Enrofloxacin for Poultry; Notice of Hearing

概要

The Food and Drug Administration (FDA) is announcing a hearing on a proposal to withdraw approval of a new animal drug application (NADA). In the Federal Register of October 31, 2000 (65 FR 64954), the Director of FDA's Center for Veterinary Medicine (CVM) issued a notice of opportunity for a hearing (NOOH) proposing to withdraw approval of NADA 140-828 for enrofloxacin (Baytril 3.23% Concentrate Antimicrobial Solution). Bayer Corp., the sponsor of the new animal drug, responded by filing a request for a hearing on November 29, 2000. This notice of hearing (NOH) provides factual and legal information concerning CVM's proposal to withdraw the NADA and identifies the factual issues that will be the subject of the evidentiary hearing.