Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Drug User Fee Program
Published Date: 1/14/2025
Notice
Summary
The FDA wants your thoughts on how it collects info for its Generic Drug User Fee Program, which helps speed up generic drug approvals. This affects drug companies who pay fees to get their products reviewed faster. You’ve got until March 17, 2025, to share your comments, so don’t miss out on shaping how this program runs and how fees are handled!
Analyzed Economic Effects
1 provisions identified: 0 benefits, 1 costs, 0 mixed.
Increased Paperwork Burden for GDUFA
If you run or work for a generic drug company subject to the Generic Drug User Fee Program (GDUFA), FDA estimates the collection will require 8,808 total responses and 26,904 total hours of work per year. That includes 3,808 submissions of the Generic Drug User Fee Cover Sheet (Form FDA 3974) at 0.5 hours each (1,904 hours) and 5,000 controlled correspondence submissions at 5 hours each (25,000 hours).
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