[Federal Register Volume 61, Number 63 (Monday, April 1, 1996)]
[Notices]
[Pages 14336-14337]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-7797]



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DEPARTMENT OF JUSTICE

Drug Enforcement Administration
[DEA #147I]


Controlled Substances: 1996 Aggregate Production Quotas

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Interim notice establishing 1996 aggregate production quotas 
and request for comments.

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SUMMARY: This interim notice establishes revised 1996 aggregate 
production quotas for amobarbital and hydromorphone, Schedule II 
controlled substances, as required under the Controlled Substances Act 
of 1970.

DATES: The is effective on April 1, 1996. Comments must be submitted on 
or before May 1, 1996.

ADDRESSES: Send comments or objections to the Administrator, Drug 
Enforcement Administration, Washington, DC 20537, Attn: DEA Federal 
Register Representative/CCR.

FOR FURTHER INFORMATION CONTACT: Howard McClain, Jr., Chief, Drug and 
Chemical Evaluation Section, Drug Enforcement Administration, 
Washington, DC 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 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 Sec. 0.14 of Tile 28 of the Code of Federal Regulations.
    The DEA established initial 1996 aggregate production quotas for 
controlled substances in Schedules I and II, including amobarbital and 
hydromorphone, in a Federal Register notice published on November 21, 
1995 (60 FR 57808). Since publication of the initial 1996 aggregate 
production quotas, DEA has received information which necessities an 
immediate increase in the initial 1996 aggregate production quotas for 
amobarbital and hydromorphone. The company which is currently the only 
bulk manufacturer of amobarbital, did not request a 1996 individual 
manufacturing quota for amobarbital. Since the company now needs to 
manufacture amobarbital to meet unexpected customer demands, the 
established initial 1996 aggregate production quota for amobarbital 
must be increased so that they may receive an individual manufacturing 
quota. The increase proposed for hydromorphone is necessary for a 
company to meet its customers' product development activities. For 
these reasons, an interim notice is being published.
    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 establishes the 
following revised 1996 aggregate production quotas for the listed 
controlled substances, expressed in grams of anhydrous base or acid:

------------------------------------------------------------------------
                                                             Established
                        Basic class                            revised  
                                                              1996 quota
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Amobarbital................................................     301,000 
Hydromorphone..............................................     718,000 
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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 interest must be 
considered under the Regulary 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 manufacturers, their impact upon small entities is 
neither negative nor beneficial. Accordingly, the Deputy Administrator 
has determined

[[Page 14337]]
that this action does not require a regulatory flexibility analysis.

    Dated: March 22, 1996.
Stephen H. Green,
Deputy Administrator.
[FR Doc. 96-7797 Filed 3-29-96; 8:45 am]
BILLING CODE 4410-09-M