[Federal Register Volume 61, Number 101 (Thursday, May 23, 1996)]
[Notices]
[Pages 25895-25897]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-12899]
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DEPARTMENT OF JUSTICE
[DEA No. 150P]
Controlled Substances: Notice of Proposed 1996 Aggregate
Production Quotas
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of proposed revised aggregate production quotas for
1996.
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SUMMARY: This notice proposes revised 1996 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 24,
1996.
ADDRESSES: Send comments or objections to the Administrator, Drug
Enforcement Administration, Washington, D.C. 20537, Attn: DEA Federal
Register Representative/CCR.
FOR FURTHER INFORMATION CONTACT: Howard McClain, Jr., Chief, Drug &
Chemical Evaluation Section, Drug Enforcement Administration,
Washington, D.C. 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 section 0.104
of Title 28 of the Code of Federal Regulations.
On November 21, 1995, a notice of the 1996 established aggregate
production quotas was published in the Federal Register (60 FR 57808).
The notice stipulated that the Deputy Administrator of the DEA would
adjust the quotas in early 1996 as provided for in Title 21, Code of
Federal Regulations, Section 1303.23(c). Subsequently, the DEA revised
1996 aggregate production quotas for amobarbital, heroin and
hydromorphone as published in the Federal Register (61 FR 19090 and 61
FR 14336). Those revised figures are included with the proposed 1996
revised aggregate production quotas below. These proposed aggregate
production quotas represent those amounts of controlled substances that
may be produced in the United States in 1996 and do not include amounts
which may be imported for use in industrial processes.
The proposed revisions are based on a review of 1995 year-end
inventories, 1995 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.
[[Page 25896]]
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 Section 0.100 of Title 28 of the Code of Federal
Regulations, and redelegated to the Deputy Administrator by Section
0.104 of Title 28 of the Code of Federal Regulations, the Deputy
Administrator of the DEA hereby proposes the following 1996 aggregate
production quotas for the listed controlled substances, expressed in
grams of anhydrous acid or base.
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Previously established 1996 Proposed revised 1996
Basic class aggregate production quotas aggregate production quotas
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Schedule I:
Acetylmethadol.................................... 7 7
Alphacetylmethadol................................ 7 7
Aminorex.......................................... 7 7
Cathinone......................................... 9 9
Difenoxin......................................... 14,000 14,000
Dihydromorphine................................... 7 7
2, 5-Dimethoxyamphetamine......................... 10,650,000 10,650,000
Dimethylamphetamine............................... 7 7
Ethylamine analog of Phencyclidine................ 5 5
N-Ethylamphetamine................................ 7 7
Heroin............................................ 5 5
Lysergic acid diethylamide........................ 58 58
Mescaline......................................... 7 7
Methaqualone...................................... 17 17
Methcathinone..................................... 9 9
4-Methoxyamphetamine.............................. 17 17
4-Methylaminorex.................................. 2 2
3,4-Methylenedioxyamphetamine..................... 17 17
3,4-Methylenedioxy-N-ethylamphetamine............. 27 27
3,4-Methylenedioxymethamphetamine................. 42 42
3-Methylfentanyl.................................. 14 14
Normethadone...................................... 7 7
Normorphine....................................... 7 7
Psilocybin........................................ 2 2
Psilocyn.......................................... 2 2
Tetrahydrocannabinols............................. 55,100 55,100
Schedule II:
Alfentanil........................................ 8,500 8,500
Amobarbital....................................... 301,000 301,000
Amphetamine....................................... 1,863,200 2,280,000
Cocaine........................................... 550,040 550,040
Codeine (for sale)................................ 58,395,000 47,000,000
Codeine (for conversion).......................... 16,632,000 17,519,000
Desoxyephedrine................................... 1,044,000 1,044,000
(1,000,000 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product and 44,000 grams
for methamphetamine)
Dextropropoxyphene................................ 118,066,000 118,066,000
Dihydrocodeine.................................... 116,000 214,000
Diphenoxylate..................................... 1,063,000 1,002,000
Ecgonine (for conversion)......................... 650,100 650,100
Ethylmorphine..................................... 12 12
Fentanyl.......................................... 120,100 143,000
Hydrocodone (for sale)............................ 10,575,000 12,145,000
Hydrocodone (for conversion)...................... 2,800,000 2,800,000
Hydromorphone..................................... 718,000 718,000
Isomethadone...................................... 12 12
Levo-alpha-acetylmethadol......................... 200,000 200,000
Levorphanol....................................... 14,300 14,300
Meperidine........................................ 10,822,000 10,822,000
Methadone......................................... 4,551,000 4,551,000
Methadone (for conv).............................. 364,000 364,000
Methadone Int. (for conv)......................... 5,534,000 5,534,000
Methamphetamine (for conv)........................ 723,000 723,000
Methylphenidate................................... 10,291,000 11,090,000
Morphine (for sale)............................... 12,450,000 12,450,000
Morphine (for conv)............................... 76,735,000 76,735,000
Noroxymorphone (for sale)......................... 2,000 2,000
Noroxymorphone (for conv)......................... 3,400,000 3,400,000
Opium............................................. 1,226,000 714,000
Oxycodone (for sale).............................. 5,571,000 5,571,000
Oxycodone (for conv).............................. 37,300 37,300
Oxymorphone....................................... 11,200 11,200
Pentobarbital..................................... 15,100,000 15,100,000
Phencyclidine..................................... 40 40
Phenylacetone (for conv).......................... 5,280,000 10
1-Phenylcyclohexylamine........................... 10 10
[[Page 25897]]
1-Piperidinocyclohexanecarbonitrile............... 12 12
Secobarbital...................................... 400,000 400,000
Sufentanil........................................ 1,000 1,000
Thebaine.......................................... 9,217,000 9,387,000
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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 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 15, 1996.
Stephen H. Greene,
Deputy Administrator.
[FR Doc. 96-12899 Filed 5-22-96; 8:45 am]
BILLING CODE 4410-09-M
