[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:
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Proposed 1997
Basic class quotas
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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
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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