Controlled Substances: Final Revised Aggregate Production Quotas for 2010, 55828-55831 [2010-22785]

Download as PDF 55828 Federal Register / Vol. 75, No. 177 / Tuesday, September 14, 2010 / Notices 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. Overview of This Information Collection (1) Type of Information Collection: Extension of a Currently Approved Collection. (2) Title of the Form/Collection: Certification of Identity. (3) Agency form number, if any, and the applicable component of the Department of Justice sponsoring the collection: Form DOJ–361. Facilities and Administrative Services Staff, Justice Management Division, U.S. Department of Justice. (4) Affected public who will be asked or required to respond, as well as a brief abstract: Primary: American Citizens. Other: Federal Government. The information collection will be used by the Department to identify individuals requesting certain records under the Privacy Act. Without this form an individual cannot obtain the information requested. (5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: It is estimated that 27,000 respondents will complete the form within approximately 30 minutes. (6) An estimate of the total burden (in hours) associated with the collection: There are an estimated 13,500 annual burden hours associated with this collection. If Additional Information is Required Contact: Lynn Murray, Department Clearance Officer, United States Department of Justice, Policy and Planning Staff, Justice Management Division, Suite 1600, Patrick Henry Building, 601 D Street, NW., Washington, DC 20530. Dated: September 8, 2010. Lynn Murray, Department Clearance Officer, PRA, United States Department of Justice. [FR Doc. 2010–22888 Filed 9–13–10; 8:45 am] BILLING CODE 4410–CW–P jlentini on DSKJ8SOYB1PROD with NOTICES DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–318F] Controlled Substances: Final Revised Aggregate Production Quotas for 2010 Drug Enforcement Administration (DEA), Justice. AGENCY: VerDate Mar<15>2010 16:38 Sep 13, 2010 Jkt 220001 Notice of final aggregate production quotas for 2010. ACTION: This notice establishes final 2010 aggregate production quotas for controlled substances in schedules I and II of the Controlled Substances Act (CSA). DEA has taken into consideration comments received in response to a notice of the proposed revised aggregate production quotas for 2010 published June 23, 2010 (75 FR 35838). DATES: Effective Date: September 14, 2010. SUMMARY: FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, Ph.D., Chief, Drug and Chemical Evaluation Section, Drug Enforcement Administration, 8701 Morrissette Drive, Springfield, VA 22152, Telephone: (202) 307–7183. SUPPLEMENTARY INFORMATION: Section 306 of the CSA (21 U.S.C. 826) requires that the Attorney General establish aggregate production quotas for each basic class of controlled substance listed in schedules I and II. This responsibility has been delegated to the Administrator of the DEA by 28 CFR 0.100. The Administrator, in turn, has redelegated this function to the Deputy Administrator, pursuant 28 CFR 0.104. The 2010 aggregate production quotas represent those quantities of controlled substances in schedules I and II that may be produced in the United States in 2010 to provide adequate supplies of each substance for: The estimated medical, scientific, research and industrial needs of the United States; lawful export requirements; and the establishment and maintenance of reserve stocks (21 U.S.C. 826(a) and 21 CFR 1303.11). These quotas do not include imports of controlled substances. On June 23, 2010, a notice of the proposed revised 2010 aggregate production quotas for certain controlled substances in schedules I and II was published in the Federal Register (75 FR 35838). All interested persons were invited to comment on or object to these proposed aggregate production quotas on or before July 23, 2010. Fourteen companies, thirteen DEA registered manufacturers and one nonregistrant, commented on a total of 28 schedules I and II controlled substances within the published comment period. Comments received proposed that the aggregate production quotas for alfentanil, amphetamine (for conversion), amphetamine (for sale), codeine (for conversion), codeine (for sale), dextropropoxyphene, dihydromorphine, diphenoxylate, gamma hydroxybutyric acid, hydrocodone, hydromorphone, PO 00000 Frm 00093 Fmt 4703 Sfmt 4703 lisdexamfetamine, meperidine, methadone, methylphenidate, morphine (for conversion), morphine (for sale), nabilone, opium (tincture), oxycodone (for conversion), oxycodone (for sale), oxymorphone (for sale), remifentanil, sufentanil, tapentadol, tetrahydrocannabinols, thebaine and tilidine 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. DEA has taken into consideration the above comments along with the relevant 2009 year-end inventories, initial 2010 manufacturing quotas, 2010 export requirements, actual and projected 2010 sales, research, product development requirements and additional applications received. Based on this information, the DEA has adjusted the final 2010 aggregate production quotas for alfentanil, amphetamine (for conversion), amphetamine (for sale), carfentanil, dihydromorphine, diphenoxylate, marihuana, morphine (for sale), noroxymorphone (for sale), opium (tincture), oxycodone (for conversion), oxycodone (for sale), oxymorphone (for conversion), oxymorphone (for sale), tapentadol, tetrahydrocannabinols, and tilidine. 4-anilino-N-phenethyl-4-piperidine (ANPP) pursuant to DEA’s final rule published in the Federal Register on June 29, 2010 (75 FR 37295) will be controlled as a schedule II controlled substance on August 30, 2010. As such, DEA has established an aggregate production quota for ANPP to meet the estimated medical, scientific, research, and industrial needs of the United States; lawful export requirements; and the establishment and maintenance of reserve stocks. Regarding codeine (for conversion), codeine (for sale), dextropropoxyphene, gamma hydroxybutyric acid, hydrocodone, hydromorphone, lisdexamfetamine, meperidine, methadone, methylphenidate, morphine (for conversion), nabilone, remifentanil, sufentanil, and thebaine, DEA has determined that the proposed revised 2010 aggregate production quotas are sufficient to meet the current 2010 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 E:\FR\FM\14SEN1.SGM 14SEN1 Federal Register / Vol. 75, No. 177 / Tuesday, September 14, 2010 / Notices Administrator hereby orders that the 2010 final aggregate production quotas for the following controlled substances, 55829 expressed in grams of anhydrous acid or base, be established as follows: Final revised 2010 quotas Basic class jlentini on DSKJ8SOYB1PROD with NOTICES Schedule I 2,5-Dimethoxyamphetamine .......................................................................................................................................................... 2,5-Dimethoxy-4-ethylamphetamine (DOET) ................................................................................................................................ 3-Methylfentanyl ............................................................................................................................................................................. 3-Methylthiofentanyl ....................................................................................................................................................................... 3,4-Methylenedioxyamphetamine (MDA) ...................................................................................................................................... 3,4-Methylenedioxy-N-ethylamphetamine (MDEA) ....................................................................................................................... 3,4-Methylenedioxymethamphetamine (MDMA) ........................................................................................................................... 3,4,5-Trimethoxyamphetamine ...................................................................................................................................................... 4-Bromo-2,5-dimethoxyamphetamine (DOB) ................................................................................................................................ 4-Bromo-2,5-dimethoxyphenethylamine (2-CB) ............................................................................................................................ 4-Methoxyamphetamine ................................................................................................................................................................ 4-Methylaminorex .......................................................................................................................................................................... 4-Methyl-2,5-dimethoxyamphetamine (DOM) ................................................................................................................................ 5-Methoxy-3,4-methylenedioxyamphetamine ................................................................................................................................ Acetyl-alpha-methylfentanyl ........................................................................................................................................................... Acetyldihydrocodeine ..................................................................................................................................................................... Acetylmethadol .............................................................................................................................................................................. Allylprodine .................................................................................................................................................................................... Alphacetylmethadol ........................................................................................................................................................................ Alpha-ethyltryptamine .................................................................................................................................................................... Alphameprodine ............................................................................................................................................................................. Alphamethadol ............................................................................................................................................................................... Alpha-methylfentanyl ..................................................................................................................................................................... Alpha-methylthiofentanyl ................................................................................................................................................................ Alpha-methyltryptamine (AMT) ...................................................................................................................................................... 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-Benzylpiperazine ........................................................................................................................................................................ N,N-Dimethylamphetamine ............................................................................................................................................................ N-Ethylamphetamine ..................................................................................................................................................................... N-Hydroxy-3,4-methylenedioxyamphetamine ................................................................................................................................ Noracymethadol ............................................................................................................................................................................. Norlevorphanol ............................................................................................................................................................................... Normethadone ............................................................................................................................................................................... Normorphine .................................................................................................................................................................................. Para-fluorofentanyl ......................................................................................................................................................................... Phenomorphan .............................................................................................................................................................................. Pholcodine ..................................................................................................................................................................................... Psilocybin ....................................................................................................................................................................................... Psilocyn .......................................................................................................................................................................................... Tetrahydrocannabinols .................................................................................................................................................................. Thiofentanyl ................................................................................................................................................................................... VerDate Mar<15>2010 16:38 Sep 13, 2010 Jkt 220001 PO 00000 Frm 00094 Fmt 4703 Sfmt 4703 E:\FR\FM\14SEN1.SGM 14SEN1 2 2 2 2 20 10 20 2 2 2 77 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 3 3 602 2 3,000 3,608,000 3 52,156,000 20 2 2 1 15 21,000 5 7 4 2 605 2 2 2 2 2 52 2 16 2 2 2 2 2 264,000 2 g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g 55830 Federal Register / Vol. 75, No. 177 / Tuesday, September 14, 2010 / Notices Final revised 2010 quotas Basic class Tilidine ............................................................................................................................................................................................ Trimeperidine ................................................................................................................................................................................. 10 g 2g Schedule II 1-Phenylcyclohexylamine .............................................................................................................................................................. 4-anilino-N-phenethyl-4-piperidine (ANPP) ................................................................................................................................... Alfentanil ........................................................................................................................................................................................ Alphaprodine .................................................................................................................................................................................. Amobarbital .................................................................................................................................................................................... Amphetamine (for conversion) ...................................................................................................................................................... Amphetamine (for sale) ................................................................................................................................................................. Carfentanil ...................................................................................................................................................................................... Cocaine .......................................................................................................................................................................................... Codeine (for conversion) ............................................................................................................................................................... Codeine (for sale) .......................................................................................................................................................................... Dextropropoxyphene ...................................................................................................................................................................... Dihydrocodeine .............................................................................................................................................................................. Diphenoxylate ................................................................................................................................................................................ Ecgonine ........................................................................................................................................................................................ Ethylmorphine ................................................................................................................................................................................ Fentanyl ......................................................................................................................................................................................... Glutethimide ................................................................................................................................................................................... Hydrocodone .................................................................................................................................................................................. Hydromorphone ............................................................................................................................................................................. Isomethadone ................................................................................................................................................................................ Levo-alphacetylmethadol (LAAM) .................................................................................................................................................. Levomethorphan ............................................................................................................................................................................ Levorphanol ................................................................................................................................................................................... Lisdexamfetamine .......................................................................................................................................................................... Meperidine ..................................................................................................................................................................................... Meperidine Intermediate-A ............................................................................................................................................................ Meperidine Intermediate-B ............................................................................................................................................................ Meperidine Intermediate-C ............................................................................................................................................................ Metazocine ..................................................................................................................................................................................... Methadone ..................................................................................................................................................................................... Methadone Intermediate ................................................................................................................................................................ Methamphetamine ......................................................................................................................................................................... 2 1,100,000 8,000 2 3 7,500,000 18,600,000 200 247,000 65,000,000 39,605,000 92,000,000 800,000 827,000 83,000 2 1,428,000 2 55,000,000 3,455,000 11 3 5 10,000 9,000,000 6,600,000 3 7 3 1 20,000,000 26,000,000 3,130,000 g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g g jlentini on DSKJ8SOYB1PROD with NOTICES 750,000 g of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 2,331,000 g for methamphetamine (for conversion) mostly for conversion to a schedule III product; and 49,000 g for methamphetamine (for sale) Methylphenidate ............................................................................................................................................................................. Morphine (for conversion) .............................................................................................................................................................. Morphine (for sale) ........................................................................................................................................................................ Nabilone ......................................................................................................................................................................................... Noroxymorphone (for conversion) ................................................................................................................................................. Noroxymorphone (for sale) ............................................................................................................................................................ Opium (powder) ............................................................................................................................................................................. Opium (tincture) ............................................................................................................................................................................. Oripavine ........................................................................................................................................................................................ Oxycodone (for conversion) .......................................................................................................................................................... Oxycodone (for sale) ..................................................................................................................................................................... Oxymorphone (for conversion) ...................................................................................................................................................... Oxymorphone (for sale) ................................................................................................................................................................. Pentobarbital .................................................................................................................................................................................. Phenazocine .................................................................................................................................................................................. Phencyclidine ................................................................................................................................................................................. Phenmetrazine ............................................................................................................................................................................... Phenylacetone ............................................................................................................................................................................... Racemethorphan ........................................................................................................................................................................... Remifentanil ................................................................................................................................................................................... Secobarbital ................................................................................................................................................................................... Sufentanil ....................................................................................................................................................................................... Tapentadol ..................................................................................................................................................................................... Thebaine ........................................................................................................................................................................................ The Deputy Administrator further orders that the aggregate production quotas for all other schedule I and II VerDate Mar<15>2010 16:38 Sep 13, 2010 Jkt 220001 controlled substances included in 21 CFR 1308.11 and 1308.12 shall be zero. PO 00000 Frm 00095 Fmt 4703 Sfmt 4703 50,000,000 83,000,000 39,000,000 9,002 9,000,000 41,000 230,000 1,500,000 15,000,000 5,600,000 105,500,000 12,800,000 3,070,000 28,000,000 1 14 2 12,500,001 2 2,500 67,000 7,000 1,000,000 126,000,000 g g g g g g g g g g g g g g g g g g g g g g g g The Office of Management and Budget has determined that notices of aggregate production quotas are not subject to E:\FR\FM\14SEN1.SGM 14SEN1 jlentini on DSKJ8SOYB1PROD with NOTICES Federal Register / Vol. 75, No. 177 / Tuesday, September 14, 2010 / Notices centralized review under Executive Order 12866. This action does not preempt or modify any provision of state law; nor does it impose enforcement responsibilities on any state; nor does it diminish the power of any state to enforce its own laws. Accordingly, this action does not have federalism implications warranting the application of Executive Order 13132. The Deputy Administrator hereby certifies that this action will have no significant impact upon small entities whose interests must be considered under the Regulatory Flexibility Act, 5 U.S.C. 601 et seq. The establishment of aggregate production quotas for schedules I and II controlled substances is mandated by law and by international treaty obligations. The quotas are necessary to provide for the estimated medical, scientific, research and industrial needs of the United States, for export requirements and the establishment and maintenance of reserve stocks. While aggregate production quotas are of primary importance to large manufacturers, their impact upon small entities is neither negative nor beneficial. Accordingly, the Deputy Administrator has determined that this action does not require a regulatory flexibility analysis. This action meets the applicable standards set forth in Sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform. This action will not result in the expenditure by state, local, and tribal governments, in the aggregate, or by the private sector, of $126,400,000 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: September 2, 2010. Michele M. Leonhart, Deputy Administrator. [FR Doc. 2010–22785 Filed 9–13–10; 8:45 am] BILLING CODE 4410–09–P VerDate Mar<15>2010 16:38 Sep 13, 2010 Jkt 220001 OFFICE OF NATIONAL DRUG CONTROL POLICY Appointment of Members of Senior Executive Services Performance Review Board. Office of National Drug Control Policy [ONDCP]. ACTION: Notice of Appointments. AGENCY: Heading: Appointment of Members of Senior Executive Services Performance Review Board. SUMMARY: The following persons have been appointed to the ONDCP Senior Executive Service Performance Review Board: Dr. Terry Zobeck, Ms. Martha Gagne, Ms. Christine Leonard, and Mr. Patrick Ward. FOR FURTHER INFORMATION CONTACT: Please direct any questions to Linda V. Priebe, Deputy General Counsel (202) 395–6622, Office of National Drug Control Policy, Executive Office of the President, Washington, DC 20503. Linda V. Priebe, Deputy General Counsel. [FR Doc. 2010–22794 Filed 9–13–10; 8:45 am] BILLING CODE 3180–02–P NUCLEAR REGULATORY COMMISSION Advisory Committee on the Medical Uses of Isotopes: Call for Nominations U.S. Nuclear Regulatory Commission. ACTION: Call for Nominations. AGENCY: The U.S. Nuclear Regulatory Commission (NRC) is advertising for nominations for the patients’ rights advocate position on the Advisory Committee on the Medical Uses of Isotopes (ACMUI). Nominees should have professional or personal experience with or knowledge about patient advocacy. Also, involvement or leadership with patient advocacy organizations is preferred. DATES: Nominations are due on or before November 15, 2010. NOMINATION PROCESS: Submit an electronic copy of resume or curriculum vitae, along with a cover letter, to Ms. Ashley Cockerham, ashley. cockerham@nrc.gov. The cover letter should describe the nominee’s current involvement with patients’ rights advocacy and express the nominee’s interest in the position. Please ensure that resume or curriculum vitae includes the following information, if applicable: education; certification; professional association membership SUMMARY: PO 00000 Frm 00096 Fmt 4703 Sfmt 4703 55831 and committee membership activities; and number of years, recentness, and type of setting for patient advocacy. FOR FURTHER INFORMATION CONTACT: Ms. Ashley Cockerham, U.S. Nuclear Regulatory Commission, Office of Federal and State Materials and Environmental Management Programs; (240) 888–7129; ashley.cockerham@nrc. gov. SUPPLEMENTARY INFORMATION: The patients’ rights advocate provides advice to NRC staff on patients’ issues associated with the regulation of medical applications of byproduct material. This advice includes ensuring patients’ rights are represented during the development and implementation of NRC medical-use policy. This individual is appointed based on his or her professional and personal experience with and/or knowledge about patient advocacy, involvement and/or leadership with patient advocacy organizations, and other information obtained in letters or during the selection process. Nominees should have the demonstrated ability to establish effective work relationships with peers and implement successful approaches to problem solving and conflict resolution. ACMUI members currently serve a four-year term and may be considered for reappointment to an additional term. The current membership is comprised of the following professionals: (a) Nuclear medicine physician; (b) nuclear cardiologist; (c) nuclear medicine physicist; (d) therapy medical physicist; (e) radiation safety officer; (f) nuclear pharmacist; (g) two radiation oncologists; (h) patients’ rights advocate; (i) Food and Drug Administration representative; (j) Agreement State representative; (k) health care administrator; and (l) diagnostic radiologist. For additional information about membership on the ACMUI, visit the ACMUI Membership Web page, https://www.nrc.gov/aboutnrc/regulatory/advisory/acmui/ membership.html. Nominees must be U.S. citizens and be able to devote approximately 160 hours per year to Committee business. Members are expected to attend semiannual meetings in Rockville, Maryland and to participate in teleconferences, as needed. Members who are not Federal employees are compensated for their service. In addition, these members are reimbursed for travel and correspondence expenses. Full-time Federal employees are reimbursed for travel expenses only. Security Background Check: The selected nominee will undergo a E:\FR\FM\14SEN1.SGM 14SEN1

Agencies

[Federal Register Volume 75, Number 177 (Tuesday, September 14, 2010)]
[Notices]
[Pages 55828-55831]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-22785]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-318F]


Controlled Substances: Final Revised Aggregate Production Quotas 
for 2010

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of final aggregate production quotas for 2010.

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

SUMMARY: This notice establishes final 2010 aggregate production quotas 
for controlled substances in schedules I and II of the Controlled 
Substances Act (CSA). DEA has taken into consideration comments 
received in response to a notice of the proposed revised aggregate 
production quotas for 2010 published June 23, 2010 (75 FR 35838).

DATES: Effective Date: September 14, 2010.

FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, Ph.D., Chief, 
Drug and Chemical Evaluation Section, Drug Enforcement Administration, 
8701 Morrissette Drive, Springfield, VA 22152, Telephone: (202) 307-
7183.

SUPPLEMENTARY INFORMATION: Section 306 of the CSA (21 U.S.C. 826) 
requires that the Attorney General establish aggregate production 
quotas for each basic class of controlled substance listed in schedules 
I and II. This responsibility has been delegated to the Administrator 
of the DEA by 28 CFR 0.100. The Administrator, in turn, has redelegated 
this function to the Deputy Administrator, pursuant 28 CFR 0.104.
    The 2010 aggregate production quotas represent those quantities of 
controlled substances in schedules I and II that may be produced in the 
United States in 2010 to provide adequate supplies of each substance 
for: The estimated medical, scientific, research and industrial needs 
of the United States; lawful export requirements; and the establishment 
and maintenance of reserve stocks (21 U.S.C. 826(a) and 21 CFR 
1303.11). These quotas do not include imports of controlled substances.
    On June 23, 2010, a notice of the proposed revised 2010 aggregate 
production quotas for certain controlled substances in schedules I and 
II was published in the Federal Register (75 FR 35838). All interested 
persons were invited to comment on or object to these proposed 
aggregate production quotas on or before July 23, 2010.
    Fourteen companies, thirteen DEA registered manufacturers and one 
non-registrant, commented on a total of 28 schedules I and II 
controlled substances within the published comment period. Comments 
received proposed that the aggregate production quotas for alfentanil, 
amphetamine (for conversion), amphetamine (for sale), codeine (for 
conversion), codeine (for sale), dextropropoxyphene, dihydromorphine, 
diphenoxylate, gamma hydroxybutyric acid, hydrocodone, hydromorphone, 
lisdexamfetamine, meperidine, methadone, methylphenidate, morphine (for 
conversion), morphine (for sale), nabilone, opium (tincture), oxycodone 
(for conversion), oxycodone (for sale), oxymorphone (for sale), 
remifentanil, sufentanil, tapentadol, tetrahydrocannabinols, thebaine 
and tilidine 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.
    DEA has taken into consideration the above comments along with the 
relevant 2009 year-end inventories, initial 2010 manufacturing quotas, 
2010 export requirements, actual and projected 2010 sales, research, 
product development requirements and additional applications received. 
Based on this information, the DEA has adjusted the final 2010 
aggregate production quotas for alfentanil, amphetamine (for 
conversion), amphetamine (for sale), carfentanil, dihydromorphine, 
diphenoxylate, marihuana, morphine (for sale), noroxymorphone (for 
sale), opium (tincture), oxycodone (for conversion), oxycodone (for 
sale), oxymorphone (for conversion), oxymorphone (for sale), 
tapentadol, tetrahydrocannabinols, and tilidine.
    4-anilino-N-phenethyl-4-piperidine (ANPP) pursuant to DEA's final 
rule published in the Federal Register on June 29, 2010 (75 FR 37295) 
will be controlled as a schedule II controlled substance on August 30, 
2010. As such, DEA has established an aggregate production quota for 
ANPP to meet the estimated medical, scientific, research, and 
industrial needs of the United States; lawful export requirements; and 
the establishment and maintenance of reserve stocks.
    Regarding codeine (for conversion), codeine (for sale), 
dextropropoxyphene, gamma hydroxybutyric acid, hydrocodone, 
hydromorphone, lisdexamfetamine, meperidine, methadone, 
methylphenidate, morphine (for conversion), nabilone, remifentanil, 
sufentanil, and thebaine, DEA has determined that the proposed revised 
2010 aggregate production quotas are sufficient to meet the current 
2010 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

[[Page 55829]]

Administrator hereby orders that the 2010 final aggregate production 
quotas for the following controlled substances, expressed in grams of 
anhydrous acid or base, be established as follows:

------------------------------------------------------------------------
                                                         Final revised
                     Basic class                          2010 quotas
------------------------------------------------------------------------
                               Schedule I
------------------------------------------------------------------------
2,5-Dimethoxyamphetamine.............................                2 g
2,5-Dimethoxy-4-ethylamphetamine (DOET)..............                2 g
3-Methylfentanyl.....................................                2 g
3-Methylthiofentanyl.................................                2 g
3,4-Methylenedioxyamphetamine (MDA)..................               20 g
3,4-Methylenedioxy-N-ethylamphetamine (MDEA).........               10 g
3,4-Methylenedioxymethamphetamine (MDMA).............               20 g
3,4,5-Trimethoxyamphetamine..........................                2 g
4-Bromo-2,5-dimethoxyamphetamine (DOB)...............                2 g
4-Bromo-2,5-dimethoxyphenethylamine (2-CB)...........                2 g
4-Methoxyamphetamine.................................               77 g
4-Methylaminorex.....................................                2 g
4-Methyl-2,5-dimethoxyamphetamine (DOM)..............                2 g
5-Methoxy-3,4-methylenedioxyamphetamine..............                2 g
Acetyl-alpha-methylfentanyl..........................                2 g
Acetyldihydrocodeine.................................                2 g
Acetylmethadol.......................................                2 g
Allylprodine.........................................                2 g
Alphacetylmethadol...................................                2 g
Alpha-ethyltryptamine................................                2 g
Alphameprodine.......................................                2 g
Alphamethadol........................................                2 g
Alpha-methylfentanyl.................................                2 g
Alpha-methylthiofentanyl.............................                2 g
Alpha-methyltryptamine (AMT).........................                2 g
Aminorex.............................................                2 g
Benzylmorphine.......................................                2 g
Betacetylmethadol....................................                2 g
Beta-hydroxy-3-methylfentanyl........................                2 g
Beta-hydroxyfentanyl.................................                2 g
Betameprodine........................................                2 g
Betamethadol.........................................                2 g
Betaprodine..........................................                2 g
Bufotenine...........................................                3 g
Cathinone............................................                3 g
Codeine-N-oxide......................................              602 g
Diethyltryptamine....................................                2 g
Difenoxin............................................            3,000 g
Dihydromorphine......................................        3,608,000 g
Dimethyltryptamine...................................                3 g
Gamma-hydroxybutyric acid............................       52,156,000 g
Heroin...............................................               20 g
Hydromorphinol.......................................                2 g
Hydroxypethidine.....................................                2 g
Ibogaine.............................................                1 g
Lysergic acid diethylamide (LSD).....................               15 g
Marihuana............................................           21,000 g
Mescaline............................................                5 g
Methaqualone.........................................                7 g
Methcathinone........................................                4 g
Methyldihydromorphine................................                2 g
Morphine-N-oxide.....................................              605 g
N-Benzylpiperazine...................................                2 g
N,N-Dimethylamphetamine..............................                2 g
N-Ethylamphetamine...................................                2 g
N-Hydroxy-3,4-methylenedioxyamphetamine..............                2 g
Noracymethadol.......................................                2 g
Norlevorphanol.......................................               52 g
Normethadone.........................................                2 g
Normorphine..........................................               16 g
Para-fluorofentanyl..................................                2 g
Phenomorphan.........................................                2 g
Pholcodine...........................................                2 g
Psilocybin...........................................                2 g
Psilocyn.............................................                2 g
Tetrahydrocannabinols................................          264,000 g
Thiofentanyl.........................................                2 g

[[Page 55830]]

 
Tilidine.............................................               10 g
Trimeperidine........................................                2 g
------------------------------------------------------------------------
                               Schedule II
------------------------------------------------------------------------
1-Phenylcyclohexylamine..............................                2 g
4-anilino-N-phenethyl-4-piperidine (ANPP)............        1,100,000 g
Alfentanil...........................................            8,000 g
Alphaprodine.........................................                2 g
Amobarbital..........................................                3 g
Amphetamine (for conversion).........................        7,500,000 g
Amphetamine (for sale)...............................       18,600,000 g
Carfentanil..........................................              200 g
Cocaine..............................................          247,000 g
Codeine (for conversion).............................       65,000,000 g
Codeine (for sale)...................................       39,605,000 g
Dextropropoxyphene...................................       92,000,000 g
Dihydrocodeine.......................................          800,000 g
Diphenoxylate........................................          827,000 g
Ecgonine.............................................           83,000 g
Ethylmorphine........................................                2 g
Fentanyl.............................................        1,428,000 g
Glutethimide.........................................                2 g
Hydrocodone..........................................       55,000,000 g
Hydromorphone........................................        3,455,000 g
Isomethadone.........................................               11 g
Levo-alphacetylmethadol (LAAM).......................                3 g
Levomethorphan.......................................                5 g
Levorphanol..........................................           10,000 g
Lisdexamfetamine.....................................        9,000,000 g
Meperidine...........................................        6,600,000 g
Meperidine Intermediate-A............................                3 g
Meperidine Intermediate-B............................                7 g
Meperidine Intermediate-C............................                3 g
Metazocine...........................................                1 g
Methadone............................................       20,000,000 g
Methadone Intermediate...............................       26,000,000 g
Methamphetamine......................................        3,130,000 g
------------------------------------------------------------------------
750,000 g of levo-desoxyephedrine for use in a non-controlled, non-
 prescription product; 2,331,000 g for methamphetamine (for conversion)
 mostly for conversion to a schedule III product; and 49,000 g for
 methamphetamine (for sale)
------------------------------------------------------------------------
Methylphenidate......................................       50,000,000 g
Morphine (for conversion)............................       83,000,000 g
Morphine (for sale)..................................       39,000,000 g
Nabilone.............................................            9,002 g
Noroxymorphone (for conversion)......................        9,000,000 g
Noroxymorphone (for sale)............................           41,000 g
Opium (powder).......................................          230,000 g
Opium (tincture).....................................        1,500,000 g
Oripavine............................................       15,000,000 g
Oxycodone (for conversion)...........................        5,600,000 g
Oxycodone (for sale).................................      105,500,000 g
Oxymorphone (for conversion).........................       12,800,000 g
Oxymorphone (for sale)...............................        3,070,000 g
Pentobarbital........................................       28,000,000 g
Phenazocine..........................................                1 g
Phencyclidine........................................               14 g
Phenmetrazine........................................                2 g
Phenylacetone........................................       12,500,001 g
Racemethorphan.......................................                2 g
Remifentanil.........................................            2,500 g
Secobarbital.........................................           67,000 g
Sufentanil...........................................            7,000 g
Tapentadol...........................................        1,000,000 g
Thebaine.............................................      126,000,000 g
------------------------------------------------------------------------

    The Deputy Administrator further orders that the aggregate 
production quotas for all other schedule I and II controlled substances 
included in 21 CFR 1308.11 and 1308.12 shall be zero.
    The Office of Management and Budget has determined that notices of 
aggregate production quotas are not subject to

[[Page 55831]]

centralized review under Executive Order 12866.
    This action does not preempt or modify any provision of state law; 
nor does it impose enforcement responsibilities on any state; nor does 
it diminish the power of any state to enforce its own laws. 
Accordingly, this action does not have federalism implications 
warranting the application of Executive Order 13132.
    The Deputy Administrator hereby certifies that this action will 
have no significant impact upon small entities whose interests must be 
considered under the Regulatory Flexibility Act, 5 U.S.C. 601 et seq. 
The establishment of aggregate production quotas for schedules I and II 
controlled substances is mandated by law and by international treaty 
obligations. The quotas are necessary to provide for the estimated 
medical, scientific, research and industrial needs of the United 
States, for export requirements and the establishment and maintenance 
of reserve stocks. While aggregate production quotas are of primary 
importance to large manufacturers, their impact upon small entities is 
neither negative nor beneficial. Accordingly, the Deputy Administrator 
has determined that this action does not require a regulatory 
flexibility analysis.
    This action meets the applicable standards set forth in Sections 
3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform.
    This action will not result in the expenditure by state, local, and 
tribal governments, in the aggregate, or by the private sector, of 
$126,400,000 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: September 2, 2010.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 2010-22785 Filed 9-13-10; 8:45 am]
BILLING CODE 4410-09-P
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