[Federal Register Volume 64, Number 161 (Friday, August 20, 1999)]
[Notices]
[Pages 45566-45569]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-21583]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[DEA #179R]
Controlled Substances: Proposed Revised Aggregate Production
Quotas for 1999
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of proposed revised 1999 aggregate production quotas.
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SUMMARY: This notice proposes revised 1999 aggregate production quotas
for controlled substances in Schedule I and II of the Controlled
Substances Act (CSA).
DATES: Comments or objections must be received on or before September
20, 1999.
ADDRESSES: Send comments or objections to the Deputy Administrator,
[[Page 45567]]
Drug Enforcement Administration, Washington, D.C. 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, Telephone: (202) 307-7183.
SUPPLEMENTARY INFORMATION:
Background
Section 306 of the CSA (21 U.S.C. 826) requires that the Attorney
General establish aggregate production quotas for each basic class of
controlled substance listed in Schedule 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.
On December 23, 1998 DEA published a notice of established initial
1999 aggregate production quotas for certain controlled substances in
Schedules I and II (63 FR 71160). This notice stipulated that the
Deputy Administrator of the DEA would adjust the quotas in early 1999
as provided for in Section 1303 of Title 21 of the Code of Federal
Regulations.
The proposed revised 1999 aggregate production quotas represent
those quantities of controlled substances in Schedules I and II that
may be produced in the United States in 1999 to provide adequate
supplies of each substance for: the estimated medical, scientific,
research, and industrial needs of the United States; lawful export
requirements; and the establishment and maintenance of reserve stocks.
These quotas do not include imports of controlled substances for use in
industrial processes.
The proposed revisions are based on a review of 1998 year-end
inventories, 1998 disposition data submitted by quota applicants,
estimates of the medical needs of the United States, and other
information available to the DEA. In light of potential Y2K concerns,
the DEA has included 50 percent inventories for each basic class of
controlled substance manufactured for legitimate medical use.
Therefore, the aggregate production quotas proposed in this notice may
be significantly higher than usual.
Proposed Aggregate Production Quotas
Under the authority vested in the Attorney General by Section 306
of the CSA 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 Section 0.104
of Title 28 of the Code of Federal Regulations, the Deputy
Administrator hereby proposes the following revised 1999 aggregate
production quotas for the following controlled substances, expressed in
grams of anhydrous acid or base:
------------------------------------------------------------------------
Previously
established Proposed
Basic class initial 1999 revised 1999
quotas quotas
------------------------------------------------------------------------
SCHEDULE I
------------------------------------------------------------------------
2,5-Dimethoxyamphetamine................ 10,501,000 10,501,000
2,5-Dimethoxy-4-ethylamphetamine (DOET). 2 2
3-Methylfentanyl........................ 14 14
3-Methylthiofentanyl.................... 2 2
3,4-Methylenedioxyamphetamine (MDA)..... 20 20
3,4-Methylenedioxy-N-ethylamphetamine 30 30
(MDEA..................................
3,4-Methylenedioxymethamphetamine (MDMA) 20 20
3,4,5-Trimethoxyamphetamine............. 2 2
4-Bromo-2,5-Dimethoxyamphetamine (DOB).. 2 2
4-Bromo-2,5-Dimethoxyphenethylamine (2- 2 2
CB)....................................
4-Methoxyamphetamine.................... 101,000 101,000
4-Methylaminorex........................ 3 3
4-Methyl-2,5-Dimethoxyamphetamine (DOM). 2 2
5-Methoxy-3,4-Methylenedioxyamphetamine. 2 2
Acetyl-alpha-methylfentanyl............. 2 2
Acetyldihydrocodeine.................... 2 2
Acetylmethadol.......................... 7 7
Allylprodine............................ 2 2
Alpha-acetylmethadol.................... 7 7
Alpha-ethyltryptamine................... 2 2
Alphameprodine.......................... 2 2
Alpha-methadol.......................... 2 2
Alpha-methylfentanyl.................... 2 2
Alpha-methylthiofentanyl................ 2 2
Alphaprodine............................ 2 2
Aminorex................................ 7 8
Benzylmorphine.......................... 2 2
Beta-acetylmethadol..................... 2 2
Beta-hydroxy-3-methylfentanyl........... 2 2
Beta-hydroxyfentanyl.................... 2 2
Betameprodine........................... 2 2
Beta-methadol........................... 2 2
Betaprodine............................. 2 2
Bufotenine.............................. 2 2
Cathinone............................... 9 9
Codeine-N-oxide......................... 2 2
Diethyltryptamine....................... 3 3
Difenoxin............................... 9,000 9,000
Dihydromorphine......................... 7 8
[[Page 45568]]
Dimethyltryptamine...................... 3 4
Heroin.................................. 2 2
Hydroxypethidine........................ 2 2
Lysergic acid diethylamide (LSD)........ 57 57
Mescaline............................... 8 8
Methaqualone............................ 17 17
Methcathinone........................... 11 11
Morphine-N-oxide........................ 2 2
N,N-Dimethylamphetamine................. 7 7
N-Ethyl-1-Phenylcyclohexylamine (PCE)... 5 5
N-Ethylamphetamine...................... 7 7
N-Hydroxy-3,4-Methylenedioxyamphetamine. 4 4
Noracymethadol.......................... 2 2
Norlevorphanol.......................... 2 2
Normethadone............................ 7 7
Normorphine............................. 7 7
Para-fluorofentanyl..................... 2 2
Pholcodine.............................. 2 2
Propiram................................ 415,000 415,000
Psilocin................................ 2 2
Psilocybin.............................. 2 2
Tetrahydrocannabinols................... 52,000 76,000
Thiofentanyl............................ 2 2
Trimeperidine........................... 2 2
------------------------------------------------------------------------
SCHEDULE II
------------------------------------------------------------------------
1-Phenylcyclohexylamine................. 12 12
1-Piperidinocyclohexanecarbonitrile 12 12
(PCC)..................................
Alfentanil.............................. 3,800 3,800
Amobarbital............................. 12 12
Amphetamine............................. 5,740,000 9,007,000
Cocaine................................. 251,000 251,000
Codeine (for sale)...................... 67,332,000 58,248,000
Codeine (for conversion)................ 22,950,000 45,780,000
Desoxyephedrine--942,000 grams of levo- 697,000 1,055,000
desoxyephedrine for use in a non-
controlled, non-prescription product
and 113,000 grams for methamphetamine..
Dextropropoxyphene...................... 109,500,000 112,985,000
Dihydrocodeine.......................... 121,000 268,000
Diphenoxylate........................... 846,000 846,000
Ecgonine................................ 151,000 151,000
Ethylmorphine........................... 13 13
Fentanyl................................ 234,000 269,000
Glutethimide............................ 2 2
Hydrocodone (for sale).................. 16,314,000 20,208,000
Hydrocodone (for conversion)............ 6,000,000 12,100,000
Hydromorphone........................... 856,000 856,000
Isomethadone............................ 12 12
Levo-alphacetylmethadol (LAAM).......... 201,000 201,000
Levomethorphan.......................... 2 2
Levorphanol............................. 15,000 15,000
Meperidine.............................. 10,294,000 11,207,000
Metazocine.............................. 0 1
Methadone (for sale).................... 4,992,000 8,347,000
Methadone (for conversion).............. 267,000 267,000
Methadone Intermediate.................. 7,223,000 9,503,000
Methamphetamine (for conversion)........ 723,000 1,522,000
Methylphenidate......................... 14,442,000 14,957,000
Morphine (for sale)..................... 12,445,000 12,445,000
Morphine (for conversion)............... 82,300,000 94,900,000
Nabilone................................ 2 2
Noroxymorphone (for sale)............... 25,000 25,000
Noroxymorphone (for conversion)......... 2,067,000 2,067,000
Opium................................... 640,000 640,000
Oxycodone (for sale).................... 15,120,000 18,517,000
Oxycodone (for conversion).............. 106,000 106,000
Oxymorphone............................. 166,000 166,000
Pentobarbital........................... 18,039,000 22,037,000
Phencyclidine........................... 40 40
Phenmetrazine........................... 2 2
Phenylacetone........................... 10 10
[[Page 45569]]
Secobarbital............................ *1,011,000 1,155,000
Sufentanil.............................. 852 952
Thebaine................................ 22,880,000 31,117,000
------------------------------------------------------------------------
*The aggregate production quota for secobarbital was revised from 25
grams to 1,011,000 grams in an interim notice 64 FR 29358 (June 1,
1999).
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 remain at zero.
Comments and Y2K Issues
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.
The DEA is aware of concerns regarding a potential increase in
sales due to customer stockpiling for Y2K. In response to this issue,
the DEA has adjusted the aggregate production quotas to include the
allowable maximum of 50 percent inventory for those controlled
substances manufactured for medical use. Additional Y2K concerns should
be included when commenting or objecting to this proposal.
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 the 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
Federal Assessment.
The Deputy Administrator hereby certifies that this action will
have no significant impact upon small entities whose interests must by
considered under the Regulatory Flexibility Act, 5 U.S.C. 601 et seq.
The establishment of 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 Deputy
Administrator has determined that this action does not require a
regulatory flexibility analysis.
Dated: August 11, 1999.
Donnie R. Marshall,
Deputy Administrator.
[FR Doc. 99-21583 Filed 8-19-99; 8:45 am]
BILLING CODE 4410-09-M
