New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of a New Animal Drug Application; 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 500, 510, 516, 520, 522, 524, 529, 556, and 558 [Docket No. FDA-2021-N-0002] AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendments. SUMMARY: The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), and a conditionally approved new animal drug application (cNADA) during July, August, and September 2021. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to improve the accuracy of the regulations. DATES: This rule is effective February 28, 2022. The incorporation by reference of certain material listed in this rule is approved by the Director of the Federal Register as February 28, 2022. The incorporation by reference of other material listed in this rule was approved by the Director of the Federal Register as of November 25, 2011. FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-5689, george.haibel@fda.hhs.gov . SUPPLEMENTARY INFORMATION: I. Approvals FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during Ju…