Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
BE Supplements/Amendments New 989 742 0 Form FDA 3674
Other-Guidance
Clinical Amendments to Marketing Applications New 1 1 0 Form FDA 3674
Other-Guidance
Clinical Amendments to Marketing Applications Modified 932 699 0 Form FDA 3674
Other-Guidance
Clinical Protocol Amendments (IND) Modified 492 123 0 Form FDA 3674
Other-Guidance
Clinical Protocol Amendments (IND) Modified 14328 3582 0 Form FDA 3674
Other-Guidance
Efficacy Supplements/Resubmissions Modified 173 130 0 Form FDA 3674
Other-Guidance
Efficacy Supplements/Resubmissions (BLA Only) New 25 19 0 Other-Guidance
Form 3674
New Applications (IND) Modified 451 113 0 Form FDA 3674
Other-Guidance
New Applications (IND) Modified 1564 391 0 Form FDA 3674
Other-Guidance
New Marketing Applications (includes PMAs, HDEs, Supplements and 510(k)s expected to contain clinical data) New 530 398 0 Form FDA 3674
Other-Guidance
New Marketing Applications/Resubmissions (NDA/BLA) Modified 191 144 0 Form FDA 3674
Other-Guidance
New Marketing Applications/Resubmissions (NDA/BLA) Modified 35 26 0 Form FDA 3674
Other-Guidance
Original Applications New 1001 751 0 Form FDA 3674
Other-Guidance
Total burden requested under this ICR: 20712 7119 0  
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