Page Range | 59135-59136 | |
FR Document | 2016-19915 |
[Federal Register Volume 81, Number 167 (Monday, August 29, 2016)] [Rules and Regulations] [Pages 59135-59136] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-19915] ----------------------------------------------------------------------- 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, [email protected]. 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: ------------------------------------------------------------------------ 21 CFR File No. Product name section ------------------------------------------------------------------------ 012-548 \1\............ TYLOSIN (tylosin phosphate)/ 558.274 HYGROMIX (hygromycin B). 013-162 \1\............ TYLAN TM (tylosin phosphate) 558.625 Type A medicated article. [[Page 59136]] 013-388 \1\............ TYLAN (tylosin phosphate)/ 558.274 HYGROMIX (hygromycin B) Premix. 015-166 \1\............ TYLAN TM (tylosin phosphate) 558.625 Type A medicated article. 127-507 \1\............ TYLAN 5 SULFA-G (tylosin 558.630 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). 141-164 \1\............ TYLAN (tylosin phosphate)/COBAN 558.355 (monensin). 141-170 \1\............ TYLAN (tylosin phosphate)/ 558.363 MONTEBAN (narasin). 141-198 \1\............ TYLAN TM (tylosin phosphate)/ 558.550 BIO-COX (salinomycin). ------------------------------------------------------------------------ \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 Sec. 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] BILLING CODE 4164-01-P
Category | Regulatory Information | |
Collection | Federal Register | |
sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
Publisher | Office of the Federal Register, National Archives and Records Administration | |
Section | Rules and Regulations | |
Action | Notification of withdrawal. | |
Dates | Withdrawal of approval is effective September 8, 2016. | |
Contact | Sujaya Dessai, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5761, [email protected] | |
FR Citation | 81 FR 59135 |