g 9,000,000 g
Opium (powder)............................................................ 230,000 g 230,000 g
Opium (tincture).......................................................... 1,050,000 g 1,050,000 g
Oripavine................................................................. 15,000,000 g 15,000,000 g
Oxycodone (for sale)...................................................... 88,000,000 g 88,000,000 g
Oxycodone (for conversion)................................................ 4,000,000 g 4,000,000 g
Oxymorphone............................................................... 2,570,000 g 2,570,000 g
Oxymorphone (for conversion).............................................. 12,000,000 g 12,000,000 g
Pentobarbital............................................................. 28,000,000 g 28,000,000 g
Phenazocine............................................................... 1 g 1 g
Phencyclidine............................................................. 20 g 14 g
Phenmetrazine............................................................. 2 g 2 g
Phenylacetone............................................................. 12,500,001 g 12,500,001 g
Racemethorphan............................................................ 2 g 2 g
Remifentanil.............................................................. 500 g 2,500 g
Secobarbital.............................................................. 67,000 g 67,000 g
Sufentanil................................................................ 10,300 g 7,000 g
Thebaine.................................................................. 126,000,000 g 126,000,000 g
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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 remain 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 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. Persons wishing to request a hearing should
note that such requests must be written and manually signed; requests
for a hearing will not be accepted via electronic means. 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 as per 21 CFR 1303.13(c).
Regulatory Certifications
Regulatory Flexibility Act
The Deputy Administrator hereby certifies that this action will not
have a significant economic impact upon small entities whose interests
must be considered under the Regulatory Flexibility Act, 5 U.S.C. 601-
612. 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 lawful 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.
Executive Order 12866
The Office of Management and Budget has determined that notices of
aggregate production quotas are not subject to centralized review under
Executive Order 12866.
Executive Order 13132
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.
Executive Order 12988
This action meets the applicable standards set forth in Sections
3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform.
Unfunded Mandates Reform Act of 1995
This action will not result in the expenditure by State, local, and
tribal governments, in the aggregate, or by the private sector, of
$126,000,000 or more (adjusted for inflation) in any one year,
[[Page 35841]]
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.
Congressional Review Act
This action is not a major rule as defined by Section 804 of the
Small Business Regulatory Enforcement Fairness Act of 1996
(Congressional Review Act). 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: June 17, 2010.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 2010-15159 Filed 6-22-10; 8:45 am]
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