New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications

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, and 522 [Docket No. FDA-2019-N-5405] AGENCY: Food and Drug Administration, HHS. ACTION: Notification of withdrawal. SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of seven new animal drug applications (NADAs) from multiple holders of these applications. The basis for the withdrawals is that the holders of these applications have repeatedly failed to file required annual reports for the applications. DATES: Withdrawal of approval is effective February 23, 2021. FOR FURTHER INFORMATION CONTACT: David Alterman, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5720, david.alterman@fda.hhs.gov . SUPPLEMENTARY INFORMATION: The holders of approved applications to market new animal drugs are required to submit annual reports to FDA concerning each of their approved applications in accordance with § 514.80 ( 21 CFR 514.80 ). In the Federal Register of January 8, 2020 ( 85 FR 919 ), FDA published a notice offering an opportunity for a hearing (NOOH) on a proposal to withdraw approval of seven NADAs because the sponsors had failed to submit the required annual reports for these applications. The holders of these applications did not respond to the NOOH. Failure to file a written notice of participation and request for a hearing as required by § 514.200(b) ( 21 CFR 514.200(b) ) c…