[Federal Register Volume 64, Number 201 (Tuesday, October 19, 1999)]
[Notices]
[Pages 56366-56368]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-27291]
[[Page 56366]]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[DEA # 179F]
Controlled Substances: 1999 Aggregate Production Quotas
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of final 1999 aggregate production quotas.
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SUMMARY: This notice establishes final 1999 aggregate production quotas
for controlled substances in Schedules I and II of the Controlled
Substances Act (CSA). The DEA has taken into consideration comments
received in response to a notice of the proposed revised aggregate
production quotas for 1999 published August 20, 1999 (64 FR 45566). No
comments were received in response to an interim notice establishing
revised 1999 aggregate production quotas published August 27, 1999 (64
FR 46955). The interim notice is adopted with one change, as described
below.
EFFECTIVE DATES: October 19, 1999.
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 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 pursuant to Sec. 0.104 of Title
28 of the Code of Federal Regulations.
On August 20, 1999, a notice of the proposed revised 1999 aggregate
production quotas for certain controlled substances in Schedules I and
II was published in the Federal Register (64 FR 45566). All interested
parties were invited to comment on or object to these proposed
aggregate production quotas on or before September 20, 1999.
Several companies commented that the revised aggregate production
quotas for amphetamine, dextropropoxyphene, dihydrocodeine,
hydromorphone, meperidine, methadone (for sale), methadone
intermediate, methylphenidate, and opium 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. Two companies included information
concerning potential increases in sales due to Y2K concerns.
DEA has taken into consideration the above comments along with the
relevant 1998 year-end inventories, initial 1999 manufacturing quotas,
1999 export requirements, and actual and projected 1999 sales. Based on
this information, the DEA has adjusted the final 1999 aggregate
production quotas for amphetamine, desoxyephedrine, dextropropoxyphene,
dihydrocodeine, hydromorphone, methadone (for sale), methadone
intermediate and opium to meet the legitimate needs of the United
States.
Regarding meperidine and methylphenidate, the DEA has determined
that no adjustments of the aggregate production quotas are necessary to
meet the 1999 estimated medical, scientific, research and industrial
needs of the United States.
In addition, on August 27, 1999, an interim notice establishing
revised 1999 aggregate production quotas for amphetamine, codeine (for
conversion), hydrocodone (for sale), hydrocodone (for conversion),
morphine (for conversion), oxycodone (for sale) and thebaine was
published in the Federal Register (64 FR 46955). All interested parties
were invited to comment on or before September 27, 1999. No comments or
objections were received regarding this interim notice. The aggregate
production quota for amphetamine has been revised in response to
comments received on 64 FR 45566. The remainder of the aggregate
production quotas established in the interim notice are adopted without
change.
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 Sec. 0.100 of Title 28 of the Code of
Federal Regulations, and redelegated to the Deputy Administrator
pursuant to Sec. 0.104 of Title 28 of the Code of Federal Regulations,
the Deputy Administrator hereby orders that the final 1999 aggregate
production quotas for the following controlled substances, expressed in
grams of anhydrous acid or base, be established as follows:
------------------------------------------------------------------------
Established
Basic class final 1999
quotas
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Schedule I
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2,5-Dimethoxyamphetamine................................ 10,501,000
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.................................... 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
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Alpha-methadol.......................................... 2
Alpha-methylfentanyl.................................... 2
Alpha-methylthiofentanyl................................ 2
Alphaprodine............................................ 2
Aminorex................................................ 8
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......................................... 8
Dimethyltryptamine...................................... 4
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-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................................... 76,000
Thiofentanyl............................................ 2
Trimeperidine........................................... 2
------------------------------------------------------------------------
Schedule II
------------------------------------------------------------------------
1-Phenylcyclohexylamine................................. 12
1-Piperidinocyclohexanecarbonitrile (PCC)............... 12
Alfentanil.............................................. 3,900
Amobarbital............................................. 12
Amphetamine............................................. 9,174,000
Cocaine................................................. 251,000
Codeine (for sale)...................................... 58,248,000
Codeine (for conversion)................................ 45,780,000
Desoxyephedrine (942,000 grams of levo-desoxyephedrine 1,108,000
for use in a non-controlled, non-prescription product
and 166,000 grams for methamphetamine).................
Dextropropoxyphene...................................... 113,837,000
Dihydrocodeine.......................................... 301,000
Diphenoxylate........................................... 846,000
Ecgonine................................................ 151,000
Ethylmorphine........................................... 13
Fentanyl................................................ 269,000
Glutethimide............................................ 2
Hydrocodone (for sale).................................. 20,208,000
Hydrocodone (for conversion)............................ 12,100,000
Hydromorphone........................................... 878,000
Isomethadone............................................ 12
Levo-alphacetylmethadol (LAAM).......................... 201,000
Levomethorphan.......................................... 2
Levorphanol............................................. 15,000
Meperidine.............................................. 11,207,000
Metazocine.............................................. 1
Methadone (for sale).................................... 8,753,000
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Methadone (for conversion).............................. 267,000
Methadone Intermediate.................................. 9,580,000
Methamphetamine (for conversion)........................ 1,522,000
Methylphenidate......................................... 14,957,000
Morphine (for sale)..................................... 12,445,000
Morphine (for conversion)............................... 94,900,000
Nabilone................................................ 2
Noroxymorphone (for sale)............................... 25,000
Noroxymorphone (for conversion)......................... 2,067,000
Opium................................................... 682,000
Oxycodone (for sale).................................... 18,517,000
Oxycodone (for conversion).............................. 106,000
Oxymorphone............................................. 166,000
Pentobarbital........................................... 22,037,000
Phencyclidine........................................... 40
Phenmetrazine........................................... 2
Phenylacetone........................................... 10
Secobarbital............................................ 1,155,000
Sufentanil.............................................. 952
Thebaine................................................ 31,117,000
------------------------------------------------------------------------
The Deputy Administrator further orders 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 remain 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 section 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; October 12, 1999.
Donnie R. Marshall,
Deputy Administrator.
[FR Doc. 99-27291 Filed 10-18-99 8:45 am]
BILLING CODE 4410-09-M