|
Federal
Register Notices > Quotas -
2007 > Controlled Substances: Final Revised Aggregate Production Quotas for 2007
FR Doc E7-16730 [Federal Register: August 24, 2007 (Volume 72, Number
164)] [Notices] [Page 48686-48689] From the Federal Register Online via
GPO Access [wais.access.gpo.gov] [DOCID:fr24au07-114]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-290F]
Controlled Substances: Final Revised Aggregate Production Quotas for
2007
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of final aggregate production quotas for 2007.
SUMMARY: This notice establishes final 2007 aggregate production
quotas for controlled substances in schedules I and II of the Controlled
Substances Act (CSA). The DEA has taken into consideration comments
received in response to a notice of the proposed revised aggregate
production quotas for 2007 published May 3, 2007 (72 FR 24608).
EFFECTIVE DATE: August 24, 2007.
FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, PhD, 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 28 CFR 0.100. The Administrator, in turn, has redelegated this
function to the Deputy Administrator, pursuant to 28 CFR 0.104.
The 2007 aggregate production quotas represent those quantities of
controlled substances in schedules I and II 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 (21 U.S.C. 826(a) and 21 CFR
1303.11).
These quotas do not include imports of controlled substances.
On May 3, 2007, a notice of the proposed revised 2007 aggregate
production quotas for certain controlled substances in schedules I and
II was published in the Federal Register (72 FR 24608). All interested
persons were invited to comment on or object to these proposed aggregate
production quotas on or before May 24, 2007.
Nine companies commented on a total of 31 schedules I and II
controlled substances within the published comment period. Nine
companies proposed that the aggregate production quotas for 14-
hydroxymorphinone, alfentanil, amphetamine (for sale), amphetamine (for
conversion), cocaine, codeine (for conversion), dextropropoxyphene,
dihydromorphine, diphenoxylate, ecgonine, fentanyl, gamma hydroxybutyric
acid, hydrocodone, hydromorphone, lisdexamfetamine, meperidine,
methadone, methadone intermediate, methylphenidate, morphine, morphine
(for conversion), nabilone, noroxymorphone (for conversion), oxycodone,
oxymorphone, oxymorphone (for conversion), pentobarbital, remifentanil,
sufentanil, 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.
The DEA has determined that the compound 14-hydroxymorphinone is a
morphine derivative. The comment received concerning this substance was
therefore, considered as a comment for morphine.
DEA has taken into consideration the above comments along with the
relevant 2006 year-end inventories, initial 2007 manufacturing quotas,
2007 export requirements, actual and projected 2007 sales, research,
product development requirements and additional applications received.
Based on this information, the DEA has adjusted the final 2007 aggregate
production quotas for 2,5-dimethoxyamphetamine, alfentanil, amphetamine
(for conversion), gamma-hydroxybutyric acid, hydrocodone,
methylphenidate, oxycodone, oxycodone (for conversion), pentobarbital,
remifentanil, sufentanil and thebaine to meet the legitimate needs of
the United States.
Regarding amphetamine (for sale), cocaine, codeine (for conversion),
dextropropoxyphene, dihydromorphine, diphenoxylate, ecgonine, fentanyl,
hydromorphone, lisdexamfetamine, meperidine, methadone, methadone
intermediate, morphine, morphine (for conversion), nabilone,
noroxymorphone (for conversion), oxymorphone, oxymorphone (for
conversion), and tetrahydrocannabinols the DEA has determined that the
proposed revised 2007 aggregate production quotas are sufficient to meet
the current 2007 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 Administrator hereby
orders that the 2007 final aggregate production quotas for the following
controlled substances, expressed in grams of anhydrous acid or base, be
established as follows:
| Basic class--Schedule I |
Final revised 2007 quotas
(grams) |
| 2,5-Dimethoxyamphetamine |
2 |
| 2,5-Dimethoxy-4-ethylamphetamine (DOET) |
2 |
| 2,5-Dimethoxy-4-(n)-propylthiophenethylamine
(2C-T-7) |
10 |
| 3-Methylfentanyl |
2 |
| 3-Methylthiofentanyl |
2 |
| 3,4-Methylenedioxyamphetamine (MDA) |
20 |
| 3,4-Methylenedioxy-N-ethylamphetamine (MDEA) |
10 |
| 3,4-Methylenedioxymethamphetamine (MDMA) |
22 |
| 3,4,5-Trimethoxyamphetamine |
2 |
| 4-Bromo-2,5-dimethoxyamphetamine (DOB) |
2 |
| 4-Bromo-2,5-dimethoxyphenethylamine (2-CB) |
7 |
| 4-Methoxyamphetamine |
77 |
| 4-Methylaminorex |
2 |
| 4-Methyl-2,5-dimethoxyamphetamine (DOM) |
12 |
| 5-Methoxy-3,4-methylenedioxyamphetamine |
2 |
| 5-Methoxy-N,N-diisopropyltryptamine |
5 |
| Acetyl-alpha-methylfentanyl |
2 |
| Acetyldihydrocodeine |
2 |
| Acetylmethadol |
2 |
| Allylprodine |
2 |
| Alphacetylmethadol |
2 |
| Alpha-ethyltryptamine |
2 |
| Alphameprodine |
2 |
| Alphamethadol |
3 |
| Alpha-methylfentanyl |
2 |
| Alpha-methylthiofentanyl |
2 |
| Alpha-methyltryptamine |
5 |
| Aminorex |
8 |
| Benzylmorphine |
2 |
| Betacetylmethadol |
2 |
| Beta-hydroxy-3-methylfentanyl |
2 |
| Beta-hydroxyfentanyl |
2 |
| Betameprodine |
2 |
| Betamethadol |
2 |
| Betaprodine |
2 |
| Bufotenine |
8 |
| Cathinone |
3 |
| Codeine-N-oxide |
302 |
| Diethyltryptamine |
2 |
| Difenoxin |
50 |
| Dihydromorphine |
2,549,000 |
| Dimethyltryptamine |
3 |
| Gamma-hydroxybutyric acid |
23,600,000 |
| Heroin |
5 |
| Hydromorphinol |
3,000 |
| Hydroxypethidine |
2 |
| Ibogaine |
1 |
| Lysergic acid diethylamide (LSD) |
61 |
| Marihuana |
4,500,000 |
| Mescaline |
2 |
| Methaqualone |
10 |
| Methcathinone |
4 |
| Methyldihydromorphine |
2 |
| Morphine-N-oxide |
310 |
| N,N-Dimethylamphetamine |
7 |
| N-Ethylamphetamine |
2 |
| N-Hydroxy-3,4-methylenedioxyamphetamine |
2 |
| Noracymethadol |
2 |
| Norlevorphanol |
52 |
| Normethadone |
2 |
| Normorphine |
16 |
| Para-fluorofentanyl |
2 |
| Phenomorphan |
2 |
| Pholcodine |
2 |
| Psilocybin |
7 |
| Psilocyn |
7 |
| Tetrahydrocannabinols |
312,500 |
| Thiofentanyl |
2 |
| Trimeperidine |
2 |
| Basic class--Schedule II |
Final revised 2007 quotas
(grams) |
| 1-Phenylcyclohexylamine |
2 |
| Alfentanil |
5,200 |
| Alphaprodine |
2 |
| Amobarbital |
3 |
| Amphetamine (for sale) |
17,000,000 |
| Amphetamine (for conversion) |
5,000,000 |
| Cocaine |
286,000 |
| Codeine (for sale) |
39,605,000 |
| Codeine (for conversion) |
59,000,000 |
| Dextropropoxyphene |
120,000,000 |
| Dihydrocodeine |
2,435,000 |
| Diphenoxylate |
828,000 |
| Ecgonine |
83,000 |
| Ethylmorphine |
2 |
| Fentanyl |
1,428,000 |
| Glutethimide |
2 |
| Hydrocodone (for sale) |
46,000,000 |
| Hydrocodone (for conversion) |
1,500,000 |
| Hydromorphone |
3,300,000 |
| Isomethadone |
2 |
| Levo-alphacetylmethadol (LAAM) |
6 |
| Levomethorphan |
5 |
| Levorphanol |
6,000 |
| Lisdexamfetamine |
6,200,000 |
| Meperidine |
9,753,000 |
| Metazocine |
1 |
| Methadone (for sale) |
25,000,000 |
| Methadone Intermediate |
26,000,000 |
| Methamphetamine |
3,130,000 |
| Methylphenidate |
50,000,000 |
| Morphine (for sale) |
35,000,000 |
| Morphine (for conversion) |
110,774,000 |
| Nabilone |
3,002 |
| Noroxymorphone (for sale) |
1,002 |
| Noroxymorphone (for conversion) |
11,000,000 |
| Opium |
1,400,000 |
| Oxycodone (for sale) |
70,000,000 |
| Oxycodone (for conversion) |
3,100,000 |
| Oxymorphone |
1,800,000 |
| Oxymorphone (for conversion) |
15,300,000 |
| Pentobarbital |
35,200,000 |
| Phencyclidine |
2,021 |
| Phenmetrazine |
2 |
| Racemethorphan |
2 |
| Remifentanil |
3,000 |
| Secobarbital |
2 |
| Sufentanil |
10,300 |
| Thebaine |
126,000,000 |
The Deputy Administrator further orders that the aggregate production
quotas for all other schedules 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 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
[[Page 48689]]
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 15, 2007.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E7-16730 Filed 8-23-07; 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).
|
