Controlled Substances: Proposed Revised Aggregate Production Quotas for 2007, 24608-24611 [E7-8422]

Download as PDF mmaher on DSK3CLS3C1PROD with $$_JOB 24608 Federal Register / Vol. 72, No. 85 / Thursday, May 3, 2007 / Notices approved [by the FDA] for medical use and placed in a Schedule other than Schedule I, DEA cannot grant an application to manufacture * * * these substances to anyone who seeks to manufacture [them] for the purpose of distributing * * * or dispensing [them] to[ ] ‘patients.’ ’’ Id. The Government also argued that marijuana and tetrahydrocannabinols are Schedule I controlled substances under Washington law and that the State’s Medical Use of Marijuana Act creates only ‘‘a narrow exception to the classification of marijuana as a Schedule I controlled substance.’’ Id. at 5–6. According to the Government, the exception allows only a ‘‘qualifying patient’’ to possess marijuana, and such person may only ‘‘ ‘possess no more marijuana than is necessary for the patient’s personal, medical use, not exceeding the amount necessary for a sixty-day supply.’ ’’ Id. at 6 (quoting RCW section 69.51A.040(2)(b)). The Government thus contends that Respondent’s proposed activities go ‘‘well beyond what is permitted to be manufactured under applicable Washington * * * law,’’ and thus Respondent would be non-compliant with state law. Id. (citing 21 U.S.C. 823(a)(2)) (requiring Attorney General to consider ‘‘compliance with applicable State law’’ in considering application to manufacture Schedule I controlled substances). In its submission, Respondent’s owners stated that ‘‘there are no witnesses,’’ that ‘‘[a]ll documents have been submitted,’’ and that ‘‘[o]ther testimony ha[d] been submitted in the’’ questionnaire they had previously sent to DEA. Resp. Letter 1 (July 11, 2006). Respondent’s owners further stated that it was their ‘‘intention to manufacture, package and sell [marijuana] to the various authorized outlets (state pharmacies within the state of Washington).’’ Id. With respect to the legal issue presented, Respondent stated that it is ‘‘[t]he position and law of the State of Washington * * * that certain qualified persons in this State have the right as given by the voice of the people to possess and use marijuana for specific medical needs as described in Washington State law.’’ Id. Respondent further maintained that ‘‘DEA should allow the State of Washington and [itself] to engage [in] the legal and correct distribution of marijuana.’’ Id. Concluding that there were no material facts in dispute, the ALJ granted the Government’s motion. As the ALJ explained, marijuana and tetrahydrocannabinols ‘‘have a high potential for abuse, have no currently accepted medical use in treatment, and VerDate Mar 15 2010 05:02 Aug 19, 2011 Jkt 223001 lack safety for use in treatment under medical supervision.’’ ALJ Dec. at 3. Because ‘‘these substances cannot be manufactured for distribution to patients for medical use,’’ the ALJ concluded that DEA ‘‘cannot register an applicant with the intention to manufacture and distribute contrary to federal law.’’ Id. Finally, the ALJ also held that the Washington state law exception does not ‘‘extend to the manufacturing of these substances and therefore Respondent lacks state authority’’ to conduct its proposed activity. The ALJ thus recommended that I deny Respondent’s application and forwarded the record to me for final agency action. Neither party filed exceptions. Having considered the record as a whole, I adopt the ALJ’s opinion in its entirety and deny Respondent’s application. Section 303(a) of the Controlled Substances Act provides that the ‘‘Attorney General shall register an applicant to manufacture controlled substances in schedule I or II if he determines that such registration is consistent with the public interest.’’ 21 U.S.C. 823(a). While Congress provided six factors to be considered in determining the public interest, id., it is well settled that I may rely on any one or a combination of factors, and may give each factor the weight I deem appropriate in determining whether an application for registration should be denied. See ALRA Laboratories, Inc., 59 FR 50620, 50621 (1994). Moreover, I am ‘‘not required to make findings as to all of the factors.’’ Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005); Morall v. DEA, 412 F.3d 165, 173–74 (D.C. Cir. 2005). Here, it is clear that Respondent’s proposed activity would not comply with applicable Federal and State laws and would be inconsistent with public health and safety. See 21 U.S.C. 823(a)(2) & (6). Congress placed marijuana (and tetrahydrocannabinols) on Schedule I based on its determination that both substances have ‘‘ ‘no currently accepted medical use’ at all.’’ Oakland Cannabis Buyers, 532 U.S. at 483, 491 (2001). Until Congress revises that determination, it is a federal criminal offense to manufacture either of these substances for any purpose other than to supply an FDA preapproved research project. See Gonzales v. Raich, 545 U.S. 1, 14 (2005). Moreover, it also appears that Respondent’s proposed activities would violate Washington law. See State v. Tracy, 147 P.3d 559, 561–62 (Wash. 2006) (upholding conviction for possession and manufacturing of marijuana because ‘‘only qualifying patients are entitled to the defense PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 under the act’’). Accordingly, Respondent’s registration would be inconsistent with the public interest. See 21 U.S.C. 823(a). Order Pursuant to the authority vested in me by 21 U.S.C. 823(a), as well as by 28 CFR 0.100(b) & 0.104, I hereby order that the application of Green Acres Farm, Inc., for a DEA Certificate of Registration to manufacture marijuana and tetrahydrocannabinols be, and it hereby is, denied. This order is effective June 4, 2007. Dated: April 25, 2007. Michele M. Leonhart, Deputy Administrator. [FR Doc. E7–8454 Filed 5–2–07; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–290R] Controlled Substances: Proposed Revised Aggregate Production Quotas for 2007 Drug Enforcement Administration (DEA), Justice. ACTION: Notice of proposed revised 2007 aggregate production quotas. AGENCY: SUMMARY: This notice proposes revised 2007 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 May 24, 2007. ADDRESSES: To ensure proper handling of comments, please reference ‘‘Docket No. DEA–290R 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 E:\FEDREG\03MYN1.LOC 03MYN1 Federal Register / Vol. 72, No. 85 / Thursday, May 3, 2007 / Notices 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. On December 11, 2006, a notice of established initial 2007 aggregate production quotas for certain controlled substances in schedules I and II was published in the Federal Register (71 FR 71559). This notice stipulated that the DEA would adjust the quotas in early 2007 as provided for in 21 CFR Part 1303. The proposed revised 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. mmaher on DSK3CLS3C1PROD with $$_JOB These quotas do not include imports of controlled substances for use in industrial processes. The proposed revisions are based on a review of 2006 year-end inventories, 2006 disposition data submitted by quota applicants, estimates of the medical needs of the United States, product development, and other information available to the DEA. Therefore, under the authority vested in the Attorney General by Section 306 of the CSA (21 U.S.C. 826), and delegated to the Administrator of the DEA by 28 CFR 0.100, and redelegated to the Deputy Administrator pursuant to 28 CFR 0.104, the Deputy Administrator hereby proposes the following revised 2007 aggregate production quotas for the following controlled substances, expressed in grams of anhydrous acid or base: Previously established initial 2007 quotas 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 ........................................................................................................................................... VerDate Mar 15 2010 05:02 Aug 19, 2011 Jkt 223001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 24609 E:\FEDREG\03MYN1.LOC 2,001,000 g 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 13,100,000 5 3,000 2 1 03MYN1 Proposed revised 2007 quotas 2,001,000 g 2 10 2 2 20 10 22 2 2 2 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 13,100,000 5 3,000 2 1 24610 Federal Register / Vol. 72, No. 85 / Thursday, May 3, 2007 / Notices Previously established initial 2007 quotas Basic class—Schedule I 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 ................................................................................................................................... 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 Previously established initial 2007 quotas Basic class—Schedule II 1–Phenylcyclohexylamine ................................................................................................................ Alfentanil .......................................................................................................................................... Alphaprodine .................................................................................................................................... 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 ........................................................................................................................... 2g 7,200 2 3 17,000,000 0 286,000 39,605,000 59,000,000 120,000,000 2,435,000 828,000 83,000 2 1,428,000 2 42,000,000 1,500,000 3,300,000 2 6 5 6,000 0 9,753,000 1 25,000,000 26,000,000 3,130,000 Proposed revised 2007 quotas 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 Proposed revised 2007 quotas 2g 7,200 2 3 17,000,000 2,760,000 286,000 39,605,000 59,000,000 120,000,000 2,435,000 828,000 83,000 2 1,428,000 2 42,000,000 1,500,000 3,300,000 2 6 5 6,000 6,200,000 9,753,000 1 25,000,000 26,000,000 3,130,000 mmaher on DSK3CLS3C1PROD with $$_JOB [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 .................................................................................................................................. Oxymorphone (for conversion) ........................................................................................................ Pentobarbital .................................................................................................................................... Phencyclidine ................................................................................................................................... Phenmetrazine ................................................................................................................................. VerDate Mar 15 2010 05:02 Aug 19, 2011 Jkt 223001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 E:\FEDREG\03MYN1.LOC 35,000,000 g 35,000,000 110,774,000 3,002 1,002 11,000,000 1,400,000 56,000,000 25,000,000 1,800,000 15,300,000 28,000,000 2,021 2 03MYN1 35,000,000 g 35,000,000 110,774,000 3,002 1,002 11,000,000 1,400,000 56,000,000 25,000,000 1,800,000 15,300,000 28,000,000 2,021 2 Federal Register / Vol. 72, No. 85 / Thursday, May 3, 2007 / Notices Previously established initial 2007 quotas Basic class—Schedule II mmaher on DSK3CLS3C1PROD with $$_JOB 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. 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 VerDate Mar 15 2010 05:02 Aug 19, 2011 Jkt 223001 importance to large manufacturers, their impact upon small entities is neither negative nor beneficial. Accordingly, the Deputy Administrator has determined that this action does not require a regulatory flexibility analysis. This action meets the applicable standards set forth in Sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform. This action will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $120,000,000 or more in any one year, and will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995. This action is not a major rule as defined by Section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996. This action will not result in an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreignbased companies in domestic and export markets. Dated: April 25, 2007. Michele M. Leonhart, Deputy Administrator. [FR Doc. E7–8422 Filed 5–2–07; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Federal Bureau of Investigation Meeting of the Compact Council for the National Crime Prevention and Privacy Compact Federal Bureau of Investigation. ACTION: Meeting notice. AGENCY: SUMMARY: The purpose of this notice is to announce a meeting of the National Crime Prevention and Privacy Compact Council (Council) created by the National Crime Prevention and Privacy Compact Act of 1998 (Compact). Thus PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 2 5,000 2 12,300 102,000,000 24611 Proposed revised 2007 quotas 2 5,000 2 12,300 102,000,000 far, the Federal Government and 27 states are parties to the Compact which governs the exchange of criminal history records for licensing, employment, and similar purposes. The Compact also provides a legal framework for the establishment of a cooperative federalstate system to exchange such records. The United States Attorney General appointed 15 persons from federal and state agencies to serve on the Council. The Council will prescribe system rules and procedures for the effective and proper operation of the Interstate Identification Index System. Matters for discussion are expected to include: (1) Establishment of State Noncriminal Justice Audit Programs (2) New National Child Protection Act/Volunteers for Children Act Guidelines (3) New Compact Council Strategic Plan The meeting will be open to the public on a first-come, first-seated basis. Any member of the public wishing to file a written statement with the Council or wishing to address this session of the Council should notify Mr. Todd C. Commodore at (304) 625–2803, at least 24 hours prior to the start of the session. The notification should contain the requestor’s name and corporate designation, consumer affiliation, or government designation, along with a short statement describing the topic to be addressed and the time needed for the presentation. Requesters will ordinarily be allowed up to 15 minutes to present a topic. The Council will meet in open session from 9 a.m. until 5 p.m., on May 23–24, 2007. DATES AND TIMES: The meeting will take place at the Hyatt Regency Louisville, 320 West Jefferson Street, Louisville, Kentucky, telephone (502) 581–1234. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Inquiries may be addressed to Mr. Todd C. Commodore, FBI Compact Officer, Compact Council Office, Module B3, 1000 Custer Hollow Road, Clarksburg, West Virginia 26306–0148, telephone (304) 625–2803, facsimile (304) 625– 2539. E:\FEDREG\03MYN1.LOC 03MYN1

Agencies

[Federal Register Volume 72, Number 85 (Thursday, May 3, 2007)]
[Notices]
[Pages 24608-24611]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-8422]


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

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-290R]


Controlled Substances: Proposed Revised Aggregate Production 
Quotas for 2007

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of proposed revised 2007 aggregate production quotas.

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

SUMMARY: This notice proposes revised 2007 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 May 24, 2007.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-290R 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

[[Page 24609]]

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.
    On December 11, 2006, a notice of established initial 2007 
aggregate production quotas for certain controlled substances in 
schedules I and II was published in the Federal Register (71 FR 71559). 
This notice stipulated that the DEA would adjust the quotas in early 
2007 as provided for in 21 CFR Part 1303.
    The proposed revised 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. 
These quotas do not include imports of controlled substances for use in 
industrial processes.
    The proposed revisions are based on a review of 2006 year-end 
inventories, 2006 disposition data submitted by quota applicants, 
estimates of the medical needs of the United States, product 
development, and other information available to the DEA.
    Therefore, under the authority vested in the Attorney General by 
Section 306 of the CSA (21 U.S.C. 826), and delegated to the 
Administrator of the DEA by 28 CFR 0.100, and redelegated to the Deputy 
Administrator pursuant to 28 CFR 0.104, the Deputy Administrator hereby 
proposes the following revised 2007 aggregate production quotas for the 
following controlled substances, expressed in grams of anhydrous acid 
or base:

------------------------------------------------------------------------
                                   Previously
   Basic class--Schedule I     established initial    Proposed revised
                                   2007 quotas           2007 quotas
------------------------------------------------------------------------
2,5-Dimethoxyamphetamine....           2,001,000 g           2,001,000 g
2,5-Dimethoxy-4-                                 2                     2
 ethylamphetamine (DOET)....
2,5-Dimethoxy-4-(n)-                            10                    10
 propylthiophenethylamine
 (2C-T-7)...................
3-Methylfentanyl............                     2                     2
3-Methylthiofentanyl........                     2                     2
3,4-Methylenedioxyamphetamin                    20                    20
 e (MDA)....................
3,4-Methylenedioxy-N-                           10                    10
 ethylamphetamine (MDEA)....
3,4-Methylenedioxymethamphet                    22                    22
 amine (MDMA)...............
3,4,5-Trimethoxyamphetamine.                     2                     2
4-Bromo-2,5-                                     2                     2
 dimethoxyamphetamine (DOB).
4-Bromo-2,5-                                     7                     2
 dimethoxyphenethylamine (2-
 CB)........................
4-Methoxyamphetamine........                    77                    77
4-Methylaminorex............                     2                     2
4-Methyl-2,5-                                   12                    12
 dimethoxyamphetamine (DOM).
5-Methoxy-3,4-                                   2                     2
 methylenedioxyamphetamine..
5-Methoxy-N,N-                                   5                     5
 diisopropyltryptamine......
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
Alpha-methyltryptamine......                     5                     5
Aminorex....................                     8                     8
Benzylmorphine..............                     2                     2
Betacetylmethadol...........                     2                     2
Beta-hydroxy-3-                                  2                     2
 methylfentanyl.............
Beta-hydroxyfentanyl........                     2                     2
Betameprodine...............                     2                     2
Betamethadol................                     2                     2
Betaprodine.................                     2                     2
Bufotenine..................                     8                     8
Cathinone...................                     3                     3
Codeine-N-oxide.............                   302                   302
Diethyltryptamine...........                     2                     2
Difenoxin...................                    50                    50
Dihydromorphine.............             2,549,000             2,549,000
Dimethyltryptamine..........                     3                     3
Gamma-hydroxybutyric acid...            13,100,000            13,100,000
Heroin......................                     5                     5
Hydromorphinol..............                 3,000                 3,000
Hydroxypethidine............                     2                     2
Ibogaine....................                     1                     1

[[Page 24610]]

 
Lysergic acid diethylamide                      61                    61
 (LSD)......................
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.....                     7                     7
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
------------------------------------------------------------------------


------------------------------------------------------------------------
                                   Previously
  Basic class--Schedule II     established initial    Proposed revised
                                   2007 quotas           2007 quotas
------------------------------------------------------------------------
1-Phenylcyclohexylamine.....                   2 g                   2 g
Alfentanil..................                 7,200                 7,200
Alphaprodine................                     2                     2
Amobarbital.................                     3                     3
Amphetamine (for sale)......            17,000,000            17,000,000
Amphetamine (for conversion)                     0             2,760,000
Cocaine.....................               286,000               286,000
Codeine (for sale)..........            39,605,000            39,605,000
Codeine (for conversion)....            59,000,000            59,000,000
Dextropropoxyphene..........           120,000,000           120,000,000
Dihydrocodeine..............             2,435,000             2,435,000
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)......            42,000,000            42,000,000
Hydrocodone (for conversion)             1,500,000             1,500,000
Hydromorphone...............             3,300,000             3,300,000
Isomethadone................                     2                     2
Levo-alphacetylmethadol                          6                     6
 (LAAM).....................
Levomethorphan..............                     5                     5
Levorphanol.................                 6,000                 6,000
Lisdexamfetamine............                     0             6,200,000
Meperidine..................             9,753,000             9,753,000
Metazocine..................                     1                     1
Methadone (for sale)........            25,000,000            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 g          35,000,000 g
Morphine (for sale).........            35,000,000            35,000,000
Morphine (for conversion)...           110,774,000           110,774,000
Nabilone....................                 3,002                 3,002
Noroxymorphone (for sale)...                 1,002                 1,002
Noroxymorphone (for                     11,000,000            11,000,000
 conversion)................
Opium.......................             1,400,000             1,400,000
Oxycodone (for sale)........            56,000,000            56,000,000
Oxycodone (for conversion)..            25,000,000            25,000,000
Oxymorphone.................             1,800,000             1,800,000
Oxymorphone (for conversion)            15,300,000            15,300,000
Pentobarbital...............            28,000,000            28,000,000
Phencyclidine...............                 2,021                 2,021
Phenmetrazine...............                     2                     2

[[Page 24611]]

 
Racemethorphan..............                     2                     2
Remifentanil................                 5,000                 5,000
Secobarbital................                     2                     2
Sufentanil..................                12,300                12,300
Thebaine....................           102,000,000           102,000,000
------------------------------------------------------------------------

    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 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 
$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.

    Dated: April 25, 2007.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E7-8422 Filed 5-2-07; 8:45 am]
BILLING CODE 4410-09-P