[Federal Register Volume 62, Number 169 (Tuesday, September 2, 1997)]
[Notices]
[Pages 46373-46375]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-23224]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration
[DEA # 167P]


Controlled Substances: Proposed Aggregate Production Quotas for 
1998

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of proposed aggregate production quotas for 1998.

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SUMMARY: This notice proposes initial 1998 aggregate production quotas 
for controlled substances in Schedules I and II of the Controlled 
Substances Act.

DATES: Comments or objections must be received on or before October 2, 
1997.

ADDRESSES: Send comments or objections to the Administrator, Drug 
Enforcement Administration, Washington, DC 20537, Attn.: DEA Federal 
Register Representative (CCR).

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 Controlled Substances Act 
(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 Acting Deputy Administrator pursuant to Sec. 0.104 of 
Title 28 of the Code of Federal Regulations.
    The quotas are to provide adequate supplies of each substance for: 
(1) The estimated medical, scientific, research, and industrial needs 
of the United States; (2) lawful export requirements; and (3) the 
establishment and maintenance of reserve stocks.
    In determining the proposed 1998 aggregate production quotas, the 
Acting Deputy Administrator considered the following factors; (1) Total 
actual 1996 and estimated 1997 and 1998 net disposals of each substance 
by all manufacturers; (2) estimates of 1997 year-end inventories of 
each substance and of any substance manufactured from it and trends in 
accumulation of such inventories; (3) product development requirements 
of both bulk and finished dosage form manufacturers; (4) projected 
demand as indicated by procurement quota applications filed pursuant to 
Sec. 1303.12 of Title 21 of the Code of Federal Regulations and (5) 
other pertinent information.
    Pursuant to Sec. 1303.23(c) of Title 21 of the Code of Federal 
Regulations, the Acting Deputy Administrator of the DEA will, in early 
1998, adjust aggregate production quotas and individual manufacturing 
quotas allocated for the year based upon 1997 year-end inventory and 
actual 1997 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 Acting Deputy 
Administrator pursuant to Sec. 0.104 of Title 28 of the Code of Federal 
Regulations, the Acting Deputy Administrator hereby proposes that the 
aggregate production quotas for 1998 for the following controlled 
substances, expressed in grams of anhydrous acid or base, be 
established as follows:

------------------------------------------------------------------------
                                                           Proposed 1998
                       Basic class                            quotas    
------------------------------------------------------------------------
                               Schedule I                               
------------------------------------------------------------------------
2,5-Dimethoxyamphetamine................................      15,000,100
2,5-Dimethoxy-4-ethylamphetamine (DOET).................               2
3-Methylfentanyl........................................              14
3-Methylthiofentanyl....................................               2
3,4-Methylenedioxyamphetamine (MDA).....................              25
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)............              30
3,4-Methylenedioxymethamphetamine (MDMA)................              20
3,4,5-Trimethoxyamphetamine.............................               2
4-Bromo-2,5-Dimethoxyamphetamine........................               2
4-Bromo-2,5-Dimethoxyphenethylamine (2-CB)..............               2
4-Methoxyamphetamine....................................         100,100
4-Methylaminorex........................................               2
4-Methyl-2,5-Dimethoxyamphetamine (DOM).................               2
5-Methoxy-3,4-Methylenedioxyamphetamine.................               2
Acetyl-alpha-methylfentanyl.............................               2
Acetylmethadol..........................................               7
Allylprodine............................................               2
Alpha-acetylmethadol....................................               7
Alpha-ethyltryptamine...................................               2

[[Page 46374]]

                                                                        
Alphameprodine..........................................               2
Alpha-methadol..........................................               2
Alpha-methylfentanyl....................................               2
Alphaprodine............................................               2
Alpha-methylthiofentanyl................................               2
Aminorex................................................               7
Beta-acetylmethadol.....................................               2
Beta-hydroxyfentanyl....................................               2
Beta-hydroxy-3-methylfentanyl...........................               2
Beta-methadol...........................................               2
Betaprodine.............................................               2
Bufotenine..............................................               2
Cathinone...............................................               9
Codeine-N-oxide.........................................               2
Diethyltryptamine.......................................               2
Difenoxin...............................................          16,000
Dihydromorphine.........................................               7
Dimethyltryptamine......................................               2
Ethylamine Analog of PCP................................               5
Heroin..................................................               2
Hydroxypethidine........................................               2
Lysergic acid diethylamide (LSD)........................              57
Mescaline...............................................               7
Methaqualone............................................              17
Methcathinone...........................................              11
Morphine-N-oxide........................................               2
N-Ethylamphetamine......................................               7
N-Hydroxy-3,4-Methylenedioxyamphetamine.................               4
N,N-Dimethylamphetamine.................................               7
Noracymethadol..........................................               2
Norlevorphanol..........................................               2
Normethadone............................................               7
Normorphine.............................................               7
Para-fluorofentanyl.....................................               2
Pholcodine..............................................               2
Psilocin................................................               2
Psilocybin..............................................               2
Tetrahydrocannabinols...................................          26,000
Thiofentanyl............................................               2
Trimeperidine...........................................               2
------------------------------------------------------------------------
                               Schedule II                              
------------------------------------------------------------------------
1-Phenylcyclohexylamine.................................              15
1-Piperidinocyclohexanecarbonitrile (PCC)...............              12
Alfentanil..............................................           8,100
Amobarbital.............................................              12
Amphetamine.............................................       3,580,000
Cocaine.................................................         550,100
Codeine (for sale)......................................      56,334,000
Codeine (for conversion)................................      18,460,000
Desoxyephedrine.........................................       1,332,000
                                                                        
   1,300,000 grams of levodesoxyephedrine for use in a non-controlled,  
non-prescription product and 32,000 grams for methamphetamine.          
                                                                        
Dextropropoxyphene......................................     109,500,000
Dihydrocodeine..........................................         189,000
Diphenoxylate...........................................       1,600,000
Ecgonine................................................         651,000
Ethylmorphine...........................................              12
Fentanyl................................................         202,000
Glutethimide............................................               2
Hydrocodone (for sale)..................................      13,908,000
Hydrocodone (for conversion)............................       3,000,000
Hydromorphone...........................................         766,000
Isomethadone............................................              12
Levo-alpha-acetylmethadol (LAAM)........................         356,000
Levomethorphan..........................................               2
Levorphanol.............................................          15,000
Meperidine..............................................       9,311,000
Methadone (for sale)....................................       3,790,000
Methadone (for conversion)..............................       1,169,000
Methadone Intermediate..................................       6,777,000
Methamphetamine (for conversion)........................         723,000
Methylphenidate.........................................      14,442,000

[[Page 46375]]

                                                                        
Morphine (for sale).....................................      10,654,000
Morphine (for conversion)...............................      75,918,000
Nabilone................................................               2
Noroxymorphone (for sale)...............................          25,000
Noroxymorphone (for conversion).........................       2,117,000
Opium...................................................         615,000
Oxycodone (for sale)....................................       8,393,000
Oxymorphone.............................................         120,000
Pentobarbital...........................................      16,562,000
Phencyclidine...........................................              60
Phenmetrazine...........................................               2
Phenylacetone...........................................              10
Secobarbital............................................         301,000
Sufentanil..............................................             700
Thebaine................................................       9,580,000
------------------------------------------------------------------------

    The Acting Deputy Administrator further proposes 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.
    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.
    In the event that comments or objections to this proposal raise one 
or more issues which the Acting Deputy Administrator finds warrant a 
hearing, the Acting Deputy Administrator finds warrant a hearing, the 
Acting 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 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 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 annual 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: August 25, 1997.
James S. Milford,
Acting Deputy Administrator.
[FR Doc. 97-23224 Filed 8-29-97; 8:45 am]
BILLING CODE 4410-09-M