PRA IC List
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Agenda
Reg Review
ICR
Information Collection List
IC Title
Status
Responses
Hours
Dollars
Document Type
Form No.
Form Name
Applications, amendments, resubmissions using form FDA 3674
Modified
17409
5976
0
Form and Instruction
FDA 3674
Certificate of Compliance Under 42 U.S.C. 282(j)(5)(B), with Requirements of ClinicalTrials.gov Data Bank
Other-Guidance
BE Supplements/Amendments - ODG
Removed
0
0
0
Form
FDA 3674
Certification of Compliance
Other-Guidance
Clinical Amendments to Marketing Applications - CDER and CBER
Removed
0
0
0
Form
FDA 3674
Certification of Compliance
Other-Guidance
Clinical Protocol Amendments (IND) - CDER and CBER
Removed
0
0
0
Form
FDA 3674
Certification of Compliance
Other-Guidance
Efficacy Supplements/Resubmissions - CDER and CBER
Removed
0
0
0
Form
FDA 3674
Certification of Compliance
Other-Guidance
New Marketing Applications/Resubmissions - CDER, CBER and CDRH
Removed
0
0
0
Form
FDA 3674
Certification of Compliance
Other-Guidance
Original Applications - ODG
Removed
0
0
0
Form
FDA 3674
Certification of Compliance
Other-Guidance
Total burden requested under this ICR:
17409
5976
0
To view an IC, click on IC Title
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