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Federal
Register Notices > Quotas - 2009
> Notice of proposed revised 2009 aggregate production
quotas.
FR Doc E9-17536[Federal Register: July 23, 2009 (Volume 74, Number
140)] [Notices] [Page 36511-36515] From the Federal Register Online via
GPO Access [wais.access.gpo.gov] [DOCID:fr23jy09-78]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-317R]
Controlled Substances: Proposed Revised Aggregate Production
Quotas for 2009
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of proposed revised 2009 aggregate production
quotas.
SUMMARY: This notice proposes revised 2009 aggregate
production quotas for
[[Page 36512]]
controlled substances in schedules I and II of the Controlled
Substances Act (CSA).
DATES: Written comments must be postmarked, and electronic
comments must be sent, on or before August 24, 2009.
ADDRESSES: To ensure proper handling of comments, please
reference ``Docket No. DEA-317R'' on all written and electronic
correspondence. Written comments should be sent to the DEA Headquarters,
Attention: DEA Federal Register Representative/ODL, 8701 Morrissette
Drive, Springfield, VA 22152. Comments may be directly sent to DEA
electronically by sending an electronic message to dea.diversion.policy@usdoj.gov.
An electronic copy of this document is also available at the http://www.regulations.gov
Web site. However, persons wishing to request a hearing should note that
such requests must be written and manually signed; requests for a
hearing will not be accepted via electronic means. 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, Drug Enforcement
Administration, 8701 Morrissette Drive, Springfield, VA 22152, or by
telephone at (202) 307-7183.
SUPPLEMENTARY INFORMATION: Section 306 of the CSA (21
U.S.C. 826) requires that the Attorney General establish aggregate
production quotas for each basic class of controlled substance listed in
schedules I and II. This responsibility has been delegated to the
Administrator of the DEA by 28 CFR 0.100. The Administrator in turn, has
redelegated this function to the Deputy Administrator, pursuant to 28
CFR 0.104.
On November 7, 2008, a notice of proposed 2009 aggregate production
quotas for certain controlled substances in schedules I and II was
published in the Federal Register (73 FR 66256). This notice stipulated
that the DEA would adjust the quotas in 2009 as provided for in 21
CFR part 1303.
The proposed revised 2009 aggregate production quotas represent those
quantities of controlled substances in schedules I and II 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. These quotas do not
include imports of controlled substances for use in industrial
processes.
The proposed revisions are based on a review of 2008 year-end
inventories, 2008 disposition data submitted by quota applicants,
estimates of the medical needs of the United States, product
development, and other information available to the DEA.
Therefore, under the authority vested in the Attorney General by
Section 306 of the CSA (21
U.S.C. 826), and delegated to the Administrator of the DEA by 28 CFR
0.100, and redelegated to the Deputy Administrator pursuant to 28 CFR
0.104, the Deputy Administrator hereby proposes the following revised
2009 aggregate production quotas for the following controlled
substances, expressed in grams of anhydrous acid or base:
| Basic class--schedule I |
Previously established initial 2009
quotas |
Proposed revised 2009 quotas |
| 2,5-Dimethoxyamphetamine |
2 g |
2 g |
| 2,5-Dimethoxy-4-ethylamphetamine (DOET) |
2 g |
2 g |
| 3-Methylfentanyl |
2 g |
2 g |
| 3-Methylthiofentanyl |
2 g |
2 g |
| 3,4-Methylenedioxyamphetamine (MDA) |
25 g |
25 g |
| 3,4-Methylenedioxy-N-ethylamphetamine (MDEA) |
10 g |
10 g |
| 3,4-Methylenedioxymethamphetamine (MDMA) |
20 g |
20 g |
| 3,4,5-Trimethoxyamphetamine |
2 g |
2 g |
| 4-Bromo-2,5-dimethoxyamphetamine (DOB) |
2 g |
2 g |
| 4-Bromo-2,5-dimethoxyphenethylamine
(2-CB) |
2 g |
2 g |
| 4-Methoxyamphetamine |
27 g |
27 g |
| 4-Methylaminorex |
2 g |
2 g |
| 4-Methyl-dimethoxyamphetamine (DOM) |
2,5- 2 g |
2 g |
| 5-Methoxy-3,4-methylenedioxyamphetamine |
2 g |
2 g |
| 5-Methoxy-N,N-diisopropyltryptamine |
5 g |
5 g |
| Acetyl-alpha-methylfentanyl |
2 g |
2 g |
| Acetyldihydrocodeine |
2 g |
2 g |
| Acetylmethadol |
2 g |
2 g |
| Allylprodine |
2 g |
2 g |
| Alphacetylmethadol |
2 g |
2 g |
| Alpha-ethyltryptamine |
2 g |
2 g |
| Alphameprodine |
2 g |
2 g |
| Alphamethadol |
2 g |
2 g |
| Alpha-methylfentanyl |
2 g |
2 g |
| Alpha-methylthiofentanyl |
2 g |
2 g |
| Aminorex |
2 g |
2 g |
| Benzylmorphine |
2 g |
2 g |
| Betacetylmethadol |
2 g |
2 g |
| Beta-hydroxy-3-methylfentanyl |
2 g |
2 g |
| Beta-hydroxyfentanyl |
2 g |
2 g |
| Betameprodine |
2 g |
2 g |
| Betamethadol |
2 g |
2 g |
| Betaprodine |
2 g |
2 g |
| Bufotenine |
3 g |
3 g |
| Cathinone |
3 g |
3 g |
| Codeine-N-oxide |
602 g |
602 g |
| Diethyltryptamine |
2 g |
2 g |
| Difenoxin |
3,000 g |
3,000 g |
| Dihydromorphine |
2,549,000 g |
2,549,000 g |
| Dimethyltryptamine |
3 g |
3 g |
| Gamma-hydroxybutyric acid |
24,200,00 g |
24,200,000 g |
| Heroin |
20 g |
20 g |
| Hydromorphinol |
2 g |
2 g |
| Hydroxypethidine |
2 g |
2 g |
| Ibogaine |
1 g |
1 g |
| Lysergic acid diethylamide (LSD) |
10 g |
10 g |
| Marihuana |
4,500,000 g |
4,500,000 g |
| Mescaline |
7 g |
7 g |
| Methaqualone |
5 g |
5 g |
| Methcathinone |
4 g |
4 g |
| Methyldihydromorphine |
2 g |
2 g |
| Morphine-N-oxide |
605 g |
605 g |
| N-Benzylpiperazine |
2 g |
2 g |
| N,N-Dimethylamphetamine |
7 g |
7 g |
| N-Ethylamphetamine |
2 g |
2 g |
| N-Hydroxy-3,4-methylenedioxyamphetamine |
2 g |
2 g |
| Noracymethadol |
2 g |
2 g |
| Norlevorphanol |
52 g |
52 g |
| Normethadone |
2 g |
2 g |
| Normorphine |
16 g |
16 g |
| Para-fluorofentanyl |
2 g |
2 g |
| Phenomorphan |
2 g |
2 g |
| Pholcodine |
2 g |
2 g |
| Psilocybin |
7 g |
7 g |
| Psilocyn |
7 g |
7 g |
| Tetrahydrocannabinols |
312,500 g |
312,500 g |
| Thiofentanyl |
2 g |
2 g |
| Trimeperidine |
2 g |
2 g |
>
| Basic class--schedule II |
Previously established initial 2009
quotas |
Proposed revised 2009 quotas |
| 1-Phenylcyclohexylamine |
2 g |
2 g |
| 1-Piperdinocyclohexanecarbonitrile |
2 g |
2 g |
| Alfentanil |
8,000 g |
8,000 g |
| Alphaprodine |
2 g |
2 g |
| Amobarbital |
3 g |
3 g |
| Amphetamine (for sale) |
17,000,000 g |
17,000,000 g |
| Amphetamine (for conversion) |
5,000,000 g |
5,000,000 g |
| Cocaine |
247,000 g |
247,000 g |
| Codeine (for sale) |
39,605,000 g |
39,605,000 g |
| Codeine (for conversion) |
65,000,000 g |
65,000,000 g |
| Dextropropoxyphene |
106,000,000 g |
106,000,000 g |
| Dihydrocodeine |
1,200,000 g |
1,200,000 g |
| Diphenoxylate |
947,000 g |
947,000 g |
| Ecgonine |
83,000 g |
83,000 g |
| Ethylmorphine |
2 g |
2 g |
| Fentanyl |
1,428,000 g |
1,428,000 g |
| Glutethimide |
2 g |
2 g |
| Hydrocodone (for sale) |
55,000,000 g |
55,000,000 g |
| Hydromorphone |
3,300,000 g |
3,300,000 g |
| Isomethadone |
2 g |
2 g |
| Levo-alphacetylmethadol (LAAM) |
3 g |
3 g |
| Levomethorphan |
5 g |
5 g |
| Levorphanol |
10,000 g |
10,000 g |
| Lisdexamfetamine |
6,200,000 g |
6,200,000 g |
| Meperidine |
8,600,000 g |
8,600,000 g |
| Meperidine Intermediate-A |
3 g |
3 g |
| Meperidine Intermediate-B |
7 g |
7 g |
| Meperidine Intermediate-C |
3 g |
3 g |
| Metazocine |
1 g |
1 g |
| Methadone (for sale) |
25,000,000 g |
25,000,000 g |
| Methadone Intermediate |
26,000,000 g |
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 |
3,130,000 g |
| Methylphenidate |
50,000,000 g |
50,000,000 g |
| Morphine (for sale) |
35,000,000 g |
35,000,000 g |
| Morphine (for conversion) |
100,000,000 g |
100,000,000 g |
| Nabilone |
9,002 g |
9,002 g |
| Noroxymorphone (for sale) |
10,000 g |
10,000 g |
| Noroxymorphone (for conversion) |
9,000,000 g |
9,000,000 g |
| Opium (powder) |
1,050,000 g |
230,000 g |
| Opium (tincture) |
230,000 g |
1,050,000 g |
| Oripavine |
15,000,000 g |
15,000,000 g |
| Oxycodone (for sale) |
77,560,000 g |
77,560,000 g |
| Oxycodone (for conversion) |
3,400,000 g |
3,400,000 g |
| Oxymorphone |
2,000,000 g |
2,000,000 g |
| Oxymorphone (for conversion) |
12,000,000 g |
12,000,000 g |
| Pentobarbital |
28,000,000 g |
28,000,000 g |
| Phenazocine |
1 g |
1 g |
| Phencyclidine |
20 g |
20 g |
| Phenmetrazine |
2 g |
2 g |
| Phenylacetone |
1 g |
1 g |
| Racemethorphan |
2 g |
2 g |
| Remifentanil |
500 g |
500 g |
| Secobarbital |
67,000 g |
67,000 g |
| Sufentanil |
10,300 g |
10,300 g |
| Tapentadol \1\ |
0 g |
519,000 g |
| Thebaine |
126,000,000 g |
126,000,000 g |
\1\ Tapentadol was placed in schedule II of the Controlled
Substances Act by a final order published by the Drug Enforcement
Administration on May 21, 2009 (74 FR 23790).
The Deputy Administrator further proposes that aggregate production
quotas for all other schedules I and II controlled substances included
in 21 CFR
1308.11 and 1308.12
remain at zero.
All interested persons are invited to submit their comments in
writing or electronically regarding this proposal following the
procedures in the ADDRESSES section of this document. A person may
object to or comment on the proposal relating to any of the above-
mentioned substances without filing comments or objections regarding the
others. If a person believes that one or more of these issues warrant a
hearing, the individual should so state and summarize the reasons for
this belief. Persons wishing to request a hearing should note that such
requests must be written and manually signed; requests for a hearing
will not be accepted via electronic means. In the event that comments or
objections to this proposal raise one or more issues which the Deputy
Administrator finds warrant a hearing, the Deputy Administrator shall
order a public hearing by notice in the Federal Register, summarizing
the issues to be heard and setting the time for the hearing as per 21
CFR 1303.13(c).
Regulatory Certifications
Regulatory Flexibility Act
The Deputy Administrator hereby certifies that this action will not
have a significant economic impact upon small entities whose interests
must be considered under the Regulatory Flexibility Act, 5 U.S.C. 601-
612. 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 lawful 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.
Executive Order 12866
The Office of Management and Budget has determined that notices of
aggregate production quotas are not subject to centralized review under
Executive Order 12866.
Executive Order 13132
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.
Executive Order 12988
This action meets the applicable standards set forth in Sections 3(a)
and 3(b)(2) of Executive Order 12988 Civil Justice Reform.
Unfunded Mandates Reform Act of 1995
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 (adjusted for inflation) 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.
Congressional Review Act
This action is not a major rule as defined by Section 804 of the
Small Business Regulatory Enforcement Fairness Act of 1996
(Congressional Review Act). 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,
[[Page 36515]]
investment, productivity, innovation, or on the ability of United
States-based companies to compete with foreign-based companies in
domestic and export markets.
Dated: July 16, 2009.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E9-17536 Filed 7-22-09; 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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