Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
BE Supplements/Amendments - ODG Modified 698 524 0 Form FDA 3674
Other-Guidance
Clinical Amendments to Marketing Applications Removed 0 0 0 Form FDA 3674
Other-Guidance
Clinical Amendments to Marketing Applications - CDER and CBER Modified 1067 800 0 Form FDA 3674
Other-Guidance
Clinical Protocol Amendments (IND) Removed 0 0 0 Form FDA 3674
Other-Guidance
Clinical Protocol Amendments (IND) - CDER and CBER Modified 15741 3935 0 Form FDA 3674
Other-Guidance
Efficacy Supplements/Resubmissions (BLA Only) Removed 0 0 0 Other-Guidance
Form 3674
Efficacy Supplements/Resubmissions - CDER and CBER Modified 253 190 0 Form FDA 3674
Other-Guidance
New Applications (IND) Removed 0 0 0 Form FDA 3674
Other-Guidance
New Applications (IND) - CDER and CBER Modified 2050 512 0 Form FDA 3674
Other-Guidance
New Marketing Applications (includes PMAs, HDEs, Supplements and 510(k)s expected to contain clinical data) Removed 0 0 0 Form FDA 3674
Other-Guidance
New Marketing Applications/Resubmissions (NDA/BLA) Removed 0 0 0 Form FDA 3674
Other-Guidance
New Marketing Applications/Resubmissions - CDER, CBER and CDRH Modified 582 437 0 Form FDA 3674
Other-Guidance
Original Applications - ODG Modified 1036 777 0 Form FDA 3674
Other-Guidance
Total burden requested under this ICR: 21427 7175 0  
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