Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
Clinical Amendments to Marketing Applications for CDER and CBER New 1483 1113 0 Other-Guidance document
Form and Instruction FDA 3674
Clinical Protocol Amendments (IND) for CDER and CBER Modified 13240 3310 0 Other-Guidance document
Form and Instruction FDA 3674
Efficacy Supplements/Resubmissions for CDER and CBER New 191 144 0 Other-Guidance document
Form and Instruction FDA 3674
New Applications (IND) for CDER and CBER Modified 2033 508 0 Other-guidance document
Form and Instruction FDA 3674
New Marketing Applications for CDRH New 892 669 0 Other-Guidance document
Form and Instruction FDA 3674
New Marketing Applications/Resubmissions (NDA/BLA) for CDER and CBER New 165 124 0 Other-Guidance document
Form and Instruction FDA 3674
Original Applications New 854 641 0 Other-Guidance document
Form and Instruction FDA 3674
Supplements/Amendments New 495 372 0 Other-Guidance document
Form and Instruction FDA 3674
Total burden requested under this ICR: 19353 6881 0  
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