[Federal Register Volume 62, Number 169 (Tuesday, September 2, 1997)]
[Notices]
[Pages 46373-46375]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-23224]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[DEA # 167P]
Controlled Substances: Proposed Aggregate Production Quotas for
1998
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of proposed aggregate production quotas for 1998.
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SUMMARY: This notice proposes initial 1998 aggregate production quotas
for controlled substances in Schedules I and II of the Controlled
Substances Act.
DATES: Comments or objections must be received on or before October 2,
1997.
ADDRESSES: Send comments or objections to the Administrator, Drug
Enforcement Administration, Washington, DC 20537, Attn.: DEA Federal
Register Representative (CCR).
FOR FURTHER INFORMATION CONTACT:
Frank L. Sapienza, Chief, Drug and 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 Sec. 0.100 of Title 28 of the Code of
Federal Regulations. The Administrator, in turn, has redelegated this
function to the Acting Deputy Administrator pursuant to Sec. 0.104 of
Title 28 of the Code of Federal Regulations.
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 proposed 1998 aggregate production quotas, the
Acting Deputy Administrator considered the following factors; (1) Total
actual 1996 and estimated 1997 and 1998 net disposals of each substance
by all manufacturers; (2) estimates of 1997 year-end inventories of
each substance and of any substance manufactured from it and trends in
accumulation of such inventories; (3) product development requirements
of both bulk and finished dosage form manufacturers; (4) projected
demand as indicated by procurement quota applications filed pursuant to
Sec. 1303.12 of Title 21 of the Code of Federal Regulations and (5)
other pertinent information.
Pursuant to Sec. 1303.23(c) of Title 21 of the Code of Federal
Regulations, the Acting Deputy Administrator of the DEA will, in early
1998, adjust aggregate production quotas and individual manufacturing
quotas allocated for the year based upon 1997 year-end inventory and
actual 1997 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 Sec. 0.100 of Title 28 of
the Code of Federal Regulations, and redelegated to the Acting Deputy
Administrator pursuant to Sec. 0.104 of Title 28 of the Code of Federal
Regulations, the Acting Deputy Administrator hereby proposes that the
aggregate production quotas for 1998 for the following controlled
substances, expressed in grams of anhydrous acid or base, be
established as follows:
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Proposed 1998
Basic class quotas
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Schedule I
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2,5-Dimethoxyamphetamine................................ 15,000,100
2,5-Dimethoxy-4-ethylamphetamine (DOET)................. 2
3-Methylfentanyl........................................ 14
3-Methylthiofentanyl.................................... 2
3,4-Methylenedioxyamphetamine (MDA)..................... 25
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)............ 30
3,4-Methylenedioxymethamphetamine (MDMA)................ 20
3,4,5-Trimethoxyamphetamine............................. 2
4-Bromo-2,5-Dimethoxyamphetamine........................ 2
4-Bromo-2,5-Dimethoxyphenethylamine (2-CB).............. 2
4-Methoxyamphetamine.................................... 100,100
4-Methylaminorex........................................ 2
4-Methyl-2,5-Dimethoxyamphetamine (DOM)................. 2
5-Methoxy-3,4-Methylenedioxyamphetamine................. 2
Acetyl-alpha-methylfentanyl............................. 2
Acetylmethadol.......................................... 7
Allylprodine............................................ 2
Alpha-acetylmethadol.................................... 7
Alpha-ethyltryptamine................................... 2
[[Page 46374]]
Alphameprodine.......................................... 2
Alpha-methadol.......................................... 2
Alpha-methylfentanyl.................................... 2
Alphaprodine............................................ 2
Alpha-methylthiofentanyl................................ 2
Aminorex................................................ 7
Beta-acetylmethadol..................................... 2
Beta-hydroxyfentanyl.................................... 2
Beta-hydroxy-3-methylfentanyl........................... 2
Beta-methadol........................................... 2
Betaprodine............................................. 2
Bufotenine.............................................. 2
Cathinone............................................... 9
Codeine-N-oxide......................................... 2
Diethyltryptamine....................................... 2
Difenoxin............................................... 16,000
Dihydromorphine......................................... 7
Dimethyltryptamine...................................... 2
Ethylamine Analog of PCP................................ 5
Heroin.................................................. 2
Hydroxypethidine........................................ 2
Lysergic acid diethylamide (LSD)........................ 57
Mescaline............................................... 7
Methaqualone............................................ 17
Methcathinone........................................... 11
Morphine-N-oxide........................................ 2
N-Ethylamphetamine...................................... 7
N-Hydroxy-3,4-Methylenedioxyamphetamine................. 4
N,N-Dimethylamphetamine................................. 7
Noracymethadol.......................................... 2
Norlevorphanol.......................................... 2
Normethadone............................................ 7
Normorphine............................................. 7
Para-fluorofentanyl..................................... 2
Pholcodine.............................................. 2
Psilocin................................................ 2
Psilocybin.............................................. 2
Tetrahydrocannabinols................................... 26,000
Thiofentanyl............................................ 2
Trimeperidine........................................... 2
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Schedule II
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1-Phenylcyclohexylamine................................. 15
1-Piperidinocyclohexanecarbonitrile (PCC)............... 12
Alfentanil.............................................. 8,100
Amobarbital............................................. 12
Amphetamine............................................. 3,580,000
Cocaine................................................. 550,100
Codeine (for sale)...................................... 56,334,000
Codeine (for conversion)................................ 18,460,000
Desoxyephedrine......................................... 1,332,000
1,300,000 grams of levodesoxyephedrine for use in a non-controlled,
non-prescription product and 32,000 grams for methamphetamine.
Dextropropoxyphene...................................... 109,500,000
Dihydrocodeine.......................................... 189,000
Diphenoxylate........................................... 1,600,000
Ecgonine................................................ 651,000
Ethylmorphine........................................... 12
Fentanyl................................................ 202,000
Glutethimide............................................ 2
Hydrocodone (for sale).................................. 13,908,000
Hydrocodone (for conversion)............................ 3,000,000
Hydromorphone........................................... 766,000
Isomethadone............................................ 12
Levo-alpha-acetylmethadol (LAAM)........................ 356,000
Levomethorphan.......................................... 2
Levorphanol............................................. 15,000
Meperidine.............................................. 9,311,000
Methadone (for sale).................................... 3,790,000
Methadone (for conversion).............................. 1,169,000
Methadone Intermediate.................................. 6,777,000
Methamphetamine (for conversion)........................ 723,000
Methylphenidate......................................... 14,442,000
[[Page 46375]]
Morphine (for sale)..................................... 10,654,000
Morphine (for conversion)............................... 75,918,000
Nabilone................................................ 2
Noroxymorphone (for sale)............................... 25,000
Noroxymorphone (for conversion)......................... 2,117,000
Opium................................................... 615,000
Oxycodone (for sale).................................... 8,393,000
Oxymorphone............................................. 120,000
Pentobarbital........................................... 16,562,000
Phencyclidine........................................... 60
Phenmetrazine........................................... 2
Phenylacetone........................................... 10
Secobarbital............................................ 301,000
Sufentanil.............................................. 700
Thebaine................................................ 9,580,000
------------------------------------------------------------------------
The Acting Deputy Administrator further proposes that 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 be 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 Acting Deputy Administrator finds warrant a
hearing, the Acting Deputy Administrator finds warrant a hearing, the
Acting 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 Acting 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. Aggregate production quotas apply to
approximately 200 DEA registered bulk and dosage form manufacturers of
Schedules I and II controlled substances. 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 Acting Deputy Administrator has determined that this
action does not require a regulatory flexibility analysis.
Dated: August 25, 1997.
James S. Milford,
Acting Deputy Administrator.
[FR Doc. 97-23224 Filed 8-29-97; 8:45 am]
BILLING CODE 4410-09-M