[Federal Register Volume 70, Number 150 (Friday, August 5, 2005)]
[Notices]
[Pages 45432-45435]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-15493]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-259R]


Controlled Substances: Proposed Revised Aggregate Production 
Quotas for 2005

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of proposed revised 2005 aggregate production quotas.

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SUMMARY: This notice proposes revised 2005 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

[[Page 45433]]

must be sent, on or before August 26, 2005.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-259R on all written and electronic correspondence. 
Written comments being sent via regular mail should be sent to the 
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration, Washington, DC 20537, Attention: DEA 
Federal Register Representative/ODL. Written comments sent via express 
mail should be sent to DEA Headquarters, Attention: DEA Federal 
Register Representative/ODL, 2401 Jefferson-Davis Highway, Alexandria, 
VA 22301. 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, Ph.D., Chief, 
Drug and Chemical Evaluation Section, Drug Enforcement Administration, 
Washington, DC 20537, 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 Section 0.100 of Title 28 of the Code of Federal 
Regulations. The Administrator, in turn, has redelegated this function 
to the Deputy Administrator, pursuant to Section 0.104 of Title 28 of 
the Code of Federal Regulations.
    On January 3, 2005, DEA published a notice of established initial 
2005 aggregate production quotas for certain controlled substances in 
Schedules I and II (70 FR 120). This notice stipulated that the DEA 
would adjust the quotas in early 2005 as provided for in Part 1303 of 
Title 21 of the Code of Federal Regulations.
    The proposed revised 2005 aggregate production quotas represent 
those quantities of controlled substances in Schedules I and II that 
may be produced in the United States in 2005 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 2004 year-end 
inventories, 2004 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 of 1970 (21 U.S.C. 826), delegated to the 
Administrator of the DEA by Section 0.100 of Title 28 of the Code of 
Federal Regulations, and redelegated to the Deputy Administrator 
pursuant to Section 0.104 of Title 28 of the Code of Federal 
Regulations, the Deputy Administrator hereby proposes the following 
revised 2005 aggregate production quotas for the following controlled 
substances, expressed in grams of anhydrous acid or base:

----------------------------------------------------------------------------------------------------------------
                                                                         Previously
                                                                    established initial   Proposed revised 2005
                      Basic class--schedule I                           2005 quotas          quotas  (grams)
                                                                          (grams)
----------------------------------------------------------------------------------------------------------------
2,5-Dimethoxyamphetamine..........................................            2,801,000                2,801,000
2,5-Dimethoxy-4-ethylamphetamine (DOET)...........................                    2                        2
2,5-Dimethoxy-4-(n)-propylthiophenethylamine......................                   10                       10
3-Methylfentanyl..................................................                    2                        2
3-Methylthiofentanyl..............................................                    2                        2
3,4-Methylenedioxyamphetamine (MDA)...............................                   15                       15
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)......................                    5                        5
3,4-Methylenedioxymethamphetamine(MDMA)...........................                   15                       17
3,4,5-Trimethoxyamphetamine.......................................                    2                        2
4-Bromo-2,5-dimethoxyamphetamine (DOB)............................                    2                        2
4-Bromo-2,5-dimethoxyphenethylamine (2-CB)........................                    2                        2
4-Methoxyamphetamine..............................................                    2                        5
4-Methylaminorex..................................................                    2                        2
4-Methyl-2,5-dimethoxyamphetamine (DOM)...........................                    2                        2
5-Methoxy-3,4-methylenedioxyamphetamine...........................                    2                        2
5-Methoxy-N,N-diisopropyltryptamine (5-MeO-DIPT)..................                   10                       10
Acetyl-alpha-methylfentanyl.......................................                    2                        2
Acetyldihydrocodeine..............................................                    2                        2
Acetylmethadol....................................................                    2                        2
Allylprodine......................................................                    2                        2
Alphacetylmethadol................................................                    2                        2
Alpha-ethyltryptamine.............................................                    2                        2
Alphameprodine....................................................                    2                        2
Alphamethadol.....................................................                    3                        3
Alpha-methyltryptamine (AMT)......................................                   10                       10
Alpha-methylfentanyl..............................................                    2                        2
Alpha-methylthiofentanyl..........................................                    2                        2
Aminorex..........................................................                    2                        2
Benzylmorphine....................................................                    2                        2
Betacetylmethadol.................................................                    2                        2
Beta-hydroxy-3-methylfentanyl.....................................                    2                        2
Beta-hydroxyfentanyl..............................................                    2                        2
Betameprodine.....................................................                    2                        2
Betamethadol......................................................                    2                        2

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Betaprodine.......................................................                    2                        2
Bufotenine........................................................                    2                        2
Cathinone.........................................................                    2                        2
Codeine-N-oxide...................................................                  252                      252
Diethyltryptamine.................................................                    2                        2
Difenoxin.........................................................                5,000                    5,000
Dihydromorphine...................................................            1,551,000                1,826,000
Dimethyltryptamine................................................                    3                        3
Gamma-hydroxybutyric acid.........................................            8,000,000                8,000,000
Heroin............................................................                    2                        2
Hydromorphinol....................................................                    2                        2
Hydroxypethidine..................................................                    2                        2
Lysergic acid diethylamide (LSD)..................................                   61                       61
Marihuana.........................................................              913,020                4,500,000
Mescaline.........................................................                    2                        2
Methaqualone......................................................                    5                        5
Methcathinone.....................................................                    4                        4
Methyldihydromorphine.............................................                    2                        2
Morphine-N-oxide..................................................                  252                      252
N,N-Dimethylamphetamine...........................................                    2                        2
N-Ethylamphetamine................................................                    2                        2
N-Hydroxy-3,4-methylenedioxyamphetamine...........................                    2                        2
Noracymethadol....................................................                    2                        2
Norlevorphanol....................................................                   52                       52
Normethadone......................................................                    2                        2
Normorphine.......................................................                   12                       12
Para-fluorofentanyl...............................................                    2                        2
Phenomorphan......................................................                    2                        2
Pholcodine........................................................                    2                        2
Propiram..........................................................               50,000                   50,000
Psilocybin........................................................                    2                        2
Psilocyn..........................................................                    7                        7
Tetrahydrocannabinols.............................................              312,500                  312,500
Thiofentanyl......................................................                    2                        2
Trimeperidine.....................................................                    2                        2
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----------------------------------------------------------------------------------------------------------------
                                                                             Previously
                                                                        established initial    Proposed revised
                       Basic class--schedule II                             2005 quotas          2005 quotas
                                                                              (grams)              (grams)
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1-Phenylcyclohexylamine...............................................                    2                    2
Alfentanil............................................................                2,500                2,500
Alphaprodine..........................................................                    2                    2
Amobarbital...........................................................                    2                    2
Amphetamine...........................................................           12,700,000           14,500,000
Cocaine...............................................................              228,000              228,000
Codeine (for sale)....................................................           39,605,000           39,605,000
Codeine (for conversion)..............................................           55,000,000           55,000,000
Dextropropoxyphene....................................................          167,365,000          167,365,000
Dihydrocodeine........................................................              748,000              750,000
Diphenoxylate.........................................................              571,000              828,000
Ecgonine..............................................................               53,000               73,000
Ethylmorphine.........................................................                    2                    2
Fentanyl..............................................................            1,428,000            1,428,000
Glutethimide..........................................................                    2                    2
Hydrocodone (for sale)................................................           37,604,000           37,604,000
Hydrocodone (for conversion)..........................................            1,500,000            1,500,000
Hydromorphone.........................................................            2,751,000            3,300,000
Isomethadone..........................................................                    2                    2
Levo-alphacetylmethadol (LAAM)........................................                    2                    2
Levomethorphan........................................................                    2                    2
Levorphanol...........................................................                5,000                5,000
Meperidine............................................................            9,753,000            9,753,000
Metazocine............................................................                    1                    1
Methadone (for sale)..................................................           13,900,000           15,490,000
Methadone Intermediate................................................           18,000,000           19,208,000
Methamphetamine.......................................................            2,932,000            2,340,000
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  [680,000 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 1,615,000 grams
 for methamphetamine mostly for conversion to a Schedule III product; and 45,000 grams for methamphetamine (for
                                                     sale)]
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Methylphenidate.......................................................           30,817,000         35,000,000 g

[[Page 45435]]

 
Morphine (for sale)...................................................           35,000,000           35,000,000
Morphine (for conversion).............................................          110,774,000          110,774,000
Nabilone..............................................................                    2                    2
Noroxymorphone (for sale).............................................                1,002                1,002
Noroxymorphone (for conversion).......................................            4,000,000            4,000,000
Opium.................................................................            1,180,000            1,280,000
Oxycodone (for sale)..................................................           49,200,000           49,200,000
Oxycodone (for conversion)............................................              920,000              920,000
Oxymorphone...........................................................              534,000              534,000
Pentobarbital.........................................................           18,251,000           18,251,000
Phencyclidine.........................................................                2,006                2,006
Phenmetrazine.........................................................                    2                    2
Racemethorphan........................................................                    2                    2
Remifentanil..........................................................                    0                1,800
Secobarbital..........................................................                    2                    2
Sufentanil............................................................                4,000                4,000
Thebaine..............................................................           72,453,000           72,453,000
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    The Deputy Administrator further proposes that aggregate production 
quotas for all other Schedules I and II controlled substances included 
in Sections 1308.11 and 1308.12 of Title 21 of the Code of Federal 
Regulations 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.
    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).
    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 not 
have a 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 
$115,000,000 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: July 29, 2005
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 05-15493 Filed 8-4-05; 8:45 am]
BILLING CODE 4410-09-P