[Federal Register Volume 59, Number 149 (Thursday, August 4, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-19054]
[[Page Unknown]]
[Federal Register: August 4, 1994]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Controlled Substances: Proposed Aggregate Production Quotas for
1995
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of proposed aggregate production goals for 1995.
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SUMMARY: This notice proposes initial 1995 aggregate production quotas
for controlled substances in Schedules I and II of the Controlled
Substances Act.
DATES: Comments or objections should be received on or before September
6, 1994.
ADDRESSES: Send comments or objections to the Administrator, Drug
Enforcement Administration, Washington, DC 20537, Attn: DEA Federal
Register Representative (CCR).
FOR FURTHER INFORMATION CONTACT: Howard McClain, Jr., Chief, Drug &
Chemical Evaluation Section, Drug Enforcement Administration,
Washington, DC 20537, Telephone: (202) 307-7183.
SUPPLEMENTARY INFORMATION: Section 306 of the Controlled Substances Act
(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 59 FR 23637 (May 6,
1994).
The quotas are to provide adequate supplies of each substance for:
(1) The estimated medical, scientific, research, and industrial needs
of the United States; (2) lawful export requirements; and (3) the
establishment and maintenance of reserve stocks.
In determining the below listed proposed 1995 aggregate production
quotas, the Deputy Administrator considered the following factors: (1)
Total actual 1993 and estimated 1994 and 1995 net disposals of each
substance by all manufacturers; (2) estimates of 1994 year end
inventories of each substance and of any substance manufactured from it
and trends in accumulation of such inventories; and (3) projected
demand as indicated by procurement quota applications filed pursuant to
Sec. 1303.12 of Title 21 of the Code of Federal Regulations.
Pursuant to Sec. 1303.23(c) of Title 21 of the Code of Federal
Regulations, the Deputy Administrator of the DEA will, in early 1995,
adjust aggregate production quotas and individual manufacturing quotas
allocated for the year based upon 1994 year-end inventory and actual
1994 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 Controlled Substances Act of 1970 (21 U.S.C. 826),
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 59 FR 23637 (May 6, 1994), the Deputy
Administrator hereby proposes that the aggregate production quotas for
1995 for the following controlled substances, expressed in grams of
anhydrous acid or base, be established as follows:
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Proposed
Basic class 1995 quotas
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Schedule I
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Acetylmethadol............................................. 2
Aminorex................................................... 2
Bufotenine................................................. 10
Cathinone.................................................. 4
Difenoxin.................................................. 14,000
2, 5-Dimethoxyamphetamine.................................. 15,650,000
Dimethylamphetamine........................................ 2
N-Ethylamphetamine......................................... 4
Lysergic acid diethylamide................................. 41
Mescaline.................................................. 2
4-Methoxyamphetamine....................................... 12
4-Methylaminorex........................................... 2
3-Methylfentanyl........................................... 12
Methaqualone............................................... 2
Methcathinone.............................................. 9
3, 4-Methylenedioxyamphetamine............................. 12
3, 4-Methylenedioxy-N-ethylamphetamine..................... 2
3, 4-Methylenedioxymethamphetamine......................... 12
Normorphine................................................ 2
Tetrahydrocannibinols...................................... 35,000
Thiophene Analog of Phencyclidine.......................... 10
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Schedule II
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Alfentanil................................................. 7,000
Amobarbital................................................ 5
Amphetamine................................................ 635,000
Cocaine.................................................... 550,000
Codeine (for sale)......................................... 67,312,000
Codeine (for conversion)................................... 16,181,000
Desoxyephedrine 900,000 grams of levodesoxyephedrine for
use in a noncontrolled, nonprescription product and 20
grams for methamphetamine................................. 900,020
Dextropropoxyphene......................................... 124,012,000
Dihydrocodeine............................................. 202,000
Diphenoxylate.............................................. 688,000
Ecgonine (for conversion).................................. 650,000
Fentanyl................................................... 76,000
Hydrocodone................................................ 8,474,000
Hydromorphone.............................................. 393,000
Levo-alpha-acetylmethadol.................................. 200,000
Levorphanol................................................ 8,000
Meperidine................................................. 8,637,000
Methadone.................................................. 3,779,000
Methadone (for conversion)................................. 364,000
Methadone Intermediate (for sale).......................... 300,000
Methadone Intermediate (for conversion).................... 4,393,000
Methylphenidate............................................ 7,935,000
Morphine (for sale)........................................ 7,612,000
Morphine (for conversion).................................. 78,105,000
Noroxymorphone (for sale).................................. 21,000
Noroxymorphone (for conversion)............................ 3,500,000
Opium...................................................... 1,118,000
Oxycodone (for sale)....................................... 3,613,000
Oxycodone (for conversion)................................. 6,200
Oxymorphone................................................ 2,500
Pentobarbital.............................................. 15,706,000
Phencyclidine.............................................. 52
Phenylacetone (for conversion)............................. 3,528,000
Secobarbital............................................... 480,000
Sufentanil................................................. 700
Thebaine................................................... 9,383,000
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Aggregate production quotas for all other Schedules I and II
controlled substances included in Secs. 1308.11 and 1308.12 of Title 21
of the Code of Federal Regulations are established at zero.
All interested persons are invited to submit their comments and
objections in writing regarding this proposal. 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 has been analyzed in accordance with
the principles and criteria contained in Executive Order 12612, and it
has been determined that this matter does not have sufficient
federalism implications to warrant the preparation of a Federalism
Assessment.
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 annual aggregate production quotas for Schedules I
and II controlled substances is mandated by law and by international
treaty obligations. 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.
Dated: July 28, 1994.
Stephen H. Greene,
Deputy Administrator.
[FR Doc. 94-19054 Filed 8-3-94; 8:45 am]
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