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Approval of Tricaine-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 529 Certain Other Dosage Form New Animal Drugs; Tricaine Methanesulfonate AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Western Chemical, Inc. The ANADA provides for the use of tricaine methanesulfonate in the water of fish and other cold-blooded aquatic animals for temporary immobilization. The sponsor for TRICAINE-S is Western Chemical, Inc., 1269 Lattimore Road, Ferndale, WA 98248, telephone (800) 283-5292. Note effective date of February 17, 1998. This approval now makes available two MS-222 products for use in the U.S. The other product is FINQUEL. Only approved products should be used in a proper manner according to specific label instructions, unless otherwise prescribed by a licensed veterinarian. EFFECTIVE DATE: February 17, 1998 FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0209. SUPPLEMENTARY INFORMATION: Western Chemical, Inc., 1269 Lattimore Rd., Ferndale, WA 98248, is the sponsor of ANADA 200-226, which provides for the use of tricaine methanesulfonate powder to be mixed in the water of fish and other cold-blooded animals to be used for anesthesia and tranquilization. Western Chemical’s ANADA 200-226 is approved as a generic copy of Argent Chemical Laboratories’ NADA 42-427 Finquel ®. The ANADA is approved as of November 21, 1997, and the regulations are amended in 21 CFR 529.2503(b) to reflect the approval. The basis of approval is discussed in the freedom of information summary. In accordance with the freedom of information provisions of 21 CFR part 20 and 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Dockets Management Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, between 9 a.m. to 4 p.m., Monday through Friday. The agency has determined under 21 CFR 25.33(a)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. List of Subjects in 21 CFR Part 529
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 529 is amended as follows: PART 529-CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 529 continues to read as follows:
2. Section 529.2503 Tricaine methanesulfonate is amended in paragraph (b) by removing "No. 051212" and adding in its place "Nos. 050378 and 051212". [p7703]
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