[Federal Register Volume 74, Number 140 (Thursday, July 23, 2009)]
[Notices]
[Pages 36511-36515]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-17536]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-317R]


Controlled Substances: Proposed Revised Aggregate Production 
Quotas for 2009

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of proposed revised 2009 aggregate production quotas.

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SUMMARY: This notice proposes revised 2009 aggregate production quotas 
for

[[Page 36512]]

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 August 24, 2009.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-317R'' 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, Ph.D., Chief, 
Drug and Chemical Evaluation Section, Drug Enforcement Administration, 
8701 Morrissette Drive, Springfield, VA 22152, or by telephone at (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 November 7, 2008, a notice of proposed 2009 aggregate production 
quotas for certain controlled substances in schedules I and II was 
published in the Federal Register (73 FR 66256). This notice stipulated 
that the DEA would adjust the quotas in 2009 as provided for in 21 CFR 
part 1303.
    The proposed revised 2009 aggregate production quotas represent 
those quantities of controlled substances in schedules I and II 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.
    The proposed revisions are based on a review of 2008 year-end 
inventories, 2008 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 2009 aggregate production quotas for the 
following controlled substances, expressed in grams of anhydrous acid 
or base:

------------------------------------------------------------------------
                                      Previously
                                      established      Proposed revised
     Basic class--schedule I         initial  2009        2009 quotas
                                        quotas
------------------------------------------------------------------------
2,5-Dimethoxyamphetamine........                 2 g                 2 g
2,5-Dimethoxy-4-ethylamphetamine                 2 g                 2 g
 (DOET).........................
3-Methylfentanyl................                 2 g                 2 g
3-Methylthiofentanyl............                 2 g                 2 g
3,4-Methylenedioxyamphetamine                   25 g                25 g
 (MDA)..........................
3,4-Methylenedioxy-N-                           10 g                10 g
 ethylamphetamine (MDEA)........
3,4-                                            20 g                20 g
 Methylenedioxymethamphetamine
 (MDMA).........................
3,4,5-Trimethoxyamphetamine.....                 2 g                 2 g
4-Bromo-2,5-dimethoxyamphetamine                 2 g                 2 g
 (DOB)..........................
4-Bromo-2,5-                                     2 g                 2 g
 dimethoxyphenethylamine (2-CB).
4-Methoxyamphetamine............                27 g                27 g
4-Methylaminorex................                 2 g                 2 g
4-Methyl-2,5-                                    2 g                 2 g
 dimethoxyamphetamine (DOM).....
5-Methoxy-3,4-                                   2 g                 2 g
 methylenedioxyamphetamine......
5-Methoxy-N,N-                                   5 g                 5 g
 diisopropyltryptamine..........
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
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

[[Page 36513]]

 
Diethyltryptamine...............                 2 g                 2 g
Difenoxin.......................             3,000 g             3,000 g
Dihydromorphine.................         2,549,000 g         2,549,000 g
Dimethyltryptamine..............                 3 g                 3 g
Gamma-hydroxybutyric acid.......         24,200,00 g        24,200,000 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)                10 g                10 g
Marihuana.......................         4,500,000 g         4,500,000 g
Mescaline.......................                 7 g                 7 g
Methaqualone....................                 5 g                 5 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                 7 g
N-Ethylamphetamine..............                 2 g                 2 g
N-Hydroxy-3,4-                                   2 g                 2 g
 methylenedioxyamphetamine......
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                 7 g
Psilocyn........................                 7 g                 7 g
Tetrahydrocannabinols...........           312,500 g           312,500 g
Thiofentanyl....................                 2 g                 2 g
Trimeperidine...................                 2 g                 2 g
------------------------------------------------------------------------


------------------------------------------------------------------------
                                      Previously
                                      established      Proposed revised
    Basic class--schedule II         initial  2009        2009 quotas
                                        quotas
------------------------------------------------------------------------
1-Phenylcyclohexylamine.........                 2 g                 2 g
1-                                               2 g                 2 g
 Piperdinocyclohexanecarbonitril
 e..............................
Alfentanil......................             8,000 g             8,000 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)....         5,000,000 g         5,000,000 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       106,000,000 g
Dihydrocodeine..................         1,200,000 g         1,200,000 g
Diphenoxylate...................           947,000 g           947,000 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         3,300,000 g
Isomethadone....................                 2 g                 2 g
Levo-alphacetylmethadol (LAAM)..                 3 g                 3 g
Levomethorphan..................                 5 g                 5 g
Levorphanol.....................            10,000 g            10,000 g
Lisdexamfetamine................         6,200,000 g         6,200,000 g
Meperidine......................         8,600,000 g         8,600,000 g
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        25,000,000 g
Methadone Intermediate..........        26,000,000 g        26,000,000 g
Methamphetamine.................         3,130,000 g         3,130,000 g
------------------------------------------------------------------------

[[Page 36514]]

 
[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        50,000,000 g
Morphine (for sale).............        35,000,000 g        35,000,000 g
Morphine (for conversion).......       100,000,000 g       100,000,000 g
Nabilone........................             9,002 g             9,002 g
Noroxymorphone (for sale).......            10,000 g            10,000 g
Noroxymorphone (for conversion).         9,000,000 g         9,000,000 g
Opium (powder)..................         1,050,000 g           230,000 g
Opium (tincture)................           230,000 g         1,050,000 g
Oripavine.......................        15,000,000 g        15,000,000 g
Oxycodone (for sale)............        77,560,000 g        77,560,000 g
Oxycodone (for conversion)......         3,400,000 g         3,400,000 g
Oxymorphone.....................         2,000,000 g         2,000,000 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                20 g
Phenmetrazine...................                 2 g                 2 g
Phenylacetone...................                 1 g                 1 g
Racemethorphan..................                 2 g                 2 g
Remifentanil....................               500 g               500 g
Secobarbital....................            67,000 g            67,000 g
Sufentanil......................            10,300 g            10,300 g
Tapentadol \1\..................                 0 g           519,000 g
Thebaine........................       126,000,000 g       126,000,000 g
------------------------------------------------------------------------
\1\ Tapentadol was placed in schedule II of the Controlled Substances
  Act by a final order published by the Drug Enforcement Administration
  on May 21, 2009 (74 FR 23790).

    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 
$120,000,000 or more (adjusted for inflation) 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.

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,

[[Page 36515]]

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 16, 2009.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E9-17536 Filed 7-22-09; 8:45 am]
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