[Federal Register Volume 60, Number 224 (Tuesday, November 21, 1995)]
[Notices]
[Pages 57808-57810]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-28550]
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Notices
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains documents other than rules
or proposed rules that are applicable to the public. Notices of hearings
and investigations, committee meetings, agency decisions and rulings,
delegations of authority, filing of petitions and applications and agency
statements of organization and functions are examples of documents
appearing in this section.
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Federal Register / Vol. 60, No. 224 / Tuesday, November 21, 1995 /
Notices
[[Page 57808]]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[DEA No. 134F]
Controlled Substances: Established Initial 1996 Aggregate
Production Quotas
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of aggregate production quotas for 1996.
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SUMMARY: This notice establishes initial 1996 aggregate production
quotas for some controlled substances in Schedules I and II of the
Controlled Substances Act (CSA).
EFFECTIVE DATE: This order is effective upon November 21, 1995.
FOR FURTHER INFORMATION CONTACT: Howard McClain, Jr., Chief, Drug &
Chemical Evaluation Section, Drug Enforcement Administration,
Washington, DC 20537, Telephone: (202) 307-7183.
SUPPLEMENTARY INFORMATION: Section 306 of the CSA (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 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.
On July 27, 1995, a notice of the proposed initial 1996 aggregate
production quotas for certain controlled substances in Schedules I and
II was published in the Federal Register (60 FR 38576). All interested
persons were invited to comment on or object to the proposed aggregate
production quotas on or before August 28, 1995. The following comments
were received.
A company commented that the proposed initial 1996 aggregate
production quotas for dihydrocodeine, hydrocone and noroxymorphone (for
conversion), are insufficient to provide for the estimated medical
needs of the United States, estimated export requirements and for the
establishment and maintenance of reserve stocks. The company's comments
are based on their actual 1995 and projected 1996 domestic sales and
1995 manufacturing quotas. After reviewing the company's current 1995
and forecasted 1996 sales and inventory levels, the DEA determined that
the initial 1996 aggregate production quotas for dihydrocodeine,
hydrocodone and noroxymorphone (for conversion) must be increased to
meet the 1996 medical needs of the United States, and are adjusted
accordingly.
Several companies commented that the proposed initial 1996
aggregate production quota for amphetamine is insufficient to provide
for the estimated medical, scientific, research and industrial needs of
the United States, estimated export requirements and for the
establishment and maintenance of reserve stocks. The company comments
are based on their actual 1995 sales, projected 1996 sales and exports,
projected 1995 and 1996 inventories and 1996 research requirements.
Based on 1995 manufacturing quotas, the 1996 Food and Drug
Administration estimate for amphetamine and projected 1996 inventories,
the DEA increased the initial 1996 aggregate production quota for
amphetamine. The DEA received no comments regarding the proposed
aggregate production quotas for any other substances in schedule I or
II.
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 has no
significant impact upon small entities whose interest 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 manufactures, their impact upon small entities is
neither negative nor beneficial. Accordingly, the Deputy Administrator
determined that this action does not require a regulatory flexibility
analysis.
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, pursuant to Section 0.104 of Title 28 of the Code of
Federal Regulations, the Deputy Administrator hereby orders that the
1996 initial aggregate production quotas, expressed in grams of
anhydrous base, be established as follows.
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Established
Basic class initial 1996
quotas
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Schedule I:
Acetylmethadol...................................... 7
Alphacetylmethadol.................................. 7
Aminorex............................................ 7
Cathinone........................................... 9
Difenoxin........................................... 14,000
Dihydromorphine..................................... 7
[[Page 57809]]
2,5-Dimethoxyamphetamine............................ 10,650,000
N,N-Dimethylamphetamine............................. 7
Ethylamine Analog of Phencyclidine.................. 5
N-Ethylamphetamine.................................. 7
Lysergic Acid Diethylamide.......................... 58
Mescaline........................................... 7
Methaqualone........................................ 17
Methacathinone...................................... 9
4-Methoxyamphetamine................................ 17
4-Methylaminorex.................................... 2
3-Methylfentanyl.................................... 14
3,4-Methylenedioxyamphetamine....................... 17
3,4-Methylenedioxy-N-ethylamphetamine............... 27
3,4-Methylenedioxymethamphetamine................... 42
Normethadone........................................ 7
Normorphine......................................... 7
Psilocybin.......................................... 2
Psilocyn............................................ 2
Tetrahydrocannabinols............................... 55,100
Schedule II:
Alfentanil.......................................... 8,500
Amobarbital......................................... 15
Amphetamine (includes the d,1-, d- and 1- forms of
amphetamine........................................ 1,863,200
Cocaine............................................. 550,040
Codeine (for sale).................................. 58,395,000
Codeine (for conversion)............................ 16,632,000
Desoxyephedrine (1,000,000 grams of levo-
desoxyephedrine for use in a non-controlled, non-
prescription product and 44,000 grams for
methamphetamine)................................... 1,044,000
Dextropropoxyphene.................................. 118,066,000
Dihydrocodeine...................................... 116,000
Diphenoxylate....................................... 1,063,000
Ecgonine (for conversion)........................... 650,100
Ethylmorphine....................................... 12
Fentanyl............................................ 120,100
Hydrocodone (for sale).............................. 10,575,000
Hydrocodone (for conversion)........................ 2,800,000
Hydromorphone....................................... 448,000
Isomethadone........................................ 12
Levo-alpha-acetylmethadol........................... 200,000
Levorphanol......................................... 14,300
Meperidine.......................................... 10,822,000
Methadone (for sale)................................ 4,551,000
Methadone (for conversion).......................... 364,000
Methadone Intermediate (for conversion)............. 5,534,000
Methamphetamine (for conversion).................... 723,000
Methylphenidate..................................... 10,291,000
Morphine (for sale)................................. 12,450,00
Morphine (for conversion)........................... 76,735,000
Noroxymorphone (for sale)........................... 2,000
Noroxymorphone (for conversion)..................... 3,400,000
Opium............................................... 1,226,000
Oxycodone (for sale)................................ 5,571,000
Oxycodone (for conversion).......................... 37,300
Oxymorphone......................................... 11,200
Pentobarbital....................................... 15,100,000
Phencyclidine....................................... 40
Phenylacetone....................................... 5,280,000
1-Phenylcyclohexylamine............................. 10
1-Piperidinocyclohexanecarbonitrile................. 12
Secobarbital........................................ 400,000
Sufentanil.......................................... 1,000
Thebaine............................................ 9,217,000
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[[Page 57810]]
Dated: November 16, 1995.
Stephen H. Greene,
Deputy Administrator.
[FR Doc. 95-28550 Filed 11-20-95; 8:45 am]
BILLING CODE 4410-09-M
