[Federal Register Volume 62, Number 108 (Thursday, June 5, 1997)]
[Notices]
[Pages 30883-30885]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-14698]
[[Page 30883]]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[DEA # 153R]
Controlled Substances: Notice of Proposed Revised 1997 Aggregate
Production Quotas
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of proposed revised 1997 aggregate production quotas and
request for comments.
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SUMMARY: This notice proposes revised 1997 aggregate production quotas
for controlled substances in Schedules I and II, as required under the
Controlled Substances Act of 1970.
DATES: Comments or objections should be received on or before July 7,
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, D.C. 20537, (202) 307-7183.
SUPPLEMENTARY INFORMATION: Section 306 of the Controlled Substances
Act, (21 U.S.C. 826), requires the Attorney General to establish
aggregate production quotas for controlled substances in Schedules I
and II each year. This responsibility has been delegated to the
Administrator of the DEA pursuant to 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 December 17, 1996, a notice of the established initial 1997
aggregate production quotas was published in the Federal Register (61
FR 66311). The notice stipulated that the Deputy Administrator of the
DEA would adjust the quotas in early 1997 as provided for in Title 21,
Code of Federal Regulations, Sec. 1303.13(c). The proposed revised 1997
aggregate production quotas represent those quantities of controlled
substances that may be produced in the United States in 1997, and do
not include imports of controlled substances for use in industrial
processes.
The proposed revisions are based on a review of 1996 year-end
inventories, 1996 disposition data submitted by quota applicants,
estimates of the medical needs of the United States submitted to the
DEA by the Food and Drug Administration, and other information
available to the DEA.
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 Deputy
Administrator, pursuant to Sec. 0.104 of Title 28 of the Code of
Federal Regulations, the Deputy Administrator hereby proposes the
following revised 1997 aggregate production quotas for the listed
controlled substances, expressed in grams of anhydrous acid or base:
------------------------------------------------------------------------
Previously Proposed
established revised 1997
Basic class 1997 aggregate aggregate
production production
quotas quotas
------------------------------------------------------------------------
Schedule I
2,5-Dimethoxyamphetamine................ 15,200,100 15,200,100
2,5-Dimethoxy-4-ethylamphetamine........ 2 2
3-Methylfentanyl........................ 14 14
3-Methylthiofentanyl.................... 2 2
3,4-Methylenedioxyamphetamine........... 22 22
3,4-Methylenedioxy-N-ethylamphetamine... 27 27
3,4-Methylenedioxymethamphetamine....... 7 7
3,4,5-Trimethoxyamphetamine............. 2 2
4-Bromo-2,5-Dimethoxyamphetamine........ 2 2
4-Bromo-2,5-Dimethoxyphenethylamine..... 2 2
4-Methoxyamphetamine.................... 17 17
4-Methylaminorex........................ 2 2
4-Methyl-2,5-Dimethoxyamphetamine....... 2 2
5-Methoxy-3,4-Methylenedioxyamphetamine. 2 2
Acetyl-alpha-methylfentanyl............. 2 2
Acetylmethadol.......................... 7 7
Alpha-acetylmethadol.................... 7 7
Alpha-ethyltryptamine................... 2 2
Alpha-methadol.......................... 2 2
Alpha-methylfentanyl.................... 2 2
Alpha-methylthiofentanyl................ 2 2
Aminorex................................ 7 7
Beta-acetylmethadol..................... 2 2
Beta-hydroxyfentanyl.................... 2 2
Beta-hydroxy-3-methylfentanyl........... 2 2
Beta-methadol........................... 2 2
Bufotenine.............................. 2 2
Cathinone............................... 9 9
Codeine-N-oxide......................... 2 2
Difenoxin............................... 14,000 14,000
Dihydromorphine......................... 7 7
Ethylamine Analog of PCP................ 5 5
Heroin.................................. 2 2
Lysergic acid diethylamide.............. 32 32
Mescaline............................... 7 7
Methaqualone............................ 17 17
Methcathinone........................... 11 11
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Morphine-N-oxide........................ 2 2
N-Ethylamphetamine...................... 7 7
N-Hydroxy-3,4-Methylenedioxyamphetamine. 2 2
N,N-Dimethyltryptamine.................. 7 7
Norlevorphanol.......................... 2 2
Normethadone............................ 7 7
Normorphine............................. 7 7
Para-fluorofentanyl..................... 2 2
Pholcodine.............................. 2 2
Psilocin................................ 2 2
Psilocybin.............................. 2 2
Tetrahydrocannibinols................... 25,100 25,100
Thiofentanyl............................ 2 2
Thiophene Analog of Phencyclidine....... 5 5
Schedule II
1-Phenylcyclohexylamine................. 10 10
1-Piperidinocyclohexanecarbonitrile..... 12 12
Alfentanil.............................. 9,300 9,300
Amobarbital............................. 15 15
Amphetamine............................. 2,968,000 3,137,000
Carfentanil............................. 500 500
Cocaine................................. 550,100 550,100
Codeine (for sale)...................... 49,103,000 53,140,000
Codeine (for conv)...................... 19,679,000 19,679,000
Desoxyephedrine......................... 1,422,000 1,393,000
1,361,000 grams of levodesoxyephedrine for use in a noncontrolled,
nonprescription product and 32,00 grams for methamphetamine.
Dextroproproxyphene..................... 116,469,000 116,469,000
Dihydrocodeine.......................... 255,100 188,000
Diphenoxylate........................... 1,572,000 1,572,000
Ecgonine (for conv)..................... 651,000 651,000
Ethylmorphine........................... 12 12
Fentanyl................................ 193,000 193,000
Glutethimide............................ 2 2
Hydrocodone (for sale).................. 13,891,000 13,891,000
Hydrocodone (for conv).................. 1,769,000 1,769,000
Hydromorphone........................... 563,000 563,000
Isomethadone............................ 12 12
Levo-alpha-acetylmethadol............... 356,000 356,000
Levomethorphan.......................... 2 2
Levorphanol............................. 16,400 12,000
Meperidine.............................. 9,843,000 9,843,000
Methadone (for sale).................... 3,977,000 3,977,000
Methadone (for conv).................... 364,000 364,000
Methadone Intermediate (for conv)....... 5,275,000 5,275,000
Methamphetamine (for conv).............. 723,000 723,000
Methylphenidate......................... 13,824,000 13,824,000
Morphine (for sale)..................... 11,126,000 11,126,000
Morphine (for conv)..................... 68,165,000 68,165,000
Noroxymorphone (for sale)............... 30,000 30,000
Noroxymorphone (for conv)............... 2,000,000 2,000,000
Opium................................... 937,000 575,000
Oxycodone (for sale).................... 6,634,000 6,634,000
Oxycodone (for conv).................... 1,200 1,200
Oxymorphone............................. 56,000 56,000
Pentobarbital........................... 16,772,000 16,772,000
Phencyclidine........................... 60 60
Phenmetrazine........................... 2 2
Phenylacetone........................... 10 10
Secobarbital............................ 491,000 491,000
Sufentanil.............................. 1,000 1,000
Thebaine................................ 9,325,000 9,325,000
------------------------------------------------------------------------
All interested persons are invited to submit their comments 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
[[Page 30885]]
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 thereby 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 schedule 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: May 28, 1997.
James S. Milford,
Acting Deputy Administrator.
[FR Doc. 97-14698 Filed 6-4-97; 8:45 am]
BILLING CODE 4410-09-M
