The Food and Drug Administration (FDA) today published an Advance Notice of Public Rulemaking in the Federal Register titled “Antimicrobial Animal Drug Sales and Distribution Reporting.”  FDA is soliciting comments regarding potential changes to its regulations relating to records and reports for approved new animal drugs.

FDA is considering revisions to this regulation to incorporate the requirements of section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA 105).  Specifically, FDA is seeking input on three pertinent areas including how FDA should be reporting Section 105 information; should FDA include ionophores and other non-medically important antibiotics in the reporting, and are there other sources of use information and how can it be used to supplement the current 105 data.

FDA said that collecting data on antimicrobial drugs used in food-producing animals will assist the agency in tracking antimicrobial use trends and examining how such trends may relate to antimicrobial resistance.

Comments are due by September 25, 2012. The National Chicken Council will be working with its members to formulate a response.  The Advance Notice of Public Rulemaking is available here.

 

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