Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
Breakthrough Therapy Designation Request Unchanged 113 7910 0 Other-Agency Guidance
Fast track designation request Unchanged 187 11220 0 Other-Agency Guidance
Premeeting packages Modified 142 14200 0 Other-Agency Guidance
Other-Agency Guidance
Priority Review Designation Request Unchanged 82 2400 0 Other-Agency Guidance
RMAT Designation Requests New 35 35 0 Other-Agency Guidance
Total burden requested under this ICR: 559 35765 0  
To view an IC, click on IC Title