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Federal
Register Notices > Quotas - 2009
> Notice of proposed year 2010 aggregate production quotas.
FR Doc E9-11929[Federal Register: May 21, 2009 (Volume 74, Number
97)] [Notices] [Page 23881-23884] From the Federal Register Online via
GPO Access [wais.access.gpo.gov] [DOCID:fr21my09-78]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-318P]
Controlled Substances: Proposed Aggregate Production Quotas for 2010
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of proposed year 2010 aggregate production quotas.
SUMMARY: This notice proposes initial year 2010 aggregate
production quotas for controlled substances in schedules I and II of the
Controlled Substances Act (CSA).
DATES: Comments or objections must be received on or before
June 22, 2009.
ADDRESSES: To ensure proper handling of comments, please
reference "Docket No. DEA-318P'' on all written and electronic
correspondence. Written comments should be sent to the DEA Headquarters,
Attn: DEA Federal Register Representative/ODL, 8701 Morrissette Drive,
Springfield, Virginia 22152. Comments may be directly sent to DEA
electronically by sending an electronic message to dea.diversion.policy@usdoj.gov.
Comments may also be sent electronically through http://www.regulations.gov
using the electronic comment form provided on that site. An electronic
copy of this document is also available at the http://www.regulations.gov
Web site. DEA will accept attachments to electronic comments in
Microsoft Word, WordPerfect, Adobe PDF, or Excel file formats only. DEA
will not accept any file format other than those specifically listed
here.
FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, Ph.D.,
Chief, Drug and Chemical Evaluation Section, 8701 Morrissette Drive,
Springfield, Virginia 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 Section 0.100. The Administrator, in turn, has
redelegated this function to the Deputy Administrator, pursuant to 28
CFR Section 0.104.
The proposed year 2010 aggregate production quotas represent those
quantities of controlled substances 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. These quotas do not include imports of
controlled substances for use in industrial processes.
In determining the year 2010 aggregate production quotas, the Deputy
Administrator considered the following factors: Total actual 2008 and
estimated 2009 and 2010 net disposals of each substance by all
manufacturers; estimates of 2009 year-end inventories of each substance
and of any substance manufactured from it and trends in accumulation of
such inventories; product development requirements of both bulk and
finished dosage form manufacturers; projected demand as indicated by
procurement quota applications filed pursuant to 21 CFR Section
1303.12;
and other pertinent information.
Pursuant to 21 CFR Section
1303, the Deputy Administrator of the DEA
will adjust the 2010 aggregate production quotas and individual
manufacturing quotas allocated for the year based upon 2009 year-end
inventory and actual 2009 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 Sec.
306 of the CSA of 1970 (21 U.S.C. 826), and delegated to the
Administrator of the DEA by 28 CFR Section 0.100, and redelegated to the
Deputy Administrator pursuant to 28 CFR Section 0.104, the Deputy
Administrator hereby proposes that the year 2010 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 2010 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 |
7g |
| 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 2010 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) |
230,000 g |
| Opium (tincture) |
1,050,000 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 |
| Tapentadol |
519,000 g |
| Thebaine |
126,000,000 g |
The Deputy Administrator further proposes that aggregate production
quotas for all other schedules I and II controlled substances included
in 21 CFR Sections 1308.11 and
1308.12 be established at zero.
All interested persons are invited to submit their comments in
writing or electronically regarding this proposal following the
procedures in the "ADDRESSES'' section of this document. A person may
object to or comment on the proposal relating to any of the above-
mentioned substances without filing comments or objections regarding the
others. If a person believes that one or more of these issues warrant a
hearing, the individual should so state and summarize the reasons for
this belief.
In the event that comments or objections to this proposal raise one
or more issues which the Deputy Administrator finds warrant a hearing,
the Deputy Administrator shall order a public hearing by notice in the
Federal Register, summarizing the issues to be heard and setting the
time for the hearing.
The Office of Management and Budget has determined that notices of
aggregate production quotas are not subject to centralized review under
Executive Order 12866.
This action does not preempt or modify any provision of State law;
nor does it impose enforcement responsibilities on any State; nor does
it diminish the power of any State to enforce its own laws. Accordingly,
this action does not have federalism implications warranting the
application of Executive Order 13132.
The Deputy Administrator hereby certifies that this action will have
no significant impact upon small entities whose interests must be
considered under the Regulatory Flexibility Act, 5 U.S.C. 601 et seq.
The establishment of aggregate production quotas for schedules I and II
controlled substances is mandated by law and by international treaty
obligations. The quotas are necessary to provide for the estimated
medical, scientific, research and industrial needs of the United States
for export requirements and the establishment and maintenance of reserve
stocks. While aggregate production quotas are of primary importance to
large manufacturers, their impact upon small entities is neither
negative nor beneficial. Accordingly, the Deputy Administrator has
determined that this action does not require a regulatory flexibility
analysis.
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 23884]]
Dated: May 15, 2009.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E9-11929 Filed 5-20-09; 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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