[Federal Register Volume 64, Number 104 (Tuesday, June 1, 1999)]
[Notices]
[Pages 29358-29359]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-13829]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration
[DEA #179S]


Controlled Substances: 1999 Aggregate Production Quota

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Interim notice establishing a revised 1999 aggregate production 
quota and request for comments.

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SUMMARY: This interim notice establishes a revised 1999 aggregate 
production quota for secobarbital, a Schedule II controlled substance 
in the Controlled Substances Act (CSA).

DATES: This is effective on June 1, 1999. Comments or objections must 
be received on or before July 1, 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 basis 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 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.
    The DEA established initial 1999 aggregate production quotas for 
controlled substances in Schedules I and II, including secobarbital, in 
a Federal Register notice published on December 23, 1998 (63 FR 71160). 
A consideration of the information available at that time resulted in 
the establishment of an aggregate production quota of 25 grams for 
secobarbital. Since publication of the initial 1999 aggregate 
production quotas, the DEA has received information which necessitates 
an immediate increase in the 1999 aggregate production quota for 
secobarbital. The increase in the quota for secobarbital is necessary 
in order for the sole U.S. manufacturer to meet unforeseen domestic 
requirements. For this reason, an interim notice is being published.
    Therefore, under 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 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 establishes the following revised 1999 aggregate 
production quota for the listed controlled substance, expressed in 
grams of anhydrous acid:

[[Page 29359]]



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                                                           Revised 1999
                       Basic class                             quota
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Secobarbital............................................       1,011,000
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    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 from 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 
Unites 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. Furthermore, this action 
involves only one basic class of controlled substance. Accordingly, the 
Deputy Administrator has determined that this action does not require a 
regulatory flexibility analysis.

    Dated: May 13, 1999.
Donnie R. Marshall,
Deputy Administrator.
[FR Doc. 99-13829 Filed 5-28-99; 8:45 am]
BILLING CODE 4410-09-M