H.R.2079 - Minor Use and Minor Species Animal Health Act of 2003108th Congress (2003-2004)
Summary: H.R.2079 — 108th Congress (2003-2004)
Minor Use and Minor Species Animal Health Act of 2003 - Amends the Federal Food, Drug, and Cosmetic Act to define: "minor species" as animals other than cattle, horses, swine, chickens, turkeys, dogs, and cats; and (2) "minor use" as use on minor species or on other species for a disease or condition that occurs infrequently or in limited geographic areas. Provides for: (1) designation of new animal drugs for minor use; and (2) three-year approval exclusivity.
Introduced in House (05/13/2003)
Provides for establishment of an index of unapproved new animal drugs for minor species, and allows marketing of such drugs that evidence no human food safety concern.
Authorizes: (1) designation of new animal drugs for minor use or minor species; and (2) grants or contracts for development (and exclusivity) of designated new animal drugs. Modifies new animal drug approval requirements.