FDA Proposes Removing Obsolete Antimicrobial Regulations

August 8, 2003

The Food and Drug Administration (FDA) is proposing to remove regulations that required sponsors to submit safety and effectiveness data about subtherapeutic uses of certain antibiotics, nitrofuran, and sulfonamide drugs in animal feed, and that exempted certain new animal drugs administered in feed from batch certification requirements. These regulations are obsolete and redundant, and their removal will not adversely affect CVM’s ability to address the issue of antimicrobial resistance.

CVM has developed a new strategy for assessing the safety of all antimicrobial new animal drugs and will soon be finalizing guidance on this issue. FDA published draft Guidance for Industry #152, entitled “Evaluating the Safety of Antimicrobial New Animal Drugs With Regard to Their Microbiological Effects on Bacteria of Human Health Concern,” on September 13, 2002. The draft Guidance outlines a risk analysis process for evaluating the safety of antimicrobial new animal drugs. This guidance, subject to public comment, represents the FDA’s current best thinking on how to assure the safety of antimicrobial new animal drugs intended for use in food animals.

Additionally, CVM is announcing the effective conditions of use for certain drug products and use combinations subject to the listings in the subject regulations. It 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 For applications proposed to be withdrawn, the Agency is providing an opportunity for hearing.

Additional information about these actions may be found in the August 8, 2003, Federal Register

New Animal Drugs; Removal of Obsolete and Redundant Regulations,

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 and

New Animal Drugs for Use in Animal Feeds; Chlortetracycline, Procaine Penicillin, and Sulfamethazine

and from Dr. Andrew J. Beaulieu, Center for Veterinary Medicine (HFV-1), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 301-827-2954; Fax 301-827-4335 or e-mail: abeaulie@cvm.fda.gov.