[Federal Register Volume 66, Number 108 (Tuesday, June 5, 2001)]
[Notices]
[Page 30230]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-14114]



[[Page 30230]]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 01-3]


Penick Corp., Newark, New Jersey; 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 Penick Corporation (Penick) 
for registration as an importer of the Schedule II controlled 
substances coca leaves, raw opium, poppy straw, and poppy straw 
concentrate is published pursuant to 21 CFR 1301.34(a). On August 18, 
200, notice was published in the Federal Register, 65 FR 50568 (DEA 
2000), stating that Penick has applied to be registered as an importer 
of coca leaves, raw opium, poppy straw, and poppy straw concentrate.
    Both Noramco of Delaware, Inc. (Noramco), and Mallinckrodt, Inc. 
(Mallinckrodt), timely filed comments and objections to and requested a 
hearing on Penick's application. Organichem Corporation (Organichem) 
filed comments on Penick's application. Notice is hereby given that a 
hearing with respect to Penick's application to be registered as an 
importer of raw opium and of poppy straw concentrate will be conducted 
pursuant to the provisions of 21 U.S.C. 952(a) and 958 and 21 CFR 
1301.34.

Hearing Date

    The hearing will begin at 9:30 a.m. on July 9, 2001, 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 any person not involved in the preparation or presentation 
of the case.

Notice of Appearance

    Any person entitled to participate in this hearing pursuant to 21 
CFR 1301.34, and desiring to do so, may participate by filing a notice 
of intention to participate, in triplicate, and in accordance with 21 
CFR 1301.34, with the Hearing Clerk, Office of 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 CFR 1316.48. Penick, Noramco, Mallinckrodt, 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, Office of Administrative Law Judges, 
Washington, DC 20537; Telephone (202) 307-8188.

Summary of Comments and Objections

Mallinckrodt's Comments

    Mallinckrodt states that Penick has not manufactured controlled 
substances for the last ten years and is now owned by a company with no 
experience in controlled substance manufacturing or importation, that 
consequently Penick would likely be wasteful in manufacturing opiate 
based products, and that the ability of current registrants to provide 
and maintain an adequate and uninterrupted supply of controlled 
substances would be undermined. Mallinckrodt contends that it, unlike 
Penick, has taken significant efforts to maintain adequate and 
uninterrupted supplies of active pharmaceutical ingredients.
    Mallinckrodt further asserts that the United States is obligated to 
limit the international shipment of narcotics to the minimum to meet 
medical and scientific needs, and that inasmuch as the current 
registrants can adequately supply those needs, it is inconsistent with 
the United States' treaty obligations under the Single Convention on 
Narcotic Drugs to register Penick to import raw opium and poppy straw 
concentrate.
    Mallinckrodt also states that Penick has a history of ``marginal 
compliance'' with DEA regulations, and that if it resumes manufacturing 
controlled substances it will be unable to comply with Environmental 
Protection Agency and Food and Drug Administration requirements. 
Mallinckrodt contends that competition among domestic manufacturers is 
adequate, that registering Penick will not enhance competition, and 
that any difference between domestic and foreign prices of relevant 
substances reflects the regulations and policies faced by domestic 
producers. Finally, Mallinckrodt states that Penick's lack of adequate 
manufacturing facilities indicates that it is not capable of 
maintaining effective controls against diversion.

Noramco's Comments

    Noramco asserts that because Penick has not produced significant 
quantities of bulk narcotic substances since 1991, it will be difficult 
for Penick to produce these materials as efficiently as existing 
registrants, thereby aggravating the long-term shortage of narcotics 
raw materials. Noramco also states that existing manufacturers of bulk 
narcotic substances are producing an adequate and uninterrupted supply 
under adequately competitive conditions, that Penick's troubled 
financial history raises concerns regarding its ability to manufacture 
narcotic substances in a manner consistent with the public interest, 
and that Penick will have to demonstrate that it can effectively 
control diversion. Additionally, Noramco asserts that Penick's 
management intends to fund the business with a sum that is inadequate 
to the task of starting and maintaining a viable narcotic raw material 
import and bulk manufacturing business.

Organichem's Comments

    Organichem states that Penick's financial difficulties have 
prevented it from heretofore operating successfully, that it should be 
required to comply with current DEA security requirements, and that it 
should also be required to demonstrate that it can meet current Food 
and Drug Administration, environmental, and international standards.
    Organichem further asserts that Penick should be required to 
demonstrate that it has the financial resources necessary to finance 
production and a business plan adequate to establish and maintain a 
profitable business.

    Dated: May 29, 2001.
Donnie R. Marshall,
Administrator, Drug Enforcement Administration.
[FR Doc. 01-14114 Filed 6-4-01; 8:45 am]
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