[Federal Register Volume 67, Number 161 (Tuesday, August 20, 2002)]
[Notices]
[Page 53968]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-21187]



[[Page 53968]]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 01-45]


Chattem Chemicals, Inc., Chattanooga, Tennessee; 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 Chattem Chemicals, Inc. 
(Chattem), for registration as an importer of the Schedule II 
controlled substances raw opium and poppy straw concentrate is 
published pursuant to 21 CFR 1301.34(a). On August 10, 2001, notice was 
published in the Federal Register, 65 FR 42239 (DEA 2001), stating that 
Chattem has applied to be registered as an importer of amphetamine, 
methamphetamine, phenylacetone, thebaine, raw opium, and poppy straw 
concentrate.
    On September 7, 2001, Organichem Corporation (Organichem), filed 
comments and a request for hearing on Chattem's application with 
respect to amphetamine. On September 10, 2001, Noramco of Delaware, 
Inc. (Noramco), filed comments and a request for hearing on Chattem's 
application with respect to raw opium, poppy straw concentrate, and 
thebaine; and Penick Corporation (Penick), filed comments and requested 
a hearing on Chattem's application with respect to raw opium, poppy 
straw concentrate, thebaine, phenylacetone, methamphetamine, and 
amphetamine. On September 13, 2001, Mallinckrodt, Inc. (Mallinckrodt), 
filed a request for hearing on Chattem's application with respect 
thebaine, raw opium, amphetamine, and poppy straw concentrate. On 
December 5, 2001, Chattem withdrew its application with respect to 
amphetamine and thebaine; thus the comments of other manufacturers with 
respect to these substances are moot and Organichem is not a party to 
this proceeding. Subsequently, Penick limited its request for a hearing 
to Chattem's application to import raw opium and poppy straw 
concentrate. Notice is hereby given that a hearing with respect to 
Chattem's application to be registered as an importer of raw opium and 
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 September 23, 
2002, 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. Chattem, 
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

    Noramco's Comments: Noramco asserts that Chattem bears the burden 
of proving that its registration to import would be consistent with the 
public interest, that because Chattem lacks experience manufacturing 
active pharmaceutical ingredients from raw opium and poppy straw 
concentrate, it will be difficult for Chattem to produce these 
materials as efficiently as existing registrants, thereby aggravating 
the long-term shortage of narcotic raw materials. Noramco also states 
that existing manufacturers of bulk narcotic substances are producing 
an adequate and uninterrupted supply under adequately competitive 
conditions
    Penick's Comments: Penick states that Chattem bears the burden of 
proving that its registration would be consistent with the public 
interest, that there needs to be a finding of the sufficiency of 
adequate competition in the marketplace, that it is not possible to 
determine Chattem's capabilities for processing opium or poppy straw 
concentrate, that Chattem lacks experience in the processing of opium 
and poppy straw concentrate, and there is insufficient public 
information about Chattem's knowledge and prior experience in the 
international marketplace.

    Dated: August 14, 2002.
John B. Brown III,
Deputy Administrator, Drug Enforcement Administration.
[FR Doc. 02-21187 Filed 8-19-02; 8:45 am]
BILLING CODE 4410-09-M