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Federal
Register Notices > Quotas -
2007 > Controlled Substances: Proposed Aggregate Production Quotas for 2008
FR Doc E7-16729 [Federal Register: August 24, 2007 (Volume 72, Number
164)] [Notices] [Page 48683-48686] From the Federal Register Online via
GPO Access [wais.access.gpo.gov] [DOCID:fr24au07-113]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-307P]
Controlled Substances: Proposed Aggregate Production Quotas for 2008
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of proposed year 2008 aggregate production quotas.
SUMMARY: This notice proposes initial year 2008 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
14, 2007.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-307P'' 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, 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, 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 proposed year 2008 aggregate production quotas represent those
quantities of controlled substances that may be produced in the United
States in 2008 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 2008 aggregate production quotas,
the Deputy Administrator considered the following factors: Total actual
2006 and estimated 2007 and 2008 net disposals of each substance by all
manufacturers; estimates of 2007 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
1303.12; and
other pertinent information.
Pursuant to 21 CFR 1303, the Deputy Administrator of the DEA will, in
early 2008, adjust aggregate production quotas and individual
manufacturing quotas allocated for the year based upon 2007 year-end
inventory and actual 2007 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 28 CFR 0.100, and redelegated to the Deputy
Administrator pursuant to 28 CFR 0.104, the Deputy Administrator hereby
proposes that the year 2008 aggregate production quotas for the
following controlled substances, expressed in grams of anhydrous acid or
base, be established as follows:
[[Page 48684]]
| Basic class--Schedule I |
Proposed year 2008 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 |
| 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 |
106,000,000 |
| Dihydrocodeine |
1,200,000 |
| 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) |
3 |
| 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) |
100,000,000 |
| Nabilone |
3,002 |
| Noroxymorphone (for sale) |
1,002 |
| Noroxymorphone (for conversion) |
8,000,000 |
| Opium |
1,400,000 |
| Oxycodone (for sale) |
70,000,000 |
| Oxycodone (for conversion) |
3,100,000 |
| Oxymorphone |
1,800,000 |
| Oxymorphone (for conversion) |
11,000,000 |
| 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 proposes 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.
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.
[[Page 48686]]
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.
August 15, 2007.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E7-16729 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).
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