The Food and Drug Administration (FDA) is seeking comments on a proposed revision to its reporting requirements for new animal drugs.
FDA is considering incorporating the requirements of section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA 105).
As part of that process, the agency is reviewing other reporting requirements related to antimicrobial new animal drug sponsors to determine whether additional information should be reported.
“Collecting data on antimicrobial drugs used in food-producing animals will assist FDA in tracking antimicrobial use trends and examining how such trends may relate to antimicrobial resistance,” the agency said in a Federal Register notice.
“The sales and distribution information that is currently being collected from antimicrobial new animal drug sponsors in accordance with ADUFA 105 is important in supporting efforts such as the National Antimicrobial Resistance Monitoring System (NARMS), a surveillance program that tracks trends related to antimicrobial resistance in food- producing animals and humans.”
The notice referenced a recent Government Accountability Office report that concluded that sales and distribution information collected by FDA “does not provide sufficient data needed to analyze trends in antimicrobial resistance, such as information on actual drug use in specific food-producing animal species.”
Comments may be submitted by Sept. 25.
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