Rules and Regulations. Final rule

328 words·~1 min read·/register/2002/12/03/02-30638·

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BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs; Change of Sponsor AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration

(FDA)is amending the animal drug regulations to reflect a change of sponsor for an approved new animal drug application

(NADA)from Boehringer Ingelheim Vetmedica, Inc., to Pennfield Oil Co. DATES: This rule is effective December 3, 2002. FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for Veterinary Medicine (HFV-104), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 301-827-8549, e-mail: lluther@cvm.fda.gov. SUPPLEMENTARY INFORMATION: Boehringer Ingelheim Vetmedica, Inc., 2621 North Belt Hwy., St. Joseph, MO 64506-2002, has informed FDA that it has transferred ownership of, and all rights and interest in, NADA 128-550 for ANCHOR Zinc Bacitracin Type A medicated article to Pennfield Oil Co., 14040 Industrial Rd., Omaha, NE 68137. Accordingly, the agency is amending the regulations in 21 CFR 558.78 to reflect the transfer of ownership. This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808. List of Subjects in 21 CFR Part 558 Animal drugs, Animal feeds. 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 558 is amended as follows: PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 1. The authority citation for 21 CFR part 558 continues to read as follows: Authority: 21 U.S.C. 360b, 371. § 558.78 [Amended] 2. Section 558.78 *Bacitracin zinc* is amended in paragraph (a)(2) by removing “To 000010” and by adding in its place “No. 053389”. Dated: November 8, 2002. Steven D. Vaughn, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. 02-30638 Filed 12-2-02; 8:45 am]

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