Enrofloxacin for Poultry; Final Decision on Withdrawal of New Animal Drug Application Following Formal Evidentiary Public Hearing; Availability

Samenvatting

The Food and Drug Administration (FDA) is announcing the availability of the final decision setting forth the findings of fact and conclusions of law on the issues addressed in a formal evidentiary public hearing to determine whether FDA should withdraw approval of the new animal drug application (NADA) for use of enrofloxacin in poultry. Once this final decision becomes effective on September 12, 2005, this drug may no longer be distributed or administered for this use in the United States, nor may it be exported except as allowed by law. Elsewhere in this issue of the Federal Register, a final rule removing the applicable regulations is published.