[Federal Register Volume 64, Number 201 (Tuesday, October 19, 1999)]
[Notices]
[Pages 56366-56368]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-27291]



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DEPARTMENT OF JUSTICE

Drug Enforcement Administration
[DEA # 179F]


Controlled Substances: 1999 Aggregate Production Quotas

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of final 1999 aggregate production quotas.

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SUMMARY: This notice establishes final 1999 aggregate production quotas 
for controlled substances in Schedules I and II of the Controlled 
Substances Act (CSA). The DEA has taken into consideration comments 
received in response to a notice of the proposed revised aggregate 
production quotas for 1999 published August 20, 1999 (64 FR 45566). No 
comments were received in response to an interim notice establishing 
revised 1999 aggregate production quotas published August 27, 1999 (64 
FR 46955). The interim notice is adopted with one change, as described 
below.

EFFECTIVE DATES: October 19, 1999.

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: 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 of the DEA pursuant to Sec. 0.104 of Title 
28 of the Code of Federal Regulations.
    On August 20, 1999, a notice of the proposed revised 1999 aggregate 
production quotas for certain controlled substances in Schedules I and 
II was published in the Federal Register (64 FR 45566). All interested 
parties were invited to comment on or object to these proposed 
aggregate production quotas on or before September 20, 1999.
    Several companies commented that the revised aggregate production 
quotas for amphetamine, dextropropoxyphene, dihydrocodeine, 
hydromorphone, meperidine, methadone (for sale), methadone 
intermediate, methylphenidate, and opium 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. Two companies included information 
concerning potential increases in sales due to Y2K concerns.
    DEA has taken into consideration the above comments along with the 
relevant 1998 year-end inventories, initial 1999 manufacturing quotas, 
1999 export requirements, and actual and projected 1999 sales. Based on 
this information, the DEA has adjusted the final 1999 aggregate 
production quotas for amphetamine, desoxyephedrine, dextropropoxyphene, 
dihydrocodeine, hydromorphone, methadone (for sale), methadone 
intermediate and opium to meet the legitimate needs of the United 
States.
    Regarding meperidine and methylphenidate, the DEA has determined 
that no adjustments of the aggregate production quotas are necessary to 
meet the 1999 estimated medical, scientific, research and industrial 
needs of the United States.
    In addition, on August 27, 1999, an interim notice establishing 
revised 1999 aggregate production quotas for amphetamine, codeine (for 
conversion), hydrocodone (for sale), hydrocodone (for conversion), 
morphine (for conversion), oxycodone (for sale) and thebaine was 
published in the Federal Register (64 FR 46955). All interested parties 
were invited to comment on or before September 27, 1999. No comments or 
objections were received regarding this interim notice. The aggregate 
production quota for amphetamine has been revised in response to 
comments received on 64 FR 45566. The remainder of the aggregate 
production quotas established in the interim notice are adopted without 
change.
    Therefore, 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 Sec. 0.104 of Title 28 of the Code of Federal Regulations, 
the Deputy Administrator hereby orders that the final 1999 aggregate 
production quotas for the following controlled substances, expressed in 
grams of anhydrous acid or base, be established as follows:

------------------------------------------------------------------------
                                                            Established
                       Basic class                          final 1999
                                                              quotas
------------------------------------------------------------------------
                               Schedule I
------------------------------------------------------------------------
2,5-Dimethoxyamphetamine................................      10,501,000
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....................................         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

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Alpha-methadol..........................................               2
Alpha-methylfentanyl....................................               2
Alpha-methylthiofentanyl................................               2
Alphaprodine............................................               2
Aminorex................................................               8
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.........................................               8
Dimethyltryptamine......................................               4
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-Phenylcyclohexylamine (PCE)...................               5
N-Ethylamphetamine......................................               7
N-Hydroxy-3,4-Methylenedioxyamphetamine.................               4
Noracymethadol..........................................               2
Norlevorphanol..........................................               2
Normethadone............................................               7
Normorphine.............................................               7
Para-fluorofentanyl.....................................               2
Pholcodine..............................................               2
Propiram................................................         415,000
Psilocin................................................               2
Psilocybin..............................................               2
Tetrahydrocannabinols...................................          76,000
Thiofentanyl............................................               2
Trimeperidine...........................................               2
------------------------------------------------------------------------
                               Schedule II
------------------------------------------------------------------------
1-Phenylcyclohexylamine.................................              12
1-Piperidinocyclohexanecarbonitrile (PCC)...............              12
Alfentanil..............................................           3,900
Amobarbital.............................................              12
Amphetamine.............................................       9,174,000
Cocaine.................................................         251,000
Codeine (for sale)......................................      58,248,000
Codeine (for conversion)................................      45,780,000
Desoxyephedrine (942,000 grams of levo-desoxyephedrine         1,108,000
 for use in a non-controlled, non-prescription product
 and 166,000 grams for methamphetamine).................
Dextropropoxyphene......................................     113,837,000
Dihydrocodeine..........................................         301,000
Diphenoxylate...........................................         846,000
Ecgonine................................................         151,000
Ethylmorphine...........................................              13
Fentanyl................................................         269,000
Glutethimide............................................               2
Hydrocodone (for sale)..................................      20,208,000
Hydrocodone (for conversion)............................      12,100,000
Hydromorphone...........................................         878,000
Isomethadone............................................              12
Levo-alphacetylmethadol (LAAM)..........................         201,000
Levomethorphan..........................................               2
Levorphanol.............................................          15,000
Meperidine..............................................      11,207,000
Metazocine..............................................               1
Methadone (for sale)....................................       8,753,000

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Methadone (for conversion)..............................         267,000
Methadone Intermediate..................................       9,580,000
Methamphetamine (for conversion)........................       1,522,000
Methylphenidate.........................................      14,957,000
Morphine (for sale).....................................      12,445,000
Morphine (for conversion)...............................      94,900,000
Nabilone................................................               2
Noroxymorphone (for sale)...............................          25,000
Noroxymorphone (for conversion).........................       2,067,000
Opium...................................................         682,000
Oxycodone (for sale)....................................      18,517,000
Oxycodone (for conversion)..............................         106,000
Oxymorphone.............................................         166,000
Pentobarbital...........................................      22,037,000
Phencyclidine...........................................              40
Phenmetrazine...........................................               2
Phenylacetone...........................................              10
Secobarbital............................................       1,155,000
Sufentanil..............................................             952
Thebaine................................................      31,117,000
------------------------------------------------------------------------

    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 remain 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 section 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; October 12, 1999.
Donnie R. Marshall,
Deputy Administrator.
[FR Doc. 99-27291 Filed 10-18-99 8:45 am]
BILLING CODE 4410-09-M