[Federal Register Volume 74, Number 97 (Thursday, May 21, 2009)]
[Notices]
[Pages 23881-23884]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-11929]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-318P]


Controlled Substances: Proposed Aggregate Production Quotas for 
2010

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of proposed year 2010 aggregate production quotas.

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SUMMARY: This notice proposes initial year 2010 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 June 22, 
2009.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-318P'' 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, Ph.D., 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 Section 0.100. The Administrator, in turn, has 
redelegated this function to the Deputy Administrator, pursuant to 28 
CFR Section 0.104.
    The proposed year 2010 aggregate production quotas represent those 
quantities of controlled substances 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.
    In determining the year 2010 aggregate production quotas, the 
Deputy Administrator considered the following factors: Total actual 
2008 and estimated 2009 and 2010 net disposals of each substance by all 
manufacturers; estimates of 2009 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 Section 
1303.12; and other pertinent information.
    Pursuant to 21 CFR Section 1303, the Deputy Administrator of the 
DEA will adjust the 2010 aggregate production quotas and individual 
manufacturing quotas allocated for the year based upon 2009 year-end 
inventory and actual 2009 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 
Sec.  306 of the CSA of 1970 (21 U.S.C. 826), and delegated to the 
Administrator of the DEA by 28 CFR Section 0.100, and redelegated to 
the Deputy Administrator pursuant to 28 CFR Section 0.104, the Deputy 
Administrator hereby proposes that the year 2010 aggregate production 
quotas for the following controlled substances, expressed in grams of 
anhydrous acid or base, be established as follows:

------------------------------------------------------------------------
         Basic class--schedule I              Established 2010 quotas
------------------------------------------------------------------------
2,5-Dimethoxyamphetamine................  2 g
2,5-Dimethoxy-4-ethylamphetamine (DOET).  2 g
3-Methylfentanyl........................  2 g
3-Methylthiofentanyl....................  2 g
3,4-Methylenedioxyamphetamine (MDA).....  25 g
3,4-Methylenedioxy-N-ethylamphetamine     10 g
 (MDEA).
3,4-Methylenedioxymethamphetamine (MDMA)  20 g
3,4,5-Trimethoxyamphetamine.............  2 g
4-Bromo-2,5-dimethoxyamphetamine (DOB)..  2 g
4-Bromo-2,5-dimethoxyphenethylamine (2-   2 g
 CB).
4-Methoxyamphetamine....................  27 g
4-Methylaminorex........................  2 g
4-Methyl-2,5-dimethoxyamphetamine (DOM).  2 g
5-Methoxy-3,4-methylenedioxyamphetamine.  2 g
5-Methoxy-N,N-diisopropyltryptamine.....  5 g
Acetyl-alpha-methylfentanyl.............  2 g
Acetyldihydrocodeine....................  2 g
Acetylmethadol..........................  2 g
Allylprodine............................  2 g
Alphacetylmethadol......................  2 g
Alpha-ethyltryptamine...................  2 g
Alphameprodine..........................  2 g
Alphamethadol...........................  2 g

[[Page 23882]]

 
Alpha-methylfentanyl....................  2 g
Alpha-methylthiofentanyl................  2 g
Aminorex................................  2 g
Benzylmorphine..........................  2 g
Betacetylmethadol.......................  2 g
Beta-hydroxy-3-methylfentanyl...........  2 g
Beta-hydroxyfentanyl....................  2 g
Betameprodine...........................  2 g
Betamethadol............................  2 g
Betaprodine.............................  2 g
Bufotenine..............................  3 g
Cathinone...............................  3 g
Codeine-N-oxide.........................  602 g
Diethyltryptamine.......................  2 g
Difenoxin...............................  3,000 g
Dihydromorphine.........................  2,549,000 g
Dimethyltryptamine......................  3 g
Gamma-hydroxybutyric acid...............  24,200,000 g
Heroin..................................  20 g
Hydromorphinol..........................  2 g
Hydroxypethidine........................  2 g
Ibogaine................................  1 g
Lysergic acid diethylamide (LSD)........  10 g
Marihuana...............................  4,500,000 g
Mescaline...............................   7g
Methaqualone............................  5 g
Methcathinone...........................  4 g
Methyldihydromorphine...................  2 g
Morphine-N-oxide........................  605 g
N-Benzylpiperazine......................  2 g
N,N-Dimethylamphetamine.................  7 g
N-Ethylamphetamine......................  2 g
N-Hydroxy-3,4-methylenedioxyamphetamine.  2 g
Noracymethadol..........................  2 g
Norlevorphanol..........................  52 g
Normethadone............................  2 g
Normorphine.............................  16 g
Para-fluorofentanyl.....................  2 g
Phenomorphan............................  2 g
Pholcodine..............................  2 g
Psilocybin..............................  7 g
Psilocyn................................  7 g
Tetrahydrocannabinols...................  312,500 g
Thiofentanyl............................  2 g
Trimeperidine...........................  2 g
------------------------------------------------------------------------


------------------------------------------------------------------------
        Basic class--schedule II              Established 2010 quotas
------------------------------------------------------------------------
1-Phenylcyclohexylamine.................  2 g
1-piperdinocyclohexanecarbonitrile......  2 g
Alfentanil 8,...........................  000 g
Alphaprodine............................  2 g
Amobarbital.............................  3 g
Amphetamine (for sale)..................  17,000,000 g
Amphetamine (for conversion)............  5,000,000 g
Cocaine.................................  247,000 g
Codeine (for sale)......................  39,605,000 g
Codeine (for conversion)................  65,000,000 g
Dextropropoxyphene......................  106,000,000 g
Dihydrocodeine..........................  1,200,000 g
Diphenoxylate...........................  947,000 g
Ecgonine................................  83,000 g
Ethylmorphine...........................  2 g
Fentanyl................................  1,428,000 g
Glutethimide............................  2 g
Hydrocodone (for sale)..................  55,000,000 g
Hydromorphone...........................  3,300,000 g
Isomethadone............................  2 g
Levo-alphacetylmethadol (LAAM)..........  3 g
Levomethorphan..........................  5 g
Levorphanol.............................  10,000 g
Lisdexamfetamine........................  6,200,000 g

[[Page 23883]]

 
Meperidine..............................  8,600,000 g
Meperidine Intermediate-A...............  3 g
Meperidine Intermediate-B...............  7 g
Meperidine Intermediate-C...............  3 g
Metazocine..............................  1 g
Methadone (for sale)....................  25,000,000 g
Methadone Intermediate..................  26,000,000 g
Methamphetamine.........................  3,130,000 g
[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 g
Morphine (for sale).....................  35,000,000 g
Morphine (for conversion)...............  100,000,000 g
Nabilone................................  9,002 g
Noroxymorphone (for sale)...............  10,000 g
Noroxymorphone (for conversion).........  9,000,000 g
Opium (powder)..........................  230,000 g
Opium (tincture)........................  1,050,000 g
Oripavine...............................  15,000,000 g
Oxycodone (for sale)....................  77,560,000 g
Oxycodone (for conversion)..............  3,400,000 g
Oxymorphone (for sale)..................  2,000,000 g
Oxymorphone (for conversion)............  12,000,000 g
Pentobarbital...........................  28,000,000 g
Phenazocine.............................  1 g
Phencyclidine...........................  20 g
Phenmetrazine...........................  2 g
Phenylacetone...........................  1 g
Racemethorphan..........................  2 g
Remifentanil............................  500 g
Secobarbital............................  67,000 g
Sufentanil..............................  10,300 g
Tapentadol..............................  519,000 g
Thebaine................................  126,000,000 g
------------------------------------------------------------------------

    The Deputy Administrator further proposes that aggregate production 
quotas for all other schedules I and II controlled substances included 
in 21 CFR Sections 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 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.


[[Page 23884]]


    Dated: May 15, 2009.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E9-11929 Filed 5-20-09; 8:45 am]
BILLING CODE 4410-09-P