[Federal Register Volume 63, Number 200 (Friday, October 16, 1998)]
[Notices]
[Pages 55640-55642]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-27740]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[DEA #179P]
Controlled Substances: Proposed Aggregate Production Quotas for
1999
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of proposed 1999 aggregate production quotas.
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SUMMARY: This notice proposes initial 1999 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 November
16, 1998.
ADDRESSES: Send comments or objections to the Acting Deputy
Administrator, Drug Enforcement Administration, Washington, D.C. 20537,
Attn: DEA Federal Register Representative (CCR).
FOR FURTHER INFORMATION CONTACT:
Frank L. Sapienza, Chief, Drug and Chemical Evaluation Section, Drug
Enforcement Administration, Washington, D.C. 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 Section 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 pursuant to Section 0.104 of
Title 28 of the Code of Federal Regulations.
The proposed 1999 aggregate production quotas represent those
quantities of controlled substances that may be produced in the United
States in 1999 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 1999 aggregate production quotas, the
Acting Deputy Administrator considered the following factors: total
actual 1997 and estimated 1998 and 1999 net disposals of each substance
by all manufacturers; estimates of 1998 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 Section
1303.12 of Title 21 of the Code of Federal Regulations; and other
pertinent information.
Pursuant to Section 1303 of Title 21 of the Code of Federal
Regulations, the Acting Deputy Administrator of the DEA will, in early
1999, adjust aggregate production quotas and individual manufacturing
quotas allocated for the year based upon 1998 year-end inventory and
actual 1998 disposition data supplied by quotas recipients for each
basic class of Scheudle 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), 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 Section 0.104 of Title 28 of the Code of Federal
Regulations, the Acting Deputy Administrator hereby proposes that the
1999 aggregate production quotas for the following controlled
substances, expressed in grams of anhydrous acid or base, be
established as follows:
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Proposed 1999
Basic class quotas
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Schedule I:
2,5-Dimethoxyamphetamine............................ 10,001,000
2,5-Dimethoxy-4-ethylamphetamine (DOET)............. 2
3-Methylfentanyl.................................... 14
3-Methylthiofentanyl................................ 2
3,4-Methylenedioxyamphetamine (MDA)................. 20
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)........ 30
3,4-Methylenedioxymethamphetamine (MDMA)............ 20
3,4,5-Trimethoxyamphetamine......................... 2
4-Bromo-2,5-Dimethoxyamphetamine (DOB).............. 2
4-Bromo-2,5-Dimethoxyphenethylamine (2-CB).......... 2
4-Methoxyamphetamine................................ 17
4-Methylaminorex.................................... 3
4-Methyl-2,5-Dimethoxyamphetamine (DOM)............. 2
5-Methoxy-3,4-Methylenedioxyamphetamine............. 2
Acetyl-alpha-methylfentanyl......................... 2
Acetyldihydrocodeine................................ 2
Acetylmethadol...................................... 7
Allylprodine........................................ 2
Alpha-acetylmethadol................................ 7
[[Page 55641]]
Alpha-ethyltryptamine............................... 2
Alphameprodine...................................... 2
Alpha-methadol...................................... 2
Alpha-methylfentanyl................................ 2
Alpha-methylthiofentanyl............................ 2
Alphaprodine........................................ 2
Aminorex............................................ 7
Benzylmorphine...................................... 2
Beta-acetylmethadol................................. 2
Beta-hydroxy-3-methylfentanyl....................... 2
Beta-hydroxyfentanyl................................ 2
Betameprodine....................................... 2
Beta-methadol....................................... 2
Betaprodine......................................... 2
Bufotenine.......................................... 2
Cathinone........................................... 9
Codeine-N-oxide..................................... 2
Diethyltryptamine................................... 3
Difenoxin........................................... 9,000
Dihydromorphine..................................... 7
Dimethyltryptamine.................................. 3
Heroin.............................................. 2
Hydroxypethidine.................................... 2
Lysergic acid diethylamide (LSD).................... 57
Mescaline........................................... 8
Methaqualone........................................ 17
Methcathinone....................................... 11
Morphine-N-oxide.................................... 2
N,N-Diemethylamphetamine............................ 7
N-Ethyl-1-Phenylcyclohexylamine (PCE)............... 5
N-Ethylamphetamine.................................. 7
N-Hydroxy-3,4-Methylenedioxyamphetamine............. 4
Noracymethadol...................................... 2
Norlevorphanol...................................... 2
Normethadone........................................ 7
Normorphine......................................... 7
Para-fluorofentanyl................................. 2
Pholcodine.......................................... 2
Propiram............................................ 415,000
Psilocin............................................ 2
Psilocybin.......................................... 2
Tetrahydrocannabinols............................... 52,000
Thiofentanyl........................................ 2
Trimeperidine....................................... 2
Schedule II:
1-Phenylcyclohexylamine............................. 12
1-Piperidinocyclohexanecarbonitrile (PCC)........... 12
Alfentanil.......................................... 2
Amobarbital......................................... 12
Amphetamine......................................... 5,554,000
Cocaine............................................. 251,000
Codeine (for sale).................................. 60,641,000
Codeine (for conversion)............................ 22,950,000
Desoxyephedrine--662,000 grams of
levodesoxyephedrine for use in a non-controlled,
non-prescription product and 35,000 grams for
methamphetamine.................................... 697,000
Dextropropoxyphene.................................. 109,500,000
Dihydrocodeine...................................... 121,000
Diphenoxylate....................................... 1,240,000
Ecgonine............................................ 151,000
Ethylmorphine....................................... 13
Fentanyl............................................ 228,000
Glutethimide........................................ 2
Hydrocodone (for sale).............................. 16,314,000
Hydrocodone (for conversion)........................ 1,300,000
Hydromorphone....................................... 856,000
Isomethadone........................................ 12
Levo-alpha-acetylmethadol (LAAM).................... 201,000
Levomethorphan...................................... 2
Levorphanol......................................... 15,000
Meperidine.......................................... 10,294,000
Methadone (for sale)................................ 4,992,000
Methadone (for conversion).......................... 267,000
Methadone Intermediate.............................. 7,223,000
[[Page 55642]]
Methamphetamine (for conversion).................... 723,000
Methylphenidate..................................... 14,442,000
Morphine (for sale)................................. 12,445,000
Morphine (for conversion)........................... 76,300,000
Nabilone............................................ 2
Noroxymorphone (for sale)........................... 25,000
Noroxymorphone (for conversion)..................... 2,067,000
Opium............................................... 640,000
Oxycodone (for sale)................................ 12,118,000
Oxycodone (for conversion).......................... 51,000
Oxymorphone......................................... 166,000
Pentobarbital....................................... 17,356,000
Phencyclidine....................................... 40
Phenmetrazine....................................... 2
Phenylacetone....................................... 10
Secobarbital........................................ 25
Sufentanil.......................................... 752
Thebaine............................................ 17,695,000
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The Acting Deputy Administrator further proposes that aggregate
production quotas for all other Schedules I and II controlled
substances included in Sections 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 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 aggregate production quotas for Schedules
I and II controlled substance 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: October 8, 1998.
Donnie R. Marshall,
Acting Deputy Administrator.
[FR Doc. 98-27740 Filed 10-15-98; 8:45 am]
BILLING CODE 4410-09-M