Proposals to Increase the Legal Availability of Animal Drugs for Minor Species and Minor Uses; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of a report entitled ``Proposals to Increase the Legal Availability of Animal Drugs for Minor Species and Minor Uses.'' The report contains proposals for legislative, regulatory, and policy changes to the approval process for new animal drugs intended for use in minor species and for minor uses in major species (minor use drugs). This report is the agency's response to the requirement of the Animal Drug Availability Act of 1996 (the ADAA ) that the Secretary of Health and Human Services (the Secretary) consider and announce proposals to facilitate approvals for minor use drugs. Implementation of these proposals should result in an increase in the number of approved new animal drugs for use in minor species and for minor uses.