Controlled Substances: Proposed Revised Aggregate Production Quotas for 2006, 38174-38176 [E6-10467]

Download as PDF 38174 Federal Register / Vol. 71, No. 128 / Wednesday, July 5, 2006 / Notices Total Annual Burden Hours: 2,000 hours. Request for Comments The Bureau of Indian Affairs solicits comments in order to: (1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the bureau, including whether the information will have practical utility; (2) Evaluate the bureau’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Enhance the quality, utility and clarity of the information to be collected; and (4) Minimize the burden of the collection of the information on those who are to respond. Please note that the Office of Management and Budget has 60 days after receipt in which to make a decision but may make a decision after 30 days. Therefore, early submissions of comments have a better chance of receiving full consideration. Dated: June 14, 2006. Michael D. Olsen, Acting Principal Deputy Assistant Secretary— Indian Affairs. [FR Doc. E6–10448 Filed 7–3–06; 8:45 am] BILLING CODE 4310–4N–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–270R] Controlled Substances: Proposed Revised Aggregate Production Quotas for 2006 Drug Enforcement Administration (DEA), U.S. Department of Justice. ACTION: Notice of proposed revised 2006 aggregate production quotas. AGENCY: SUMMARY: This notice proposes revised 2006 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 26, 2006. ADDRESSES: To ensure proper handling of comments, please reference ‘‘Docket No. DEA–270R 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/CCD. Written comments sent via express mail should be sent to DEA Headquarters, Attention: DEA Federal Register Representative/CCD, 2401 Jefferson-Davis Highway, Alexandria, VA 22301. Comments may be directly sent to DEA electronically by sending an electronic message to dea.diversion.policy@usdoj.gov. Comments may also be sent electronically through https:// www.regulations.gov using the electronic comment form provided on that site. An electronic copy of this document is also available at the https://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 28 CFR 0.100. The Administrator in turn, has redelegated this function to the Deputy Administrator, pursuant to 28 CFR 0.104. On December 9, 2005, DEA published a notice of established initial 2006 aggregate production quotas for certain controlled substances in Schedules I and II (70 FR 73269). This notice stipulated that the DEA would adjust the quotas in early 2006 as provided for in 21 CFR part 1303. The proposed revised 2006 aggregate production quotas represent those quantities of controlled substances in Schedules I and II that may be produced in the United States in 2006 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 2005 year-end inventories, 2005 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 28 CFR 0.100, and redelegated to the Deputy Administrator pursuant to 28 CFR 0.104, the Deputy Administrator hereby proposes the following revised 2006 aggregate production quotas for the following controlled substances, expressed in grams of anhydrous acid or base: rwilkins on PROD1PC63 with NOTICES Previously established initial 2006 quotas (grams) Basic Class—Schedule I: 2,5–Dimethoxyamphetamine ............................................................................................................................ 2,5–Dimethoxy-4-ethylamphetamine (DOET) .................................................................................................. 3–Methylfentanyl ............................................................................................................................................... 3–Methylthiofentanyl ......................................................................................................................................... 3,4–Methylenedioxyamphetamine (MDA) ........................................................................................................ 3,4–Methylenedioxy-N-ethylamphetamine (MDEA) ......................................................................................... 3,4–Methylenedioxymethamphetamine (MDMA) ............................................................................................. 3,4,5–Trimethoxyamphetamine ........................................................................................................................ 4–Bromo-2,5-dimethoxyamphetamine (DOB) .................................................................................................. 4–Bromo-2,5-dimethoxyphenethylamine (2–CB) ............................................................................................. 4–Methoxyamphetamine .................................................................................................................................. 4–Methylaminorex ............................................................................................................................................ VerDate Aug<31>2005 19:34 Jul 03, 2006 Jkt 205001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 E:\FR\FM\05JYN1.SGM 05JYN1 2,801,000 2 2 2 20 10 22 2 2 2 77 2 Proposed revised 2006 quotas (grams) 2,801,000 2 2 2 20 10 22 2 2 2 77 2 Federal Register / Vol. 71, No. 128 / Wednesday, July 5, 2006 / Notices rwilkins on PROD1PC63 with NOTICES Previously established initial 2006 quotas (grams) 4–Methyl-2,5-dimethoxyamphetamine (DOM) .................................................................................................. 5–Methoxy-3,4-methylenedioxyamphetamine .................................................................................................. Acetyl-alpha-methylfentanyl .............................................................................................................................. Acetyldihydrocodeine ........................................................................................................................................ Acetylmethadol ................................................................................................................................................. Allylprodine ....................................................................................................................................................... Alphacetylmethadol .......................................................................................................................................... Alpha-ethyltryptamine ....................................................................................................................................... Alphameprodine ................................................................................................................................................ Alphamethadol .................................................................................................................................................. Alpha-methylfentanyl ........................................................................................................................................ Alpha-methylthiofentanyl .................................................................................................................................. Aminorex ........................................................................................................................................................... Benzylmorphine ................................................................................................................................................ Betacetylmethadol ............................................................................................................................................ Beta-hydroxy-3-methylfentanyl ......................................................................................................................... Beta-hydroxyfentanyl ........................................................................................................................................ Betameprodine ................................................................................................................................................. Betamethadol .................................................................................................................................................... Betaprodine ...................................................................................................................................................... Bufotenine ......................................................................................................................................................... Cathinone ......................................................................................................................................................... Codeine-N-oxide ............................................................................................................................................... Diethyltryptamine .............................................................................................................................................. Difenoxin ........................................................................................................................................................... Dihydromorphine .............................................................................................................................................. Dimethyltryptamine ........................................................................................................................................... Gamma-hydroxybutyric acid ............................................................................................................................. Heroin ............................................................................................................................................................... Hydromorphinol ................................................................................................................................................ Hydroxypethidine .............................................................................................................................................. Lysergic acid diethylamide (LSD) ..................................................................................................................... Marihuana ......................................................................................................................................................... Mescaline .......................................................................................................................................................... Methaqualone ................................................................................................................................................... Methcathinone .................................................................................................................................................. Methyldihydromorphine .................................................................................................................................... Morphine-N-oxide ............................................................................................................................................. N,N-Dimethylamphetamine ............................................................................................................................... N-Ethylamphetamine ........................................................................................................................................ N-Hydroxy-3,4-methylenedioxyamphetamine ................................................................................................... Noracymethadol ................................................................................................................................................ Norlevorphanol ................................................................................................................................................. Normethadone .................................................................................................................................................. Normorphine ..................................................................................................................................................... Para-fluorofentanyl ........................................................................................................................................... Phenomorphan ................................................................................................................................................. Pholcodine ........................................................................................................................................................ Psilocybin .......................................................................................................................................................... Psilocyn ............................................................................................................................................................ Tetrahydrocannabinols ..................................................................................................................................... Thiofentanyl ...................................................................................................................................................... Trimeperidine .................................................................................................................................................... Basic Class—Schedule II: 1-Phenylcyclohexylamine ................................................................................................................................. Alfentanil ........................................................................................................................................................... Alphaprodine ..................................................................................................................................................... Amobarbital ....................................................................................................................................................... Amphetamine .................................................................................................................................................... Cocaine ............................................................................................................................................................. Codeine (for sale) ............................................................................................................................................. Codeine (for conversion) .................................................................................................................................. Dextropropoxyphene ........................................................................................................................................ Dihydrocodeine ................................................................................................................................................. Diphenoxylate ................................................................................................................................................... Ecgonine ........................................................................................................................................................... Ethylmorphine ................................................................................................................................................... Fentanyl ............................................................................................................................................................ Glutethimide ...................................................................................................................................................... Hydrocodone (for sale) ..................................................................................................................................... Hydrocodone (for conversion) .......................................................................................................................... VerDate Aug<31>2005 19:34 Jul 03, 2006 Jkt 205001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 E:\FR\FM\05JYN1.SGM 05JYN1 38175 Proposed revised 2006 quotas (grams) 12 2 2 2 2 2 2 2 2 3 2 2 2 2 2 2 2 2 2 2 5 3 302 2 5,000 1,826,000 3 8,000,000 5 2 2 61 4,500,000 2 10 4 2 310 2 2 2 2 52 2 16 2 2 2 7 7 312,500 2 2 12 2 2 2 2 2 2 2 2 3 2 2 2 2 2 2 2 2 2 2 5 3 302 2 5,000 1,826,000 3 8,000,000 5 2 2 61 4,500,000 2 10 4 2 310 2 2 2 2 52 2 16 2 2 2 7 7 312,500 2 2 2 5,000 2 101,000 17,000,000 286,000 39,605,000 55,000,000 167,365,000 1,261,000 828,000 83,000 2 1,428,000 2 41,252,000 1,500,000 2 5,000 2 101,000 17,000,000 286,000 39,605,000 55,000,000 167,365,000 1,261,000 828,000 83,000 2 1,428,000 2 41,252,000 1,500,000 38176 Federal Register / Vol. 71, No. 128 / Wednesday, July 5, 2006 / Notices Previously established initial 2006 quotas (grams) rwilkins on PROD1PC63 with NOTICES Hydromorphone ................................................................................................................................................ Isomethadone ................................................................................................................................................... Levo-alphacetylmethadol (LAAM) .................................................................................................................... Levomethorphan ............................................................................................................................................... Levorphanol ...................................................................................................................................................... Meperidine ........................................................................................................................................................ Metazocine ....................................................................................................................................................... Methadone (for sale) ........................................................................................................................................ Methadone Intermediate ................................................................................................................................... Methamphetamine ............................................................................................................................................ [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 ............................................................................................................................................... Morphine (for sale) ........................................................................................................................................... Morphine (for conversion) ................................................................................................................................ Nabilone ............................................................................................................................................................ Noroxymorphone (for sale) ............................................................................................................................... Noroxymorphone (for conversion) .................................................................................................................... Opium ............................................................................................................................................................... Oxycodone (for sale) ........................................................................................................................................ Oxycodone (for conversion) ............................................................................................................................. Oxymorphone ................................................................................................................................................... Pentobarbital ..................................................................................................................................................... Phencyclidine .................................................................................................................................................... Phenmetrazine .................................................................................................................................................. Racemethorphan .............................................................................................................................................. Remifentanil ...................................................................................................................................................... Secobarbital ...................................................................................................................................................... Sufentanil .......................................................................................................................................................... Thebaine ........................................................................................................................................................... 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 abovementioned 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. VerDate Aug<31>2005 19:34 Jul 03, 2006 Jkt 205001 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 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 Proposed revised 2006 quotas (grams) 3,300,000 2 6 5 5,000 9,753,000 1 21,000,000 26,000,000 3,130,000 3,300,000 2 6 5 5,000 9,753,000 1 25,000,000 26,000,000 3,130,000 35,000,000 35,000,000 110,774,000 2 1,002 5,600,000 1,280,000 49,200,000 920,000 534,000 20,335,000 2,021 2 2 2,700 2 6,500 72,453,000 35,000,000 35,000,000 110,774,000 2 1,002 5,600,000 1,280,000 49,200,000 920,000 534,000 28,000,000 2,021 2 2 2,700 2 6,500 72,453,000 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 $118,000,000 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 foreignbased companies in domestic and export markets. Dated: June 26, 2006. Michele M. Leonhart, Deputy Administrator. [FR Doc. E6–10467 Filed 7–3–06; 8:45 am] BILLING CODE 4410–09–P E:\FR\FM\05JYN1.SGM 05JYN1

Agencies

[Federal Register Volume 71, Number 128 (Wednesday, July 5, 2006)]
[Notices]
[Pages 38174-38176]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-10467]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-270R]


Controlled Substances: Proposed Revised Aggregate Production 
Quotas for 2006

AGENCY: Drug Enforcement Administration (DEA), U.S. Department of 
Justice.

ACTION: Notice of proposed revised 2006 aggregate production quotas.

-----------------------------------------------------------------------

SUMMARY: This notice proposes revised 2006 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 26, 2006.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-270R 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/CCD. Written comments sent via express 
mail should be sent to DEA Headquarters, Attention: DEA Federal 
Register Representative/CCD, 2401 Jefferson-Davis Highway, Alexandria, 
VA 22301. Comments may be directly sent to DEA electronically by 
sending an electronic message to dea.diversion.policy@usdoj.gov. 
Comments may also be sent electronically through https://
www.regulations.gov using the electronic comment form provided on that 
site. An electronic copy of this document is also available at the 
https://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 28 CFR 0.100. The Administrator in turn, has redelegated 
this function to the Deputy Administrator, pursuant to 28 CFR 0.104.
    On December 9, 2005, DEA published a notice of established initial 
2006 aggregate production quotas for certain controlled substances in 
Schedules I and II (70 FR 73269). This notice stipulated that the DEA 
would adjust the quotas in early 2006 as provided for in 21 CFR part 
1303.
    The proposed revised 2006 aggregate production quotas represent 
those quantities of controlled substances in Schedules I and II that 
may be produced in the United States in 2006 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 2005 year-end 
inventories, 2005 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 28 CFR 0.100, and redelegated to the Deputy 
Administrator pursuant to 28 CFR 0.104, the Deputy Administrator hereby 
proposes the following revised 2006 aggregate production quotas for the 
following controlled substances, expressed in grams of anhydrous acid 
or base:

------------------------------------------------------------------------
                                            Previously
                                            established      Proposed
                                           initial 2006    revised 2006
                                          quotas (grams)  quotas (grams)
------------------------------------------------------------------------
 Basic Class--Schedule I:
    2,5-Dimethoxyamphetamine............       2,801,000       2,801,000
    2,5-Dimethoxy-4-ethylamphetamine                   2               2
     (DOET).............................
    3-Methylfentanyl....................               2               2
    3-Methylthiofentanyl................               2               2
    3,4-Methylenedioxyamphetamine (MDA).              20              20
    3,4-Methylenedioxy-N-                             10              10
     ethylamphetamine (MDEA)............
    3,4-Methylenedioxymethamphetamine                 22              22
     (MDMA).............................
    3,4,5-Trimethoxyamphetamine.........               2               2
    4-Bromo-2,5-dimethoxyamphetamine                   2               2
     (DOB)..............................
    4-Bromo-2,5-dimethoxyphenethylamine                2               2
     (2-CB).............................
    4-Methoxyamphetamine................              77              77
    4-Methylaminorex....................               2               2

[[Page 38175]]

 
    4-Methyl-2,5-dimethoxyamphetamine                 12              12
     (DOM)..............................
    5-Methoxy-3,4-                                     2               2
     methylenedioxyamphetamine..........
    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-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
    Betaprodine.........................               2               2
    Bufotenine..........................               5               5
    Cathinone...........................               3               3
    Codeine-N-oxide.....................             302             302
    Diethyltryptamine...................               2               2
    Difenoxin...........................           5,000           5,000
    Dihydromorphine.....................       1,826,000       1,826,000
    Dimethyltryptamine..................               3               3
    Gamma-hydroxybutyric acid...........       8,000,000       8,000,000
    Heroin..............................               5               5
    Hydromorphinol......................               2               2
    Hydroxypethidine....................               2               2
    Lysergic acid diethylamide (LSD)....              61              61
    Marihuana...........................       4,500,000       4,500,000
    Mescaline...........................               2               2
    Methaqualone........................              10              10
    Methcathinone.......................               4               4
    Methyldihydromorphine...............               2               2
    Morphine-N-oxide....................             310             310
    N,N-Dimethylamphetamine.............               2               2
    N-Ethylamphetamine..................               2               2
    N-Hydroxy-3,4-                                     2               2
     methylenedioxyamphetamine..........
    Noracymethadol......................               2               2
    Norlevorphanol......................              52              52
    Normethadone........................               2               2
    Normorphine.........................              16              16
    Para-fluorofentanyl.................               2               2
    Phenomorphan........................               2               2
    Pholcodine..........................               2               2
    Psilocybin..........................               7               7
    Psilocyn............................               7               7
    Tetrahydrocannabinols...............         312,500         312,500
    Thiofentanyl........................               2               2
    Trimeperidine.......................               2               2
 Basic Class--Schedule II:
    1-Phenylcyclohexylamine.............               2               2
    Alfentanil..........................           5,000           5,000
    Alphaprodine........................               2               2
    Amobarbital.........................         101,000         101,000
    Amphetamine.........................      17,000,000      17,000,000
    Cocaine.............................         286,000         286,000
    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......................       1,261,000       1,261,000
    Diphenoxylate.......................         828,000         828,000
    Ecgonine............................          83,000          83,000
    Ethylmorphine.......................               2               2
    Fentanyl............................       1,428,000       1,428,000
    Glutethimide........................               2               2
    Hydrocodone (for sale)..............      41,252,000      41,252,000
    Hydrocodone (for conversion)........       1,500,000       1,500,000

[[Page 38176]]

 
    Hydromorphone.......................       3,300,000       3,300,000
    Isomethadone........................               2               2
    Levo-alphacetylmethadol (LAAM)......               6               6
    Levomethorphan......................               5               5
    Levorphanol.........................           5,000           5,000
    Meperidine..........................       9,753,000       9,753,000
    Metazocine..........................               1               1
    Methadone (for sale)................      21,000,000      25,000,000
    Methadone Intermediate..............      26,000,000      26,000,000
    Methamphetamine.....................       3,130,000       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.....................      35,000,000      35,000,000
    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).....       5,600,000       5,600,000
    Opium...............................       1,280,000       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.......................      20,335,000      28,000,000
    Phencyclidine.......................           2,021           2,021
    Phenmetrazine.......................               2               2
    Racemethorphan......................               2               2
    Remifentanil........................           2,700           2,700
    Secobarbital........................               2               2
    Sufentanil..........................           6,500           6,500
    Thebaine............................      72,453,000      72,453,000
------------------------------------------------------------------------

    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 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 
$118,000,000 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: June 26, 2006.
Michele M. Leonhart,
Deputy Administrator.
 [FR Doc. E6-10467 Filed 7-3-06; 8:45 am]
BILLING CODE 4410-09-P
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