Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
Appeal requests Modified 6 72 0 Other-Authority to Assess and Use Drug Fees
Other waivers, reductions, refunds, exemptions under secs. 735 & 736 Modified 181 3077 0 Other-Statutory Authority
Prescription Drug User Fee Cover Sheet Modified 164 82 0 Other-E-form Screenshot
Instruction
Form Form FDA 3397 Prescription Drug User Fee Cover Sheet
Other-PDUFA VII Commitment Letter
Reconsideration requests Modified 22 528 0 Other-Authority to Assess and Use Drug Fees
Small business waiver requests Modified 35 70 0 Other-Agency Guidance
Form and Instruction FDA 3971 Small Business Waiver and Refund Request
Other-Statutory Authority
Instruction
Total burden requested under this ICR: 408 3829 0  
To view an IC, click on IC Title