[Federal Register Volume 63, Number 246 (Wednesday, December 23, 1998)]
[Notices]
[Pages 71160-71162]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-33888]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[DEA # 179I]
Controlled Substances: Established Initial Aggregate Production
Quotas for 1999
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of aggregate production quotas for 1999.
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SUMMARY: This notice establishes initial 1999 aggregate production
quotas for controlled substances in Schedules I and II of the
Controlled Substances Act (CSA).
EFFECTIVE DATE: December 23, 1998.
FOR FURTHER INFORMATION CONTACT:
Frank L. Sapienza, Chief, Drug & 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, pursuant to Section 0.104 of Title 28 of
the Code of Federal Regulations.
The 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 (21 U.S.C. 826(a) and 21 CFR 1303.11).
These quotas do not include imports of controlled substances for use in
industrial processes.
On October 16, 1998, a notice of the proposed initial 1999
aggregate production quotas for certain controlled substances in
Schedules I and II was published in the Federal Register (63 FR 55640).
All interested persons were invited to comment on or object to these
proposed aggregate production quotas on or before November 16, 1998.
Nine companies commented on a total of 28 Schedules I and II
controlled substances. The companies commented that the proposed
aggregate production quotas for 2,5-dimethoxyamphetamine, 4-
methoxyamphetamine, alfentanil, amphetamine, codeine (for sale),
codeine (for conversion), dextropropoxyphene, dihydrocodeine, fentanyl,
hydrocodone (for sale), hydrocodone (for conversion), hydromorphone,
levorphanol, meperidine, methadone (for sale), methadone (for
conversion), methadone intermediate, methylphenidate, morphine (for
sale), morphine (for conversion), oxycodone (for sale), oxycodone (for
conversion), pentobarbital, propiram, secobarbital, sufentanil and
thebaine were insufficient to provide for the estimated medical,
scientific, research and industrial needs of the United States, for
export requirements and for the establishment and maintenance of
reserve stocks. In addition, one company commented that the initial
[[Page 71161]]
aggregate production quota for diphenoxylate should be decreased.
After a review of 1998 manufacturing quotas, current 1998 sales and
inventories, 1999 export requirements and research and product
development requirements, the DEA agrees that changes are necessary for
2,5-dimethoxyamphetamine, 4-methoxyamphetamine, alfentanil,
amphetamine, codeine (for sale), diphenoxylate, fentanyl, hydrocodone
(for conversion), morphine (for conversion), oxycodone (for sale),
oxycodone (for conversion), pentobarbital, sufentanil and thebaine.
In addition, one company requested a hearing to address the
aggregate production quota for oxycodone (for sale) if the aggregate
production quota was not increased sufficiently. The DEA has increased
the aggregate production quota for oxycodone (for sale) and has
determined that a hearing is not necessary.
The DEA also reviewed comments received concerning the aggregate
production quotas for codeine (for conversion), dextropropoxyphene,
dihydrocodeine, hydrocodone (for sale), hydromorphone, levorphanol,
meperidine, methadone (for sale), methadone (for conversion), methadone
intermediate, methylphenidate, morphine (for sale), propiram and
secobarbital. In addition, 1998 manufacturing quotas, current 1998
sales and inventories, 1999 export requirements and research and
product development requirements were reviewed, as well as other
available data. Based on a review of the comments and this data, the
DEA has determined that the proposed initial 1999 aggregate production
quotas for these substances are sufficient to meet the current 1999
estimated medical, scientific, research and industrial needs of the
United States.
Pursuant to Section 1303 of Title 21 of the Code of Federal
Regulations, the 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 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 Section 0.104 of Title 28 of the Code of
Federal Regulations, the Deputy Administrator hereby orders that the
1999 initial aggregate production quotas for the following controlled
substances, expressed in grams of anhydrous acid or base, be
established as follows:
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Established
Basic CLass initial 1999
quotas
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SCHEDULE I
------------------------------------------------------------------------
2, 5-Dimethoxyamphetamine............................... 10,501,000
2, 5-Dimethoxy-4-ethylampetamine (DOET)................. 2
3-Methylfentanyl........................................ 14
3-Methylthiofentanyl.................................... 2
3, 4-Methylenedioxyampheta- mine (MDA).................. 20
3, 4-Methylenedioxy-N-ethylamphetamine (MDEA)........... 30
3, 4-Methylendioxyme- thamphetamine (MDMA).............. 20
3, 4,5-Trimethoxyam- phetamine.......................... 2
4-Bromo-2, 5-Dimethoxy- amphetamine (DOB)............... 2
4-Bromo- 2,5-Dimethoxyphenethylamine (2-CB)............. 2
4-Methoxyamphetamine.................................... 101,000
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
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-Dimethylamphetamine................................ 7
N-Ethyl-1-Phenylcy- clohexylamine (PCE)................. 5
N-Ethylamphetamine...................................... 7
N-Hydroxy-3, 4-Methylene- dioxyamphetamine.............. 4
Noracymethodol.......................................... 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.............................................. 3,800
Amobarbital............................................. 12
Amphetamine............................................. 5,740,000
Cocaine................................................. 251,000
Codeine (for sale)...................................... 67,332,000
Codeine (for conversion)................................ 22,950,000
Desoxyephedrine......................................... 697,000
662,000 grams of levodesoxyephedrine for use in a
non-controlled, non-prescription product and 35,000
grams for methamphetamine.
Dextropropoxyphene...................................... 109,500,000
Dihydrocodeine.......................................... 121,000
Diphenoxylate........................................... 846,000
Ecgonine................................................ 151,000
Ethylmorphine........................................... 13
Fentanyl................................................ 234,000
Glutethimide............................................ 2
Hydrocodone (for sale).................................. 16,314,000
Hydrocodone (for conversion)............................ 6,000,000
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
Methamphetamine (for conversion)........................ 723,000
Methamphetamine (for conversion)........................ 723,000
Methylphenidate......................................... 14,442,000
Morphine (for sale)..................................... 12,445,000
Morphine (for conversion)............................... 82,300,000
Nabilone................................................ 2
Noroxymorphone (for sale)............................... 25,000
[[Page 71162]]
Noroxymorphone (for conversion)......................... 2,067,000
Opium................................................... 640,000
Oxycodone (for sale).................................... 15,120,000
Oxycodone (for conversion).............................. 106,000
Oxymorphone............................................. 166,000
Pentobarbital........................................... 18,039,000
Phencyclidine........................................... 40
Phenmetrazine........................................... 2
Phenylacetone........................................... 10
Secobarbital............................................ 25
Sufentanil.............................................. 852
Thebaine................................................ 22,880,000
------------------------------------------------------------------------
The Deputy Administrator further orders 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.
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 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 Deputy
Administrator has determined that this action does not require a
regulatory flexibility analysis.
Dated: December 15, 1998.
Donnie R. Marshall,
Deputy Administrator.
[FR Doc. 98-33888 Filed 12-23-98; 8:45 am]
BILLING CODE 4410-09-M
