Certain Antibiotic New Animal Drug Products and Use Combinations Subject to Listings in the New Animal Drug Regulations; Drug Efficacy Study Implementation; Notice of Opportunity for Hearing

摘要

The Food and Drug Administration (FDA) is announcing the effective conditions of use for certain drug products and use combinations in the following four categories: Bacitracin methylene disalicylate single-ingredient Type A medicated articles, oxytetracycline and neomycin fixed-combination Type A medicated articles, and combination drug Type B and Type C medicated feeds for poultry containing bacitracin. The agency is also proposing to withdraw the new animal drug applications (NADAs) for those products or use combinations lacking substantial evidence of effectiveness, following a 90-day opportunity to supplement the NADAs with labeling conforming to the relevant findings of effectiveness. For applications proposed to be withdrawn, the agency is providing an opportunity for hearing. Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule to remove certain obsolete or redundant sections of the new animal drug regulations where these subject drug products and use combinations are listed. That proposed rule contains background information about those regulations and also for this action.