[Federal Register Volume 64, Number 248 (Tuesday, December 28, 1999)]
[Notices]
[Pages 72686-72689]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-33550]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[DEA No. 1861]
Controlled Substances: Established Initial Aggregate Production
Quotas for 2000
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of aggregate production quotas for 2000.
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SUMMARY: This notice establishes initial 2000 aggregate production
quotas for controlled substances in Schedules I and II of the
Controlled Substances Act (CSA).
EFFECTIVE DATE: December 28, 1999.
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 Sec. 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 Sec. 0.104 of Title 28 of the
Code of Federal Regulations.
The 2000 aggregate production quotas represent those quantities of
controlled substances that may be produced in the United States in 2000
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 21, 1999, a notice of the proposed initial 2000
aggregate production quotas for certain controlled substances in
Schedules I and II was published in the Federal Register (64 FR 56809).
All interested persons were invited to comment on or object to these
proposed aggregate production quotas on or before November 22, 1999.
Six companies commented on a total of 16 Schedules I and II
controlled substances within the published comment period. The
companies commented that the proposed aggregate
[[Page 72687]]
production quotas for alfentanil, amphetamine, diphenoxylate, fentanyl,
hydromorphone, levorphanol, meperidine, levo-desoxyephedrine,
methamphetamine (for sale), methamphetamine (for conversion),
methylphenidate, noroxymorphone (for conversion), oxycodone (for sale),
oxycodone (for conversion), 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 comment was received after the published comment
period had ended. This comment requested that the aggregate production
quota for dihydromorphine be increased to provide for an intermediate
in a current manufacturing process. This comment was taken into
consideration in determining the established initial 2000 aggregate
production quota for dihydromorphine.
DEA has taken into consideration the above comments along with the
relevant 1999 manufacdturing quotas, current 1999 sales and
inventories, 2000 export requirements and research and product
development requirements. Based on this information, the DEA has
adjusted the initial aggregate production quotas for alfentanil,
dihydromorphine, diphenoxylate, fentanyl, hydromorphone, levorphanol,
meperidine, levo-desoxyephedrine, methamphetamine (for conversion),
noroxymorphone (for conversion), oxycodone (for sale), sufentanil and
thebaine to meet the legitimate needs of the United States. Significant
portions of the increases for alfentanil, diphenoxylate,, fentanyl,
hydromorphone, levorphanol, noroxymorphone (for conversion) and
sufentanil are due to a change in the manner in which manufacturing
losses are accounted for by a bulk manufacturer.
In addition, one company requested a hearing to address the
aggregate production quota for oxycodone (for sale) or hydromorphone if
the aggregate production quotas were not increased sufficiently. The
DA, based on the date provided, has increased the aggregate production
quotas for both oxycodone (for sale) and hydromorphone and has
determined that a hearing is not necessary.
Regarding amphetamine, methamphetamine (for sale), methylphenidate
and oxycodone (for conversion), the DEA has determined that the
proposed initial 2000 aggregate production quotas are sufficient to
meet the current 2000 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 2000,
adjust aggregate production quotas and individual manufacturing quotas
allocated for the year based upon 1999 year-end inventory and actual
1999 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 Deputy
Administrator pursuant to Sec. 0.104 of Title 28 of the Code of Federal
Regulations, the Acting Deputy Administrator hereby orders that the
2000 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 2000
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............................. 201,000
4-Methylaminoex.................................. 3
4-Methyl-2,5-Dimethoxyamphetamine (DOM).......... 2
5-Methoxy-3,4-Methylenedioxyamphetamine.......... 2
Acetyl-alpha-Methylfentanyl...................... 2
Acetyldihydrocodeine............................. 2
Acetylmethadol................................... 7
Allylprodine..................................... 2
Alphacetylmethadol............................... 7
Alpha-ethyltryptamine............................ 2
Alphameprodine................................... 2
Alphamethadol.................................... 2
Alpha-methylfentanyl............................. 2
Alpha-methylthiofentanyl......................... 2
Aminorex......................................... 7
Benzylmorphine................................... 2
Betacetylmethadol................................ 2
Beta-hydroxy-3-methylfentanyl.................... 2
Beta-hydroxyfentanyl............................. 2
Betameprodine.................................... 2
Betamethadol..................................... 2
Betaprodine...................................... 2
Bufotenine....................................... 2
Cathinone........................................ 9
Diethyltryptamine................................ 2
[[Page 72688]]
Difenoxin........................................ 10,000
Dihydromorphine.................................. 508,000
Dimethyltryptamine............................... 3
Heroin........................................... 2
Hydroxypethidine................................. 2
Lysergic acid diethylamide (LDS)................. 38
Mescaline........................................ 7
Methaqualone..................................... 17
Methcathinone.................................... 9
Morphine-N-oxide................................. 2
N,N-Dimethylamphetamine.......................... 7
N-Ethyl-1-Phenylcyclohexylamine (PCE)............ 5
N-Ethylamphetamine............................... 7
N-Hydroxy-3,4-Methylenedioxyamphetamine.......... 2
Noracymethadol................................... 2
Norlevorphanol................................... 2
Normethadone..................................... 7
Normorphine...................................... 7
Para-fluorofentanyl.............................. 2
Pholcodine....................................... 2
Propiram......................................... 415,000
Psilocybin....................................... 2
Psilocyn......................................... 2
Tetrahydrocannabinols............................ 101,000
Thiofentanyl..................................... 2
Trimeperidine.................................... 2
Schedule II:
1-Phenylcyclohexylamine.......................... 12
1-Piperidinocyclohexanecarbonitrile (PCC)........ 10
Alfentanil....................................... 8,000
Alphaprodine..................................... 2
Amobarbital...................................... 12
Amphetamine...................................... 9,007,000
Cocaine.......................................... 251,000
Codeine (for sale)............................... 54,504,000
Codeine (for conversion)......................... 52,384,000
Dextropropoxyphene............................... 114,078,000
Dihydrocodeine................................... 268,000
Diphenoxylate.................................... 931,000
Ecgonine......................................... 36,000
Ethylmorphine.................................... 12
Fentanyl......................................... 300,000
Glutethimide..................................... 2
Hydrocodone (for sale)........................... 20,208,000
Hydrocodone (for conversion)..................... 20,700,000
Hydromorphone.................................... 1,239,000
Hydrocodone (For conversion)..................... 20,700,000
Hydromorphone.................................... 1,239,000
Isomethadone..................................... 12
Levo-alphacetylmethadol (LAAM)................... 201,000
Levomethorphan................................... 2
Levorphanol...................................... 27,000
Meperidine....................................... 11,335,000
Metazocine....................................... 1
Methadone (for sale)............................. 8,347,000
Methadone (for conversion)....................... 600,000
Methadone Intermediate........................... 9,503,000
Methamphetamine.................................. 2,049,000
750,000 grams of levo-desoxyephedrine for use in a non-
controlled, non-prescription product; 1,225,000 grams for
methamphetamine for conversion to a Schedule III product; and
74,000 grams for methamphetamine (for sale)....................
Methylphenidate.................................. 14,957,000
Morphine (for sale).............................. 14,706,000
Morphine (for conversion)........................ 97,160,000
Nabilone......................................... 2
Noroxymorphone (for sale)........................ 25,000
Noroxymorphone (for conversion).................. 3,813,000
Opium............................................ 720,000
Oxycodone (for sale)............................. 29,826,000
Oxycodone (for conversion)....................... 271,000
Oxymorphone...................................... 166,000
Pentobarbital.................................... 22,037,000
Phencyclidine.................................... 41
Phenmetrazine.................................... 2
[[Page 72689]]
Phenylacetone.................................... 10
Secobarbital..................................... 22
Sufentanil....................................... 1,700
Thebaine......................................... 41,300,000
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The Acting 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 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 his 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: December 21, 1999.
Julio F. Mercado,
Acting Deputy Administrator.
[FR Doc. 99-33550 Filed 12-27-99; 8:45 am]
BILLING CODE 4410-09-M