[Federal Register Volume 60, Number 89 (Tuesday, May 9, 1995)]
[Notices]
[Pages 24649-24651]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-11370]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[DEA No. 132P]
Controlled Substances: Proposed 1995 Aggregate Production Quotas
AGENCY: Drug Enforcement Administration.
ACTION: Notice of proposed revised aggregate production quotas for
1995.
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SUMMARY: This notice proposes revised 1995 aggregate production quotas
for controlled substances in Schedules I and II, as required under the
Controlled Substances Act of 1970.
DATES: Comments or objections should be received on or before June 8,
1995.
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
(CSA) (21 U.S.C. 826) requires that the Attorney General establish
aggregate production quotas for all controlled substances listed in
Schedules I and II. This responsibility has been delegated to the
Administrator of the DEA pursuant to Sec. 0.100 of Title 28 of the Code
of Federal Regulations.
The Administrator, in turn, has redelegated this function to the
Deputy Administrator of the DEA by Sec. 0.104 of Title 28 of the Code
of Federal Regulations.
On October 20, 1994, a notice of the 1995 established aggregate
production quotas was published in the Federal Register (59 FR 52991).
The notice stipulated that the Deputy Administrator of the DEA would
adjust the quotas in early 1995 as provided for in Title 21, Code of
Federal Regulations, Sec. 1303.23(c). These aggregate production quotas
represent those amounts of controlled substances that may be produced
in the United States in 1995 and do not include amounts which may be
imported for use in industrial processes.
The proposed revisions are based on a review of 1994 year-end
inventories, 1994 disposition data submitted by quota applicants,
estimates of the medical needs of the United States submitted to the
DEA by the Food and Drug Administration and other information available
to the DEA.
Therefore, under the authority vested in the Attorney General by
section 306 of the CSA of 1970 (21 U.S.C. 826), delegated to the
Administrator by Sec. 0.100 of Title 28 of the Code of Federal
Regulations, and redelegated to the Deputy Administrator by Sec. 0.104
of Title 28 of the Code of Federal Regulations, the Deputy
Administrator of the DEA hereby proposes the following changes in the
1995 aggregate production quotas for the listed controlled substances,
expressed in grams of anhydrous acid or base.
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Previously Proposed
established revised 1995
Basic class 1995 aggregate aggregate
production production
quotas quotas
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Schedule I:.............................
Acetylmethadol...................... 2 7
Alphacetymethadol................... 0 5
Aminorex............................ 2 7
Bufotenine.......................... 10 10
Cathinone........................... 4 9
Difenoxin........................... 14,000 14,000
[[Page 24650]]
Dihydromorphine..................... 0 5
2,5-Dimethylamphetamine............. 15,650,000 15,650,000
Dimethylamphetamine................. 2 7
Ethylamine analog of Phencyclidine.. 0 5
N-Ethylamphetamine.................. 4 9
Lysergic acid diethylamide.......... 41 56
Mescaline........................... 2 7
Methaqualone........................ 2 7
Methcathinone....................... 9 14
4-Methoxyamphetamine................ 12 17
4-Methylaminorex.................... 2 2
3,4-Methylenedioxyamphetamine....... 12 17
3,4-Methylenedioxy-N-
ethylamphetamine................... 2 27
3,4-Methylenedioxymethamphetamine... 12 17
3-Methylfentanyl.................... 12 14
Normethadone........................ 0 5
Normorphine......................... 2 7
Tetrahydrocannabinols............... 35,000 35,000
Thiophene Analog of Phencyclidine... 10 10
Schedule II:............................
Alfentanil.......................... 7,000 7,000
Amobarbital......................... 5 15
Amphetamine......................... 1,026,100 1,026,100
Cocaine............................. 550,000 550,000
Codeine (for sale).................. 67,312,000 67,312,000
Codeine (for conversion)............ 16,181,000 16,181,000
Desoxyephedrine..................... 900,000 1,154,000
(1,138,000 grams of levo-desoxyephedrine for use in a non-controlled,
non-prescription product and 16,000 grams for methamphetamine).........
Dextropropoxyphene...................... 124,012,000 124,012,000
Dihydrocodeine.......................... 202,000 100,000
Diphenoxylate........................... 688,000 346,000
Ecgonine (for conversion)............... 650,000 650,000
Ethylmorphine........................... 0 10
Fentanyl................................ 76,000 52,000
Hydrocodone............................. 8,474,000 8,474,000
Hydromorphone........................... 404,000 404,000
Isomethadone............................ 0 10
Levo-alpha-acetylmethadol............... 200,000 200,000
Levorphanol............................. 8,000 8,000
Meperidine.............................. 8,637,000 9,521,000
Methadone............................... 3,779,000 3,779,000
Methadone (for conv).................... 364,000 364,000
Methadone Intermediate (for sale)....... 300,000 0
Methadone Int. (for conv)............... 4,393,000 4,393,000
Methylphenidate......................... 8,886,000 10,410,000
Morphine (for sale)..................... 7,612,000 7,612,000
Morphine (for conv)..................... 78,105,000 78,105,000
Noroxymorphone (for sale)............... 21,000 21,000
Noroxymorphone (for conv)............... 3,500,000 3,500,000
Opium................................... 1,118,000 1,304,000
Oxycodone (for sale).................... 3,613,00 4,254,000
Oxycodone (for conv).................... 23,000 25,500
Oxymorphone............................. 9,200 10,200
Pentobarbital........................... 15,706,000 15,706,000
Phencyclidine........................... 52 72
Phenylacetone (for conv)................ 3,528,000 3,528,000
1-Phenylcyclohexylamine................. 0 10
1-Piperidinocyclohexanecarbonitrile..... 0 10
Secobarbital............................ 480,000 322,000
Sufentanil.............................. 1,600 1,600
Thebaine................................ 9,383,000 9,383,000
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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 [[Page 24651]] Register, summarizing the issues to be heard and
setting the time for the hearing.
The Office of Management and budget has determined that notice of
aggregate production quotas are not subject to centralized review under
Executive Order 12866.
Rules establishing aggregate production quotas for controlled
substances in Schedules I and II are required by statute, fulfill
United States obligations under the Single Convention on Narcotic
Drugs, 1961, and other international treaties, and are essential to a
criminal law enforcement function of the United States. Without the
periodic establishment and adjustment of aggregate production quotas,
pharmaceutical manufacturers in the United States could not lawfully
produce a wide variety of medically necessary pharmaceutical drugs.
These actions have been analyzed in accordance with the principles
and criteria contained in Executive Order 12612 and it has been
determined that this matter raises no Federalism implications which
would 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 and revision of annual production quotas for
Schedules I and II controlled substances is mandated by law and by the
international obligations of the United States. Such quotas impact
predominantly upon major manufacturers of the affected controlled
substances.
Dated: May 3, 1995.
Stephen H. Greene,
Deputy Administrator.
[FR Doc. 95-11370 Filed 5-8-95; 8:45 am]
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