Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of seven new animal drug applications (NADAs) for lack of compliance with the reporting requirements in an FDA regulation.
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: Final rule, technical amendment. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of seven new animal drug applications (NADAs) for lack of compliance with the reporting requirements in an FDA regulation. DATES: This rule 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: I. Background Elsewhere in this issue of the Federal Register , FDA gave notice that approval of the seven NADAs listed in table 1, and all supplements and amendments thereto, is withdrawn, effective February 23, 2021, for lack of compliance with reporting requirements in 21 CFR 514.80 . As provided in the regulatory text of this document, the animal drug regulations are amended to reflect withdrawal of approval of the following applications and a current format. Withdrawal of approval of NADA 065-067 for Tetracycline Hydrochloride (HCl) Tablets did not require amending the regulations. Table 1—NADAs for Which Approval Is Withdrawn Application No. Trade name (drug) Sponsor 21 CFR section 031-971 CUPRATE (cupric glycinate) Walco International,…
Other Federal Register documents from the same docket.
Citation: 86 FR 10818
