FDA Submits Proposed Animal Drug Information Collection to OMB

The Food and Drug Administration (FDA) has submitted a proposed collection of information involving antimicrobial animal drugs to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act. According to the Federal Register notice, a 2008 amendment to the Federal Food, Drug, and Cosmetic Act requires that “the sponsor of each new animal drug that contains an antimicrobial agent submit an annual report to FDA on the amount of each antimicrobial active ingredient in the drug that is sold or distributed for use in food-producing animals.”

The first report under the law will be due March 31, 2010, and must specify (i) “The amount of each antimicrobial active ingredient by container size, strength, and dosage form”; (ii) “quantities distributed domestically and quantities exported”; and (iii) “a listing of the target animals, indications, and production classes that are specified on the approved label of the product.” Enacted to “address the problem of antimicrobial resistance,” the legislation was intended to ensure that the agency had the information it needs to “examine safety concerns related to the use of antibiotics in food-producing animals.” Written comments on the antimicrobial animal drug distribution reports must be submitted to OMB by March 22, 2010. See Federal Register, February 18, 2010.