Extension of Comment Period - Request for Information on Rosuvastatin Calcium
On September 26, 2003, the Office of Environmental Health Hazard Assessment (OEHHA) published a notice in the California Regulatory Notice Register (Register 03, No. 39) soliciting information that may be relevant to the evaluation of carcinogenicity of rosuvastatin calcium. A solicitation of information for six other statin drugs (atorvastatin calcium, cerivastatin sodium, fluvastatin sodium, lovastatin, pravastatin sodium, and simvastatin) has already been completed. The Carcinogen Identification Committee (CIC) at its December 17, 2002, meeting recommended that OEHHA, as resources are available, prepare hazard identification documents for each of the statin drugs and present them to the CIC at a future meeting. The CIC at that time would consider each of the statin drugs for possible listing within the context of Proposition 65. Information being solicited in the September 26 request is to assist in the development of the hazard identification document for rosuvastatin calcium.
The solicitation for information announced on September 26 was to close on November 25, 2003. OEHHA has received a request from an interested party that an extension of the solicitation period for rosuvastatin calcium be provided to allow for the submittal of complete and relevant information. OEHHA hereby extends the public comment period to 5 p.m., Friday, January 9, 2004 for rosuvastatin calcium. Interested parties or members of the public wishing to provide information relevant to the assessment of carcinogenicity for this chemical should forward such information including, but not limited to, cancer bioassays, cancer epidemiological studies, genotoxicity testing, pharmacokinetics, biomarkers, effects on biochemical and physiological processes in humans, and clinical histopathologic information exclusive of that related to muscle damage, to the address given below. Relevant information should be sent in triplicate by mail or fax to:
Cynthia Oshita
Office of Environmental Health Hazard Assessment
Proposition 65 Implementation
P.O. Box 4010
1001 I Street, 19th floor
Sacramento, California 95812-4010
FAX: (916) 323-8803 Telephone: (916) 445-6900
In order to be considered, the relevant information must be postmarked (if sent by mail) or received at OEHHA (if delivered in person or sent by FAX) by 5:00 p.m. on Friday, January 9, 2004.
