[Federal Register Volume 65, Number 28 (Thursday, February 10, 2000)]
[Notices]
[Pages 6635-6637]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-3149]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[DEA # 186I]


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). This notice replaces and supersedes 
the final order dated December 21, 1999 and published in the Federal 
Register (64 FR 72686). Since the aggregate production quotas listed 
herein are the same as those published in 64 FR 72686, except as noted 
below, this will not effect individual manufacturing quotas or 
procurement quotas previously issued by DEA. Further, this notice 
corrects two errors in the notice published in 64 FR 72686 as follows: 
the aggregate production quota of 2 grams for the Schedule I substance 
codeine-N-oxide was inadvertantly deleted from the notice; and, the 
aggregate production quotas for hydrocodone (for conversion) and 
hydromorphone were inadvertantly listed twice. These two corrections 
are incorporated into the list of aggregate production quotas below.

EFFECTIVE DATE: February 10, 2000.

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 production quotas for 
alfentanial, 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

[[Page 6636]]

period had ended. This comment requested that the aggregate production 
quota for dihydromorphone 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 manufacturing 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, methaphetamine (for conversion), noroxymorphone (for 
conversion), osycodone (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 
DEA, based on the data 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 Schedules 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 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-Methylenedioxyamphet- amine (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-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
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
Codeine-N-oxide...........................................             2
Diethyltryptamine.........................................             2
Difenoxin.................................................        10,000
Dihydromorphine...........................................       508,000
Dimethyltryptamine........................................             3
Heroin....................................................             2
Hydroxypethidine..........................................             2
Lysergic acid diethylamide (LSD)..........................            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-Piperidinocyclohexane-   carbonitrile (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
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

[[Page 6637]]

 
Oxycodone (for conversion)................................       271,000
Oxymorphone...............................................       166,000
Pentobarbital.............................................    22,037,000
Phencyclidine.............................................            41
Phenmetrazine.............................................             2
Phenylacetone.............................................            10
Secobarbital..............................................            22
Sufentanil................................................         1,700
Thebaine..................................................    41,300,000
------------------------------------------------------------------------

    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 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: February 3, 2000.
Donnie R. Marshall,
Deputy Administrator.
[FR Doc. 00-3149 Filed 2-9-00; 8:45 am]
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