Defining “Small Number of Animals” for Minor Use Designation

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 Part 516 [Docket No. FDA-2008-N-0176; Formerly Docket No. 2008N-0011] RIN 0910-AG03 AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The designation provision of the Minor Use and Minor Species Animal Health Act of 2004 (MUMS Act) provides incentives to animal drug sponsors to encourage drug development and approval for minor species and for minor uses in major animal species. Congress provided a statutory definition of “minor use” that relied on the phrase “small number of animals” to characterize such use. At this time, the Food and Drug Administration (FDA) is amending the implementing regulations of the MUMS Act. In response to Congress' charge to the agency to further define minor use, this amendment establishes a specific “small number of animals” for each of the seven major animal species to be used in determining whether any particular intended use in a major species is a minor use. DATES: This rule is effective November 9, 2009. FOR FURTHER INFORMATION CONTACT: Meg Oeller, Center for Veterinary Medicine (HFV-50), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-9005, e-mail: Margaret.Oeller@fda.hhs.gov . SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of March 18, 2008 ( 73 FR 14411 ), FDA issued a proposed rule (the March 2008 proposed rule) intended to define the term “small number…