The direct final rule will increase the upper limit thresholds (i.e., “small numbers”) for dogs and cats in the definition of “small number of animals” to reflect current market conditions related to drug development costs and drug treatment values for purposes of determining eligibility for drug development incentives under the Minor Use and Minor Species Animal Health Act of 2004 (MUMS Act). By expanding incentives for new animal drug development under the MUMS Act, the rule could benefit pet owners by improving the health of dogs and cats with uncommon diseases or conditions. These health improvements could result from the earlier marketing of new animal drugs by sponsors that apply for and receive conditional approval as a result of the rule. The rule also could result in cost savings to new animal drug sponsors and FDA.
Because the rule could increase the number of uncommon diseases or conditions in dogs and cats that qualify for minor use drug development incentives, sponsors could incur costs to prepare and submit additional minor use determination requests and, for those sponsors that pursue designation for their new animal drug, annual designation reports to FDA. FDA will bear costs to review any additional minor use determination requests and annual designation reports. Potential sponsors of new animal drugs for minor uses in dogs and cats will also incur a one-time cost to read and understand the rule.
Regulatory Impact Analysis
Federal Register: 87 FR 56583, September 15, 2022