October 18, 2013 at 05:00PM SOPP 8406: CBER Processing of PDUFA Payment Information

This document describes the procedures used to determine the accuracy of information submitted by an applicant and to verify user fee payments relative to the Prescription Drug User Fee Act (PDUFA) of 1992, as reauthorized by the Food and Drug Administration Amendments Act of 2007. In addition, this document identifies other user fee activities for which the Office of Management’s Regulatory Information Management Staff (RIMS) is responsible.



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