MUMS Update- FDA Publishes Final Rule Defining “Small Number of Animals”

By Susan J. Matthees –

After years of anticipation, FDA has finally published a final rule establishing a specific small number of animals for each of the seven major species for purposes of the Minor Use and Minor Species Animal Health Act of 2004 (MUMS Act).  The final rule, codified in 21 C.F.R. § 516.3(b), defines a small number of animals as “equal to or less than 50,000 horses; 70,000 dogs; 120,000 cats; 310,000 cattle; 1,450,000 pigs; 14,000,000 turkeys; and 72,000,000 chickens.” 

In the Federal Register notice announcing the final rule, FDA explained that the agency will “periodically reevaluate the definition of ‘small number of animals’” because the number of animals affected by a disease may change over time.  FDA also noted that the agency could change the definition if the development cost versus market value of the drug changes.  FDA will make any changes to the definition through proposed rulemaking.