Summary: H.R.2079 — 108th Congress (2003-2004)All Information (Except Text)

There is one summary for H.R.2079. Bill summaries are authored by CRS.

Shown Here:
Introduced in House (05/13/2003)

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.

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.