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Federal
Register Notices > Quotas -
2006 > Controlled Substances: Proposed Aggregate Production Quotas for
2007
FR Doc E6-14284 [Federal Register: August 29, 2006 (Volume 71, Number 167)]
[Notices] [Page 51214-51217] From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29au06-70]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-290P]
Controlled Substances: Proposed Aggregate Production Quotas for 2007
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of proposed year 2007 aggregate production quotas.
SUMMARY: This notice proposes initial year 2007 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 September 19,
2006.
ADDRESSES: To ensure proper handling of comments, please reference ``Docket
No. DEA-290P'' on all written and electronic correspondence. Written comments
being sent via regular mail should be sent to the Deputy Assistant
Administrator, Office of Diversion Control, Drug Enforcement Administration,
Washington, DC 20537,
[[Page 51215]]
Attention: DEA Federal Register Representative/ODL. Written comments sent
via express mail should be sent to DEA Headquarters, Attention: DEA Federal
Register Representative/ODL, 2401 Jefferson-Davis Highway, Alexandria, VA
22301. 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, 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 Section
0.100 of Title 28 of the Code of Federal Regulations. The Administrator, in
turn, has redelegated this function to the Deputy Administrator, pursuant to
Section 0.104 of Title 28 of the Code of Federal Regulations.
The proposed year 2007 aggregate production quotas represent those
quantities of controlled substances that may be produced in the United States
in 2007 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 proposed year 2007 aggregate production quotas, the
Deputy Administrator considered the following factors: total actual 2005 and
estimated 2006 and 2007 net disposals of each substance by all manufacturers;
estimates of 2006 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 Section 1303.12 of Title 21 of the Code of Federal Regulations; and other
pertinent information.
Pursuant to Section 1303 of Title 21 of the Code of Federal
Regulations,
the Deputy Administrator of the DEA will, in early 2007, adjust aggregate
production quotas and individual manufacturing quotas allocated for the year
based upon 2006 year-end inventory and actual 2006 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 of 1970 (21 U.S.C. 826), and delegated to the Administrator of
the DEA by Section 0.100 of Title 28 of the Code of Federal Regulations, and
redelegated to the Deputy Administrator pursuant to Section 0.104 of Title 28
of the Code of Federal Regulations, the Deputy Administrator hereby proposes
that the year 2007 aggregate production quotas for the following controlled
substances, expressed in grams of anhydrous acid or base, be established as
follows:
| Basic class--schedule I |
Proposed year 2007 quotas |
| 2,5-Dimethoxyamphetamine |
2,001,000 g |
| 2,5-Dimethoxy-4-ethylamphetamine (DOET) |
2 g |
| 2,5-Dimethoxy-4-(n)-propylthiophenethylamine (2C-T-7) |
10 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) |
22 g |
| 3,4,5-Trimethoxyamphetamine |
2 g |
| 4-Bromo-2,5-dimethoxyamphetamine (DOB) |
2 g |
| 4-Bromo-2,5-dimethoxyphenethylamine (2-CB) |
7 g |
| 4-Methoxyamphetamine |
77 g |
| 4-Methylaminorex |
2 g |
| 4-Methyl-2,5-dimethoxyamphetamine (DOM) |
12 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 |
3 g |
| Alpha-methylfentanyl |
2 g |
| Alpha-methylthiofentanyl |
2 g |
| Alpha-methyltryptamine |
5 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 |
8 g |
| Cathinone |
3 g |
| Codeine-N-oxide |
302 g |
| Diethyltryptamine |
2 g |
| Difenoxin |
50 g |
| Dihydromorphine |
2,549,000 g |
| Dimethyltryptamine |
3 g |
| Gamma-hydroxybutyric acid |
8,000,000 g |
| Heroin |
5 g |
| Hydromorphinol |
3,000 g |
| Hydroxypethidine |
2 g |
| Lysergic acid diethylamide (LSD) |
61 g |
| Marihuana |
4,500,000 g |
| Mescaline |
2 g |
| Methaqualone |
10 g |
| Methcathinone |
4 g |
| Methyldihydromorphine |
2 g |
| Morphine-N-oxide |
310 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
|
Proposed year 2007 quotas
|
|
1-Phenylcyclohexylamine
|
2 g
|
|
Alfentanil
|
5,000 g
|
|
Alphaprodine
|
2 g
|
|
Amobarbital
|
2 g
|
|
Amphetamine
|
17,000,000 g
|
|
Cocaine
|
286,000 g
|
|
Codeine (for sale)
|
39,605,000 g
|
|
Codeine (for conversion)
|
55,000,000 g
|
|
Dextropropoxyphene
|
167,365,000 g
|
|
Dihydrocodeine
|
2,200,000 g
|
|
Diphenoxylate
|
828,000 g
|
|
Ecgonine
|
83,000 g
|
|
Ethylmorphine
|
2 g
|
|
Fentanyl
|
1,428,000 g
|
|
Glutethimide
|
2 g
|
|
Hydrocodone (for sale)
|
41,252,000 g
|
|
Hydrocodone (for conversion)
|
1,500,000 g
|
|
Hydromorphone
|
3,300,000 g
|
|
Isomethadone
|
2 g
|
|
Levo-alphacetylmethadol (LAAM)
|
6 g
|
|
Levomethorphan
|
5 g
|
|
Levorphanol
|
6,000 g
|
|
Meperidine
|
9,753,000 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; 2405,000 grams for methamphetamine mostly for conversion
to a Schedule III product; and 45,000 grams for methamphetamine (for sale)]
|
3,130,000 g
|
|
Methylphenidate
|
35,000,000 g
|
|
Morphine (for sale)
|
35,000,000 g
|
|
Morphine (for conversion)
|
110,774,000 g
|
|
Nabilone
|
2 g
|
|
Noroxymorphone (for sale)
|
1,002 g
|
|
Noroxymorphone (for conversion)
|
6,600,000 g
|
|
Opium
|
1,400,000 g
|
|
Oxycodone (for sale)
|
49,200,000 g
|
|
Oxycodone (for conversion)
|
2,600,000 g
|
|
Oxymorphone
|
1,500,000 g
|
|
Pentobarbital
|
28,000,000 g
|
|
Phencyclidine
|
2,021 g
|
|
Phenmetrazine
|
2 g
|
|
Racemethorphan
|
2 g
|
|
Remifentanil
|
2,700 g
|
|
Secobarbital
|
2 g
|
|
Sufentanil
|
6,500 g
|
|
Thebaine
|
72,453,000 g
|
The Deputy Administrator further proposes that aggregate production quotas
for all other Schedules I and II controlled substances included in Sections
1308.11 and 1308.12
of Title 21 of the Code of Federal Regulations 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 $118,000,000 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.
Dated: August 22, 2006.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E6-14284 Filed 8-28-06; 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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