[Federal Register Volume 60, Number 249 (Thursday, December 28, 1995)]
[Notices]
[Page 67142]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-31384]



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DEPARTMENT OF JUSTICE
[Docket No. 95-47]


Roxane Laboratories, Inc., Columbus, OH; Notice of Administrative 
Hearing, Summary of Comments and Objections; Notice of Hearing

    This Notice of Administrative Hearing, Summary of Comments and 
Objections, regarding the application of Roxane Laboratories, Inc. 
(Roxane) for registration as an importer of cocaine, a Schedule II 
controlled substance, is published pursuant to 21 C.F.R. 
Sec. 1301.42(a). On June 8, 1995, notice was published in the Federal 
Register \1\ stating that Roxane has applied to be registered as an 
importer of cocaine.

    \1\ 60 Fed. Reg. 30320.
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    On July 7, 1995, Mailinckrodt Chemical, Inc. (Mallinckrodt) filed 
comments and objections on the application and requested a hearing in 
the event that the application is not denied. Stepan Company (Stephan) 
also filed objections to the application. Notice is hereby given that a 
hearing with respect to Roxane's application to be registered as an 
importer of cocaine will be conducted pursaunt to the provisions of 5 
U.S.C. 952(a) and 958 and 21 C.F.R. Sec. 1311.42.

Hearing Date

    The hearing will begin at 9:30 a.m. on February 5, 1996, and will 
be held at the Drug Enforcement Administration Headquarters, 600 Army 
Navy Drive, Hearing Room, Room E-2103, Arlington, Virginia. The hearing 
will be closed to the public except to the parties and those persons 
who have a right to participate under 21 C.F.R. Sec. 1311.42(a) and 
request a hearing or enter a notice of appearance.

Notice of Appearance

    Any person entitled to participate in this hearing pursuant to 21 
C.F.R. Sec. 1311.42(a), and desiring to do so, may participate by 
filing a notice of intention to participate in accordance with 21 
C.F.R. Sec. 1311.54, in duplicate, with the Hearing Clerk, Office of 
the Administrative Law Judges, Drug Enforcement Administration, 
Washington, DC 20537, within 30 days of the date of publication of this 
notice in the Federal Register. Each notice of appearance must be in 
the form prescribed in 21 C.F.R. Sec. 1316.48. Mallinckrodt, Roxane, 
and DEA Office of Chief Counsel need not file a notice of intention to 
participate.

FOR FURTHER INFORMATION CONTACT: Helen Farmer, Hearing Clerk, Drug 
Enforcement Administration, Washington, DC 20537; Telephone (202) 307-
8188.

Summary of Comments and Objections

Mallinckrodt's Comments

    Mallinckrodt, a manufacturer of bulk cocaine, intends to show that 
registration of Roxane as an importer of cocaine would be contrary to 
21 U.S.C. Sec. 952(a) because there is no emergency in which domestic 
supplies of cocaine are inadequate and because competition among 
domestic manufacturers of cocaine either is adequate or could be 
rendered adequate by registration of additional domestic manufacturers. 
Mallinckrodt argues that supply and competition are adequate. In 
support of its argument that supply is adequate, Mallinckrodt asserts 
that it is able to supply the entire licit United States cocaine market 
and that the quality, reliability, and quantity of foreign sources of 
raw materials varies considerably. In support of its argument that 
competition is sufficient, Mallinckrodt asserts that the domestic 
market for cocaine is very small and is flat or declining, and that 
even if competition were inadequate, it could be rendered adequate by 
the registration of additional domestic manufacturers. Mallinckrodt 
also argues that because it could meet the market needs for cocaine, 
allowing the importation of cocaine would needlessly increase the risk 
of diversion, foster international commerce in cocaine, and result in 
an increased demand on DEA's regulatory resources.

Stepan's Comments

    Stepan, an importer of coca leaf and manufacturer of cocaine, 
states that it is concerned that the importation of finished cocaine 
raises a question whether adequate controls will exist to prevent its 
diversion. Stepan further asserts that importation would raise issues 
of quality and sponsorship that do not exist in the current 
arrangement, whereby Stepan manufacturers cocaine in accordance with 
long-standing, approved, and controlled processes. Finally, Stepan 
asserts that there is no shortage of domestic manufacturing capability 
or facilities.

    Dated: December 21, 1995.
Stephen H. Greene,
Deputy Administrator, Drug Enforcement Administration.
[FR Doc. 95-31384 Filed 12-27-95; 8:45 am]
BILLING CODE 4410-09-M