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Defining Small Number of Animals for Minor Use Designation (US Food and Drug Administration Regulation) (FDA) (2018 Edition) The Law Library

Defining Small Number of Animals for Minor Use Designation (US Food and Drug Administration Regulation) (FDA) (2018 Edition) The Law Library presents the complete text of the Defining Small Number of Animals for Minor Use Designation (US Food and Drug Administration Regulation) (FDA) (2018 Edition). Updated as of May 29, 2018 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. This book contains: - The complete text of the Defining Small Number of Animals for Minor Use Designation (US Food and Drug Administration Regulation) (FDA) (2018 Edition) - A table of contents with the page number of each section