Controlled Substances: Proposed Aggregate Production Quotas for 2008, 48683-48686 [E7-16729]

Download as PDF Federal Register / Vol. 72, No. 164 / Friday, August 24, 2007 / Notices proposed collection of information, including the validity of the methodology and assumptions used; —Enhance the quality, utility, and clarity of the information to be collected; and —Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. yshivers on PROD1PC66 with NOTICES Overview of This Information Collection 14:35 Aug 23, 2007 Jkt 211001 BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–307P] Controlled Substances: Proposed Aggregate Production Quotas for 2008 Drug Enforcement Administration (DEA), Justice. ACTION: Notice of proposed year 2008 aggregate production quotas. AGENCY: (1) Type of Information Collection: Extension of a currently approved collection. (2) Title of the Form/Collection: Application for Import Quota for Ephedrine, Pseudoephedrine, and Phenylpropanolamine. (3) Agency form number, if any and the applicable component of the Department sponsoring the collection: Form number: DEA Form 488. Component: Office of Diversion Control, Drug Enforcement Administration, U.S. Department of Justice. (4) Affected public who will be asked or required to respond, as well as a brief abstract: Primary: Business or other for-profit. Other: None. Abstract: 21 U.S.C. 952 and 21 CFR 1315.34 require that persons who desire to import the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine during the next calendar year shall apply on DEA Form 488 for import quota for such List I chemicals. (5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: DEA estimates that ninety-one (91) individual respondents will apply for import quotas. DEA estimates that each response will take one hour. (6) An estimate of the total public burden (in hours) associated with the collection: DEA estimates that this collection will involve ninety-one (91) annual public burden hours. If additional information is required contact: Lynn Bryant, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Patrick Henry Building, Suite 1600, 601 D Street NW, Washington, DC 20530. VerDate Aug<31>2005 Dated: August 20, 2007. Lynn Bryant, Department Clearance Officer, PRA, Department of Justice. [FR Doc. E7–16792 Filed 8–23–07; 8:45 am] SUMMARY: This notice proposes initial year 2008 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 September 14, 2007. To ensure proper handling of comments, please reference ‘‘Docket No. DEA–307P’’ 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 dea.diversion.policy@usdoj.gov. Comments may also be sent electronically through http:// www.regulations.gov using the electronic comment form provided on that site. An electronic copy of this document is also available at the http:// www.regulations.gov Web site. DEA will accept attachments to electronic comments in Microsoft Word, WordPerfect, Adobe PDF, or Excel file formats only. DEA will not accept any file format other than those specifically listed here. FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, PhD, Chief, Drug and Chemical Evaluation Section, Drug Enforcement Administration, ADDRESSES: PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 48683 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. The proposed year 2008 aggregate production quotas represent those quantities of controlled substances that may be produced in the United States in 2008 to provide adequate supplies of each substance for: The estimated medical, scientific, research, and industrial needs of the United States; lawful export requirements; and the establishment and maintenance of reserve stocks. These quotas do not include imports of controlled substances for use in industrial processes. In determining the proposed year 2008 aggregate production quotas, the Deputy Administrator considered the following factors: Total actual 2006 and estimated 2007 and 2008 net disposals of each substance by all manufacturers; estimates of 2007 year-end inventories of each substance and of any substance manufactured from it and trends in accumulation of such inventories; product development requirements of both bulk and finished dosage form manufacturers; projected demand as indicated by procurement quota applications filed pursuant to 21 CFR 1303.12; and other pertinent information. Pursuant to 21 CFR 1303, the Deputy Administrator of the DEA will, in early 2008, adjust aggregate production quotas and individual manufacturing quotas allocated for the year based upon 2007 year-end inventory and actual 2007 disposition data supplied by quota recipients for each basic class of schedule I or II controlled substance. Therefore, under the authority vested in the Attorney General by Section 306 of the CSA of 1970 (21 U.S.C. 826), and delegated to the Administrator of the DEA by 28 CFR 0.100, and redelegated to the Deputy Administrator pursuant to 28 CFR 0.104, the Deputy Administrator hereby proposes that the year 2008 aggregate production quotas for the following controlled substances, expressed in grams of anhydrous acid or base, be established as follows: E:\FR\FM\24AUN1.SGM 24AUN1 48684 Federal Register / Vol. 72, No. 164 / Friday, August 24, 2007 / Notices Proposed year 2008 quotas (grams) yshivers on PROD1PC66 with NOTICES Basic class—Schedule I 2,5-Dimethoxyamphetamine .......................................................................................................................................................... 2,5-Dimethoxy-4-ethylamphetamine (DOET) ................................................................................................................................ 2,5-Dimethoxy-4-(n)-propylthiophenethylamine (2C-T-7) .............................................................................................................. 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 .......................................................................................................................................................................... 4-Methyl-2,5-dimethoxyamphetamine (DOM) ................................................................................................................................ 5-Methoxy-3,4-methylenedioxyamphetamine ................................................................................................................................ 5-Methoxy-N,N-diisopropyltryptamine ............................................................................................................................................ Acetyl-alpha-methylfentanyl ........................................................................................................................................................... Acetyldihydrocodeine ..................................................................................................................................................................... Acetylmethadol .............................................................................................................................................................................. Allylprodine .................................................................................................................................................................................... Alphacetylmethadol ........................................................................................................................................................................ Alpha-ethyltryptamine .................................................................................................................................................................... Alphameprodine ............................................................................................................................................................................. Alphamethadol ............................................................................................................................................................................... Alpha-methylfentanyl ..................................................................................................................................................................... Alpha-methylthiofentanyl ................................................................................................................................................................ Alpha-methyltryptamine ................................................................................................................................................................. 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 ........................................................................................................................................................................... Ibogaine ......................................................................................................................................................................................... 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 ................................................................................................................................................................................. 1-Phenylcyclohexylamine .............................................................................................................................................................. Alfentanil ........................................................................................................................................................................................ Alphaprodine .................................................................................................................................................................................. VerDate Aug<31>2005 14:35 Aug 23, 2007 Jkt 211001 PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 E:\FR\FM\24AUN1.SGM 24AUN1 2 2 10 2 2 20 10 22 2 2 7 77 2 12 2 5 2 2 2 2 2 2 2 3 2 2 5 8 2 2 2 2 2 2 2 8 3 302 2 50 2,549,000 3 23,600,000 5 3,000 2 1 61 4,500,000 2 10 4 2 310 7 2 2 2 52 2 16 2 2 2 7 7 312,500 2 2 2 5,200 2 Federal Register / Vol. 72, No. 164 / Friday, August 24, 2007 / Notices Proposed year 2008 quotas (grams) Basic class—Schedule I yshivers on PROD1PC66 with NOTICES Amobarbital .................................................................................................................................................................................... Amphetamine (for sale) ................................................................................................................................................................. Amphetamine (for conversion) ...................................................................................................................................................... Cocaine .......................................................................................................................................................................................... Codeine (for sale) .......................................................................................................................................................................... Codeine (for conversion) ............................................................................................................................................................... Dextropropoxyphene ...................................................................................................................................................................... Dihydrocodeine .............................................................................................................................................................................. Diphenoxylate ................................................................................................................................................................................ Ecgonine ........................................................................................................................................................................................ Ethylmorphine ................................................................................................................................................................................ Fentanyl ......................................................................................................................................................................................... Glutethimide ................................................................................................................................................................................... Hydrocodone (for sale) .................................................................................................................................................................. Hydrocodone (for conversion) ....................................................................................................................................................... Hydromorphone ............................................................................................................................................................................. Isomethadone ................................................................................................................................................................................ Levo-alphacetylmethadol (LAAM) .................................................................................................................................................. Levomethorphan ............................................................................................................................................................................ Levorphanol ................................................................................................................................................................................... Lisdexamfetamine .......................................................................................................................................................................... Meperidine ..................................................................................................................................................................................... Metazocine ..................................................................................................................................................................................... Methadone (for sale) ..................................................................................................................................................................... Methadone Intermediate ................................................................................................................................................................ Methamphetamine ......................................................................................................................................................................... Methylphenidate ............................................................................................................................................................................. Morphine (for sale) ........................................................................................................................................................................ Morphine (for conversion) .............................................................................................................................................................. Nabilone ......................................................................................................................................................................................... Noroxymorphone (for sale) ............................................................................................................................................................ Noroxymorphone (for conversion) ................................................................................................................................................. Opium ............................................................................................................................................................................................ Oxycodone (for sale) ..................................................................................................................................................................... Oxycodone (for conversion) .......................................................................................................................................................... Oxymorphone ................................................................................................................................................................................ Oxymorphone (for conversion) ...................................................................................................................................................... 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 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 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 VerDate Aug<31>2005 14:35 Aug 23, 2007 Jkt 211001 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 PO 00000 Frm 00077 Fmt 4703 48685 Sfmt 4703 3 17,000,000 5,000,000 286,000 39,605,000 59,000,000 106,000,000 1,200,000 828,000 83,000 2 1,428,000 2 46,000,000 1,500,000 3,300,000 2 3 5 6,000 6,200,000 9,753,000 1 25,000,000 26,000,000 3,130,000 50,000,000 35,000,000 100,000,000 3,002 1,002 8,000,000 1,400,000 70,000,000 3,100,000 1,800,000 11,000,000 35,200,000 2,021 2 2 3,000 2 10,300 126,000,000 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. E:\FR\FM\24AUN1.SGM 24AUN1 48686 Federal Register / Vol. 72, No. 164 / Friday, August 24, 2007 / Notices 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 foreignbased companies in domestic and export markets. August 15, 2007. Michele M. Leonhart, Deputy Administrator. [FR Doc. E7–16729 Filed 8–23–07; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–290F] Controlled Substances: Final Revised Aggregate Production Quotas for 2007 Drug Enforcement Administration (DEA), Justice. ACTION: Notice of final aggregate production quotas for 2007. AGENCY: yshivers on PROD1PC66 with NOTICES SUMMARY: This notice establishes final 2007 aggregate production quotas for controlled substances in schedules I and II of the Controlled Substances Act (CSA). The DEA has taken into consideration comments received in response to a notice of the proposed revised aggregate production quotas for 2007 published May 3, 2007 (72 FR 24608). EFFECTIVE DATE: August 24, 2007. FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, PhD, 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. The 2007 aggregate production quotas represent those quantities of controlled substances in schedules I and II that may be produced in the United States in 2007 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 (21 U.S.C. 826(a) and 21 CFR 1303.11). These quotas do not include imports of controlled substances. On May 3, 2007, a notice of the proposed revised 2007 aggregate production quotas for certain controlled substances in schedules I and II was published in the Federal Register (72 FR 24608). All interested persons were invited to comment on or object to these proposed aggregate production quotas on or before May 24, 2007. Nine companies commented on a total of 31 schedules I and II controlled substances within the published comment period. Nine companies proposed that the aggregate production quotas for 14-hydroxymorphinone, alfentanil, amphetamine (for sale), amphetamine (for conversion), cocaine, codeine (for conversion), dextropropoxyphene, dihydromorphine, diphenoxylate, ecgonine, fentanyl, gamma hydroxybutyric acid, hydrocodone, hydromorphone, lisdexamfetamine, meperidine, methadone, methadone intermediate, methylphenidate, morphine, morphine (for conversion), nabilone, noroxymorphone (for conversion), oxycodone, oxymorphone, oxymorphone (for conversion), pentobarbital, remifentanil, sufentanil, tetrahydrocannabinols, and thebaine were insufficient to provide for the estimated medical, scientific, research, and industrial needs of the United States, for export requirements and for the establishment and maintenance of reserve stocks. The DEA has determined that the compound 14-hydroxymorphinone is a morphine derivative. The comment received concerning this substance was therefore, considered as a comment for morphine. DEA has taken into consideration the above comments along with the relevant 2006 year-end inventories, initial 2007 manufacturing quotas, 2007 export requirements, actual and projected 2007 sales, research, product development requirements and additional applications received. Based on this information, the DEA has adjusted the final 2007 aggregate production quotas for 2,5-dimethoxyamphetamine, alfentanil, amphetamine (for conversion), gamma-hydroxybutyric acid, hydrocodone, methylphenidate, oxycodone, oxycodone (for conversion), pentobarbital, remifentanil, sufentanil and thebaine to meet the legitimate needs of the United States. Regarding amphetamine (for sale), cocaine, codeine (for conversion), dextropropoxyphene, dihydromorphine, diphenoxylate, ecgonine, fentanyl, hydromorphone, lisdexamfetamine, meperidine, methadone, methadone intermediate, morphine, morphine (for conversion), nabilone, noroxymorphone (for conversion), oxymorphone, oxymorphone (for conversion), and tetrahydrocannabinols the DEA has determined that the proposed revised 2007 aggregate production quotas are sufficient to meet the current 2007 estimated medical, scientific, research, and industrial needs of the United States and to provide for adequate inventories. 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 orders that the 2007 final aggregate production quotas for the following controlled substances, expressed in grams of anhydrous acid or base, be established as follows: Final revised 2007 quotas (grams) Basic class—Schedule I 2,5-Dimethoxyamphetamine ............................................................................................................................................................ 2,5-Dimethoxy-4-ethylamphetamine (DOET) .................................................................................................................................. 2,5-Dimethoxy-4-(n)-propylthiophenethylamine (2C-T-7) ................................................................................................................ VerDate Aug<31>2005 14:35 Aug 23, 2007 Jkt 211001 PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 E:\FR\FM\24AUN1.SGM 24AUN1 2 2 10

Agencies

[Federal Register Volume 72, Number 164 (Friday, August 24, 2007)]
[Notices]
[Pages 48683-48686]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-16729]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-307P]


Controlled Substances: Proposed Aggregate Production Quotas for 
2008

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of proposed year 2008 aggregate production quotas.

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

SUMMARY: This notice proposes initial year 2008 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 September 
14, 2007.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-307P'' 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 dea.diversion.policy@usdoj.gov. 
Comments may also be sent electronically through http://
www.regulations.gov using the electronic comment form provided on that 
site. An electronic copy of this document is also available at the 
http://www.regulations.gov Web site. DEA will accept attachments to 
electronic comments in Microsoft Word, WordPerfect, Adobe PDF, or Excel 
file formats only. DEA will not accept any file format other than those 
specifically listed here.

FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, PhD, Chief, 
Drug and Chemical Evaluation Section, 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.
    The proposed year 2008 aggregate production quotas represent those 
quantities of controlled substances that may be produced in the United 
States in 2008 to provide adequate supplies of each substance for: The 
estimated medical, scientific, research, and industrial needs of the 
United States; lawful export requirements; and the establishment and 
maintenance of reserve stocks. These quotas do not include imports of 
controlled substances for use in industrial processes.
    In determining the proposed year 2008 aggregate production quotas, 
the Deputy Administrator considered the following factors: Total actual 
2006 and estimated 2007 and 2008 net disposals of each substance by all 
manufacturers; estimates of 2007 year-end inventories of each substance 
and of any substance manufactured from it and trends in accumulation of 
such inventories; product development requirements of both bulk and 
finished dosage form manufacturers; projected demand as indicated by 
procurement quota applications filed pursuant to 21 CFR 1303.12; and 
other pertinent information.
    Pursuant to 21 CFR 1303, the Deputy Administrator of the DEA will, 
in early 2008, adjust aggregate production quotas and individual 
manufacturing quotas allocated for the year based upon 2007 year-end 
inventory and actual 2007 disposition data supplied by quota recipients 
for each basic class of schedule I or II controlled substance.
    Therefore, under the authority vested in the Attorney General by 
Section 306 of the CSA of 1970 (21 U.S.C. 826), and delegated to the 
Administrator of the DEA by 28 CFR 0.100, and redelegated to the Deputy 
Administrator pursuant to 28 CFR 0.104, the Deputy Administrator hereby 
proposes that the year 2008 aggregate production quotas for the 
following controlled substances, expressed in grams of anhydrous acid 
or base, be established as follows:

[[Page 48684]]



------------------------------------------------------------------------
                                                         Proposed year
               Basic class--Schedule I                    2008 quotas
                                                            (grams)
------------------------------------------------------------------------
2,5-Dimethoxyamphetamine.............................                  2
2,5-Dimethoxy-4-ethylamphetamine (DOET)..............                  2
2,5-Dimethoxy-4-(n)-propylthiophenethylamine (2C-T-7)                 10
3-Methylfentanyl.....................................                  2
3-Methylthiofentanyl.................................                  2
3,4-Methylenedioxyamphetamine (MDA)..................                 20
3,4-Methylenedioxy-N-ethylamphetamine (MDEA).........                 10
3,4-Methylenedioxymethamphetamine (MDMA).............                 22
3,4,5-Trimethoxyamphetamine..........................                  2
4-Bromo-2,5-dimethoxyamphetamine (DOB)...............                  2
4-Bromo-2,5-dimethoxyphenethylamine (2-CB)...........                  7
4-Methoxyamphetamine.................................                 77
4-Methylaminorex.....................................                  2
4-Methyl-2,5-dimethoxyamphetamine (DOM)..............                 12
5-Methoxy-3,4-methylenedioxyamphetamine..............                  2
5-Methoxy-N,N-diisopropyltryptamine..................                  5
Acetyl-alpha-methylfentanyl..........................                  2
Acetyldihydrocodeine.................................                  2
Acetylmethadol.......................................                  2
Allylprodine.........................................                  2
Alphacetylmethadol...................................                  2
Alpha-ethyltryptamine................................                  2
Alphameprodine.......................................                  2
Alphamethadol........................................                  3
Alpha-methylfentanyl.................................                  2
Alpha-methylthiofentanyl.............................                  2
Alpha-methyltryptamine...............................                  5
Aminorex.............................................                  8
Benzylmorphine.......................................                  2
Betacetylmethadol....................................                  2
Beta-hydroxy-3-methylfentanyl........................                  2
Beta-hydroxyfentanyl.................................                  2
Betameprodine........................................                  2
Betamethadol.........................................                  2
Betaprodine..........................................                  2
Bufotenine...........................................                  8
Cathinone............................................                  3
Codeine-N-oxide......................................                302
Diethyltryptamine....................................                  2
Difenoxin............................................                 50
Dihydromorphine......................................          2,549,000
Dimethyltryptamine...................................                  3
Gamma-hydroxybutyric acid............................         23,600,000
Heroin...............................................                  5
Hydromorphinol.......................................              3,000
Hydroxypethidine.....................................                  2
Ibogaine.............................................                  1
Lysergic acid diethylamide (LSD).....................                 61
Marihuana............................................          4,500,000
Mescaline............................................                  2
Methaqualone.........................................                 10
Methcathinone........................................                  4
Methyldihydromorphine................................                  2
Morphine-N-oxide.....................................                310
N,N-Dimethylamphetamine..............................                  7
N-Ethylamphetamine...................................                  2
N-Hydroxy-3,4-methylenedioxyamphetamine..............                  2
Noracymethadol.......................................                  2
Norlevorphanol.......................................                 52
Normethadone.........................................                  2
Normorphine..........................................                 16
Para-fluorofentanyl..................................                  2
Phenomorphan.........................................                  2
Pholcodine...........................................                  2
Psilocybin...........................................                  7
Psilocyn.............................................                  7
Tetrahydrocannabinols................................            312,500
Thiofentanyl.........................................                  2
Trimeperidine........................................                  2
1-Phenylcyclohexylamine..............................                  2
Alfentanil...........................................              5,200
Alphaprodine.........................................                  2

[[Page 48685]]

 
Amobarbital..........................................                  3
Amphetamine (for sale)...............................         17,000,000
Amphetamine (for conversion).........................          5,000,000
Cocaine..............................................            286,000
Codeine (for sale)...................................         39,605,000
Codeine (for conversion).............................         59,000,000
Dextropropoxyphene...................................        106,000,000
Dihydrocodeine.......................................          1,200,000
Diphenoxylate........................................            828,000
Ecgonine.............................................             83,000
Ethylmorphine........................................                  2
Fentanyl.............................................          1,428,000
Glutethimide.........................................                  2
Hydrocodone (for sale)...............................         46,000,000
Hydrocodone (for conversion).........................          1,500,000
Hydromorphone........................................          3,300,000
Isomethadone.........................................                  2
Levo-alphacetylmethadol (LAAM).......................                  3
Levomethorphan.......................................                  5
Levorphanol..........................................              6,000
Lisdexamfetamine.....................................          6,200,000
Meperidine...........................................          9,753,000
Metazocine...........................................                  1
Methadone (for sale).................................         25,000,000
Methadone Intermediate...............................         26,000,000
Methamphetamine......................................          3,130,000
Methylphenidate......................................         50,000,000
Morphine (for sale)..................................         35,000,000
Morphine (for conversion)............................        100,000,000
Nabilone.............................................              3,002
Noroxymorphone (for sale)............................              1,002
Noroxymorphone (for conversion)......................          8,000,000
Opium................................................          1,400,000
Oxycodone (for sale).................................         70,000,000
Oxycodone (for conversion)...........................          3,100,000
Oxymorphone..........................................          1,800,000
Oxymorphone (for conversion).........................         11,000,000
Pentobarbital........................................         35,200,000
Phencyclidine........................................              2,021
Phenmetrazine........................................                  2
Racemethorphan.......................................                  2
Remifentanil.........................................              3,000
Secobarbital.........................................                  2
Sufentanil...........................................             10,300
Thebaine.............................................        126,000,000
------------------------------------------------------------------------

    The Deputy Administrator further proposes that aggregate production 
quotas for all other schedules I and II controlled substances included 
in 21 CFR 1308.11 and 1308.12 be established at zero.
    All interested persons are invited to submit their comments in 
writing or electronically regarding this proposal following the 
procedures in the addresses section of this document. A person may 
object to or comment on the proposal relating to any of the above-
mentioned substances without filing comments or objections regarding 
the others. If a person believes that one or more of these issues 
warrant a hearing, the individual should so state and summarize the 
reasons for this belief.
    In the event that comments or objections to this proposal raise one 
or more issues which the Deputy Administrator finds warrant a hearing, 
the Deputy Administrator shall order a public hearing by notice in the 
Federal Register, summarizing the issues to be heard and setting the 
time for the hearing.
    The Office of Management and Budget has determined that notices of 
aggregate production quotas are not subject to centralized review under 
Executive Order 12866.
    This action does not preempt or modify any provision of state law; 
nor does it impose enforcement responsibilities on any state; nor does 
it diminish the power of any state to enforce its own laws. 
Accordingly, this action does not have federalism implications 
warranting the application of Executive Order 13132.
    The Deputy Administrator hereby certifies that this action will 
have no significant impact upon small entities whose interests must be 
considered under the Regulatory Flexibility Act, 5 U.S.C. 601 et seq. 
The establishment of aggregate production quotas for schedules I and II 
controlled substances is mandated by law and by international treaty 
obligations. The quotas are necessary to provide for the estimated 
medical, scientific, research and industrial needs of the United 
States, for export requirements and the establishment and maintenance 
of reserve stocks. While aggregate production quotas are of primary 
importance to large manufacturers, their impact upon small entities is 
neither negative nor beneficial. Accordingly, the Deputy Administrator 
has determined that this action does not require a regulatory 
flexibility analysis.

[[Page 48686]]

    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.

    August 15, 2007.
Michele M. Leonhart,
Deputy Administrator.
 [FR Doc. E7-16729 Filed 8-23-07; 8:45 am]
BILLING CODE 4410-09-P