[Federal Register Volume 73, Number 217 (Friday, November 7, 2008)]
[Notices]
[Pages 66256-66259]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-26609]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-317P]


Controlled Substances: Proposed Aggregate Production Quotas for 
2009

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of proposed year 2009 aggregate production quotas.

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SUMMARY: This notice proposes initial year 2009 aggregate production 
quotas for controlled substances in schedules I and II of the 
Controlled Substances Act (CSA).

DATES: Comments or objections must be received on or before December 8, 
2008.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-317P'' on all written and electronic correspondence. 
Written comments should be sent to the DEA Headquarters, Attn: DEA 
Federal Register Representative/ODL, 8701 Morrissette Drive, 
Springfield, Virginia 22152. Comments may be directly sent to DEA 
electronically by sending an electronic message to 
[email protected]. Comments may also be sent 
electronically through http://www.regulations.gov using the electronic 
comment form provided on that site. An electronic copy of this document 
is also available at the  http://www.regulations.gov Web site. 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, 8701 Morrissette Drive, 
Springfield, Virginia 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.
    The proposed year 2009 aggregate production quotas represent those 
quantities of controlled substances that may be produced in the United 
States in 2009 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 proposed year 2009 aggregate production quotas, 
the Deputy Administrator considered the following factors: Total actual 
2007 and estimated 2008 and 2009 net disposals of each substance by all 
manufacturers; estimates of 2008 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 aggregate production quotas and individual manufacturing quotas 
allocated for the year based upon 2008 year-end inventory and actual 
2008 disposition data supplied by quota recipients for each basic class 
of schedule I or II controlled substance.
    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 2009 aggregate production quotas for the 
following controlled substances, expressed in grams of anhydrous acid 
or base, be established as follows:

------------------------------------------------------------------------
                                                          Proposed 2009
                Basic class--Schedule I                    quotas (g)
------------------------------------------------------------------------
2,5-Dimethoxyamphetamine..............................                 2
2,5-Dimethoxy-4-ethylamphetamine (DOET)...............                 2
3-Methylfentanyl......................................                 2
3-Methylthiofentanyl..................................                 2
3,4-Methylenedioxyamphetamine (MDA)...................                25
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)..........                10
3,4-Methylenedioxymethamphetamine (MDMA)..............                20
3,4,5-Trimethoxyamphetamine...........................                 2

[[Page 66257]]

 
4-Bromo-2,5-dimethoxyamphetamine (DOB)................                 2
4-Bromo-2,5-dimethoxyphenethylamine (2-CB)............                 2
4-Methoxyamphetamine..................................                27
4-Methylaminorex......................................                 2
4-Methyl-2,5-dimethoxyamphetamine (DOM)...............                 2
5-Methoxy-3,4-methylenedioxyamphetamine...............                 2
5-Methoxy-N,N-diisopropyltryptamine...................                 5
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
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.............................................                50
Dihydromorphine.......................................         2,549,000
Dimethyltryptamine....................................                 3
Gamma-hydroxybutyric acid.............................        21,940,000
Heroin................................................                20
Hydromorphinol........................................                 2
Hydroxypethidine......................................                 2
Ibogaine..............................................                 1
Lysergic acid diethylamide (LSD)......................                10
Marihuana.............................................         4,500,000
Mescaline.............................................                 7
Methaqualone..........................................                 5
Methcathinone.........................................                 4
Methyldihydromorphine.................................                 2
Morphine-N-oxide......................................               605
N,N-Dimethylamphetamine...............................                 7
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............................................                 7
Psilocyn..............................................                 7
Tetrahydrocannabinols.................................           312,500
Thiofentanyl..........................................                 2
Trimeperidine.........................................               2 g
------------------------------------------------------------------------
               Basic class--Schedule II                   Proposed 2009
                                                              quotas (g)
------------------------------------------------------------------------
1-Phenylcyclohexylamine...............................                 2
Alfentanil............................................             8,000
Alphaprodine..........................................                 2
Amobarbital...........................................                 3
Amphetamine (for sale)................................        17,000,000
Amphetamine (for conversion)..........................         5,000,000
Cocaine...............................................           247,000
Codeine (for sale)....................................        39,605,000
Codeine (for conversion)..............................        65,000,000
Dextropropoxyphene....................................       106,000,000

[[Page 66258]]

 
Dihydrocodeine........................................         1,200,000
Diphenoxylate.........................................           947,000
Ecgonine..............................................            83,000
Ethylmorphine.........................................                 2
Fentanyl..............................................         1,428,000
Glutethimide..........................................                 2
Hydrocodone (for sale)................................        55,000,000
Hydromorphone.........................................         3,300,000
Isomethadone..........................................                 2
Levo-alphacetylmethadol (LAAM)........................                 3
Levomethorphan........................................                 5
Levorphanol...........................................            10,000
Lisdexamfetamine......................................         6,200,000
Meperidine............................................         8,600,000
Metazocine............................................                 1
Methadone (for sale)..................................        25,000,000
Methadone Intermediate................................        26,000,000
Methamphetamine.......................................         3,130,000
------------------------------------------------------------------------
[680,000 grams of levo-desoxyephedrine for use in a non-controlled, non-
 prescription product; 2,405,000 grams for methamphetamine mostly for
 conversion to a schedule III product; and 45,000 grams for
 methamphetamine (for sale)]
------------------------------------------------------------------------
Methylphenidate.......................................        50,000,000
Morphine (for sale)...................................        35,000,000
Morphine (for conversion).............................       100,000,000
Nabilone..............................................             5,502
Noroxymorphone (for sale).............................            10,000
Noroxymorphone (for conversion).......................         9,000,000
Opium (powder)........................................         1,050,000
Opium (tincture)......................................           230,000
Oripavine.............................................        15,000,000
Oxycodone (for sale)..................................        70,000,000
Oxycodone (for conversion)............................         3,400,000
Oxymorphone (for sale)................................         2,000,000
Oxymorphone (for conversion)..........................        12,000,000
Pentobarbital.........................................        28,000,000
Phenazocine...........................................                 1
Phencyclidine.........................................                20
Phenmetrazine.........................................                 2
Phenylacetone.........................................                 1
Racemethorphan........................................                 2
Remifentanil..........................................               500
Secobarbital..........................................            67,000
Sufentanil............................................            10,300
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 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

[[Page 66259]]

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 
$120,000,000 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: October 31, 2008.
Michele M. Leonhart,
Deputy Administrator.
 [FR Doc. E8-26609 Filed 11-6-08; 8:45 am]
BILLING CODE 4410-09-P