[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:

------------------------------------------------------------------------
                                                          Established
                     Basic class                          initial 2000
                                                             quotas
------------------------------------------------------------------------
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
------------------------------------------------------------------------

    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