Conditional Approval of a New Animal Drug No Longer in Effect; Masitinib

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 and 516 [Docket No. FDA-2015-N-0002] AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect that the conditional approval of an application for masitinib mesylate tablets, a new animal drug for a minor use, is no longer in effect. DATES: This rule is effective January 21, 2016. FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5689, george.haibel@fda.hhs.gov . SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations to reflect that application 141-308 for conditional approval of KINAVET-CA1 (masitinib mesylate) Tablets, a new animal drug for a minor use sponsored by AB Science, 3 Avenue George V, 75008 Paris, France, is no longer in effect. Elsewhere in this issue of the Federal Register, FDA gave notice that conditional approval of this drug, by operation of law, was no longer in effect as of December 15, 2015. This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808 . List of Subjects 21 CFR Part 510 Administrative practice and procedure Animal drugs Labeling Reporting and reco…