New Animal Drugs for Minor Use and Minor Species

The respondents to this information collection are pharmaceutical companies that sponsor new animal drugs for Minor Use and Minor Species (MUMS) designation or requesters wishing to add a new animal drug to the index listing of legally marketed unapproved new animal drugs for minor species animals. MUMS drug designation makes the sponsor eligible for incentives to support the approval or conditional approval of the designated use and is completely optional for drug sponsors. The MUMS designation regulations specify the criteria and procedures for requesting MUMS designation as well as the annual reporting requirements for MUMS designees. Indexing provides a basis for legally marketing an unapproved new animal drug intended for use in a minor species. The indexing regulations specify the criteria and procedures for requesting eligibility for indexing and for requesting addition to the index, as well as the annual reporting requirements for holders of an index listing.

The latest form for New Animal Drugs for Minor Use and Minor Species expires 2026-08-31 and can be found here.

Reporting; Designated New Animal Drugs for Minor Use and MInor Species (MUMS)

Federal Enterprise Architecture: Health - Consumer Health and Safety