[Federal Register Volume 63, Number 178 (Tuesday, September 15, 1998)]
[Notices]
[Pages 49369-49370]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-24621]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[DEA #167F]
Controlled Substances: Revised Aggregate Production Quotas for
1998
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of final revised 1998 aggregate production quotas.
-----------------------------------------------------------------------
SUMMARY: This notice establishes revised 1998 aggregate production
quotas for controlled substances in Schedules I and II of the
Controlled Substances Act (CSA).
EFFECTIVE DATE: September 15, 1998.
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 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.
On July 17, 1998, a notice of the proposed revised 1998 aggregate
production quotas for certain controlled substances in Schedules I and
II was published in the Federal Register (63 FR 38671). All interested
parties were invited to comment on or object to these proposed
aggregate production quotas on or before August 17, 1998.
Several companies commented that the revised aggregate production
quotas for amphetamine, codeine (for conversion), desoxyephedrine
(methamphetamine), dihydrocodeine, fentanyl, hydrocodone (for sale),
meperidine, methadone (for sale), methadone intermediate,
methylphenidate, morphine (for sale), morphine (for conversion),
oxycodone (for sale), oxymorphone, pentobarbital, propiram,
secobarbital, sufentanil, tetrahydrocannabinols, 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.
DEA has reviewed the involved companies' 1997 year-end inventories,
their initial 1998 manufacturing quotas, 1998 export requirements and
their actual and projected 1998 sales. Based on this data, the DEA has
adjusted the revised 1998 aggregate production quotas for amphetamine,
desoxyephedrine (methamphetamine), dihydrocodeine, fentanyl,
meperidine, methadone (for sale), methadone intermediate, morphine (for
sale), morphine (for conversion), oxycodone (for sale), oxymorphone,
pentobarbital, propiram, tetrahydrocannabinols and thebaine to meet the
estimated medical, scientific, research and industrial needs of the
United States.
Regarding codeine (for conversion), hydrocodone (for sale),
methylphenidate, secobarbital and sufentanil, the DEA has determined
that no adjustments of the aggregate production quotas are necessary to
meet the 1998 estimated medical, scientific, research and industrial
needs of the United States.
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 redelgated to the Deputy Administrator
pursuant to Section 0.104 of Title 28 of the Code of Federal
Regulations, the Acting Deputy Administrator hereby orders that the
revised 1998 aggregate production quotas for the following controlled
substances, expressed in grams of anhydrous acid or base, be
established as follows:
------------------------------------------------------------------------
Established
Basic class revised
1998 quotas
------------------------------------------------------------------------
SCHEDULE I
2,5-Dimethoxyamphetamine................................... 20,000,100
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 (DOB)..................... 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
Alphameprodine............................................. 2
Alpha-methadol............................................. 2
Alpha-methylfentanyl....................................... 2
Alphaprodine............................................... 2
[[Page 49370]]
Alpha-methylthiofentanyl................................... 2
Aminorex................................................... 7
Beta-acetylmethadol........................................ 2
Beta-hydroxyfentanyl....................................... 2
Beta-hydroxy-3-metthylfentanyl............................. 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
Propiram................................................... 412,800
Psilocin................................................... 2
Psilocybin................................................. 2
Tetrahydrocannabinols...................................... 51,000
Thiofentanyl............................................... 2
Trimeperidine.............................................. 2
SCHEDULE II
1-Phenylcyclohexylamine.................................... 15
1-Piperidinocyclohexanecarbonitrile (PCC).................. 12
Alfentanil................................................. 8,100
Amobarbital................................................ 12
Amphetamine................................................ 5,554,000
Cocaine.................................................... 550,100
Codeine (for sale)......................................... 62,020,000
Codeine (for conversion)................................... 23,906,000
Desoxyephedrine............................................ 1,184,000
1,151,000 grams of levodesoxyephedrine for use in a non-
controlled, non-prescription product and 33,000 grams
for methamphetamine.
Dextropropoxyphene......................................... 109,500,000
Dihydrocodeine............................................. 141,000
Diphenoxylate.............................................. 1,600,000
Ecgonine................................................... 651,000
Ethylmorphine.............................................. 12
Fentanyl................................................... 228,000
Glutethimide............................................... 2
Hydrocodone (for sale)..................................... 16,314,000
Hydrocodone (for conversion)............................... 3,000,000
Hydromorphone.............................................. 766,000
Isomethadone............................................... 12
Levo-alpha-acetylmethadol (LAAM)........................... 356,000
Levomethorphan............................................. 2
Levorphanol................................................ 15,000
Meperidine................................................. 10,111,000
Methadone (for sale)....................................... 5,975,000
Methadone (for conversion)................................. 585,000
Methadone Intermediate..................................... 8,939,000
Methamphetamine (for conversion)........................... 723,000
Methylphenidate............................................ 14,442,000
Morphine (for sale)........................................ 12,445,000
Morphine (for conversion).................................. 77,975,000
Nabilone................................................... 2
Noroxymorphone (for sale).................................. 25,000
Noroxymorphone (for conversion)............................ 2,117,000
Opium...................................................... 615,000
Oxycodone (for sale)....................................... 12,118,000
Oxymorphone................................................ 198,000
Pentobarbital.............................................. 19,501,000
Phencyclidine.............................................. 60
Phenmetrazine.............................................. 2
Phenylacetone.............................................. 10
Secobarbital............................................... 397,000
Sufentanil................................................. 1,800
Thebaine................................................... 17,695,000
------------------------------------------------------------------------
The Acting 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 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 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 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: September 3, 1998.
Donnie R. Marshall,
Acting Deputy Administrator.
[FR Doc. 98-24621 Filed 9-14-98; 8:45 am]
BILLING CODE 4410-09-M
