02-21187. 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 [phone].

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.