New Animal Drugs; Change of Sponsor

Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration 21 CFR Parts 510, 520, 522, 524, and 558 [Docket No. FDA-2014-N-0002] AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. ( printed page 48701) SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 57 approved new animal drug applications (NADAs) and 14 approved abbreviated new animal drug applications (ANADAs) from Elanco Animal Health, A Division of Eli Lilly & Co. to Elanco US, Inc. DATES: This rule is effective July 26, 2016. FOR FURTHER INFORMATION CONTACT: Steven D. Vaughn, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-0571, steven.vaughn@fda.hhs.gov . SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285 has informed FDA that it has transferred ownership of, and all rights and interest in, the 71 approved NADAs and ANADAs in table 1 to Elanco US, Inc., 2500 Innovation Way, Greenfield, IN 46140. Table 1—NADAs and ANADAs Transferred From Elanco Animal Health, a Division of Eli Lilly & Co. to Elanco US, Inc. File No. Product name 21 CFR Section 010-918 HYGROMIX 8 (hygromycin B) Type A medicated article 558.274 011-948 HYGROMIX 2.4 (hygromycin B) Type A medicated article 558.274 012-491 TYLAN 100 (tylosin) Injection 522.2640 012-548 TYLAN (tylosin phosphate)/HYGROM…