S.1346 - Minor Use and Minor Species Animal Health Act of 2001107th Congress (2001-2002)
Summary: S.1346 — 107th Congress (2001-2002)
Minor Use and Minor Species Animal Health Act of 2001 - 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 Senate (08/02/2001)
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.
Amends the Internal Revenue Code to allow a business research tax credit (not applicable to grant or contract funds) for minor use qualified safety and effectiveness testing expenses.
Directs the Secretary of Health and Human Services to establish within the Food and Drug Administration an Office of Minor Use and Minor Species Animal Drug Development.