On December 6, 2007 (72 FR 69108), FDA published a final rule in the Federal Register, entitled “Index of Legally Marketed Unapproved New Animal Drugs for Minor Species.” This final rule implements section 572 of the Federal Food, Drug, and Cosmetic Act (FFDCA), which provides for a public index listing of legally marketed unapproved new animal drugs for minor species of animals (species other than cattle, horses, swine, chickens, turkeys, dogs, and cats). Within limitations established by the statute, such indexing provides a basis for legally marketing an unapproved new animal drug intended for use in a minor species.

FDA has prepared this Small Entities Compliance Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121). This document is intended to provide guidance on the requirements of Title 21, Code of Federal Regulations, new Part 516, subpart C.

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