Rules and Regulations. Notification of withdrawal
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/register/2016/08/29/2016-19915A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4164-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 [Docket No. FDA-2016-N-0002] New Animal Drugs for Use in Animal Feed; Withdrawal of Approval of a New Animal Drug Application AGENCY: Food and Drug Administration, HHS. ACTION: Notification of withdrawal. SUMMARY: The Food and Drug Administration
(FDA)is withdrawing approval of eight new animal drug applications (NADAs) at the sponsor's request because these products are no longer manufactured or marketed. DATES: Withdrawal of approval is effective September 8, 2016. FOR FURTHER INFORMATION CONTACT: Sujaya Dessai, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5761, *sujaya.dessai@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285 has requested that FDA withdraw approval of the NADAs listed in the following table because the products are no longer manufactured or marketed: File No. Product name 21 CFR section 012-548 1 TYLOSIN (tylosin phosphate)/HYGROMIX (hygromycin B) 558.274 013-162 1 TYLAN TM (tylosin phosphate) Type A medicated article 558.625 013-388 1 TYLAN (tylosin phosphate)/HYGROMIX (hygromycin B) Premix 558.274 015-166 1 TYLAN TM (tylosin phosphate) Type A medicated article 558.625 127-507 1 TYLAN 5 SULFA-G (tylosin phosphate and sulfamethazine), TYLAN 10 SULFA-G (tylosin phosphate and sulfamethazine), TYLAN 20 SULFA-G (tylosin phosphate and sulfamethazine), TYLAN 40 SULFA-G (tylosin phosphate and sulfamethazine) 558.630 141-164 1 TYLAN (tylosin phosphate)/COBAN (monensin) 558.355 141-170 1 TYLAN (tylosin phosphate)/MONTEBAN (narasin) 558.363 141-198 1 TYLAN TM (tylosin phosphate)/BIO-COX (salinomycin) 558.550 1 These NADAs were identified as being affected by guidance for industry #213, “New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209,” December 2013. Therefore, under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, and in accordance with § 514.116 *Notice of withdrawal of approval of application* (21 CFR 514.116), notice is given that approval of NADAs 012-548, 013-162, 013-388, 015-166, 127-507, 141-164, 141-170, and 141-198, and all supplements and amendments thereto, is hereby withdrawn, effective September 8, 2016. Elsewhere in this issue of the **Federal Register** , FDA is amending the animal drug regulations to reflect the voluntary withdrawal of approval of these applications. Dated: August 8, 2016. Tracey H. Forfa, Deputy Director, Center for Veterinary Medicine. [FR Doc. 2016-19915 Filed 8-26-16; 8:45 am]
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- 21 CFR 558
- 21 CFR 012
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