[Federal Register Volume 63, Number 246 (Wednesday, December 23, 1998)]
[Notices]
[Pages 71160-71162]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-33888]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration
[DEA # 179I]


Controlled Substances: Established Initial Aggregate Production 
Quotas for 1999

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of aggregate production quotas for 1999.

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SUMMARY: This notice establishes initial 1999 aggregate production 
quotas for controlled substances in Schedules I and II of the 
Controlled Substances Act (CSA).

EFFECTIVE DATE: December 23, 1998.

FOR FURTHER INFORMATION CONTACT:
Frank L. Sapienza, Chief, Drug & 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 Section 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 Section 0.104 of Title 28 of 
the Code of Federal Regulations.
    The 1999 aggregate production quotas represent those quantities of 
controlled substances that may be produced in the United States in 1999 
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 16, 1998, a notice of the proposed initial 1999 
aggregate production quotas for certain controlled substances in 
Schedules I and II was published in the Federal Register (63 FR 55640). 
All interested persons were invited to comment on or object to these 
proposed aggregate production quotas on or before November 16, 1998.
    Nine companies commented on a total of 28 Schedules I and II 
controlled substances. The companies commented that the proposed 
aggregate production quotas for 2,5-dimethoxyamphetamine, 4-
methoxyamphetamine, alfentanil, amphetamine, codeine (for sale), 
codeine (for conversion), dextropropoxyphene, dihydrocodeine, fentanyl, 
hydrocodone (for sale), hydrocodone (for conversion), hydromorphone, 
levorphanol, meperidine, methadone (for sale), methadone (for 
conversion), methadone intermediate, methylphenidate, morphine (for 
sale), morphine (for conversion), oxycodone (for sale), oxycodone (for 
conversion), pentobarbital, propiram, secobarbital, 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 company commented that the initial

[[Page 71161]]

aggregate production quota for diphenoxylate should be decreased.
    After a review of 1998 manufacturing quotas, current 1998 sales and 
inventories, 1999 export requirements and research and product 
development requirements, the DEA agrees that changes are necessary for 
2,5-dimethoxyamphetamine, 4-methoxyamphetamine, alfentanil, 
amphetamine, codeine (for sale), diphenoxylate, fentanyl, hydrocodone 
(for conversion), morphine (for conversion), oxycodone (for sale), 
oxycodone (for conversion), pentobarbital, sufentanil and thebaine.
    In addition, one company requested a hearing to address the 
aggregate production quota for oxycodone (for sale) if the aggregate 
production quota was not increased sufficiently. The DEA has increased 
the aggregate production quota for oxycodone (for sale) and has 
determined that a hearing is not necessary.
    The DEA also reviewed comments received concerning the aggregate 
production quotas for codeine (for conversion), dextropropoxyphene, 
dihydrocodeine, hydrocodone (for sale), hydromorphone, levorphanol, 
meperidine, methadone (for sale), methadone (for conversion), methadone 
intermediate, methylphenidate, morphine (for sale), propiram and 
secobarbital. In addition, 1998 manufacturing quotas, current 1998 
sales and inventories, 1999 export requirements and research and 
product development requirements were reviewed, as well as other 
available data. Based on a review of the comments and this data, the 
DEA has determined that the proposed initial 1999 aggregate production 
quotas for these substances are sufficient to meet the current 1999 
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 1999, 
adjust aggregate production quotas and individual manufacturing quotas 
allocated for the year based upon 1998 year-end inventory and actual 
1998 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 Section 0.100 of Title 28 
of the Code of Federal Regulations, and redelegated to the Deputy 
Administrator pursuant to Section 0.104 of Title 28 of the Code of 
Federal Regulations, the Deputy Administrator hereby orders that the 
1999 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 1999
                                                              quotas
------------------------------------------------------------------------
                               SCHEDULE I
------------------------------------------------------------------------
2, 5-Dimethoxyamphetamine...............................      10,501,000
2, 5-Dimethoxy-4-ethylampetamine (DOET).................               2
3-Methylfentanyl........................................              14
3-Methylthiofentanyl....................................               2
3, 4-Methylenedioxyampheta- mine (MDA)..................              20
3, 4-Methylenedioxy-N-ethylamphetamine (MDEA)...........              30
3, 4-Methylendioxyme- thamphetamine (MDMA)..............              20
3, 4,5-Trimethoxyam- phetamine..........................               2
4-Bromo-2, 5-Dimethoxy- amphetamine (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
Alpha-methadol..........................................               2
Alpha-methylfentanyl....................................               2
Alpha-methylthiofentanyl................................               2
Alphaprodine............................................               2
Aminorex................................................               7
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.........................................               7
Dimethyltryptamine......................................               3
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-Phenylcy- clohexylamine (PCE).................               5
N-Ethylamphetamine......................................               7
N-Hydroxy-3, 4-Methylene- dioxyamphetamine..............               4
Noracymethodol..........................................               2
Norlevorphanol..........................................               2
Normethadone............................................               7
Normorphine.............................................               7
Para-fluorofentanyl.....................................               2
Pholcodine..............................................               2
Propiram................................................         415,000
Psilocin................................................               2
Psilocybin..............................................               2
Tetrahydrocannabinols...................................          52,000
Thiofentanyl............................................               2
Trimeperidine...........................................               2
------------------------------------------------------------------------
                               SCHEDULE II
------------------------------------------------------------------------
1-Phenylcyclohexylamine.................................              12
1-Piperidinocyclohexanecarbonitrile (PCC)...............              12
Alfentanil..............................................           3,800
Amobarbital.............................................              12
Amphetamine.............................................       5,740,000
Cocaine.................................................         251,000
Codeine (for sale)......................................      67,332,000
Codeine (for conversion)................................      22,950,000
Desoxyephedrine.........................................         697,000
    662,000 grams of levodesoxyephedrine for use in a
     non-controlled, non-prescription product and 35,000
     grams for methamphetamine.
Dextropropoxyphene......................................     109,500,000
Dihydrocodeine..........................................         121,000
Diphenoxylate...........................................         846,000
Ecgonine................................................         151,000
Ethylmorphine...........................................              13
Fentanyl................................................         234,000
Glutethimide............................................               2
Hydrocodone (for sale)..................................      16,314,000
Hydrocodone (for conversion)............................       6,000,000
Hydromorphone...........................................         856,000
Isomethadone............................................              12
Levo-alpha-acetylmethadol (LAAM)........................         201,000
Levomethorphan..........................................               2
Levorphanol.............................................          15,000
Meperidine..............................................      10,294,000
Methadone (for sale)....................................       4,992,000
Methadone (for conversion)..............................         267,000
Methadone Intermediate..................................       7,223,000
Methamphetamine (for conversion)........................         723,000
Methamphetamine (for conversion)........................         723,000
Methylphenidate.........................................      14,442,000
Morphine (for sale).....................................      12,445,000
Morphine (for conversion)...............................      82,300,000
Nabilone................................................               2
Noroxymorphone (for sale)...............................          25,000

[[Page 71162]]

 
Noroxymorphone (for conversion).........................       2,067,000
Opium...................................................         640,000
Oxycodone (for sale)....................................      15,120,000
Oxycodone (for conversion)..............................         106,000
Oxymorphone.............................................         166,000
Pentobarbital...........................................      18,039,000
Phencyclidine...........................................              40
Phenmetrazine...........................................               2
Phenylacetone...........................................              10
Secobarbital............................................              25
Sufentanil..............................................             852
Thebaine................................................      22,880,000
------------------------------------------------------------------------

    The 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 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: December 15, 1998.
Donnie R. Marshall,
Deputy Administrator.
[FR Doc. 98-33888 Filed 12-23-98; 8:45 am]
BILLING CODE 4410-09-M