To amend the Federal Food, Drug, and Cosmetic Act with regard to new animal drugs, and for other purposes.
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.
Read twice and referred to the Committee on Finance.
Introduced in House
Introduced in House
Sponsor introductory remarks on measure. (CR E904-905)
Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Subcommittee on Health.
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