Manufacturer of Controlled Substances; Notice of Application

Pursuant to 21 CFR 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on July 28, 2004, Guilford Pharmaceuticals, Inc., 6611 Tributary Street, Baltimore, Maryland 21224, made application by renewal to the Drug Enforcement Administration (DEA) for registration as a bulk manufacturer of Cocaine (9041), a basic class of controlled substance in Schedule II.

The company plans to manufacture a cocaine derivative to be used as an intermediate for the production of Dopascan Injection. Cocaine derivatives are a Schedule II controlled substance in the cocaine basic class.

Any other such applicant and any person who is presently registered with DEA to manufacture such a substance may file comments or objections to the issuance of the proposed registration pursuant to 21 CFR 1301.33(a).

Any such comments or objections may be addressed, in quintuplicate, to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, United States Department of Justice, Washington, DC 20537, Attention: DEA Federal Register Representative Office of Liaison and Policy (ODLR) and must be filed no later than January 10, 2005.