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45624 Federal Register / Vol. 77, No. 148 / Wednesday, August 1, 2012 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA2012N0806 Animal Drug User Fee Rates
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What is animal drug user fee?
The animal drug user fee is a fee that is required to be paid by certain animal drug sponsors to the U.S. Food and Drug Administration (FDA) in order to support the review of new animal drug applications and the ongoing regulation of approved animal drugs.
Who is required to file animal drug user fee?
Animal drug sponsors who meet certain criteria, such as those with pending animal drug applications or who market approved animal drugs, are required to file the animal drug user fee.
How to fill out animal drug user fee?
The animal drug user fee can be filled out by using the FDA's online submission system. Sponsors can provide the necessary information and pay the fee online.
What is the purpose of animal drug user fee?
The purpose of the animal drug user fee is to provide funding for the FDA's activities related to the review and regulation of animal drugs. It helps to ensure the safety and effectiveness of these drugs for animals.
What information must be reported on animal drug user fee?
The animal drug user fee requires sponsors to report information such as the number of animals treated with the drug, the drug's sales data, and any adverse events or incidents related to the drug use.
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