[Federal Register Volume 61, Number 202 (Thursday, October 17, 1996)]
[Notices]
[Pages 54222-54224]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-26581]


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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[DEA #153P]


Controlled Substances: Proposed Aggregate Production Quotas for 
1997

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of proposed aggregate production quotas for 1997.

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SUMMARY: This notice proposes initial 1997 aggregate production quotas 
for controlled substances in Schedules I and II of the Controlled 
Substances Act.

DATES: Comments or objections should be received on or before November 
18, 1996.

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

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 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 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.
    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 below listed proposed 1997 aggregate production 
quotas, the Deputy Administrator considered the following factors: (1) 
total actual 1995 and estimated 1996 and 1997 net disposals of each 
substance by all manufacturers; (2) estimates of 1996 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 Section 1303.12 of Title 21 of the Code of Federal 
Regulations and (5) other pertinent information.
    Pursuant to Section 1303.23(c) of Title 21 of the Code of Federal 
Regulations, the Deputy Administrator of the DEA will, in early 1997, 
adjust aggregate production quotas and individual manufacturing quotas 
allocated for the year based upon 1996 year-end inventory and actual 
1996 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 by Section 0.104 of Title 28 of the Code of Federal 
Regulations, the Deputy Administrator hereby proposes that the 
aggregate production quotas for 1997 for the following controlled 
substances, expressed in grams of anhydrous acid or base, be 
established as follows:

------------------------------------------------------------------------
                                                          Proposed 1997 
                      Basic class                             quotas    
------------------------------------------------------------------------
Schedule I:                                                             
    2,5-Dimethoxyamphetamine...........................       15,200,100
    2,5-Dimethoxy-4-ethylamphetamine (DOET)............                2
    3-Methylfentanyl...................................               14
    3-Methylthiofentanyl...............................                2
    3,4-Methylenedioxyamphetamine (MDA)................               22
    3,4-Methylenedioxy-N-ethylamphetamine (MDEA).......               27
    3,4-Methylenedioxymethamphetamine (MDMA)...........                7
    3,4,5-Trimethoxyamphetamine........................                2
    4-Bromo-2,5-Dimethoxyamphetamine...................                2
    4-Bromo-2,5-Dimethoxyphenethylamine (2-CB).........                2
    4-Methoxyamphetamine...............................               17
    4-Methylaminorex...................................                2
    4-Methyl-2,5-Dimethoxyamphetamine (DOM)............                2

[[Page 54223]]

                                                                        
    5-Methoxy-3,4-Methylenedioxyamphetamine............                2
    Acetyl-alpha-methylfentanyl........................                2
    Acetylmethadol.....................................                7
    Alpha-acetylmethadol...............................                7
    Alpha-ethyltryptamine..............................                2
    Alpha-methadol.....................................                2
    Alpha-methylfentanyl...............................                2
    Alpha-methylthiofentanyl...........................                2
    Aminorex...........................................                7
    Beta-acetylmethadol................................                2
    Beta-hydroxyfentanyl...............................                2
    Beta-hydroxy-3-methylfentanyl......................                2
    Beta-methadol......................................                2
    Bufotenine.........................................                2
    Cathinone..........................................                9
    Codenine-N-oxide...................................                2
    Difenoxin..........................................           14,000
    Dihydromorphine....................................                7
    Ethylamine Analog of PCP...........................                5
    Heroin.............................................                2
    Lysergic acid diethylamide (LSD)...................               27
    Mescaline..........................................                7
    Methaqualone.......................................               17
    Methcathinone......................................               11
    Morphine-N-oxide...................................                2
    N-Ethylamphetamine.................................                7
    N-Hydroxy-3,4-Methylenedioxyamphetamine............                2
    N,N-Dimethyltryptamine.............................                7
    Norlevorphanol.....................................                2
    Normethadone.......................................                7
    Normorphine........................................                7
    Para-fluorofentanyl................................                2
    Pholcodine.........................................                2
    Psilocin...........................................                2
    Psilocybin.........................................                2
    Tetrahydrocannibinols..............................           25,100
    Thiofentanyl.......................................                2
    Thiophene Analog of Phencyclidine..................                5
Schedule II:                                                            
    1-Phenylcyclohexylamine............................               10
    1-Piperidinocyclohexanecarbonitrile (PCC)..........               12
    Alfentanil.........................................            9,300
    Amobarbital........................................               15
    Amphetamine........................................        2,968,000
    Carfentanil........................................              500
    Cocaine............................................          550,100
    Codeine (for sale).................................       49,103,000
    Codeine (for conversion)...........................       19,679,000
    Desoxyephedrine....................................        1,422,000
                                                                        
  1,361,000 grams of levodesoxyephedrine for use in a                   
noncontrolled, nonprescription product and 61,000 grams                 
                  for methamphetamine.                                  
                                                                        
    Dextropropoxyphene.................................      116,469,000
    Dihydrocodeine.....................................          255,100
    Diphenoxylate......................................          701,000
    Ecogonine (for conversion).........................          651,000
    Ethylmorphine......................................               12
    Fentanyl...........................................          137,000
    Glutethimide.......................................                2
    Hydrocodone (for sale).............................       13,891,000
    Hydrocodone (for conversion).......................        1,769,000
    Hydromorphone......................................          563,000
    Isomethadone.......................................               12
    Levo-alpha-acetylmethadol (LAAM)...................          200,100
    Levomethorphan.....................................                2
    Levorphanol........................................           16,400
    Meperidine.........................................        9,843,000
    Methadone (for sale)...............................        3,729,000
    Methadone (for conversion).........................          364,000
    Methadone Intermediate (for conversion)............        4,295,000
    Methamphetamine (for conversion)...................          723,000
    Methylphenidate....................................       13,824,000
    Morphine (for sale)................................       11,126,000

[[Page 54224]]

                                                                        
    Morphine (for conversion)..........................       68,165,000
    Noroxymorphone (for conversion)....................        2,000,000
    Opium..............................................          937,000
    Oxycodone (for sale)...............................        5,589,000
    Oxycodone (for conversion).........................            1,200
    Oxymorphone........................................            9,000
    Pentobarbital......................................       16,772,000
    Phencyclidine......................................               60
    Phenmetrazine......................................                2
    Phenylacetone......................................               10
    Secobarbital.......................................          491,000
    Sufentanil.........................................            1,000
    Thebaine...........................................        9,325,000
------------------------------------------------------------------------

    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 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 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 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 annual aggregate production quotas for Schedules I 
and II controlled substances is mandated by law and by international 
treaty obligations. 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 10, 1996.
James S. Milford,
Acting Deputy Administrator.
[FR Doc. 96-26581 Filed 10-16-96; 8:45 am]
BILLING CODE 4410-09-M