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Federal
Register Notices > Quotas -
2008 > Controlled Substances: Established Initial Aggregate
Production Quotas for 2009
FR Doc E8-30807[Federal Register: December 29, 2008 (Volume 73,
Number 249)] [Notices] [Page 79514-79518] From the Federal Register
Online via GPO Access [wais.access.gpo.gov] [DOCID:fr29de08-93]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[DEA 317E]
Controlled Substances: Established Initial Aggregate Production
Quotas for 2009
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of aggregate production quotas for 2009.
SUMMARY: This notice establishes initial 2009 aggregate
production quotas for
[[Page 79515]]
controlled substances in schedules I and II of the Controlled
Substances Act (CSA).
DATES: Effective Date: December 29, 2008.
FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, Ph.D.,
Chief, Drug & Chemical Evaluation Section, Drug Enforcement
Administration, Washington, DC 20537, Telephone: (202) 307-7183.
SUPPLEMENTARY INFORMATION: Section 306 of the CSA (21
U.S.C. 826) requires that the Attorney General establish aggregate production
quotas for each basic class of controlled substance listed in schedules
I and II. This responsibility has been delegated to the Administrator of
the DEA by 28 CFR 0.100. The Administrator, in turn, has redelegated
this function to the Deputy Administrator, pursuant to 28 CFR 0.104.
The 2009 aggregate production quotas represent those quantities of
controlled substances that may be produced in the United States in 2009
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 for use in industrial
processes.
On November 7, 2008, a notice of the proposed initial 2009 aggregate
production quotas for certain controlled substances in schedules I and
II was published in the Federal Register (73 FR 66256). All interested
persons were invited to comment on or object to these proposed aggregate
production quotas on or before December 8, 2008.
Six responses were received within the published comment period,
offering comments on a total of 20 schedule I and II controlled
substances. The commenters stated that the proposed aggregate production
quotas for 1-piperdinocyclohexanecarbonitrile, codeine (for sale),
difenoxin, dihydromorphine, gamma hydroxybutyric acid, hydromorphone,
meperidine, merperidine intermediate A, meperidine intermediate B,
meperidine intermediate C, methadone, methadone intermediate,
methamphetamine (for conversion), methylphenidate, morphine (for sale),
nabilone, N-benzylpiperazine, oxycodone (for sale),
tetrahydrocannabinols, and thebaine were insufficient to provide for the
estimated medical, scientific, research and industrial needs of the
United States, for export requirements and for the establishment and
maintenance of reserve stocks.
One of the commenters also stated that publication of the proposed
aggregate production quotas in November leaves insufficient time to
consider comments and further commented that DEA has not complied with
the requirement of 21
U.S.C. 826(c) to establish manufacturing quota for
individual companies by October 1 for the entire calendar year.
DEA is unable to issue individual manufacturing quotas until the
initial aggregate production quotas have been established. DEA strives
to publish all Federal Register notices pertaining to the aggregate
production quotas as early as possible, but is limited by the timeliness
and availability of information utilized by the agency in establishing
the aggregate production quotas. The publication of the aggregate
production quotas was delayed, in part, due to incomplete and late
submissions of manufacturer year-end inventories and untimely
procurement and manufacturing quota applications. In addition, DEA had
to give priority to the current manufacturing and procurement quota
requests to ensure the maintenance of an uninterrupted supply in 2008.
In arriving at the aggregate production quotas, DEA has taken into
consideration the above comments along with the factors set forth at 21
CFR 1303.11(b) and other relevant 2008 factors, including 2008
manufacturing quotas, current 2008 sales and inventories, 2009 export
requirements, additional applications received, and research and product
development requirements. Based on this information, DEA has adjusted
the initial aggregate production quotas for 1-
piperdinocyclohexanecarbonitrile, difenoxin, gamma hydroxybutyric acid,
meperidine intermediate A, meperidine intermediate B, meperidine
intermediate C, nabilone, N-benzylpiperazine and oxycodone (for sale) to
meet the legitimate needs of the United States.
Regarding codeine (for sale), dihydromorphine, hydromorphone,
methadone, methadone intermediate, methamphetamine (for conversion),
morphine (for sale), tetrahydrocannabinols, and thebaine, DEA has
determined that the proposed initial 2009 aggregate production quotas
are sufficient to meet the current 2009 estimated medical, scientific,
research and industrial needs of the United States.
Pursuant to 21 CFR
1303, the Deputy Administrator of DEA will, in
2009, adjust aggregate production quotas and individual manufacturing
quotas allocated for the year based upon 2008 year-end inventory and
actual 2008 disposition data supplied by quota recipients for each basic
class of schedule I or II controlled substance.
Therefore, under the authority vested in the Attorney General by
Section 306 of the CSA (21 U.S.C. 826), and delegated to the
Administrator of DEA by 28 CFR 0.100, and redelegated to the Deputy
Administrator pursuant to 28 CFR 0.104, the Deputy Administrator hereby
orders that the 2009 initial aggregate production quotas for the
following controlled substances, expressed in grams of anhydrous acid or
base, be established as follows:
| Basic class--Schedule I |
Established 2009 quotas |
| 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) |
25 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 |
27 g |
| 4-Methylaminorex |
2 g |
| 4-Methyl-2,5-dimethoxyamphetamine
(DOM) |
2 g |
| 5-Methoxy-3,4-methylenedioxyamphetamine |
2 g |
| 5-Methoxy-N,N-diisopropyltryptamine |
5 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 |
| 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 |
2,549,000 g |
| Dimethyltryptamine |
3 g |
| Gamma-hydroxybutyric acid |
24,200,000 g |
| Heroin |
20 g |
| Hydromorphinol |
2 g |
| Hydroxypethidine |
2 g |
| Ibogaine |
1 g |
| Lysergic acid diethylamide (LSD) |
10 g |
| Marihuana |
4,500,000 g |
| Mescaline |
7 g |
| Methaqualone |
5 g |
| Methcathinone |
4 g |
| Methyldihydromorphine |
2 g |
| Morphine-N-oxide |
605 g |
| N-Benzylpiperazine |
2 g |
| N,N-Dimethylamphetamine |
7 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 |
7 g |
| Psilocyn |
7 g |
| Tetrahydrocannabinols |
312,500 g |
| Thiofentanyl |
2 g |
| Trimeperidine |
2 g |
| Basic class--Schedule II |
Established 2009 quotas |
| 1-Phenylcyclohexylamine |
2 g |
| 1-piperdinocyclohexanecarbonitrile |
2 g |
| Alfentanil |
8,000 g |
| Alphaprodine |
2 g |
| Amobarbital |
3 g |
| Amphetamine (for sale) |
17,000,000 g |
| Amphetamine (for conversion) |
5,000,000 g |
| Cocaine |
247,000 g |
| Codeine (for sale) |
39,605,000 g |
| Codeine (for conversion) |
65,000,000 g |
| Dextropropoxyphene |
106,000,000 g |
| Dihydrocodeine |
1,200,000 g |
| Diphenoxylate |
947,000 g |
| Ecgonine |
83,000 g |
| Ethylmorphine |
2 g |
| Fentanyl |
1,428,000 g |
| Glutethimide |
2 g |
| Hydrocodone (for sale) |
55,000,000 g |
| Hydromorphone |
3,300,000 g |
| Isomethadone |
2 g |
| Levo-alphacetylmethadol (LAAM) |
3 g |
| Levomethorphan |
5 g |
| Levorphanol |
10,000 g |
| Lisdexamfetamine |
6,200,000 g |
| Meperidine |
8,600,000 g |
| Meperidine Intermediate-A |
3 g |
| Meperidine Intermediate-B |
7 g |
| Meperidine Intermediate-C |
3 g |
| Metazocine |
1 g |
| Methadone (for sale) |
25,000,000 g |
| Methadone Intermediate |
26,000,000 g |
Methamphetamine
[680,000 grams of levo-desoxyephedrine for use in a
non-controlled, non- prescription product; 2,405,000 grams for
methamphetamine mostly for conversion to a schedule III product;
and 45,000 grams for methamphetamine (for sale)] |
3,130,000 g |
| Methylphenidate |
50,000,000 g |
| Morphine (for sale) |
35,000,000 g |
| Morphine (for conversion) |
100,000,000 g |
| Nabilone |
9,002 g |
| Noroxymorphone (for sale) |
10,000 g |
| Noroxymorphone (for conversion) |
9,000,000 g |
| Opium (powder) |
1,050,000 g |
| Opium (tincture) |
230,000 g |
| Oripavine |
15,000,000 g |
| Oxycodone (for sale) |
77,560,000 g |
| Oxycodone (for conversion) |
3,400,000 g |
| Oxymorphone (for sale) |
2,000,000 g |
| Oxymorphone (for conversion) |
12,000,000 g |
| Pentobarbital |
28,000,000 g |
| Phenazocine |
1 g |
| Phencyclidine |
20 g |
| Phenmetrazine |
2 g |
| Phenylacetone |
1 g |
| Racemethorphan |
2 g |
| Remifentanil |
500 g |
| Secobarbital |
67,000 g |
| Sufentanil |
10,300 g |
| Thebaine |
126,000,000 g |
The Deputy Administrator further orders that aggregate production
quotas for all other schedules I and II controlled substances included
in 21 CFR 1308.11 and
1308.12 be established at zero.
The Office of Management and Budget has determined that notices of
aggregate production quotas are not subject to centralized review under
Executive Order 12866.
This action does not preempt or modify any provision of state law;
nor does it impose enforcement responsibilities on any state; nor does
it diminish the power of any state to enforce its own laws. Accordingly,
this action does not have federalism implications warranting the
application of Executive Order 13132.
The Deputy Administrator hereby certifies that this action will have
no significant impact upon small entities whose interests must be
considered under the Regulatory Flexibility Act, 5 U.S.C. 601 et seq.
The establishment of aggregate production quotas for schedules I and II
controlled substances is mandated by law and by international treaty
obligations. The quotas are necessary to provide for the estimated
medical, scientific, research and industrial needs of the United States,
for export requirements and the establishment and maintenance of reserve
stocks. While aggregate production quotas are of primary importance to
large manufacturers, their impact upon small entities is neither
negative nor beneficial. Accordingly, the Deputy Administrator has
determined that this action does not require a regulatory flexibility
analysis.
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.
[[Page 79518]]
Dated: December 19, 2008.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E8-30807 Filed 12-24-08; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an
unofficial version. An official version of these publications may be obtained
directly from the Government Printing Office (GPO).
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