[Federal Register Volume 64, Number 166 (Friday, August 27, 1999)]
[Notices]
[Page 46955]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-22306]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[DEA #179IR]
Controlled Substances: 1999 Aggregate Production Quotas
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Interim notice establishing revised 1999 aggregate production
quotas and request for comments.
-----------------------------------------------------------------------
SUMMARY: This interim notice establishes revised 1999 aggregate
production quotas for amphetamine, codeine (for conversion),
hydrocodone (for sale), hydrocodone (for conversion), morphine (for
conversion), oxycodone (for sale) and thebaine, all of which are
Schedule II controlled substances in the Controlled Substances Act
(CSA).
DATES: This is effective on August 27, 1999. Comments or objections
must be received on or before September 27, 1999.
ADDRESSES: Send comments or objections to the Deputy Administrator,
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: 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 Schedules
I and II each year. 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, the 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.
In a recently published Federal Register Notice, the DEA has
proposed revised aggregate production quotas for controlled substances
in Schedules I and II, including amphetamine, codeine (for conversion),
hydrocodone (for sale), hydrocodone (for conversion), morphine (for
conversion), oxycodone (for sale) and thebaine. However, due to the
unforeseen and dramatic increase in sales of amphetamine, oxycodone and
hydrocodone, the quotas for these three substances and four of the
controlled substances used in their manufacture must be increased
immediately. Without this immediate increase, bulk manufacturers will
not be able to produce the material needed by the dosage form
manufacturers. This could, in turn, impact the supply of products to
distributors and retail pharmacies. In order to avoid this situation,
an interim notice is being published. This interim notice will
establish revised 1999 aggregate production quotas for amphetamine,
codeine (for conversion), hydrocodone (for conversion), morphine (for
conversion), oxycodone (for sale) and thebaine effective immediately.
Therefore, under the authority vested in the Attorney General by
Section 306 of the authority vested in the Attorney General by Section
306 of the CSA (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 establishes the following revised 1999 aggregate
production quotas for the listed controlled substances, expressed in
grams of anhydrous base:
------------------------------------------------------------------------
Revised
Basic class 1999 quota
------------------------------------------------------------------------
Amphetamine................................................ 9,007,000
Codeine (for conversion)................................... 45,780,000
Hydrocodone (for sale)..................................... 20,208,000
Hydrocodone (for conversion)............................... 12,100,000
Morphine (for conversion).................................. 94,900,000
Oxycodone (for sale)....................................... 18,517,000
Thebaine................................................... 31,117,000
------------------------------------------------------------------------
All interested persons are invited to submit their comments in
writing regarding this interim notice.
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 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 19, 1999.
Donnie R. Marshall,
Deputy Administrator.
[FR Doc. 99-22306 Filed 8-26-99; 8:45 am]
BILLING CODE 4410-09-M
