[Federal Register Volume 64, Number 161 (Friday, August 20, 1999)]
[Notices]
[Pages 45566-45569]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-21583]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration
[DEA #179R]


Controlled Substances: Proposed Revised Aggregate Production 
Quotas for 1999

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of proposed revised 1999 aggregate production quotas.

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

DATES: Comments or objections must be received on or before September 
20, 1999.

ADDRESSES: Send comments or objections to the Deputy Administrator,

[[Page 45567]]

Drug Enforcement Administration, Washington, D.C. 20537, Attn.: DEA 
Federal Register Representative (CCR).

FOR FURTHER INFORMATION CONTACT: Frank L. Sapienza, Chief, Drug and 
Chemical Evaluation Section, Drug Enforcement Administration, 
Washington, D.C. 20537, Telephone: (202) 307-7183.

SUPPLEMENTARY INFORMATION: 

Background

    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 Schedule 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 December 23, 1998 DEA published a notice of established initial 
1999 aggregate production quotas for certain controlled substances in 
Schedules I and II (63 FR 71160). This notice stipulated that the 
Deputy Administrator of the DEA would adjust the quotas in early 1999 
as provided for in Section 1303 of Title 21 of the Code of Federal 
Regulations.
    The proposed revised 1999 aggregate production quotas represent 
those quantities of controlled substances in Schedules I and II 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. 
These quotas do not include imports of controlled substances for use in 
industrial processes.
    The proposed revisions are based on a review of 1998 year-end 
inventories, 1998 disposition data submitted by quota applicants, 
estimates of the medical needs of the United States, and other 
information available to the DEA. In light of potential Y2K concerns, 
the DEA has included 50 percent inventories for each basic class of 
controlled substance manufactured for legitimate medical use. 
Therefore, the aggregate production quotas proposed in this notice may 
be significantly higher than usual.

Proposed Aggregate Production Quotas

    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 Sec. 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 proposes the following revised 1999 aggregate 
production quotas for the following controlled substances, expressed in 
grams of anhydrous acid or base:

------------------------------------------------------------------------
                                            Previously
                                            established      Proposed
               Basic class                 initial 1999    revised 1999
                                              quotas          quotas
------------------------------------------------------------------------
                               SCHEDULE I
------------------------------------------------------------------------
2,5-Dimethoxyamphetamine................      10,501,000      10,501,000
2,5-Dimethoxy-4-ethylamphetamine (DOET).               2               2
3-Methylfentanyl........................              14              14
3-Methylthiofentanyl....................               2               2
3,4-Methylenedioxyamphetamine (MDA).....              20              20
3,4-Methylenedioxy-N-ethylamphetamine                 30              30
 (MDEA..................................
3,4-Methylenedioxymethamphetamine (MDMA)              20              20
3,4,5-Trimethoxyamphetamine.............               2               2
4-Bromo-2,5-Dimethoxyamphetamine (DOB)..               2               2
4-Bromo-2,5-Dimethoxyphenethylamine (2-                2               2
 CB)....................................
4-Methoxyamphetamine....................         101,000         101,000
4-Methylaminorex........................               3               3
4-Methyl-2,5-Dimethoxyamphetamine (DOM).               2               2
5-Methoxy-3,4-Methylenedioxyamphetamine.               2               2
Acetyl-alpha-methylfentanyl.............               2               2
Acetyldihydrocodeine....................               2               2
Acetylmethadol..........................               7               7
Allylprodine............................               2               2
Alpha-acetylmethadol....................               7               7
Alpha-ethyltryptamine...................               2               2
Alphameprodine..........................               2               2
Alpha-methadol..........................               2               2
Alpha-methylfentanyl....................               2               2
Alpha-methylthiofentanyl................               2               2
Alphaprodine............................               2               2
Aminorex................................               7               8
Benzylmorphine..........................               2               2
Beta-acetylmethadol.....................               2               2
Beta-hydroxy-3-methylfentanyl...........               2               2
Beta-hydroxyfentanyl....................               2               2
Betameprodine...........................               2               2
Beta-methadol...........................               2               2
Betaprodine.............................               2               2
Bufotenine..............................               2               2
Cathinone...............................               9               9
Codeine-N-oxide.........................               2               2
Diethyltryptamine.......................               3               3
Difenoxin...............................           9,000           9,000
Dihydromorphine.........................               7               8

[[Page 45568]]

 
Dimethyltryptamine......................               3               4
Heroin..................................               2               2
Hydroxypethidine........................               2               2
Lysergic acid diethylamide (LSD)........              57              57
Mescaline...............................               8               8
Methaqualone............................              17              17
Methcathinone...........................              11              11
Morphine-N-oxide........................               2               2
N,N-Dimethylamphetamine.................               7               7
N-Ethyl-1-Phenylcyclohexylamine (PCE)...               5               5
N-Ethylamphetamine......................               7               7
N-Hydroxy-3,4-Methylenedioxyamphetamine.               4               4
Noracymethadol..........................               2               2
Norlevorphanol..........................               2               2
Normethadone............................               7               7
Normorphine.............................               7               7
Para-fluorofentanyl.....................               2               2
Pholcodine..............................               2               2
Propiram................................         415,000         415,000
Psilocin................................               2               2
Psilocybin..............................               2               2
Tetrahydrocannabinols...................          52,000          76,000
Thiofentanyl............................               2               2
Trimeperidine...........................               2               2
------------------------------------------------------------------------
                               SCHEDULE II
------------------------------------------------------------------------
1-Phenylcyclohexylamine.................              12              12
1-Piperidinocyclohexanecarbonitrile                   12              12
 (PCC)..................................
Alfentanil..............................           3,800           3,800
Amobarbital.............................              12              12
Amphetamine.............................       5,740,000       9,007,000
Cocaine.................................         251,000         251,000
Codeine (for sale)......................      67,332,000      58,248,000
Codeine (for conversion)................      22,950,000      45,780,000
Desoxyephedrine--942,000 grams of levo-          697,000       1,055,000
 desoxyephedrine for use in a non-
 controlled, non-prescription product
 and 113,000 grams for methamphetamine..
Dextropropoxyphene......................     109,500,000     112,985,000
Dihydrocodeine..........................         121,000         268,000
Diphenoxylate...........................         846,000         846,000
Ecgonine................................         151,000         151,000
Ethylmorphine...........................              13              13
Fentanyl................................         234,000         269,000
Glutethimide............................               2               2
Hydrocodone (for sale)..................      16,314,000      20,208,000
Hydrocodone (for conversion)............       6,000,000      12,100,000
Hydromorphone...........................         856,000         856,000
Isomethadone............................              12              12
Levo-alphacetylmethadol (LAAM)..........         201,000         201,000
Levomethorphan..........................               2               2
Levorphanol.............................          15,000          15,000
Meperidine..............................      10,294,000      11,207,000
Metazocine..............................               0               1
Methadone (for sale)....................       4,992,000       8,347,000
Methadone (for conversion)..............         267,000         267,000
Methadone Intermediate..................       7,223,000       9,503,000
Methamphetamine (for conversion)........         723,000       1,522,000
Methylphenidate.........................      14,442,000      14,957,000
Morphine (for sale).....................      12,445,000      12,445,000
Morphine (for conversion)...............      82,300,000      94,900,000
Nabilone................................               2               2
Noroxymorphone (for sale)...............          25,000          25,000
Noroxymorphone (for conversion).........       2,067,000       2,067,000
Opium...................................         640,000         640,000
Oxycodone (for sale)....................      15,120,000      18,517,000
Oxycodone (for conversion)..............         106,000         106,000
Oxymorphone.............................         166,000         166,000
Pentobarbital...........................      18,039,000      22,037,000
Phencyclidine...........................              40              40
Phenmetrazine...........................               2               2
Phenylacetone...........................              10              10

[[Page 45569]]

 
Secobarbital............................      *1,011,000       1,155,000
Sufentanil..............................             852             952
Thebaine................................      22,880,000      31,117,000
------------------------------------------------------------------------
*The aggregate production quota for secobarbital was revised from 25
  grams to 1,011,000 grams in an interim notice 64 FR 29358 (June 1,
  1999).

    The Deputy Administrator further proposes 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.

Comments and Y2K Issues

    All interested persons are invited to submit their comments and 
objections in writing regarding this proposal. A person may object to 
or comment on the proposal relating to any of the above-mentioned 
substances without filing comments or objections regarding the others. 
If a person believes that one or more of these issues warrant a 
hearing, the individual should so state and summarize the reasons for 
this belief.
    The DEA is aware of concerns regarding a potential increase in 
sales due to customer stockpiling for Y2K. In response to this issue, 
the DEA has adjusted the aggregate production quotas to include the 
allowable maximum of 50 percent inventory for those controlled 
substances manufactured for medical use. Additional Y2K concerns should 
be included when commenting or objecting to this proposal.
    In the event that comments or objections to this proposal raise one 
or more issues which the Deputy Administrator finds warrant a hearing, 
the Deputy Administrator shall order a public hearing by notice in the 
Federal Register, summarizing the issues to be heard and setting the 
time for the hearing.
    The Office of Management and Budget has determined that the 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 
Federal Assessment.
    The Deputy Administrator hereby certifies that this action will 
have no significant impact upon small entities whose interests must by 
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: August 11, 1999.
Donnie R. Marshall,
Deputy Administrator.
[FR Doc. 99-21583 Filed 8-19-99; 8:45 am]
BILLING CODE 4410-09-M