Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
CBER, Form FDA 3500A Unchanged 58702 71029 0 Instruction
Form 3500A
CBER/CDER Form FDA 3500 Unchanged 58711 38749 0 Form 3500
CBER/CDER Form FDA 3500B Unchanged 32711 15047 0 Form and Instruction Form FDA 3500B
Form and Instruction FDA 3500B
CDRH Forms FDA 3500, FDA 3500B Unchanged 15304 7040 0 Form and Instruction 3500
Form 3500B
CTP Form FDA 3500 Unchanged 39 26 0
HFP Form FDA 3500 Unchanged 7442 5211 0 Form and Instruction FDA 3500
Other-Agency Guidance
Form and Instruction Form FDA 3500B
HFP Form FDA 3500A Unchanged 1659 2007 0 Other-Agency Guidance
Form 3500A
Instruction
Submissions via SRP, including voluntary submissions Modified 5288 3558 0 Other-Unified Intake Tool
Written Request for temporary waiver of mandatory electronic reporting Unchanged 1 1 0
Total burden requested under this ICR: 179857 142668 0  
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