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US - FDA Designation of New Animal Drugs for Minor Uses or Minor Species

US - FDA Designation of New Animal Drugs for Minor Uses or Minor Species

The Office of Minor Use and Minor Species Animal Drug Development (OMUMS) in the Center for Veterinary Medicine at the Food and Drug Administration has published a new Guidance for Industry: “Designation of New Animal Drugs for Minor Uses or Minor Species.”

On July 26, 2007 (72 FR 41010), FDA published a final rule in the Federal Register, entitled “Designation of New Animal Drugs for Minor Uses or Minor Species.” This final rule, which implemented section 573 of the Minor Use and Minor Species Animal Health Act of 2004 (MUMS act), established new regulatory procedures that provided incentives intended to make more drugs legally available to veterinarians and animal owners for the treatment of minor animal species and uncommon diseases in major animal species. These regulations described the procedures for designating a new animal drug as a minor use or minor species drug. Such designation establishes eligibility for the incentives provided by the MUMS act. 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 B.

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