Agency Emergency Processing Under Office of Management and Budget Review; Animal Drug User Fee Cover Sheet

Riepilogo

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for emergency processing under the Paperwork Reduction Act of 1995 (the PRA). The proposed collection of information, Animal Drug User Fee Cover Sheet (cover sheet), will be used to assure that each animal drug user fee payment and each animal drug application for which payment is made is appropriately linked to the payment that is made. FDA is requesting this emergency processing under the PRA to implement new statutory requirements of the Animal Drug User Fee Act (ADUFA) (section 740(a)(1) of the Federal Food Drug and Cosmetic Act (the act). ADUFA requires FDA to collect fees from each person who submits certain new animal drug applications or supplements on or after September 1, 2003, and FDA may not accept applications for review if all fees have not been paid (section 740(e) of the act).