The Office of Minor Use and Minor Species Animal Drug Development was established in response to the Minor Use and Minor Species (MUMS) Animal Health Act of 2004. The Office grants MUMS designations for new animal drugs. It will add drugs to an index of legally marketed unapproved new animal drugs and will grant money to support MUMS drug approval or conditional approval once final regulations providing for indexing and designation are published.
The first task for the new Office was to formally establish its functions and relationship to other organizations within FDA. Subsequently, the Office began the lengthy and complex process of publishing implementing regulations for MUMS drug designation. MUMS drug designation will help make more medications legally available to veterinarians and animal owners to treat minor animal species and also uncommon diseases in the major animal species. Because the designation provisions of the statute went into effect immediately upon its signature by the President, the Office is processing requests for designation before the implementing regulations are established.
The Office is also working on establishing implementing regulations to provide for indexing of new animal drugs intended for use only in minor species, and will assist the Office of New Animal Drug Evaluation in developing regulations to implement the conditional approval provisions of the MUMS act.
Questions concerning MUMS should be addressed to:
Dr. Andrew Beaulieu Office of Minor Use and Minor Species Animal Drug Development Center for Veterinary Medicine 7519 Standish Place Rockville, MD 20855 240-276-9090 mailto:abeaulie@cvm.fda.gov
or
Dr. Meg Oeller, Office of Minor Use and Minor Species Animal Drug Development Center for Veterinary Medicine 7519 Standish Place Rockville, MD 20855 240-276-9005 mailto:moeller@cvm.fda.gov
Web Page Updated by hd - September 20, 2005, 3:28 PM ET
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