[Federal Register Volume 75, Number 177 (Tuesday, September 14, 2010)]
[Notices]
[Pages 55828-55831]
From the Federal Register Online via the Government Publishing 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.
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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:
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Final revised
Basic class 2010 quotas
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Schedule I
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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